- Email: [email protected]
Counterfeit medicines: Report of a cross-sectional retrospective study in Iran
p u b l i c h e a l t h 1 2 5 ( 2 0 1 1 ) 1 6 5 e1 7 1
available at www.sciencedirect.com
Public Health journal homepage: www.elsevier.com/puhe
Original Research
Counterfeit medicines: Report of a cross-sectional retrospective study in Iran S.A.R. Hosseini a,*, Sh. Darbooy a, S.A. Tehrani Banihashemi a, S.M. Naseri a, R. Dinarvand b a
Office of Applied Research, Food and Drug Research Center, Deputy Ministry for Food and Drugs, Ministry of Health and Medical Education, Tehran, Iran b Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
article info
summary
Article history:
Objectives: To gain insight into the pharmaceutical grey market in Iran by reviewing
Received 14 January 2010
inspection files of the Special Inspectorate Unit, Deputy Ministry for Food and Drugs,
Received in revised form
Ministry of Health and Medical Education, and to define the counterfeit pharmaceutical
9 August 2010
pattern in Iran.
Accepted 25 November 2010
Study design: Cross-sectional retrospective study. Methods: In total, 382 inspection files of pharmaceutical counterfeit cases between 2007 and 2008 were reviewed. A database was constructed in Microsoft Access, and all cases of
Keywords:
counterfeit medicines together with the details recorded in the files were entered. A
Counterfeit medicines
primary list of all items in all files was produced (n ¼ 7910), and this contained 716 different
Inspection
counterfeit medicines. This article reports the analysis of these 716 items and the outcome.
Pharmaceutical market
Subsequently, the list of items was further filtered, and a final working list of 100 items was
Retrospective study
selected for further analysis. Drug samples of the working list were collected and checked
Iran
against a modified version of the ‘Checklist for the visual inspection of medicines to identify suspicious drug products’ of the US Pharmacopeia Convention, Inc. and recommended by IMPACT (International Medical Products Anti-Counterfeiting Taskforce). Details of items in the working list recorded in the checklist were then entered into the database. Data were analysed using Statistical Package for the Social Sciences Version 12.0 and Microsoft Excel. Results: Of the 716 items, 64.5% were supplements, 10.2% were analgesics, 7.8% were hormones and 3.2% were antihistamines. Unnamed items and/or items of unknown origin accounted for 2.4% of the total. Herbal medicines, drugs used in the central nervous system, gastrointestinal system and genito-urinary systems, and drugs used for cardiovascular disease and diabetes represented 1e2% of items, and other drug groups accounted for <1% of the 716 counterfeit medicines. Drugs used in professional settings accounted for w20% and drugs used in non-professional settings accounted for w15% of the 716 items. Selected items were checked against the World Health Organization’s visual checking tool, and the following observations were made: 15.8% showed mismatch between the label and the container, 7.9% showed the incorrect manufacturer’s name and
* Corresponding author. P.O. Box 13475/358, Tehran, Iran. Tel./fax: þ98 2166417252. E-mail address: [email protected] (S.A.R. Hosseini). 0033-3506/$ e see front matter ª 2010 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.puhe.2010.11.015
166
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address, 82.9% showed existence or a different view of the logo and hologram of the product, and 18.4% used poor-quality paper for the insert. In 73.7% of products checked, the ink of the packaging or inserts was not smudge-proof. Conclusion: Results from this study have been utilized by the Deputy Ministry for Food and Drugs in Iran and the outcome was a faster registration and market authorization of supplements compared with other pharmaceutical products. Inter- and intra-section collaboration, active vigilance and conducting educational programs at different levels would reduce the risk of counterfeit medicines and protect public health. ª 2010 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.
1.
Introduction
According to the World Health Organization (WHO), ‘a counterfeit drug/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. Counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging’.1 Counterfeit medicines are becoming an increasing threat to patient safety, representing at least 10% of medicines available on the global market, and are found in both developed and developing countries.2 In developed countries, counterfeiting most frequently affects lifestyle drugs such as hormones, steroids, drugs used for erectile dysfunction and anti-allergy medicines. However, in developing countries, livesaving pharmaceuticals used to treat malaria, tuberculosis and HIV/AIDS, and other antibiotics are often counterfeit. WHO reports suggest that developing countries account for up to 60% of all reported cases of counterfeit and substandard drugs, and predict that the total counterfeit drug market will increase by >90% in 2010 compared with 2005.3 A WHO survey on counterfeit medicines in 20 countries found that an active ingredient was missing from the product in 60% of the 325 cases studied. This study found that only 4% of counterfeit medicines contained the same quantity and quality of medication as their authentic counterparts. This study also found that counterfeit drugs included analgesics, drugs for fever control, anti-malarials, anti-asthma and antiallergy drugs, antibiotics, hormones and steroids.4 From a public health point of view, the most threatening consequences of counterfeit medicines include waste of resources, lack of or poor patient outcomes, poisoning, disability and even death. In addition, violation of trademark law and/or the rights of the originators, regardless of the drug being a brand or generic product, are important commercial issues.5 Breakdown in healthcare infrastructure, insufficient or lax regulatory structure and law enforcement, and highly priced essential medicines have been proposed to make a country susceptible to counterfeit medicines.6 Iran is a large country with a population of approximately 70 million people; it is ranked as a loweremiddle income country. The overall size of the pharmaceutical market in Iran is approximately $2.3 billion, at retail prices, including all subsidies. Most of the drugs are manufactured locally (95% in volume, 70% in value) by approximately 70 different manufacturers.7 Market access and prices are regulated by the
