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Pharmacoepidemiology and Drug Safety

Jacob A Lebin, David L Murphy, Stevan Geoffrey Severtson, Gabrielle E Bau, Nabarun Dasgupta, Richard C Dart
BACKGROUND: Diverted prescription opioids are significant contributors to drug overdose mortality. Street price has been suggested as an economic metric of the diverted prescription opioid black market. This study examined variables that may influence the street price of diverted oxycodone and oxymorphone. METHODS: A cross-sectional study was conducted utilizing data from the previously validated, crowdsourcing website StreetRx. Street price reports of selected oxycodone and oxymorphone products, between August 22, 2014 and June 30, 2016, were considered for analysis...
May 15, 2018: Pharmacoepidemiology and Drug Safety
Pierre-Olivier Blotière, Alain Weill, Marie Dalichampt, Cécile Billionnet, Myriam Mezzarobba, Fanny Raguideau, Rosemary Dray-Spira, Mahmoud Zureik, Joël Coste, François Alla
PURPOSE: Access to claims databases provides an opportunity to study medication use and safety during pregnancy. We developed an algorithm to identify pregnancy episodes in the French health care databases and applied it to study antiepileptic drug (AED) use during pregnancy between 2007 and 2014. METHODS: The algorithm searched the French health care databases for discharge diagnoses and medical procedures indicative of completion of a pregnancy. To differentiate claims associated with separate pregnancies, an interval of at least 28 weeks was required between 2 consecutive pregnancies resulting in a birth and 6 weeks for terminations of pregnancy...
May 15, 2018: Pharmacoepidemiology and Drug Safety
Sarah F Feldman, Nathanaël Lapidus, Céline Dorival, Alpha Diallo, Imane Amri, Hélène Fontaine, Stanislas Pol, Fabrice Carrat
No abstract text is available yet for this article.
May 11, 2018: Pharmacoepidemiology and Drug Safety
Tomofumi Ishikawa, Taku Obara, Hidekazu Nishigori, Keiko Miyakoda, Ryusuke Inoue, Tetsuro Hoshiai, Masatoshi Saito, Nobuo Yaegashi, Nariyasu Mano
PURPOSE: To develop and assess algorithms to determine the onset of pregnancy and delivery date using health administrative data from a university hospital in Japan. METHODS: All women who were hospitalized in the maternity ward and had at least one pregnancy that ended with a delivery during the period of January 2014 and December 2015 were included in this study. The true delivery date was obtained from the electronic medical records and was used as a gold standard...
May 11, 2018: Pharmacoepidemiology and Drug Safety
Alexandra Pacurariu, Kelly Plueschke, Carla Alonso Olmo, Xavier Kurz
PURPOSE: Building on previous research, we examined whether delayed study start and low patient accrual rates found in 31 postauthorization registry-based studies requested by European Medicines Agency (EMA) are maintained after 2 additional years of follow-up. METHOD: The registries identified in the previous EMA study and the same methodology were used. The follow-up was extended from June 2015 to November 2017. The information available for the following variables was updated: marketing authorization status, study and registry status, study end date, planned duration, number of patients planned to be enrolled, and actual patients enrolled...
May 11, 2018: Pharmacoepidemiology and Drug Safety
Lucia Cea-Soriano, Luis A García-Rodríguez, Kimberly G Brodovicz, Elvira Gonzalez-Masso, Dorothee B Bartels, Sonia Hernández-Díaz
PURPOSE: Our goal was to describe the management of pregestational diabetes in pregnant women in the United Kingdom. METHODS: We used electronic medical records from The Health Improvement Network database between January 1995 and June 2012 to identify the first pregnancy in women 15 to 45 years of age with pregestational diabetes type 1 or type 2. Information on lifestyle factors, demographic characteristics, prescription of specific antidiabetic medications, and glycemic control measures (HbA1c) was obtained from primary care provider records...
May 8, 2018: Pharmacoepidemiology and Drug Safety
Alisha Kamboj, Henry A Spiller, Marcel J Casavant, Thitphalak Chounthirath, Nichole L Hodges, Gary A Smith
PURPOSE: To investigate unintentional therapeutic medication errors associated with antidepressant and antipsychotic medications in the United States and expand current knowledge on the types of errors commonly associated with these medications. METHODS: A retrospective analysis of non-health care facility unintentional therapeutic errors associated with antidepressant and antipsychotic medications was conducted using data from the National Poison Data System. RESULTS: From 2000 to 2012, poison control centers received 207 670 calls reporting unintentional therapeutic errors associated with antidepressant or antipsychotic medications that occurred outside of a health care facility, averaging 15 975 errors annually...
