News

DEA Guidance Regarding Information Pharmacists May Provide on CS II Prescriptions

Topics: Controlled substances and Dea

Recognizing that pharmacists are sometimes presented with prescriptions for Schedule II controlled substances that are missing information required by law, Drug Enforcement Administration provides guidance for pharmacists regarding allowed changes or additions to such prescriptions.

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Nominations for 2014 NABP Annual Awards Now Being Accepted

NABP invites you to nominate a colleague or board of pharmacy for a 2014 NABP award.

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FDA Issues Rule to Improve Manufacturer Notifications Regarding Potential Drug Shortages

Food and Drug Administration (FDA) issued an interim final rule that will require manufacturers that are the only producer of certain drug products to report to FDA all interruptions in manufacturing that could lead to drug shortages. This rule applies...

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Legislation to Require Valid Prescription for Non-CS Prescription Drugs Ordered Online Introduced to US Senate

Topics: Controlled substances

The Online Pharmacy Safety Act (S 2002), a bill developed to protect consumers from Internet drug outlets that distribute drugs without requiring a valid prescription, was introduced to the United States Senate on December 15, 2011. The legislation builds on...

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NABP PMP InterConnect Successfully Meets 2011 Development Timeline; More States to Go Live in Early 2012

Topics: Prescription monitoring program

Originally published in the January 2012 NABP Newsletter Successful implementation of the NABP PMP InterConnectSM continues, with eight additional states scheduled to make NABP InterConnect available to prescription monitoring program (PMP) users in early 2012, for a total of 11...

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CPE Monitor Provider Pilot Approaching Completion; Additional ACPE-Accredited CPE Providers to Transition to Service Soon

Topics: Continuing education

Originally published in the January 2012 NABP Newsletter The CPE Monitor™ provider pilot is nearing completion with great success. The Accreditation Council for Pharmacy Education (ACPE) has worked with NABP and 42 ACPE-accredited continuing pharmacy education (CPE) providers to test...

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NABP Legal Briefs: Boards Are Employers Too

By Dale J. Atkinson, JD Originally published in the January 2012 NABP Newsletter Sometimes lost in the regulatory issues discussed in the NABP Newsletter Legal Briefs is the fact that boards of pharmacy are employers, in addition to acting as...

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Regulators Review Reverse Distribution Process to Prevent Diversion, Environmental Hazards

Topics: Controlled substances

Originally published in the January 2012 NABP Newsletter. Regulators have renewed focus on the reverse distribution process in the context of a national prescription drug abuse epidemic, which creates a market for diverted drugs, and national concerns for the safety...

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Pharmacists Rated High for Honesty and Ethical Standards in Gallup's 2011 Poll

Pharmacists ranked number 2 in the 2011 Gallup Poll that asked consumers to rate 21 professions according to their honesty and ethical standards. Pharmacists were ranked as very high or high in this category by 73% of those surveyed, with...

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Ephedrine Products Seized By US Marshals

More than 4,000 pounds of raw material – Cissus quadrangularis and Cassia angustifolia extracts – containing ephedrine alkaloids were seized by United States Marshals at the request of the Food and Drug Administration (FDA). FDA reports that the materials contained...

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DEA Final Rule Places Carisoprodol in Schedule IV

Drug Enforcement Administration (DEA) issued a final rule, placing carisoprodol into Schedule IV of the Controlled Substances Act (CSA), effective January 11, 2012. The DEA notice (PDF) regarding the final rule includes a summary of the background and procedural history...

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Nevada Supreme Court Rules State's Pharmacists Have Duty to Warn in Cases of Known Patient-Specific Risks

Based upon a ruling issued by the Nevada Supreme Court, November 23, 2011, it is now common law in Nevada that if a pharmacist knows of a patient-specific risk with respect to a prescribed medication, the pharmacist has a duty...

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Governors Petition DEA to Reclassify Marijuana as Schedule II

Topics: Medical marijuana

A petition to reclassify marijuana as a Schedule II controlled substance with accepted medical use was filed with the United States Drug Enforcement Administration (DEA) by Washington Governor Chris Gregoire and Rhode Island Governor Lincoln Chafee. Gregoire stated in a...

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Counterfeit Phentermine HCI Tablets Found in United States

Topics: Counterfeit drugs

Actavis Elizabeth LLC is warning consumers and health care providers that counterfeit phentermine HCl Tablets (USP 37.5 mg) that contain fenfluramine, a dangerous ingredient, have been found in the US. The manufacturer explains in a press release that phentermine is...

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Law Enforcement in China Break Up Expansive Counterfeit Drug Network

Topics: Counterfeit drugs

Chinese law enforcement arrested 1,770 suspects and seized $315 million worth of counterfeit drugs and packaging in a police operation on November 17, 2011. The raid was part of a nationwide effort involving 16,000 police officers and breaking up “more...

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FDA Takes Actions Against Dietary Supplement Manufacturers Due to GMP Violations and Misbranding

Topics: Patient safety

FDA has taken actions against two manufacturers of dietary supplements due to violations of current Good Manufacturing Practice (cGMP) regulations and for misbranding their products. The agency filed a permanent injunction that stops a Pennsylvania dietary supplement producer from making...

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Senate Bill Aims to Deter Counterfeit Drug Traffickers

Topics: Counterfeit drugs

A bill aimed to prevent trafficking in counterfeit drugs was introduced by Senator Patrick Leahy (D-VT) to the United States Senate on November 17, 2011. The Counterfeit Drug Penalty Enhancement Act of 2011 responds to recommendations made by the US...

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Providers and Patients Should be Cautious When Ordering Vaccines Online, Study Concludes

Topics: Internet pharmacy and Patient safety

Web sites marketing certain biologic vaccines to providers and consumers were analyzed in a recent study that stressed patient safety dangers, particularly in the context of vaccine shortages. The study evaluated online sellers appearing in the top five Internet search...

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European Health Care Providers Collaborate on Plan to Reduce Counterfeit Drug Dangers

Topics: Counterfeit drugs

The World Health Professions Alliance (WHPA) Prague Call to Action (PDF), a plan developed to reduce the impact of counterfeit drugs on patients and the public in central Europe and beyond, was endorsed by participants of a recent WHPA-sponsored workshop...

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NICHD Encourages Pharmacists to Educate Patients on SIDS Risk Reduction

Topics: Patient counseling

The National Institute of Child Health and Human Development (NICHD) encourages pharmacists to educate parents and caregivers on Sudden Infant Death Syndrome (SIDS) risk reduction. NICHD provides a free, online educational opportunity that presents to pharmacists the latest SIDS research...

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Boards Report 846 Disciplinary Actions in Third Quarter

Topics: Disciplinary action

Originally published in the November-December 2011 NABP Newsletter Reporting trends continue to reflect efforts by boards of pharmacy to report disciplinary actions to the NABP Clearinghouse. During third quarter 2011, a total of 846 actions were reported to the NABP...

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NABP PMP InterConnect Steering Committee Finalizes Governance Structure and Policies

Topics: Prescription monitoring program

Originally published in the November-December 2011 NABP Newsletter The NABP PMP InterConnectSM Steering Committee met August 30-31, 2011, to finalize the governance structure of the committee and develop policies and procedures, as well as to review implementation progress and discuss...

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NABP Legal Briefs: School Gets In Your Facebook

By Dale J. Atkinson, JD Originally published in the November-December 2011 NABP Newsletter In recent times, the regulatory community has questioned more and more the role (or obligation) educational programs have in communicating ultimate criteria for licensure to its applicants...

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FDA to Release Guidance Document on Approval Pathway for Biosimilars

Originally published in the November-December 2011 NABP Newsletter Food and Drug Administration (FDA) continues the process of developing an approval pathway for biosimilars, the generic equivalent of biologic drug products. The agency plans to release a draft guidance for applicants...

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Board of Pharmacy Executive Officers Share Successes, Challenges at Interactive Forum

Originally published in the November-December 2011 NABP Newsletter Thirty-one executive officers gathered at the Interactive Executive Officer Forum, held September 21-22, 2011, to discuss with their colleagues the challenges their boards face on a daily basis. The second in a...

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Delaware Pharmacist to Face Federal Charges for Distributing Prescription Pain Pills to Drug Dealers

Topics: Diversion and Prescription drug abuse

A Delaware pharmacist will face charges related to the distribution of OxyContin® pills for sale to drug dealers, as reported by Delawareonline. The distribution scheme was uncovered by federal agents during an investigation in 2009 and the pharmacist, Bruce E....

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Over 300 People in Oklahoma Arrested for Illegal Purchase of PSE Products to Make Meth

Topics: Pseudoephedrine

Agents of the Oklahoma Bureau of Narcotics and Dangerous Drugs Control (OBN), along with local law enforcement officers, have initiated a sting operation targeting customers who purchase or attempt to purchase pseudoephedrine (PSE) products to produce methamphetamine. Beginning November 4,...

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More Physicians Using E-Prescribing

Topics: Electronic prescriptions

Surescripts, operator of the largest e-prescription network that connects prescribers’ e-prescribing software to pharmacies, reports that 94% of retail pharmacies are connected and receiving e-prescribing. Surescripts also indicates in a press release that 52% of office-based physicians across the country...

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FDA Video Encourages Consumers to Lock Up Medications

Topics: Patient safety

Food and Drug Administration (FDA) has released a new video encouraging consumers to securely lock up medications to prevent accidental ingestion by children and misuse by teens or others. FDA stresses that “every year thousands of children are hospitalized –...

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Pain Medication Overdose Fatalities Continue to Increase, CDC Reports

Topics: Patient safety and Prescriptions

More than 40 people die every day due to overdoses involving prescription pain medications, stresses a Centers for Disease Control and Prevention (CDC) Vital Signs report released in November 2011. The report indicates that the death rate from overdoses of...

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Another 188 Tons of Unneeded Medications Collected During Third National DEA Prescription Drug Take-Back Day

Topics: Medication collection program disposal and Prescriptions

Consumers disposed of more than 188 tons of unneeded, unwanted, or expired medications at the third National DEA Prescription Drug Take-Back Day coordinated by the Drug Enforcement Administration (DEA) on October 29, 2011. Law enforcement and community partners coordinated with...

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Third CDC Get Smart About Antibiotics Week

The third national Get Smart About Antibiotics Week will be observed November 14-20, 2011, and is coordinated by CDC. The week-long observance promotes awareness of the dangers of antibiotic resistance and the importance of appropriate antibiotic use. The campaign is...

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Emergency Department Visits Due to Carisoprodol Misuse Doubled in Five Years

Topics: Patient safety

The number of emergency department visits involving misuse of carisoprodol doubled from 15,830 visits in 2004, to 31,763 visits in 2009, according to the Drug Abuse Warning Network Report (PDF) published October 27, 2011. The report, published by the Center...

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Investigation of Counterfeit Drug Network in China Results in 114 Arrests

Topics: Counterfeit drugs

A four-month investigation by law enforcement in China resulted in the seizure of more than 65 million fake drugs and the arrest of 114 suspects. The criminal network producing and distributing the fake drugs extended over eight Chinese provinces, and...

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'Script Your Future' Provides Tools and Outreach to Encourage Medication Adherence

Topics: Patient safety and Patient counseling

US Surgeon General Regina Benjamin called upon pharmacists, physicians, nurses, and other health care providers to talk with their patients about the importance of taking medications as directed to help prevent serious health complications at the recent launch of the...

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NABP and APhA Partner to Develop Voluntary Accreditation for Community Pharmacies

NABP is partnering with the American Pharmacists Association (APhA) to develop a voluntary accreditation program for community pharmacies. The associations will work together to develop, test, and implement standards and the accreditation process, and the program is expected to launch...

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President Obama Issues Executive Order Aimed to Reduce Prescription Drug Shortages

Topics: Prescriptions

President Obama has issued an executive order that directs Food and Drug Administration (FDA) to take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines. Stressing that “shortages of pharmaceutical drugs...

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FDA Recommends Use of Sterile Needle and Syringe for Administration of Inactivated Influenza Vaccines

Topics: Vaccinations

FDA has released a communication recommending that health care providers use a sterile needle and syringe to administer inactivated influenza vaccines. The communication was released in response to questions regarding the use of jet injector devices to administer inactivated influenza...

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Partnership for Safe Medicines Honors NABP with Guardian Award for Efforts to Fight Counterfeit Medicines

Topics: Counterfeit drugs

The Partnership for Safe Medicines (PSM) presented NABP with the inaugural Guardian award, recognizing the Association’s efforts in raising awareness of and combating unlicensed online pharmacies. The award was presented at the PSM Interchange, October 27, 2011, an annual conference...

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Prescription Fraud Investigation Results in Federal Charges Against 17 People in California

A federal investigation resulted in charges against 17 people in California, including a doctor and several pharmacy owners, allegedly involved in a prescription harvesting scheme that attempted to defraud Medicare and Medi-Cal of $18 million. Allegedly, Manor Medical Imaging Clinic,...

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Training Video Provides Tips on Preventing Pharmacy Robbery

RxPATROL (Pattern Analysis Tracking Robberies and Other Losses) has released a training video discussing pharmacy robbery and how to prevent it. The video features a pharmacist and law enforcement liaison as they tour a pharmacy, evaluating security measures and discussing...

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Washington News: No. 1079 Board to Launch National Precursor Log Exchange - Tracking Sales of Meth Precursors

Topics: Pseudoephedrine

Originally published in the October 2011 Washington Board of Pharmacy Newsletter Washington has become one of 18 states to implement the National Precursor Log Exchange (NPLEx) electronic tracking system to stop the production of methamphetamine. The Washington State Board of...

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South Dakota News: Prescription Drug Monitoring Program Update

Topics: Prescription monitoring program

Originally published in the October 2011 South Dakota Board of Pharmacy Newsletter The Board of Pharmacy has selected Health Information Designs (HID) as the vendor for data collection, data storage, and data reporting for the South Dakota Prescription Drug Monitoring...

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North Carolina News: Electronic Tracking of Pseudoephedrine Sales

Topics: Pseudoephedrine

Originally published in the October 2011 North Carolina Board of Pharmacy Newsletter H12 (Session Law 2011-240) requires all “retailers” to submit required information to the National Precursor Log Exchange – or NPLEx (not to be confused with NAPLEX®) – an...

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Louisiana News: Prescription Monitoring Program

Originally published in the October 2011 Louisiana Board of Pharmacy Newsletter The Board knows that most pharmacies are diligent about reporting their dispensing transactions to the prescription monitoring program (PMP) database every week. PMP staff monitors that activity and sends...