Ministry of Health and Medical Education (MOHME; the Ministries of Medical Education and Health were integrated in 1985), and high tariffs protect the local industry against foreign competition. A generic drug policy, in which all medicines were only registered by their generic names not the brand names, constructed a major component of Iran’s pharmaceutical policy. This policy continued until 2002, after which the concept of branded generics has been adopted to provide an identity for generic pharmaceutical products and provoke competition amongst domestic drug producers. In this setting, while most of the drugs are manufactured locally, certain life-saving or disease-modifying patented drugs that cannot be made in Iran (e.g. drugs for haemophilia, thalassaemia, multiple sclerosis, kidney and hepatic transplants, diabetes) are imported and subsidized by MOHME so that retail prices are much lower than the real prices in other countries. This has led to some degree of smuggling of these drugs out of Iran into other countries, where they can be sold at a profit. This issue, while requiring urgent attention and intervention, has not been covered in this report since the scope of the current study was on counterfeiting in the pharmaceutical grey market inside Iran. Iran is a major transit country for the illicit narcotics trade, and it is assumed that the transit pathways are also used as a major route for other illegal goods, including counterfeit medicines. While it is difficult to provide exact evidence for the size and value of the pharmaceutical grey market in Iran due to the nature of this phenomenon, officials estimate that approximately 7e10% of the total market (around $200 million) is represented by the pharmaceutical grey market.8 Counterfeit medicines have been discovered in certain areas. In addition to the official channels of some 8000 pharmacies, there seem to be ‘grey’ import channels for certain branded drugs that are not listed in the Iran National Drug List (INDL). These products are sometimes sold through official outlets. There is also a market for unregistered, unnamed drugs of dubious origin and composition which are sold outside regular pharmacies, in fitness studios, cosmetic salons or on street corners. In terms of regulation, the Deputy Ministry for Food and Drugs, MOHME has the highest regulatory authority over pharmaceutical affairs at national level. At regional level, the Deputies of Food and Drugs in 41 medical universities, all guided by MOHME, are in charge and oversee pharmaceutical matters. Therefore, inspections of pharmacies and monitoring of the pharmaceutical market in the provinces are conducted at 3-month intervals by the medical universities, and the Special Inspectorate Unit supervises all inspections in
p u b l i c h e a l t h 1 2 5 ( 2 0 1 1 ) 1 6 5 e1 7 1
the country and undertakes inspections on important and serious issues. The definition of counterfeit medicine in Iran is much wider than that of WHO previously described and this may result in different impact in communities once it is put in practice in executive and law enforcement settings. It states that ‘any action taken on import, transportation, storage, distribution, dispensing, selling, buying and production of any kind of medicines and nutritional supplements, without government approval (regulatory authorities), in the pharmaceutical market is considered illegal and such medicines are considered as counterfeit’. This study aimed to gain insight into the pharmaceutical grey market in Iran by reviewing inspection files of the Special Inspectorate Unit, Deputy Ministry for Food and Drugs, MOHME, and checking the confiscated counterfeit samples against a visual checking tool recommended by WHO. This study also aimed to define the counterfeit pharmaceutical pattern in Iran.
2.
Methods
This cross-sectional retrospective study reviewed 382 inspection files of pharmaceutical counterfeit cases in the 18 months prior to this study (i.e. cases of 2007 and 2008) at the Special Inspectorate Unit, Deputy Ministry for Food and Drugs, MOHME. As explained above, inspecting pharmacies and monitoring the
167
pharmaceutical market in the provinces is a routine activity for the 41 medical universities in Iran. The Special Inspectorate Unit supervises these activities and deals with the most serious cases. All cases handled by the Special Inspectorate Unit during the study period were therefore included in this study. A database was constructed in Microsoft Access and all cases of counterfeit medicines together with the details recorded in the files were entered into the database. A primary list of all items in all files was produced (n ¼ 7910), and this contained 716 different counterfeit medicines. Analysis of this list of 716 items and the outcome are presented in the Results section. Unnamed items (including unreadable items), items of unknown origin (manufacturer) and counterfeit medicines with very few cases were filtered, and the resulting list was presented to an expert panel of inspectors (pharmacy doctors) and clinicians (medical doctors) from medical universities. The expert panel scored individual items in the drug list (0-100) for two criteria of clinical importance (A) and volume of the item in the grey market (B). The drug list was then sorted based on total score of (2A þ B) calculated for each item. A final list of 100 items was selected which included the most widely used items with the highest clinical importance. This list of products formed the working list for further analysis. Selected items of the working list were collected and checked against a modified version of the ‘Checklist for the visual inspection of medicines to identify suspicious drug products’ of the US Pharmacopoeia Convention, Inc. and recommended by IMPACT (International Medical Products Anti-Counterfeiting
Fig. 1 e Frequency of drug items in counterfeit market in Iran. CNS, central nervous system; GI, gastrointestinal; ENT, ear, nose and throat.
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Table 1 e Counterfeit medicine market in Iran. Location of discovery
Frequency (%)
Vendors Shops/supermarkets/pharmacies Hidden stores House Car Unknown
42.2 37.3 19.05 1.17 0.26 0.02
Taskforce).9 Permission was also obtained from the judicial system to access the actual medications, since all confiscated counterfeit drugs were under the authority and control of this system following discovery by MOHME inspectors. Further details of items in the working list recorded in the checklist were entered into the database. Data were analysed using Statistical Package for the Social Sciences Version 12.0 and Microsoft Excel.
3.
Results
Data from 382 inspections by the Special Inspectorate Unit were analysed in this study to gain insight into the pharmaceutical grey market in Iran, and to define the counterfeit pharmaceutical pattern in the country. In total, 716 counterfeit medicines were found, according to the Iranian definition. These items were classified in drug groups and the frequency of each group was determined. Supplements were the most common counterfeit medicine (64.5%), followed by analgesics (10.2%), hormones (excluding drugs used in diabetes) (7.8%) and antihistamines (3.2%).