May 8, 2018: Pharmacoepidemiology and Drug Safety
Cristina Rebordosa, Estel Plana, Jaume Aguado, Steven Thomas, Esther García-Gil, Susana Perez-Gutthann, Jordi Castellsague
PURPOSE: To evaluate availability of spirometry and symptom data in the Clinical Practice Research Datalink (United Kingdom) to assess COPD severity using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2016 definition and comparing it with an algorithm used in other studies. METHODS: This was a descriptive, noninterventional, secondary database cohort study of patients with COPD aged 40 years or older, who initiated treatment with specific COPD medications...
May 8, 2018: Pharmacoepidemiology and Drug Safety
Terhi Kurko, Leena K Saastamoinen, Annamari Tuulio-Henriksson, Tero Taiminen, Jari Tiihonen, Marja Airaksinen, Jarmo Hietala
PURPOSE: Long-term benzodiazepine (BZD) treatment continues to be a debated topic. Because individual BZDs have different clinical profiles, we assessed the nationwide trends of long-term BZD use at active substance level during years 2006 to 2014. METHODS: This study covered all reimbursed BZD purchases (n = 408 572-521 823 annually) for adults recorded in the Finnish Prescription Register. We assessed long-term use (annual cumulative purchase of ≥180 defined daily doses) in general, and at active substance level with the most commonly used BZD anxiolytics (oxazepam, diazepam, alprazolam, and clonazepam for nonepilepsy indications) and hypnotics (zopiclone, zolpidem, and temazepam) included...
May 4, 2018: Pharmacoepidemiology and Drug Safety
Mélanie Lelubre, Jamila Hamdani, Christelle Senterre, Karim Amighi, Marion Peres, Marie-Paule Schneider, Olivier Bugnon, Carine De Vriese
PURPOSE: To evaluate awareness of and compliance in Belgium by French-speaking health care professionals and patients with the isotretinoin safety recommendations regarding its teratogenic risk. METHOD: Survey using online questionnaires, delivered from December 2014 to March 2015 for patients, pharmacists, dermatologists, and GPs and delivered again from September 2015 to October 2015 for GPs. RESULTS: Questionnaires were completed by 24 dermatologists, 24 GPs, 58 pharmacists, and 33 female patients...
May 3, 2018: Pharmacoepidemiology and Drug Safety
Shirley V Wang, Martin Kulldorff, Robert J Glynn, Joshua J Gagne, Anton Pottegård, Kenneth J Rothman, Sebastian Schneeweiss, Alexander M Walker
No abstract text is available yet for this article.
April 27, 2018: Pharmacoepidemiology and Drug Safety
Rebecca B Naumann, Stephen W Marshall, Nisha C Gottfredson, Jennifer L Lund, Christopher L Ringwalt, Asheley C Skinner
PURPOSE: "Lock-in" programs (LIPs) are used by health insurers to address potential substance (eg, opioid) misuse among beneficiaries. We sought to (1) examine heterogeneity in trajectories of dispensed opioids (in average daily morphine milligram equivalents (MMEs)) over time: prior to, during, and following release from a LIP, and (2) assess associations between trajectory patterns and beneficiary characteristics. METHODS: Medicaid claims were linked to Prescription Drug Monitoring Program records for a cohort of beneficiaries enrolled in the North Carolina Medicaid LIP (n = 2701)...
April 26, 2018: Pharmacoepidemiology and Drug Safety
Osemeke U Osokogu, Alexandra Pacurariu, Mees Mosseveld, Peter Rijnbeek, Daniel Weibel, Katia Verhamme, Miriam C J M Sturkenboom
PURPOSE: Accurate estimates of disease incidence in children are required to support pediatric drug development. Analysis of electronic health care records (EHR) may yield such estimates but pediatric-specific methods are lacking. We aimed to understand the impact of assumptions regarding duration of disease episode and length of run-in period on incidence estimates from EHRs. METHODS: Children aged 0 to 17 years (5-17 years for asthma) registered in the Integrated Primary Care Information database between 2002 and 2014 were studied...
April 24, 2018: Pharmacoepidemiology and Drug Safety
Kathryn Rough, Krista F Huybrechts, Sonia Hernandez-Diaz, Rishi J Desai, Elisabetta Patorno, Brian T Bateman
OBJECTIVE: Compare and validate 5 algorithms to detect aberrant behavior with opioids: Opioid Misuse Score, Controlled Substance-Patterns of Utilization Requiring Evaluation (CS-PURE), Overutilization Monitoring System, Katz, and Cepeda algorithms. STUDY DESIGN AND SETTING: We identified new prescription opioid users from 2 insurance databases: Medicaid (2000-2006) and Clinformatics Data Mart (CDM; 2004-2013). Patients were followed 1 year, and aberrant opioid behavior was defined according to each algorithm, using Cohen's kappa to assess agreement...