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NABP Legal Briefs: Certifican't Can

Originally published in the October 2011 NABP Newsletter By Dale J. Atkinson, JD Boards of pharmacy rely upon NABP for expertise and uniformity in the development, implementation, administration, and maintenance of programs designed to assist such member boards in regulating...

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FPGEC Revises Policy on Exam Retakes and Score Validity

Topics: Fpgee and Fpgec

The NABP Executive Committee recently approved policy changes to the Foreign Pharmacy Graduate Examination Committee (FPGEC) Certification Program that limit the number of times a candidate may take the Foreign Pharmacy Graduate Equivalency Examination (FPGEE) to five and establishes a...

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DEA Clarifications On Certification Process for Audits of CS E-Prescribing Software

Topics: Electronic prescriptions

In a Federal Register notice (PDF), DEA emphasizes that third-party audits of software applications for Electronic Prescriptions for Controlled Substances (EPCS) must encompass all applicable requirements in DEA regulations, including security, and must address “processing integrity” as set forth in...

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DEA Announces Temporary Scheduling of Three Synthetic Cathinones and Proposed Scheduling of Ezogabine

Topics: Controlled substances

The administrator of the DEA has issued a final order to temporarily schedule three synthetic cathinones – 4-methyl-Nmethylcathinone (mephedrone), 3,4- methylenedioxy-N-methylcathinone (methylone), and 3,4- methylenedioxypyrovalerone (MDPV) – placing them into Schedule I of the Controlled Substances Act (CSA) effective as...

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Nearly 20 Products Marketed as Natural Supplements Contain Sibutramine, FDA Warns

Topics: Controlled substances

FDA has posted public warnings regarding 19 products, frequently marketed as natural supplements, and found to contain sibutramine, a controlled substance that was removed from the US market in October 2010 for safety reasons. These products pose a threat to...

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FDA Videos Warn Consumers About Health Fraud Scams

Topics: Patient safety

FDA has released two new videos aimed to educate consumers about health fraud scams such as products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses. FDA...

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Michigan and New Mexico PMPs Sign On to Participate in NABP PMP InterConnect

Topics: Prescription monitoring program

The Michigan prescription monitoring program (PMP), known as the Michigan Automated Prescription System, and the New Mexico PMP have entered into agreements with NABP to participate in the NABP PMP InterConnectSM. The NABP InterConnect facilitates the sharing of data between...

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MA Parents Believe Children Can Easily Obtain Prescription Pain Pills, Survey Shows

Topics: Prescription drug abuse

Over half of parents, about 56%, reported that their children have access to their prescription pain medications, in an online survey conducted by the Partnership at Drugfree.org. The study surveyed 305 Massachusetts parents with one or more children ages 12-25,...

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PSM Report Warns of Increased Counterfeit Drug Risk if US Imports Foreign Drugs

Topics: Counterfeit drugs

Approximately three million parcels of fraudulent medications – including fakes of arthritis, AIDS, and high cholesterol drug treatments – were seized in 2010 by United States Customs and Border Protection, according to a new report from the Partnership for Safe...

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Report Explores Drug Shortage Causes, Impact, and Proposed Solutions

A report on the growing shortage of life-saving cancer drugs, presents some possible reasons for shortages, the impact of the problem, and solutions being explored, and stresses that regulators and lawmakers have not identified the cause of the shortage. According...

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Bill for Redistribution of Prescription Drugs to be Introduced to Michigan Legislature

Topics: Medication collection program disposal

A bill that would allow collection and redistribution of prescription medications will be introduced to the Michigan Legislature in the next session, as reported by the Associated Press. The bill “would allow medical facilities to donate unused drugs for distribution...

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FDA Releases Guidance for Industry on Developing Appropriate Warning Labeling

Topics: Prescription label

Amended labeling requirements aimed to help ensure clear, useful, informative, and consistent warning labeling are described in a new FDA guidance document. The document, “Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription...

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AWARxE Launches 'Does a Drug Dealer Lurk in Your Medicine Cabinet' Ad Campaign

Topics: Counterfeit drugs

NABP Foundation Program Encourages Consumers to Get the Facts on Prescription Drug Abuse, Rogue Internet Drug Sites, and Counterfeit Drug Dangers AWARxETM, a consumer protection program provided by the National Association of Boards of Pharmacy® (NABP®) Foundation, has launched a...

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Third DEA National Prescription Drug Take-Back Day, October 29, 2011

Topics: Medication collection program disposal

The next Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day will take place Saturday, October 29, 2011 from 10 AM to 2 PM, providing consumers in every state with a safe means for the disposal of unwanted, unused prescription...

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Four Connecticut Technicians Charged with Prescription Drug Theft and Illegal Distribution

Topics: Diversion

Four former Connecticut pharmacy technicians were arrested on federal charges related to their alleged theft of prescription drugs from retail pharmacies where they worked, and the subsequent sale and distribution of the drugs. Specifically, Michael Hannon, Dorothy Grier, Kevin Winzer,...

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Idaho Grants Pharmacists Limited Prescriptive Authority, Amends Definition of 'Drug Outlet' to Expand Regulatory Authority

Originally published in the October 2011 NABP Newsletter In keeping with nationwide efforts to further integrate pharmacists into the provision of primary care, the Idaho legislature recently approved a number of pharmacy-related statute changes that took effect in July of...

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FDA Releases 'Use Medicines Wisely' Video

Topics: Patient safety

Food and Drug Administration (FDA) Office of Women’s Health has released a new public service announcement (PSA) video titled, “Use Medicines Wisely,” to help raise awareness about safe medication use. As stated in an FDA news release, “Millions of people...

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CMS Provides DMEPOS Suppliers Information on Round 2 of Competitive Bidding

Topics: Dmepos

Centers for Medicare and Medicaid Services (CMS) has released additional information for suppliers submitting bids in round 2 of the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) Competitive Bidding Program process. CMS reminds suppliers planning to submit bids to...

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FDA Efforts Help to Shut Down Nearly 600 Internet Drug Outlets During Operation Pangea IV

Topics: Counterfeit drugs and Internet pharmacy

Food and Drug Administration (FDA), along with regulatory agencies from 81 countries, participated in this year’s International Internet Week of Action (IIWA), a cooperative effort to curb online sales and distribution of counterfeit and illegal medical products. Dubbed Operation Pangea...

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Las Vegas Physician and Pharmacist Indicted in Oxycodone Distribution Scheme

Topics: Prescription drug abuse

Las Vegas physician Henri Wetselaar and his assistant David Litwin, along with pharmacist Jason C. Smith, have been indicted by a federal grand jury on charges that they conspired to unlawfully distribute large quantities of oxycodone in and around Las...

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FDA Action Prohibits Hill Companies from Introducing Adulterated Drugs Into Commerce

FDA has announced that Hill Dermaceuticals, Inc, and Hill Labs, Inc (collectively referred to as “Hill”) have been prohibited from introducing adulterated drugs into interstate commerce due to numerous deviations from current good manufacturing practice (cGMP) for drugs. The District...

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FDA Guidance Document Describes Enforcement Priorities for Unapproved New Drugs

Food and Drug Administration (FDA) has published a guidance document detailing the agency’s enforcement priorities for unapproved new drugs. Specifically, the guidance aims to clarify for FDA personnel and industry how FDA intends to exercise enforcement discretion regarding unapproved drugs...

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FDA Conducts Preliminary Review of Supply Chain Vulnerabilities Related to Diversion, Counterfeits, and Substandard Products

Topics: Counterfeit drugs

As part of FDA’s proactive approach to preventing diverted, counterfeit, and substandard products from entering the legitimate US drug supply chain, the agency has analyzed information from judicial diversion and counterfeiting cases to help prioritize the agency’s risk management activities....

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CDC Advises Influenza Vaccination for Everyone 6 Months and Older

Topics: Vaccinations

Centers for Disease Control and Prevention (CDC) advises that everyone 6 months of age and older should receive a yearly flu vaccine and the agency has updated flu vaccination information for consumers on the CDC Web site. The National Foundation...

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OTC Asthma Inhalers Containing CFCs Phased Out By Year End, Prescription Needed for Replacement Products

Topics: Over the counter

FDA reminds consumers using over-the-counter (OTC) asthma inhalers containing chlorofluorocarbons (CFCs) that the products will no longer be made or sold after December 31, 2011. Consumers should plan now to obtain a prescription for a replacement product, FDA advises. The...

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NABP Legal Briefs: Hey Mabel, Another Generic Label

Topics: Prescription label

Originally published in the September 2011 NABP Newsletter By Dale J. Atkinson, JD At times, federal law and state law conflict, creating a situation that may lead to difficulty, if not impossibility, for compliance. Relative to the research and development,...

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Senate Committee Hears Testimony Regarding Securing the US Drug Supply Chain

Securing the pharmaceutical supply chain from vulnerabilities related to the complex global supply chain was the focus of a United States Senate Committee on Health Education Labor and Pensions hearing held September 14, 2011. Deborah Autor, JD, deputy commissioner for...

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Multiple Lots of Oral Contraceptives Recalled by Qualitest Due to Packaging Error

Qualitest Pharmaceuticals has issued a voluntary, nationwide, retail-level recall of multiple lots of oral contraceptives because a packaging error may result in the daily regimen for these products being incorrect and could leave women without adequate contraception, and at risk...

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Regulatory Authority Over Compounding Pharmacies Resides with Boards of Pharmacy, Federal Judge Holds

Topics: Compounding

In the case of US v Franck's Lab, Inc, US District Court for the Middle District of Florida has ruled that FDA does not have jurisdictional authority over the compounding of medications by a licensed pharmacy as long as the...

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Federal Officers Seize 8,000 Counterfeit Pills at Cincinnati Shipping Facility

Topics: Counterfeit drugs

US Customs and Border Protection (CBP) officers seized 8,000 tablets of counterfeit tadalafil at a shipping facility in Cincinnati, OH. The shipment was labeled “harmless generic medicine” and had been shipped from India. CBP officers added the seized package “to...

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Emergency Department Visits for Medication Poisonings In Children Under 5 Increased, Study Finds

Topics: Patient safety

The number of emergency department visits due to medication poisoning for children under age 5 increased 30% from 2001 to 2008, according to a new study published in The Journal of Pediatrics. Researchers analyzed data for 2001-2008 provided by the...

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Virginia Deploys NABP PMP InterConnect

Topics: Prescription monitoring program

The Virginia prescription monitoring program (PMP) has gone live with the NABP PMP InterConnectTM, and pilot users now have the ability to request and share program data with PMPs in Ohio and Indiana. NABP’s PMP InterConnect facilitates the sharing of...

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First DEA-Approved System for Processing Controlled Substance e-Prescriptions in Use

Topics: Electronic prescriptions

Systems for electronic prescribing of controlled substances (EPCS) used at Supervalu pharmacies in Virginia and California are available for use after successfully meeting Drug Enforcement Administration (DEA) certification requirements. Supervalu pharmacies in those states are the first to accept e-prescriptions...

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Latest SAMHSA Data Shows Prescription Drug Abuse Rates Still High, Meth Use is Down

Topics: Prescription drug abuse

An estimated 7 million people used prescription drugs nonmedically in 2009 and 2010, second only to rates of marijuana use, according to the latest National Survey on Drug Use and Health (NSDUH). The NSDUH, a survey conducted annually by the...

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California Law Prohibits Sales of Dextromethorphan Products to Minors

A new law in California prohibits the sale of medications containing dextromethorphan without a prescription to persons under 18 years of age. The law effectively requires that retail staff request appropriate identification if a purchaser of a dextromethorphan product appears...

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New Hampshire Pharmacists' Authorization to Immunize Expanded

Pharmacists in New Hampshire are now authorized to administer pneumococcal and varicella zoster vaccines to individuals 18 years of age or older with the passage of Senate Bill 93. Effective as of August 26, 2011, the law also changed the...

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FDA Video Shows Consumers How to Use OTC Drug Labels

Topics: Over the counter

A new video from Food and Drug Administration (FDA) seeks to educate consumers on how to use the drug facts labels provided on over-the-counter (OTC) medications. The video introduces and explains the importance of each section of the OTC Drug...

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ISMP Survey Suggests Gray Market Distributors Take Advantage of Drug Shortages

In a survey of purchasing agents and pharmacists at 549 hospitals on gray market activities associated with drug shortages, 52% of respondents indicated that they have purchased pharmaceutical products from gray market vendors during the past two years, reports the...

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Florida Pharmacists Begin Submitting Data to State's PMP

Topics: Prescription monitoring program

On September 1, 2011, pharmacists began submitting data to the Florida Prescription Drug Monitoring Program (PMP), a program implemented to fight the epidemic of prescription drug abuse and diversion in the state. Florida’s law requires that pharmacists submit applicable controlled...

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Pill Mill Shut Down Results in the Indictment of 32 People in Florida

Twin brothers Christopher George and Jeffrey George face federal charges related to the operation, management, and financing of four alleged pain management clinics in Florida that illegally distributed approximately 20 million oxycodone pills, among other drug products. John V. Gillies,...

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FDA Alert: Infection Risk from Repackaged Avastin Intravitreal Injections

FDA alerts health care providers that repackaged intravitreal injections of Avastin® (bevacizumab) have caused a cluster of serious eye infections in the Miami, FL, area. Avastin is a solution for intravenous infusion that is approved for the treatment of various...

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FDA Provides Guidance for Industry on Tablet Scoring

Topics: Patient safety

Recognizing the need for consistent tablet scoring that allows a patient to adjust a drug dose, FDA has provided a draft guidance for industry outlining the guidelines, data, and criteria that will facilitate the evaluation and labeling of scored tablets....

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Seven in New Jersey Face Federal Charges of Illegal Oxcodone Distribution

New Jersey pharmacist Vincent Hsia and six other individuals face federal charges related to their alleged involvement in the illegal distribution of oxycodone. A 26-count superseding indictment was filed on August 29, 2011, against Hsia, the proprietor of Lincoln Pharmacy...

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USP and CDC Webinar Offered on Compounding TPN Preparations and the 2011 Investigation of Bacterial Outbreak

In April 2011, the Alabama Department of Public Health (ADPH) and Centers for Disease Control and Prevention (CDC) reported that a failure in a step of the sterilization process for compounded total parenteral nutrition (TPN) led to its contamination with...