Unnamed items and/or items of unknown origin accounted for 2.4% of the total. Herbal medicines, drugs used in the central nervous system, gastrointestinal system and genitourinary (including sexual dysfunction) system, and drugs for cardiovascular disease and diabetes accounted for 1e2% of items, and all other drug groups accounted for <1% of the 716 counterfeit medicines (Fig. 1). Of the 716 counterfeit medicines, 21.8% could have been legally imported, indicating that they were all registered medicines and included in the INDL. However, 64% were not existed in the INDL, suggesting that there is demand for this proportion of medicines in the community. Forty-two percent of the 712 counterfeit medicines were distributed by vendors, and 37% were discovered in shops, supermarkets and pharmacies (Table 1). With the exclusion of supplements, the other drug groups were classified as ‘drugs used in professional settings’ and ‘drugs used in non-professional settings’ (see Fig. 2 for definitions). Drugs used in professional settings accounted for w20% of the 716 counterfeit medicines, and drugs used in nonprofessional settings accounted for w15%. Supplements were the most common type of counterfeit medicine (64.5%) (Fig. 2). The top 10 brands of supplements, and drugs used in professional and non-professional settings are presented in Tables 2e4. Table 5 summarizes the information from WHO’s recommended checklist of selected samples of counterfeit medicines in Iran. While some items in the checklist could be indicative of products being counterfeit [e.g. mismatch on the label and container (15.8%), incorrect manufacturer’s name
Counterfeit Classification in Iran (Drug Use)
Supplements Professional setting
Percentage
80.00
Non-professional setting Unknown
60.00 40.00 20.00 0.00 Drug Class
Definitions: Drugs used in professional settings: cardiovascular, diabetes, gynaecology, respiratory, central nervous system (including cyclo-oxygenase II inhibitors), antibiotics, gastrointestinal, hormones, musculoskeletal. Drugs used in non-professional settings: analgesics (others), cold preparations, herbal laxatives, over-thecounter drugs. Supplements: vitamins, minerals, glucosamines, omega3, weight lowering/increasing.
Fig. 2 e Counterfeit medicine market in Iran: proportion of drugs used in professional and non-professional settings (excluding supplements).
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Table 2 e Top 10 brands of drugs used in professional settings in counterfeit market in Iran.
Table 4 e Top 10 supplements found in counterfeit market in Iran.
Brand used in professional settings (manufacturer)
Supplement (manufacturer)
Anabol Tab (British Dispensary) L-Thyroxin Tab (Berlin Chemie) Glucophage Tab (Merck) Fin pecia Tab (Cipla) Diclofenac Inj (Troge) Lipitor 20 mg Tab (Parke Davis) Tramadol Cap (Hexal) Omeprazole Cap (Brown & Burk & Essential) Norvasc 5 mg Tab (Pfizer) Tenuate retard Tab (Artegodan)
Frequency (%) 17.64 9.00 4.55 4.22 4.08 2.94 2.90 2.85 2.84 2.24
and address (7.9%), having a logo or a different view of the logo and hologram of the product (82.9%) and quality of the insert paper (18.4%)], these may not be applicable in all cases confiscated from the Iranian grey pharmaceutical market. In 73.7% of the products checked, the ink on the packaging or inserts was not smudge-proof (Table 5, item 17). This could be a good indicator to consider in visual checking of these types of product, and could be included in public education programmes in the country. Nevertheless, it would be difficult to mark a product as counterfeit using many other items in the visual checklist, given that a high frequency of the samples checked in this study seemed to be correct (Table 5). Of course, laboratory checking of these products would identify the actual nature of medications checked using the visual checking tool.
4.
Discussion
In this survey, the pattern of counterfeit medicine in the pharmaceutical grey market in Iran was defined by reviewing MOHME’s inspection files from 2007 to 2008. Supplements were the most common type of counterfeit medicine, followed by analgesics, hormones and antihistamines. Drugs used in professional settings, including drugs for cardiovascular diseases, diabetes, gynaecology, respiratory system, central nervous system [including cyclo-oxygenase II (COX II) inhibitors], antibiotics, gastrointestinal system, hormones and
Table 3 e Top 10 brands of drugs used in nonprofessional settings in counterfeit market in Iran. Brand used in non-professional settings (manufacturer) Aspirin 81 Tab (Kirkland) Zinadin Tab (Unknown) Bio Yeast Tab (Zanza) Novafen Cap (Brown & Burc) Radian Massage Cream (Roche) Panadol Tab (GSK) Advil Tab (Wyeth) Advil Cold & Sinus Tab (Wyeth) Exedrin Tab (Novartis) Novapen Cap (Unknown)
Frequency (%) 26.10 13.59 11.49 9.10 3.95 3.13 2.34 2.09 1.96 1.92
Omega 3 1000 mg Softgel (Now) Fefol Cap (Smith Kline) Glucosamine 500 mg Cap (Phyto pay) Fish Oil Cap (Alaska) Zink Plus Cap (Vitalia) Royal Jelly Softgel (Nature’s Bounty) Vit E 400 Tab (Nutrilab) Centrum Tab (Wyeth) Multivitamin Eff Tab (Kruger) Cider Vinegar Tab (Nature’s Bounty)
Frequency (%) 23.05 9.60 7.48 5.35 3.86 2.75 2.66 2.07 1.95 1.92
musculoskeletal system, accounted for w20% of the 716 counterfeit medicines. Drugs used in non-professional settings, including analgesics (excluding COX II inhibitors), cold preparations, herbal laxatives and over-the-counter drugs, represented w15% of the 716 counterfeit medicines. Drugs to treat malaria, tuberculosis and HIV/AIDS, reportedly found in the counterfeit market in developing countries, were absent in the pharmaceutical grey market in Iran. This is because national disease control programmes on certain diseases, including malaria, tuberculosis and HIV/AIDS, provide all health services including pharmaceutical procurement and care for patients through the national primary healthcare network. Therefore, it seems that the drug counterfeit pattern in Iran is more similar to that in developed countries, and that the counterfeit market in Iran is influenced by the global counterfeit network. The main items found in the pharmaceutical counterfeit market in Iran were supplements (64.5%), which suggested the need for urgent intervention. The Deputy Ministry for Food and Drugs, therefore, set up a special line for registration of supplements during the course of this study, such that regulations for their registration became more straightforward compared with other pharmaceuticals, facilitating faster approval and market authorization of these products. Other interventions undertaken by the Deputy Ministry for Food and Drugs, reflecting its multi-section collaboration strategy, included conducting regular joint meetings with the security forces, the police and the law enforcement judiciary system to promote collaborations, identify the gaps in regulations and achieve a common understanding of the impact of counterfeit medicines in public health. These interventions are ongoing. Currently, legislation does not allow punishment of counterfeiters or distributors of counterfeit drugs in accordance with the severity of the crime (given that counterfeit drugs can kill), and sanctions for counterfeiting medicines are not very heavy. Since the current legislations for food and drugs are under revision and a comprehensive law for food and drugs is being considered for approval by Parliament, it is envisaged that making or selling counterfeit drugs will become a separate criminal offence in new drug law. Other studies on drug use in Iran suggest that the demand for pharmaceuticals not listed in the INDL is partly generated by doctors who received training abroad or by patients who have received treatment abroad.10e12 Promotion of pharmaceuticals through mass media is currently prohibited according
