Pharmacy and therapeutics committees strategy to address olmesartan safety issues at a primary care level

Int J Clin Pharm. 2020 Apr;42(2):737-743. doi: 10.1007/s11096-020-00993-7. Epub 2020 Feb 20.

Abstract

Background Olmesartan, an antihypertensive drug, has been associated with a severe and potentially life-threatening sprue-like enteropathy, consisting of a serious, chronic diarrhoea and malabsorption syndrome. Treatment with this drug should be discontinued if patients develop such symptoms. Objective To retrospectively determine the reduction in olmesartan prescription following a strategy promoted by pharmacy and therapeutics committees within daily clinical practice to manage updated safety information on olmesartan. Setting Three primary healthcare centres. Method In May 2016, local pharmacy and therapeutics committees integrated by general practitioners, nursing staff and clinical pharmacists sent information about olmesartan safety issues to general practitioners, together with an individual list of their patients who were then being treated with olmesartan. Moreover, information about dose equivalents between angiotensin II receptor blockers and angiotensin II receptor blockers versus angiotensin-converting-enzyme inhibitors was also attached. The strategy aimed to promote individual benefit/risk assessment by general practitioners of the continuation of olmesartan treatment as a means to achieving a decrease in the risk of sprue-like enteropathy. The investigation team retrospectively reviewed the clinical records. Main outcome measure Reduction of olmesartan prescription. Results Olmesartan was discontinued in 44.4% of patients (197/444) in the year after the safety alert e-mail. In their medical records general practitioners registered that, after informing about olmesartan safety warnings, in four cases (0.9%), patients reported gastrointestinal symptoms. Conclusion A multidisciplinary strategy implemented to promote individual benefit/risk assessment regarding continuation of olmesartan treatment showed an important reduction in olmesartan prescriptions 1 year later.

Keywords: Adverse event; Medication safety; Olmesartan; Pharmacist intervention; Primary care; Sprue-like enteropathy.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angiotensin Receptor Antagonists / adverse effects*
  • Antihypertensive Agents / adverse effects*
  • Celiac Disease / chemically induced
  • Celiac Disease / epidemiology
  • Drug Prescriptions / standards*
  • Female
  • Humans
  • Imidazoles / adverse effects*
  • Malabsorption Syndromes / chemically induced
  • Malabsorption Syndromes / epidemiology
  • Male
  • Middle Aged
  • Pharmacy and Therapeutics Committee / standards*
  • Primary Health Care / methods
  • Primary Health Care / standards*
  • Retrospective Studies
  • Risk Factors
  • Tetrazoles / adverse effects*

Substances

  • Angiotensin Receptor Antagonists
  • Antihypertensive Agents
  • Imidazoles
  • Tetrazoles
  • olmesartan