Article

Health Risks of Counterfeit Pharmaceuticals

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Abstract

Pharmaceutical products are not exempt from the practice of counterfeiting. In recent years, many reports have become available demonstrating the presence of fake medicines on the market. Several studies have demonstrated that they are quite often of bad quality. It is estimated that 5% of all world trade in branded goods is counterfeit, leading to huge financial losses for the pharmaceutical industry. But much more important, from a public health point of view, is that history has shown that such products may lead to a great health risk. The essence of counterfeit products and the reason they are so dangerous is the complete absence of quality control, since they are often indistinguishable from the genuine product. The existence of counterfeit drugs has long been ignored both by the pharmaceutical industry and by drug regulatory authorities. At present initiatives are being taken, nationally and internationally, to curb counterfeiting. It is now realised that a strong regulatory agency is essential, but the initiatives can only be successful if all parties concerned actively co-operate.

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... Proizvodnja i stavljanje lažiranih lekova na tržište imaju višestruke efekte, pre svega, zdravstvene i finansijske. Na ilegalnom tržištu lekova na primer, proizvodnja i stavljanje lažiranih lekova i sredstava za prevenciju i zbrinjavanje bolesti, uopšte, uključujući i lekove za pandemijski grip izazvan virusom A(H1N1) 2009 (za koji se koriste i nazivi meksički i svinjski), veliki je izazov, jer proizvođačima donosi izuzetno visoki profit 5 . Ponuda lažiranih lekova posebno raste kada kapacitet proizvodnje leka nije usklađen sa potrebama, kao što bi moglo da se desi sa oseltamivirom u slučaju potencijalne pandemije ptičjeg gripa i teškog oblika pandemije gripa izazvanog virusom A(H1N1) 2009. ...
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... Other pharmacotherapeutic groups were represented in almost equal frequencies. 60 There are 8-10 times more reports for counterfeit antibiotics and 2-3 times more reports for antiparasitic drugs in comparison with other counterfeit drugs. 60 ...
... 60 There are 8-10 times more reports for counterfeit antibiotics and 2-3 times more reports for antiparasitic drugs in comparison with other counterfeit drugs. 60 ...
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... Comparaison des aires thérapeutiques ciblées par le contrefacteurs entre les pays en voie de développement et les pays industrialisésSource : TenHam, 2003 ...
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Thesis
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Article
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... (20, 74, 78) A good example of how public education can have a major impact is the information campaign in Cambodia on how to detect counterfeit antimalarials by their external appearance, backed by dye-testing and quality assurance. (72, 78) Consumers should be advised to: (20, 74, 81, 83, 84) @BULLET Buy drugs from legitimate sources (pharmacies only) and not from the marketplaces, hawkers, or peddlers; @BULLET Buy drugs in a reliable pharmacy before leaving home for holiday or business trips abroad; @BULLET Never use drugs with deficient, damaged, or soiled packaging; @BULLET Do not use drugs without detailed information on their exact designation, expiry date, batch number, or the name of the manufacturer, or drugs with obviously incorrect information; @BULLET Do not use drugs if their shelf life has already expired; @BULLET Be wary of unusually inexpensive drugs; and @BULLET Report to their prescribers or physicians any lack of improvement in their health status in spite of the therapy or any adverse reactions experienced. ...
... Reports from the pharmaceutical industry and governments clearly indicate that the methods and channels used by counterfeiters are now more sophisticated, thus making counterfeit medicines difficult to detect. (4,10,11,12) This survey shows that majority of the respondents have experienced stocking some counterfeit drug products in their premises. The common means by which they screen for phoney products was by close visual scrutiny. ...
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... Medicines exported from many industrialized countries to LDCs are not regulated to the same extent as medicines produced and distributed within a given nation, increasing the likelihood of counterfeit drugs being distributed worldwide (Frankish 2003). The overall lack of regulation and enforcement has intensified the counterfeit drug situation (Bouchie 2003;Ham 2003). ...
