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Psychoactive Prescription Drug Use Disorders, Misuse and Abuse Pharmacoepidemiological Aspects

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Psychoactive Prescription Drug Use Disorders, Misuse and Abuse Pharmacoepidemiological Aspects Psychoactive prescription drug use disorders, misuse and abuse Pharmacoepidemiological aspects Micaela Tjäderborn Division of Drug Research Institution of Medical and Health Sciences Linköping University Linköping, Sweden 2016 Psychoactive prescription drug use disorders, misuse and abuse © Micaela Tjäderborn 2016 [email protected] ISBN: 978-91-7685-770-0 ISSN: 0345-0082 Printed in Linköping, Sweden 2016 Liu-Tryck AB ii All the passionate work I put into this thesis is dedicated to my parents, who always emphasized the importance of knowledge and of caring for the less fortunate. iii iv Psychoactive prescription drug use disorders, misuse and abuse Pharmacoepidemiological aspects Micaela Tjäderborn Division of Drug Research Institution of Medical and Health Sciences Linköping University, Linköping, Sweden Background: There is a widespread and increasing use of psychoactive prescription drugs, such as opioid analgesics, anxiolytics, hypnotics and anti-epileptics, but their use is associated with a risk of drug use disorder, misuse and abuse. Today, these are globally recognised and emerging public health concerns. Aim: The aim of this thesis is to estimate the occurrence and prevalence of psychoactive prescription drug use disorders, misuse and abuse, and to investigate the association with some potential risk factors. Methods: A study using register data from forensic cause of death investigations analysed and described cases of fatal unintentional intoxications with tramadol (Study I). Based on register data on spontaneously reported adverse drug reactions (ADRs) reported cases of tramadol dependence were scrutinized and summarised (Study II). In a study in suspected drug-impaired drivers with a toxicology analysis confirming intake of tramadol, diazepam, flunitrazepam, zolpidem and zopiclone, the prevalence of non-prescribed use was assessed and associated factors were investigated (Study III). From a national cohort of patients initiating prescribed treatment with pregabalin, identified using data on prescription fills, a study investigated longitudinal utilisation patterns during five years with regards to use above the maximum approved daily dose (MAD) of the drug, and factors associated with the utilisation patterns (Study IV). Results: In the first study, 17 cases of unintentional intoxications were identified, in which tramadol was judged to have caused or contributed to the death. Of the deceased, more were men, the median age was 44 years and the majority used multiple psychoactive substances (prescription drugs, alcohol and/or illicit drugs). In the second study, 104 spontaneously v reported cases of possible or probable tramadol dependence were identified, of which more concerned women. The median age in these cases was 45 years and in about a third of cases the person had a history of substance abuse and in 40% of cases there was documented history of psychoactive medication use. Severe addiction was reported. In the third study, more than half of the individuals suspected of drug-impaired driving used the drug without a recent prescription. Non prescribed use was most frequent in users of benzodiazepines and of tramadol compared to users of zolpidem or zopiclone, and was more likely in younger individuals and in multiple- substance users and less likely in individuals with a recent prescription for another psychoactive medication. In the last paper, five longitudinal utilisation patterns were found in pregabalin users, with two patterns associated with a particularly high risk of use of doses above the maximum approved daily dose. The highest risk of use of daily doses above the MAD over time was associated with male sex, younger age, non-urban residency, and a recent prescribed treatment with an antiepileptic or opioid analgesic drug. Conclusions: This thesis shows that psychoactive prescription drug use disorders, misuse and abuse occur across groups in the population and may have serious and even fatal consequences. The prevalence varies between different drugs and groups in the population. Abuse and misuse seem to be more common in young people. Fatal intoxications and misuse of prescribed drugs may be more common in men, while drug use disorders following prescribed treatment may be more common in women and non-prescribed use equally distributed between women and men. Individuals with a history of mental illness, past use of other psychoactive medications, or substance use disorder or abuse, are likely important risk groups. The findings suggest a potential for improvements in the utilisation of psychoactive prescription drugs. The results may be useful in the planning of