Usage patterns of paracetamol in France

Abstract

AIMSThe aim of the present study was to describe the real-life usage patterns of paracetamol. METHODSThe Echantillon Généraliste de Bénéficiaires (EGB) database, the permanent 1/97 representative sample from the French national healthcare insurance system, was searched in 2011 to identify usage patterns, concomitant chronic diseases and use of cardiovascular medication in users prescribed single-ingredient (SP) and combination (CP) paracetamol, representing 85% of all sales. RESULTSOf 526 108 subjects aged ≥15 years in the EGB, 268 725 (51%) had paracetamol dispensed on ≥1 occasion; of these, 207 707 (77%) were dispensed only SP and 61 018 (23%) received CP with or without SP. SP users were younger (48.3 years vs. 50.5 years), and 57% of SP users vs. 58% of CP users were female. Chronic comorbidities were more common in CP than SP users. SP users had, on average, 3.4 dispensings per year vs. 5.0 for CP users, for 36 defined daily doses (DDD, 3 g) of SP vs. 53 DDD per year for CP; 49% SP users bought 14 DDD or fewer; 15% bought >60 DDD. Use of paracetamol increased with age from about 16 DDD per year in 15-30-yearolds to over 90 DDD per year in patients above the age of 75; 53% of patients ≤60 years bought fewer than 14 DDD per year, whereas 55% of those >60 bought more than 30 DDD per year. More than half the dispensings exceeded the legal per-box limit of 8 g. CONCLUSIONSOver 50% of the French adult population were dispensed paracetamol at least once over the course of a year, generally for shortterm use. Considering recent misgivings on the real efficacy and safety of paracetamol, such widespread use might have important public health consequences. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Although paracetamol is used mostly in mild-to-moderate pain conditions and in chronic arthritis, and its usage pattern might be derived from these indications, there are few or no studies of actual usage patterns and drug exposure or burden. WHAT THIS STUDY ADDS• Over 50% of all adults in the database were dispensed paracetamol at least once in 2011.• The median amount of paracetamol dispensed over 1 year was seven defined daily doses (or 21 g), and this increased with age.• Only 15% of subjects received more than 60 days' worth of paracetamol in a year. British Journal of Clinical PharmacologyBr J Clin Pharmacol (2016) 82 498-503 498

Trends in analgesic consumption in France over the last 10 years and comparison of patterns across Europe

“…Paracetamol was found to be the most consumed analgesic in France in 2015 (61.5 DDDs 1000 inhabitants –1 day –1 ), representing 64% of the total market share for analgesics. This high consumption rate is consistent with previous findings , and with the fact that paracetamol is perceived as safe and is considered as the first‐choice treatment for chronic pain . The OTC availability of paracetamol may also contribute to its high consumption.…”

Risk of hospital admission for liver injury in users of NSAIDs and nonoverdose paracetamol: Preliminary results from the EPIHAM study

“…EGB is a random permanent representative 1/97 sample of SNIIRAM, and is therefore representative by design . In addition, the vast majority of OTC strength (low‐dose) NSAIDs, mostly ibuprofen, and paracetamol sold in France are recorded in the database . On the down side, the study has some limitations, firstly the lack of power in the EGB database.…”

“…Another limitation could be poor recording of occasional medication (ie, paracetamol) or toxic exposure (ie, alcohol). However, in France, over 80% of paracetamol use is prescription, and is recorded in the database . It is possible that instances of paracetamol exposure may be missed.…”

The national healthcare system claims databases in France, SNIIRAM and EGB: Powerful tools for pharmacoepidemiology

“…Coverage may concern any use of the drug or specific indications: for example, Mediator (benfluorex) was in theory eligible only for use in diabetes, but apparently all dispensings were covered in practice. Some drugs available over the counter (OTC) such as ibuprofen or paracetamol may be prescribed and reimbursed . It also includes medical visits, paramedical activities such as nursing or physiotherapy, lab tests, and devices.…”

“…In France, certain drugs available OTC such as paracetamol or low‐dose ibuprofen can also be prescribed and reimbursed, and over 70% of OTC‐strength ibuprofen and 84% of paracetamol sales are reimbursed and found in the database . This has allowed us to describe the usage patterns of these drugs, in contrast with the prescription strength NSAIDs (POM) …”