Author(s): Michael Green

In many low- and middle-income countries, national drug regulatory authorities lack the capacity to monitor and enforce drug quality standards effectively and to keep poor-quality products, including drugs, vaccines, and medical devices, off the market. Consequently, substandard and fake medicines are a public health concern in these locations. Many poor-quality products also are trafficked by pharmacy websites that misrepresent themselves as reputable or located in countries with mature regulatory systems. Even high-income countries are not immune to the problem, because counterfeiters become adept at thwarting the efforts of more advanced regulatory systems.

Poor regulatory oversight breeds poor-quality medicines, whether they are counterfeit, falsified, substandard, or degraded (Box 6-05). A report from the World Health Organization identified that 10% of 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, Latin America, and Asia, the chance of purchasing a counterfeit drug can be <30%.

Because counterfeit drugs are not made by legitimate manufacturers and are produced under unlawful circumstances, improper or toxic ingredients in these products can cause serious harm. For example, the active pharmaceutical ingredient could be absent, present in small quantities, or replaced 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 might not respond to treatment or could have adverse reactions to unknown substituted or toxic ingredients.

Vaccines and other products (e.g., condoms, disinfectants, insecticide-treated mosquito nets, masks, water purification devices) also could have quality problems or be counterfeit. Vaccine integrity typically 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. As expected, criminal networks have exploited the coronavirus disease 2019 (COVID-19) pandemic by producing fake vaccines. An international alert issued by INTERPOL resulted in confiscation of thousands of fake vaccines in China and in South Africa. INTERPOL’s Secretary General described the number of seized vaccines as being “the tip of the iceberg.”

Avoiding Counterfeit Drugs when Traveling

The best way to avoid counterfeit drugs is to reduce the need to purchase medications abroad. Instruct travelers to purchase anticipated amounts of medications for chronic conditions (e.g., arthritis, diabetes, hypertension), medications for travelers’ diarrhea, and prophylactic medications for infectious diseases (e.g., malaria) before traveling. Advise travelers to avoid buying drugs online, because the source of the medication often cannot be verified. Travelers should also be aware that other health-related items obtained abroad (e.g., medical devices, insect repellents, mosquito nets) also could be counterfeit, falsified, or substandard.

In preparation for international travel, travelers should obtain all medicines and other health-related items needed for the trip. Prescriptions written in the United States usually cannot be filled overseas, and although many US prescription medications are available for over-the-counter purchase in foreign countries, some might not be available at all. Because checked baggage can get lost, travelers should pack medications and first aid items in a carry-on bag, and bring extra medicine in case of travel delays. Travelers should carry medicines in their original containers; for prescription drugs, the patient’s name and dose regimen should appear on the container. Travelers also should bring the “patient prescription information” sheet, which provides information on common generic and brand names, use, side effects, precautions, and drug interactions. Travelers should check with the embassies of their destination countries for prohibited drugs; many countries have restrictions on medicines, including over-the-counter medications, entering their borders.

If travelers run out of and require additional medications, they should take steps to ensure the medicines they buy are safe (see Box 6-06 for a traveler checklist of good practices, and Table 6-01 for a list of online resources). One way to ensure medication safety is by comparing distinguishing features of the packaging, especially when authentic packaging is unavailable or if the traveler is not familiar with the brand. For example, the batch and lot numbers, manufacturing date, and expiration date printed on the outside of the box should match what is on the insert or blister pack.

. . . perspectives chapters supplement the clinical guidance in this book with additional content, context, and expert opinion. The views expressed do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC).