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Effects of Generic Substitution on Refill Adherence to Statin Therapy: a Nationwide Population-Based Study Henrik Trusell1 and Karolina Andersson Sundell1,2*

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Effects of Generic Substitution on Refill Adherence to Statin Therapy: a Nationwide Population-Based Study Henrik Trusell1 and Karolina Andersson Sundell1,2* Trusell and Andersson Sundell BMC Health Services Research 2014, 14:626 http://www.biomedcentral.com/1472-6963/14/626 RESEARCH ARTICLE Open Access Effects of generic substitution on refill adherence to statin therapy: a nationwide population-based study Henrik Trusell1 and Karolina Andersson Sundell1,2* Abstract Background: Several countries have introduced generic substitution, but few studies have assessed its effect on refill adherence. This study aimed to analyse whether generic substitution influences refill adherence to statin treatment. Methods: Between 1 July 2006 and 30 June 2007, new users of simvastatin (n = 108,806) and atorvastatin (n = 7,464) were identified in the Swedish Prescribed Drug Register . The present study included atorvastatin users as an unexposed control group because atorvastatin was patent-protected and thus not substitutable. We assessed refill adherence using continuous measure of medication acquisition (CMA). To control for potential confounders, we used analysis of covariance (ANCOVA). Differences in CMA associated with generic substitution and generic substitution at first-time statin purchase were analysed. Results: Nine of ten simvastatin users were exposed to generic substitution during the study period, and their adherence rate was higher than that of patients without substitution [84.6% (95% CI 83.5-85.6) versus 59.9% (95% CI 58.4-61.4), p < 0.001]. CMA was higher with increasing age (60–69 years 16.7%, p < 0.0001 and 70–79 years 17.8%, p < 0.0001, compared to 18–39 years) and secondary prevention (12.8%, p < 0.0001). CMA was lower among patients who were exposed to generic substitution upon initial purchase, compared to those who were exposed to a generic substitution subsequently [80.4% (95% CI 79.4-90.9) versus 89.8% (88.7-90.9), p < 0.001]. This difference decreased when those with only one statin purchase were excluded. Conclusions: Statin refill adherence was higher among patients who exposed to generic substitution compared to those who were not. Increasing age and previous cardiovascular disease affected refill adherence. Keywords: Medication adherence, Generic substitution, Statins, Lipid-lowering therapy Background Although few studies have explored whether generic Based on register data on dispensed medicines, previous substitution affects refill adherence, some reports sug- studies reported an indirect measure of statin refill ad- gest that patients find it more difficult to keep track of herence totalling more than 80% [1,2]. Refill adherence their medication after generic substitution [5,6]. How- is a valid estimate of adherence to medication [3]. Good ever, a small proportion of patients reported intake er- adherence to statin treatment associates with signifi- rors following generic substitution [5], most commonly cantly lower risks for cardiovascular disease (CVD) they simultaneously used two different products with and mortality [4]. the same active pharmaceutical ingredient. Some reports express concern that generics have lower quality than brand-name products [7,8]. However, a survey reported * Correspondence: [email protected] that only a small group of the patients thought that ge- 1Section of Social Medicine and Epidemiology, Department of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy nerics caused more side effects than their brand-name at University of Gothenburg, PO Box 453, 405 30 Gothenburg, Sweden equivalent [8]. 2Nordic School of Public Health, Gothenburg, Sweden © 2014 Trusell and Andersson Sundell; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Trusell and Andersson Sundell BMC Health Services Research 2014, 14:626 Page 2 of 8 http://www.biomedcentral.com/1472-6963/14/626 Studies investigating whether generic medication and pharmacy dispensed a product other than the one pre- generic substitution affect refill adherence report that scribed (due to generic substitution), information about adherence is higher among patients who start treatment both products is provided. with generics, compared to those who start with brand- Information about participants’ highest attained level name drugs [7,9]. We wanted determine whether this of education and migration background were collected pattern of adherence applies to refill adherence for sta- from the Swedish Longitudinal Integration Database for tins, using a method