Counterfeit Drugs

Reference 1

A Global Problem

Counterfeit drugs are killing thousands daily, millions yearly, and the producers are making billions in illegal profits [1]. The true extent of the fake pharmaceutical crisis is difficult to measure as regulators and investigators battle increasingly sophisticated manufacturers. The problem is clearly widespread but especially so in developing countries of Asia, Africa, and the Middle East [1-4]. The main producers appear to be located in southern China, Mexico, and India. It is estimated that counterfeit drugs comprise 10% of the global market, 25% of the market in developing countries, and up to 50% of the market in selected countries such as Nigeria and Pakistan. In industrialized countries like the United States, the incidence is estimated to be less than 1% of market sales. Counterfeit pills can contain no active drug, an insufficient dose of active drug, another medication, or a toxic substance. In known cases, poisons like diethylene glycol (the ingredient in anti-freeze) have been added to fake cough syrups resulting in numerous deaths [3].

Lack of Regulation and Information

Many reports of counterfeit drug operations appear in the popular media and are the result of investigative journalism. Very little information is available in the scientific literature or from government sources. In fact, many governments are reluctant to reveal the existence of problem and may even be involved in the procurement, distribution, and certification of fake medications [2]. Corruption at many levels is probably a major facilitator of the counterfeit trade both in drugs and other goods. High taxes and tariffs in many countries on legally-produced pharmaceuticals force up prices and encourage the illegal production of fake drugs [3]. Furthermore, there is no requirement of pharmaceutical companies to report knowledge of counterfeit operations to government authorities. Many companies fear that public awareness of the existence of bogus pills will result in a drop in sales of their legitimate products.

Consequences of Counterfeit Medications

Fake pills have been distributed for many conditions including malaria, HIV, cancer, and heart disease [5]. Bogus oral contraceptive pills and even meningitis vaccines have been discovered. In the case of malaria, the World Health Organization estimates that 20% of the one million deaths every year are related to counterfeit anti-malarial drugs. One consequence of the counterfeit market is the development of drug resistance by the parasite that causes malaria. If the counterfeit pills contain active drug at an inadequate dose, widespread use will result in very few cured patients and encourage resistant organisms.

What is Being Done to Fight the Illegal Trade

The World Health Organization formed the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) in 2006. The coalition involves representatives from international organizations, non-governmental organizations, regulatory authorities, enforcement agencies, including the International Criminal Police Organization (Interpol), and pharmaceutical manufacturers [6]. The US Food and Drug Administration have issued guidelines for the use of unique physical or chemical additives to pills to allow identification of authentic medications [7]. These include non-toxic inks, pigments, and flavors. A unified and collaborative international approach will be required to make a significant impact on the global trade of counterfeit medications.

How to Avoid Counterfeit Drugs When Traveling

The best way to avoid counterfeit drugs is to reduce the need to purchase medications abroad. Anticipated amounts of medications for chronic conditions such as hypertension, sinusitis, arthritis, hay fever, etc., medications for gastroenteritis (travelers’ diarrhea), and prophylactic medications for infectious diseases such as malaria (depending on the destinations) should all be purchased at home prior to traveling.

To do before you leave

• Make sure you have all your vaccinations before embarking. Immunizations provide the best protection against many serious diseases.
• Purchase in advance, in your home country, all the medicines you will need for the entire trip. Prescriptions from your doctor usually cannot be filled overseas, and over-thecounter medicines may not be available in many foreign countries. Checked baggage can get lost; therefore pack as much as possible in a carry-on bag. Bring along extra in case of travel delays.
• Make sure your medicines are in their original containers. If the drug is a prescription, make sure your name and dosage requirements are on the container.
• Bring your “Patient Prescription Information” sheet. This sheet provides information on common generic and brand names, usage, side effects, precautions, and drug interactions.

What to do if you run out and require additional medications

• Purchase medicines from a legitimate pharmacy. In some places, it is difficult to know if a pharmacy has a genuine license. Your chances of receiving a counterfeit drug are less if you avoid buying from open markets, street vendors, or suspicious-looking pharmacies. Request a receipt when making the purchase. The U.S. Embassy may be able to assist you in finding a legitimate pharmacy in the area.
• Do not buy medicines that are significantly cheaper than the typical price. Although generics are usually less expensive, many counterfeited brand names are sold at prices significantly below the normal price for that particular brand.
• Make sure the medicines you purchase are in their original packages or containers. Many times medicines are sold to the pharmacy in bulk and the pharmacist will dispense the required amount of medicine into another container. If you receive medicines as loose tablets or capsules supplied in a plastic bag or envelope, ask the pharmacist to see the container from which it was originally dispensed. Record the brand, batch number, and expiration date. Sometimes a wary consumer will prompt the seller into making sure he or she supplies you with quality medicine.
• Be familiar with your medications. The size, shape, color, and taste of counterfeit medicines may be different from the authentic. Discoloration, splits, cracks, spots, and stickiness of the tablets or capsules are indications of a possible counterfeit. Keep examples of authentic medications available for comparison if you purchase the same brand.
• Be familiar with the packaging. Different color inks, poor-quality print or packaging material, and misspelled words are clues to counterfeit material. Also, keep an example of packaging for comparison. Observe the expiration date to make sure the medicine has not expired and the package contains the drug insert.

Useful Websites on Counterfeit Drugs

• General Information:

• CDC:

• http://wwwn.cdc.gov/travel/contentCounterfeitDrugs.aspx
• http://www.cdc.gov/malaria/travel/counterfeit_drugs.htm

• World Health Organization: http://www.who.int/mediacentre/factsheets/fs275/en
• U.S. Food and Drug Administration: http://www.fda.gov/counterfeit/
• U.S. Pharmacopeia: http://www.usp.org/worldwide/dqi/drugQuality.html
• Warnings and alerts: http://www.safemedicines.org/in_the_news/drug_alerts.php
• What can you pack in your luggage (for travelers with disabilities and medical conditions):

• Transportation Security Administration: http://www.tsa.gov/travelers/airtravel/specialneeds/editorial_1059.shtm

• What can you bring back:

• U.S. Customs and Border Protection: http://www.cbp.gov/xp/cgov/travel/clearing/restricted/medication_drugs.xml

• Reporting counterfeit cases: http://www.who.int/medicines/services/counterfeit/report/en/

References

1] The Fatal Consequences of Counterfeit Drugs: http://www.smithsonianmag.com/people-places/Prescription-for-Murder.html#

2] The Global Threat of Counterfeit Drugs: Why Industry and Governments Must Communicate the Dangers: http://www.plosmedicine.org, (April 2005) Volume 2, Issue 4, 0302-0308.

3] Counterfeit Medicines in Less Developed Countries: http://www.policynetwork.net/health/publication/counterfeit-medicines-less-developed-countries

4] WHO Fact Sheet no. 275, January 2010; Medicines: counterfeit medicines: http://www.who.int/mediacentre/factsheets/fs275/en/

5] Newton PN, Green MD, Fernández FM, et al. Counterfeit anti-infective drugs. Lancet Infect Dis. 2006;6(9):602–13.

6] WHO; International Medical Products Anti-Counterfeiting Taskforce – IMPACT: http://www.who.int/impact/en/index.html

7]Guidance for Industry Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm[[Category:|Category:]]