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Both nationally and internationally, pharmaceutical counterfeiting has become a problem that is threatening economic stability and public health. The purpose of the present research study review was to analyze the scope and severity of pharmaceutical counterfeiting and to establish if the implantation of the Radio Frequency Identification Device (RFID) model can more efficiently be used within the pharmaceutical supply chain to reduce the problem counterfeit drugs impose on public health and international economic stability. Results indicated that implementing the RFID model for tracking drugs at the item level in the pharmaceutical supply chain has potential to alleviate the scope of the counterfeit drug problem. Recommendations for how the pharmaceutical industry may sooner adopt the RFID model are made.
... In order to delay or even overcome the emerging of resistance, the control of malaria chemotherapy requires reducing the overall drug pressure throughout more selective use of qualified drugs and improving the ways the drugs are used and sold in the markets. However, one of the most critical challenges to the chemotherapy of malaria in developing countries is the wide scale availability of fake and substandard drug products (Ten, 2003). Quality control is an important process in the pharmaceutical industry and marketing of safe drugs with consistent and predictable therapeutically active formulations (Levi et al., 1964). ...
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Malaria is the biggest killer of African children, yet it is cheaply preventable and curable with insecticides spraying, impregnated bednets and effective drugs. This study aimed to evaluate the quality of Chloroquine (CQ) tablets available in selected African countries. Twenty-six samples of antimalarial CQ tablet of 100, 150 and 250 mg were collected from 12 African countries and evaluated for their quality in the Drugs Quality Control Laboratory of Rabat, Morocco. The identification and dosage of active pharmaceutical ingredients in the tablets, dissolution rate, hardness and the friability of CQ tablets were performed according to the United States Pharmacopeia (USP) and European Pharmacopoeia (Eur.Ph.) recommended methods. The results showed that 7·7% of the sampled CQ tablets available in Burkina Faso were of low quality. Failure in dissolution profile was found in 50% of CQ tablets sampled from Benin, Burkina Faso, Comoros Union, Mali and Senegal. The findings showed poor quality of CQ tablets available in the African market. This problem may affect the efforts to control malaria in Africa. Efficient regulatory systems of drugs quality control should be implemented.
... The issue of fake and adulterated drug, a common phenomenon in Nigeria (Raufu, 2002) might also necessitate a study of this nature. Use of fake drugs causes not only premature death, but sometimes permanent disability (Raufu, 2002; ten Ham, 2003; Seiter 2009). One major cause of this problem is the use of substandard chemicals in the preparation of these drugs, sometimes not only the active ingredient itself, but the additives as well. ...
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Studies' reports in both humans and experimental animals have supported the use of methionine as an effective antidote to counteract the manifestation of hepatotoxicity, which is a common occurrence of acetaminophen at overdose levels of exposure. This study was embarked on to test the hepatoprotective effect of methionine in acetaminophen tablets, produced by a leading paracetamol brand in Nigeria especially in ameliorating the hepatocellular damage for which acetaminophen is noted for. Ten percent methionine was detected in this formulation using HPLC technique. Twenty male Wistar rats were used for this purpose, they were divided equally into four groups, and the first group served as the control and received 2 ml of physiologic saline per rat. The other three groups served as the test groups and received 100, 350 and 1000 mg\kg BW of acetaminophen dissolved in 2 ml of physiologic saline per rat. The drug was introduced into the rats by intra-peritoneal route of administration. The study lasted for 48 h after which the animals were sacrificed and blood obtained by cardiac puncture. Results showed that all these hepatotoxic indices and liver function tests (aspartate and alanine amino transferases, alkaline phoshatase, total and conjugated bilirubin, total proteins, albumin and globulins) of rats in both 350 and 1000 mg\kg levels were not statistically different compared to the controls (p > 0.05). The rats in the 100 mg\kg set showed the same pattern except that total proteins and globulins were statistically increased in these rats compared to controls (p < 0.05). These results therefore, show that methionine containing acetaminophen in tablet form ameliorated the toxic effects of acetaminophen even at toxic level of 1000 mg\kg level BW.