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Table 5 e Collated information of World Health Organization recommended checklist on counterfeit medicines in pharmaceutical grey market in Iran. Checked item Packaging 1 Does the container and closure protect the product from the outside environment? Properly sealed? 2 Are the container and closure appropriate for the product inside? 3 Is the container safely sealed? 4 Does the label on the carton match the label on the container? 5 Is all information on the label legible and Indelible? 6 Is the trade name spelt correctly? 7 Is the medicinal product (trade name) registered in the country by the Drug Regulatory Authority? 8 Does the symbol follow the trade name? 9 Is the active ingredient name spelt correctly? 10 Are the manufacturer’s name and logo legible and correct? 11 Does the logo or hologram (if applicable) change colour when viewed from different angles? 12 Is the manufacturer’s full address legible and correct? 13 Does the number of dosage units listed on the label match that of dosage units stated on the container? 14 Are the manufacture and expiry dates clearly indicated on the label? 15 Are the storage conditions indicated on the label? 16 Is the package insert printed on the same coloured or same quality paper as the original? 17 Is the ink on the package insert or packaging smudge-proof? Physical characteristics of tablets/capsules 18 Are the tablets/capsules uniform in shape? 19 Are the tablets/capsules uniform in size? 20 Are the tablets/capsules uniform in colour? 21 Do the tablets have a uniform coating? 22 Are the bases of the tablets fully covered? 23 Are the tablets/capsules free of breaks, cracks, splits or pinholes?
Yes No Unknown % % % 92.1
3.9
3.9
94.7
2.6
2.6
76.3 81.6
15.8 15.8
7.9 2.6
88.2
7.9
3.9
97.4 0 See Fig. 2
2.6
39.5
55.3
5.3
90.8
3.9
5.3
85.5
7.9
6.6
13.2
82.9
3.9
78.9 117.1
3.9
85.5
2.6
11.8
22.4
2.6
88.2
7.9
3.9
60.5
18.4
21.1
5.3
73.7
21.1
88.2
2.6
9.2
90.8
0
9.2
86.8
3.9
9.3
89.5 89.5
1.3 1.3
9.2 9.2
85.5
5.3
9.2
Food and Drugs. Educational packages on counterfeit medicines for different groups of healthcare providers, including doctors, pharmacists and nurses, have been developed and included in continuous medical education programmes. Public education programmes on counterfeit medicines are also in practice using all types of mass media to address different dimensions and impacts of counterfeit medicines. The Deputy Ministry for Food and Drugs has also established a drug regulatory network within Economic Cooperation Organization countries (ECODRAN), and the first meeting of ECODRAN was held in 2008. Combating counterfeit medicines was an important area of collaboration addressed at this meeting, and a working group for this initiative was formed to define further actions and follow-ups to establish a reporting centre to share information on counterfeit medicines, control borders to minimize counterfeit transport, and collaborate in laboratory testing of counterfeit drugs. In conclusion, this study provided insight into a growing public health problem, defined the pattern of counterfeit medicines in the pharmaceutical grey market, and reviewed relevant strategies and interventions of MOHME in Iran. Greater political commitment, promotion of inter- and intrasection collaborations, active vigilance, educational programmes and active follow-up on the interventions described would minimize the impact of counterfeit medicines on public health.
Ethical approval None sought.
Funding 75
to the current laws and regulations in Iran. However, Iranian citizens have wide access to the Internet and satellite television, through which all means of drug promotion and direct-tocustomer services are provided. This also seems to have an important impact on Iranian demand for new pharmaceutical products advertised and their lifestyle in terms of drug use. In this respect, conducting target-oriented educational programmes is an important strategy of the Deputy Ministry for
Deputy Ministry for Co-ordination, Ministry of Health and Medical Education, Iran.
Competing interests None declared.
Acknowledgements The authors wish to thank Dr Andreas Zeiter, Dr Fatemeh Kheirkhah, Mr Mohammad Poursafar, Dr Siavash Golmohammadi, Dr Morteza Pirali, Mr Salaman Bahremandi, Dr Ali Asghar Motahhari and Mr Abolfazl Mirrafie.
references
1. World Health Organization. General information on counterfeit medicines. Geneva: WHO. Available from: http://www.who.int/medicines/services/counterfeit/ overview/en/ [accessed 03.11.09]. 2. International Council of Nurses. Counterfeits kill. Nurses target counterfeit medicines. Geneva (Switzerland): WHO. Available from: http://www.icn.ch/indkit2005; 2005 [accessed 03.11.09]. 3. World Health Organization. Counterfeit medicines fact sheet. Geneva: WHO. Available from: http://www.who.int/ medicines/services/counterfeit/impact; 2006 [01.11.09].
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4. World Health Organization. Substandard and counterfeit medicines fact sheet. Geneva: WHO. Available from: http://www. who.int/mediacentre/factsheets/2003; 2003 [accessed 03.11.09]. 5. World Health Organization. Combating counterfeit drugs: a concept paper for effective international cooperation. Geneva: WHO. Available from: www.who.int/medicines/counterfeit conference/en/index.html; 2006 [accessed 07.11.09]. 6. World Health Organization. What encourages counterfeiting of medicines. Geneva: WHO. Available from: http://www.who.int/ medicines/services/counterfeit/faqs/15/en/index.html [accessed 05.11.09]. 7. Dinarvand R. New national drug policy in Iran leading to expanded pharmaceutical market and extended access of public to medicines. Iran J Public Health 2009;38(Suppl. 1): 158e61. 8. Director General of Pharmaceutical and Narcotic Affairs, Ministry of Health and Medical Education. Media interview.
9.
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12.
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Available from: http://www.behdasht.gov.ir; 2010 [accessed 30.07.10]. Tool for visual inspection of medicines. A checklist for visual inspection of medicines in order to identify suspicious products for further examination. Geneva: WHO. Available from: http://www.fip.org/counterfeitmedicines.com [accessed 12.11.09]. Sepehri Gh, Shamsi Meimandi M. The quality of prescribing in general practice in Kerman, Iran. Int J Health Care Qual Assur 2005;18(5):353e60. Garjani A, Shamsmohamadi M, Baghchevan V, Vahidi RG, Maleki Dijazi N, Rezazadeh H. Effect of interactive group discussion among physicians to promote rational prescribing. East Med Health J 2009;15:408e15. Jafari M, Ranjdoost H, Ayatollahi B. Frequency of illegal medicines prescribing by Zanjan physicians. J Zanjan Univ Med Sci 2006;14:40e6 [in Farsi].
available at www.sciencedirect.com
Public Health journal homepage: www.elsevier.com/puhe
Original Research
Counterfeit medicines: Report of a cross-sectional retrospective study in Iran S.A.R. Hosseini a,*, Sh. Darbooy a, S.A. Tehrani Banihashemi a, S.M. Naseri a, R. Dinarvand b a
Office of Applied Research, Food and Drug Research Center, Deputy Ministry for Food and Drugs, Ministry of Health and Medical Education, Tehran, Iran b Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
article info
summary
Article history:
Objectives: To gain insight into the pharmaceutical grey market in Iran by reviewing
Received 14 January 2010
inspection files of the Special Inspectorate Unit, Deputy Ministry for Food and Drugs,
Received in revised form
Ministry of Health and Medical Education, and to define the counterfeit pharmaceutical
9 August 2010
pattern in Iran.
Accepted 25 November 2010
Study design: Cross-sectional retrospective study. Methods: In total, 382 inspection files of pharmaceutical counterfeit cases between 2007 and 2008 were reviewed. A database was constructed in Microsoft Access, and all cases of
Keywords:
counterfeit medicines together with the details recorded in the files were entered. A
Counterfeit medicines
primary list of all items in all files was produced (n ¼ 7910), and this contained 716 different
Inspection
counterfeit medicines. This article reports the analysis of these 716 items and the outcome.
Pharmaceutical market
Subsequently, the list of items was further filtered, and a final working list of 100 items was
Retrospective study
selected for further analysis. Drug samples of the working list were collected and checked
Iran
against a modified version of the ‘Checklist for the visual inspection of medicines to identify suspicious drug products’ of the US Pharmacopeia Convention, Inc. and recommended by IMPACT (International Medical Products Anti-Counterfeiting Taskforce). Details of items in the working list recorded in the checklist were then entered into the database. Data were analysed using Statistical Package for the Social Sciences Version 12.0 and Microsoft Excel. Results: Of the 716 items, 64.5% were supplements, 10.2% were analgesics, 7.8% were hormones and 3.2% were antihistamines. Unnamed items and/or items of unknown origin accounted for 2.4% of the total. Herbal medicines, drugs used in the central nervous system, gastrointestinal system and genito-urinary systems, and drugs used for cardiovascular disease and diabetes represented 1e2% of items, and other drug groups accounted for <1% of the 716 counterfeit medicines. Drugs used in professional settings accounted for w20% and drugs used in non-professional settings accounted for w15% of the 716 items. Selected items were checked against the World Health Organization’s visual checking tool, and the following observations were made: 15.8% showed mismatch between the label and the container, 7.9% showed the incorrect manufacturer’s name and
* Corresponding author. P.O. Box 13475/358, Tehran, Iran. Tel./fax: þ98 2166417252. E-mail address: [email protected] (S.A.R. Hosseini). 0033-3506/$ e see front matter ª 2010 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.puhe.2010.11.015
166
p u b l i c h e a l t h 1 2 5 ( 2 0 1 1 ) 1 6 5 e1 7 1
address, 82.9% showed existence or a different view of the logo and hologram of the product, and 18.4% used poor-quality paper for the insert. In 73.7% of products checked, the ink of the packaging or inserts was not smudge-proof. Conclusion: Results from this study have been utilized by the Deputy Ministry for Food and Drugs in Iran and the outcome was a faster registration and market authorization of supplements compared with other pharmaceutical products. Inter- and intra-section collaboration, active vigilance and conducting educational programs at different levels would reduce the risk of counterfeit medicines and protect public health. ª 2010 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.
1.
