Medical vigilance

GUARDIAN ANGELS KNOWING OUR MOLECULES, DRUG AND VACCINE DESIGN, MEDICAL DECISION SUPPORT, MEDICAL VIGILANCE AND DEFENSE... 

Despite the extensive investigations that must be undertaken prior to placing a drug on the market, it is not possible to guarantee that all safety issues have been identified. Thus, market vigilance systems must be maintained after a dmg has been launched so as to detect safety issues that were not evident prior to commercialisation. For such systems to be effective requires the participation and cooperation of the medical profession, the pharmaceutical industry and the regulators, in order that critical safety information can be identified and acted on in a timely manner. In some... 

The responsibilities of Competent Authorities in terms of market vigilance are set out in the Articles of the device directives, whereas the obligations for manufacturers are contained in the Armexes. MEDDEV guide 2.12-1 provides detailed practical guidance on how the medical device vigilance system should operate within the EU, the European Economic Area (EEA) and Switzerland. This guidance was significantly... 

The requirements for market vigilance and oversight in the US are set out in 21 CFR 803, Medical Device Reporting, 21 CFR 806, Reports of Corrections and Removals and 21 CFR 822 Post market Surveillance. 

Active Implantable Medical Devices Directive 90/385 EEC Article 8 (Competent Authority Vigilance procedure), Annex II 3.1 (manufacturer s vigilance and reporting duties)... 

MEDDEV guide 2.12-1 Guidelines on a Medical Devices Vigilance System http //ec.europa.eu/enterprise/medicaLdevices/meddev/index.htm. 

Vigilance for drug-drug interactions is required because of the greater number of medications prescribed to elderly patients and enhanced sensitivity to adverse effects. Pharmacokinetic interactions include metabolic enzyme induction or inhibition and protein binding displacement interactions (e.g., divalproex and warfarin). Pharmacodynamic interactions include additive sedation and cognitive toxicity, which increases risk of falls and other impairments. 

The impact of immunomodulatory protein therapeutics on diseases having unmet medical need has already proven remarkable. These new treatments have been credited with a favorable clinical profile from slowing the disease progression to outright cures. Although the cost of these advanced medicines may be offset by the enormous improvement in the quality of life of numerous patients, we must remain vigilant throughout their clinical development. 

Guidance is issued by the European Commission on medical device vigilance which includes an explanation of the difficult concept of when a deterioration in state of health should be considered serious ... 

The Medical Devices Vigilance System European Commission Guidelines, Medical Devices Agency, undated. 

Maybe the message would have to do with. .. not being too rigid.. .. I felt I needed to be open to medication but.. . still somewhat skeptical.. .. So I had to be open in both directions, and I had to keep vigilant in both directions. So I guess I would say something like, [Practice] open-minded vigilance. ... 

The American Medical Association s Council on Ethical Affairs was sufficiently concerned 10 years ago about these matters to issue guidelines to discourage expensive gifts without medical purpose (Council on Ethical and Judicial Affairs, American Medical Association, 1991). These guidelines were a start in addressing this problem, and the council encourages even more vigilance now (Wazana, 2000). 

Although it is not normally feasible to include comprehensive psychological or psychophysiological testing during the first tolerability trials, because medical aspects have to be paramount at this stage, it is possible to determine with considerable reliability any pronounced central actions of a substance as well as the approximate duration of such effects. Examples are effects on vigilance, attention, concentration and potential side effects such as sedation, stimulation, euphoric effects, etc. Further data also will be available as to the effects of the preparation on vital functions such as ECG, respiration and circulation, as well as on biochemical laboratory tests, liver enzyme and renal functions. 

---