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DEA Guidance Regarding Information Pharmacists May Provide on CS II Prescriptions

Topics: Controlled substances

Recognizing that pharmacists are sometimes presented with prescriptions for Schedule II controlled substances (CS) that are missing information required by law, Drug Enforcement Administration (DEA) provides guidance (PDF) for pharmacists regarding allowed changes or additions to such prescriptions. First, DEA...

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Google Agrees to Forfeiture, Continues Steps Taken to Protect US Consumers from Internet Drug Outlets

Topics: Internet pharmacy

The Department of Justice (DOJ) announced that Google Inc has agreed to forfeit $500 million for allowing online Canadian pharmacies to place advertisements through its AdWords program targeting consumers in the United States. The department notes further that, “from 2003...

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FDA Notice: High Doses of Celexa Can Cause Abnormal Heart Rhythms

FDA alerts health care providers that the antidepressant Celexa (citalopram hydrobromide; also marketed as generics) should no longer be used at doses greater than 40 mg per day. Data has demonstrated that doses greater than 40 mg per day can...

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FDA Strategic Plan Outlines Steps for Advancing Regulatory Science

FDA has released “Advancing Regulatory Science at FDA: A Strategic Plan,” a publication outlining the agency’s strategic plan for facilitating the development and evaluation of new treatments and innovative medical products, so that the products can be brought to market...

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Preparing for the FPGEE

Topics: Fpgee

Test Day Tips and Requirements Refer to the FPGEE Administration section of the FPGEC Application Bulletin for full information on test-day requirements. The tips that follow summarize some common concerns. Identification You are required to bring your Foreign Pharmacy Graduate Equivalency...

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ISMP Issues Safety Alert Regarding Insulin Preparation and Administration

Due to numerous reports of serious errors associated with the misadministration of insulin, the Institute for Safe Medication Practices (ISMP) has issued a medication safety alert explaining the common causes of these errors and presenting safe practice recommendations for avoiding...

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New PSM Report Alerts Parents to Growing Threat of Counterfeit Children's Medications

Topics: Counterfeit drugs

A new report from the Partnership for Safe Medicines (PSM) alerts parents to the growing threats of counterfeit medications – often distributed via Internet drug outlets – and argues that opening the United States drug supply chain to imported prescription...

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New Research Shows Search Engines are Manipulated to Lead Consumers to Internet Drug Outlets

Topics: Internet pharmacy

A recent report from researchers at Carnegie Mellon University provides new information showing growth in the number of Internet drug outlets and describes some of the technology used by the operators of such sites. For example, the researchers analyzed the...

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FDA Announces Updated Labeling Information for 32 Products

Topics: Prescription label

Food and Drug Administration (FDA) has provided information on safety labeling changes to boxed warning, contraindications, warnings, precautions, adverse reactions, or patient package insert/medication guide sections for 32 products. A table available on the FDA Web site lists the affected...

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Medication Disposal Programs Offered Across the Nation

Topics: Medication collection program disposal

As more attention is being focused on the alarming rates of prescription drug misuse and abuse, proper disposal of unused medications has been identified as one method of prevention. To aid consumers, chain and independent pharmacy locations have been implementing...

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Prescription Fraud and Drug Trafficking Charges Brought Against 53 Defendants in Philadelphia

Federal officials announced the indictment of 53 defendants facing multiple charges related to their involvement in a prescription fraud and drug trafficking scheme in Philadelphia, PA. The 498-count indictment charges the defendants – among them physician Norman Werther and pharmacist...

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Iowa Task Force to Make Recommendations for Reducing Prescription Drug Abuse Rates in the State

Topics: Prescription drug abuse

In Iowa a new Prescription Abuse Reduction Task Force convened on August 9, 2011, for the first of several meetings scheduled to address the rising rates of prescription drug abuse in the state. “The goal of the task force is...

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NABP to Participate in National Interstate Data Sharing Meeting

Topics: Prescription monitoring program

NABP, along with Ohio and Mississippi, two of the 10 prescription monitoring programs participating in the NABP PMP InterConnectTM, will be attending a meeting organized by the Bureau of Justice Assistance (BJA) on Thursday, August 18. PMP administrators and staff...

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Ohio Deploys NABP PMP InterConnect Statewide, Arizona Signs On to Participate

Topics: Prescription monitoring program

The Ohio Automated Rx Reporting System (OARRS) is the first prescription monitoring program (PMP) to exchange program data across state lines on a statewide basis using the NABP PMP InterConnectTM. Effective Tuesday, OARRS began allowing its pharmacist and prescriber users...

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Interstate PMP Data Sharing through NABP PMP InterConnect Is Now a Reality

Topics: Prescription monitoring program

Two PMPs Already Using National System for Tracking Drug Abuse & Diversion NABP is pleased to announce that the NABP PMP InterConnect™ is now fully operational, providing state prescription monitoring program (PMP) users with an advanced tool for reducing prescription...

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NCPDP White Paper Recommends Consistent Labeling for Prescription Acetaminophen Products to Promote Patient Safety

Topics: Over the counter, Patient safety, and Prescriptions

In the interest of patient safety, the National Council for Prescription Drug Programs (NCPDP) has published a white paper providing recommendations to industry intended to facilitate consistency in labels for both over-the-counter (OTC) and prescription products containing acetaminophen. The paper,...

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Federal Indictment Charges 26 Individuals in Large Scale Prescription Fraud Scheme

Topics: Diversion

A federal grand jury indicted 26 individuals, with allegations related to their involvement in a large scale prescription drug and health care fraud scheme associated with multiple pharmacies across Michigan. The 34-count indictment alleges that Babubhai “Bob” Patel, a Canton,...

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Pilot Programs Facilitate Successful International Regulatory Collaborative Efforts, FDA Reports

Food and Drug Administration (FDA) reports that two pilot programs involving prescription drug regulatory agencies of Europe and Australia have been successful in increasing international collaborations aimed to enhance drug quality and safety on a global basis. Two reports detail...

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Manufacturer Recalls Vasopressin Injection USP, Multiple Dose Vials

A nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the retail and hospital level has been initiated by American Regent, Inc, because some vials may not maintain potency throughout their shelf-life. Solutions that are below potency limits...

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Counterfeit Emergency Birth Control Medication May be in US Drug Supply Chain, FDA Warns

Topics: Counterfeit drugs

FDA warns consumers not to use the emergency birth control product labeled as Evital, as these products may be counterfeit versions of the “morning after pill” and may not be safe or effective in preventing pregnancy. FDA stresses that Evital...

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CMS Policy Change Requires Physicians to Bill Medicare for Medications in Certain Situations

Centers for Medicare & Medicaid Services (CMS) has issued Change Request (CR) 7397 (PDF), which clarifies policy with respect to restrictions on pharmacy billing for drugs provided “incident to” a physician service and rescinds and fully replaces CR 7109. Under...

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Interstate PMP Data Sharing through NABP PMP InterConnect Is Now a Reality

Topics: Prescription monitoring program

Two PMPs Already Using National System for Tracking Drug Abuse & Diversion The National Association of Boards of Pharmacy® (NABP®) is pleased to announce that the NABP PMP InterConnect™ is now fully operational, providing state prescription monitoring program (PMP) users...

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NABP Issues Rogue Online Drug Outlet Public Health Alert

Topics: Internet pharmacy

New Report Shows 85% of Fake Online Drug Outlets Don’t Require Valid Prescription, Fuel Prescription Drug Abuse NABP has issued a public health alert to warn Americans about the serious dangers associated with medicines purchased through fake online pharmacies. NABP’s...

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New Acetaminophen Dosing Instructions for OTC Products to Help Ensure Appropriate Use

Topics: Over the counter

To decrease the potential for accidental overdose, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. has announced that single-ingredient Extra Strength Tylenol® (acetaminophen) products sold in the US will include new dosing instructions beginning in fall 2011. The new dosing instructions...

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FDA Provides Updated Information for Safe Administration of Acetaminophen to Children

Topics: Patient safety

To help prevent acetaminophen overdose in children, Food and Drug Administration (FDA) has provided consumers with updated information on the safe use of the drug for treating pain and fever in infants and children. FDA stresses to consumers that “improper...

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FDA Safety Notices on Drug-Drug Interactions Involving Methylene Blue or Linezolid and Certain Psychiatric Medications

FDA has issued two safety communications regarding adverse drug reactions in patients taking certain psychiatric medications, and also given methylene blue or linezolid (Zyvox®). Specifically, FDA has received reports of serious central nervous system reactions in patients taking serotonergic psychiatric...

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USP Invites Comments on Good Storage and Shipping Practices Chapter

United States Pharmacopeial Convention (USP) invites public comments on a new revision of USP General Chapter <1079> Good Storage and Shipping Practices. This general information chapter provides guidance on the proper storage and transportation of drug products from manufacturer to...

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NABP Accepting Applications for Exam and Assessment Item Writers

NABP is seeking individuals to serve as item writers for the North American Pharmacist Licensure Examination® (NAPLEX®), the Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®), and the Pharmacy Curriculum Outcomes Assessment® (PCOA®). Pharmacists in all areas of practice, and faculty from...

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NABP Legal Briefs: FTC: Facinorous Teeth Case

Originally published in the August 2011 NABP Newsletter By Dale J. Atkinson, JD Generally, the Legal Briefs article is reserved for an analysis of a judicial opinion of binding or persuasive precedent in the regulatory community. Occasionally, cases are initiated...

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White House Implements Plan to Fight Abuse of Prescription Opioids and Other Medications

Topics: Prescription drug abuse

Originally published in the August 2011 NABP Newsletter Unintentional drug overdose is now the leading cause of injury death in 17 states, reports Centers for Disease Control and Prevention Director Thomas Frieden, MD, in a press release on the White...

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NABP Issues Rogue Online Pharmacy Public Health Alert

Topics: Buying medicine online and Internet pharmacy

New Report Shows 85% of Fake Online Drug Outlets Don’t Require Valid Prescription, Fuel Prescription Drug Abuse The National Association of Boards of Pharmacy® (NABP®) today issued a public health alert to warn Americans about the serious dangers associated with...

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2011-2012 Influenza Vaccines Approved by Food and Drug Administration

Topics: Vaccinations

Food and Drug Administration (FDA) announced that it has approved the 2011-2012 influenza vaccine formulation for all six manufacturers licensed to produce and distribute influenza vaccine for the United States. The vaccine formulation protects against the three virus strains that...

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Third DEA National Prescription Drug Take-Back Day in October

Topics: Medication collection program disposal and Prescriptions

The next Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day will take place Saturday, October 29, 2011, from 10 AM to 2 PM, and will be the third event coordinated by DEA to help consumers safely dispose of unused,...

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Medical Marijuana and the Montana Pharmacist

Topics: Medical marijuana

The following excerpt is from an article originally published in the July 2011 Montana Board of Pharmacy Newsletter (PDF). In Montana, medical marijuana is a hot issue. It was the most contentious issue put before the 2011 Montana Legislature, which...

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NABP Task Force Recommends CSA Revisions Aimed to Support Patient Care and Safety

Topics: Patient safety

To address public health and patient safety issues, such as escalating rates of prescription drug abuse and medication errors, federal legislators have adopted laws amending the Controlled Substances Act (CSA), such as the Secure and Responsible Drug Disposal Act of...

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Minnesota Board Reopens after State Government Shutdown Ends

On Wednesday, July 20, Minnesota Governor Mark Dayton signed the state budget appropriation bills into law, ending the budget impasse that caused the closure of the Minnesota Board of Pharmacy since July 1. The Board resumed work on July 21...

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Tamiflu with New Concentration In Distribution

Manufacturer Genentech, working with FDA, has made changes to the influenza drug Tamiflu® aimed to reduce chances of medication errors stemming from prescribing or dosing confusion. The concentration of Tamiflu has been changed from 12 mg/mL to 6 mg/mL, to...

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US Senator Supports Bills to Fight Prescription Drug Abuse and Related Crimes

Topics: Prescription drug abuse

Senator Chuck Schumer is pushing for the adoption of two bills to prevent prescription drug abuse and to penalize individuals convicted of related crimes. The Prescription Drug Abuse Prevention and Treatment Act of 2011 (S507), introduced to the United States...

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Michigan Officials Note Alarming Prescription Drug Abuse Trends in the State

Topics: Prescription drug abuse

Officials in Michigan agencies have stressed the alarming rates of overdose and addiction associated with prescription drug abuse in the state. According to the Detroit Free Press, in Michigan, of every 100,000 patient visits to the emergency room due to...

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FDA Issues Draft Guidance for Development of Personalized Medicine Diagnostics

FDA published a draft guidance to facilitate the development and review of companion diagnostics used to help health care providers determine appropriate drug therapies for individual patients. The guidance provides information on FDA policy for reviewing companion diagnostics and corresponding...

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ISMP Calls for Cheers Awards Nominees

The Institute for Safe Medication Practices (ISMP) is calling for nominees for the ISMP Cheers Awards. The Cheers Awards honor individuals, organizations, companies, and agencies that have set a superlative standard of excellence in the prevention of medication errors during...

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Minnesota Scores Now Available Online; Board Closed Due to Government Shutdown

To alleviate the concerns of candidates in Minnesota, the Minnesota Board of Pharmacy now allows candidates who have taken the NAPLEX or MPJE to view their scores on the NABP Web site. Below follows a message from Cody Wiberg, PharmD,...

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New York State Assembly Considers Prescription Monitoring Program Bill

Topics: Prescription monitoring program

New York Attorney General Eric Schneiderman introduced legislation requiring the establishment of a prescription monitoring program (PMP) in the state. As reported by New York’s ABC 50, the “Internet System for Tracking Over-Prescribing Act,” or “I-STOP,” calls for the development...

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Study Offers Recommendations for Improving E-Prescribing Systems to Prevent Errors

Topics: Electronic prescriptions

A recent study analyzed the rate of error in different electronic prescribing systems and offered recommendations on improving such systems to decrease errors. A clinician panel studied 3,850 e-prescriptions generated in three states over a four-week period in 2008. The...

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Iowa Drug Repository Program Serves Growing Number of Patients

Topics: Medication collection program disposal

The Iowa Prescription Drug Donation Repository Program, administered through the Iowa Department of Public Health, continues to grow, providing more prescription drug assistance to uninsured and underinsured Iowans. The Des Moines Register reports that the program has grown from serving...

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Illinois Man Guilty of Distributing Controlled Substances Via Internet Drug Outlets

Topics: Controlled substances

Steven Immergluck of Aurora, IL pleaded guilty to conspiracy to distribute and dispense controlled substances and to using the Internet to facilitate a drug crime. According to a Department of Justice press release, the government had evidence to prove that...

