The Crucial Role of Pharmacovigilance in Combatting Counterfeit Drugs

It would be possible to put a stop to counterfeit medicines. However, simple controls are often still lacking. That's why researchers want to help drug detectives.

In 2015, health officials in the northern region of the Democratic Republic of the Congo stated that they had seen unexplained symptoms in hundreds of children, including convulsions, vertigo, and an erect posture. An emergency team was dispatched by Médecins sans Frontières (Doctors Without Borders) in response to a possible meningitis outbreak. Nevertheless, none of the patients have meningitis infections discovered by the investigators. The children's urine samples were submitted to France. The medication that the physicians eventually discovered astounded them: haloperidol, a psychotropic medication for schizophrenia. As a side effect, it had given rise to the children's ailments. However, how did the medication enter the kids' bodies?

However, diazepam was initially intended to be administered to all the youngsters instead of haloperidol. In the Congo, benzodiazepines, an anticonvulsant and sedative, are also used to manage pain and fever. The humanitarian group purchased samples from a nearby market and inspected them. Haloperidol was indeed present in the diazepam that they discovered there. The medicine was counterfeit. These haloperidol tablets, which were most likely past their expiration date, may have been part of a batch that a criminal dealer had remaining. The dealer may not have known what to do with it - only that there is a high demand for diazepam. Thus, it's likely that he created a counterfeit label and distributed the phony medications.

Inferior Drugs

The other issue is the lower concentration of active ingredients. According to a systematic review, 10.5 percent of all medicines in middle- and lower-income countries are substandard or falsified.[1] Often, the concentration in the drugs are not correct. The active ingredient is used, but this medicine is inferior. This means that the quality is poor, but unlike counterfeits, the manufacturer cannot be proven to have knowingly tampered with the medicine. It probably originally contained the right amount but was poorly manufactured or not properly stabilized.

Such inferior drugs, which doctors unknowingly use to treat potentially life-threatening diseases, often do not work. Or unexpectedly, sometimes fatal adverse drug reactions occur. At the beginning of 2023, the United Nations Office on Drugs and Crime (UNODC), estimated that half a million people die every year in sub-Saharan Africa due to counterfeit and substandard antimalarials and antibiotics.[2]

Safety, Efficacy and Quality

Counterfeit products are most frequently found on the black market. In many African countries, for example, they are sold by illegal street vendors, while in Europe they are distributed by illegal online pharmacies selling lifestyle drugs such as Viagra or anabolic steroids. In the European Union, for a drug to be approved, the manufacturer must prove that it is safe, effective, and of good quality. This requirement also applies in poorer countries. However, they often lack the resources for government controls.

Pharmacovigilance (PV) and Counterfeit drugs

Counterfeit drugs pose a significant threat to public health worldwide. These medications are produced illegally and may contain incorrect dosages, wrong ingredients, or even harmful substances. PV, which is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, plays a crucial role in combating the circulation of counterfeit drugs. PV deals with counterfeit drugs in the following ways:

1. Detection and Reporting: PV systems are designed to monitor the safety and efficacy of medicines. If counterfeit drugs are detected through these systems, they can be reported to regulatory authorities for further investigation and action.
2. Monitoring Adverse Events: Counterfeit drugs may lead to adverse events due to incorrect ingredients or dosages. PV programs help in monitoring and analyzing these adverse events, which can provide clues about the presence of counterfeit drugs in the market.
3. Post-Marketing Surveillance: After a drug is approved and enters the market, PV continues to monitor its safety and effectiveness. This surveillance helps in detecting any anomalies or unexpected patterns that may indicate the presence of counterfeit versions of the drug.
4. Collaboration with Regulatory Authorities: PV teams often work closely with regulatory agencies to share information and coordinate efforts to combat counterfeit drugs. This collaboration may involve developing strategies for detecting counterfeit drugs, conducting investigations, and implementing measures to protect public health.
5. Education and Awareness: PV programs also play a role in educating healthcare professionals, patients, and the public about the risks associated with counterfeit drugs. By raising awareness, these programs help individuals recognize the signs of counterfeit medications and report suspicious products.
6. Technology and Data Analysis: PV utilizes advanced technologies such as data mining, signal detection, and machine learning to analyze large datasets for identifying potential safety issues, including those related to counterfeit drugs. These tools can help in detecting patterns and trends that may indicate the presence of counterfeit products in the market.

PV plays a critical role in detecting, monitoring, and preventing the circulation of counterfeit drugs by leveraging surveillance systems, collaboration with regulatory authorities, education, and advanced technologies for data analysis. By actively monitoring the safety and efficacy of medicines, PV helps safeguard public health and ensure the integrity of the pharmaceutical supply chain.

[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324280/

[2] https://www.un.org/africarenewal/magazine/february-2023/fake-medicines-kill-almost-500000-sub-saharan-africans-year-unodc-report-0