A group of drugs known as “bath salts” were linked to an estimated 22,904 visits to hospital emergency departments in 2011.

With flu shots now available across the country, and consumers stocking home medicine cabinets ahead of the coming cold and flu season, the Acetaminophen Awareness Coalition has issued a consumer message to “Double Check, Don’t Double Up” on acetaminophen when treating winter illnesses.

Food and Drug Administration updated its label requirements for the drug labels on fluoroquinolone-based medications.

FDA has issued a Consumer Update that warns of rare but serious skin reactions that may occur in patients taking acetaminophen.

In a study recently published by the Journal of Pediatrics, researchers concluded that flow regulators for liquid medication bottles are an effective way to limit the amount of medication administered to young children. 

Nova Diabetes Care and Food and Drug Administration (FDA) officials have announced a voluntary recall of 21 lots of blood glucose test strips.

Food and Drug Administration (FDA) stresses that domperidone is not an FDA-approved drug, and that it may not be legally marketed in the US. 

FDA is warning consumers not to use a product marketed as a Vitamin B dietary supplement due to the presence of potentially harmful anabolic steroids. 

FDA advises consumers not to use, and is taking action to remove from the market, illegal products claiming to treat diabetes.

A new law in Maine will allow residents to import prescription drugs for personal use from mail order pharmacies located in Australia, Canada, New Zealand, and the United Kingdom.

A bill aimed to ensure the security of pharmaceuticals in the drug supply chain has passed the United States House of Representatives. 

Sandoz US is voluntarily recalling two lots of methotrexate sodium, USP, 25 mg/mL, 40 mL vial injectable product because of particulate matter found during a routine test of samples. 

Fresenius Kabi USA, LLC, is voluntarily recalling one lot of magnesium sulfate injection, USP because of possible glass particles in the vials, according to an FDA alert. 

To further protect the integrity of the United States drug supply chain, the National Association of Boards of Pharmacy^® (NABP^®) has updated the criteria for the Association’s Verified-Accredited Wholesale Distributors^® (VAWD^®) accreditation program. 

To further protect the integrity of the United States drug supply chain, the National Association of Boards of Pharmacy^® (NABP^®) has updated the criteria for the Association’s Verified-Accredited Wholesale Distributors^® (VAWD^®) accreditation program. 

The National Association of Boards of Pharmacy^® (NABP^®) today issued a report emphasizing that the global distribution of counterfeit and substandard medications, fueled by illegal online sellers, demands an international response.

Nevada-based Green Valley Drugs has issued a voluntary recall of all lots of all its compounded, repackaged drugs because of a lack of sterility assurance. 

The emergency pharmacy status reporting tool operated by Rx Response now goes by an easy-to-remember name, Rx Open, with a matching URL, www.RxOpen.org.

Fentanyl patches should be securely stored out of the sight and reach of children and disposed of properly, advises Food and Drug Administration (FDA).

To ensure patient safety, Pallimed Solutions, Inc, of Woburn, MA, has initiated a voluntary recall of all sterile compounded products dispensed since January 1, 2013. 

With the arrival of allergy season, FDA has a released a new video to help educate patients about safe use of medications containing acetaminophen.

Stressing the potential danger to patients, NABP expressed its opposition to legislation introduced in Maine that would allow the dispensing of drugs from mail-order pharmacies located around the world.

Former New England Compounding Center (NECC) employees reveal how workload and facility conditions contributed to the tragic meningitis outbreak linked to the company’s contaminated drugs in a 60 Minutes segment.

Inspections of 30 entities engaged in compounding are underway by Food and Drug Administration (FDA) inspectors as part of the agency’s response to the 2012 meningitis outbreak linked to contaminated compounded injectable drugs.

Pharmacies compounding sterile drug products for dispensing to patients in California would be required to obtain a license to engage in that practice under a bill introduced to the state’s senate on February 19, 2013.

Aimed to protect public health, a bill introduced in the Oklahoma Legislature would bring pharmacy benefit managers under the regulation of the Oklahoma State Board of Pharmacy. 

