Pharmacovigilance plays a specialized and pivotal role in ensuring safety of medicinal products and health supplements.
What are health supplements
Dietary or health supplements are substances that addnutrientsto the diet or lower risks of health problems. The supplements available in the market reveal a world of promises and a sea of choices related to nutrition, dieting and bodybuilding. The dosage form of supplements can vary from capsules, gel tabs, powders, extracts or liquids toinclude vitamins, minerals, amino acids, herbal extracts or enzymes.Supplements can provideindividual or combination of nutrients extracted from synthetic or food sources. Awareness of the ingredients used in the supplements along with physiologic effects and potential adverse outcomes is possible through pharmacovigilance. Adequate evidence or impetus to evaluate regulatory obligations by undertaking rigorous testing for safety and efficacy of supplements before over-the-counter (OTC) sale is necessary.
Pharmacovigilance is essential in developing reliable supplements made available to the public with all the safety information. Pharmacovigilance is of paramount importance in detecting unwanted reactions so that supplements available in the market are thoroughly tested for pharmacology and toxicology. The unwanted reactions to be considered include predictable side effects; overdose, tolerance or dependence-addiction reactions; hypersensitivity, allergic and idiosyncratic reactions; mid-term and long-term cardiac, liver, renal toxicity or neurotoxic, genotoxic and teratogenic effects. The major concern for ensuring safety and toxicity of supplements by national and international authorities has increased globally with increasing cases of adulterations and occurrence of adverse events. The unique challenges of dietary supplements add to the problems associated with pharmacovigilance practice.
The existing pharmacovigilance models, tools and methodologies developed for drugs include scientific activities of detection, assessment and prevention of adverse effects or possible drug-related problems. Systematic pharmacovigilance system with appropriate guidelines is essential for safe and effective health supplements available to the public. Safety surveillance and reporting adverse events is also important for over-the-counter health products such as dietary or health supplements. Harmonized rules can help ensure that supplements are safe and properly labelled. The importance to strengthen application of pharmacovigilance principles and regulatory system calls for collaboration among various stakeholders to create awareness and establish comprehensive pharmacovigilance program for supplements.
Pharmacovigilance is a continuous process requiring active participation of pharmacists, patients, manufacturers and regulatory authorities. Regulatory bodies like Food and Drug Administration (FDA)ensure safety associated with prescription medicines and over-the-counter drugs.They also enforce mandatory adverse event reporting requirements for manufacturers of dietary supplements such as data archiving; record keeping; establishment of policies and procedures related to management, documentation and timely submissions of adverse events. Regulators should routinely monitor marketed products to identify signals, sentinel events or other safety factors and issues. The manufacturer penalties stipulated track deviations such as failure to submit reports, inaccurate information submissions or incomplete disclosure of information, lack of written procedures or failing to adhere to reporting requirements. Manufacturers are expected to engage experienced and appropriately trained medical personnel in pharmacovigilance management and monitoring. Post market data surveillance and monitoring is necessary for all stakeholders including regulators and manufacturers. A comprehensive product registry available to all stakeholders will aid in more accurate identification and monitoring of supplements.
Online Course at JLI
James Lind Institute (JLI) provides an online program – Advanced PG Diploma in Clinical Research & Pharmacovigilance to impart knowledge on pharmacovigilance.
For more information please visit: www.jliedu.com