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Drug quality

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Donor's bottom line

Donors should be concerned that organizations they support may purchase and provide ineffective drugs due to counterfeiting or improper manufacturing or storage. However, there is relatively little information regarding (a) the degree of the problem or (b) what types of drug delivery mechanisms (e.g., private pharmacies, government-run hospitals) are most susceptible.

Table of Contents

The basics

What are low quality drugs?

  • Counterfeit drugs, maliciously produced by the manufacturer. For example, a manufacturer might produce an ineffective agent and inaccurately label it as Mectizan (brand name for ivermectin from Merck).1
  • Incompetently produced, substandard drugs.2
  • Improperly stored, degraded drugs.3

Who is responsible for low quality drugs?

We haven't identified a clear answer to this question. It appears that any of the following actors may contribute to the problem:

  • A supplier to the manufacturer who provides inactive ingredients for the drugs.4
  • A manufacturer who purposely counterfeits drugs and sells them as high quality, effective treatments.
  • A pharmacist that sells inactive (or non-recommended treatments).

How large a problem are low quality drugs?

Little information exists that clearly defines the magnitude of the problem. The information that does exist may come from (a) reported cases of intercepted, low-quality drugs or (b) surveys of drugs to determine their quality.5 There is scant existing literature of well-conducted surveys of drug quality that provides evidence of the magnitude of the problem.6

Below, we provide a sample of findings from recent surveys in South-East Asia and Africa.

  • One set of surveys of the quality of anti-malarials in South-East Asia "suggested that 33-53% of bought artusenate [a key component of the recommended malaria treatment regimen] was counterfeit."7
  • A recent survey of the quality of malarial drugs in randomly selected, private pharmacies8 in six African countries found a significant presence of low-quality drugs: approximately 1/3 did not contain the recommended active ingredients and an additional 1/3 were monotherapies, not the World Health Organization-recommended treatment regimen, ACT.9 (For more, see our report on treatment for malaria.)
  • A recent survey of the "main pharmacies" in Naiorobi, Kenya and Bukavu in DR Congo10 found that 9 of 24 drug samples tested did not comply with requirements.11

What drugs are counterfeited the most?

The World Health Organization believes that anti-malarials and antibiotics are commonly counterfeited drugs in the developing world.12

What types of drug delivery mechanisms are most susceptible to low-quality drugs?

Most of the sources we've found on this topic are based on surveys of private pharmacies. We don't know whether this is because private pharmacies are considered more likely to provide counterfeit drugs than government- or NGO-run facilities or whether there's another explanation.

Which regions or countries have the largest problem?

Again, we are not sure. Most of the literature appears to focus on anti-malarials in South-East Asia, but we don't know whether this is because the problem is thought to be larger there or whether there's another explanation.

Sources

  • 1.

    • "A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of) active ingredient(s) or with fake packaging." World Health Organization, "What Are Counterfeit Medicines?"
    • "On May 22, 2006, British customs officials made a troubling discovery at Heathrow Airport in London. They intercepted 846 pounds of pharmaceuticals, mostly counterfeits of products made by such well-known companies as Merck, Novartis, AstraZeneca, Pfizer and Procter & Gamble. Some medication contained traces of metal. These were not just lifestyle drugs; this medicine was supposed to treat high blood pressure, high cholesterol, osteoporosis and acid reflux, among other ailments...Pfizer took a particular interest in the case. Thousands of pills of its cholesterol-fighting drug Lipitor had been among those counterfeited, the company said." New York Times, "Counterfeit Drugs' Path Eased by Free Trade Zones."
  • 2.
    • "Substandard medicines (also called out of specification (OOS) products) are genuine medicines produced by manufacturers authorized by the NMRA which do not meet quality specifications set for them by national standards. Normally, each medicine that a manufacturer produces has to comply with quality standards and specifications. These are reviewed and assessed by the national medicines regulatory authority before the product is authorized for marketing." World Health Organization, "What Are Substandard Medicines?"
    • "They arise mostly due to the application of poor manufacturing practices by the producer..." World Health Organization, "How Do Substandard Medicines Arise?"
  • 3.