Compelling progress has been made by stakeholders seeking to address the public health issue of acetaminophen overdose, indicates a white paper published by the National Council for Prescription Drug Programs (NCPDP).

With high rates of flu across the country, FDA in conjunction with the Federal Trade Commission (FTC) took action to help protect consumers from an unapproved product marketed to treat the flu. 

The Institute for Safe Medication Practices (ISMP) has issued a National Alert Network (NAN) notice (PDF) advising that health care organizations should take immediate steps to ensure that only diluted acetic acid solutions are used in patient care.

A spike in flu activity and limited supplies of vaccine and Tamiflu^® doses across the country have prompted Rx Response to move its operations to Alert status.

The Institute for Safe Medication Practices (ISMP) has launched a National Vaccine Error Reporting Program (VERP) that allows health care providers to confidentially report vaccine administration errors and near misses.

Emphasizing risks to patient safety, Food and Drug Administration (FDA) has alerted more than 350 medical practices (PDF) across the country that they may have received unapproved medications.

As FDA continues to seek a balance between minimizing opioid drug abuse and enabling the appropriate treatment of pain, the agency will hold a two-day public hearing to obtain information.

The Oregon State Board of Pharmacy and LegitScript took actions to prevent rogue Internet drug outlets from distributing products.

In an effort to improve oversight of compounding pharmacies in the state, the Florida Board of Pharmacy formed a committee of its colleagues to create a series of permits.

In an attempt to tighten federal oversight of compounding pharmacies in the wake of the meningitis outbreak, the S.A.F.E. Compounded Drugs Act of 2012 (HR 6638) was introduced in Congress.

The Massachusetts Board of Registration in Pharmacy is considering eight potential solutions for improving the state’s regulation of pharmacy compounding. The solutions are part of the Board’s efforts to streamline compounding rules and improve patient safety.

Hospitals and medical centers that relied upon the NECC and its sister company, Ameridose LLC, are suffering shortages of antibiotics, pain medications, and other drugs.

Qualitest, a subsidiary of Endo Health Solutions, issued a voluntary recall of 101 lots of hydrocodone bitartrate and acetaminophen tablets.

The AWARxE^® Consumer Protection Program encourages consumers to move medications from their medicine cabinets into a secure area for the holidays to protect loved ones. 

Supporting state board of pharmacy efforts to enforce compounding regulations, the National Association of Boards of Pharmacy® (NABP®) is implementing a four-part action plan centered around inspection of nonresident compounding pharmacies and creating an information sharing network of regulatory details...

Legislation that would give Food and Drug Administration (FDA) clear, new authority to oversee compounding pharmacy practices throughout the country was introduced to Congress on November 2, 2012, by Representative Edward J. Markey (D-MA). The Verifying Authority and Legality In...

FDA announced that Ameridose, LLC, voluntarily recalled all of its unexpired drug products on October 31, 2012. Ameridose, based in Westborough, MA, initiated the recall in response to findings from an FDA inspection that raised concerns about lack of sterility...

As the investigation continues into the multistate outbreak of meningitis due to contaminated methylprednisolone injections compounded by the New England Compounding Center (NECC), Centers for Disease Control and Prevention (CDC) reports that at least 363 individuals have been affected. Further,...

Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have confirmed that the contaminated intrathecal methylprednisolone injections compounded by the New England Compounding Center (NECC) are linked to the multistate outbreak of fungal meningitis and joint...

At least 231 cases of fungal meningitis, including 15 deaths, have been reported to be caused by intrathecal methylprednisolone injections compounded by the New England Compounding Center (NECC). Of the 231 cases reported as of October 16, 2012, a total...

In the wake of Hurricane Isaac, Food and Drug Administration (FDA) reminds consumers of safety tips for using medications after a natural disaster occurs. Storms, flooding, wildfires, and other natural disasters can expose medications to unsafe water or excessive heat,...

Bringing together experts addressing the global counterfeit drug problem, the Partnership for Safe Medicines' (PSM) annual Interchange conference will take place on September 28, 2012, at the National Press Club in Washington DC. The PSM annual Interchange brings together policymakers,...