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PCOA Administration Continues to Demonstrate Students' Progression of Knowledge through Program Years

Originally published in the June-July 2011 NABP Newsletter After four annual administrations, the Pharmacy Curriculum Outcomes Assessment® (PCOA®) continues to display consistent data representing the progression of pharmacy students’ knowledge of pharmacy curriculum during the professional years. Measurement of students’...

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Global Threat of Counterfeit Drugs Gain Exposure; NABP Quarterly Progress Report Highlights Actions Taken

Topics: Counterfeit drugs

Originally published in the June-July 2011 NABP Newsletter Counterfeit drugs continue to threaten the public health and safety as thousands of rogue Internet drug outlets continue to operate unhindered. These counterfeit drugs harm patients with inaccurate dose levels, contaminated, or...

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NABP Clearinghouse Sees More Than 100% Increase in Disciplinary Actions Reported by Boards of Pharmacy During First Quarter

Originally published in the June-July 2011 NABP Newsletter Reporting trends continue to reflect consistent efforts by boards of pharmacy to report disciplinary actions to the NABP Clearinghouse. During first quarter 2011, a total of 1,584 actions were reported to the...

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NABP Government Affairs Department Supports Vermont Board's Efforts to Increase Operations Efficiency

Originally published in the June-July 2011 NABP Newsletter As part of an ongoing effort to support boards of pharmacy with customized services, the NABP Government Affairs Department recently completed an assessment of operations for the Vermont Board of Pharmacy. To...

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NABP Legal Briefs: 107th Annual Meeting Report of Counsel: Catch Me If You Can

Originally published in the June-July 2011 NABP Newsletter By Dale J. Atkinson, JD On behalf of its member boards of pharmacy, NABP develops, administers, scores, and maintains multiple examination programs for use in the licensure process. These examinations command significant...

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Task Force Recommends CSA Revisions Aimed to Support Patient Care and Safety

Originally published in the June-July 2011 NABP Newsletter To address public health and patient safety issues, such as escalating rates of prescription drug abuse and medication errors, federal legislators have adopted laws amending the Controlled Substances Act (CSA), such as...

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Washington Board Votes Against Rescheduling Medical Marijuana

Topics: Medical marijuana

The Washington State Board of Pharmacy voted unanimously to not consider rescheduling medical marijuana at a hearing held June 8, 2011. The Board hearing was held in response to petitions requesting that the Board reschedule medical marijuana out of Schedule...

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CASA Study Concludes Half of High School Students Use Addictive Substances

Topics: Prescription drug abuse

A new report from Columbia University’s National Center on Addiction and Substance Abuse (CASA) concludes that nearly 15% of all United States high school students have misused prescription controlled substance drugs. The report “Adolescent Substance Use: America’s #1 Public Health...

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FDA and Manufacturer Alert: Diabetes Care Products Stolen from Shipping Facility

A shipment of blood glucose monitoring products was stolen from a shipping carrier facility in Louisville, KY, on June 19, 2011, and the manufacturer, Abbott Diabetes Care, is working with the Food and Drug Administration (FDA) Office of Criminal Investigations...

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New York Dietary Supplement Manufacturer Prohibited from Distributing Products

Topics: Patient safety

FDA has announced that Howard Sousa, dba Artery Health Institute LLC, and DeSousa LLC, in New York, NY, is prohibited from distributing products that make claims in the labeling to cure, treat, mitigate, or prevent diseases, under a consent decree...

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FDA Strategy Aimed to Ensure Safety of Imported FDA-Regulated Drug Products

Food and Drug Administration (FDA) has announced new long-term strategies to help ensure the safety of imported FDA-regulated drug products, as more and more drug products are either manufactured overseas, or contain active ingredients produced overseas. The agency’s report "Pathway...

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NABP Participates in Congressional Briefing on Rogue Internet Drug Outlets

Topics: Internet pharmacy

NABP participated in a Congressional briefing coordinated by the Partnership for Safe Medicines (PSM) and Senator Chris Coons, on June 23, 2011, to discuss the problem of rogue Internet drug outlets. Topics included the risks of drug products distributed by...

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Manufacturer Recalls Two Lots of Risperdal (risperidone) and Risperidone Due to Possible TBA

Topics: Patient safety

A recall of two lots of Risperdal® (risperidone) 3 mg tablets and risperidone 2 mg tablets has been initiated by the manufacturer due to possible trace amounts of TBA (2,4,6 tribromoanisole). Ortho-McNeil-Janssen Pharmaceuticals notes that the recall was initiated due...

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Counterfeit Trafficker Sentenced to Over Seven Years Federal Prison

Shengyang Zhou was sentenced to 87 months in federal prison for trafficking and attempting to traffic in counterfeit goods, namely counterfeit versions of the pharmaceutical weight loss drug Alli®. Zhou was also ordered to pay over $500,000 in restitution to...

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Printed Drug Ads Study Concludes that Format Can Effect Consumer Understanding of Risks

Topics: Patient safety

Conclusions from three studies designed by experts in FDA’s Division of Drug, Marketing, Advertising and Communications in the Center for Drug Evaluation and Research, indicate that the way information is conveyed and displayed in printed drug advertising impacts consumers’ understanding...

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New Tamper Resistant Oxycodone Product Approved

FDA has approved OXECTATM Tablets CII, an oxycodone HC1 product that is designed to discourage common methods of tampering associated with opioid abuse and misuse. OXECTA is an immediate-release oxycodone HCl medicine for the management of acute and chronic moderate...

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PSM Calls on Internet Ad Networks to Adopt Stricter Policies for Pharmacy Advertisers

Topics: Internet pharmacy

The Partnership for Safe Medicines (PSM) sent letters to 10 of the top Internet advertising networks, calling upon them to adopt policies specifying that sponsored advertisements from Internet pharmacies will only be accepted if the pharmacy is VIPPS® (Verified Internet...

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FDA 'Bad Ad' Program Raises Awareness of Provider Role in Ensuring Truthful Prescription Drug Promotion

Topics: Prescriptions

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research has reported on the success of its "Bad Ad" outreach program, launched May 11, 2010, to educate health care providers about their role in ensuring that prescription drug...

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FDA Alert Regarding Errors Resulting from Confusion Between Risperidone and Ropinirole

Topics: Patient safety and Prescriptions

FDA is alerting health care providers and patients that a number of medication errors, in which patients were given risperidone (Risperdal®) instead of ropinirole (Requip®) and vice versa, have been reported. Some cases have resulted in patient hospitalization. FDA notes...

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FDA Sunscreen Labeling Requirements, Proposed Rule, and Consumer Information Released

Topics: Patient safety

FDA will require sunscreen manufacturers to include in labels accurate information as to whether the product does or does not help protect against skin cancer and early skin aging. Specifically, products that pass the FDA test for protection against both...

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FDA Takes Action Against OTC Product Manufacturer and Distributor Due to cGMP Violations

Topics: Patient safety

FDA has taken action against two entities and three individuals that prohibits them from manufacturing or distributing over-the-counter (OTC) drug products until they establish an acceptable quality assurance and quality control program. Specifically, FDA has announced that on June 13,...

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Transfer NAPLEX Score for Up to 90 Days After the Examination

Topics: Naplex

Recently, NABP updated its processes to allow candidates to transfer their NAPLEX scores to additional jurisdictions after they have taken the examination. Candidates may now transfer their NAPLEX score up to 90 days after sitting for the examination. To submit...

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Kansas to Participate in NABP PMP InterConnect

Topics: Prescription monitoring program

The Kansas prescription monitoring program (PMP) known as K-TRACS (Kansas Tracking and Reporting of Controlled Substances) has entered into an agreement with NABP to participate in the NABP PMP InterConnectTM, currently under development. The NABP InterConnect will facilitate the secure...

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Tracking PSE Sales and New Penalties Part of Tennessee Law to Fight Meth

Topics: Pseudoephedrine

In Tennessee, a new law aimed to combat the illegal manufacture of methamphetamine (meth) was approved by Governor Bill Haslam on June 6, 2011. As explained in a news release on the governor’s Web site, the law will require that...

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'Know Your Dose' Campaign Aims to Prevent Acetaminophen Overdose

Topics: Patient safety

The Acetaminophen Awareness Coalition, has launched KnowYourDose.org, a Web site aimed to educate consumers about the dangers of acetaminophen overdose and how to ensure that the correct, safe dosage is administered. 'Know Your Dose' stresses to patients the importance of...

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Two Indicted, and Three Pleaded Guilty to Charges Related to Pharmaceutical Trafficking

Rey Parra and Abimael Fuente of Florida were indicted on charges of conspiring to traffic in pharmaceutical drugs from a shipment stolen at a Georgia truck stop and driven to New Jersey, United States Attorney Paul J. Fishman announced. According...

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FDA Issues New Recommendation for High-Dose Simvastatin

FDA is alerting health care providers and patients, that the highest approved dose (80 mg) of the cholesterol-lowering medication simvastatin, has been associated with an elevated risk of muscle injury or myopathy. This warning applies to patients particularly during the...

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South Carolina to Participate in NABP PMP InterConnect

Topics: Prescription monitoring program

The South Carolina Prescription Monitoring Program (PMP), known as SCRIPTS (South Carolina Reporting & Identification Prescription Tracking System) has entered into an agreement with NABP to participate in the NABP PMP InterConnectTM, currently under development. The NABP InterConnect will facilitate...

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HHS Proposed Rule Would Allow Patients to Learn Who Has Accessed Their Health Records

United States Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) is developing a rule that would allow patients to request a report that lists anyone who has electronically accessed and viewed their protected health information. The...

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Medication Disposal Drop Box Program Pilot Launched in Fairfield County, CT

Topics: Medication collection program disposal

Police departments in four Fairfield County, CT towns are providing residents a secure, legal, and anonymous means for safely disposing of unused, unwanted, and expired medications. Beginning June 1, 2011, secure medication disposal drop boxes will be available at police...

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SimplyThick Product Linked to Cases of Infant NEC and Two Deaths

Topics: Patient safety

Food and Drug Administration (FDA) has issued a safety alert regarding SimplyThick, a thickening agent for management of swallowing disorders, and advises parents and caregivers not to use the product to feed premature infants as it may cause necrotizing enterocolitis...

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Three Additional Online Pharmacy Services Granted Approved e-Advertiser Status

NABP recently granted three additional online pharmacy services Approved e-Advertiser status. More information about the NABP e-Advertiser ApprovalCM Program and a full listing of online pharmacy services with Approved e-Advertiser status is available under Programs on the NABP Web site....

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Idaho News: Board Initiated 2011 Statute Changes

Originally published in the June 2011 Idaho Board of Pharmacy Newsletter Statute changes are effective on July 1, 2011, unless noted that they are enacted with an emergency clause. Full text of these changes can be viewed at the Idaho...

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Kentucky News: Legislation Update 2011

Originally published in the June 2011 Kentucky Board of Pharmacy Newsletter SB 40 was passed during the 2011 Legislative Session and signed into law by Governor Steve Beshear. This bill authorizes pharmacists to administer flu vaccines only to individuals nine...

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Tennessee News: Tramadol and Carisoprodol Now Classified Schedule IV

Originally published in the June 2011 Tennessee Board of Pharmacy Newsletter Effective April 7, 2011, tramadol, carisoprodol, and products containing tramadol or carisoprodol have been classified as Schedule IV controlled substances in the state of Tennessee pursuant to Tenn. Comp....

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Tennessee News: New Label Law Allows Legend Drug Indications for All Patients

Originally published in the June 2011 Tennessee Board of Pharmacy Newsletter BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE: SECTION 1. Tennessee Code Annotated, Section 53-10- 110(a), is amended by deleting the subsection in its entirety...

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Wyoming News: Tramadol and Carisoprodol to Become Schedule IV in Wyoming

Originally published in the June 2011 Wyoming State Board of Pharmacy Newsletter By Jonathan Beattie, PharmD Candidate On July 1, 2011, tramadol and carisoprodol will become Schedule IV controlled substances in Wyoming. Wyoming is the fifth state to make tramadol...

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Wyoming News: Wyoming Legislative Update

Originally published in the June 2011 Wyoming State Board of Pharmacy Newsletter The sixty-first legislature of the state of Wyoming concluded its General Session in March 2011. Three bills of interest to pharmacy were passed. Senate File 0059 sponsored by...

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NABP PMP InterConnect Development Complete

Topics: Prescription monitoring program

PMPs Continue to Sign on to Participate in National System for Tracking Drug Abuse and Diversion As part of its continuing efforts to protect public health by reducing abuse, misuse, and diversion of prescription medications, the National Association of Boards...

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State Senate Passes Louisiana Bill to Allow Pharmacists to Provide More Immunizations

A bill being considered by the Louisiana legislature would allow pharmacists to provide additional immunizations to patients 18 years of age and older. Current Louisiana law allows pharmacists to administer the influenza vaccination to patients seven years of age or...

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Rhode Island Bill Would Authorize Pharmacists to Vaccinate Children

Topics: Vaccinations

The Rhode Island Senate passed a bill that would authorize pharmacists to administer vaccinations to children between the ages of nine and 18. As stated in a Rhode Island news release, pharmacists in the state are currently allowed to immunize...

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AHRQ and NCPIE Partner to Provide Patients Medication Adherence Resources

Topics: Patient safety

The Agency for Healthcare Research and Quality (AHRQ) and the National Council on Patient Information and Education (NCPIE) have partnered to provide a new patient resource, “Your Medicine: Be Smart. Be Safe,” that promotes medication safety and adherence. The site...

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Iowa Board Developing Rules for Internet Pharmacy and VIPPS Requirement

Topics: Internet pharmacy

The Iowa Board of Pharmacy is developing rules to regulate Internet pharmacies pursuant to House File 381, which called for rules to define Internet pharmacies and Internet pharmacy sites. In addition, the rules establish requirements for site registration and site...

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Indiana to Participate in NABP PMP Interconnect

Topics: Prescription monitoring program

The Indiana Prescription Monitoring Program (PMP), known as INSPECT (Indiana Scheduled Prescription Electronic Collection and Tracking program), has entered into an agreement with NABP to participate in the NABP PMP InterconnectTM, currently under development. The NABP PMP Interconnect will facilitate...

