Effective Pharmacovigilance Systems to Ensure Drug Safety

The U.S. FDA regulates food, drugs, cosmetics, medical devices, tobacco, and radiation-emitting electronic products. FDA falls within the Department of Health and Human Services and headed by the Commissioner of Food and Drugs, appointed by the President, and confirmed by the U.S. Senate. The Office of the Commissioner oversees all the Agency's components and is responsible for the efficient and effective implementation of FDA's mission.

FDA's Office of the Commissioner is divided into departments. The Office of Medical Products and Tobacco oversees the Center for Drug Evaluation and Research which regulates drug products sold in the U.S.

These include:

Active Pharmaceutical Ingredients (API): An Active Pharmaceutical Ingredient is any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body.

Drug Intermediates: These are materials produced during the steps in the synthesis of an Active Pharmaceutical Ingredient (API) that must undergo further molecular change or processing before becoming an API.

Prescription Drugs: is a human drug that is not safe for use except under the supervision of licensed medical practitioner.

Over the Counter (OTC) Drugs: is a human drug that is safe and effective for use without prescription by a licensed medical writing services practitioner.

Homeopathic Drugs: A homeopathic drug is any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.

Animal Drugs: A new animal drug is defined, in part, as any drug intended for use in animals other than man, including any drug intended for use in animal feed but not including the animal feed, the composition of which is susar that the drug is not generally

recognized as safe and effective for the use under the conditions prescribed, recommended, or suggest in the labeling of the drug.

Medical Gases: Medical gases (e.g. oxygen, carbon dioxide, helium, nitrogen, nitrous oxide, medical air, and 49 combinations of these) are drugs within the meaning of section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (Act) and, pursuant to section 503(b)(1)(A) of 51 the Act, are required to be dispensed by prescription.

The Drug Establishment Registration with FDA must be submitted annually. The Food and Drug Administration Safety and Innovation Act (FDASIA) requires drug companies to submit annual establishment registrations during the period from October 1 to December 31 of each calendar year. Firms must also list any drugs not previously listed during this period.

Following the incessant health troubles evoked by pharmaceutical drugs, a major emphasis has been placed on ensuring drug safety. Pharmacovigilance has a major role to play in doing so. It helps in detection, assessment, research and prevention of adverse side effects by drugs. Since it has such an important function in ensuring drug safety services, an effective methodology that optimally recognizes the damage causing factor in a particular drug and helps eliminate that factor should be designed. Different pharmaceutical firms use different Pharmacovigilance methods. The comprehensiveness of the system is very important in detecting the problem causing element in the drug quickly and most precisely.

Over the past decade there has been a shift in the drug safety standards, driven by the regulatory authorities. The policies on risk management and the standards of pre marketing and post marketing techniques have been made stringent. This has created a need to constantly document every detail of manufacture, pre marketing and post marketing aspects of each drug. It has become important for drug manufacturers to increase the transparency of their activities and maintain intra industry, inter industry and consumer communication about various aspects about the drug.