Pharmacoepidemiology and drug safety
-
Pharmacoepidemiol Drug Saf · Jul 2015
Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?
The US Food and Drug Administration (FDA) priority review process applies to a drug that is considered a significant improvement over the available alternatives. The European Medicines Agency (EMA) accelerated approval applies to a product that is of major public health interest. This study assessed differences in the characteristics of priority review new molecular entities and new therapeutic biologic products approved by the FDA and the EMA. ⋯ Significant differences exist in the characteristics of the priority review drugs approved by the FDA and the EMA. Harmonization of the US and European regulatory frameworks may facilitate timely approval of pharmaceutical products.
-
Pharmacoepidemiol Drug Saf · Jun 2015
Opioid analgesic prescribing in Australia: a focus on gender and age.
The use of prescription opioid analgesics has been increasing over the last few decades in Australia. In particular, oxycodone and fentanyl have increased substantially. We examined the gender and age trends in the prescribing of subsidised opioid analgesics in the Australian population for non-palliative care indications. ⋯ Reasons for increased use may include increased prevalence of people with cancer and use for acute pain. The overall benefit and risk in this escalation of opioid use are difficult to determine; however, the increasing risk of tolerance, dependence, overdose and drug diversion suggests to clinicians and policy makers that this escalation may not be in the best interest of all Australians.
-
Pharmacoepidemiol Drug Saf · May 2015
Impact of antibiotic exposure on the risk of colorectal cancer.
Gut microbiota has been postulated to serve as a significant promoter of CRC formation, and colonic dysbiosis was previously reported in CRC tissue. Our aim was to evaluate the association between the type and cumulative duration of antibiotic exposure and CRC risk. ⋯ Past exposure to multiple courses of penicillins is related to a modest elevation in CRC risk.
-
Pharmacoepidemiol Drug Saf · Apr 2015
Comparative Study Historical ArticleCharacteristics and temporal trends in patient registries: focus on the life sciences industry, 1981-2012.
Patient registries are used to monitor safety, examine real-world effectiveness, and may potentially contribute to comparative effectiveness research. To our knowledge, life sciences industry (LSI)-sponsored registries have not been systematically categorized. This study represents a first step toward understanding such registries over time. ⋯ The LSI registries represent a substantial proportion of all patient registries documented in ClinicalTrials.gov. These prospective studies are growing in number and encompass diverse therapeutic areas and geographic regions. Most registries measure multiple outcomes and capture real-world data that may be unavailable through other study designs. This classification of LSI registries documents their use for studying heterogeneity of diseases, examining treatment patterns, measuring patient-reported outcomes, examining economic outcomes, and performing comparative effectiveness research.
-
Pharmacoepidemiol Drug Saf · Apr 2015
Historical ArticleAccuracy of ICD-9-CM coding to identify small for gestational age newborns.
This study aimed to evaluate the accuracy of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis code for small for gestational age (SGA) recorded in administrative healthcare records using birthweight and gestational age information recorded in electronic medical records. ⋯ Identification of SGA infants using ICD-9-CM code, 656.5x, from administrative healthcare records has low sensitivity but high specificity; the accuracy did not differ across demographic and delivery characteristics. Thus, although this source of information would underestimate the prevalence of SGA, it could produce valid relative risk estimates.