Informing patients, ADRs

For purposes of validation and to avoid ciny double reporting, the Dutch reports should include the reporter s name and address. The Chief Inspectorate can request interim reports of ADRs. Physicians prescribing medicines to individual patients according to the declaration of awareness procedure outside clinical re-seetfch have to be informed by the licence holders of the product that they have to report the ADRs of their patients to the Healthcare Inspectorate. 

In 1993, the Royal Pharmaceutical Society of Great Britain created checklists for pharmacists that served as a guide to the types of communication that should occur between hospital and community pharmacists regarding patients medication and pharmaceutical needs. These checklists contained information that should be completed by the community pharmacist to the hospital pharmacist on hospital admission of a patient, such as the medication history and domiciliary circumstances and known adverse drug reactions (ADRs),... 

Therefore pre-marketing trials are limited in information on a drugs full safety profile because they employ too few patients. The "rule of three" slates that to detect an unintended drug effect that occurs with a particular frequency, the number of subjects needed to follow up is 3 times that of the estimated frequency of the event. Consequently if an ADR occurs in 1 in... 

Not all the changes observed in a proteomic experiment will be related to toxicity some will be adaptive. While more difficult to conduct, it is important to recognise that more useful information may be gained from clinical research and every effort should be made to facilitate this. Such studies may take the form of collecting samples (blood, urine) from all subjects in a clinical trial for retrospective analysis when the outcomes of exposure are known. Alternatively it would be possible to establish tissue banks (of blood, urine, skin or liver biopsies) from patients with clinically well characterised ADRs. 

The need for patients to be informed about possible ADRs. 

An important consideration is how quickly information needs to be made available to users (i.e. health professionals and patients). A new life-threatening ADR requires immediate communication whereas the addition of a symptom which does not appear to be associated with serious consequences (e.g. nausea) to the undesirable effects section of the product information could be part of the next routine revision of the SPC. Most issues come between these two extremes and a judgement needs to be made about the speed of action and the most appropriate method of communication. 

Spontaneous ADR report A case report relating to an individual patient describing a suspected adverse reaction (see p. 33). Summary of Product Characteristics A regulatory document attached to the marketing authorisation which forms the basis of the product information made available to prescribers and patients (see p. 52-3). 

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