Some prescription medicines can be addictive and could cause problems for people taking them or coming off them. However, many people benefit from these medicines that are used to treat problems like pain, anxiety, and insomnia, and so it is important to support their safe use. This study will describe the use of three classes of medicines; gabapentinoids, benzodiazepines and Z-drugs, which can produce dependence. The purpose of the study is to provide evidence as part of a review of these drugs, the aim of which is to guide regulatory action to ensure their safe and effective use.
Many people benefit from medicines that treat problems like pain, anxiety, and insomnia, however some of these medicines are highly addictive and result in dependence and withdrawal issues. In September 2019, Public Health England (PHE) published a report looking at dependency in which they recommended that “building on its review of opioids, the Commission on Human Medicines (CHM) considers evidence and guidance on the labelling of other medicines that may cause dependence or withdrawal”. The purpose of this descriptive study is to help inform the MHRA and Commission on Human Medicines (CHM) response to the PHE dependency review, by providing baseline data on the use of these drugs within primary care. Ultimately with the aim to reduce the number of adverse drug reactions (ADRs) related to dependency with these drugs and support their safe use.
The study population will comprise all acceptable patients in CPRD AURUM, aged 16 and over, with at least one prescription for one of the drugs under study issued between 01/01/2014 and 31/03/2024. The exposure will be a prescription for any drug within three classes: gabapentinoids, benzodiazepines and Z-drugs. Overall (prevalence) and new-user (incidence) prescribing rates over time will be calculated and summary measures will be used to describe duration of treatment and dose at a population level. Following this initial analysis a more exploratory analysis will be carried out for selected drugs within the classes under study. This analysis will aim to describe treatment indication and line of treatment. The drugs for this secondary analysis will be chosen based on prior knowledge, including expert recommendation, and on usage identified in the primary analysis. Analyses will be stratified by sex and age-groups.
Primary outcomes: prevalence and incidence of patients prescribed gabapentinoids, benzodiazepines and Z-drugs; descriptive measures of treatment duration; descriptive measures of treatment dose.
Secondary outcomes: treatment indication; line of treatment.
Sophie Scanlon - Chief Investigator - MHRA
Sophie Scanlon - Corresponding Applicant - MHRA
Katherine Donegan - Collaborator - MHRA