Perspectives: Pharmaceutical Quality & Falsified Drugs
The quality of medicines available outside the United States should not always be taken for granted. In many countries, national drug regulatory authorities lack the resources to effectively monitor drug quality and keep poor-quality pharmaceuticals off the market. These poor-quality drugs include falsified (the product’s identity or source is falsely represented), counterfeit (a product bearing an unauthorized representation of a registered trademark), and substandard (a medicine not conforming to the specifications set by an accepted pharmacopeia) medications. Poor-quality medicines also include products that are not stored correctly, such that high temperature and humidity can alter the chemical composition. These drugs are an international problem contributing to illness, toxicity, drug resistance, and death. Although this problem exists on a worldwide scale, reliable global estimates of its prevalence are scarce because consensus is lacking on harmonized international definitions of poor-quality medicines and surveillance methods. Recent survey studies of antimicrobial drug quality in Africa and Southeast Asia revealed that 9%–41% failed quality specifications. Previous reports have shown that global estimates of drug counterfeiting range from 1% of sales in developed countries to >10% in developing countries. In specific regions in Africa, Asia, and Latin America, chances of purchasing a counterfeit drug may be >30%.
Since counterfeit drugs are not made by the legitimate manufacturer and are produced under unlawful circumstances, toxic contaminants or lack of proper ingredients may cause serious harm. For example, the active pharmaceutical ingredient may be completely lacking, present in small quantities, or substituted by a less-effective compound. In addition, the wrong inactive ingredients (excipients) can contribute to poor drug dissolution and bioavailability. As a result, a patient may not respond to treatment or may have adverse reactions to unknown substituted or toxic ingredients.
Before international departure, travel health care providers should alert travelers to the dangers of counterfeit and substandard drugs and provide suggestions on how to avoid them.
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, and hay fever), medications for gastroenteritis (such as travelers’ diarrhea), and prophylactic medications for infectious diseases (such as malaria) should all be purchased before traveling. Purchasing these drugs via the Internet is not recommended, since the source of the medicines is always questionable. The traveler should also be aware that other health-related items such as medical devices, mosquito nets, and insect repellents could also be counterfeit, falsified, or substandard.
Before departure, travelers should do the following:
- Obtain all medicines and other health-related items needed for the trip in advance. Prescriptions written in the United States usually cannot be filled overseas, and over-the-counter medicines may not be available in many foreign countries. Checked baggage can get lost; therefore, travelers should pack as much as possible in a carry-on bag and bring extra medicine in case of travel delays.
- Make sure medicines are in their original containers. If the drug is a prescription, the patient’s name and dose regimen should be on the container.
- Bring the “patient prescription information” sheet. This sheet provides information on common generic and brand names, use, side effects, precautions, and drug interactions.
Many countries have restrictions on medicines (including over-the-counter medications) entering their borders. Check with the embassies of your destination countries for prohibited items. A listing of foreign embassies and consulates in the United States is available on the Department of State’s website at www.state.gov/s/cpr/rls/dpl/32122.htm.
If travelers run out and require additional medications, they should take steps to ensure the medicines they buy are safe:
- Obtain medicines from a legitimate pharmacy. Patients should not buy from open markets, street vendors, or suspicious-looking pharmacies; they should request a receipt when making the purchase. The US embassy may be able to help find a legitimate pharmacy in the area.
- Do not buy medicines that are substantially cheaper than the typical price. Although generics are usually less expensive, many counterfeit brand names are sold at prices substantially lower than the normal price for that particular brand.
- Make sure the medicines are in their original packages or containers. If travelers receive medicines as loose tablets or capsules supplied in a plastic bag or envelope, they should ask the pharmacist to see the container from which the medicine was originally dispensed. The traveler should record the brand, batch number, and expiration date. Sometimes a wary consumer will prompt the seller into supplying quality medicine.
- Be familiar with 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. These defects may also indicate improper storage. Travelers should keep examples of authentic medications to compare if they 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 drugs. Travelers should keep an example of packaging for comparison and observe the expiration date.
If the authentic packaging is not available or if you are not familiar with the brand, compare the distinguishing features of the package with that of the insert or blister pack. For example, batch/lot numbers, manufacturing date, and expiration date should match.
General Information about Counterfeit Drugs
Traveling and Customs Guidelines
Researching what travelers can pack and bring back into the United States, especially for travelers with disabilities and medical conditions, is helpful in preparing for travel.
- Transportation Security Administration: www.tsa.gov/traveler-information/travelers-disabilities-and-medical-conditions
- Customs and Border Protection: www.cbp.gov/newsroom/local-media-release/2015-04-22-000000/cbp-advises-travelers-entry-regulations-pertaining
- Gaurvika ML, Nayyar JG, Bremen JG, Herrington JE. The global pandemic of falsified medicines: laboratory and field innovations and policy perspectives. Am J Trop Med Hyg 2012 Jun;92(6 suppl):2–7.
- Institute of Medicine. Countering the problem of falsified and substandard drugs. Washington, DC: The National Academics Press; 2013 Feb.
- World Health Organization. Medicines: counterfeit medicines [fact sheet no. 275]. Geneva: World Health Organization; 2012 [cited 2016 Sep. 22]; Available from: www.who.int/mediacentre/factsheets/fs275/en/.
Michael D. Green
Perspectives sections are written as editorial discussions aiming to add depth and clinical perspective to the official recommendations contained in the book. The views and opinions expressed in this section are those of the author and do not necessarily represent the official position of CDC.