PREVENTION

Lower risks to patients, higher risks for traffickers

Even though it has reached alarming proportions, global traffic in fake drugs is not a fatality.

Around the world, Governments, health agencies, associations and pharmaceutical laboratories in turn are taking individual or concerted actions that are effectively stemming the scourge and better protecting populations. These approaches are extremely varied and complementary, aiming to foster more ethical behaviour, to increase vigilance or to secure the pharmaceutical products and their supply lines. If such measures could be coordinated on a large scale and optimized in a comprehensive global strategy, the risk balance would certainly sway in favour of the patients and to the detriment of the traffickers.

1. Informing, training and advising healthcare professionals.

The health profession embraces all professionals involved in the conception, production, regulation, distribution and marketing of medicines or in health care. From the pharmaceutical laboratory that produces the medicines to the patient consumer, all these professionals (doctors, wholesaler or retailer pharmacists, nurses, auxiliaries and administrative personnel) are qualified intermediaries who are ideally placed to track down false medicines.
Government ministries and departments, national health authorities, and international and national associations representing the different healthcare professions lead a number of actions to inform, train and advise health professionals to be more watchful.
These initiatives address various audiences and comprise educating, communicating and counselling. They include the editing and distribution of good practice guidelines, the publication of pharmacists’ advice on what to do in case of doubt about the authenticity of a drug, and warnings to the staff of health-focused non-governmental organizations on the risks of buying or administering fake drugs purchased from suppliers outside secure supply lines.
Actions such as these, carried out throughout the world, are even more efficient in that they are implemented by professionals with a strong safety culture (pharmacovigilance) and an acute sense of responsibility.
In emerging countries where risks are stronger and supply lines less structured, these measures are gradually managing to make health systems more secure by creating virtuous work habits.
-The International Pharmaceutical Federation (FIP) and US Pharmacopeia have jointly designed and released a detailed list of guidelines for visual drug inspections to help nurses to detect the signs of a possible infringement: defective packaging, poor labelling, incorrect dosage …
-Since 2000, the WHO provides a Guide to developing measures to eliminate counterfeit medicines.

2. Securing the supply chains.

In South America and its hospitals, in the UK, in China, in the United States or in Pakistan and its pharmacies, in online pharmacies on the internet…
Around the world, on a more or less large scale (from isolated incidents to dismantled networks), the discovery of fake medicines in official supply networks attests to the continuous necessity to improve the security of  local and international distribution channels.
Today many initiatives led by laboratories, private security specialists, or professional or patient associations, are devoted to making these networks safer and act at different levels to:

  • Develop tools to enable the traceability and localization of drugs.
  • Distribute control apparatus to wholesale distributors and retail pharmacies for drug identification and authentication and train staff in their use.
  • Restrict the number of intermediaries in the supply systems while preserving free competition.
  • Multiply inspections among the wholesalers and retailers, particularly targeting those who engage in parallel imports, who are more exposed to the risks of intrusion of falsified medicines.
  • Quickly and effectively analyze the suspected drugs and centralize “identification sheets” for each infringing product in a central and unique database.
  • Purchase products on the internet to test and subsequently, if necessary, to pursue with thorough investigations and possible prosecution.
  • Validate the security of websites by awarding a label and a logo to sites who legally sell drugs and who meet the criteria of quality and reliability.
  • Publish an official online list of these trustworthy sites.

The coordinated use of these technological, organizational or behavioural levers within the official and parallel trade distribution channels increases the chances to identify and eliminate forged drugs before they reach the patient.
Moreover, the diversity of these actions and their implementation at several levels  is likely to complicate the task of the traffickers, obliging them to develop more random workaround strategies.

  • In the United States, some pharmaceutical companies have tested several imported drugs to validate the security of their supply chain. (Making a Killing , p68 )
  • In 2008, the SANOFI Group inaugurated a central anti-counterfeit laboratory.
  • In December 2003, a large American laboratory required all its distributors in the United States to buy its products directly from its services or from selected wholesalers. Three years later, the laboratory excluded 18 wholesalers from its distribution channel in the United Kingdom. (Making a Killing 69 p ))
  • The National Association of Boards of Pharmacy (NABP) has created a “Verified Internet Pharmacy Practice Sites” (VIPPS) accreditation for online pharmacies that meet VIPPS specifications and publishes the list of these approved e-pharmacies on its web site: http://www.nabp.net/

3. Organizing vigilance, monitoring incidents and systematizing feedback.

In order to contribute effectively to securing health systems, quality information must be collected and widely communicated and the players must be very reactive in treating the information they receive.
Most of the information coordination work is done by national health agencies, international organizations and through interstate cooperation, but private associations or pharmaceutical companies also contribute:
Some of the most pertinent actions consist in:

  • Making and updating a check list of the drugs that are most likely to be forged to better target actions.
  • Systematically reporting to the competent authorities all incidents related to pharmaceutical products: poisoning, discovery of batches of counterfeit drugs, theft or illegal diversion of drugs …
  • Exchanging information regularly and transparently between the different international actors.
  • Systematically recalling suspect batches and quickly alerting the field players.
  • Conducting in-depth investigations of incidents and making recommendations for change.
  • Setting up a permanent (24/24 h) hotline in laboratories enabling to rapidly verify the authenticity of suspect drugs.

Raising the actors’ awareness that they have a key role to play in this vigilance leads to the emergence of an international spirit of cooperation and transparency between health authorities, health professionals, associations and the patients themselves.

  • PSI offers an incident notification system (CIS) for pharmaceutical companies to report cases of counterfeit drugs found in supply chains. (Making a Killing 68 p )).
  • the WHO has created an online portal: Rapid Alert System (http://www.counterfeitmedalert.info) allowing local officials to report and to alert the authorities about counterfeit drugs.

4. Facilitating access to authentic medicines in developing countries.

One of most effective means of prevention is to better meet the demand for authentic drugs in developing countries.
Many actions are thus undertaken to limit the retail prices of medicines for the most disadvantaged populations.
A transfer of know-how between developed and emerging countries allows local laboratories to improve the quality of their pharmaceutical products in the respect of industrial property rights.
Some laboratories also practice a preferential price policy for the poorest populations by reducing their production costs and by selling drugs of first necessity at no-profit prices. Unfortunately, these measures have sometimes been offset by the action of traffickers who have diverted these drugs to resell them at a much more expensive price in other countries.
Elsewhere, large pharmaceutical companies improve access to drugs by encouraging the establishment of drug manufacturing factories in developing countries, which at the same time reduces their manufacturing and transportation costs (and therefore drug retail prices) and supply times.
Even if generic drugs have also turned out to be the target of counterfeiters, the lower cost of authentic generics (approximately 30% cheaper) favours access to quality medicines for the poor.
Finally, some countries have removed or reduced customs duties on imported vital drugs, in an endeavour to avoid artificially inflated retail prices.

  • In 2005 and 2006, a large French laboratory distributed more than 10 million anti-malarial treatments (ACT) at preferential prices in 16 endemic countries in the context of its program to facilitate access to anti-malarial drugs (CAP). In 2 years, more than 26 000 families benefited from the “Malaria Impact card” distributed by 400 retail pharmacies. Thus, nearly 47 000 patients obtained treatment against malaria at a lower cost.
  • The American and European Pharmacopoeia (USP) help emerging countries to enhance the quality of their drugs by providing detailed guidelines of the basic requirements that drug regulating agencies should fulfil (evaluation, registration, inspection…). (Making a Killing, p 67)
  • USP offers to help volunteer laboratories to improve the quality of their drugs by providing them with standards, product test services, audits… Their products are then certified by a «verified pharmaceutical ingredient” label
  • 6 African countries (Guinea, Kenya, Mauritius, Tanzania Uganda and Papua New Guinea. have removed customs duties for the products that the WHO recommends as essential to effectively combat malaria
  • Since 1999, Burundi has removed customs duties on antiretroviral drugs and treatments for AIDS-related infections. (Source: Berne Declaration website, http://www.evb.ch/fr/index.cfm)
  • India applies no customs duties to certain vital drugs such as antiretroviral and anti-cancer treatments. (Source: Berne Declaration website, http://www.evb.ch/fr/index.cfm)

5. Educate and communicate to the general public.

Among the factors promoting the proliferation of fake drugs, the lack of awareness of patients and the general lack of information concerning the risks are a major concern.
The need to fill this gap is even more urgent in emerging countries where the penetration rates of false medicines and the weaknesses in the health systems are the greatest. Therefore, informing the patient, who is by nature always victim and never complicit in the trafficking, is the ultimate bolster to halt the pandemic.
As a rule, the populations of developed countries trust in their health systems. And yet, many factors tend to generate risky behaviours: the absence of questioning about the overall quality of the drugs, the will to circumvent the regulations limiting access to certain medical products (psychotropic drugs, steroids…), the development of self-medication practices and the advent of the internet ….
Here, international organizations, health agencies and associations, and the laboratories themselves play an important role.
Their most effective initiatives are dedicated to:

  • Promoting access to accurate, complete and reliable information through the publication of brochures and educating via internet sites.
  • Promoting transparency and building good relations with the press as information relays.
  • Designing and financing communication campaigns containing preventive messages for populations at risk.
  • Issuing warnings and preventive messages about the low level of security in internet transactions, informing them of the dangers of counterfeit drugs.
  • Communicating about the preventive and punitive measures in place in order to reassure the patients and to deter traffickers.
  • In the Ivory Coast, the National Council of the Order of Pharmacists and the Ministry of Health have launched a campaign of communication ” Do not eat street drugs” to educate populations at risk. (http://www.ciopf.org/)
  • In 2008, in the Lebanon, a campaign co-signed by the Ministry of Health, the College of Pharmacists, The Eastern Mediterranean FIP-WHO and the CIOPF released the message: “the counterfeit drug is a silent killer distributed by criminals” (http://www.ciopf.org/)
  • In 2011, the Observatory of Illicit Traffic organised a cartoon contest in the countries of the Mekong on the theme of counterfeits that threaten health or safety. Using the slogan “Counterfeiters are death merchants” for inspiration, young people aged from 16 to 25, from Cambodia, Laos and Vietnam, were invited to illustrate their vision and their reactions concerning dangerous fake health products. http://mekongcartooncontest.com
  • Performed for the first time in Nairobi in October 2011, the song “Proud to be” aims to alert populations about the dangers of falsified medicines. “Proud to be” is the fruit of an artistic collaboration between 2 famous African singers, Yvonne Chaka Chaka and Youssou N’Dour  and INTERPOL’s will to make the greatest number aware of  the risks.
    (http://www.interpol.int/fr/Centre-des-médias/Vidéos/(video_id)/12130)

All counterfeit medicines are dangerous 
By definition, fake medicines are never inspected by competent authorities. They always present a health risk for patients. False medicines are manufactured and sold by criminal or mafia networks exclusively to make money. Most often they are of very bad quality and manufactured under deplorable sanitary conditions. Analysis of the various fake medicines seized throughout the world makes it clear that there are several types of drugs, each with its own specific dangers.

  • Fake drugs with “no active ingredient” (principle): the counterfeit is a pure con with no therapeutic effect.

Danger: The patient believes that he is taking treatment but it is not the case. His pathology is therefore no longer treated and gets worse. Depending on his illness, he could die after a few weeks (in the case of HIV, cancer or malaria) or suffer irremediable damage to his health due to the absence of medication.
-The WHO carried out a study in 2001 concerning anti-malaria products in Asia. The study revealed that 38 of the 104 drugs on the market did not contain any active substance and therefore had no effect.

  • Fake drugs with “insufficient active ingredients”: The counterfeit product contains one or more principles but the proportions are lower than in the real drug.

Danger: The product is not efficient enough and the illness continues to develop. In the case of malaria for example, this kind of fake medicine has a very harmful effect for the patient as the parasite becomes more resistant to future treatments.
-In Burma, in 2006, under-dosed fake artesunate drugs were seized. Each tablet contained between 3.5 and 12.1 mg of artesunate, that is less than one fifth of the quantity present in the authentic product. (Source: Centre for Tropical Medicine, University of Oxford, Edition n° 5, July 2006)

  • Overdosed fake drugs: the fake drug contains higher quantities of one or more active ingredients than in the real medicine.

Danger: The excessive quantity of active principle directly endangers the patient and exposes him to harmful overdose effects According to the nature of the product and /or the treated pathology, these effects can be fatal.

  • False “toxic” medication: The false drug contains one or more deliberately or accidently introduced toxic substances.

Danger: The toxic substance is likely to kill the patient at its first ingestion.
– In 1995, 89 Haitians died after drinking a forged cough syrup which actually contained antifreeze. (Source: The WHO)

  • False drugs containing “another active principle”: The false drug contains a different active ingredient than announced.

Danger: If the patient is allergic, the substitute active principles can cause death by anaphylaxis (exacerbated allergic reaction)