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Enhanced Drug Safety in Developing Countries Protection against Counterfeited AIDS Drugs / GPHF Presents New Test Methods for its Minilab The development of the new test methods presented at a press briefing in Berlin is the GPHF's reaction to the growing worldwide need for efficient HIV / AIDS drug therapies, since counterfeits have already been identified in this therapy field, too. The tests for the drug agents didanosine, indinavir, lamivudine, nevirapine, stavudine and zidovudine are particularly aimed at governmental supervisory agencies, hospitals and healthcare projects with a view to protecting patients against counterfeited or substandard-quality HIV / AIDS drugs. Worldwide Use Since 1998, the GPHF-Minilab® has proved itself a highly valuable tool for a speedy, reliable and cost-effective check of the quality of ready to use drugs even under the specific conditions prevailing in developing countries. Over 130 minilabs are now in worldwide use - in particular in Asia and in Africa, the regions most affected by drug counterfeits. The best equipped country is Tanzania, where, with a total of 20 laboratory units installed, a comprehensive control system has been set up.
Well-proven in Practice At the presentation of the new tests, the GPHF also gave an interim statement on five years' practical use of the minilab. According to Dr. Gabriele Küsters, the GPHF chairwoman, the test methods have proved to be both reliable and practicable. "The minilab allows for a speedy and cost-effective quality check of drugs, thus ensuring efficient protection against the consumption of counterfeit or substandard medicines. For instance, a case study conducted in Cameroon shows that when checking the quality of a malaria drug, 52 of the 70 samples tested were counterfeited and substandard drugs." Those countries that do not have facilities for checking the local drug market offer or that are equipped with unsatisfactory facilities are thus provided with a valuable tool for quickly laying the foundations for efficient control of their drug market, continued Gabriele Küsters. Speedy and Efficient Check Besides antiretroviral agents, the GPHF-Minilab® effectively tests antibiotics, antiasthmatics, antiallergics, analgetics, antiinfectives, malaria drugs and tuberculosis medicaments. The tests are performed in four stages: a visual inspection, followed by a disintegration and a colour reaction test, and concluded by a semi quantitative thin-layer-chromatography test. The tests allow a quick determination of whether the analysed drug contains the appropriate agent in sufficient quantity and quality. Since the GPHF provides the minilab - supplied in two containers of the size of standard suitcases - complete with all required laboratory tools, reference standards, reagents and manuals, without any external power supply being needed, this compact laboratory can be very quickly set up and used almost anywhere in the world. In addition, the training courses organised by the GPHF provide efficient and complete training of the future users within a couple of days.
Minilab Survey on Malaria Drugs conducted in Indochina On the occasion of the GPHF press briefing in Berlin, Dr Souly Phanouvong (United States Pharmacopiea, USP) also presented an up to date survey that has been conducted as part of the USP Drug Quality Initiative using the GPHF-Minilab® in Cambodia. The objective of this survey was to test the malaria drugs locally provided. In four provinces, a total of 183 drug samples were collected. When tested using the Minilab, 51 of these samples (= 28 per cent) proved to be counterfeited. As far as individual agents were concerned, the counterfeit ratio reached 77 per cent.
WHO: Ten Per Cent of all Drugs globally supplied are Counterfeits The danger of being harmed by taking counterfeited or substandard drugs is constantly growing. Last November, the World Health Organisation (WHO) pointed out that ten per cent of all drugs globally supplied are now counterfeited. According to the WHO statement, the US Food and Drug Administration even proceeds on the assumption that in developing countries 25 per cent of all drugs supplied are counterfeited or of substandard quality, thus resulting in a direct danger to health. The turnover generated annually with drug counterfeits is estimated at more than 30 billion USD by the FDA.
There is no component - agents, dosage, packaging, lot numbers and associated documents - which is not subject of adulteration, dilution or counterfeiting, with no drug categories being spared. In numerous cases, the unscrupulousness of the counterfeiters has lethal consequences. For instance, 2,500 people died in 1995 in Niger during a meningitis epidemic because they were injected a counterfeited vaccine. In the same year, 89 children died in Haiti after taking an antipyretic containing a solvent. In 1999, at least 30 deaths resulting from counterfeited malaria drugs were reported from Cambodia. In China, the situation is hardly less dramatic: in 2002, the health authorities here shut down more than 1,300 companies which had produced medicines illegally. To date, many countries lack the basic facilities to test the quality of the locally provided drugs so that in most cases counterfeits are identified as such only after having led to sickness or death. Apart from the consequences for those directly affected, counterfeit drugs necessarily result in confidence in the healthcare system and the drug therapies being undermined, the danger of resistance to drugs increasing and the resources urgently needed by the healthcare system being unnecessarily wasted.
