NABP e-News: October 15, 2008

October 15, 2008 12:00 AM

Drug Spam Network Busted; TV Newscasts Feature NABP
A federal judge in Chicago, IL, has shut down a worldwide spam operation soliciting Web sites selling prescription medications illegally, ABC News reported on October 14, 2008. The newscast, available on the ABC Web site under the headline “Authorities shut down global spam operation,” also cites NABP and its finding that 97% of the Internet drug outlets it has reviewed appear to be operating out of compliance with state and federal laws and established patient safety and pharmacy practice standards. A similar newscast also appeared October 14 on FOX News Chicago and is posted on the FOX Web site under the headline “FTC Cracks Down on Email Spam.”

California Legislature Extends Deadline for Implementing Pedigree System
Recent legislation in California extends the deadline for full implementation of track and trace technology until 2017, replacing the California State Board of Pharmacy's previous 2011 deadline. The legislation prohibits a wholesaler, repackager, or pharmacy from selling, trading,or transferring a prescription drug without a pedigree or from acquiring a prescription drug without receiving a pedigree. The new law creates a graduated implementation schedule requiring manufacturers to serialize half of their product lines by January 1, 2015, for tracking throughout the supply chain and requiring the remaining 50% to be completed the following year. Pharmaceutical wholesalers have until July 1, 2016, to meet the ePedigree requirements, and pharmacies must comply no later than July 1, 2017. More information is available on the Board Web site and will be provided in the November-December 2008 NABP Newsletter.

Wall Street Journal Article Discusses Internet Pharmacy Bill, Cites NABP and VIPPS
Federal legislation to help crack down on the illegal sale of controlled substances over the Internet is expected to be signed by President Bush, the Wall Street Journal reported on October 9, 2008. Approved by Congress in September, the bill would prohibit Internet drug outlets from dispensing medications to patients without a valid prescription from a practitioner who has examined the patient in person at least once. The article, “New Bill Targets Rogue Druggists on the Internet,” cites NABP, the Verified Internet Pharmacy Practice Sites^™ (VIPPS^®) accreditation program, and the list of Not Recommended Sites posted in the Internet Pharmacies section of the NABP Web site.

HHS Issues Interim Guidance for Patient Safety Organizations
A new interim guidance that outlines how to become a Patient Safety Organization (PSO) is now available from the United States Department of Health and Human Services (HHS). The Patient Safety and Quality Improvement Act authorized the creation of PSOs to improve safety through the collection and analysis of data on patient safety events. By providing both privilege and confidentiality, PSOs will create a secure environment where clinicians and health care organizations can voluntarily collect, aggregate, and analyze data that enable the identification and reduction of the risks and hazards associated with patient care. The interim guidance allows HHS' Agency for Healthcare Research and Quality to begin receiving applications from qualified entities that wish to become PSOs. This guidance will remain effective until HHS issues a final rule for PSOs, which will then supersede the interim guidance. A final rule is expected to be released by the end of 2008. More information, the interim guidance, and the notice of proposed rulemaking are available on the PSO Web site.

Consumer Healthcare Group Warns Against Giving Cold Medicines to Young Children
The Consumer Healthcare Products Association agreed on October 7, 2008, to add “do not use” warnings advising parents not to give children younger than 4 over-the-counter (OTC) cough and cold medicines, and to read the fine print on labels. The voluntary move comes in response to intensifying criticism from consumer groups, lawmakers, and pediatricians, saying they are not effective in very young children and that the risks to this age group outweigh the benefits.

Food and Drug Administration (FDA) convened a public hearing on October 2, 2008, to obtain input regarding OTC cough and cold drugs marketed for pediatric use. FDA is developing a proposed rule to revise the pediatric labeling contained in the Final Monograph for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. Transcripts of the hearing will be available online approximately 30 days after the hearing. FDA will accept comments on the issue [Docket No. FDA-2008-N-0466] until December 2, 2008.

Tests Find Several Pharmaceutical Product Packages Lacking in Safety
Testing of prescription packages by nine major manufacturers found several of them lacking in terms of child resistance, resistance to moisture vapor permeation, and/or resistance to light transmission. Pharmacy Healthcare Solutions, Inc (PHSI), a Pittsburgh, PA-based consulting firm, conducted the study based on Consumer Product Safety Commission standards for child resistance and United States Pharmacopeia standards for moisture vapor permeation and light transmission. SPC Technologies, LLC, also in Pittsburgh, PA, provided analysis of the test data. Of the products and manufacturers tested, only one product passed all three test criteria at the highest levels. To ensure the safety and integrity of the medications dispensed, PHSI advises pharmacists to request documentation from prescription package manufacturers on test results for child resistant protocol, moisture permeation, and light transmission. The results should show that the package meets or exceeds all testing standards. Study results are available from PHSI.