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Study Analyzes ER Visits Related to Acetaminophen Overdose to Support Development of Prevention Strategies

Topics: Patient safety

Over 78,000 emergency department visits annually were associated with non-abuse-related overdoses of acetaminophen, according to a recent study. Using nationally representative data from 2006, investigators hoped to better understand acetaminophen-related ER visits to support the development of appropriate overdose prevention...

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Delaware Medical Marijuana Law Calls for Establishment of State-Regulated Compassion Centers

Topics: Medical marijuana

The Delaware Medical Marijuana Act, signed into law by Governor Jack Markell on May 13, 2011, allows registered qualified patients to possess up to 6 ounces of marijuana for medical use. The state’s Department of Health and Social Services will...

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Iowa Board Adopts New Rules for Pharmacy Closures

The Iowa Board of Pharmacy has adopted new rules regulating pharmacy closures, including a requirement that the pharmacy give the Board, Drug Enforcement Administration, and patients at least 14 days notice of the closure. The new rules also include the...

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FDA Warning Regarding Counterfeit ExtenZe

FDA warns consumers about a counterfeit version of ExtenZe, a dietary supplement marketed for male sexual enhancement. The potentially harmful counterfeit product looks similar to the actual product, but contains tadalafil, or a combination of tadalafil and sildenafil, both active...

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'Script Your Future' Provides Patients and Providers with Adherence Tools

Topics: Patient safety

The 'Script Your Future' campaign, launched May 11, 2011 by the National Consumers League (NCL), provides information, online tools, and other resources aimed to promote medication adherence among United States patients. The campaign Web site, www.ScriptYourFuture.org, provides patients with medication...

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NADDI Online Service Accepts Tips on Prescription Drug Crimes

Topics: Prescriptions

To assist law enforcement around the country, information about prescription drug-related crimes may be submitted to the online Rx Tip service launched by the National Association of Drug Diversion Investigators (NADDI). Tips submitted using the online form will be routed...

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2010-2011 Report of the Committee on Law Enforcement/Legislation Released

Topics: Committee and task force reports

The Committee on Law Enforcement/Legislation met March 8-9, 2011. Committee members reviewed their charge and accepted it as follows: Review and comment on existing legislation and rules for the practice of pharmacy, legal distribution of drugs, and related areas within...

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2010-2011 Report of the Task Force to Review and Recommend Revisions to the Controlled Substances Act Issued

Topics: Committee and task force reports

The Task Force to Review and Recommend Revisions to the Controlled Substances Act met January 25-26, 2011. Task force members reviewed their charge and accepted it as follows: Review selected provisions of the CSA and accompanying administrative regulations; Identify those...

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Task Force on Pharmacy Practice Technology Systems (Resolution 107-1-11)

Topics: Resolutions

Resolution No. 107-1-11 Title: Task Force on Pharmacy Practice Technology Systems Action: Pass Whereas, significant advances in technologies, including the use of automated pharmacy systems, remote dispensing systems, electronic prescribing systems, and other methodologies have rapidly emerged to support the...

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Information Exchange for Prescription Monitoring Programs (Resolution 107-2-11)

Topics: Prescription monitoring program and Resolutions

Resolution No. 107-2-11 Title: Information Exchange for Prescription Monitoring Programs Action: Pass Whereas, the development and implementation of prescription monitoring programs (PMP) provide a valuable resource for state boards of pharmacy, state boards of medicine, pharmacists, prescribers, and law enforcement...

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Control and Accountability of Prescription Medications (Resolution 107-3-11)

Topics: Resolutions

Resolution No. 107-3-11 Title: Control and Accountability of Prescription Medications Action: Pass Whereas, state boards of pharmacy are aware that prescription medications, including controlled substances, that are diverted from licensed pharmacies contribute to drug abuse, including abuse by children, adolescents,...

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Pharmacists and Pharmacy Care (Resolution 107-4-11)

Topics: Resolutions

Resolution No. 107-4-11 Title: Pharmacists and Pharmacy Care Action: Pass Whereas, population demographics are leading the United States health care delivery system toward an inadequate supply of physicians and other practitioners that provide primary health care to the burgeoning population...

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Recognition Resolution (Resolution 107-5-11)

Topics: Resolutions

Resolution No. 107-5-11 Title: Recognition Resolution Whereas, the individuals listed here have made significant contributions to NABP, the protection of the public health, and the profession of pharmacy: Thomas Dudley (OK) Thomas Foster (KY) Francis H. Hicks (ID) Joseph Hodge...

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NABP 2011-2012 Executive Committee Inaugurated at 107th Annual Meeting in San Antonio, TX

Delegates to the National Association of Boards of Pharmacy® (NABP®) 107th Annual Meeting, held May 21-24, 2011, in San Antonio, TX, elected individuals to fill the president-elect, treasurer, and open member positions on the Association’s 2011-2012 Executive Committee. The newly...

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NABP Honors Leaders at the Forefront of Public Health Protection at Association's 107th Annual Meeting

The National Association of Boards of Pharmacy® (NABP®) honored leaders in the protection of public health at the Association’s 107th Annual Meeting, held May 21-24, 2011, in San Antonio, TX. Each year, the Association presents awards to individuals who have...

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Delegates Approve Five Resolutions at the NABP 107th Annual Meeting

Topics: Resolutions

Delegates from the member boards of pharmacy adopted five resolutions during the National Association of Boards of Pharmacy® (NABP®) 107th Annual Meeting, held May 21-24, 2011, in San Antonio, TX. The resolutions addressed the following: Establishing a task force to...

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Malcolm J. Broussard, RPh, Begins Term as NABP President During the Association's 107th Annual Meeting

Malcolm J. Broussard, RPh, began his term as president of the National Association of Boards of Pharmacy® (NABP® ) during the Final Business Session of the Association’s 107th Annual Meeting, May 21-24, 2011, in San Antonio, TX. During his presidency,...

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Michael A. Burleson, RPh, Elected NABP President-elect at Association's 107th Annual Meeting

Michael A. Burleson, RPh, was elected to serve as the 2011-2012 president-elect of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 107th Annual Meeting, May 21-24, 2011, in San Antonio, TX. Prior to the election, Mr Burleson...

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Karen M. Ryle, MS, RPh, Elected NABP Treasurer at Association's 107th Annual Meeting

Karen M. Ryle, MS, RPh, was elected to serve as the 2011-2012 treasurer of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 107th Annual Meeting, May 21-24, 2011, in San Antonio, TX. Ms Ryle served for four...

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NABP Reelects Hal Wand, MBA, RPh, to Serve as Member of NABP Executive Committee at Association's 107th Annual Meeting

Hal Wand, MBA, RPh, was reelected to serve a second three-year member term, representing District 8, on the Executive Committee of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 107th Annual Meeting, May 21-24, 2011, in San...

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William J. Cover, RPh, Elected to Serve as Member of NABP Executive Committee at Association's 107th Annual Meeting

William J. Cover, RPh, was elected to serve a three-year member term, representing District 4, on the Executive Committee of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 107th Annual Meeting, May 21-24, 2011, in San Antonio,...

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NABP Reelects Mark T. Conradi, RPh, JD, to Serve as Member of NABP Executive Committee at Association's 107th Annual Meeting

Mark T. Conradi, RPh, JD, was reelected to serve a three-year member term, representing District 3, on the Executive Committee of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 107th Annual Meeting, May 21-24, 2011, in San...

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NABP Executive Committee Names 2011 Honorary President

Each year the National Association of Boards of Pharmacy® (NABP®) Executive Committee selects an individual to serve as its honorary president for the coming year. NABP is pleased to announce that Kim A. Caldwell, RPh, has been awarded this honor...

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William T. Winsley, MS, RPh, Assumes Chair of NABP 2011-2012 Executive Committee, Receives President's Award

William T. Winsley, MS, RPh, immediate past president of the National Association of Boards of Pharmacy® (NABP®), assumed the office of chairperson of the Association’s 2011-2012 Executive Committee during the Final Business Session of the NABP 107th Annual Meeting, held...

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2010-2011 Report of the Committee on Constitution and Bylaws Issued

Topics: Committee and task force reports

The 2010-2011 Committee on Constitution and Bylaws met via teleconference on April 12, 2011. Review of the Committee Charge The committee reviewed its charge as stated in the NABP Constitution and Bylaws. No additions or changes were proposed. Therefore, the...

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Secure Use of SSNs by Private Entities, Including NABP

As pharmacists and pharmacy technicians create their NABP e-Profiles to obtain their e-Profile ID for use in the CPE Monitor service, some have asked for clarification regarding the use of Social Security numbers (SSNs) in the profile information. Although some...

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West Virginia Signs On to Participate in NABP PMP Interconnect

Topics: Prescription monitoring program

The West Virginia Controlled Substances Monitoring Program has entered into an agreement with NABP to participate in the NABP PMP InterconnectTM, currently under development. The NABP PMP Interconnect will facilitate the secure transfer of PMP data across state lines and...

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Law Enforcement Collects 188 Tons of Unwanted Medications for Safe Disposal at DEA's Second Take-Back Event

Topics: Medication collection program disposal

Collecting 188 tons of unwanted medications at over 5,300 sites across the country, the Drug Enforcement Administration’s (DEA’s) second National Prescription Drug Take-Back Day on April 30, 2011, was a success. The event provided consumers a means to safely dispose...

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Ohio Physician Convicted for Illegally Prescribing and Dispensing Pain Pills

Topics: Controlled substances

Convicted by a US District Court jury of illegally prescribing and dispensing millions of pain pills outside the scope of a legitimate medical practice, Dr Paul H. Volkman faces at least 20 years in prison. At the conclusion of a...

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Ohio Pill Mill Legislation in the State's Senate

Topics: Patient safety and Prescription drug abuse

Ohio legislation aimed to fight illegally operating pain clinics is currently being considered by the state’s senate. As explained in the May 2011 Ohio State Board of Pharmacy Newsletter, the bill (HB 93) includes the following provisions: “First of all,...

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Federal Bill Aims to Fight Rogue Internet Sites Selling Counterfeit Goods

Topics: Counterfeit drugs and Internet pharmacy

Legislation aimed to fight rogue Web sites dedicated to the sale of infringing or counterfeit goods, including rogue Internet drug outlets, has been introduced to the US Senate. The “Preventing Real Online Threats to Economic Creativity and Theft of Intellectual...

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Use of e-Prescribing Continues to Grow

Topics: Electronic prescriptions

Since federal support was offered in 2008, 234,000 prescribers are using electronic prescribing, up 216% from 74,000, according to the latest "National Progress Report on E-Prescribing and Interoperable Healthcare," published by Surescripts, operator of the largest e-prescription network that connects...

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Pharm Spam Proliferates; Spam Attachments Disseminating Destructive Software On the Rise

Spam e-mail messages promoting pharmacy or pharmaceutical-related ads, or pharm spam, remained the most common type of spam, according to the April 2011 “Internet Threats Trend Report” (PDF) released by Commtouch, an Internet security service provider. Pharm spam accounted for...

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Oregon News: No. 487: Synthetic Cannabis and 'Bath Salts'

Originally published in the May 2011 Oregon State Board of Pharmacy Newsletter At its April 6, 2011 meeting, the Board adopted permanent rules listing synthetic cannabinoids and substituted cathinone type drugs commonly sold as bath salts or pond cleaner in...

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Oregon News: No. 485: Oregon's Prescription Drug Monitoring Program

Topics: Prescription monitoring program

Originally published in the May 2011 Oregon State Board of Pharmacy Newsletter By Todd Beran, PDMP Program Coordinator The Oregon Prescription Drug Monitoring Program (PDMP) is a new program intended to help health care providers give patients better care. Practitioners...

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Ohio News: Corresponding Responsibility Is Needed More Than Ever

Originally published in the May 2011 Ohio State Board of Pharmacy Newsletter In last year’s May Newsletter, the Board mentioned that it is having a tremendous problem in Ohio with so-called pain clinics that are doing nothing but providing large...

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Ohio News: 4729-5-24 Transfer (Copy) Rule Revised Again

Originally published in the May 2011 Ohio State Board of Pharmacy Newsletter On January 1, 2011, the Board changed its transfer rule to limit the number of transfers on every prescription to one transfer during the life of the prescription....

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Missouri News: Missouri Pharmacy Practice Guide

Originally published in the May 2011 Missouri Board of Pharmacy Newsletter The Missouri Board of Pharmacy is pleased to announce the release of the Missouri Pharmacy Practice Guide (Practice Guide). The Practice Guide is designed to increase licensee compliance by...

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Alabama News: Rule 680-X-2-.16 Practical Training Programs Standards

Originally published in the May 2011 Alabama State Board of Pharmacy Newsletter Effective April 4, 2011, the Alabama State Board of Pharmacy Rule 680-X-2-.16 was amended in part as follows: Four hundred traditional hours of the minimum total requirement may...

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FDA Takes Action Against Fraudulent OTC Products

Topics: Over the counter

Food and Drug Administration (FDA), in partnership with the Federal Trade Commission, has taken action against over-the-counter (OTC) products marketed as treatments, cures, and for prevention of sexually transmitted diseases (STDs). The agencies have sent letters to companies making such...

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Arkansas to Implement Prescription Drug Monitoring Program

Topics: Prescription monitoring program

Arkansas has adopted a law to require the development of a prescription drug monitoring program (PDMP) to be developed by the Arkansas State Board of Health. Senate Bill 345 was approved by Governor Mike Beebe on March 17, 2011. According...

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Manufacturer Recalls Coumadin Tablets

Bristol-Myers Squibb has initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin® (warfarin) 5-mg tablets due to the possible presence of high potency tablets. The recall was initiated as a precautionary measure because one tablet in a...

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Single Concentration OTC Pediatric Pain Relievers in Distribution Soon

Topics: Over the counter

To help prevent acetaminophen overdose in infants and children, drug manufacturers will begin distributing a single concentration OTC pain reliever for pediatric use. Current formulations in different concentrations for infants and for older children have caused some confusion among parents...

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FDA Releases Final Guidance for OTC Dosage Delivery Devices

Topics: Over the counter

To address concerns about the risk of accidental overdoses with OTC medications, especially in children, FDA has released a final draft guidance for industry regarding the manufacture of dosage delivery devices. The document “Guidance for Industry Dosage Delivery Devices for...

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Ohio Board Revised Transfer Rule to Previous Language

Topics: Prescription transfer

Originally published in the May 2011 Ohio State Board of Pharmacy Newsletter On January 1, 2011, the Ohio State Board of Pharmacy changed its transfer rule (4729-5-24) to limit the number of transfers on every prescription to one transfer during...

