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Pharmacoepidemiology and Drug Safety

Hilda W Chan, Andrea M Russell, Meredith Y Smith
BACKGROUND: Poor-quality patient drug information has been identified as a major cause of preventable medication errors in the United States. The US Food and Drug Administration (FDA) has the authority to require marketing authorization holders of medicinal products to implement risk evaluation and mitigation strategies (REMS) to ensure that the benefits of a drug or biological product outweigh its risks. Aside from medication guides, no research has been conducted to assess the quality of patient-targeted REMS materials, including whether, and to what extent, patients find these materials understandable and actionable...
July 13, 2018: Pharmacoepidemiology and Drug Safety
Eric M Ammann, Iftekhar Kalsekar, Andrew Yoo, Stephen S Johnston
PURPOSE: To quantify the sensitivity and positive predictive value (PPV) of body mass index (BMI)-related ICD-9-CM and ICD-10-CM diagnosis codes in claims data. METHODS: De-identified electronic health record (EHR) and claims data were obtained from the Optum Integrated Claims-Clinical Database for cross-sections of commercial and Medicare Advantage health plan members age ≥ 20 years in 2013, 2014, and 2016. In each calendar year, health plan members' BMI as coded in the insurance claims data (error-prone measure) was compared with their BMI as recorded in the EHR (gold standard) to estimate the sensitivity and PPV of BMI-related ICD-9-CM and ICD-10-CM diagnosis codes...
July 12, 2018: Pharmacoepidemiology and Drug Safety
Cecilia P Chung, William D Dupont, Katherine T Murray, Kathi Hall, C Michael Stein, Wayne A Ray
PURPOSE: Despite significant growth of opioid prescriptions, only limited data are available regarding the comparative safety of long-acting opioids for chronic non-cancer pain. Recent data suggest that transdermal fentanyl and oxycodone CR may have greater toxicity than morphine SR in patients with non-cancer pain. Thus, we compared the risk of out-of-hospital deaths in patients with non-cancer pain filling prescriptions for transdermal fentanyl or oxycodone CR with that for morphine SR...
July 12, 2018: Pharmacoepidemiology and Drug Safety
Daniel Pinto, Ana Silva, Bruno Heleno, David Silvério Rodrigues, Isabel Santos, Pedro A Caetano
PURPOSE: Following safety concerns regarding trimetazidine, the European Medicines Agency (EMA) recommended restrictions on its use. Our objective was to determine the impact of regulatory actions on trimetazidine utilization in Portugal. METHODS: Retrospective interrupted time-series analysis of monthly ambulatory pharmacy reimbursement records for the Portuguese National Health Service between January 2006 and December 2015. Regulatory actions were identified by searching the EMA, Portuguese Medicines Authority, and European Commission's websites...
July 10, 2018: Pharmacoepidemiology and Drug Safety
Nhung T H Trinh, Elodie Solé, Mehdi Benkebil
BACKGROUND: Change-point analysis (CPA) is a powerful method to analyse pharmacovigilance data but it has never been used on the disproportionality metric. OBJECTIVES: To optimize signal detection investigating the interest of time-series analysis in pharmacovigilance and the benefits of combining CPA with the proportional reporting ratio (PRR). METHODS: We investigated the couple benfluorex and aortic valve incompetence (AVI) using the French National Pharmacovigilance and EudraVigilance databases: CPA was applied on monthly counts of reports and the lower bound of monthly computed PRR (PRR-)...
July 10, 2018: Pharmacoepidemiology and Drug Safety
Andrew M Tomlin, David J Woods, Hywel S Lloyd, Ralph A H Stewart, Murray W Tilyard
PURPOSE: Existing knowledge of medicines that increase the risk of an adverse event may be corroborated and augmented by population studies specifically assessing the risk associated with the concurrent use of these medicines and use by patients with existing comorbidity. An American Heart Association review recently identified a variety of medicines that may cause or exacerbate heart failure (HF), many with evidence from limited evaluation of population data. We assessed the risk of first-time HF associated with the use of 50 of these medicines by New Zealand's primary care population...
July 10, 2018: Pharmacoepidemiology and Drug Safety
Julie Maria Thrane, Henrik Støvring, Maja Hellfritzsch, Jesper Hallas, Anton Pottegård
OBJECTIVES: In many prescription databases, the duration of treatment for the single prescription is not recorded. This study aimed to validate 2 different types of approaches for estimating prescription durations, using the oral anticoagulant warfarin as a case. METHODS: The approaches undergoing empirical validation covered assumptions of a fixed daily intake of either 0.5 or 1.0 defined daily dose (DDD), as well as estimates based on the reverse parametric waiting time distribution (rWTD), with different sets of covariates...
