Substandard drugs: a potential crisis for public health

Abstract

Poor-quality medicines present a serious public health problem, particularly in emerging economies and developing countries, and may have a significant impact on the national clinical and economic burden. Attention has largely focused on the increasing availability of deliberately falsified drugs, but substandard medicines are also reaching patients because of poor manufacturing and quality-control practices in the production of genuine drugs (either branded or generic). Substandard medicines are widespread and represent a threat to health because they can inadvertently lead to healthcare failures, such as antibiotic resistance and the spread of disease within a community, as well as death or additional illness in individuals. This article reviews the different aspects of substandard drug formulation that can occur (for example, pharmacological variability between drug batches or between generic and originator drugs, incorrect drug quantity and presence of impurities). The possible means of addressing substandard manufacturing practices are also discussed. A concerted effort is required on the part of governments, drug manufacturers, charities and healthcare providers to ensure that only drugs of acceptable quality reach the patient.

Keywords: drug quality; falsification; inspection; regulation; substandard.

Figure 1

Examples of recent accounts of substandard drugs around the world. (A) GlaxoSmithKline fined because four drugs it marketed did not meet US Food and Drug Administration's strength and purity standards (Boston.com). (B) Outbreak of fungal meningitis traced to contaminated methylprednisolone injections produced by the New England Compounding Center [103]. (C) Five deaths and 300 people infected due to distribution of contaminated prefilled heparin and saline syringes by AM2PAT (The Institute for Southern Studies, 2009). (D) Defects in quality of antimalarial drugs held at national and state facilities [90]. (E) Plasticizers, including diisodecyl phthalate and diisononyl phthalate, found in Augmentin formulations manufactured in the UK; products recalled in Hong Kong and China (The Telegraph/FiercePharma). (F) Ethyl mesylate contamination of nelfinavir at Roche's Swiss manufacturing plant (National AIDS Manual, 2007). (G) Ghana's medicines regulatory authority ordered Pfizer to recall substandard Camoquine-plus suspension manufactured in Senegal and distributed in Ghana (Ghana News Agency). (H) Nigeria's National Agency for Food and Drug Administration raided pharmacies and other outlets and impounded a variety of drugs believed to be falsified (Nigerian Tribune). (I) Pharmacy, Medicines and Poisons Board recalled aspirin tablets on suspicion of being substandard (Malawi News). (J) The Tanzania Food and Drugs Authority suspended importation, distribution, sale and use of nine types of medicines found to be substandard (The Citizen, Tanzania). (K) As of November 2012, almost 300 drugs have been listed as being found to be substandard in 2012 (DrugsControl.org, India). (L) Thirteen women died in little over a week due to contaminated intravenous fluids. No system was in place for testing or checking medicines (The New Indian Express). (M) Russia's Federal Service on Surveillance in Healthcare (Roszdravnadzor) discovered and removed 530 series of ‘low-quality’ drugs from circulation in 2012; over 70% of these were produced by domestic manufacturers (HIS Global Insight/Rossiyskaya Gazeta). (N) Six hundred and sixty-nine batches of gel capsules from 254 drug manufacturers were found to have high chromium levels (30 May 2012; FiercePharmaManufacturing). (O) More than 60 tonnes of fake and substandard pharmaceuticals and medical equipment were destroyed by Beijing's municipal drug supervision bureau (People's Daily Online). (P) Batches of Typhim Vi vaccine were recalled because they may have lower than expected antigen content (Therapeutic Goods Administration)