Pharmaceutical policies: effects of policies regulating drug marketing.

BACKGROUND: The costs of developing new treatments and bringing them to the market are substantial. The pharmaceutical industry uses drug promotion to gain a competitive market share, and drive sale volumes and industry profitability. This involves disseminating information about new treatments to relevant targets. However, conflicts of interest can arise when profits are prioritised over patient care and its benefits. Drug promotion regulations are complex interventions that aim to prevent potential harm associated with these activities. OBJECTIVES: To assess the effects of policies that regulate drug promotion on drug utilisation, coverage or access, healthcare utilisation, patient outcomes, adverse events and costs. SEARCH METHODS: We searched Epistemonikos for related reviews and their included studies. To find primary studies we searched MEDLINE, CENTRAL, Embase, EconLit, Global Index Medicus, Virtual Health Library, INRUD Bibliography, two trial registries and two sources of grey literature. All databases and sources were searched in January 2023. SELECTION CRITERIA: We planned to include studies that assessed policies regulating drug promotion to consumers, healthcare professionals or regulators and third-party payers, or any combination of these groups.In this review we defined policies as laws, rules, guidelines, codes of practice, and financial or administrative orders made by governments, non-government organisations or private insurers. One of the following outcomes had to be reported: drug utilisation, coverage or access, healthcare utilisation, patient health outcomes, any adverse effects (unintended consequences), and costs. The study had to be a randomised or non-randomised trial, an interrupted time series analysis (ITS), a repeated measures (RM) study or a controlled before-after (CBA) study. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed eligibility for inclusion of studies. When consensus was not reached, any disagreements were discussed with a third review author.  We planned to use the criteria suggested by Cochrane Effective Practice and Organisation of Care (EPOC) to assess the risk of bias of included studies. For randomised trials, non-randomised trials, and CBA studies, we planned to estimate relative effects, with 95% confidence intervals (CI). For dichotomous outcomes, we planned to report the risk ratio (RR) when possible and adjusted for baseline differences in the outcome measures. For ITS and RM, we planned to compute changes along two dimensions: change in level and change in slope. We planned to undertake a structured synthesis following EPOC guidance.  MAIN RESULTS: The search yielded 4593 citations, and 13 studies were selected for full-text review. No study met the inclusion criteria. AUTHORS' CONCLUSIONS: We sought to assess the effects of policies that regulate drug promotion on drug use, coverage or access, use of health services, patient outcomes, adverse events, and costs, however we did not find studies that met the review's inclusion criteria. As pharmaceutical policies that regulate drug promotion have untested effects, their impact, as well as their positive and negative influences, is currently only a matter of opinion, debate, informal or descriptive reporting. There is an urgent need to assess the effects of pharmaceutical policies that regulate drug promotion using well-conducted studies with high methodological rigour.

Critical appraisal of clinical practice guidelines for treatment of urinary incontinence: Protocol for a systematic review.

BACKGROUND: Urinary incontinence is a common complaint in all parts of the world, cause of distress, as well as significant costs for both individuals and society. The aim of this study will be to evaluate the rigor of the development of clinical practice guidelines and to identify the recommendations of interventions for urinary incontinence in adult women. METHODS: In this systematic review, clinical practice guidelines will be identified using a prospective protocol through a systematic search of: MEDLINE (via Ovid); EMBASE (Excerpt Medical Database, via Ovid); Web of Science and Virtual Health Library. Specific databases of guidelines for clinical practice will also be searched (National Institute for Health and Care Excellence, American Urological Association, and others). Reviewers, independently and in duplicate, will assess the quality of the guidelines using the Appraisal of Guidelines Research and Evaluation (AGREE II). The results will be checked for discrepancies. Differences between the scores equal to or greater than 2 will be considered as discrepant and the final result will be decided by consensus. A comparison of the recommendations of interventions and information about the level of evidence, the degree of recommendation, the level of agreement and the level of acceptance will be described. This step will also be done independently and in duplicate, and the result will be decided by consensus. The results will be presented in tables and the descriptive statistics will be calculated for all domains of the AGREE II instrument as mean (standard deviation) and median (interquartile range). RESULTS: The results derived from this study will increase the knowledge about the development of recommendations guidelines for urinary incontinence of high methodological rigor. This study may also identify key areas for future research. CONCLUSION: This study may guide health professionals, policy makers, and health policy managers in choosing the guidelines for recommendation in clinical practice. PROTOCOL REGISTRATION: PROSPERO - CRD42018116517.