The Pharmaceutical Journal
Vol 275 (Supplement) F11-F12
October 2005

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FIP Congress 2005

Problems and dangers of counterfeit medicines — a major health concern

Sabine Kopp, of the World Health Organization, Switzerland, told the congress during a practice symposium on 7 September that counterfeiting is a major public health concern. Counterfeit medicines may be ineffective and in many cases (eg, antibiotics and vaccines) can lead to treatment failure. The presence of harmful ingredients can result in toxicity and adverse drug reactions. This, in turn, leads to erosion of public confidence in medical and pharmaceutical care, she added.

She explained that the WHO defines a counterfeit medicine as “a product that is deliberately and fraudulently mislabelled with respect to source and/or identity”. Counterfeiting can apply to both generic and branded products. Counterfeit products include products with the correct ingredients, the wrong ingredients or no active ingredients. Active ingredients may be present, but in the wrong quantities with fake packaging.

Discussing reports received by the WHO on counterfeit drugs since 1982, Dr Kopp said that about 70 per cent of cases have been reported by developing countries. The majority of these reports do not distinguish between substandard and counterfeit drugs and most sources of the counterfeit drugs are unclear, she said. Existing data are not comprehensive, partly because those concerned seem reluctant to report. “As a result the real magnitude of the problem is unknown.”

Pharmaceutical companies are trying to protect their products through a variety of methods, for example, by adding holograms to the label. However, counterfeiting is an increasingly sophisticated business. Holograms themselves can be counterfeited and “real” products may carry no holograms. “Pharmacists must therefore be watchful and if they have an odd feeling about a package, it is wise to check,” she emphasised.

Continuing her presentation, she said that counterfeiting of medicines is being encouraged by a range of factors. The social value of medicines is not given priority when defining national drug policies and there is a lack of government commitment to create strong regulation. “Approximately one third of WHO member states have well developed regulatory systems while approximately one third do not.”

Another issue, she said, is that payers — both health care providers and patients — look for cheap sources of drugs and, in developing countries, scarcity or erratic supply of drugs leads to corruption. Manufacturing often occurs in the absence of good manufacturing practice (GMP) standards and conditions of storage and distribution may be poor. Opening of borders for trade, as well as trade on the internet, are difficult to control. “Denial of the problem by governments, industry and regulators does not help the situation,” she added.

Dr Kopp went on to describe the work of the WHO in combating counterfeiting. First, the organisation is providing tools and guidelines to help ensure that drugs circulating nationally and internationally are safe, efficacious and of good quality. Quality assurance guidelines cover the entire medication process from manufacture using GMP standards through to distribution and delivery to the patient. Secondly, the WHO is providing support to its member states to build national regulatory capacity. Thirdly, the problem is also being addressed through the WHO’s global activities. In particular, the WHO has developed a new rapid alert reporting system, she said. National authorities, anti-counterfeiting liaison officers, manufacturers, distributors, health professionals and others who detect counterfeit medicines are encouraged to report cases to the WHO.

She went on to say that because counterfeiting is becoming so serious and national measures are proving insufficient to counteract it, the WHO is also planning to hold an international convention to address the issue. The aim is to formulate a co-ordinated approach to prevent and combat the problem, to foster responsible trade in medicines and to identify a common understanding, language and definition for counterfeit drugs.

Outlining key points of advice that pharmacists should give to patients, Dr Kopp emphasised that patients should be encouraged to buy medicines from licensed pharmacies, examine packages to see if they are sealed and check the label for the name, manufacturer, expiry date and instructions for use. Purchase of loose tablets, capsules or injections should be avoided and the patient should insist on having a receipt, she said. If disease symptoms persist, patients should be advised to see their doctor or health care provider and, if counterfeiting is suspected, they should tell their pharmacy or medicines control authorities. “In giving this advice, however, it is important not to frighten patients, because they have to take the medicine,” she concluded.

Further details of WHO’s work on counterfeit medicines

FIP activities against counterfeit medicines

Dick Tromp, chairman of the FIP board of pharmaceutical practice, provided an overview of FIP’s activities against counterfeit medicines together with steps taken in his own pharmacy in the Netherlands to provide a “safe haven” from poor quality medicines. Speaking on 7 September, he said: “An integrated and international approach is vital. There should be better sharing of information and data among stakeholders, as well as increased law enforcement and increased awareness among the public.”

All health care systems, including pharmacies, should act as safe havens for the public, he said.

“Health professionals have responsibilities in reporting suspected counterfeits and exchanging information with drug regulatory authorities. Only authorised sources of drugs should be used and it is important to be aware of low prices. Educating the public and raising awareness of the problem is key.”

He went on to highlight the internet as a particular source of counterfeit medicines. In the US, the National Association of Boards of Pharmacy (NABP) has responded to this problem by developing the Verified Internet Pharmacy Practice Sites (VIPPS) programme. A coalition of state and federal regulatory associations, professional associations and consumer advocacy groups pooled their expertise, he explained, to develop a set of criteria that VIPPS-certified pharmacies must follow. To be VIPPS-certified, a pharmacy must comply with the licensing and inspection requirements for each state in which it dispenses medicines. The pharmacy must also adhere to a recognised quality assurance policy, including security of prescription orders, and provide for consultation between patients and pharmacists, he said. (For further information see www.nabp.net/vipps.)

Turning more specifically to FIP’s activities, Dr Tromp said that FIP has a task force on medicines reimportation and an awareness campaign to member associations. It also participates in various activities at a European and global level. Other activities include a “Play safe with medicines” campaign for the public, he said.

