Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Stopping the "murder by fake drugs".
- Peter W. Richards, GY24JS (7 April 2002)
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Murder by fake drugs - prioritising the measures available to tackle the problem
- Stephen Jan, Damian Walker (10 April 2002)
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Triple murder through poor quality medicines, vaccines and diagnostics
- Subhash C. Arya (10 April 2002)
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Peter W. Richards, GP Principal St Sampsons Health Centre, St Sampsons, Guernsey, GY24JS
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Dear Sir, Re. “Murder by fake drugs”. BMJ 2002; 324:800-801 (6th April) Like you we have also been concerned by the increasing problem of “fake drugs” so succinctly described in your editorial. We very much agree with your conclusion that “simple, inexpensive and low tech methods to identify fakes should be pursued.” These fakes are potentially so damaging to the unsuspecting patient that we have developed a “foolproof” and highly cost effective anti counterfeiting system (called Microbar) in a joint venture with Debden Security Printing Ltd. the commercial arm of The Bank of England Printing Works. Our method is to hide a statistical signature within a digital print file which when printed can be read and recovered at low resolution by either a standard flat bed scanner or a recently developed new type of pen reader BUT essentially cannot be copied or counterfeited using today’s current technology. Our invention enables us to validate and authenticate printed materials including all packaging and even blister packs, with precision, all with a norm of 2 orders of magnitude between original and best copy. The invention uses a new area of mathematics “quantum fractional dynamics” (based on fractal statistics and chaos theory). Additionally and most importantly we can also put a covert “bar code” within a print file that can also be recovered by a simple scanner or pen reader. This gives Microbar a capability both to authenticate and to “track and trace”. The print file can be added to existing printing systems with minute additional cost. We anticipate that a number of large pharmaceutical companies will use this technology in the near future not only to stop counterfeiting of their products but also to start tackling the problem of parallel imports, and indeed follow the journey of their pharmaceuticals from the factory to the patient. This technology that can differentiate between apparently identical images may also be applicable in a medical context to differentiate between normal and abnormal images e.g. cervical smears, mammograms, ECGs, etc. Yours faithfully, Dr Peter Richards MB ChB General Practitioner, St Sampson’s Surgery, Guernsey richards@guernsey.net Prof. Jonathan Brostoff MA DM DSc(Med) FRCP FRCPath. Professor Emeritus of Allergy and Environmental Health at Kings College, London.SE1 9NN jonathan.brostoff@kcl.ac.uk Dr William Johnson Hon D Des. Chairman Microbar Security Ltd. 52 Shrivenham Hundred Business Park, Majors Road, Watchfield, Swindon, SN6 8TY willy.johnson@dtlgroup.com |
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Stephen Jan, lecturer London School of Hygiene and Tropical Medicine Keppel St London WC1E 7HT UK, Damian Walker
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EDITOR Your recent editorial rightly highlights the grave dangers associated with the existing trade in counterfeit drugs.1 Although the dismantling of this form of market is clearly in the public interest, it is not immediately apparent how best to do so. In addressing this, your editorial presents an overview of possible strategies. Our concern, however, is that some of these suggestions are likely to be more effective than others. With limited resources to tackle this problem, there is thus a need to prioritise. Our concern focuses particularly on the measures that rely on patients to identify fake drugs (including social marketing strategies) and thereby seem to place unrealistically high expectations on the ability of individuals, with often low levels of formal education, to competently make such decisions. As mentioned in the editorial, counterfeiters can be very sophisticated in their methods and indeed, even researchers attempting to discern fake drugs have had to use laboratory tests.2 Moreover, the burden on the individual consumer, in practice, is compounded when faced with the need to make such decisions across a number of types of drugs. This, however, is not to deny that there is intrinsic value in informing and empowering consumers but, in tackling this problem there seem strict limits on how far this type of measure is likely to be effective. Perhaps ironically, a programme of consumer education and empowerment might have the opposite to the desired effect by stimulating consumer demand and given the inherent difficulties associated with the identification of fakes, thus could conceivably promote rather than retard the development of such markets. We suggest that there should be a focus on measures aimed at the distribution of genuine drugs through legitimate public and private clinics. One of the other options mentioned in the editorial, ensuring genuine drugs are allocated widely and cheaply would, if effectively employed, undercut the demand for counterfeits. As part of this programme, greater emphasis would need to be given to stock control measures that prevent pilferage, wastage and other forms of 'leakage'.3,4 Ultimately, it is the existence of black markets in health care commodities that provides incentives for the production of counterfeit drugs. Thus one way of addressing this problem is to undermine the conditions that allow for their development. 