Changing Product Information

Product information is both a potential tool for communicating with users of medicines and a regulatory document with legal implications (for example, in the EU advertising must be consistent with the authorised Summary of Product Characteristics). The identification of a new adverse drug reaction or the accumulation of important new evidence about a recognised reaction leads to a need to make changes to the product information, and hence to vary the marketing authorisa-tion(s). Variations to marketing authorisations on safety grounds may be initiated by the regulatory authority or pharmaceutical company. Regardless of who proposes the changes, it is essential that there is exchange of information and discussion between the parties before a proposed variation is submitted, since this is likely to promote agreement on the actions proposed and facilitate rapid implementation.

Decisions about the actions needed to respond to a specific drug safety issue require consultation between the regulatory authorities and the relevant marketing authorisation holder(s). When the regulatory authorities and companies are in broad agreement about the nature and impact of a drug safety issue, it is likely that negotiations regarding the necessary action will be successful and changes can be made on a voluntary basis. If the parties do not agree about the actions required, then authorities may exercise compulsory powers to remove a drug from the market or change the conditions of the authorisation. These are usually accompanied by rights of appeal for the company. Both companies and authorities normally try to avoid such procedures for safety issues since they may involve unsatisfactory delay and limit the actions that can be taken until the outcome is known. When the issue has urgent public health implications the authority may act rapidly without a right of appeal by the company. In such situations, the usual action taken is immediate withdrawal of the product(s) from the market.

Any change to the marketing authorisation and product information that has significant safety implications should be actively drawn to the attention of the relevant health professionals, usually by circulating the new product information under cover of a "Dear Doctor/Pharmacist" letter. Invariably such changes also require production of a new patient information leaflet and may require revision of the information on the packaging. When the changes being made are vital for ensuring patient safety they need to be implemented very quickly and it may be necessary to recall all stock.

The distribution of revised safety information may be targeted at specialists or generalists. However, even for drugs used primarily by specialists there may be a need to ensure that generalists are made aware. This is because the generalist may supervise long-term patient care and be in a position to prevent, identify or manage adverse reactions. If there is doubt about how widely information should be distributed it is therefore wise to distribute the information more rather than less widely. Consultation with the relevant experts, professional bodies and patient groups is important before making such a decision.

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