Participants heard that the FIP board of pharmacy practice has established a working group (see www.pharmacistscombatcounterfeiting.org). This group has created a case reporting form for individual pharmacists that makes member organisations think about adapting their codes of ethics. Member associations have responsibilities to support FIP’s actions in several ways. They should raise awareness with pharmacists, directing them to the FIP website and providing instruments such as the FIP report sheet for counterfeit medicines. Identification of safe suppliers is another important role of member associations, said Dr Tromp. FIP also encourages pharmacists to keep the quality chain closed and help create a knowledge base.

Dr Tromp went on to describe the efforts made in his own pharmacy to ensure that it is a safe haven for patients. Closing the quality chain is key, he emphasised. This involves using a reliable source of raw materials and developing a protocol for checking the integrity of the supplier. Patients are made aware that the pharmacy takes quality of medicines seriously and an annual quality report is produced. The pharmacy website provides links to safe places for medicines information.

In conclusion, Dr Tromp said that the medicines market is becoming increasingly interesting to fraudsters and neither national nor international rules are enough. Health care is increasingly expensive and commercially driven and managers do not know the value of medicines. More use needs to be made of ethical codes and statements and FIP membership needs to be kept “clean”. It is also important to create a quality chain with suppliers. Caution should be exerted in relation to the internet, but there is no point in objecting to it. Patients have free choice, so it is important that pharmacists educate them about the internet. By providing a “safe haven”, pharmacists can significantly enhance patient safety, an issue that that FIP’s working group will continue to tackle. A symposium has also been planned at next year’s FIP congress, he said.

Improving the integrity of medicines in Tanzania

Margareth Ndomondo-Sigonda, director general, Tanzanian Food and Drugs Authority, discussed strategies for improving the integrity of the medicinal marketplace in Tanzania. Speaking on 7 September, she identified two types of counterfeit medicines, neither of which contain active ingredients: first, specially manufactured counterfeits with excellent labelling and all processes well controlled; secondly, hacker-manufactured counterfeits which are poor quality products with non-uniform colours, poor labelling and poorly compressed. “A perfect counterfeit product cannot be detected and a well-made and well-labelled counterfeit is also difficult to detect, even with direct comparisons between authentic and fake products. Testing may the best available option,” she said.

She went on to highlight recent examples of counterfeit medicines in Tanzania. These have included fake Metakelfin (an anti-malarial), labelled as a genuine product from the original manufacturer, Pharmacia & Upjohn, which was found in circulation in some pharmacies in Tanzania in 1999. Laboratory analysis confirmed that counterfeit Metakelfin actually contained paracetamol. Counterfeit ampicillin capsules containing only potato starch were found in some community pharmacies during 2000. Expired chloroquine injection from an unregistered Indian company and relabelled as quinine dihydrochloride injection from a company in Cyprus was circulated in 2001. In 2004, use of thin layer chromatography identified three fake samples of quinine and two fake samples of erythromycin. During the same year, products poorly made and likely to be fake, including ciprofloxacin tablets, aminophylline tablets and levamisole tablets, were identified, she said. Unscrupulous dealers were also found to be repackaging and relabelling expired drugs, she said.

Factors promoting counterfeiting in Tanzania are similar to those in other countries, she explained. Weak regulatory enforcement capacity, lack of skills and experienced drug inspectors coupled with a lack of guidelines on how to detect, confiscate or investigate suspected counterfeit medicines all play a part. Lack of co-operation between stakeholders, such as drug regulatory authorities, professionals and the industry associations contributes to missed detection, failure to arrest the perpetrators and no penal sanctions. Outdated legislation can also facilitate counterfeit trade, as can long drug distribution channels and free trade zones. For example, a product manufactured in India may pass via a trading company in Europe, a regional distributor in Kenya, a wholesaler in Tanzania and retail distributors. Lack of access to essential medicines, particularly in poor countries, where unsuspecting patients are not aware of the health consequences of taking counterfeit medicines is another factor. Low government salaries for law enforcers, who must confront unscrupulous dealers, may contribute to the problem of drug counterfeiting through corrupt practices.

Combating trade in counterfeit drugs is challenging, particularly in developing countries. “All efforts should be made in parallel with implementation of strong and effective drug regulatory measures,” she said. “In Tanzania, with limited resources available to the food and drugs authority, priorities for counteracting counterfeiting had to be set.” Enforcement was also strengthened with passage of the Tanzania Food, Drugs and Cosmetics Act 2003, with fines of $5,000 for counterfeiting drugs, she added. A quality assurance programme with primary screening at points of entry into the country for medicines was introduced. Training of drug inspectors, development of inspection guidelines and guidelines for the control of importation of drugs have also been introduced to strengthen post-marketing surveillance. “These policies have resulted in a fall in the number of substandard products from 13 per cent in 2001 to 3.7 per cent among 1,257 screened drugs in 2005,” said Dr Ndomondo-Sigonda.

Turning her attention to the challenges for developing countries, she said the capacity of the drug regulatory authorities to detect and investigate counterfeit cases must be strengthened. This can be achieved, she explained, by training drug inspectors on how to identify and investigate counterfeit medicines. Poor documentation of counterfeit cases could be addressed by use of a reporting form. Legislation needs to be strengthened with tougher penalties and sanctions to deter counterfeiters. There is also a need for timely public alert notices by drug regulatory authorities when counterfeit medicines are found. “Consumers and professionals need to be continually on the alert. Post-marketing surveillance should be expanded through improved laboratory testing. Pharmacovigilance centres at both regional and country level should be established. However, combating counterfeit medicines is not high on the agenda, both at country and regional level in East African communities. The WHO should take a leading role in this growing public health problem,” she concluded.