Risk of medicines: Counterfeit drugs

Article type: Research Article

Authors: Akunyili, Dora Nkem | Nnani, Ijeoma P.C.^;

Affiliations: Director General, National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria | Deputy Director, NAFDAC, Nigeria

Note: [] Address for correspondence: Ijeoma P.C. Nnani, Corporate Headquarters, National Agency for Food and Drug Administration and Control (NAFDAC), Plot 2032 Olusegun Obasanjo Way, Wuse Zone 7, Abuja, Nigeria. Tel.: +00 9234 09 6702823; Fax: +00 9234 09 5241108; E‐mail: [email protected].

Abstract: Living in general is a risky endeavour. Certain risks are taken without much thought because of the apparent overwhelming benefits. This is often the case for many consumers of medicines who assume medicines to be wholly safe and health care providers infallible. Patients rely on healthcare providers for information, risk assessment, and protection from risks due to medical interventions. Some common risks due to medical interventions include medication errors, exposure to radiation, over/under dosing, adverse events/reactions, hospital acquired infections, counterfeit drugs, etc. Unfortunately, risk factors such as counterfeit medicines (though occurring for a long time) are just becoming apparent in the last three decades, first to only a few countries while others still seem unaware or choose to dwell in denial of their existence. There has been an astronomical increase in the detection of counterfeit medicines worldwide. The magnitude of this increase and consequent death toll demands greater attention in the consideration of the safety of medicines. Counterfeit medicines constitute a risk to the pharmaceutical industry, healthcare providers, the healthcare system as a whole and ultimately to the patient. The risks to the patient include, lack of effect, toxicity, adverse drug reactions (ADRs), loss of economic and other resources and ultimately death. Due to dearth of information and research and lack of a globally coordinated approach to anti‐counterfeiting, global estimates of deaths due to counterfeit medicines can only be guessed. Indications from both published data and anecdotal evidence indicate that millions of lives may be saved annually if there are no counterfeit antibiotics, antiretrovirals, anti‐malarial, anti‐tubercular drugs, vaccines and other life saving medicines. This paper identifies these risks and proposes a concerted global action towards reducing the production and circulation of counterfeit pharmaceuticals on the world market. It also suggests a possible role for pharmacovigilance in anti‐counterfeiting.

Keywords: Counterfeit medicines, safety of medicines, pharmacovigilance, global anti‐counterfeiting organ

Journal: International Journal of Risk and Safety in Medicine, vol. 16, no. 3, pp. 181-190, 2004