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Deadlines for the September 2011 FPGEE

Topics: Fpgee

Register for the FPGEE with NABP September 8, 2011 is the last day to register for the September 27 FPGEE. Schedule your Exam with Pearson VUE The last day to schedule the September 27 FPGEE with Pearson VUE is September 15. Cancellation Candidates...

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FPGEE Score Reports Released May 9

Score reports from the April 2011 FPGEE will be available Monday, May 9 at 12 PM central time. Candidates may enter their EE number and date of birth to access their score reports through the secure log in. Visit the...

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Mississippi to Participate in NABP PMP Interconnect

Topics: Prescription monitoring program

The Mississippi Prescription Monitoring Program (PMP) has entered into an agreement with NABP to participate in the NABP PMP InterconnectTM, currently under development. The NABP PMP Interconnect will facilitate the secure transfer of PMP data across state lines and on...

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DEA Prescription Drug Take-Back Days Part of White House Plan to Fight Abuse

Topics: Medication collection program disposal

Over 5,300 medication take-back sites across the nation participated in the Drug Enforcement Administration’s (DEA’s) second National Prescription Drug Take-Back Day, Saturday, April 30, 2011. DEA coordinated drug take-back sites with local public health and law enforcement officials, offering convenient...

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Mississippi Board of Pharmacy to Regulate PBMs Under Amended Pharmacy Practice Act

Amendments to the Mississippi Pharmacy Practice Act establish that pharmacy benefit managers (PBMs) doing business in the state will be regulated by the Mississippi Board of Pharmacy effective July 1, 2011. Senate Bill 2445, amending the act, was signed into...

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Montana Medical Marijuana Bill Will Require Stricter Regulations

Topics: Medical marijuana

After much debate and several revisions, Montana legislators approved a bill (SB 423) that would revise the state’s medical marijuana law, implementing restrictions aimed to reduce the number of registered medical marijuana users. Governor Brian Schweitzer announced that he will...

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Nebraska Medication Collection and Disposal Law Adopted

Topics: Medication collection program disposal

A new law in Nebraska will allow pharmacies to accept expired, unwanted medications – except for controlled substances – for disposal beginning in September 2011. As reported by the Omaha World-Herald, pharmacies may choose to participate in the program and...

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FDA to Regulate e-Cigarettes As a Tobacco Product

Food and Drug Administration (FDA) recently issued a statement regarding the agency’s regulation of e-cigarettes in light of a recent court decision that concluded the products may be regulated as a tobacco product. As explained in the statement, the United...

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Best Practices for Reducing Cargo Thefts Topic of FDA/DIA Meeting

FDA and Drug Information Association (DIA) will host a meeting to discuss current best practices to ensure progress in reducing the number of cargo thefts by enhancing storage and in-transit security practices and providing a prompt and effective response when...

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National, International Stakeholders Develop New Strategies for Fighting Counterfeit Drugs

Topics: Counterfeit drugs

Originally published in the May 2011 NABP Newsletter “It is shocking to realize that, in some parts of the world, somewhere between 30 and 50 percent of drugs to treat serious diseases are actually counterfeit,” said Food and Drug Administration...

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States, FDA Pressing Forward with Pedigree, Track and Trace Rules and Regulations

Topics: Pedigrees

Originally published in the May 2011 NABP Newsletter One method of helping ensure the integrity of the US drug supply chain is through the use of drug pedigrees, verifiable written or electronic documents that track each move in a drug’s...

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Boards of Pharmacy, State Legislators, and Law Enforcement Continue to Tackle Methamphetamine Problem

Topics: Pseudoephedrine

Originally published in the May 2011 NABP Newsletter On February 23, 2011, Sheriff Joe Guy of McMinn County, TN, released a community memorandum requesting retailers in his jurisdiction to stop selling pseudoephedrine (PSE) products for 100 days – his plea...

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NABP Legal Briefs: I.N.S.P.E.C.T. . . . Find Out What It Means To Me

Originally published in the May 2011 NABP Newsletter By Dale J. Atkinson, JD Providing members of the boards of pharmacy, along with administrative staff, inspectors, and attorneys with certain immunity protections is essential to the efficient and undeterred operations of...

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NAPLEX/MPJE: Change of Jurisdiction Requests

Topics: Mpje and Naplex

On March 28, 2011, NABP launched a new online registration system for NAPLEX and MPJE. Due to differences in the new and the old registration systems, change of primary jurisdiction requests are not available through the online application for candidates...

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NABP Granted Judgment on Exam Score Invalidation Claim

The National Association of Boards of Pharmacy® (NABP®) motion for summary judgment was granted by the United States District Court for the Eastern District of Michigan on April 13, 2011, dismissing all claims that were filed against the Association and...

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NABP Announces Winners of APhA Drawing; CPE Monitor Service Draws Enthusiasm from Attendees

Topics: Continuing education

Attendees who stopped by the NABP booth at the American Pharmacists Association (APhA) Annual Meeting and Exposition, shared their enthusiasm for the recently launched NABP CPE Monitor service, a collaborative effort between NABP and the Accreditation Council for Pharmacy Education...

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FDA Publishes Draft Guidance for Industry on Safety Labeling Changes

Topics: Prescription label

FDA has published a draft guidance for industry, “Safety Labeling Changes – Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act,” (PDF) that provides information on the implementation of safety label changes, as well as FDA procedures...

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Washington Bans 'Bath Salt' Chemicals Through Extended Rule on Illegal Synthetic Cannabinoids

Topics: Controlled substances

The Washington State Board of Pharmacy filed a second emergency rule, WSR 11-09-044 (PDF), to extend the state’s ban on synthetic cannabinoid chemicals and include chemicals used in "bath salts." The rule, adopted on April 15, 2011, effectively keeps illegal...

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Two Lots of Topomax Recalled Due to Suspected Presence of TBA

Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, has initiated a voluntarily recall of two lots of Topomax® (topiramate) 100 mg tablets due to four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of 2,4,6 tribromoanisole...

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New FDA Drug Info Rounds Training Video

FDA Drug Info Rounds, a series of online training videos, provides important and timely drug information to practicing clinical and community pharmacists so they can help patients make better medication decisions. In the latest Drug Info Rounds video, pharmacists discuss...

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Rogue Sites Still Fueling Prescription Drug Abuse and Counterfeit Drug Trade, NABP Reports

Topics: Counterfeit drugs and Prescription drug abuse

Rogue Internet drug outlets continue to place consumers at risk by selling counterfeit drugs and by indiscriminately distributing prescription drugs, including controlled substances – thus, fueling misuse and addiction – as stressed in the NABP “Internet Drug Outlet Identification Program...

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April 2011 FPGEE: Questions or Concerns?

Topics: Fpgee

NABP recognizes that some candidates experienced challenges during the April 14, 2011 FPGEE. Please direct your questions or concerns regarding the April 2011 FPGEE administration to Pearson VUE via e-mail to FPGEECustomerService@pearson.com.  ...

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Washington State News: Board Reports 2011 Legislative Updates

Excerpted from the April 2011 Washington State Board of Pharmacy Newsletter The following bills regarding pharmacy technicians, crimes against pharmacies, and a medicine stewardship program are being considered by the Washington State Legislature. Additional bills in process are listed in...

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Oklahoma News: Technician Rules Committee

Topics: Technicians

Originally published in the April 2011 Oklahoma State Board of Pharmacy Newsletter The Board is planning to convene a Technician Rules Committee for the purpose of reviewing the current technician regulations and rules for both hospitals and community pharmacies. It...

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North Carolina News: Item 2221 - Safe Dispensing of U500 Insulin from the Community Pharmacy

Originally published in the April 2011 North Carolina Board of Pharmacy Newsletter Editor’s note: Thanks to Caron Misita, PharmD, BCPS, CDE, CPP, of the UNC Hospitals Highgate Specialty Center Diabetes and Endocrinology practice for this update Concentrated human insulin (Humulin...

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Nevada News: Better Communication With Your Patients

Originally published in the April 2011 Nevada State Board of Pharmacy Newsletter As you all are aware, in Nevada patient counseling by a pharmacist is mandatory for all new prescriptions, and that counseling must be documented by the counseling pharmacist....

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Alaska News: Prescription Drug Monitoring Program Update

Topics: Prescription monitoring program

Originally published in the April 2011 Alaska Board of Pharmacy Newsletter The current emphasis of the prescription drug monitoring program (PDMP) is the creation, initial orientation, and implementation of the PDMP Advisory Board. The Advisory Board is planned to include...

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Connecticut Signs MOU to Participate in NABP PMP Interconnect; Louisiana Makes Plans to Participate

Topics: Prescription monitoring program

The Connecticut Prescription Monitoring Program (PMP) has entered into an agreement with NABP to participate in PMP InterconnectTM, currently under development. PMP Interconnect will facilitate the secure transfer of PMP data across state lines and on a national scale, enhancing...

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DEA Drug Take-Back Day Approaching, Pharmacist Volunteers Needed at Collection Sites

Topics: Medication collection program disposal

Pharmacists may wish to support the Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day, to take place Saturday, April 30, 2011, by volunteering to help staff a medication collection site in their area. Collection sites will be open from...

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GA Bill to Restrict Sale of PSE to Pharmacies Awaits Governor's Signature

Topics: Pseudoephedrine

Georgia House of Representatives passed a bill that would restrict sales of pseudoephedrine (PSE) products to pharmacies, thus making it illegal for the medication to be sold by any retail establishment without a pharmacy. As reported by Georgia’s WSBTV, the...

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ISMP Calls for Action In Response to Infections Caused By Contaminated TPN; NABP Helps Educate Boards

Topics: Compounding

In response to the infections of 19 Alabama patients by contaminated total parenteral nutrition (TPN), the Institute for Safe Medication Practices (ISMP) has called upon Food and Drug Administration (FDA) to take several actions, including collaborating with boards of pharmacy...

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Florida House Considers Legislation to Fight Pill Mills

Topics: Controlled substances and Prescription monitoring program

In Florida, legislation aimed to fight unscrupulous pain clinics, or “pill mills,” is being considered by the state House of Representatives. After revisions, including the removal of a provision that would have repealed the state’s prescription drug monitoring program law,...

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New Jersey to Adopt Drug Price Registry Rules

Topics: Prescriptions

Originally Published in the April 2011 New Jersey State Board of Pharmacy Newsletter To implement the provisions of the New Jersey Prescription Drug Price Registry Act N.J.S.A. 45:14-81, which was signed into law on August 21, 2006, and became effective...

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Conscience Clause Controversy on Back Burner, but Still Simmering

Originally published in the April 2011 NABP Newsletter While public controversy over “conscience clauses” for health care providers, particularly pharmacists, has been muted in recent years, especially when compared to the furor that took place around 2005 and 2006, the...

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School of Pharmacy Study Finds Value in PCOA as Integral Component of Student and Curricular Assessment

Originally published in the April 2011 NABP Newsletter Serving as a comprehensive assessment tool, the Pharmacy Curriculum Outcomes Assessment® (PCOA®) was recently cited in one school of pharmacy’s study as a valuable assessment tool. Conducted by the Palm Beach Atlantic...

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NABP Legal Briefs: If It Walks Like a Florida Nurse and Quacks Like a Massachusetts Physician, It Must Be a Massachusetts Nurse

Originally published in the April 2011 NABP Newsletter By Dale J. Atkinson, JD With technological advancements and the ability of licensed professionals to practice their chosen vocations in several jurisdictions, sometimes without physical presence, practitioners will be more likely to...

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Customizable Inspection and Compliance Assistance Services Now Available for Boards of Pharmacy

Originally published in the April 2011 NABP Newsletter With state resources dwindling, NABP continues to evaluate ways to provide further assistance to the boards of pharmacy through new programs and services. As one of its newer endeavors, NABP is pleased...

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Paving Approval Pathway for Biosimilars Presents Unique Challenges for FDA

Originally published in the April 2011 NABP Newsletter With several patents on biologics scheduled to expire in the coming years, the need to establish an approval pathway that will ensure the safety and efficacy of follow-on biologic products is becoming...

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New Jersey to Implement PMP

Topics: Prescription monitoring program

The state of New Jersey has contracted a company to develop and implement its prescription monitoring program (PMP) system. A law requiring a PMP in the state was adopted in 2008 and the state received a federal grant of $350,000...

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New Ruling Upholds IL Pharmacies Right to Refuse, Overturns Law

Topics: Emergency contraception

An Illinois rule requiring pharmacies to dispense emergency contraception was overturned on April 5, 2011, when a Sangamon County Circuit Judge ruled in favor of the two pharmacy owners who brought a lawsuit against the state. According to The State...

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FDA Warning Regarding Benzocaine Use and Rare, But Serious Condition

Food and Drug Administration (FDA) has issued a warning to consumers and health care providers regarding the use of benzocaine and its association with a rare, but serious condition, methemoglobinemia. Methemoglobinemia results in the amount of oxygen carried through the...

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New FDA Search Tool Provides Consumers with Easier Access to Information About Recalls

Topics: Patient safety

A new recall information section on the FDA Web site allows consumers to locate information about recalls of food, drugs, and other products more easily than with the prior format. This new section organizes recall information by category – food,...

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FDA Advises Pharmacists & Patients to Follow Pradaxa Storage and Handling Instructions

Food and Drug Administration (FDA) has issued a safety alert regarding special handling instructions for Pradaxa® due to concerns that the handling requirements are not commonly known. FDA advises that Pradaxa, an anticoagulant medication known as a direct thrombin inhibitor,...

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FDA Provides Information on Medication Guides Draft Guidance

To answer questions regarding the recently published draft “Guidance for Industry: Medication Guides – Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)” (PDF) , a questions and answers page has been added to the FDA Web site....

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Safe Practice Guidelines for PN Compounding Available from ASPEN

Topics: Compounding

In response to the deaths of nine patients in Alabama hospitals who were infected with contaminated parenteral nutrition, the American Society for Parenteral and Enteral Nutrition (ASPEN) issued a statement reminding practitioners of the availability of its complimentary publications providing...

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Additional Online Pharmacy Service Granted Approved e-Advertiser Status

NABP recently granted one additional online pharmacy service Approved e-Advertiser status. More information about the NABP e-Advertiser ApprovalCM Program and a full listing of online pharmacy services with Approved e-Advertiser status is available under Programs on the NABP Web site....

