Perspectives: Avoiding Poorly Regulated Medicines and Medical Products During Travel

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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

Imitations

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.

Authentics

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.

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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

Imitations

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.

Authentics

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.

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