Introduction
According to the World Health Organization (WHO), ‘a counterfeit drug/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. Counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging’.1 Counterfeit medicines are becoming an increasing threat to patient safety, representing at least 10% of medicines available on the global market, and are found in both developed and developing countries.2 In developed countries, counterfeiting most frequently affects lifestyle drugs such as hormones, steroids, drugs used for erectile dysfunction and anti-allergy medicines. However, in developing countries, livesaving pharmaceuticals used to treat malaria, tuberculosis and HIV/AIDS, and other antibiotics are often counterfeit. WHO reports suggest that developing countries account for up to 60% of all reported cases of counterfeit and substandard drugs, and predict that the total counterfeit drug market will increase by >90% in 2010 compared with 2005.3 A WHO survey on counterfeit medicines in 20 countries found that an active ingredient was missing from the product in 60% of the 325 cases studied. This study found that only 4% of counterfeit medicines contained the same quantity and quality of medication as their authentic counterparts. This study also found that counterfeit drugs included analgesics, drugs for fever control, anti-malarials, anti-asthma and antiallergy drugs, antibiotics, hormones and steroids.4 From a public health point of view, the most threatening consequences of counterfeit medicines include waste of resources, lack of or poor patient outcomes, poisoning, disability and even death. In addition, violation of trademark law and/or the rights of the originators, regardless of the drug being a brand or generic product, are important commercial issues.5 Breakdown in healthcare infrastructure, insufficient or lax regulatory structure and law enforcement, and highly priced essential medicines have been proposed to make a country susceptible to counterfeit medicines.6 Iran is a large country with a population of approximately 70 million people; it is ranked as a loweremiddle income country. The overall size of the pharmaceutical market in Iran is approximately $2.3 billion, at retail prices, including all subsidies. Most of the drugs are manufactured locally (95% in volume, 70% in value) by approximately 70 different manufacturers.7 Market access and prices are regulated by the
Ministry of Health and Medical Education (MOHME; the Ministries of Medical Education and Health were integrated in 1985), and high tariffs protect the local industry against foreign competition. A generic drug policy, in which all medicines were only registered by their generic names not the brand names, constructed a major component of Iran’s pharmaceutical policy. This policy continued until 2002, after which the concept of branded generics has been adopted to provide an identity for generic pharmaceutical products and provoke competition amongst domestic drug producers. In this setting, while most of the drugs are manufactured locally, certain life-saving or disease-modifying patented drugs that cannot be made in Iran (e.g. drugs for haemophilia, thalassaemia, multiple sclerosis, kidney and hepatic transplants, diabetes) are imported and subsidized by MOHME so that retail prices are much lower than the real prices in other countries. This has led to some degree of smuggling of these drugs out of Iran into other countries, where they can be sold at a profit. This issue, while requiring urgent attention and intervention, has not been covered in this report since the scope of the current study was on counterfeiting in the pharmaceutical grey market inside Iran. Iran is a major transit country for the illicit narcotics trade, and it is assumed that the transit pathways are also used as a major route for other illegal goods, including counterfeit medicines. While it is difficult to provide exact evidence for the size and value of the pharmaceutical grey market in Iran due to the nature of this phenomenon, officials estimate that approximately 7e10% of the total market (around $200 million) is represented by the pharmaceutical grey market.8 Counterfeit medicines have been discovered in certain areas. In addition to the official channels of some 8000 pharmacies, there seem to be ‘grey’ import channels for certain branded drugs that are not listed in the Iran National Drug List (INDL). These products are sometimes sold through official outlets. There is also a market for unregistered, unnamed drugs of dubious origin and composition which are sold outside regular pharmacies, in fitness studios, cosmetic salons or on street corners. In terms of regulation, the Deputy Ministry for Food and Drugs, MOHME has the highest regulatory authority over pharmaceutical affairs at national level. At regional level, the Deputies of Food and Drugs in 41 medical universities, all guided by MOHME, are in charge and oversee pharmaceutical matters. Therefore, inspections of pharmacies and monitoring of the pharmaceutical market in the provinces are conducted at 3-month intervals by the medical universities, and the Special Inspectorate Unit supervises all inspections in
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the country and undertakes inspections on important and serious issues. The definition of counterfeit medicine in Iran is much wider than that of WHO previously described and this may result in different impact in communities once it is put in practice in executive and law enforcement settings. It states that ‘any action taken on import, transportation, storage, distribution, dispensing, selling, buying and production of any kind of medicines and nutritional supplements, without government approval (regulatory authorities), in the pharmaceutical market is considered illegal and such medicines are considered as counterfeit’. This study aimed to gain insight into the pharmaceutical grey market in Iran by reviewing inspection files of the Special Inspectorate Unit, Deputy Ministry for Food and Drugs, MOHME, and checking the confiscated counterfeit samples against a visual checking tool recommended by WHO. This study also aimed to define the counterfeit pharmaceutical pattern in Iran.
2.
Methods
This cross-sectional retrospective study reviewed 382 inspection files of pharmaceutical counterfeit cases in the 18 months prior to this study (i.e. cases of 2007 and 2008) at the Special Inspectorate Unit, Deputy Ministry for Food and Drugs, MOHME. As explained above, inspecting pharmacies and monitoring the
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pharmaceutical market in the provinces is a routine activity for the 41 medical universities in Iran. The Special Inspectorate Unit supervises these activities and deals with the most serious cases. All cases handled by the Special Inspectorate Unit during the study period were therefore included in this study. A database was constructed in Microsoft Access and all cases of counterfeit medicines together with the details recorded in the files were entered into the database. A primary list of all items in all files was produced (n ¼ 7910), and this contained 716 different counterfeit medicines. Analysis of this list of 716 items and the outcome are presented in the Results section. Unnamed items (including unreadable items), items of unknown origin (manufacturer) and counterfeit medicines with very few cases were filtered, and the resulting list was presented to an expert panel of inspectors (pharmacy doctors) and clinicians (medical doctors) from medical universities. The expert panel scored individual items in the drug list (0-100) for two criteria of clinical importance (A) and volume of the item in the grey market (B). The drug list was then sorted based on total score of (2A þ B) calculated for each item. A final list of 100 items was selected which included the most widely used items with the highest clinical importance. This list of products formed the working list for further analysis. Selected items of the working list were collected and checked against a modified version of the ‘Checklist for the visual inspection of medicines to identify suspicious drug products’ of the US Pharmacopoeia Convention, Inc. and recommended by IMPACT (International Medical Products Anti-Counterfeiting
Fig. 1 e Frequency of drug items in counterfeit market in Iran. CNS, central nervous system; GI, gastrointestinal; ENT, ear, nose and throat.
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Table 1 e Counterfeit medicine market in Iran. Location of discovery
Frequency (%)
Vendors Shops/supermarkets/pharmacies Hidden stores House Car Unknown
42.2 37.3 19.05 1.17 0.26 0.02
Taskforce).9 Permission was also obtained from the judicial system to access the actual medications, since all confiscated counterfeit drugs were under the authority and control of this system following discovery by MOHME inspectors. Further details of items in the working list recorded in the checklist were entered into the database. Data were analysed using Statistical Package for the Social Sciences Version 12.0 and Microsoft Excel.
