CLINICAL PROTOCOLS EVALUATION: A SYSTEMATIC APPROACH AND EXPERIENCE OF A
CLINICAL PHARMACOLOGY UNIT IN A TERTIARY HOSPITAL
Abstract
Clinical pharmacology is a recent medical specialty that deals with
everyday aspects of the relationship between drugs and humans, promoting
safe and effective use of medicines while maintaining the sustainability
of healthcare systems through pharmacoeconomics considerations. Since
its creation in 2019, our Clinical Pharmacology Unit (UFC) has
cooperated with the Pharmacy and Therapeutics Committee (CFT), creating,
at request, technical and scientific reports that support decision
processes of this local regulatory entity. As all clinical protocols
need to be approved by CFT before institutional implementation, UFC acts
as an expert and independent organ that evaluates clinical and
pharmacological evidence, providing, ultimately, better healthcare
access to patients. Our paper describes our cumulative experience and
systematic approach in clinical protocol evaluation, over 4 years, with
the use of a self-made checklist. We divided protocol evaluation into
three sections: 1) introduction; 2) critical appraisal; and 3) final
remarks and considerations. Since the most important part is critical
appraisal, we further divided this section into two parts; the first one
addresses formal aspects and the second discusses regulatory matters,
pharmacology aspects, evidence-based prescription, safety concerns, and
pharmacoeconomics considerations. We also describe key and fundamental
aspects that, from our experience, should be included to grant protocol
quality. Our experience, which derived from the evaluation of 63
protocols, showed that the suggestions emerging from the evaluation
processes were well accepted by the proponent services and that the
overall quality of the protocols was improved, resulting in better
health services.