April 24, 2018: Pharmacoepidemiology and Drug Safety
Jenna Wong, Michal Abrahamowicz, David L Buckeridge, Robyn Tamblyn
PURPOSE: To assess the accuracy of using diagnostic codes from administrative data to infer treatment indications for antidepressants prescribed in primary care. METHODS: Validation study of administrative diagnostic codes for 13 plausible indications for antidepressants compared with physician-documented treatment indications from an indication-based electronic prescribing system in Quebec, Canada. The analysis included all antidepressant prescriptions written by primary care physicians between January 1, 2003 and December 31, 2012 using the electronic prescribing system...
April 23, 2018: Pharmacoepidemiology and Drug Safety
Stephen R Pye, Thérèse Sheppard, Rebecca M Joseph, Mark Lunt, Nadyne Girard, Jennifer S Haas, David W Bates, David L Buckeridge, Tjeerd P van Staa, Robyn Tamblyn, William G Dixon
PURPOSE: Real-world data for observational research commonly require formatting and cleaning prior to analysis. Data preparation steps are rarely reported adequately and are likely to vary between research groups. Variation in methodology could potentially affect study outcomes. This study aimed to develop a framework to define and document drug data preparation and to examine the impact of different assumptions on results. METHODS: An algorithm for processing prescription data was developed and tested using data from the Clinical Practice Research Datalink (CPRD)...
April 17, 2018: Pharmacoepidemiology and Drug Safety
Christiane Gasse, Andreas Aalkjaer Danielsen, Marianne Giørtz Pedersen, Carsten Bøcker Pedersen, Ole Mors, Jakob Christensen
PURPOSE: It is not possible to fully assess intention of self-harm and suicidal events using information from administrative databases. We conducted a validation study of intention of suicide attempts/self-harm contacts identified by a commonly applied Danish register-based algorithm (DK-algorithm) based on hospital discharge diagnosis and emergency room contacts. METHODS: Of all 101 530 people identified with an incident suicide attempt/self-harm contact at Danish hospitals between 1995 and 2012 using the DK-algorithm, we selected a random sample of 475 people...
April 17, 2018: Pharmacoepidemiology and Drug Safety
Pareen Vora, Esther Artime, Montse Soriano-Gabarró, Nawab Qizilbash, Vineet Singh, Alex Asiimwe
PURPOSE: An important element of risk management is the planning and implementation of risk minimisation measures (RMMs) and the evaluation of their effectiveness by process or outcome indicators. The aim of this review is to summarize the characteristics of risk minimisation (RM) effectiveness studies in Europe and provide an overview of RMMs and their effectiveness. METHODS: This was a qualitative review of RM effectiveness studies in the European Union electronic Register of Post-Authorization Studies (EU PAS Register); data extracted included study design, population, sample size, data sources, drug information, RMMs, study period, indicators, and their reported effectiveness...
April 16, 2018: Pharmacoepidemiology and Drug Safety
Yao-Chun Wen, Fei-Yuan Hsiao, Zhen-Fang Lin, Cheng-Chung Fang, Li-Jiuan Shen
BACKGROUND: Previous studies suggested that acute respiratory infection (ARI) could trigger stroke and that use of nonsteroidal anti-inflammatory drugs (NSAIDs) was associated with increased risk of stroke. In many countries, NSAIDs have been widely used among patients with ARI or common cold for pain and fever relief. However, studies evaluating whether NSAIDs use during ARI episodes may further increase the risk of stroke were very limited. METHODS AND RESULTS: During 2007 to 2011, 29 518 patients with an incident hospitalization of stroke were identified...
April 16, 2018: Pharmacoepidemiology and Drug Safety
Seif El Hadidi, Ebtissam Darweesh, Stephen Byrne, Margaret Bermingham
INTRODUCTION: Heart failure (HF) guidelines aim to standardise patient care. Internationally, prescribing practice in HF may deviate from guidelines and so a standardised tool is required to assess prescribing quality. A systematic review and meta-analysis were performed to identify a quantitative tool for measuring adherence to HF guidelines and its clinical implications. METHODS: Eleven electronic databases were searched to include studies reporting a comprehensive tool for measuring adherence to prescribing guidelines in HF patients aged ≥18 years...
April 16, 2018: Pharmacoepidemiology and Drug Safety
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