3.
Results
Data from 382 inspections by the Special Inspectorate Unit were analysed in this study to gain insight into the pharmaceutical grey market in Iran, and to define the counterfeit pharmaceutical pattern in the country. In total, 716 counterfeit medicines were found, according to the Iranian definition. These items were classified in drug groups and the frequency of each group was determined. Supplements were the most common counterfeit medicine (64.5%), followed by analgesics (10.2%), hormones (excluding drugs used in diabetes) (7.8%) and antihistamines (3.2%).
Unnamed items and/or items of unknown origin accounted for 2.4% of the total. Herbal medicines, drugs used in the central nervous system, gastrointestinal system and genitourinary (including sexual dysfunction) system, and drugs for cardiovascular disease and diabetes accounted for 1e2% of items, and all other drug groups accounted for <1% of the 716 counterfeit medicines (Fig. 1). Of the 716 counterfeit medicines, 21.8% could have been legally imported, indicating that they were all registered medicines and included in the INDL. However, 64% were not existed in the INDL, suggesting that there is demand for this proportion of medicines in the community. Forty-two percent of the 712 counterfeit medicines were distributed by vendors, and 37% were discovered in shops, supermarkets and pharmacies (Table 1). With the exclusion of supplements, the other drug groups were classified as ‘drugs used in professional settings’ and ‘drugs used in non-professional settings’ (see Fig. 2 for definitions). Drugs used in professional settings accounted for w20% of the 716 counterfeit medicines, and drugs used in nonprofessional settings accounted for w15%. Supplements were the most common type of counterfeit medicine (64.5%) (Fig. 2). The top 10 brands of supplements, and drugs used in professional and non-professional settings are presented in Tables 2e4. Table 5 summarizes the information from WHO’s recommended checklist of selected samples of counterfeit medicines in Iran. While some items in the checklist could be indicative of products being counterfeit [e.g. mismatch on the label and container (15.8%), incorrect manufacturer’s name
Counterfeit Classification in Iran (Drug Use)
Supplements Professional setting
Percentage
80.00
Non-professional setting Unknown
60.00 40.00 20.00 0.00 Drug Class
Definitions: Drugs used in professional settings: cardiovascular, diabetes, gynaecology, respiratory, central nervous system (including cyclo-oxygenase II inhibitors), antibiotics, gastrointestinal, hormones, musculoskeletal. Drugs used in non-professional settings: analgesics (others), cold preparations, herbal laxatives, over-thecounter drugs. Supplements: vitamins, minerals, glucosamines, omega3, weight lowering/increasing.
Fig. 2 e Counterfeit medicine market in Iran: proportion of drugs used in professional and non-professional settings (excluding supplements).
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Table 2 e Top 10 brands of drugs used in professional settings in counterfeit market in Iran.
Table 4 e Top 10 supplements found in counterfeit market in Iran.
Brand used in professional settings (manufacturer)
Supplement (manufacturer)
Anabol Tab (British Dispensary) L-Thyroxin Tab (Berlin Chemie) Glucophage Tab (Merck) Fin pecia Tab (Cipla) Diclofenac Inj (Troge) Lipitor 20 mg Tab (Parke Davis) Tramadol Cap (Hexal) Omeprazole Cap (Brown & Burk & Essential) Norvasc 5 mg Tab (Pfizer) Tenuate retard Tab (Artegodan)
Frequency (%) 17.64 9.00 4.55 4.22 4.08 2.94 2.90 2.85 2.84 2.24
and address (7.9%), having a logo or a different view of the logo and hologram of the product (82.9%) and quality of the insert paper (18.4%)], these may not be applicable in all cases confiscated from the Iranian grey pharmaceutical market. In 73.7% of the products checked, the ink on the packaging or inserts was not smudge-proof (Table 5, item 17). This could be a good indicator to consider in visual checking of these types of product, and could be included in public education programmes in the country. Nevertheless, it would be difficult to mark a product as counterfeit using many other items in the visual checklist, given that a high frequency of the samples checked in this study seemed to be correct (Table 5). Of course, laboratory checking of these products would identify the actual nature of medications checked using the visual checking tool.
4.
Discussion
In this survey, the pattern of counterfeit medicine in the pharmaceutical grey market in Iran was defined by reviewing MOHME’s inspection files from 2007 to 2008. Supplements were the most common type of counterfeit medicine, followed by analgesics, hormones and antihistamines. Drugs used in professional settings, including drugs for cardiovascular diseases, diabetes, gynaecology, respiratory system, central nervous system [including cyclo-oxygenase II (COX II) inhibitors], antibiotics, gastrointestinal system, hormones and
Table 3 e Top 10 brands of drugs used in nonprofessional settings in counterfeit market in Iran. Brand used in non-professional settings (manufacturer) Aspirin 81 Tab (Kirkland) Zinadin Tab (Unknown) Bio Yeast Tab (Zanza) Novafen Cap (Brown & Burc) Radian Massage Cream (Roche) Panadol Tab (GSK) Advil Tab (Wyeth) Advil Cold & Sinus Tab (Wyeth) Exedrin Tab (Novartis) Novapen Cap (Unknown)
Frequency (%) 26.10 13.59 11.49 9.10 3.95 3.13 2.34 2.09 1.96 1.92
Omega 3 1000 mg Softgel (Now) Fefol Cap (Smith Kline) Glucosamine 500 mg Cap (Phyto pay) Fish Oil Cap (Alaska) Zink Plus Cap (Vitalia) Royal Jelly Softgel (Nature’s Bounty) Vit E 400 Tab (Nutrilab) Centrum Tab (Wyeth) Multivitamin Eff Tab (Kruger) Cider Vinegar Tab (Nature’s Bounty)
Frequency (%) 23.05 9.60 7.48 5.35 3.86 2.75 2.66 2.07 1.95 1.92
