GPHF NEWS III / 98

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Dr. Hilmar Kienzl new Chairman of the GPHF
Dr. Welters retires after years of successful activity for the GPHF

- Simple tests protect against counterfeit drugs
The GPHF-Minilab® detects counterfeit and substandard drugs / Developing countries main region of use
- GPHF 1998 appeal for donations

 

Dr. Hilmar Kienzl new Chairman of the GPHF
Dr. Welters retires after years of successful activity for the GPHF

Dr. Hilmar Kienzl has been elected the new Chairman of the German Pharma Health Fund e.V. (GPHF). He succeeds Dr. Reiner Welters, who retired on August 31, 1998, and gave up his position as Chairman of the GPHF. Dr. Kienzl (54) is member of the Executive Board of Zeneca GmbH and will work on a purely honorary basis, like all members of the Board of Directors of the GPHF. The GPHF is an initiative of the research-based pharmaceutical companies in Germany that conducts model projects to improve health care in developing countries. The GPHF comprises 22 pharmaceutical producers and the Association of Research-Based Pharmaceutical Manufacturers, whose donations make the GPHF projects possible.

Dr. Kienzl studied medicine in Bonn, Gießen and Ulm and is a certified physician. He has held a position of responsibility in the pharmaceutical industry for almost 28 years. In 1983 he became a member of the management of Zeneca GmbH (previously ICI Pharma) and is responsible for the Medical Marketing/Sales department.

Upon being elected Chairman of the GPHF, Dr. Kienzl said that he sees the very successful work of his predecessor, Dr. Welters, as setting an example for the further development of the GPHF and that he intends to build on it. Dr. Reiner Welters, a member of the GPHF Board since the founding of the organization in 1985, has been chairman since 1993. During his period of office, the GPHF conducted many successful model projects for improving health care in developing countries in cooperation with the World Health Organization. For instance, in East Africa a program for the diagnosis and therapy of parasitical infections was carried out over several years; it is a program that the WHO now describes as exemplary.

Transferring industry know-how to projects

Expanding the donor basis is regarded by Dr. Kienzl as a priority task during his period of office. This will make possible additional health projects in which people in developing countries can benefit from the specific know-how of the pharmaceutical industry. The new Chairman sees the GPHF-Minilab® project, a simple test method for detecting the counterfeit medications commonly found in developing countries, as showing the way forward. The other members of the GPHF management are Joachim Trautschold (Vice-Chairman), Dr. Gabriele Küsters (Executive Member of the Board) and Dr. Joachim Moormann (Treasurer).

 

Simple tests protect against counterfeit drugs
The GPHF-Minilab® detects counterfeit and substandard drugs /
Developing countries main region of use

The GPHF has now concluded the two-year development of simple test methods for revealing counterfeit and substandard drugs. The GPHF-Minilab® provides a reliable and inexpensive method for the easy detection of counterfeits found worldwide. This portable, tropics-compatible and easy-to-use mini laboratory will be used mainly in developing countries, which are particularly affected by counterfeit drugs.

The counterfeiting of pharmaceutical products and the proliferation of substandard drugs have come to pose a serious threat to the world’s health. International health experts believe that seven percent of all drugs marketed worldwide are counterfeit products. People in developing countries are particularly affected, for they do not have access to essential drugs in the right quality and quantity and at the right price. Moreover, these countries do not have the infrastructure or resources to ensure effective drug controls.

Against this background, the GPHF, in cooperation with Professor Peter Pachaly of the School of Pharmacy at the University of Bonn and Professor Klaus Fleischer of the Medical Mission Institute, Würzburg, has developed since 1996 simple test methods designed to protect people in developing countries from the not infrequently fatal consequences of counterfeit and substandard drugs.

Examples of counterfeit drugs

Nigeria 1990: a cough mixture is "stretched" with a poisonous solution. Over 100 children die.
Mexico 1991: Thousands of ointments for burns contain sawdust.
Turkey 1993: A pharmacist is arrested who wants to export medications to Africa. The active ingredient of his "medications" is baking powder.
Haiti 1996: At least 59 children die after taking a counterfeit fever syrup that contains a poisonous antifreeze.
China 1997: During tests, ten percent of the drugs tested proved to be of substandard or counterfeit.

Tests successfully completed

The goal of the project headed by Dr. Richard Jähnke (GPHF) was to provide simple test methods that make it possible to identify substandard or counterfeit drugs under the specific conditions encountered in the developing countries. The methods should not only be inexpensive, portable and versatile but also easy to use for less experienced personnel, and reliable. In the past 12 months, the GPHF-Minilab® underwent field testing for several weeks respectively in the Philippines, Kenya, Ghana and Tanzania. It has proved to be an effective instrument for identifying and checking the quality of drugs. These trials have confirmed that tests can be conducted easily in hospitals, rural health stations and pharmacies. Airports, seaports and other points of entry are also suitable locations for conducting the tests.