clinical and regulatory preventive interventions to promote the rational, individualised and safe use of such drugs. Key words: Psychoactive prescription drugs, psychotropic drugs, prescription drug use disorders, prescription drug misuse, abuse, pharmacovigilance, drug utilization, pharmacoepidemiology ISBN: 978-91-7685-770-0 ISSN: 0345-0082 Linköping University Medical Dissertations No: 1521 vi SVENSK SAMMANFATTNING I dag finns en utbredd användning av läkemedel med verkan på centrala nervsystemet och som kan orsaka beroende och har potential för missbruk och felaktig användning. Exempel på sådana läkemedel är vissa smärtstillande läkemedel, ångestdämpande medel, sömnmedel och epilepsiläkemedel. Icke-medicinskt motiverad felanvändning av läkemedel kan medföra allvarliga konsekvenser och anses idag vara ett globalt och ökande folkhälsoproblem. Detta avhandlingsprojekt avser att studera förekomsten av beroende, felaktig användning och missbruk av läkemedel med verkan på centrala nervsystemet, och de riskfaktorer som är kopplade till dessa. I avhandlingen ingår fyra delstudier som använde uppgifter från olika svenska nationella hälso- och sjukvårdsregister, exempelvis uppgifter om rättsmedicinsk och rättstoxikologisk utredning, spontanrapporterade biverkningar, receptförskrivna läkemedel uthämtade på apotek, och sociodemografiska faktorer. I delstudie I identifierades oavsiktliga dödliga förgiftningar med tramadol, ett smärtstillande läkemedel av opioidtyp, i rättsmedicinska register. I delstudie II identifierades spontant inrapporterade biverkningsfall av tramadolberoende i det svenska biverkningsregistret. Delstudie III studerade hur vanligt förekommande användning är av icke- förskrivna läkemedel med verkan på centrala nervsystemet, bland personer som vid utredning för misstänkt drograttfylleri har påvisats använda dessa läkemedel, och vilka faktorer som är kopplade till sådan icke-förskriven användning. I delstudie IV identifierades olika långsiktiga användningsmönster för pregabalin, ett antiepileptiskt läkemedel, med avseende på den högsta godkända dygnsdosen, bland personer som inleder förskriven behandling med läkemedlet, samt faktorer som kan vara kopplade till de olika användningsmönstren. I den första delstudien redovisas 17 dödsfall som ansågs vara orsakade av en oavsiktlig förgiftning där läkemedlet tramadol haft en central roll. Män, yngre individer, och individer som samtidigt använde andra medel med verkan på centrala nervsystemet (alkohol, illegala droger och läkemedel) föreföll vara vanliga i sådana dödsfall. I den andra delstudien där 104 rapporterade fall av möjligt eller troligt tramadolberoende studerades, drabbades kvinnor oftare. Åldern i dessa fall var i genomsnitt 45 år och i cirka en tredjedel av fallen hade personerna tidigare haft problem med beroende eller missbruk, vanligen av ett annat smärtstillande läkemedel. vii I den tredje delstudien fann man att hälften av personer som misstänktes för drograttfylleri och som hade visats använda något av läkemedlen med verkan på centrala nervsystemet, använde läkemedlet utan en förskriven pågående behandling. Vanligast var detta för bensodiazepiner och tramadol och hos unga individer och användare av många samtidiga substanser. Det var dock mindre vanligt hos individer med en pågående behandling med annat läkemedel med verkan på det centrala nervsystemet. I den sista delstudien identifierades fem olika användningsmönster för läkemedelet pregabalin. En liten andel av patienterna fanns ha en stor risk för att under loppet av sin behandling använda pregabalin över den godkända dygnsdosen. Högst risk noterades bland yngre, män, personer som inte bor i en storstad och bland personer som inom det senaste året hämtade ut ett antiepileptiskt läkemedel eller smärtstillande läkemedel av opioidtyp. Sammanfattningsvis visar detta avhandlingsprojekt att beroende, missbruk och felaktig användning av läkemedel som verkar på det centrala nervsystemet förekommer i hela befolkningen och kan ha allvarliga följder. Förekomsten skiljer sig åt mellan olika läkemedel och är särskilt hög i vissa grupper i befolkningen. Oavsett om läkemedlet är förskrivet eller ej verkar missbruk och felaktig användning vara vanligare hos unga. Dödsfall på grund av förgiftning liksom felaktig användning av förskrivna läkemedel kan vara vanligare bland män, medan beroende efter ordinerad behandling kan vara vanligare hos kvinnor och användning av icke- förskrivna läkemedel lika vanligt hos båda könen. Personer med en tidigare psykisk sjukdom och personer med en tidigare eller pågående behandling av läkemedel med verkan på det centrala nervsystemet, samt personer med tidigare beroende- eller missbruksproblematik identifierades som grupper med förhöjd risk. Sammantaget pekar avhandlingsprojektet på att det finns potential för att förhindra missbruk och felaktig användning och resultaten kan vara underlag
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