... Low-quality medicines are a global issue because of their increasing prevalence and the potentially serious consequences of their use [1,2]. Although developing countries are the principal targets of counterfeiters, developed countries also face many of the same risks [3,4]. ...
Article
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Objectives: To classify community pharmacies (CPs) in Riyadh, Saudi Arabia, in terms of the quality of medicines sold by them, using the lot quality assurance sampling (LQAS) technique with a predefined threshold. Methods: Riyadh CPs were divided into 2 categories (“lots” for the purpose of LQAS), i.e., chain and independent CPs. Upper and lower rate thresholds for CPs that sell low-quality medicines were predefined as 20% and 5%, respectively. Consumer and provider risks were predefined as 0.05 and 0.10, respectively. The calculated number of randomly selected CPs required in each lot was 36; then, sale of low-quality medicines in >3 CPs implies a prevalence of >20% of such CPs according to LQAS. A randomly selected brand of amoxicillin (selected as a quality indicator of medicines because it is both widely counterfeited and heat-sensitive) was purchased from each pharmacy by a “mystery shopper”, checked for authenticity, and analyzed for drug content and content uniformity using a validated HPLC method. Results: Substandard amoxicillin was purchased in 9 pharmacies (4 chains and 5 independent). Both lots were thus rejected as unacceptable, which may indicate that consumers in Riyadh are at risk of purchasing substandard medicines at CPs. Conclusions: The quality of medicines sold in CPs in Riyadh did not meet our acceptability criterion, and appropriate intervention by decision makers is recommended. LQAS proved to be a practical, economical, and statistically valid sampling method for surveying the quality of medicines. It should enable decision makers to allocate resources for improvement more efficiently.
... However, one of the most important challenges in the chemotherapy of malaria and other infectious diseases in less developed countries, where these diseases are of immense public health importance, is the wide scale availability of fake and substandard drug products [4]. Substandard drugs contribute to the spread of drug-resistant malaria parasites and may lead to increasing therapeutic failure and medical expense [5]. ...
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Malaria is a major public health problem in endemic countries, and the quality of antimalarial products is a concern in the therapeutic management of individual patient. In this study, we have evaluated the pharmaceutical quality of chloroquine and paracetamol oral products obtained from a major Nigerian drug “market” using a less elaborate sampling procedure. Results have shown that there are still some defects in the pharmaceutical quality of these drugs, despite the activities of the Nigeria\'s drug regulatory agency (National agency for Food and Drug Administration and Control, NAFDAC). 21% (7/34) of the drug products were not registered by NAFDAC. The pharmaceutical properties of the products indicated that 6, 15, 9, and 9% of them failed tests for disintegration, dissolution, crushing strength, and percentage of active content, respectively. 4 out of the 6 chloroquine liquid preparations evaluated had inadequate active content. These defects could have resulted from deliberate counterfeiting, poor quality control during manufacture or decomposition of the products. However, this could not be ascertained from the data available to us in this study. The implication of these findings, however, is that the newer anti-malarial drugs that have recently been introduced into the Nigerian market should be safeguarded, if their therapeutic usefulness must be sustained. African Journal of Health Sciences Vol. 14 (3-4) 2007: pp. 164-170
... Some medicines were even lacking the active ingredient [14]. The use of substandard medicines may result in therapeutic failure, resistance development, and occurrence of serious adverse events or even death due to excessive dose or the presence of toxic impurities [15][16][17]. A study conducted in sub-Saharan Africa in 2010 on the quality of selected anti-malarial medicines reported 64% overall quality failure in Nigeria, from which one artemisinin-based anti-malarial drug sample did not contain any of artemether API [18]. ...