    "Degraded medicines may result from exposure of good-quality medicines to light, heat, and humidity. It can be difficult to distinguish degraded medicines from those that left the factory as substandard, but the distinction is important as the causes and remedies are different [13]." Newton et al. 2009, Pg 0253.

  • 4.

    "A Chinese pharmaceutical firm plans to recall thousands of anti-malarial drugs supplied to Kenya after discovering a counterfeit syndicate." BBC News, "Malaria Drugs Recalled in Kenya."

  • 5.

    "Defining the extent of counterfeiting is difficult for a number of reasons. The variety of information sources makes compiling statistics a difficult task. Sources of information include reports from national medicines regulatory authorities, enforcement agencies, pharmaceutical companies and nongovernmental organizations, as well as ad hoc studies on specific geographical areas or therapeutic groups." World Health Organization, "Medicines: Counterfeit Medicines."

  • 6.

    "The existing literature includes little discussion about the most appropriate sampling and reporting strategies for medicine quality surveys [2,7,15,16], and the majority of papers either have inadequate reporting of sampling methods and/or used “convenience” sampling, which is potentially flawed by bias. Depending on whether the medicine collectors, consciously or subconsciously, prefer to find poor-quality medicines (e.g., if it might result in publications or funding) or not (e.g., if it might cause embarrassment), they may overestimate or underestimate, respectively, the prevalence of outlets selling poor-quality medicines. Convenience sampling may lead investigators to sample more geographically accessible outlets, which may be unrepresentative of those used by patients." Newton et al. 2009, Pg 0252.

  • 7.

    "Ad hoc surveys since 2000 in Burma (Myanmar), the Thai/Myanmar border, the Lao People's Democratic Republic (Lao PDR, Laos), Cambodia, and Vietnam, the most malarious countries in mainland SE Asia, suggested that 33%–53% of bought artesunate was counterfeit, containing either no or subtherapeutic quantities of artesunate (Figure 1) [7–13]." Newton et al. 2008, Pg 0210.

  • 8.

    "A simple sampling protocol was developed in line with similar studies.[12] Antimalarial drugs were obtained by local nationals from randomly selected private pharmacies in the major cities of six African countries within the high endemicity band. Study agents posed as customers were asked to purchase a sample lot of antimalarial tablet formulations available, namely: SP, amodiaquine, mefloquine, artemisinin monotherapies and any ACTs. Agents were instructed not to purchase chloroquine. Treatment packs were maintained either in the manufacturer's original packaging or loose, and stored at ambient temperature until testing. Tests were completed within 40 days of sample collection." Bate et al. 2008, Pg 3.

  • 9.

    "A range of antimalarial drugs were procured from private pharmacies in urban and peri-urban areas in the major cities of six African countries, situated in the part of that continent and the world that is most highly endemic for malaria. Semi-quantitative thin-layer chromatography (TLC) and dissolution testing were used to measure active pharmaceutical ingredient content against internationally acceptable standards. 35% of all samples tested failed either or both tests, and were substandard. Further, 33% of treatments collected were artemisinin monotherapies, most of which (78%) were manufactured in disobservance of an appeal by the World Health Organisation (WHO) to withdraw these clinically inappropriate medicines from the market." Bate et al. 2008, Pg 1.

  • 10.

    "All drugs analysed in this study were obtained randomly from the main pharmacies within Nairobi in Kenya and Bukavu in the Democratic Republic of the Congo in 2004. Samples were purchased anonymously by local nationals based on their availability in the pharmacies and maintained in the original package as supplied by the manufacturer." Atemnkeng, De Cock, and Plaizier-Vercammen 2007, Pg 69.

  • 11.

    "Nine of the 24 drug samples analysed did not comply with the pharmacopoeial requirements of 95–105%: seven samples were underdosed and two were slightly overdosed." Atemnkeng, De Cock, and Plaizier-Vercammen 2007, Pg 68.

  • 12.

    "According to reports received from national authorities in countries and information published in news papers and journals, both well established (generic) medicines and innovative medicine products are affected. The largest number of reports relate to antibiotics, antiprotozoals, hormones and steroids. In developing counties, antibiotics and other aniprotozoals such as anti-malarial medicines are commonly counterfeited." World Health Organization, "What Kind of Products Are Counterfeited Most?"

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