Falsified and substandard drugs are a global public health threat that needs to be addressed cooperatively by governments, manufacturers, and other health organizations, according to an Institute of Medicine report issued Feb. 13.
This is "a grave public health problem because [falsified and substandard drugs] are ineffective, promote drug resistance, and even cause severe illness and death, particularly in developing countries where they regularly flood the market," chair of the report committee, Lawrence Gostin, O’Neill Professor of Global Health Law, Georgetown University Law Center in Washington, said in a statement.
"Given the international nature of modern manufacturing and trade, every nation has a stake and a role to play in ensuring the production and sale of high-quality medications," he said.
The IOM committee is calling on the World Health Organization, other international organizations, governments, and stakeholders to collaborate on "a global code of practice, build national regulatory capabilities, and promote international cooperation."
The committee was convened by the IOM at the request of the Food and Drug Administration. In a statement, Commissioner Margaret A. Hamburg noted that the FDA is transforming from a "predominantly domestically focused agency to one that is fully prepared to help ensure product safety and quality within a globalized world," and that many of the recommendations in the IOM report are already underway, including having a presence in 12 countries in seven regions of the world.
Quite simply, the first thing that needs to be done, according to the report, is for the World Health Assembly to adopt consistent definitions, using "substandard" to describe drugs that do not meet pharmacopeia or manufacturer specifications, and "falsified" for those products with a "false representation" of identity and/or source.
To avoid confusion, the report recommends against using the term counterfeit, which, although widely used to refer to drugs that do not contain what they claim to, has a narrow legal definition related to infringement of registered trademarks.
Available in street markets, unregulated websites, and other unreliable sources, falsified and substandard drugs cause problems ranging from a lack of a therapeutic effect and resistance to antimalarial and tuberculosis treatments to frank poisoning.
While it is difficult to quantify the magnitude of the problem, the report cites some data, including the finding by 25 major pharmaceutical companies that in 2011, falsified or substandard drugs were sold in at least 124 countries. And although poorer countries are disproportionately affected, richer countries are impacted too. The report specifically cites the recent case of the Massachusetts compounding company that produced contaminated injectable steroid products, which caused many cases of meningitis, including 44 cases that were fatal in a 5-month period.
"Lack of clarity about the relative authority of the FDA and state pharmacy councils to regulate compounding pharmacies contributed to the outbreak," the report noted.
Another key recommendation: Establish in the United States a mandatory drug tracking system, and strengthen the requirements for licensing medication wholesalers. The report describes secondary wholesalers as the "weakest point" in the U.S. drug distribution chain. The latter should include the requirement that state licensing boards in the United States only license wholesalers that meet accreditation standards of the National Association of Boards of Pharmacy (NABP), and that the FDA and state licensing boards establish a public database with information on wholesalers with revoked or suspended licenses.
To facilitate the changes, Congress should authorize and fund the FDA to create a mandatory "track and trace system" using unique product serial numbers to track packages of medications from the factory to the consumer, according to the report.
The IOM committee also recommended better training for pharmacy staff in developing countries and improved communication and training programs to educate health care workers and consumers about poor-quality medications and how to report suspected cases.
Funding from international investment agencies should be used to help pharmaceutical manufacturers upgrade to international standards, and for governments in low- and middle-income countries to help their regulatory agencies comply with international manufacturing and quality control standards.
The study was supported by a contract between the National Academy of Sciences and the FDA.