musculoskeletal system, accounted for w20% of the 716 counterfeit medicines. Drugs used in non-professional settings, including analgesics (excluding COX II inhibitors), cold preparations, herbal laxatives and over-the-counter drugs, represented w15% of the 716 counterfeit medicines. Drugs to treat malaria, tuberculosis and HIV/AIDS, reportedly found in the counterfeit market in developing countries, were absent in the pharmaceutical grey market in Iran. This is because national disease control programmes on certain diseases, including malaria, tuberculosis and HIV/AIDS, provide all health services including pharmaceutical procurement and care for patients through the national primary healthcare network. Therefore, it seems that the drug counterfeit pattern in Iran is more similar to that in developed countries, and that the counterfeit market in Iran is influenced by the global counterfeit network. The main items found in the pharmaceutical counterfeit market in Iran were supplements (64.5%), which suggested the need for urgent intervention. The Deputy Ministry for Food and Drugs, therefore, set up a special line for registration of supplements during the course of this study, such that regulations for their registration became more straightforward compared with other pharmaceuticals, facilitating faster approval and market authorization of these products. Other interventions undertaken by the Deputy Ministry for Food and Drugs, reflecting its multi-section collaboration strategy, included conducting regular joint meetings with the security forces, the police and the law enforcement judiciary system to promote collaborations, identify the gaps in regulations and achieve a common understanding of the impact of counterfeit medicines in public health. These interventions are ongoing. Currently, legislation does not allow punishment of counterfeiters or distributors of counterfeit drugs in accordance with the severity of the crime (given that counterfeit drugs can kill), and sanctions for counterfeiting medicines are not very heavy. Since the current legislations for food and drugs are under revision and a comprehensive law for food and drugs is being considered for approval by Parliament, it is envisaged that making or selling counterfeit drugs will become a separate criminal offence in new drug law. Other studies on drug use in Iran suggest that the demand for pharmaceuticals not listed in the INDL is partly generated by doctors who received training abroad or by patients who have received treatment abroad.10e12 Promotion of pharmaceuticals through mass media is currently prohibited according
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Table 5 e Collated information of World Health Organization recommended checklist on counterfeit medicines in pharmaceutical grey market in Iran. Checked item Packaging 1 Does the container and closure protect the product from the outside environment? Properly sealed? 2 Are the container and closure appropriate for the product inside? 3 Is the container safely sealed? 4 Does the label on the carton match the label on the container? 5 Is all information on the label legible and Indelible? 6 Is the trade name spelt correctly? 7 Is the medicinal product (trade name) registered in the country by the Drug Regulatory Authority? 8 Does the symbol follow the trade name? 9 Is the active ingredient name spelt correctly? 10 Are the manufacturer’s name and logo legible and correct? 11 Does the logo or hologram (if applicable) change colour when viewed from different angles? 12 Is the manufacturer’s full address legible and correct? 13 Does the number of dosage units listed on the label match that of dosage units stated on the container? 14 Are the manufacture and expiry dates clearly indicated on the label? 15 Are the storage conditions indicated on the label? 16 Is the package insert printed on the same coloured or same quality paper as the original? 17 Is the ink on the package insert or packaging smudge-proof? Physical characteristics of tablets/capsules 18 Are the tablets/capsules uniform in shape? 19 Are the tablets/capsules uniform in size? 20 Are the tablets/capsules uniform in colour? 21 Do the tablets have a uniform coating? 22 Are the bases of the tablets fully covered? 23 Are the tablets/capsules free of breaks, cracks, splits or pinholes?
Yes No Unknown % % % 92.1
3.9
3.9
94.7
2.6
2.6
76.3 81.6
15.8 15.8
7.9 2.6
88.2
7.9
3.9
97.4 0 See Fig. 2
2.6
39.5
55.3
5.3
90.8
3.9
5.3
85.5
7.9
6.6
13.2
82.9
3.9
78.9 117.1
3.9
85.5
2.6
11.8
22.4
2.6
88.2
7.9
3.9
60.5
18.4
21.1
5.3
73.7
21.1
88.2
2.6
9.2
90.8
0
9.2
86.8
3.9
9.3
89.5 89.5
1.3 1.3
9.2 9.2
85.5
5.3
9.2
Food and Drugs. Educational packages on counterfeit medicines for different groups of healthcare providers, including doctors, pharmacists and nurses, have been developed and included in continuous medical education programmes. Public education programmes on counterfeit medicines are also in practice using all types of mass media to address different dimensions and impacts of counterfeit medicines. The Deputy Ministry for Food and Drugs has also established a drug regulatory network within Economic Cooperation Organization countries (ECODRAN), and the first meeting of ECODRAN was held in 2008. Combating counterfeit medicines was an important area of collaboration addressed at this meeting, and a working group for this initiative was formed to define further actions and follow-ups to establish a reporting centre to share information on counterfeit medicines, control borders to minimize counterfeit transport, and collaborate in laboratory testing of counterfeit drugs. In conclusion, this study provided insight into a growing public health problem, defined the pattern of counterfeit medicines in the pharmaceutical grey market, and reviewed relevant strategies and interventions of MOHME in Iran. Greater political commitment, promotion of inter- and intrasection collaborations, active vigilance, educational programmes and active follow-up on the interventions described would minimize the impact of counterfeit medicines on public health.
Ethical approval None sought.
Funding 75
to the current laws and regulations in Iran. However, Iranian citizens have wide access to the Internet and satellite television, through which all means of drug promotion and direct-tocustomer services are provided. This also seems to have an important impact on Iranian demand for new pharmaceutical products advertised and their lifestyle in terms of drug use. In this respect, conducting target-oriented educational programmes is an important strategy of the Deputy Ministry for
Deputy Ministry for Co-ordination, Ministry of Health and Medical Education, Iran.
Competing interests None declared.
Acknowledgements The authors wish to thank Dr Andreas Zeiter, Dr Fatemeh Kheirkhah, Mr Mohammad Poursafar, Dr Siavash Golmohammadi, Dr Morteza Pirali, Mr Salaman Bahremandi, Dr Ali Asghar Motahhari and Mr Abolfazl Mirrafie.
references
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