Drug Safety Approach in Administration and Nursing

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Drug Safety Approach in Administration and Nursing

Introduction

The safety of medicines used in the US has been a primary concern of the Food and Drug Administration (FDA) for more than one hundred years. It is important to assess the safety of drugs prescribed to patients to detect possible side effects, inefficiency, or danger for patients. There are some approaches to drug safety that can be applied in clinical practice. One of the approaches which meet the demands of the contemporary health care system is the use of electronic healthcare databases (Coloma et al., 2012). This research will analyze the strategy of its application and study the possible influence of the use of electronic healthcare databases for drug safety on advanced practice nursing.

The strategy of Applying Electronic Healthcare Databases for Drug Safety

Usually, after a new drug is approved by FDA and enters the market, it is necessary to detect adverse effects that were not revealed at the time of clinical trials (US Food & Drug Administration, 2017). One of the tools which can be used to assess them is an electronic database of spontaneously submitted adverse events. It comprises mandatory and voluntary reports which are later analyzed to provide post-marketing surveillance (US Food & Drug Administration, 2017). Patients, consumers, and healthcare professionals report directly to FDA or to a manufacturer which must send reports to the FDA as well.

This strategy is used not only in the United States. Research by Coloma et al. (2012) provides the investigation of eight European databases and documents such as administrative claims or medical records. The researchers study the incidence of different adverse events, for example, acute myocardial infarction, acute renal failure, anaphylactic shock; bullous eruptions; rhabdomyolysis; and upper gastrointestinal bleeding (Coloma et al., 2012). The research proved that active surveillance with the application of healthcare databases for the detection of adverse effects is appropriate. However, such an advantage maybe not suitable for rare outcomes or drugs which are not frequently used. Also, the increased volume of such databases and the inclusion of data from heterogeneous populations are likely to increase the efficiency of these surveillance systems.

The Effect of Drug Safety Approach on Advanced Practice Nursing

The use of electronic healthcare databases can be important for advanced practice nursing. First of all, nurses take responsibility for reporting the adverse effects of drug application. Moreover, nurses improve their competences to be able to provide expert guidance and responses to the audience interested in drug products (US Food & Drug Administration, 2017). The use of electronic healthcare databases simplifies the reporting system and makes data available without additional transfer. Thus, it saves time and effort, giving more time for advanced practice nurses to fulfill their professional duties. Finally, since such databases are available, it is possible to study the existing adverse effects and evaluate the appropriateness and safety of this or that drug for every patient.

Conclusions

Generally speaking, drug safety is an issue that demands complex approaches. These approaches can be efficient when applied in the cooperation of authorities, drug manufacturers, healthcare providers, and consumers. Electronic healthcare databases are a powerful tool for the detection and analysis of adverse drug effects that cannot be studied during clinical trials. However, their use needs the development of a strategy that determines the roles of all participants. Also, it provides an algorithm of adverse effects reporting and the further use of this information aimed at their reduction.

References

Coloma, P.M., Trifiro, G., Schuemie, M.J., Gini, R., Herings, R., Hippsley-Cox, J. & Sturkenboom, M. (2012). Electronic healthcare databases for active drug safety surveillance: Is there enough leverage? Pharmacoepidemiology and Drug Safety, 21(6), 611-621. Web.

US Food & Drug Administration. (2017). Center for Drug Evaluation and Research. Drug safety priorities 2015-2016. Web.

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