Testing in four steps

Testing the quality of the drugs by the GPHF-Minilab® is done as a four-stage test plan that employs very simple physical and chemical analytical techniques:

  1. Inspection of the drugs for external abnormalities on the tablet and capsule as well as on the packaging.
  2. Simple tablet and capsule dissolving test as preliminary indicator of solubility defects.
  3. Rapid proof of identity directly on the drug through the use of simple color reactions.
  4. Determining contents of critical samples and additional confirmation of identity by a semi-quantitative thin-layer chromatographic assay.

Four kinds of counterfeiting

Basically, everything can be counterfeited: Active ingredients, dosages, package leaflets, packaging, producer names, lot numbers, expiry dates and quality control documents. The counterfeits can be divided into four groups:

  • A perfect copy of a drug with the same active ingredient and identical packaging. From a medical perspective there is only a small risk provided the drugs are of perfect quality.
  • Counterfeits in packaging identical to that of a branded product. The drug usually includes the indicated active ingredient, but in insufficient quality or quantity. The consequences: inadequate efficacy and - in the case of antibiotics - build-up of resistance to pathogens.
  • A product looks like a drug but contains no active ingredient. Even if the counterfeit only contains dextrose, the illness is not cured and nor is the pain alleviated.
  • The counterfeit drug contains substances that are unhealthly or poisonous and leads to physical harm or death.

Test methods were developed initially for 15 active ingredients, taking into account the Essential Drug List of the World Health Organization and common prescription practice. The active ingredients chosen for the GPHF-Minilab® included antibiotics and antiparasitics as well as analgetic and anti-inflammatory medications that are frequently counterfeited.

A complete laboratory in two cases

The GPHF-Minilab® is designed so that all the devices necessary for testing the drugs can be accommodated in two portable units, each about the size of a suitcase. As the Minilab can be used without an external energy source and only weighs around 20 kg it is ideal for mobile use.

The mini-laboratory contains, in addition to the reference substances for the 15 active ingredients, all the necessary laboratory appliances such as test tubes, pipettes, precoated TLC plates and developing chambers as well as battery-powered UV lamps set to different wavelengths. The instructions for the tests are given in two English-language manuals, which are also part of the GPHF-Minilab®. They provide detailed and easy to understand descriptions of all the steps necessary for the tests.

The basic equipment also includes all the necessary solvents and reagents which are available separately. The Minilab also comprises test forms and contents lists that make reliable laboratory management possible at all times.

The GPHF-Minilab® tests the following active ingredients:

acetylsalicylic acid - amoxicillin - ampicillin - chloramphenicol - chloroquine - cloxacillin - co-trimoxazole - erythromycin - mebendazole - metamizole - metronidazole - paracetamol - phenoxymethylpenicillin - prednisolone - tetracycline

The active ingredients aminophyllin - furosemid - isoniazid - rifampicin - sulfadoxin/pyrimethamin are planned to be included at a later stage.

Inexpensive tests

In addition to its reliability and diverse applications, low purchase costs were the top priority in creating the GPHF-Minilab®. As a result of intensive development work, it is possible to offer the Minilab at the cost price of US$ 2,570 (EURO 2,260), in addition to taxes, shipping costs and customs duties. The start-up package includes reagents and solvents that permit approx. 3,000 identity checks by color reaction and 1,000 content checks by thin-layer chromatography, which means that the average costs per test amount to approx. 1.3 US$ or 1.0 EURO.

Training recommended

Although the GPHF-Minilab® was deliberately designed to be simple, the GPHF and the Medical Mission Institute, Würzburg, recommend introductory training on the use of the test methods. This is important in particular for those who are to conduct the tests on site in the developing countries. Inexpensive training is available.

Those responsible for the project regard the GPHF-Minilab® as making an important contribution to improving the quality of drugs for all organizations and facilities that are active in health care in developing countries.

Info on the GPHF-Minilab®

To introduce the GPHF-Minilab®, the GPHF has produced an 8-page leaflet "The GPHF-Minilab®". The leaflet is available in German, English and French and can be obtained free of charge from the offices of the GPHF, P.O. Box 150 123, D-60061 Frankfurt am Main, Germany, phone/fax:
+ 49 / 69 / 63 15 32 57 or via the internet (http:// www.gphf.org).

 

GPHF Appeal for donations 1998

The GPHF thanks Hoechst Marion Roussel Deutschland GmbH for generously supporting its project work. A total of 19 pharmaceutical producers as well as the Association of Research-Based Pharmaceutical Producers (VFA) have supported the GPHF in 1998 with donations.