Pharmacovigilance For Clinical and Scientific Discipline
Pharmacovigilance is the study of the safety of marketed drugs examined under the practical conditions of clinical use in what are usually large populations. Physical Therapy RTM Safety cannot, however, be considered except in relation to the efficacy of the drug, whether it is used in healthy or sick people, the pharmaceutical quality of the drug, the nature and seriousness of any side effects and the degree to which these can be treated, the threat posed by the disease that is treated with the drug and the rest of the complex of issues that comprise holistic patient care.
Much has happened in the world. The legal basis of the subject in Europe has changed materially, the PSUR (Periodic Safety Update Report) has come to be recognized as a major means of undertaking a comprehensive re-assessment of the balance of safety and efficacy of the drug, the use of the MedDRA dictionary has become more established, the growth of regional monitoring centres has been found increasingly useful in the UK and especially in France, adverse drug reaction monitoring has been strengthened in Germany, the structure of the regulatory body in the UK has been revised, and there has been considerable emphasis on pharmacovigilance planning and the development of risk minimization action plans.
There have also been reassessments of the place of some major drugs and drug classes in therapeutics. Drugs have been withdrawn or their usage modified due to prolongation.
All of these changes call attention to the need for yet more rigorous and proactive pharmacovigilance. The changes also highlight the need for greater transparency of the pharmacovigilance process to assure the public that regulators, health professionals, pharmaceutical companies and academics are continually reviewing risks and benefits of medicines in their fullest context.
The aims of pharmacovigilance
The principal aims of pharmacovigilance programmes are:
• To improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions.
• To improve public health and safety in relation to the use of medicines,
• To contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use.
• To promote understanding, education and clinical training in pharmacovigilance and its effective communication to health professionals and the public.
Pharmacovigilance in the regulation of medicines
Robust regulatory arrangements provide the foundation for a national ethos of medicine safety, and for public confidence in medicines. To be effective, Pt Remote Therapeutic Monitoring the remit of drug regulatory authorities needs to go further than the approval of new medicines, to encompass a wider range of issues relating to the safety of medicines, namely:
