TY - JOUR AU - Lima, Elisangela da Costa PY - 2019/06/06 Y2 - 2024/03/29 TI - Adverse drug reaction assessment by health care providers: safety patient strategy JF - Revista Brasileira de Farmácia Hospitalar e Serviços de Saúde JA - Rev Bras Farm Hosp Serv Saude VL - 8 IS - 1 SE - EDITORIAL DO - UR - https://rbfhss.org.br/sbrafh/article/view/279 SP - AB - <p>Reporting Adverse Drug Reactions (ADRs) is an important component for quality of care<br>in hospitals, especially for accreditation programs1,2 since ADR are plainly implicated in patient safety<br>incident conception3. The manipulation and administration of medicines are a common factor for<br>adverse event discussion. Nevertheless, the ADR avoidability assessment tool may have a relevant role<br>for prevention of severe events in hospitals. This editorial will highlight factors contribute to the ADR<br>assessment debate in Brazilian clinical settings.<br>Unfortunately, limited and fragmented definitions about ADR notion may hamper its<br>identification and assessment at health services3<br>. ADRs has been defined as, “an appreciably harmful or<br>unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts<br>hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage<br>regimen, or withdrawal of the product”<br>4<br>.seems more precise, acceptable to pharmacologists and it has<br>been used in several studies5<br>. This concept is particularly interesting whereas that points the possibility of<br>occurrence of adverse reactions due to medication errors6<br>.<br>ADRs are classified in as type A and B reactions. Whilst type A (augmented) reactions are generally dose related and preventable (from the known pharmacology), type B (bizarre) reactions are<br>not dose related and unpredictable. Incidence and morbidity related type A reactions are high. On the<br>other hand, type B reactions are regarded to have mortality7<br>. This classification was expanded and detailed for more four types: C (chronic – some time after prolonged administration), D (delayed – sometime<br>after use of drug), E (end of treatment – some time after withdraw of drug) and F (failure unexpected of<br>therapy)5<br>. This collection of sub-categories is useful to make health professionals aware about the stages<br>leading up to ADRs.<br>ADR severity assessment ponders features related outcomes as (i) hospitalisation necessity<br>or prolongation of hospitalisation, persistence or significant disability, life-threatening and death5<br>. Severe<br>ADR report may require fast action for understanding the problem and consequently motivate a local<br>and/or global (regulatory authorities) intervention. Severe suspect ADR must be promptly recognize and<br>assessment by hospital pharmacists.<br>The causality assessment (i.e. relationship between a suspect medicine and ADR) helps<br>healthcare professionals to make decisions for upcoming therapy8<br>. Aspects as such strength of the<br>association and consistency of association, specificity, temporarity, biological gradient, plausibility,<br>coherence, experimental evidence and analogy (in some circumstances) have been suggested by<br>Bradford Hill9<br>more than 50 years ago. Expert assessor judgement, structured guidance as algorithms<br>and Bayesian statistical method are main ways used to causality assessment10. Scales and algorithms are<br>largely used, especially the Naranjo algorithm, however, there are some difficulties for applying guidance<br>for assessment8<br>.<br>All of the attributes above bring useful outlines to improve knowledge and clinical decision<br>regarding risk and benefit of treatment. However, for the advancement of safety culture, the avoidability<br>ADR assessment is pivotal for learning and preventing drugs related damage. A meta-analysis of ADR<br>avoidability showed approximately half of the reactions in adults may be avoided11.<br>There is no model for ADR avoidability assessments, but some scales grounded on treatment<br>selection or prescribing appropriateness12. Thinking about Avoidability in hospitals, even in the absence<br>of a suitable method is extremely important to improve health care since theses scales hold indicators<br>about possibility of reaction prevention such as (i) proper drug and (ii) dose, route and frequency of<br>administration suitable for patient`s and clinical condition, (iii) necessity of drug therapeutic monitory<br>or other laboratory test before or during drug use, (iv) history allergy or prior reaction to the drug, (v)<br>presence of drug-drug interaction, (vi) poor compliance or (vi) toxic serum drug level description13.</p> ER -