June 28, 2018: Pharmacoepidemiology and Drug Safety
Lotte Rasmussen, Nicole Pratt, Morten Rix Hansen, Jesper Hallas, Anton Pottegård
PURPOSE: Standard Kaplan-Meier (KM) survival analysis is often used to study treatment persistence estimating the proportion of patients who have not yet experienced a treatment break by a given day after treatment initiation. This method only allows patients to be studied until their first treatment break. The "proportion of patients covered" (PPC) method is another approach to study treatment persistence. It measures the proportion of live patients currently covered by treatment...
June 27, 2018: Pharmacoepidemiology and Drug Safety
Ana Ruigómez, Gunnar Brobert, Kiliana Suzart-Woischnik, Luis Alberto García-Rodríguez
PURPOSE: The purpose of the study is to evaluate the impact of validation on the identification of major bleeding events in The Health Improvement Network (THIN) database in patients receiving anticoagulant therapy. METHODS: Patients aged 2 to 89 years with a first prescription for an anticoagulant (rivaroxaban or warfarin) between 2012 and 2015 were identified in THIN. Major bleeding events, defined as bleeding events necessitating hospitalization or referral to accident and emergency services or a specialist clinic, were identified using a 2-step ascertainment process based on read codes only, and then validated using a 2-step process requiring manual review of patients' records...
June 27, 2018: Pharmacoepidemiology and Drug Safety
Catherine A Panozzo, Emily C Welch, Tiffany S Woodworth, Ting-Ying Huang, Qoua L Her, Joshua J Gagne, Jenny W Sun, Catherine Rogers, Talia J Menzin, Max Ehrmann, Katherine E Freitas, Nicole R Haug, Sengwee Toh
PURPOSE: To replicate the well-established association between angiotensin-converting enzyme inhibitors versus beta blockers and angioedema in the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) era. METHODS: We conducted a retrospective, inception cohort study in a large insurance database formatted to the Sentinel Common Data Model. We defined study periods spanning the ICD-9-CM era only, ICD-10-CM era only, and ICD-9-CM and ICD-10-CM era and conducted simple-forward mapping (SFM), simple-backward mapping (SBM), and forward-backward mapping (FBM) referencing the General Equivalence Mappings to translate the outcome (angioedema) and covariates from ICD-9-CM to ICD-10-CM...
June 26, 2018: Pharmacoepidemiology and Drug Safety
Catherine A Panozzo, Tiffany S Woodworth, Emily C Welch, Ting-Ying Huang, Qoua L Her, Kevin Haynes, Catherine Rogers, Talia J Menzin, Max Ehrmann, Katherine E Freitas, Nicole R Haug, Sengwee Toh
PURPOSE: To describe the consistency in the frequency of 5 health outcomes across the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and Tenth Revision, Clinical Modification (ICD-10-CM) eras in the US. METHODS: We examined the incidence of 3 acute conditions (acute myocardial infarction [AMI], angioedema, ischemic stroke) and the prevalence of 2 chronic conditions (diabetes, hypertension) during the final 5 years of the ICD-9-CM era (January 2010-September 2015) and the first 15 months of the ICD-10-CM era (October 2015-December 2016) in 13 electronic health care databases in the Sentinel System...
June 26, 2018: Pharmacoepidemiology and Drug Safety
Mugdha Gokhale, John B Buse, Christina DeFilippo Mack, Michele Jonsson Funk, Jennifer Lund, Ross J Simpson, Til Stürmer
OBJECTIVE: In recent years, second-line diabetes treatment with dipeptidyl peptidase-4 inhibitors (DPP-4i) increased with a corresponding decrease in thiazolidinediones (TZDs). Using hospitalization for heart failure (HF) as a positive control outcome, we explored the use of calendar time as an instrumental variable (IV) and compared this approach to an active comparator new-user study. METHODS: We identified DPP-4i or TZD initiators after a 6-month washout using Medicare claims 2006-2013...
June 26, 2018: Pharmacoepidemiology and Drug Safety
David H Smith, Susan Shetterly, James Flory, Kevin Haynes, Christine Y Lu, Joshua J Gagne, Lisa Herrinton, Carsie Nyirenda, Elisabetta Patorno, Azadeh Shoaibi, Marsha A Raebel
PURPOSE: In this report, we use data from FDA's Sentinel System to focus on how augmenting a diagnosis-based chronic kidney disease cohort with patients identified through laboratory results impacts cohort characteristics and outcomes. METHODS: We used data from 2 Data Partners. Patients were eligible if they were health plan members on January 1, 2012. We classified chronic kidney disease patients into mutually exclusive categories according to the hierarchy of (1) ICD-9-CM diagnosis (DXGroup), or (2) two estimated glomerular filtration rates <60 mL/min/1...
