Central Research

Medical products of substandard quality, the main affected: the patient and the family

According to the WHO, 1 in 10 products marketed in low- and middle-income countries are of lowquality standards or counterfeit(1), this indicator does not represent all cases, since no country is exempt from this reality. Unlike counterfeit medicines, substandard products are products that go through a rigorous evaluation before being authorized by the Health Agencies and then in the marketing stage, do not meet the required quality standards or the specifications with which they were registered(2).

Limited access due to economic issues, deficient government systems and without adequate control of safe medical products allows the population to access this type of substandard quality products(3). In addition, these products can be found in illegal street markets, on unregulated websites, and even in pharmacies and hospitals(2).

To put ourselves in context, imagine that we have a family member whose medical treatment represents a life expectancy, but this does not take effect or, worse, aggravates his illness; In addition to representing an expense, it will generate a psychological impact on the patient and his family. What can it mean for the patient? Definitely, the first thing that comes to mind may not be to doubt the treatment, but in the severity of the disease and, therefore, lose hope. Now imagine that our child presents an infectious process of bacterial origin, which is treated with an antibiotic that does not contain the amount of active ingredient according to technical specifications or, what is worse, that contains more of the active ingredient and represents a risk of toxicity in the patient because it contains toxic chemical components for the body(3).

Definitely, the infectious process could worsen and generate greater hospital stay or cause other health problems in the patient. This situation generates a lack of confidence not only in medicines but also in health professionals, in the health system, and in governments, who attest to these medicines circulating in the market, opting for other alternative treatment measures that are not always safe or scientifically investigated.

This situation is not limited to the most expensive drugs or the best-known brands, but also affects generic and patented products to an equal extent(4). It is well known that generic drugs must also demonstrate bioequivalence. In many Latin American countries, there is a great difference in efficacy between a branded drug and a generic drug of the same active, for example, a study conducted in Mexico revealed that a generic corticosteroid did not reach the expected efficacy compared to other products, so generic substitution could show a lower clinical response than that of the original brand(5). There are regulatory advances in relation to the presentation of bioequivalence studies of the registrations of certain molecules by the pharmaceutical industry, however, it is the patients who must communicate the lack of efficacy or nonoptimal clinical responses with these products.

Medical products of lower or substandard quality identified with high frequency have corresponded to all categories, in particular drugs, vaccines, and in vitro diagnostics, however, the most reported are antimalarials and antibiotics(7). On the other hand, the main safety problems that have been reported with the use of substandard quality medicines are bacterial resistance, higher prevalence of diseases, hospital readmissions, overdose, misdiagnosis of communicable diseases that put public health at risk, for example, COVID-19, or poisoning due to high levels of active ingredient in products.

The WHO issued an alert in December 2022 on the detection of a product containing methotrexate (a product that belongs to the WHO list of essential medicines for its indications in cancer and autoimmune diseases) contaminated with Pseudomonas aeruginosa, which represents a high risk, given that bloodstream infection by Pseudomonas aeruginosa it is serious and can cause death. The important finding to note is that adverse events were detected in pediatric patients.

Another alert recently issued by WHO in December 2022 regarding substandard quality medical products concerns products in syrup presentation that contained unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants. These agents pose a great danger since toxic effects can include abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental status, and acute kidney damage that can lead to death.

Having substandard medical products represents a significant public health challenge that we all face, for which global authorities and organizations must take action. With this situation, the importance of having robust pharmacovigilance systems that allow addressing and prioritizing care in the post-authorization surveillance of medical products is reinforced.

The healthcare professionals involved must ensure that the drug supply chain is carried out with ethics, professionalism, and integrity so that in this way it is guaranteed that the quality control and safety of the entire process comply with regulatory and quality requirements. It is recommended to reinforce community action on the part of health professionals to educate patients to identify and report in a timely manner any suspected adverse reaction with the use of all medical products, only in this way, we can analyze and investigate the origin of substandard quality products and with these reports generate concerns and investigations by the authorities for the issuance of more safety alerts.

The authorities play an important role in stopping and controlling the entry and circulation in the market of medical products that do not demonstrate quality, efficacy, and safety. The rigor in the request of controls and minimization of risks to manufacturers can contribute to reducing this problem, in addition to the stimulation of reports by all actors in the Health and Pharmacovigilance Systems with research actions and even withdrawal of unsafe medical products of poor quality.

Q. F. Katherine Daneri

Current leader of the International Pharmacovigilance Consultancy Vigilantia Healthcare and pharmaceutical teacher at Educational Institution in Peru.

References

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OMS. Productosmédicosdecalidadsubestándaryfalsificados, Available in: https://www.who.int/es/news-room/fact-sheets/detail/ substandard-and-falsified-medical-products

Productosmédicosdecalidadsubestándaryfalsificados,el crecientedesafíoparalasaludpública. Ángel Luis Jiménez. Consalud.es, September 4, 2022. Available in: https://www.consalud.es/industria/ datos-medicamentos-falsificados_118555_102.html

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Juan Pablo Castanedo-Cázares,* Judith Quistián-Hemández,* Bertha Torres-Alvarez,* Antonio Torres-Ruvalcaba,** Benjamín Moncada,** Estudio del efecto antiinflamatorio de un corticosteroide tópico: marca reconocida versus genéricos. GacMédMéx, Vol. 137 No. 4, 2001.

Medicamento. Disponible en: https://www.cancer.gov/espanol/publicaciones/ diccionarios/diccionario-cancer/def/medicamento

Productos médicos de calidad subestándar y falsificados. International Council of Nurses position statement. Available at: https:// www.icn.ch/sites/default/files/inline-files/PS_E_Substandard_and_ Falsified_Medical_Products_es_0.pdf

Alerta de Producto Médico N°8/2022: Subestándar (contaminado) METHOTREX 50mg identificado en la región del Mediterráneo Oriental de la OMS. December 27, 2022.

Alerta de Producto Médico N°1/2023: Medicamentos de dosificación líquida subestándar (contaminados) identificados en la Región Europea de la OMS. January 11, 2023.