{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T20:11:55Z","timestamp":1790626315623,"version":"4.1.0"},"reference-count":33,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2022,2,22]],"date-time":"2022-02-22T00:00:00Z","timestamp":1645488000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2022,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>The Saudi Food and Drug Authority (SFDA) added pregabalin to the list of controlled substances in December 2017 to minimize the risk of its possible abuse and misuse. This study was aimed at assessing the impact of this decision on the overall use of pregabalin in Saudi Arabia and in comparison with drugs prescribed to treat neuropathic pain (i.e., vs. gabapentin, tramadol, duloxetine, and amitriptyline).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was an interrupted time\u2010series analysis of the Saudi quarterly sale data of the study drugs from October\/2015 to September\/2020. These data were obtained from IQVIA and were converted into use estimates (defined daily dose per 1000 inhabitant\u2010days [DDD\/TID]). Segmented regression models were conducted to assess the direct (level) and prolonged (trend) changes in use data after the decision. All analyses were completed using RStudio Version 1.4.1103.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Before the SFDA's decision, there was an increased quarter\u2010to\u2010quarter use of pregabalin (DDD\/TID: 0.16; 95% confidence interval [CI] 0.04 to 0.28). Pregabalin overall use dropped sharply by \u22121.85 DDD\/TID (95% CI \u22122.71 to \u22120.99) directly after the decision with a prolonged quarter\u2010to\u2010quarter declining effect (DDD\/TID: \u22120.22, CI to \u22120.37 to \u22120.05). The decision was associated with a direct increase in the use of gabapentin by 0.62 DDD\/TID (95% CI 0.52\u20130.72) without any impact on the use of other drugs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The results of our study showed that the SFDA decision was associated with a decrease in the overall use of pregabalin, which may help minimize the risk of its abuse and misuse.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5408","type":"journal-article","created":{"date-parts":[[2022,1,20]],"date-time":"2022-01-20T12:30:05Z","timestamp":1642681805000},"page":"577-582","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["The impact of regulatory restrictions on pregabalin use in Saudi Arabia: An interrupted time series analysis"],"prefix":"10.1002","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8030-7963","authenticated-orcid":false,"given":"Turki A.","family":"Althunian","sequence":"first","affiliation":[{"name":"Executive Directorate for Research and Studies Saudi Food and Drug Authority  Riyadh Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maha I.","family":"Alomran","sequence":"additional","affiliation":[{"name":"Executive Directorate for Research and Studies Saudi Food and Drug Authority  Riyadh Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ghada M.","family":"Alsagri","sequence":"additional","affiliation":[{"name":"Executive Directorate for Research and Studies Saudi Food and Drug Authority  Riyadh Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meshael M.","family":"Alrasheed","sequence":"additional","affiliation":[{"name":"Executive Directorate for Research and Studies Saudi Food and Drug Authority  Riyadh Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thamir M.","family":"Alshammari","sequence":"additional","affiliation":[{"name":"Executive Directorate for Research and Studies Saudi Food and Drug Authority  Riyadh Saudi Arabia"},{"name":"College of Pharmacy Riyadh Elm University  Riyadh Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,2,22]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"Saudi Food and Drug AuthorityDrug list: Lyrica 25; Reg No. 25\u2010211\u201006.https:\/\/sfda.gov.sa\/ar\/drugs-list(Accessed February 2021)."},{"key":"e_1_2_10_3_1","unstructured":"National Institute for Health and Care ExcellenceNeuropathic pain in adults: pharmacological management in non\u2010specialist settings. 2013.https:\/\/www.nice.org.uk\/guidance\/cg173\/resources\/neuropathic\u2010pain\u2010in\u2010adults\u2010pharmacological\u2010management\u2010in\u2010nonspecialist\u2010settings\u2010pdf\u201035109750554053(Accessed February 2021)."},{"key":"e_1_2_10_4_1","unstructured":"European Medicines AgencyLyrica (Pregabalin). 2005.https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/lyrica(Accessed February 2021)."},{"key":"e_1_2_10_5_1","unstructured":"U.S. National Library of MedicineDailyMed. 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