Article
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... Such policy that only considers price with very little emphasis on the quality of pharmaceutical product and service of the tenderer is one of the contributing factors to drug shortages (Management Sciences for Health, 2012; Dranitsaris et al., 2017). Moreover, many regulatory bodies around the world have recalled several pharmaceutical products from the market for safety concerns (Tawde, 2014;Ten Ham, 2003;Johnston and Holt, 2014). Therefore, the current government procurement policy for pharmaceuticals needs to be revised to include innovative payment arrangement such as outcome-based contracts (Adamski et al., 2010). ...
Article
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... The increasing prevalence of low-quality medicines has become a global public health issue because of the dangerous therapeutic consequences associated with their use (Ten Ham, 2003). Lowquality medicines are either counterfeit or substandard products. ...
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... Such policy that only considers price with very little emphasis on the quality of pharmaceutical product and service of the tenderer is one of the contributing factors to drug shortages (Management Sciences for Health, 2012; Dranitsaris et al., 2017). Moreover, many regulatory bodies around the world have recalled several pharmaceutical products from the market for safety concerns (Tawde, 2014;Ten Ham, 2003;Johnston and Holt, 2014). Therefore, the current government procurement policy for pharmaceuticals needs to be revised to include innovative payment arrangement such as outcome-based contracts (Adamski et al., 2010). ...
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The Internet is an ever expanding means for information, communication, entertainment and trade. With greater and greater frequency, patients are using the Internet to access health related information and purchase of drugs. The benefit is that on line sales of drugs by legal, reputable pharmacies has provided significant lowering of cost to patients. On the other hand, numerous online drug websites present serious health risks to patients and unique challenges to regulators, law enforcement officials and policy makers. The patient who purchases prescription drugs in cyberspace cannot easily distinguish between legal and illegal pharmacies. There is an increasing amount of evidence being published that illegal pharmacies sell drugs for which there is no quantitative or qualitative control of the active substance or the excipients they contain, that they are contaminated, and that there are no controls for their efficacy. This lack of control results to increased adverse reactions and/or decreased efficacy, and may lead to increased morbidity and mortality. There is need of institutional authorities for trade, justice and health, at national and international level to increase their vigilance and implement risk-based strategies to protect public health, regardless of the jurisdiction that a patient resides or an illegal cyber-space pharmacy is located.
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Malaria is a major public health problem in endemic countries, and the quality of anti-malarial products is a concern in the therapeutic management of individual patient. In this study, we have evaluated the pharmaceutical quality of chloroquine and paracetamol oral products obtained from a major Nigerian drug "market" using a less elaborate sampling procedure. Results have shown that there are still some defects in the pharmaceutical quality of these drugs, despite the activities of the Nigeria's drug regulatory agency (National agency for Food and Drug Administration and Control, NAFDAC). 21% (7/34) of the drug products were not registered by NAFDAC. The pharmaceutical properties of the products indicated that 6, 15, 9, and 9% of them failed tests for disintegration, dissolution, crushing strength, and percentage of active content, respectively. 4 out of the 6 chloroquine liquid preparations evaluated had inadequate active content. These defects could have resulted from deliberate counterfeiting, poor quality control during manufacture or decomposition of the products. However, this could not be ascertained from the data available to us in this study. The implication of these findings, however, is that the newer anti-malarial drugs that have recently been introduced into the Nigerian market should be safeguarded, if their therapeutic usefulness must be sustained.
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Buprenorphine, commonly known by the trademark Temgesic, is one of the most popular drugs of abuse among the opioid-addicted young individuals in Iran. Temgesic, Bungesic, etc. are the most popular and important illicit opioid drugs in Tehran's illicit drugs black market, and are now among the most widely abused by opioid addicts. Because of this, counterfeiting of this drug has increased in Tehran. In this study, the qualitative analysis of counterfeit buprenorphine by gas chromatography-mass spectrometry (GC-MS) and high performance liquid chromatography (HPLC) demonstrates the presence of diacetylmorphine, acetylcodeine and pheniramine, as well as the absence of buprenorphine. In conclusion, due to the absence of quality control and difficulties in differentiating counterfeit buprenorphine from genuine products, the use of counterfeit buprenorphine leads the opioid abusers to health risks.
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