Evaluation of the US Food and Drug Administration Sentinel Analysis Tools Using a Comparator with a Different Indication: Comparing the Rates of Gastrointestinal Bleeding in Warfarin and Statin Users.

Background: The US Food and Drug Administration's Sentinel System was established to monitor safety of regulated medical products. Sentinel investigators identified known associations between drugs and adverse events to test reusable analytic tools developed for Sentinel. This test case used a comparator with a different indication.

Trigeminal Neuralgia Secondary to Vertebrobasilar Dolichoectasia Treated with Cyberknife Stereotactic Radiosurgery.

Trigeminal neuralgia caused by vertebrobasilar dolichoectasia is a rare condition. It is characterized by paroxysmal hemifacial pain which is lancinating in type mostly refractory to medical management. This is a report of trigeminal neuralgia secondary to vertebral dolicholectasia refractory to medical management treated with cyber knife stereotactic radiosurgery to the dose of 66 Gy in single fraction to the proximal nerve root.

Evaluation of the US Food and Drug Administration sentinel analysis tools in confirming previously observed drug-outcome associations: The case of clindamycin and Clostridium difficile infection.

Purpose: The Food and Drug Administration's Sentinel System developed parameterized, reusable analytic programs for evaluation of medical product safety. Research on outpatient antibiotic exposures, and Clostridium difficile infection (CDI) with non-user reference groups led us to expect a higher rate of CDI among outpatient clindamycin users vs penicillin users. We evaluated the ability of the Cohort Identification and Descriptive Analysis and Propensity Score Matching tools to identify a higher rate of CDI among clindamycin users.

Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study.

Objective: The cardiovascular safety of saxagliptin, a dipeptidyl-peptidase 4 inhibitor, compared with other antihyperglycemic treatments is not well understood. We prospectively examined the association between saxagliptin use and acute myocardial infarction (AMI).

Research Design And Methods: We identified patients aged ≥18 years, starting from the approval date of saxagliptin in 2009 and continuing through August 2014, using data from 18 Mini-Sentinel data partners.

The impact of FDA regulatory activities on incident dispensing of LABA-containing medication: 2005-2011.

Objective: Evidence of safety issues associated with long-acting beta-agonist (LABA) treatment has led to multiple regulatory activities by the U.S. Food and Drug Administration (FDA) on this class of medications.

Sentinel Modular Program for Propensity Score-Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia.

Sentinel is a program sponsored by the US Food and Drug Administration to monitor the safety of medical products. We conducted a cohort assessment to evaluate the ability of the Sentinel Propensity Score Matching Tool to reproduce in an expedited fashion the known association between glyburide (vs. glipizide) and serious hypoglycemia.

Risk for Hospitalized Heart Failure Among New Users of Saxagliptin, Sitagliptin, and Other Antihyperglycemic Drugs: A Retrospective Cohort Study.

Background: Recent postmarketing trials produced conflicting results about the risk for hospitalized heart failure (hHF) associated with dipeptidyl peptidase-4 (DPP-4) inhibitors, creating uncertainty about the safety of these antihyperglycemic agents.

Objective: To examine the associations of hHF with saxagliptin and sitagliptin.

Design: Population-based, retrospective, new-user cohort study.

Changing patterns of asthma medication use related to US Food and Drug Administration long-acting β2-agonist regulation from 2005-2011.

Background: Safety concerns associated with long-acting β2-agonists (LABAs) have led to many US Food and Drug Administration (FDA) regulatory activities for this class of drugs. Little is known about the effect of these regulatory activities on use of LABA-containing agents or other asthma medications.

Methods: We created rolling cohorts of pediatric and adult asthmatic patients in the Mini-Sentinel Distributed Database between January 2005 and June 2011.

Validity of diagnostic codes to identify cases of severe acute liver injury in the US Food and Drug Administration's Mini-Sentinel Distributed Database.

Purpose: The validity of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes to identify diagnoses of severe acute liver injury (SALI) is not well known. We examined the positive predictive values (PPVs) of hospital ICD-9-CM diagnoses in identifying SALI among health plan members in the Mini-Sentinel Distributed Database (MSDD) for patients without liver/biliary disease and for those with chronic liver disease (CLD).

Methods: We selected random samples of members (149 without liver/biliary disease; 75 with CLD) with a principal hospital diagnosis suggestive of SALI (ICD-9-CM 570, 572.

Validation of acute myocardial infarction in the Food and Drug Administration's Mini-Sentinel program.

Purpose: To validate an algorithm based upon International Classification of Diseases, 9(th) revision, Clinical Modification (ICD-9-CM) codes for acute myocardial infarction (AMI) documented within the Mini-Sentinel Distributed Database (MSDD).

Methods: Using an ICD-9-CM-based algorithm (hospitalized patients with 410.x0 or 410.

Design for validation of acute myocardial infarction cases in Mini-Sentinel.

Purpose: To describe the acute myocardial infarction (AMI) validation project, a test case for health outcome validation within the US Food and Drug Administration-funded Mini-Sentinel pilot program.

Methods: The project consisted of four parts: (i) case identification-developing an algorithm based on the International Classification of Diseases, Ninth Revision, to identify hospitalized AMI patients within the Mini-Sentinel Distributed Database; (ii) chart retrieval-establishing procedures that ensured patient privacy (collection and transfer of minimum necessary amount of information, and redaction of direct identifiers to validate potential cases of AMI); (iii) abstraction and adjudication-trained nurse abstractors gathered key data using a standardized form with cardiologist adjudication; and (iv) calculation of the positive predictive value of the constructed algorithm.

Results: Key decision points included (i) breadth of the AMI algorithm, (ii) centralized versus distributed abstraction, and (iii) approaches to maintaining patient privacy and to obtaining charts for public health purposes.

Association of area sociodemographic characteristics and capacity for treatment with disparities in colorectal cancer care and mortality.

Background: Disparities in treatment and mortality for colorectal cancer (CRC) may reflect differences in access to specialized care or other characteristics of the area where an individual lives.

Methods: Surveillance, Epidemiology and End Results Program-Medicare data for seniors diagnosed with CRC were linked to area measures of the sociodemographic characteristics and the capacity of surgeons, medical oncologists, and radiation oncologists. Outcomes included receipt of stage-appropriate CRC care and mortality.

Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting.

Purpose: Physicians in the United States report fewer than 1% of adverse drug events (ADEs) to the Food and Drug Administration (FDA), but frequently document ADEs within electronic health records (EHRs). We developed and implemented a generalizable, scalable EHR-based system to automatically send electronic ADE reports to the FDA in real-time.

Methods: Proof-of-concept study involving 26 clinicians given access to EHR-based ADE reporting functionality from December 2008 to May 2009.

Participation in an ambulatory e-pharmacovigilance system.

Purpose: There is growing concern about whether passive surveillance can detect adverse drug events (ADEs). Our objective was to demonstrate the reach of an interactive voice response system (IVRS) to systematically monitor symptoms experienced by ambulatory patients prescribed one of 31 medications, and to document whether there were differences in our ability to contact certain populations.

Methods: Patients receiving a prescription for a target medication at one of 11 clinics were eligible for a cross-sectional IVRS survey, "e-pharmacovigilance," with a follow-up survey done 3 months later if the target medication was still listed on the patient's active medication list.

Association of local capacity for endoscopy with individual use of colorectal cancer screening and stage at diagnosis.

Background: Limited capacity for endoscopy in areas in which African Americans and Hispanics live may be a reason for persistent disparities in colorectal cancer (CRC) screening and stage at diagnosis.

Methods: The authors linked data from the National Health Interview Survey on the use of CRC screening and data from Surveillance, Epidemiology, and End Results-Medicare on CRC stage with measures of county capacity for colonoscopy and sigmoidoscopy (endoscopy) derived from Medicare claims.

Results: Hispanics lived in counties with less capacity for endoscopy than African Americans or whites (for National Health Interview Survey, an average of 1224, 1569, and 1628 procedures per 100,000 individuals aged > or = 50 years, respectively).