IOM report focuses on impact of counterfeit, substandard drugs

A new Institute of Medicine (IOM) report addresses growing concerns in the global community surrounding the public safety matters of fake and substandard drugs.

“The integrity of the pharmaceutical supply chain continues to be a primary concern in the United States especially in the wake of high-profile problems with the contaminated blood thinner sourced from China, and the ongoing challenges with counterfeit Avastin,” said Formulary Advisor Gary J. Kerr, MBA, PharmD, chief pharmacy officer, president, Mass. Society of Health Systems Pharmacists, in Springfield.

The key recommendations of the IOM report include:

• The secondary wholesale market in the United States represents a weak point in the distribution system.

“Only wholesalers with accreditation from the National Association of Boards of Pharmacy [NABP} should be licensed to distribute medicines,” said IOM Committee Member Patrick Lukulay, PhD, vice president, Global Health Impact Programs and director, Promoting the Quality of Medicines Program, a USP/USAID partnership that was established to help ensure the quality, safety and efficacy of medicines essential to USAID priority diseases. “There is currently no database for states to share information about disreputable wholesalers or pharmacies. FDA and state boards are asked to develop such a database.”

• National medicine registration systems need strengthening to make medicine registration a more efficient process to prevent rogue actors from taking advantage of medicine shortages and putting falsified or substandard medicines in the supply chain.

“In this regard, drug dossiers should adopt a common Technical Document format and regulators should share inspection reports to avoid replication of inspections,” Lukulay said.

• Procurement organizations should follow World Health Organization Quality Management Systems for procurement of pharmaceuticals. “Procurement done properly provides a good layer of protection against falsified and substandard medicines after registration systems fail,” Lukulay said.

“Internet pharmacies also are identified as a weak line, presenting challenges to public safety and requiring stronger accreditation processes,” Dr Kerr said.

In a press release, FDA Commissioner Margaret A. Hamburg, MD, praised the IOM’s efforts and said that “actions and efforts [are] already underway at the FDA, including advancing technology, strengthening global regulatory capacity, strengthening surveillance, developing science-based standards and engaging in global dialogue.”

Dr Hamburg also pointed out several related international activities already underway, all aimed at battling substandard, mislabeled and counterfeit products worldwide.

“For pharmacists, this progress on the international level addressing substandard drugs in the supply chain bears some resemblance to the ongoing work between the states, and FDA on the subject of sterile compounding,” Dr Kerr said.