By Maria A. Miralles, PhD, USAID’s Senior Pharmaceutical Management Advisor

At the moment of using a medicine, do we trust that the product is of good quality and will not cause us any harm?   For those who live in countries with competent regulatory agencies and functioning systems, the answer is yes and this trust is generally well-placed.  This is pretty amazing when you consider the myriad of opportunities for problems to arise, from product development through to manufacture, distribution and use.  So, not many people were alarmed in April 2010 when the FDA informed the manufacturers of Children’s Tylenol® of violations in its Pennsylvania manufacturing plant affecting several dozens of products. The company immediately issued a voluntary recall, products were withdrawn from the market, potentially related morbidities and deaths were subsequently monitored.[i] Unfortunately, many developing countries lack the capacity to protect their citizens in this way, much less to protect them from unscrupulous drug manufacturers and vendors. What should be a matter of trust is more like a tragic game of chance with devastating odds.

Counterfeit ampicillin discovered through the PQM monitoring program in Southeast Asia. Photo Credit: Christopher Raymond (PQM/USP)

Many of us can remember the deaths of 138 Panamanians who consumed tainted cough syrup in 2006 and the 84 children in Nigeria in 2008 that were exposed to a teething medicine made with a counterfeit ingredient.  In both cases, investigations determined that these deaths could have been avoided had the responsible systems and authorities been vigilant and the systems sufficiently responsive.[ii] Deaths are not the only sign of potential product quality and patient safety problems.  Antimicrobial medicines with sub-therapeutic quantities of active ingredients have contributed to the rise in resistant strains of various infectious diseases rendering existing cheaper products useless and prolonging treatment periods. There is no question that there are likely to be many others cases we will never know about because they have occurred in places where there was no system in place to properly document them.

For the global health community, pharmaceutical product quality and patient safety cannot be ignored.  The huge levels of donor funding for the procurement of life-saving medicines for priority health problems require us to assume responsibility for ensuring that decades of investments in public health are not undone through lack of vigilance on these issues.  For example, In order to ensure quality products for multi-drug resistant tuberculosis patients, United Nations procurement agencies, the Global Fund, and many international organizations mandate that only medicines prequalified by WHO (or approved by stringent regulatory agencies) are suitable for procurement. To expedite the process of pre-qualification with WHO— thereby expanding the pool of viable manufacturers—USAID has been providing technical assistance to selected manufacturers to be able to meet internationally recognized Good Manufacturing Practices and for the preparation of dossiers for tuberculosis drugs for submission to WHO.

In terms of patient safety in particular, the information needs are great and we know much less.   USAID has stepped up to the plate, however, by supporting the establishment and strengthening of in-country post-marketing surveillance systems to sample and test the quality of medicines in Latin America, Africa, and Southeast Asia. As the research report to Congress indicates, post-marketing surveillance data, which was previously not available, were instrumental in the success of a regional anticounterfeit operation in Southeast Asia that led to the withdrawal of $6.7 million worth of sub-standard medicines. More recently a study conducted in partnership with WHO documented that 44 percent, 30 percent and 26 percent of antimalarials sampled in Senegal, Madagascar, and Uganda respectively failed full-scale quality control tests.  The study has so far been reported in over 500 academic and professional media outlets worldwide, raising awareness on the substandard and counterfeit malaria drug problem in developing countries.  Importantly, these results provide the evidence-base that did not exist before that should inform and provoke responses from quality assurance systems and regulatory frameworks, as well as providers and patients.

Research results such as these help USAID, WHO, the Global Fund and other international stakeholders ensure that their investments in medicines are not wasted and they also provide ammunition to in-country authorities to help carry out their public health responsibilities.  USAID has supported the development of robust drug quality surveillance programs in more than 20 nations, leading to recalls of substandard and counterfeit medicines and closure of illicit pharmacies. Monitoring is currently conducted largely through more than 100 sentinel sites that can perform product quality testing and the results are tangible.  For example, in July 2009, one such sentinel site in Ghana detected a counterfeit antimalarial drug that was being sold to patients as Novartis’ Coartem®. The product, which lacked any active ingredient, was promptly seized from pharmacies in Ghana by the country’s Foods and Drug Board, helping prevent further harm to patients using the product for the treatment of malaria.

Fore more information on the report, click here.

[i] Layton, Lyndsey (May 2, 2010). “Johnson & Johnson division recalls 43 OTC medicines for infants and children”. Washington Post.

[ii] Bogdanich, Walt and Jake Hooker (May 6, 2007).   “From China to Panama”.   New York Times.;  Associated Press (February 6, 2009) “84 Nigerian children dead from tainted formula: teething medicine tainted with a chemical formula found in antifreeze.“ Food Safety on