GPHF 2004: Counterfeit Medicines - An Unscrupulous Business
Counterfeit Medicines: A Worldwide Problem
The German author Theodor Fontane once wrote that "Imitation is the sincerest form of flattery." However, you can do without this type of flattery if it harms your health. Trademarked goods such as watches and clothes are recognized all over the world and have become coveted objects; they attract the attention of unscrupulous counterfeiters everywhere. Increasingly, this is also becoming true for drugs.
Counterfeiting drugs and knowingly offering them for sale has now evolved into a serious problem for world health.
Lack of proper controls, the understandable reticence of the manufacturers affected and the fact that drug counterfeiting has now become part of organized crime, suggests that we do not know the real scale of the problem.
Cruel Reality: Examples of medicine counterfeiting
No one would argue that drugs do not play an important role in healthcare: they prevent premature death, accelerate healing and alleviate the symptoms of those diseases that cannot yet be cured. This makes drug counterfeiting all the more reprehensible since it can be the cause of suffering or death.
A cough mixture “diluted” with poisonous solvent. Over 100 children die.
Thousands of samples of an ointment for burns contain sawdust.
The quality of 37 out of 137 allegedly branded products is doubtful.
In 1993, a pharmacist is arrested after attempting to export drugs to Africa. The active ingredient in his “drugs“ is baking powder.
20 percent of the drug samples analysed were substandard drugs.
According to information provided by “Physicians without Frontiers”, a meningitis drug contains water only.
At least 59 children die after taking a counterfeit syrup used to treat fever.
Test series show that 10 percent of the drugs tested are substandard or counterfeited.
So-called malaria drugs turn out to be completely ineffective. The number of persons adversely affected can only be roughly estimated.
The renowned Africa Health journal reports a genuine flood of counterfeited drugs all over the country.
At least 30 deaths result from counterfeited malaria drugs.
The Shenzhen Evening News reports more than 100.000 people died of faked drugs in China this year.
60% of our drugs are either counterfeit, substandard or expired, says the head of the country's drug control agency.
WHO declares, on average, 10-20% of medicines in developing countries markets are substandard.
These examples show that the shortage of drugs that is still a reality in many countries is being unscrupulously taken advantage of.
Tracking Counterfeited Medicines – a Gruesome Balance Sheet
For the years 1982 through 1997, the World Health Organization (WHO) identified and documented more than 770 instances of drug counterfeiting. Over 50% of these cases concerned the period after 1993 – and show an increasing tendency. Almost 70% of the counterfeiting cases were discovered in developing countries, in particular Africa. Over a third of all cases involved counterfeit antibiotics - the group of drugs most likely to be counterfeited. Roughly 60 percent of the counterfeits documented by the WHO did not contain any active ingredient at all, 19 percent contained a wrong dosage and 16 percent completely inappropriate agents. Only a minor portion of the documented counterfeits contained the same quality and quantity of agents as their authentic counterparts.
The peoples of Africa, Asia and South America are
particularly affected by drug counterfeiting.
What is being counterfeited? Four types of medicine counterfeiting
Basically, everything is being counterfeited: active ingredients, dosage forms, package inserts, packaging, manufacturers’ names, batch numbers, expiry dates and documentation relating to supposed quality controls. Counterfeiting can be sub-divided into four different types:
- The perfect imitation of a preparation with the same active ingredients and identical packaging. From a medical point of view, the risk associated with this is small, assuming that the quality of such preparations is correct.
- Counterfeit drugs in packaging identical to that of a trademarked product. In general, such drugs contain the active ingredient stated; however, its quality is often poor and the quantity thereof is insufficient. The consequences of this are: lack of efficacy and - in the case of antibiotics - the development of resistances by pathogens.
- A product looks like a genuine drug but contains no active ingredient. Even in cases where the counterfeit drug "only" contains glucose: the patient’s disease will neither be cured nor will any pain be alleviated.
- The counterfeited drug contains harmful or poisonous substances and leads to physical injury or death.
"All you need to counterfeit drugs is a person with access to a small laboratory, a propensity for theft and a total disregard of human dignity."
(Milton Silverman, University of San Francisco)
Medicine counterfeiting - Only a problem of developing countries?
In the industrialized countries, drug-legislation regulations and monitoring controls, the efficient exchange of information and the close co-operation between manufacturers, pharmaceutical wholesalers, pharmacies and authorities ensure a high degree of drug safety. In developing countries, however, the basic prerequisites for an effective drug control are often completely lacking:
- Shortcomings in the registration of the marketed drugs
- An insufficient level of production monitoring
- Problems with import controls
- An insufficient number of laboratories and lack of staff to perform tests
In addition, the borders are more often than not poorly guarded so that drugs can be placed on the market without undergoing proper control.
However, drug counterfeiting is not just a problem of developing countries. Even in Europe and North America, the WHO reports an increasing trend in drug counterfeiting. Example: in the USA, 1.5 million oral contraceptives were seized and found to contain an insufficient dosage; in British health clubs, unauthorized injection dosages of muscle-building drugs were discovered.
"As long as the pill is the same size and colour as the original product, doctors and pharmacists - never mind patients - cannot tell it is a counterfeit."
(Richard Arnold, IFPMA)
Protection against Counterfeiting: International Initiatives
Even in Germany, patients cannot feel completely safe from counterfeited drugs, since underdosed drugs have already been shipped through German free ports, counterfeited drugs were found in German pharmacies and a ring of anabolics counterfeiters acting from Lower Bavaria was cracked down on.
All responsible national and international bodies and institutions are being called upon to further develop the stringent drug-control regulations of the industrialized countries and to help developing countries in setting up an effective basic control system.
Counterfeit Medicines - Tips for Consumers and Tourists
- Buy your drugs in pharmacies only. This is of particular importance abroad.
- Never buy your drugs on markets or from hawkers.
- When you need drugs for holiday or business trips abroad, buy them in a reliable pharmacy before leaving home.
- Check with your tour operator or the competent authorities whether you are entitled to take the drugs for your personal use into the country in question.
- Do never use drugs with a deficient, damaged or soiled packaging.
- Do not use drugs that do not come with detailed information on their exact designation, expiry date, batch number or the name of the manufacturer, or drugs with obviously incorrect information.
- Do not use drugs if their shelf life has already expired.