Pharmaceutical Students trained in Management of Drug Supply in Developing Countries Second further Training Seminar run jointly by the GPHF and Mainz University / Further Training Courses now Planned in Africa For the second time, the GPHF, in cooperation with the Pharmaceutical School of the University of Mainz, has organised a further training course entitled "Management of Drug Supply in Developing Countries". This one week seminar took place in September and was attended by pharmaceutical students and pharmacists from Benin, Jordan, Cameroon, Palestine, Togo, Switzerland and Germany. All of the 25 participants successfully took the final examination.This seminar was organised under the auspices of the Federal Minister of Health, Ulla Schmidt. The five day seminar, held in the Evangelische Akademie Arnoldshain im Taunus, covered all aspects of drugsupply management in developing countries - ranging from calculation of requirements through special purchase programmes as part of public tenders to the appropriate disposal of drugs. Other seminar sections dealt with the growing problems of drug counterfeits, the appropriate use of drug donations and basic issues on the financing of healthcare services in developing countries.
A Wealth of Practical Examples An important portion of the seminar was dedicated to the presentation of practical examples such as various drug projects from Nepal and Namibia, vaccine campaigns and public-private partnership projects in the healthcare sector jointly realised by multilateral organisations and the pharmaceutical industry. Various roundtable discussions provided the participants with the opportunity to exchange information and opinions with developmentaid experts on the perspectives open to pharmacists in international healthcare projects. The objective of this training course was to combine pharmaceutical, economic and legal issues in an overall concept and to complement them by practice-oriented knowledge of the specific conditions and requirements of drug supply in developing countries. Support by Many Sponsors The seminar contents were presented by scientists and representatives of authorities, and by experienced field experts from pharmaceutical companies and development-aid organisations. The list of lecturers included experts of Kreditanstalt für Wiederaufbau (a German promotional bank), Deutsche Gesellschaft für Technische Zusammenarbeit (German Service Enterprise for Development Cooperation), Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Medicines and Medical Products), Malteser Hilfsdienst (a German Relief Organisation), Apotheker ohne Grenzen (Pharmacists without Frontiers), Deutsches Medikamenten Hilfswerk action medeor e.V., Schering AG, Boehringer Ingelheim GmbH and of Aventis. The final examination was developed and conducted by experts from the Zentrallaboratorium der Deutschen Apotheker (Central Laboratory of German Pharmacists). Development Aid: A Management Task At the outset of the seminar, Professor Klaus Fleischer from the Würzburg-based Missionsärztliches Institut (German Institute for Medical Mission) pointed out the manifold challenges confronting any development aid project. This particularly applies to physicians and pharmacists directly responsible for public health. The central point of his introductory speech was that drug supply in developing countries must be seen as a management task requiring many more capabilities than just pharmaceutical and medical knowledge. Further Seminars Scheduled The GPHF plans to organise this seminar once a year in Germany. The target group includes in particular pharmaceutical trainees and students of advanced courses of study from developing countries who plan to return to their home countries and work there as pharmacists. In addition, the GPHF is now considering organising this seminar in 2004 in developing countries, too. The first-ever pilot project is in its final development stage and could possibly be implemented in East-Africa in 2004. More detailed information on this seminar can be obtained from the GPHF office directly at Postfach 15 23, D-61405 Oberursel. Telephone/facsimile: +49-6171/5 03 99-0. E-Mail: info@gphf.org.
"La Semaine du Diabète": GPHF Sponsors Information Sessions for Doctors and Patients / Cooperation with AfriMedicus Coinciding with the World Diabetes Day on November 14, 2003, the first-ever information week entitled "La Semaine du Diabète" addressing physicians, nurses and patients was held in the African state of Togo. It provided the participants with valuable knowledge of modern therapy concepts for diabetes mellitus. This project - an integral part of a nationwide information campaign - was developed and realised onsite by the AfriMedicus organisation with the financial support of the GPHF. In this way, AfriMedicus and the GPHF support the WHO's efforts to lay the foundations for an improved and cost-effective management of chronic diseases in the developing countries and to increase the patients' therapy adherence or compliance.
Approximately 600 persons attended the various information sessions organised in Togo's capital Lomé and run by medical specialists and by WHO experts. This project - realised under the auspices of Togo's Minister of Health - was complemented by information sessions in hospitals, surgeries, local healthcare centres and the national media. Diabetic Numbers on the Increase in the Southern Hemisphere, too Diabetes has long since ceased to be a disease affecting only the inhabitants of the rich Northern countries. In many developing countries, too, the number of patients suffering from this dangerous metabolic disorder is constantly growing. According to the WHO, the number of persons affected in many African countries is likely to triple or even quadruple by 2030.
This forecast applies to Togo, too, since the WHO anticipates an increase of diabetes cases from 63,725 in 2000 to 183,555 in 2030. For this reason, the GPHF sponsored the further training project with a view to familiarising doctors and nurses with modern diagnosis and therapy methods and informing patients and their families about diabetes and the appropriate handling of this disorder. This further training project and information campaign are intended to create an exemplary model to act as the foundations of an efficient and cost-effective management of diabetes mellitus in Togo. New WHO Programme With a view to improving the adherence of persons suffering from chronic disorders such as asthma, diabetes or tuberculosis - and thus to more efficiently deploying the resources available - the WHO recently presented a special programme ("Adherence to longterm therapies: evidence for action"). The figures underline the need for action. In the industrialised countries, according to the WHO, the therapy adherence of patients suffering from chronic disorders is on average around 50 per cent at best, whereas in developing countries, such values are far from being reached.
The GPHF would like to thank the following companies for their generous support of its project work:
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