Importance of Pharmacovigilance in Storage and Distribution of Medicines
Pharmacovigilance and monitoring are essential in ensuring the safety, efficacy, and quality of medicines, particularly in India, where improper storage and distribution can significantly affect the therapeutic outcomes of drugs. The need for pharmacovigilance arises from the risk posed by temperature excursions, humidity variations, and transport delays during the distribution of medicines, which can lead to adverse drug reactions (ADRs), reduced efficacy, and potential harm to patients.
Why Pharmacovigilance and Monitoring Are Critical in India:
- Challenges in Cold Chain Management:
Many medicines, including vaccines, biologics, insulin, and antibiotics require temperature-controlled storage and distribution. In India, lack of infrastructure, inconsistent power supply, use of non-validated packaging, and unreliable transportation often result in temperature fluctuations that can compromise the integrity of these medicines, leading to therapeutic failures or adverse events. - Adverse Drug Reactions (ADR) due to Improper Storage:
Improper storage and distribution conditions can lead to chemical degradation of medicines, changing their composition and reducing their potency. For instance, insulin and hormonal medications like FSH (follicle-stimulating hormone) lose their effectiveness when exposed to higher temperatures. A diabetic patient receiving insulin that has been exposed to excessive heat due to improper storage may experience poor blood sugar control, leading to complications like hypoglycaemia or hyperglycaemia. - Public Health Risk:
Improperly stored medicines can directly impact public health. If biologic medications like monoclonal antibodies or chemotherapy drugs lose their effectiveness due to temperature excursions, it can lead to treatment failure, allowing diseases to progress or worsen. - Increased Incidence of Fake and Substandard Medicines:
The lack of robust monitoring during the distribution phase can also lead to the circulation of counterfeit or substandard medicines in the market. Improper storage can cause medicines to degrade, creating a false sense of security about their effectiveness. Consumers might inadvertently use these substandard products, resulting in severe health risks and adverse effects. If antibiotics are improperly stored and lose their efficacy, patients may fail to respond to treatment, resulting in prolonged infection, antibiotic resistance, and even death. - Complexity of Distribution in a Large Country Like India:
India’s vast geography and lack of efficient cold chain infrastructure in remote areas create unique challenges. Medicines are often transported from urban centres to rural healthcare facilities over long distances, exposing them to environmental factors that compromise quality. This makes real-time monitoring of storage conditions and distribution channels more crucial. - Pharmacovigilance as a System to Identify, Assess, and Prevent Risks:
- Monitoring Adverse Effects: Pharmacovigilance systems actively monitor and record any adverse events or side effects caused by medicines, including those resulting from improper storage. A failure in the distribution of vaccines or biologics can be linked to adverse reactions or delayed treatment, which should be reported and analyzed.
- Risk Assessment: Pharmacovigilance allows for risk assessment of medicines in real-world settings, enabling regulatory authorities to identify potential risks related to drug degradation or ineffective medicines in specific regions.
- Patient Safety: By collecting data on patient reactions to subpotent or degraded drugs, pharmacovigilance provides the evidence needed to update safety guidelines, issue warnings, or take corrective action on faulty products.
- Regulatory Oversight and Compliance:
India’s drug regulatory agencies are responsible for ensuring that pharmaceutical products are stored and distributed according to strict GDP guidelines. Pharmacovigilance and monitoring systems are necessary to ensure compliance with these regulations and to enforce corrective actions when storage or distribution standards are not met.