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New Vet-VIPPS Accreditation

NABP accredited one additional Internet pharmacy that sells prescription pet medications through its Veterinary-Verified Internet Pharmacy Practice SitesCM (Vet-VIPPSCM) program: Kennel Vaccine Vet Supply Co, Inc www.kvsupply.com A detailed description of the Vet-VIPPS program and a full listing of accredited...

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USP to Update Quality Standards for Widely Used Medications

Topics: Over the counter and Prescriptions

United States Pharmacopeial Convention (USP) will partner with Food and Drug Administration (FDA) and the Consumer Healthcare Products Association to update quality standards for widely used medications and ingredients. So that test procedures will be revised as needed to reflect...

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New PSE Law in Arkansas Requires Pharmacists to Verify Medical Necessity of the Drug

Topics: Pseudoephedrine

A new law in Arkansas will require pharmacists to verify the legitimate medical need of individuals purchasing products containing pseudoephedrine, the key ingredient needed for illegal methamphetamine production. Senate Bill 437 was passed in the legislature and was signed into...

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Citalopram and Finasteride Recalled Due to Possible Mislabeling

Topics: Patient safety

Certain lots of citalopram and finasteride tablets have been voluntarily recalled by Greenstone LLC, a wholly owned subsidiary of Pfizer Inc, to the patient level due to the possibility that incorrect labels have been placed on the bottles by a...

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MA Pharmacists May Obtain DEA Registration If Acting Under a CDTM

Drug Enforcement Administration (DEA) has determined that, in accordance with Massachusetts law (Chapter 528), certain pharmacists acting under a signed Collaborative Drug Therapy Management (CDTM) agreement may be issued a mid-level practitioner DEA registration in Schedules II-V. The policy applies...

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Soladek May Contain Toxic Levels of Vitamins A and D, FDA Warns

Topics: Patient safety

FDA warns consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma, SA, of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D. In fact, tested samples of Soladek contained levels...

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Five Additional VAWD Accreditations

The facilities listed below were accredited through the NABP Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 450 as of March 28, 2011. A full listing of VAWD facilities is available under Programs on the...

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NAPLEX/MPJE Application 'Date of Graduation' Reminder

Topics: Mpje and Naplex

The Date of Graduation field on the NAPLEX/MPJE application refers to the date on which your degree was or will be conferred, and is not necessarily the day of the graduation ceremony. Please do not enter an estimated date. If...

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New NAPLEX/MPJE Application Launched

On March 28, 2011, NABP launched a new and improved application for online registration, which allows candidates to perform more registration tasks and view status information. As such, candidates who registered for the NAPLEX or MPJE before March 23, 2011,...

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Primetime News Program Educates Viewers on the Growing Threat of Counterfeit Drugs

Topics: Counterfeit drugs and Buying medicine online

Government officials and other security experts shared information on the growing threat of counterfeit pharmaceuticals in a CBS 60 Minutes segment that aired March 13, 2011. Margaret A. Hamburg, MD, commissioner of Food and Drugs, discussed the regulation challenges involved...

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FDA Advises US Consumers Regarding Potassium Iodide and Warns About Unapproved Products

Topics: Patient safety

Food and Drug Administration (FDA) has issued warnings regarding potassium iodide (KI) – a drug used to prevent effects of radiation exposure – and fakes of the drug, as the post-earthquake crisis continues to unfold in Japan. The section, “Radiation...

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Georgia Board Requires Pharmacy Technicians to Register

Topics: Technicians

The Georgia State Board of Pharmacy has adopted a rule (480-15-02) requiring pharmacy technicians to register with the Board of Pharmacy, in accordance with Georgia law (O.C.G.A. § 26-4-28). Pharmacy technicians in Georgia are now required to apply for registration...

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Bill to Increase Penalties on Pill Mills Introduced to US House

A bill (HR 1065) that would implement provisions to fight prescription drug abuse, with a particular focus on fighting unscrupulous pain clinics, has been introduced in the US House. The “Pill Mill Crackdown Act of 2011” was introduced by US...

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National Poison Prevention Week Raises Awareness About Drug Poisonings

Topics: Patient safety

Over 30 patient safety and stakeholder organizations have coordinated to support National Poison Prevention Week, taking place March 20-26, 2011, and aimed to alert citizens about the problem of unintentional poisonings, including poisonings resulting from prescription and over-the-counter drug misuse....

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Kansas News: Drug Disposal

Topics: Medication collection program disposal

Originally Published in the March 2011 Kansas State Board of Pharmacy Newsletter Drug Enforcement Administration (DEA) reports that increasing prevalence of prescription drug abuse, especially among teens, has become an issue of public concern in recent years. The 2009 Substance...

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NABP Unveils Relaunch of AWARERx.org

Topics: Buying medicine online and Prescription drug abuse

Web Site for AWARxE Consumer Protection Program Enhanced to Provide Important, Timely Information on Prescription Drug Abuse The National Association of Boards of Pharmacy® (NABP®) today announced the relaunch of its AWARxE™ Web site to provide consumers seeking information on...

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Three States Sign on to Participate in NABP's Interconnected Prescription Monitoring System

Topics: Prescription monitoring program

Developing System to Provide Nationwide Platform for Tracking Drug Diversion The National Association of Boards of Pharmacy® (NABP®) is pleased to announce that the prescription monitoring programs (PMPs) of North Dakota, Ohio, and Virginia have entered into agreements to participate...

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New and Improved NAPLEX/MPJE Application to be Launched

On March 28, 2011 NABP will launch an improved application for the North American Pharmacist Licensure Examination® (NAPLEX®) and Multistate Pharmacy Jurisprudence Examination® (MPJE®). In order to migrate to the new system, registrations for the NAPLEX, NAPLEX score transfer, and...

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CPE Monitor Service Launched

Topics: Continuing education

The CPE Monitor service, a continuing pharmacy education (CPE) electronic tracking system has launched. Developed by NABP and the Accreditation Council for Pharmacy Education (ACPE), this new service will provide participating state boards of pharmacy with a streamlined process to...

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FDA Action Prevents Manufacturing in Certain McNeil Facilities until GMP Requirements Met

Food and Drug Administration (FDA) has taken action against McNeil-PPC in response to the company’s failure to comply with good manufacturing practice (GMP) requirements. As reported in a news release, the agency filed a consent decree of permanent injunction against...

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Federal Bill Would Implement New Penalties for Charges Related to Drug Theft

Topics: Diversion

A bill that would increase possible penalties in cases of pharmaceutical theft has been introduced in the United States Senate. According to one of the bill’s sponsors, Senator Sherrod Brown (D-OH), the bill would increase possible sentences for pharmacy theft...

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FDA Grant Will Support Medication Adherence Campaign

FDA has announced that it will grant funds to the National Consumers League (NCL) to support a program that aims to improve medication adherence in the US. According to a Federal Register notice, the funds, administered by the FDA Center...

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Alaska Conscience Clause Bill Introduced to State's Senate

Topics: Conscience clause

A conscience clause bill (Senate Bill 14) has been introduced in the Alaska legislature and is currently being considered in the state’s senate. The bill would provide “for the protection and reasonable accommodation of a health care provider's expression of...

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NABP to Exhibit CPE Monitor Program at APhA Annual Meeting

Topics: Continuing education

Show Attendees Have a Chance to Win an Apple iPad The National Association of Boards of Pharmacy® (NABP®) is pleased to showcase the recently launched CPE Monitor program during the American Pharmacists Association (APhA) Annual Meeting and Exposition, to be...

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North Dakota to Participate in NABP PMP Interconnect

Topics: Prescription monitoring program

The North Dakota Prescription Drug Monitoring Program has entered an agreement with NABP to participate in the PMP Interconnect™ currently under development. PMP Interconnect will facilitate the secure transfer of prescription monitoring program (PMP) data across state lines and on...

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New AWARERx.org Resources on Prescription Drug Abuse and Medication Safety

Topics: Prescription drug abuse

The AWARxE™ Web site has been updated with inviting, easy-to-read, and timely content to more effectively reach consumers seeking information on prescription drug abuse and medication safety. As the primary communication vehicle of the AWARxE consumer protection program, AWARERx.org aims...

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Second DEA National Prescription Drug Take-Back Day, April 30, 2011

Topics: Medication collection program disposal and Prescriptions

The next DEA National Prescription Drug Take-Back Day will take place Saturday, April 30, 2011, providing patients a means for safe disposal of unwanted, unused prescription medications – including controlled substances – at authorized locations across the country. The event...

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DEA Emergency Scheduling of Synthetic Cannabinoids

On March 1, 2011, DEA implemented the emergency scheduling of five synthetic chemicals (JWH-018, JWH-073, JWH-200, CP-47,497, and cannabicyclohexanol) used in products that are marketed as “legal” alternatives to marijuana, packaged alone, or laced on plant material. As reported in...

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FDA Releases Draft Guidance for Industry Regarding Medication Guides

Food and Drug Administration (FDA) has released a draft guidance that addresses two topics pertaining to medication guides for drug and biological products – the agency’s enforcement discretion regarding the distribution of medication guides to health care providers and REMS...

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FDA Takes Action Against Unapproved Prescription Cough, Cold, and Allergy Products

Topics: Patient safety

FDA took action against companies that manufacture, distribute, or market certain unapproved and misbranded prescription oral cough, cold, and allergy products, as announced in a Federal Register notice (PDF) on March 3, 2011. The products are marketed without approved applications,...

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First PMPs Sign On to Participate in NABP PMP Interconnect

Topics: Prescription monitoring program

Enhancing their ability to fight prescription drug abuse, prescription monitoring programs (PMPs) in the states of Ohio and Virginia have entered agreements with NABP to participate in the PMP InterconnectTM currently under development. Building on the progress already made by...

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Georgia and Montana Legislatures Consider Bills to Establish PMPs

Topics: Prescription monitoring program

Senate Bill 36 to establish a PMP in Georgia, passed in the state’s Senate on February 23, 2011, and has been introduced to the Georgia House. Goergia’s Times-Herald reports that if the bill passes and becomes law, the implementation of...

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Identification of Counterfeit Products Prompts Manufacturer to Recall Two Lots Extenze Supplements

Topics: Counterfeit drugs

Biotab Nutraceuticals, Inc has voluntarily recalled two lots of ExtenzeTM nutritional supplement tablets, as Food and Drug Administration (FDA) has identified counterfeit versions of the product that bear the same lot numbers and may pose serious health risks. Specifically, some...

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Spam E-Mail Campaign Uses Google Branding to Promote Rogue Internet Drug Outlet

Topics: Internet pharmacy

A spam e-mail campaign promoting a rogue Internet drug outlet and misappropriating Google branding has been tracked by Symantec’s MessageLabs Intelligence. The MessageLabs blog describes how the scam works and provides images of the messages used in the scam. The...

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North Dakota Law Regarding Pharmacy Operator Requirements Remains

The North Dakota House voted 68 to 26 against House Bill 1434 that would have eliminated the state’s requirement that pharmacies be majority-owned by pharmacists licensed in the state as reported in The Dickinson Press. Currently, North Dakota code 43-15-35...

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Two Additional Online Pharmacy Services Granted Approved e-Advertiser Status

Topics: Internet pharmacy

NABP recently granted two additional online pharmacy services Approved e-Advertiser status. More information about the NABP e-Advertiser ApprovalCM Program and a full listing of online pharmacy services with Approved e-Advertiser status is available under Programs on the NABP Web site....

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CMS DMEPOS Competitive Bidding Program Now in Effect; Round 2 to Include 91 Metropolitan Statistical Areas

Topics: Dmepos

Originally published in the March 2011 NABP Newsletter With the contracts from the first round of the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program now in effect, the Centers for Medicare & Medicaid Services (CMS) has...

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Requests for License Transfer Continue to Climb Following High National Demand for Pharmacists

The number of license transfer requests submitted though the NABP Electronic Licensure Transfer Program® (ELTP®) climbed modestly from 2009 to 2010, with a total of 13,614 requests in 2010. This number represents a 3.6% increase, or 473 requests more than...

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NABP Launches Web-Based Interface to Assist Boards of Pharmacy in Reporting Facility Issues to HIPDB

Originally published in the March 2011 NABP Newsletter State boards of pharmacy now have the capability to report disciplinary actions taken against pharmacies and other health care facilities through a convenient Web-based interface developed by NABP. This online tool assists...

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Accreditation: An Essential Distinction in the Evolving Realm of Pharmacy

Originally published in the March 2011 NABP Newsletter With its first accreditation program developed more than a decade ago, NABP continues to advocate accreditation as a symbol of excellence in health care and as a means for providing additional support...

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New AWARERX.ORG Content to Educate Consumers on Prescription Drug Abuse and Medication Safety

Topics: Prescription drug abuse

Originally published in the March 2011 NABP Newsletter The AWARxE™ Web site has been updated with inviting, easy-to-read, and timely content to more effectively reach consumers seeking information on prescription drug abuse and medication safety. The site will relaunch in...

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NABP Legal Briefs: Judicial Branch, Executive Branch, Olive Branch

By Dale J. Atkinson, JD Originally published in the March 2011 NABP Newsletter The issue of expunging or sealing an administrative record, specifically an administrative disciplinary action, has been a subject of inquiry of late by multiple regulatory boards. For...

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PMP Interconnect Pilot to Launch

Topics: Prescription monitoring program

System will Enable Data Sharing Across State Lines Originally published in the March 2011 NABP Newsletter NABP has begun work with state prescription monitoring program (PMP) administrators to develop PMP InterconnectTM, with a pilot launch scheduled for spring 2011, and...

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DC Bill To Allow Pharmacists to Provide Birth Control Pills Introduced

District of Columbia council member, David A. Catania, introduced a bill that would allow women to obtain birth control pills directly from a pharmacist, rather than requiring a physician’s visit and prescription for these medications. As reported in the Washington...

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Stakeholders Share Information About Fighting Internet Drug Outlets at Senate Committee Hearing

Topics: Internet pharmacy

Stakeholders representing varied consumer organizations had the opportunity to present testimony to the Senate Committee on the Judiciary about the problem of counterfeit goods sold via the Internet, including information about efforts to fight rogue Internet drug outlets on February...

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FDA Requests Unapproved Drugs to be Seized from Manufacturer by US Marshals

Topics: Prescriptions

As part of FDA’s Unapproved Drugs Initiative, US Marshals seized all lots of Auralgan® Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections, from Integrated Commercialization Solutions Inc (ICS) in Brooks, KY on February...

