How safe is your medicine? Ahmed Abu Ghazala looks into government efforts to stamp out counterfeit drugs At her pharmacy in Nasr City, Manar, who prefers to use her first name, has seen fake medicine many times in her work. She explains how counterfeit medicines can replace active ingredients with starch, sugar or other materials. Other counterfeits include impure or less concentrated ingredients. "If the medicine's ingredients are impure, the medicine is cheaper," she says, explaining the economic interest in counterfeit medicines. Some of the counterfeit drugs do no harm, though they do no good either. However, other medicines may be toxic and may harm the patient. "The most dangerous are expired drugs with removed or relabelled expiry dates. When I find expired medicines, I always dispose of them myself to make sure that nobody will use them," Manar says, adding that there are areas of Cairo known for selling cheap and dangerous medicines. Almost every type of medicine is counterfeited today, with some sold more vigorously in Egypt than others, including nutritional supplements, dietary medicines and skin creams. "I found a skin cream product from a well-known brand selling for LE50. I contacted the company, and they told me that the price was LE105 and the other one was a counterfeit," Manar says. According to the World Health Organisation (WHO), "in extreme cases, counterfeit drugs may even cause death." Madiha Ibrahim is manager of the General Administration of the Pharmaceuticals Inspection Department (GAPID) at the Central Administration for Pharmaceutical Affairs affiliated to the Ministry of Health, and she comments that the GAPID's work resulted in 807 police reports in 2009, and 780 in 2010, against entities accused of producing, distributing or selling counterfeit medicines. Moreover, 75 entities were closed in 2009 and 100 others in 2010 on the same charges. The WHO defines counterfeit medicine as "one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products, and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging." According to Ibrahim, counterfeit drugs include almost every kind of medication on the Egyptian market, both cheap and expensive. In order to discuss government efforts to fight counterfeit medication in Egypt, Sanofi-Aventis, the international pharmaceuticals company, hosted a roundtable meeting in June attended by GAPID's Ibrahim, Mamdouh Hassan from the General Administration for the Investigation of Supplies at the Ministry of Interior, Hassanein Shabana, chairman of the Central Administration against Smuggling, and Niven Al-Khoury, public affairs director of Sanofi-Aventis. The roundtable was part of an anti-counterfeit medication initiative launched by the company in cooperation with the Ministry of Health that also included training on how to detect counterfeit medicines. In addition to fighting against counterfeit medicines, the roundtable also stressed the importance of combating expired and smuggled medicines. "Any medicines produced or distributed without the Ministry of Health's authorisation are considered to be counterfeit," Ibrahim says. Although combating smuggled drugs may be presumed to serve the interests of the pharmaceutical companies and the government more than it does those of patients, in fact Al-Khoury says that fighting smuggling could save many patients. Imported medicines are transported in special containers and follow regulations to ensure strict quality control. In the case of smuggled drugs, such guarantees cannot be given, potentially harming people's health should they use them. According to Shabana, 49 shipments of smuggled drugs were apprehended in 2009 and 26 in 2010. "Most dangerous of all was the shipment of 35 million Tramadol tablets, a centrally acting analgesic, last year, and two million sexual stimulants this year. The value of the apprehended freight has reached some LE622 million," he says. All confiscated drugs are inspected by the Ministry of Health, which destroys them in the presence of representatives from seven government entities, including representatives of the Ministry of State for Environmental Affairs, the police, the customs authorities, and the GAPID. According to Hassan, 209 cases of counterfeit and smuggled drugs were handled by the courts in 2009. These comprised a total of more than seven million tablets and packages weighing some 15 tons. The number this year has reached some 90 tons, composed of some 680,000 tablets and packages. Fighting counterfeit medicines is a matter for government, the pharmaceutical companies, pharmacists and ordinary citizens, participants at the roundtable said. According to Al-Khoury of Sanofi-Aventis, the company invests huge amounts in research and development and it tests all products to discover any attempts at counterfeiting. Watermarks and other security devices are used on packaging in order to make counterfeiting more difficult. The company also works to increase people's awareness of the problem, she says. In fact, raising public awareness is one of the most important ways of combating counterfeits. "The media has a role to play in raising awareness of the problem of unlicensed or counterfeit medicines advertised on the Internet or on satellite channels," Ibrahim says. While the government controls local broadcasting channels, it does not control satellites. For this reason, Hassan says, people should be aware of the problem of counterfeiting when watching such channels, particularly if medications are advertised without giving addresses, or contacts are provided through cell phones. One counterfeiter had been recently caught, he says. "We traced the telephone number announced in the advertisement to a line connected to a fake address." The advertisement, for a company offering treatment for Hepatitis C, was traced back to producers