Regulators press forward to fight drug counterfeiting and illicit dispensing

The years-long battle to control illicit drug dispensing, including counterfeit drugs, has some new progress to report. The National Assn. of Boards of Pharmacy (NABP), which is the professional organization of US state pharmacy regulators, has issued a new ‘Internet Drug Outlet … Progress Report,” finding that out of 11,415 internet drug outlets (NABP doesn’t want to characterize them as “pharmacies”), 96% continue to be out of compliance with state, federal or NABP laws and standards. The majority of “not recommended” sites by NABP continue to dispense prescription drugs without a valid prescription. Only about 14% of the outlets have an identified location inside the US (which is a federal requirement), although, interestingly, over half of them have a server inside the US. In theory, that puts the sites within reach of FDA and others, but policing these sites is a neverending process.

For the past two years, NABP has owned the responsibility of allocating the “.pharmacy” top-level domain (TLD), by arrangement with ICANN, the international authority on internet naming conventions. NABP says that as of Sept. 30, it has approved 406 domain names, including 244 with the .pharmacy TLD. Of those, 182 registered to pharmacies, and the remainder to various organizations. Related to pharmacy practice. NABP also reports that Google and VISA (the credit card company) now restrict online drug-purchase or -advertising transactions to sites with the .pharmacy TLD (although a quick check of the Web still shows plenty of .com drug sellers).

Meanwhile, the World Health Organization has a number of ongoing efforts related to drug quality and anti-counterfeiting. In late October, a group, the Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP), issued a “working document” draft of a guidance for testing “suspect” medicines; the draft is up for comments until January 10, 2017, after which it will presumably be finalized. ECSPP is part of the Essential Medicines and Health Products office within WHO; it has been sponsoring training meetings around the world on the topic. The ECSPP guidance is primarily a lab manual, directing readers on how to handle drug samples, how to test them, and where to report results. WHO has, over the years, evolved a description of so-called “substandard, spurious, falsely labeled, falsified and counterfeit” (SSFFC) products—the terminology sidesteps the issue of otherwise good drug products with disputed marketing authorizations (an issue that has hamstrung past WHO efforts to control counterfeit drugs).

Finally—just to round out recent reporting on the counterfeit topic—the Pharmaceutical Security Institute, a US organization funded by major pharma companies, has reported 3,002 incidents in 2015, up from 2177 the year before. An “incident” refers to an instance of counterfeit drug seizure, theft or diversion; PSI gathers this information from member companies and from national and international police and customs authorities. There were 971 seizures or raids of illegal activities in that year, up 34% from the year before (this can be a reflection both of increased regulatory vigilance as well as increased criminal activity).