validated in the Swedish setting. Health Insurance and Labour Market Studies (LISA) on Thus, this study used continuous measure of medica- individual-level. We obtained information about hospital tion acquisition (CMA) to analyse whether generic care (i.e., diagnosis codes), which was classified according substitution influences refill adherence to statin therapy. to the International Statistical Classification of Diseases We also aimed to assess to what extent socioeconomic and Related Health Problems 10th revision (ICD-10) from and clinical characteristics affect refill adherence. the Swedish National Patient Register. Methods Exposure assessment Study population and study period We defined generic substitution as not receiving the pre- Between 1 July 2006 and 30 June 2007, new users of sim- scribed product, but receiving a substitute product approved vastatin (ATC code C10AA01) and atorvastatin (ATC by the Medical Products Agency. Generic substitution can code C10AA05) were identified in the Swedish Prescribed also occur if the prescribed product is unavailable at the Drug Register (SPDR) [10]. During the study period, index pharmacy. In Sweden, the prescriber and the pharmacy can date was defined as the date each individual purchased a restrict generic substitution due to medical reasons or issues statin for the first time. Thus, a new user was defined as related to formulation, dosage regimen, etc. In that case, the an individual who did not fill any prescriptions for pharmacy dispenses the prescribed product and the lipid-lowering treatment (ATC-code C10) during the Pharmaceutical Benefit Scheme (PBS) covers the full 12 months preceding the index date. The present study cost included in the patients total co-payment [11]. If included atorvastatin as an unexposed control group the patient refuses substitution, the pharmacy attri- because no generic substitute for atorvastatin was avail- butes the price of the cheapest available substitutable able during the study period. We followed all participants product to the total PBS co-payment and the patient until death, emigration, or for a maximum of two years pays the balance out of pocket. We considered same- after the index date. If an unrecorded death occurred dur- strength products from the same manufacturer identical ing follow up, we assumed that death occurred on the even if the package size differed. However, we considered 15th of the specified month (n = 22), or on July 1st if only different strengths from the same manufacturer as differ- the year was specified (n = 2). ent products because pharmacists cannot dispense other We excluded individuals who (i) were younger than strength than that prescribed. 18 years of age at index date; (ii) received multi-dose We classified exposure to generic substitution into dispensed drugs during the study period; (iii) were regis- four groups: (i) simvastatin users who experienced gen- tered as deceased prior to the index date; (iv) purchased eric substitution during follow-up, (ii) simvastatin users more than one statin substance on their index date who did not experience generic substitution due to an (n = 15); or (v) died or emigrated on their index date active decline by the prescriber/pharmacist or the pa- (n = 2). Switching from simvastatin to another statin tient, (iii) simvastatin users who did not experience gen- was allowed because such switches are a normal part eric substitution but where no active decline was made of clinical practice. However, we excluded individuals (i.e., no cheaper substitute was available), and (iv) ator- who switched statin substances four or more times vastatin users. during the study period (n = 252). Data sources Outcome measure SPDR data on dispensed drugs included all prescriptions We calculated refill adherence using CMA [i.e., (number dispensed in Sweden during the study period [10], and of days’ supply dispensed during the study period)/(number information about (i) the dispensed drug (name, sub- of days in the study period)]. stance, drug type, strength, and amount); (ii) the patient A previous study reported that 98.4% of new simvastatin (age, sex, and place of residence); (iii) the prescriber users took one tablet or capsule per day [2]. Therefore, our (profession and workplace); (iv) the price paid by the pa- assumed dosage was one tablet or capsule per day. We tient; (v) the level of reimbursement; and (vi) the date of accounted for stockpiling of medication before the previ- issue and dispensing. Recorded as free text, dosage in- ous supply was fully consumed by adding the remaining structions sometimes include the indication. When the amount to the next purchase. When statin substances were Trusell and Andersson Sundell
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