Pharmacovigilance & Drug Safety

Introduction: Today, there has been a constant increase in the self-medication phenomenon among patientsdue to the large availability of drugs available over the counter. Overuse can lead to misuse or abuse of OTC medicines and can cause addiction and dependency.

 

Incidence of OTC abuse: OTC medicine abuse was identified in many countries. A Comprehensive search of international empirical and review literature between 1990-2011 identified five key medicine classes i.e., codeine/opioid based cough medicines, non-opioid based medicines, sedative antihistamines, decongestants,

and laxatives.

 

Harms associated with OTC abuse: A range of problems and harms associated with OTC medicine abuse were identified and these comprised three broad categories such as direct harms associated with the primary ingredient, physiological harms due to the adverse effects of another active ingredient, economic costs, and effects on personal and social life. An observational study in Finland identified various drug related problems (DRP) involving fifty-two community pharmacies using a questionnaire survey. They documented 339 drug related problems and to resolve them 641 pharmacy interventions emerged.

 

Interventions and support: Pharmacists play a major role in preventing DRP associated with OTC drugs thereby decreasing adverse events and drug-drug reactions. Most common suggested interventions include providing training to pharmacist to increase awareness among both public and health care professionals, counselling consumers to abuse potential of products, advising them to contact their doctor when needed, limiting advertisements, and making bold warnings on packets etc. OTC control varies across the globe and stricter in Poland, Germany, Austria, France, and Sweden.

 

Addressing the evidence gap and Conclusion: Robust methodologies should be used to select a representative cohort of users to answer safety related questions. Such survey data are often got unnoticed by sponsors. Since they to help quantify the benefit of OTC status it should be published in the literature. Training and practice ofpharmacy-based interventions should be encouraged to avoid the harms associated with OTC abuse.