Aimed to improve health care access for children in Illinois, a new law (SB 3513) will authorize pharmacists to administer influenza and Tdap vaccinations to children age 10 and older with a doctor’s prescription. Signed by Governor Pat Quinn on...

NABP recently amended the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act) in its effort to assist the boards of pharmacy as they work to protect the public health. The Model...

The Federal Trade Commission (FTC) will hold a workshop on pet medication related issues, including drug safety issues, and seeks public comments on the topic. Among other topics, the workshop will consider how current industry distribution and other business practices...

An FDA database provides information on pediatric medications, making it easier for both health care providers and caregivers to locate this information. The Pediatric Labeling Information Database is a one-stop resource, where providers and caregivers can search for information by...

Two online Webinars focusing on acetaminophen safety will be available to pharmacists and pharmacy technicians in July. Participants will explore factors that commonly contribute to acetaminophen overdosages, review recent regulatory action to support the safe use of acetaminophen, and discuss...

To help raise consumer awareness about health fraud scams, FDA provides numerous educational resources in the Health Fraud Scams section of its Web site. Educating consumers on how to avoid such scams, FDA videos present information on various types of...

Several pharmacies in the Charlotte, NC, area have been approached by questionable drug wholesalers attempting to sell them drug supplies that may be fake, reports WSOCTV. One pharmacy owner indicated that he received calls from companies claiming to be new...

A new search tool from LegitScript provides information on dietary supplements and other similar health care products indicating whether a product is known to be unsafe or marketed with unsupportable claims. The LegitScript Healthcare Product Search contains data on thousands...

FDA is alerting pharmacies and patients that manufacturer Sandoz has initiated a voluntary recall of 10 lots of Introvale®, a generic oral contraceptive distributed in the US, following a recent report of a packaging flaw. The recall was initiated due...

FDA issued a safety alert notifying consumers about the recall of Reumofan Plus, a product marketed as a natural dietary supplement for pain relief and other serious conditions. The product contains several active pharmaceutical ingredients not listed on the label...

Franck’s Compounding Pharmacy has initiated a recall of all sterile preparations provided from November 21, 2011 to May 21, 2012. Franck’s initiated the recall after FDA notified the pharmacy that an environmental sampling of its clean room revealed the presence...

The United States Senate voted against the proposed amendment to the Food and Drug Administration (FDA) Safety and Innovation Act that would have allowed drug importation from Canadian pharmacies on May 24, 2012. The amendment failed in a vote of...

Group of Eight (G8) leaders emphasized the importance of exchanging “information on rogue internet pharmacy sites in accordance with national law and shar[ing] best practices on combating counterfeit medical products” in order to protect public health and safety. Following their...

As part of the Know Your Dose campaign, the Acetaminophen Awareness Coalition has developed an interactive educational game to teach safe use of acetaminophen. The interactive game engages consumers, by inviting them to follow three characters – Ace, Etta, and...

The National Association of Boards of Pharmacy® (NABP®) has signed the Partnership for Safe Medicines’ (PSM) letter to United States senators to show its support of PSM’s stance that the Prescription Drug User Fee Act should not be amended to...

Sterile compounding facilities are invited to participate in the 2012 USP <797> Compliance Study, a National Study of Sterile Compounding Practices, co-directed by sterile compounding experts, Eric Kastango, RPh, MBA, FASHP, and Kate Douglass, MS, RN, APN,C, CRNI. The study...

Another counterfeit version of a cancer drug has been found in United States medical practices, placing patients at risk, Food and Drug Administration (FDA) warns. The counterfeit version of Roche’s Altuzan® 400 mg/16 ml (bevacizumab), an injectable cancer medication, originated...

Aimed to increase patient safety, a new law in New York State will require many pharmacies to provide patient counseling and drug information in a language spoken by the patient, if the patient has limited proficiency in English. The law...

