Perspectives: Avoiding Poorly Regulated Medicines and Medical Products During Travel
Perspectives: Avoiding Poorly Regulated Medicines and Medical Products During Travel
In many low- to middle-income countries, national drug regulatory authorities lack the resources to monitor and enforce drug quality standards effectively and to keep poor-quality products (including drugs, vaccines, and medical devices) off the market. As a result, substandard and fake medicines are a public health concern in these locations. Many of these poor-quality products are also trafficked by pharmacy websites that appear to be reputable or located in countries with mature regulatory systems.
Poor regulatory oversight breeds poor-quality medicines, whether they are counterfeit, falsified, substandard, or degraded (Box 6-2). A recent report from the World Health Organization (WHO) states that 1 in 10 medical products circulating in low- and middle-income countries are either substandard or falsified. Another study found that 9%–41% of tested drugs failed quality specifications. In specific regions in Africa, Asia, and Latin America, the chance of purchasing a counterfeit drug may be >30%.
Since counterfeit drugs are not made by a 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 with a less effective compound. In addition, the wrong inactive ingredients (excipients) can contribute to poor drug dissolution, bioavailability, and toxicity. As a result, a patient may not respond to treatment or may have adverse reactions to unknown substituted or toxic ingredients.
Vaccines and other products, such as insecticide-treated mosquito nets, water purification devices, condoms, and disinfectants are also subject to quality problems and counterfeiting. Vaccine integrity depends on a temperature-controlled supply chain, and, unlike medicines with stated amounts of active ingredients, the potency of vaccines is difficult to monitor and therefore easy to counterfeit. For example, WHO recently reported that falsified hepatitis B vaccines were circulating in Uganda. Insecticide-treated nets must meet standards to protect against diseases such as malaria; substandard nets were recently implicated as a cause of increased malaria incidence in Rwanda.
Box 6-2. Definitions of poorly regulated medical products
Counterfeit : A counterfeit product bears the unauthorized representation of a registered trademark on a product identical or similar to one for which the trademark is registered.
Falsified : A falsified product falsely represents the product’s identity, source, or both.
Substandard : A substandard product fails to meet national specifications cited in an accepted pharmacopeia or in the manufacturer’s approved dossier.
Degraded : A degraded product has undergone chemical or physical changes due to incorrect storage conditions.
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, diabetes, or arthritis), medications for travelers’ diarrhea, and prophylactic medications for infectious diseases (such as malaria) should all be purchased before traveling. Purchasing these drugs online 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 obtained abroad 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 although many US prescription medications may be available for purchase over-the-counter in foreign countries, some may not be available at all. Checked baggage can get lost; therefore, travelers should pack medications and first aid items 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 appear 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.
- Because many countries have restrictions on medicines (including over-the-counter medications) entering their borders, travelers should check with the embassies of their destination countries for prohibited items.
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 or consulate may be able to help locate legitimate local pharmacies.
- 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.
- Make sure the medicines are in their original packages or containers. Travelers receiving medicines as loose tablets or capsules supplied in a plastic bag or envelope should ask the pharmacist to see the container from which the medicine was 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 product. Discoloration, splits, cracks, spots, and stickiness of the tablets or capsules are indications of 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 printing or packaging materials, 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 unavailable or if the traveler is not familiar with the brand, he or she should compare the distinguishing features of the package with that of the insert or blister pack. For example, batch and lot numbers, manufacturing date, and expiration date should match.
General Information about Counterfeit Drugs
- CDC: wwwnc.cdc.gov/travel/page/counterfeit-medicine
- World Health Organization: www.who.int/mediacentre/factsheets/fs275/en
- Food and Drug Administration: www.fda.gov/drugs/drugsafety/default.htm
- US Pharmacopeia: www.usp.org/global-public-health/medicines-quality-database
Traveling and Customs Guidelines
Researching what travelers can pack, travel with, and bring back into the United States, is helpful in preparing for travel.
- Transportation Security Administration: www.tsa.gov/travel/special-procedures
- Customs and Border Protection: www.cbp.gov/travel/us-citizens/know-before-you-go/prohibited-and-restricted-item
- The International Society of Travel Medicine (ISTM) Pharmacist Professional Group recently posted on the member section of the ISTM website a multi-country table of permissible medications based on information provided by the International Narcotics Control Board and embassies, though this information is subject to change
- Institute of Medicine. Countering the problem of falsified and substandard drugs. Washington, DC: The National Academics Press; 2013 Feb.
- Ministry of Health of Rwanda. MOH Reports. [cited 2018 Mar 30]. Available from: http://moh.gov.rw/index.php....
- Nayyar GML, Bremen JG, Herrington JE. The global pandemic of falsified medicines: laboratory and field innovations and policy perspectives. Am J Trop Med Hyg 2015 Jun;92(6 suppl):2–7.
- World Health Organization. Essential medicines and health products. Full list of Medical Products Alerts. 2018 [cited 2018 March 30]. Available from: www.who.int/medicines/publications/drugalerts/en/.
- World Health Organization. Medicines: counterfeit medicines [fact sheet no. 275]. Geneva: World Health Organization; 2018 [cited 2018 Mar 30]. 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.