Introduction
Drug safety monitoring is an essential element for the effective use of medicines and for high quality medical care. It has the potential to inspire confidence and trust among patients and health professionals in medicines and contributes to raising standards of medical practice. Pharmacovigilance is a clinical discipline in its own right - one that contributes to an ethos of safety and serves as an indicator of the standards of clinical care practised within a country. Healthcare practitioners are in a position to make good use of their patients’ positive and negative experiences of treatment to contribute to medical science and to an improved understanding of disease and of the medicines.
There are three approaches that might serve to increase awareness and interest in drug safety among clinicians, and to address research issues. These are described in the following sections.
Education, training and access to reliable information
Adverse reactions tend to be viewed, incorrectly, as ‘side effects’ and thus as distractions from patients’ and doctors’ priorities. Learning about the scope and severity of ADRs should start early in professional training. Good safety monitoring encourages healthcare practitioners to take fuller responsibility for the medicines they use. It improves clinical effectiveness and increases the confidence with which they and their patients use medicines.
To achieve something nearer ideal practice more attention needs to be given to training health professionals in diagnosis, management and prevention of ADRs. Not all signals are as specific and dramatic, and readily diagnosed, as were the phocomelia and micromelia caused by thalidomide. Recognition of less obvious adverse effects requires clinical alertness, accurate diagnosis and an understanding of the principles of causality assessment.
Health professionals are more likely to identify and report important ADRs if they have confidence in their ability to diagnose, manage and prevent such reactions. National pharmacovigilance centres and training institutions play a central role in this by encouraging inclusion of the principles and methods of pharmacovigilance and the study of iatrogenic disease at undergraduate and postgraduate levels in schools of medicine, pharmacy and nursing.
Pharmacology curricula should give a higher priority to the study of the safety of medicines. This would lead to an enhanced awareness of the balance between the benefits and harms of medicines. An integrated approach to therapeutic decision-making might be encouraged. Excessive and irrational drug use contributes to adverse reactions. The misuse of medicines is largely caused by the poor quality and inaccessibility of drug information available to practitioners. These problems are worsened by:
• aggressive and inaccurate marketing and advertizing
• uninformed patient use and their demands for the latest medicines
• lack of accurate drug information.
Indicators of inappropriate drug use can be obtained from spontaneous reports of ADRs. Case examples may serve as useful teaching tools for improving the safe use of medicines. In some countries an overwhelming volume of information (as opposed to effective communication of critical information) can serve as a deterrent to rational use.
Medication errors and ADRs are well documented in hospitalized and non-hospitalized patients, and they contribute substantially to morbidity and mortality. They also contribute to the number of hospital admissions and are known to occur in the community setting. Many are predictable and preventable.
This suggests considerable opportunity for minimizing the risks of ADRs through rational use, monitoring and follow-up. Early detection is important, particularly in hospitals where systems for detecting ADRs and medication errors will save lives and money. Such systems might be linked to institutional, regional or national pharmacy and therapeutics committees so that information can be used to educate professional staff in safe drug use.
Prospective hospital-based surveillance reduces the risk and severity of ADRs. There is, furthermore, a need to provide health professionals with the skills required to evaluate drug information critically and to decide how the safety profile of a drug (e.g. developed from population data) might be applied to a particular patient. Often, the manufacturer’s product information and promotional materials are the only information available to the practitioner. Evidence-based and comprehensive sources may not be available. Availability of balanced and reliable drug information is likely to improve standards of use and to reduce the frequency of adverse reactions. Information that includes patients’ subjective experiences of adverse reactions would be most useful to patients and to prescribers of medicines. Product safety information, the way it is currently presented, often consists of lists of adverse reactions, perhaps rated in order of frequency, without real description of how these might affect quality of life. Moreover, prescribers should be free to practise without being subjected to the vested interest of manufacturers and any conflict in interest.