Abbott is warning consumers and health care providers about counterfeit Vicodin ES® purchased via the Internet. Abbott reports that the counterfeit product drug and package do not match that of Abbott’s Food and Drug Administration (FDA)-approved Vicodin ES (hydrocodone bitartrate...

Federal marshals seized more than 1,600 containers of products held by Notions-n-Things Distribution of Bogard, MO, that allegedly violate FDA approval and labeling requirements. Three products were seized from the distributor: “Chickweed Healing Salve, allegedly marketed as a skin cancer...

The 50-year anniversary of National Poison Prevention Week will be observed March 18 through March 24, 2012, to create national awareness about the risk of injury or death due to poisoning, including information on avoiding medication mistakes, overdose, or accidental...

A congressional briefing on the continued impact of counterfeit drugs in the United States will be held Thursday, March 15, 2012. The panel will include discussion of the recent situation involving the distribution of a counterfeit version of cancer drug...

US Pharmacopeial Convention (USP) has launched a new Web site developed to offer faster, simpler access to the organization’s information about the quality of drugs, foods, and dietary supplements. The redesigned Web site provides updated and expanded content, as well...

Of 72 drugs identified in shortage by FDA as of September 2011, 68, or 94%, were offered for sale online, primarily by sites on the NABP Not Recommended list, according to a new study. To determine the potential for patient...

FDA is warning health care providers and patients about a counterfeit version of Avastin® 400 mg/16 mL, which may have been purchased and used by some medical practices in the United States. Avastin is an injectable medicine used to treat...

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...

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...

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 –...

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...

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...

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...

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...

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...

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...

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....

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,...

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...

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...

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...

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...

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...

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...

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...

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,...

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...

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...

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...

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...

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...

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,...

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,...

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...

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...

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...

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....

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,...

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...

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...

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...

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...

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...

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...

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...

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,...

In partnership with NABP, and as part of its Safe Use Initiative, Food and Drug Administration (FDA) encourages pharmacies to stop using the abbreviation APAP and to spell out the drug name, acetaminophen, in an effort to help patients avoid...

Published in the August 2009 Missouri Board of Pharmacy Newsletter On April 28, 2009, the United States Substance Abuse and Mental Health Services Administration (SAMHSA) and the US Food and Drug Administration launched an initiative to help ensure the safe...

Published in the February 2009 Oregon State Board of Pharmacy Newsletter The Board expects all pharmacists and pharmacy technicians to engage in practices that provide appropriate, accurate, and professional patient care and ensure patient safety. All pharmacies should take proactive...

Published in the February 2009 Nebraska Board of Pharmacy Newsletter The Nebraska Board of Pharmacy created a grant opportunity with a mission to improve patient safety in pharmacy practice, in honor of Mr Dyke Anderson, dedicated professional to pharmacists and...

Published in the August 2008 Oregon State Board of Pharmacy Newsletter High-profile cases over the past few years, as well as heightened media exposure, now has the general public questioning the integrity of our medication distribution system. We realize that...

Reprinted from the July 2008 Minnesota Board of Pharmacy Newsletter. The Board typically investigates at least a dozen complaints each year against pharmacists and technicians involved in the alleged diversion of controlled substances, the abuse of alcohol, or the inability...

Reprinted from the January 2008 Nevada State Board of Pharmacy Newsletter. Some serious adverse events have surfaced, including patient deaths, in patients treated with Fentora® as a result of improper patient selection, improper dosing, and improper substitution. Per the manufacturer,...

Reprinted from the July 2007 Montana Board of Pharmacy Newsletter. 2007 was a busy legislative year for the practice of pharmacy. There were several pieces of legislation introduced by special interest groups that would have had a significant impact on...

Reprinted from the July 2006 New Jersey Board of Pharmacy Newsletter. The Health Care Professional Responsibility and Reporting Enhancement Act requires a health care professional to promptly notify the Division of Consumer Affairs or Board if he or she is...

Reprinted from the April 2006 North Carolina Board of Pharmacy Newsletter. The Board has received several reports of a person calling a pharmacy and having a patient’s controlled substance (CS) prescriptions transferred to a second pharmacy. The caller then picks...