based in Boulaq Al-Dakrour and the case is currently before the courts. According to the WHO, over 50 per cent of medicines purchased over the Internet from sites that conceal their physical addresses have been found to be counterfeit. Moreover, Shabana says, companies possessing the licences necessary to import goods should not "lend" these out to others, who may be involved in importing counterfeit drugs. The owners of the licences will be the ones to blame, and they will face prosecution if caught. "When we uncovered the smuggled Tramadol pills, we discovered that the importer was not the real dealer, but was another person who had 'rented out' his importation licence and then disappeared when the shipments were caught," he says. Penalising the producers or distributors of counterfeit medicines has two aspects, Ibrahim says, with administrative measures being taken to close the companies concerned pending possible criminal prosecution. "We depend on inspection campaigns and notifications we receive from pharmaceutical companies and others," she says. People should always keep the documents that come with any medicine, since these can be used to track down the producer in cases of counterfeiting. Some pharmacists interviewed by Al-Ahram Weekly say that this may not always be possible, however. Papers cannot always be provided for patients asking only for small numbers of pills or doses as prescribed by their doctor, or buying medications whose price doesn't exceed LE1 or LE2. This would mean that every strip of pills would have to have separate documentation, not every box as at present. "The best guarantee for patients is to deal with pharmacists they personally trust," says one pharmacist. Both pharmacists and members of the public should only buy drugs from authorised companies, and they should notify the GAPID of any suspected counterfeits. "We publish lists of all confiscated medicines and apprehended entities and persons on our website at www.eda.mohp.gov.eg," Ibrahim avers. Nevertheless, there may still be a lack of trust between people and the authorities that is exacerbating the problem. Many pharmacists or individuals do not report counterfeits, possibly because they are either not aware that the medicine is counterfeited, or because they do not want to risk involvement with the authorities. They may also suspect that the government will not take real action against the counterfeiters. A strategy to build trust between the public and the health sector of the government is needed to overcome such problems. According to Manar, some patients complained to her about a dietary medicine supposed to be sold for LE420 but in fact selling for LE90 in a counterfeit version. Manar says that she had been offered the counterfeit drug, but had refused to deal with it. Did she report the case to the ministry? "No, because I didn't think they would have done much." The Pharmacists Syndicate has an important role to play in combating counterfeits, and it instructs its members only to deal with companies offering the proper documentation. The syndicate also bars its members from accepting any discounts over 10 or 20 per cent. "The profit margin for pharmacists is generally between 10 and 20 per cent, so the consumer should think carefully when he sees big differences in the prices of the same product. Any pharmacist offering such discounts risks legal action," Manar says. Most counterfeit medicines can't be detected immediately by patients, though eventually they will notice that the medicine is not having the desired effects. Although testing medicines needs sophisticated laboratory facilities, a pharmacist can recognise counterfeit medicines if they do not behave as the real products should. A syrup may become cloudy, for example, or tablets may bleach and become yellowish and crumbly. The law penalising counterfeit medicines includes Law 127/ 1955, which regulates all aspects of the pharmaceuticals market, including licensing of medicines and pharmacies. Yet the law is not a sufficiently deterrent one, and the Ministry of Health aims to amend the law in order to toughen penalties. Hassan says that at the moment cases of medical counterfeiting are often judged under other laws, like those dealing with fraud. Some of those found guilty of counterfeiting have been jailed for up to five years, while others have only been fined or faced administrative closures. "It would be better to toughen up the pharmaceuticals law and to speed up the judging process," Ibrahim says. "Anyone buying narcotics knows that he is consuming something that will damage his health, but someone buying counterfeit medicine does so with the intention of treating an illness. For this reason, the counterfeiters of medicines are more dangerous than drug dealers, but at the moment they don't risk appropriate penalties," she says. In the GAPID presentation, WHO specifies the medicines that are most counterfeit Counterfeit medications are a serious global problem and the World Health Organisation predicts that sales may top $75 billion this year alone. According to the WHO, there are six features of counterfeit medicine that should be widely known: - Counterfeit medicines are medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source. - Use of counterfeit medicines can result in treatment failure or even death. - Public confidence in health-delivery systems may be eroded following use and/or detection of counterfeit medicines. - Both branded and generic products are subject to counterfeiting. - All kinds of medicines have been counterfeited, from medicines for the treatment of life- threatening conditions to inexpensive generic versions of painkillers and antihistamines. - Counterfeit medicines may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient or too much active ingredient, or with fake packaging.