June 22, 2018: Pharmacoepidemiology and Drug Safety
Beatrice Annaheim, Wiebke Bretschneider, Violet Handtke, Angelo Belardi, Bernice S Elger
PURPOSE: In prison populations, treating pain is particularly challenging, especially for the growing number of older prisoners. The objective was to find out about prevalence, frequency, and types of pain medications prescribed to older prisoners (≥50 years) in comparison with younger prisoners (<50 years). METHODS: Data were collected in Switzerland as part of a study on ageing prisoners' health. Fifteen prisons (out of 26 of the total eligible population) agreed to take part, and data from medical records of 190 older and 190 younger male prisoners were analysed...
June 21, 2018: Pharmacoepidemiology and Drug Safety
Kristina Crothers, Carla V Rodriguez, Robin M Nance, Kathleen Akgun, Shahida Shahrir, Joon Kim, Guy W Soo Hoo, Amir Sharafkhaneh, Heidi M Crane, Amy C Justice
PURPOSE: No prior studies have addressed the performance of electronic health record (EHR) data to diagnose chronic obstructive pulmonary disease (COPD) in people living with HIV (PLWH), in whom COPD could be more likely to be underdiagnosed or misdiagnosed, given the higher frequency of respiratory symptoms and smoking compared with HIV-uninfected (uninfected) persons. METHODS: We determined whether EHR data could improve accuracy of ICD-9 codes to define COPD when compared with spirometry in PLWH vs uninfected, and quantified level of discrimination using the area under the receiver-operating curve (AUC)...
June 20, 2018: Pharmacoepidemiology and Drug Safety
Blánaid Hicks, Søren Friis, Anton Pottegård
PURPOSE: Preclinical studies have suggested that proton pump inhibitors (PPIs) may increase pancreatic cancer risk; however, epidemiological studies are few, with conflicting results. This spurred us to evaluate whether PPI use is associated with an increased risk of pancreatic cancer in a large population-based study. METHODS: We conducted a nationwide case-control study using data from Danish demographic and health care registries. All patients with a first cancer diagnosis of pancreatic cancer between 2000 and 2015 were identified from the Danish Cancer Registry and age-matched, sex-matched, and calendar-matched 1:20 to population controls using risk set sampling...
June 20, 2018: Pharmacoepidemiology and Drug Safety
Yesim Ozguler, Yusuf Yazici, Gulen Hatemi, Koray Tascilar, Hasan Yazici
No abstract text is available yet for this article.
June 19, 2018: Pharmacoepidemiology and Drug Safety
Anders Engeland, Tone Bjørge, Kari Klungsøyr, Vidar Hjellvik, Svetlana Skurtveit, Kari Furu
PURPOSE: To explore trends in use of maternal medication 3 months prior to, during and 3 months after pregnancy. METHOD: Data on births from the Medical Birth Registry of Norway were linked to the Norwegian Prescription Database, identifying women's use of medications around pregnancy. All women giving birth in Norway during 2005 to 2015 (638 532 singleton births to 414 567 women) were included. Proportions of pregnant women using different medications in association with pregnancy, and annual relative change in medication use during 2005 to 2015, were calculated...
June 19, 2018: Pharmacoepidemiology and Drug Safety
Amanda Phillips, Ralf Strobl, Eva Grill, Gunter Laux
PURPOSE: To date, there is little information on the utilization of anticholinergic and sedative (AS) medications to vertigo or dizziness (VoD) patients in the German primary care setting. The objective of this study was to evaluate AS medication use and its association with VoD within the German primary care setting. METHODS: Cases with VoD from the CONTENT (CONTinuous morbidity registration Epidemiologic NeTwork) database were 1:1 matched to controls on age, sex, and comorbidities by propensity score matching...
June 13, 2018: Pharmacoepidemiology and Drug Safety
Jonathan Bates, Craig S Parzynski, Sanket S Dhruva, Andreas Coppi, Richard Kuntz, Shu-Xia Li, Danica Marinac-Dabic, Frederick A Masoudi, Richard E Shaw, Frederick Warner, Harlan M Krumholz, Joseph S Ross
PURPOSE: To estimate medical device utilization needed to detect safety differences among implantable cardioverter defibrillators (ICDs) generator models and compare these estimates to utilization in practice. METHODS: We conducted repeated sample size estimates to calculate the medical device utilization needed, systematically varying device-specific safety event rate ratios and significance levels while maintaining 80% power, testing 3 average adverse event rates (3...
June 12, 2018: Pharmacoepidemiology and Drug Safety
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