Do laws impact opioids consumption? A breakpoint analysis based on Italian sales data

Abstract

PurposeIn Italy, where the adoption of opioid analgesics in pain management has been historically poor, an increase in opioids consumption occurred between 2000 and 2015. The aim of this study is to assess, through specific time series analyses for trend changes, the impact of different intervening factors – such as the availability of new drugs, the observance of clinical guidelines, changes in prescription regulations, and in reimbursement policies – on opioids sales to community pharmacies in Italy, focusing on the time period 2000–2010.Materials and methodsFive opioids were considered: codeine, tramadol, buprenorphine, morphine, and fentanyl. The analysis is based on sales data collected at wholesale distributors. For each one of the five drugs, time series of the number of Defined Daily Doses per thousand inhabitants per day in the period 2000–2010 were analyzed, and an estimation of breakpoints was performed using segmented linear regression.ResultsDrug sales underwent a sharp increase in 2000–2010, although on different scales. Segmented regression analysis highlighted different potential breakpoints, corresponding to either a significant change in value and/or in slope. Sales of the five opioids were affected by at least one relevant event, often due to a synergy of regulatory, marketing, and technological factors. The effect of reimbursement changes has proved important.ConclusionBetween 2000 and 2010, regulatory, technological, and reimbursement changes significantly influenced opioid sales to community pharmacies in Italy. The sales of relatively new drug products seem to be less influenced by changes in reimbursement and regulatory policies than that of more established products, suggesting that physicians are more comfortable with “old” drugs, since their clinical use is supported by established clinical guidelines and protocols.

Analgesic drug use in elderly persons: A population-based study in Southern Italy

“…The trend in opioid use in Italy may be related to a law passed in 2010 known as Law 38/2010 in which the Italian government commits to improving the access to palliative care and pain relief. While a recently published study using data from pharmacy sales on a national level confirmed a relative increase in opioid use in Italy from 2000 to 2010, this study reported that opioid use is overall low; the most commonly used drug was codeine, which was used at 5 DDD per day per 1,000 persons in 2010 [23].…”

Is Europe also facing an opioid crisis?—A survey of European Pain Federation chapters

“…It is important to note that there are regional inequalities of opioid prescribing, e.g. in different regions in Italy (Musazzi et al., 2018) and the United Kingdom (Curtis et al., 2019).…”

Trends in strong opioid prescribing in Ireland: A repeated cross‐sectional analysis of a national pharmacy claims database between 2010 and 2019

“…40,41 In addition, the results suggest a tendency towards prescribing increasing treatment durations and/or higher strengths or doses of strong opioids to males compared to females (Table S3), similar to findings by Campbell et al 39 There was an increase in the prescribing of transdermal strong opioids between 2010 and 2019, comparable to observations from studies in France, Germany and Italy. [21][22][23] This trend is likely due to the ease of use and convenience afforded by these formulations and the reduction in gastrointestinal side-effects compared to oral strong opioids. The oral route of administration was the most commonly prescribed, in keeping with many clinical guidelines, [42][43][44] while the use of parenteral and transmucosal formulations was low.…”

“…9,18,20 In terms of route of administration, many studies have reported increases in utilisation of transdermal opioid formulations. [21][22][23] Regarding demographic factors, the literature would suggest a higher prescribing prevalence of strong opioids in female patients and in older age groups. 8,24,25 This study aimed to determine the pattern of strong opioid prescribing in Ireland over a 10-year period from 2010 to 2019, using a national administrative pharmacy claims database.…”