Distributing The Messages

Healthcare Professionals

It is essential to be clear which healthcare professionals need to know about the safety issue. It is also important to ensure that relevant health authority staff are informed about major drug safety issues. They may be willing to help with the dissemination of information. Usually all general practitioners will need to be informed, with hospital medical staff, hospital and community pharmacists, and nursing staff being informed depending on the drug in question. Occasionally, when the safety issue relates to a drug only used by a small number of hospital specialists, it may be acceptable to target this specialist group, together with those pharmacists and nursing staff working in the relevant speciality. However, if there is any doubt as to whether generalists may be providing healthcare to those receiving the specialist treatment, then a letter distributed widely is necessary.

Distribution lists can be accessed via commercial and professional organisations. Which to choose will depend on how the drug is used. Some commercial organisations also offer faxing services, which can be very useful when a leak has occurred, or is likely to occur.

Information being distributed should also be added to the regulatory authority and company websites. This also provides an opportunity to provide more detailed information such as a summary of the data leading to the action and a ''question and answer'' document.

Patients and the Public

In certain situations, particularly if the hazard is potentially life-threatening, it may be appropriate to include "boxed warnings'' on patient information leaflets and/or the packaging. An example of such a case is the contraindication to use of beta-blockers in patients with a history of asthma or bronchospasm, where it is vital that the patient does not use the product. Here, good patient information adds an extra safeguard in the event of a prescription being dispensed which would have potentially lethal consequences for the patient.

When information is provided to health professionals regarding an urgent drug safety issue which is likely to attract media attention, an information sheet, which can be copied and given to patients, may be of considerable value to practitioners. An example of such a leaflet is given in Figure 9.8.

It is increasingly likely that patients will first learn of a drug safety issue via the media. This reinforces the need to ensure that media briefing is clear, balanced, explains any action that patients need to take, and provides contact points for further information. Telephone helplines are essential for major safety issues. They should be staffed by appropriately trained personnel who have access to comprehensive ''question and answer'' documents. The internet is a further medium for patients to access information and for some patients will be their first port of call.

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