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Injectable Terbutaline Should Not Be Used to Treat Pregnant Women, FDA Warns

Topics: Patient safety

FDA warns health care providers and patients that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for...

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One Lot Jantoven Warfarin Sodium Tablets Recalled by Manufacturer

FDA is notifying health care providers that Upsher-Smith Laboratories has recalled one lot of Jantoven® Warfarin Sodium, USP, 3 mg Tablets, an anticoagulant, after a single bottle labeled as Jantoven Warfarin Sodium, USP, 3 mg Tablets was found to contain...

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NABP 107th Annual Meeting Attendees to Unite in San Antonio During Important Business Sessions, Timely CPE Programs, and Unique Networking Events

San Antonio, a city that blends history and culture, surrounds attendees with the perfect backdrop for the National Association of Boards of Pharmacy® (NABP®) 107th Annual Meeting, “Boards of Pharmacy and NABP – Bridging to Unity and Strength,” which will...

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Montana Bill to Repeal State's Medical Marijuana Law Passed House Vote

Topics: Medical marijuana

A bill to repeal the Montana medical marijuana law passed in the Montana House of Representatives by a vote of 63 to 37 on February 10, 2011. Some proponents of the repeal law say that the use of medical marijuana...

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Federal Investigation Leads to Indictment in Rogue Internet Drug Site Extortion Scam

Topics: Internet pharmacy and Patient safety

An indictment names 11 defendants, all citizens of the Dominican Republic, charged with crimes related to extorting money from United States citizens who had purchased drugs from rogue Internet sites. As reported in a Department of Justice news release, “the...

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Defendants Pled Guilty to Counterfeiting Charges

Topics: Counterfeit drugs

Shengyang Zhou and Qingming Hu pled guilty to charges of trafficking and distributing counterfeit versions of diet products, at court hearings during the last week of January 2011. Zhou and Hu were indicted by a federal grand jury in Denver...

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South Carolina Immunization Protocol Signed

Topics: Vaccinations

Originally Published in the February 2011 South Carolina Department of Labor, Licensing, and Regulation –Board of Pharmacy Newsletter Act No. 224, enacted by the South Carolina General Assembly, authorizes pharmacists to administer the influenza vaccine to individuals 18 years and...

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Additional VAWD Accreditations

The facilities listed below were accredited through the NABP Verified-Accredited Wholesale DistributorsCM (VAWDCM) program, bringing the total number of accredited facilities to nearly 450 as of February 11, 2011. A full listing of VAWD facilities is available under Programs on...

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ACPE International Services Program to Offer Pharmacy Education Guidance

Topics: Education

To better assist international stakeholders who seek guidance related to quality assurance and advancement of pharmacy education, the Accreditation Council for Pharmacy Education (ACPE) has established an International Services Program. As stated in a press release (PDF), “Over the past...

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USP Seeks Comments on Prescription Container Labeling Standards

Topics: Prescription label

United States Pharmacopeial Convention (USP) encourages pharmacists and other health care providers to submit comments on proposed General Chapter <17> (PDF) on prescription container labeling published January 3, 2011. The chapter is based on recommendations from the Health Literacy and...

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Oregon Board of Pharmacy Implements New Fingerprint Requirements

Effective February 1, 2011, the Oregon State Board of Pharmacy will require all new applicants (pharmacists, interns, pharmacy technicians, and certified pharmacy technicians) to submit a fingerprint card for a Federal Bureau of Investigation National Background Check. This procedure implements...

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South Carolina Requires Electronic Tracking of PSE-Product Sales

Topics: Pseudoephedrine

All pharmacies and retailers in the state of South Carolina that sell over-the-counter cold and allergy medications containing ephedrine, pseudoephedrine, and/or phenylpropanolamine products (PSE) are required to participate in a statewide, real-time electronic PSE monitoring program for the purpose of...

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Three New VIPPS Accreditations

NABP has accredited three additional Internet pharmacies through its VIPPS® (Verified Internet Pharmacy Practice SitesCM) program: Humana Pharmacy, Inc dba RightSource www.rightsourcerx.com ESI Mail Pharmacy Service, Inc dba Express Scripts www.express-scripts.com Care Services, Inc dba Diabetic Services, Inc dba Diabetic...

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NABP Legal Briefs: Canadian DisConnection

Originally published in the February 2011 NABP Newsletter By Dale J. Atkinson, JD Previous newsletter articles and presentations have addressed the unlicensed practice of pharmacy and the complex legal issues over whether boards of pharmacy have the “jurisdiction” or authority...

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New and Improved NAPLEX/MPJE Application Coming Soon

Originally published in the February 2011 NABP Newsletter In March, NABP will be launching a new and improved application process for the North American Pharmacist Licensure Examination® (NAPLEX®) and the Multistate Pharmacy Jurisprudence Examination® (MPJE®). The online application is being...

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NABP Presents at DEA Meeting on Prescription Drug Disposal Regulations

Topics: Medication collection program disposal

Stakeholders, including NABP, presented at the Drug Enforcement Administration (DEA) public meeting, January 19-20, 2011, to discuss the development of regulations to implement the Secure and Responsible Drug Disposal Act of 2010. NABP President William T. Winsley, MS, RPh, shared...

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New Clearinghouse Reporting Tool to Further Assist State Boards of Pharmacy

Topics: Disciplinary action

As of February 1, 2011, state boards of pharmacy can utilize a new NABP Clearinghouse reporting tool to report disciplinary actions on health care entities and transmit data to the federal databanks, assisting boards in maintaining compliance with National Practitioner...

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PTCB Reports Record Number of Pharmacy Technician Certification Candidates

Topics: Pharmacy technicians

The Pharmacy Technician Certification Board (PTCB) reports that over 400,000 pharmacy technicians nationwide have earned the PTCB Certified Pharmacy Technician credential since 1995, with more than 55,000 candidates having taken the Pharmacy Technician Certification Exam in 2010 alone. PTCB notes...

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Federal Agencies to Assist Maine Law Enforcement in Combating Prescription Drug Abuse

Topics: Prescription drug abuse

In response to reports that Maine has the highest proportion of residents being treated for pain pill addiction and a fivefold increase in pharmacy robberies from 2009 to 2010, federal agencies will join the state’s law enforcement in efforts to...

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Two New Vet-VIPPS Accreditations

NABP accredited two additional Internet pharmacies that sell prescription pet medications through its Veterinary-Verified Internet Pharmacy Practice SitesCM (Vet-VIPPSCM) program: National Pet Pharmacy www.nationalpetpharmacy.com Pet Meds n More, Inc www.petmedsnmore.com A detailed description of the Vet-VIPPS program and a full...

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Five Additional Online Pharmacy Services Granted Approved e-Advertiser Status

NABP recently granted five additional online pharmacy services Approved e-Advertiser status. More information about the NABP e-Advertiser ApprovalCM Program and a full listing of online pharmacy services with Approved e-Advertiser status is available under Programs on the NABP Web site....

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NABP Report Highlights Progress in Protecting Public Health from Rogue Internet Drug Outlets

Topics: Buying medicine online and Internet pharmacy

The list of Internet drug outlets ranked as Not Recommended by NABP grew 37% to 7,134 over the course of 2010, as reported in the Association’s January 2011 progress report for regulators. These Web sites, 96% of the total number...

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FDA Seeks Information on Stolen GlaxoSmithKline Consumer Health Products

Topics: Diversion and Patient safety

Food and Drug Administration (FDA), Office of Criminal Investigations (OCI) seeks information on the theft of GlaxoSmithKline (GSK) consumer health products stolen on January 9, 2011, while being transported from a GSK manufacturing facility in St Louis, MO, to a...

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Medication Error Reporting: CQI Programs Offer Avenue to Vital Follow-Up

Topics: Continuous quality improvement

Originally published in the January 2011 NABP Newsletter Patient safety advocates have long emphasized the importance of documenting medication errors as a crucial tool in preventing future adverse medical events. Even before the Institute of Medicine’s landmark 1999 report, “To...

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FDA Reminder About Emergency Compounding of Tamiflu for Oral Suspension

Topics: Compounding

The FDA has added Tamiflu® for Oral Suspension 12 mg/ml 25 ml (National Drug Code 00004-0810-95) to its current list of drug shortages, and reminds health care providers about instructions for emergency compounding of Tamiflu 75 mg capsules. While FDA...

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Additional VAWD Accreditations

The facilities listed below were accredited through the NABP Verified-Accredited Wholesale DistributorsCM (VAWDCM) program, bringing the total number of accredited facilities to 446 as of January 21, 2011. A full listing of VAWD facilities is available under Programs on the...

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Medication Error Reporting: CQI Programs Offer Avenue to Vital Follow-Up

Topics: Continuous quality improvement

Originally published in the January 2011 NABP Newsletter Patient safety advocates have long emphasized the importance of documenting medication errors as a crucial tool in preventing future adverse medical events. Even before the Institute of Medicine’s landmark 1999 report, “To...

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FDA Asks Drug Manufacturers to Limit Strength of Acetaminophen in Prescription Products

Topics: Prescription label and Prescriptions

In the interest of patient safety, Food and Drug Administration (FDA) has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products – which are predominantly combinations of acetaminophen and opioids – to 325 mg per tablet,...

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FDA Alert Regarding Liver Injury Associated with Dronedarone

Topics: Patient safety

FDA alerts health care providers about cases of rare, but severe liver injury, associated with dronedarone (Multaq®), a drug used to treat abnormal heart rhythm in patients who have had an abnormal heart rhythm (atrial fibrillation or atrial flutter) in...

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McNeil Recalls Additional Over-the-Counter Products

Topics: Over the counter and Patient safety

McNeil Consumer Healthcare has voluntarily recalled, at the wholesale level, certain lots of Tylenol® 8 Hour, Tylenol® Arthritis Pain, and Tylenol® upper respiratory products, and certain lots of Benadryl®, Sudafed PE®, and Sinutab® products distributed in the United States, the...

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FDA Warning: Scam Victimizes Consumers Who Purchased Drugs Via Internet or Telephone

Topics: Internet pharmacy and Patient safety

FDA warns the public about a continued international extortion scam in which criminals contact victims by telephone, posing as FDA special agents in attempt to obtain money. Specifically, FDA reports that the criminals call the victims – who in most...

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NABP Legal Briefs: Citizenship Kane

By Dale J. Atkinson, JD Originally published in the January 2011 NABP Newsletter The qualifications for licensure as a pharmacist of each respective jurisdiction are set forth in statute, generally referred to as the practice act. As set forth in...

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FPGEE Scheduling Notice

After February 9, 2011, Pearson VUE will open up the April 14, 2011 FPGEE testing date to other, non-FPGEE test takers wishing to test on April 14. NABP advises that you schedule your appointment for the April 14 FPGEE before...

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2011 Survey of Pharmacy Law Now Available!

Celebrating its 60th edition as a convenient reference source for individuals seeking an overview of the state laws and regulations that govern pharmacy practice, the updated 2011 Survey of Pharmacy Law is now available. The Survey, produced in a CD...

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FDA Safety Alert Regarding Mislabeled Albuterol Sulfate Inhalation Solution

Topics: Patient safety

Food and Drug Administration (FDA) issued a safety alert notifying the public that the Ritedose Corporation is conducting a voluntary recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL in 25, 30, and 60 unit dose vials. This product is...

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Massachusetts Amends PMP Regulations to Require Identification for Additional Rx

Topics: Prescription monitoring program

The Massachusetts Prescription Monitoring Program (PMP) made changes to requirements for data and customer ID collection that went into effect January 1, 2011. The regulatory amendments expand upon current requirements to include: Reporting of prescription records for Schedules II-V Collection...

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Washington Board Passed Emergency Rule Banning Synthetic Marijuana

Effective January 7, 2011, the sale and possession of synthetic marijuana products known as “K2” and “Spice” is illegal in Washington under emergency rules adopted by the Washington State Board of Pharmacy. The chemicals are often sprayed on incense products...

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Oklahoma Board Implements Regulation to Block PSE-Product Sales to Meth Drug Offenders

Topics: Pseudoephedrine

Effective November 1, 2010, the Oklahoma State Board of Pharmacy has implemented a regulation stating that any person with a previous meth-related drug offense may not possess pseudoephedrine (PSE) at all. If a pharmacy sells PSE over the counter, then...

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Alaska Board Proposes Regulation Project for Providing Safe Medical Marijuana

Topics: Medical marijuana

The Alaska Board of Pharmacy is proposing a regulation project to provide a safe means of medical marijuana to Alaska residents. According to Board Chair Richard Holm, RPh, this will require establishing a safe, clean source of marijuana grown within...

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DEA Plans Second National Prescription Drug Take Back Day

Topics: Medication collection program disposal

To provide a safe means for the disposal of unwanted, unused prescription medications, Drug Enforcement Administration (DEA) is planning a second National Prescription Drug Take Back Day to take place Saturday, April 30, 2011. This event will continue efforts to...

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DEA to Hold Public Meeting on Drug Disposal Procedures

Topics: Medication collection program disposal

DEA will hold a public meeting to discuss procedures for the surrender of unwanted controlled substances by ultimate users and long term care facilities on January 19-20, 2011. The information collected will be useful to DEA in the development of...

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Surescripts Publishes Guidance for Electronic Prescriptions

Topics: Electronic prescriptions

Surescripts has released “Guidelines for Creating High-Quality Electronic Prescriptions In The Ambulatory Healthcare Setting,” (PDF) a document that “attempts to set the measurement standard against which electronic prescriptions can be assessed for accuracy and completeness” as noted on the Surescripts...

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Proposed New Chapter on Prescription Container Labeling Available from USP

Topics: Prescription label

United States Pharmacopeia (USP) published proposed new General Chapter <17> Prescription Container Labeling (PDF) in the new online Pharmacopeial Forum available on the USP Web site on January 3, 2011. The purpose of the chapter is to standardize labeling to...

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Ohio Board Limits Number of Prescription Transfers In Interest of Patient Safety

Topics: Patient safety and Prescription transfer

In the interest of patient safety and to address prescription drug abuse, the Ohio State Board of Pharmacy has implemented a rule stipulating that prescriptions may only be transferred one time. As stated in the revised rule, effective January 1,...

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San Francisco Bill Calls for Drug Disposal Program by Drug Companies

Topics: Medication collection program disposal

The San Francisco Board of Supervisors approved a bill that would require pharmaceutical companies to implement a drug disposal program for the city by September 2011. Intended to help prevent accidental drug ingestion and prescription drug abuse, the bill would...

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