1. Newton PN, White NJ, Rozendaal NJ, Green, MD. Murder by fake drugs. Time for international action. BMJ 2002; 324: 800-1. 2. Rozendaal J. Fake antimalaria drugs in Cambodia. Lancet 2001; 357: 890. 3. Foster S. Supply and use of essential drugs in sub-Saharan Africa: some issues and possible solutions. Social Science and Medicine 1991;32(11):1201-18. 4. McPake B, Asiimwe D, Mwesigye F, Ofumbi M, Ortenblad L, Streefland P, Turinde A. Informal economic activities of public health workers in Uganda: implications for quality and accessibility of care. Social Science and Medicine 1999; 49(7): 849-65. Stephen Jan
Damian Walker
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Subhash C. Arya, Research Physician New Delhi 110048
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Triple murder through poor quality medicines, vaccines and diagnostics Editor--Your excellent editorial (April 6, p 800)1 points to the tip of an iceberg of poor quality medicines being offered to sick people globally but ignores the mandatory storage of drugs, even otherwise genuine and potent, at a controlled temperature range. Moreover, the decades old ground realities encountered with vaccines and diagnostics have failed to win even a passing reference. The scenario is very similar with vaccines and diagnostic agents. During the early 1970s unsatisfactory live poliovirus vaccines were incriminated for inadequate vaccine takes in Chicago2. Recently, the state -of-art therapy for rabies was a failure in a 9-year-old boy and a 72-year -old Thai woman in Bangkok, Thailand. Post exposure therapeutic intervention with Vero cell rabies vaccine and rabies immunoglobulin was associated with development of rabies and death in both cases3. Improperly stored or post-expiry period assay reagents for HIV antibody in a Zambian hospital had the sensitivity and specificity reduced by 11-18%. The use of pre-tested blood with such reagents was associated with at six times higher than expected risk for HIV transmission 4. Irrespective of the financial constraints the poor quality of spurious or genuine drugs, vaccines and diagnostic reagents could be addressed through implementation of not all that costly measures. For example, distinct and prominent symbols have been mandatory for poisons, inflammables and radioactive substances. Distinguishing marks pointing to correct storage temperature, in incorporated internationally, on vials, bottles, infusions and diagnostic kits should ensure safer transportation and storage. Furthermore, storage temperatures for drugs, vaccines and diagnostic reagents are listed individually in textbooks, pharmacopoeia, physicians’ desk reference and other catalogues. Consolidated lists pointing to precise storage conditions should be available in subsequent publications. That would guide warehouses, prescribes, and consumers about the ideal storage of drugs, vaccines and diagnostic reagents. Harmful effects of temperature, humidity, radiation or other adverse environmental parameters operating against drugs, vaccines and diagnostic reagents would be effectively encountered by addition of stabilizers. That is best exemplified with the least stable of common childhood vaccines: live poliovirus vaccine5. Pre-addition of pirodavir and deuterium oxide allows it to resist even a 10-hour exposure to 42oC. Multidisciplinary international efforts against fake drugs1 involving police action should be tripartite incorporating surveillance of quality of drugs, vaccines and diagnostic reagents offered to masses. These issues address every human and awareness at individual level would be mandatory to tackle the continuing triple murder with quality of drugs, vaccines and diagnostic reagents. Subhash C Arya, MBBS.PhD
References 1. Newton PN, White NJ, Rozendaal JA, Green MD. Murder by fake drugs. BMJ 2002; 324:800-801 2. Rasmussen CW, Thomas CW, Mulrooney RA. Inadequate poliovirus immunity levels in immunized Illinois children. Am J Dis Child 1973; 126:465-469 3. Hemachuda T, Mitabhakdi E, Wilde H, et al. Additional repots of failure to respond to treatment after rabies exposure in Thailand. Clinical Infectious Diseases 1999; 28(1): 143-144 4. Consten ECJ, van der Meer JTM,de Wolfe F, et al. Risk of iatrogenic human immunodeficiency virus infection through transfusion of blood tested by inappropriately stored or expired antibody assays in a Zambian hospital. Transfusion 1997; 37(9): 93-934 5. Verheyden B, Andrus K, Rombart B. Capsid and RNA stabilization of oral poliovaccine. Vaccine 2001; 19:1899-1905 |
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