Polinski JM, Gagne JJ. Concern still warranted: medication burden and persistence with lipid-lowering drugs. Am J Manag Care. 2009;15 (1) :74-5.
Gagne JJ, Patrick AR, Wang PS, Schneeweiss S. Health advisories and patterns of patient monitoring among new users of antidepressant medications. J Clin Psychopharmacol. 2009;29 (6) :590-4.Abstract
INTRODUCTION: In 2003, more intense monitoring of patients initiating antidepressants was advised because of emerging concerns of suicidality. We sought to identify patterns of patient monitoring after antidepressant initiation in British Columbia before and after issuance of health advisories. MATERIALS AND METHODS: We conducted a cohort study of antidepressant initiators between 1999 and 2005 using healthcare utilization data of all British Columbia residents. For the periods before (1999-2001) and after (2004-2005), health advisories concerning suicidality associated with antidepressants, we assessed monitoring intensity by calculating weekly physician and psychotherapy visit rates since antidepressant initiation. We also estimated monitoring patterns as the proportion of individuals who received weekly in-person contact during the first 4 weeks of treatment, then biweekly visits for 4 weeks, and then a visit at 12 weeks, as a proxy for intensive monitoring. RESULTS: Patterns of monitoring intensity were similar before and after the health advisories, but the level of intensity was lower after the advisory period. Overall, monitoring intensity peaked in the 4 weeks after antidepressant initiation. Weekly numbers of visits per subject during these 4 weeks were between 0.44 and 0.49 before the advisory and from 0.39 to 0.44 after the advisory. Among all initiators stratified by year of initiation, between 21% and 25% received intensive monitoring, and this proportion generally decreased on a yearly basis. DISCUSSION: Monitoring intensity for patients with depression initiating antidepressants decreased after the period of emergence and greater awareness of the association between antidepressants and suicidality.
Leas BF, Gagne JJ, Goldfarb NI, Rupnow MFT, Silberstein S. Assessing quality of care for migraineurs: a model health plan measurement set. Popul Health Manag. 2008;11 (4) :203-8.Abstract
Quality of care measures are increasingly important to health plans, purchasers, physicians, and patients. Appropriate measures can be used to assess quality and evaluate improvement and are necessary components of pay-for-performance programs. Despite the broad scope of activity in the development of quality measures, migraine headache has received little attention. Given the enormous costs associated with migraine, especially in terms of lost productivity and preventable health care utilization, health plans could gain from a structured approach to measuring the quality of migraine care their beneficiaries receive. A potential migraine quality measurement set was developed through a review of migraine care literature and guidelines, interviews with leaders in migraine care, health care purchasing, and managed care, and the assembly of an advisory board. The board discussed candidate measures and established consensus on a testable measurement set. Twenty measures were developed, focused primarily on diagnosis and utilization. Areas of utilization include physician visits, emergency department visits, hospitalizations, and imaging. Use of both acute and preventive medications is included. More complex aspects of migraine care are also addressed, including triptan overuse, the relationship between acute and preventive medications, and follow-up after emergency department visits. The measures are currently being tested in health plans to assess their feasibility and value. A compelling case can be made for the development of migraine-specific quality measures for health plans. This effort to develop and test a starter set of measures should lead to new and innovative efforts to assess and improve quality of care for migraineurs.
Gagne JJ, Maio V, Berghella V, Louis DZ, Gonnella JS. Prescription drug use during pregnancy: a population-based study in Regione Emilia-Romagna, Italy. Eur J Clin Pharmacol. 2008;64 (11) :1125-32.Abstract
PURPOSE: Drug utilization studies in pregnant women are crucial to inform pharmacovigilance efforts in human teratogenicity. The purpose of this study was to estimate the prevalence of prescription drug use among pregnant women in Regione Emilia-Romagna (RER), Italy. METHODS: We conducted a retrospective prevalence study using data from the RER health care database. Outpatient prescription drug data were reconciled for RER residents who delivered a baby in a hospital between January 1, 2004 and December 31, 2004. Drug data were stratified by trimester of use, pregnancy risk categorization, and anatomical classification. RESULTS: Among the 33,343 deliveries identified in 2004, 70% of women were exposed to at least one prescription medication during pregnancy and 48% were exposed to at least one prescription medication after excluding vitamin and mineral products. Many of the most commonly used medications were anti-infectives, such as amoxicillin, fosfomycin, and ampicillin. Nearly 1% of women were exposed to drugs contraindicated (i.e., category X) in pregnancy, including 189 women (0.6%) who received these drugs during the first trimester. Several statin medications were among the most common contraindicated drug exposures. CONCLUSION: A large proportion of women who gave birth in RER in 2004 were exposed to prescription medications. Approximately 1 in 100 women were exposed to contraindicated drugs. The most commonly identified drug exposures can help focus pharmacoepidemiologic efforts in drug-induced birth defects.
Gagne JJ, Maio V, Rabinowitz C. Prevalence and predictors of potential drug-drug interactions in Regione Emilia-Romagna, Italy. J Clin Pharm Ther. 2008;33 (2) :141-51.Abstract
BACKGROUND AND OBJECTIVE: Drug-drug interactions (DDIs) are preventable medication errors associated with potentially serious adverse events and death. Several studies have examined the prevalence of potential DDIs among ambulatory patients in various countries. Limited recent data on the prevalence of potential DDIs in Italy are available in the medical literature. The objective of this study was to estimate the prevalence of clinically important potential DDIs among the approximately 4 million residents of Regione Emilia-Romagna (RER), Italy, and to examine possible predictors of potential DDI exposure. METHODS: A retrospective follow-up study of 2004 outpatient prescription data from RER was conducted. A previously published list of clinically important potential DDIs was refined to include only pairs of drugs in which both drugs were reimbursed by the 2004 Italian National Formulary. A potential DDI was defined as the presence of a minimum 5-day overlap in days supply for drugs in an interacting pair. The 1-year period prevalence of each potential DDI was quantified. A logistic regression analysis was conducted to examine patient characteristics as predictors of potential DDIs. RESULTS AND DISCUSSION: The list of clinically important potential DDIs included 12 drug pairs that could be captured using the RER database. These 12 potential DDIs occurred 8894 times in the RER population in 2004. The most commonly identified potentially interacting medication pairs were warfarin and non-steroidal anti-inflammatory drugs (6824 cases), theophylline/aminophylline and ciprofloxacin/fluvoxamine (930), and warfarin and barbiturates (567). Odds of exposure were highest among those aged 65 years or older, males, and those with more chronic conditions. Odds of exposure increased 1.39 times with each addition of a prescription medication. CONCLUSION: A substantial number of clinically important potential DDIs were identified, particularly among warfarin users. Awareness of the most prevalent potential DDIs can help practitioners prevent concomitant use of these dangerous medication combinations.
Gagne JJ, Goldfarb NI. Candidemia in the in-patient setting: treatment options and economics. Expert Opin Pharmacother. 2007;8 (11) :1643-50.Abstract
Candidemia is the most common nosocomial fungal infection in the US. More than one in four adults who acquire candidemia in the hospital setting die prior to discharge. In addition to high case-fatality rates and other adverse clinical outcomes in survivors, candidemia is associated with a substantial economic burden. High costs associated with complex diagnostics and procedures contribute to this burden, as do new pharmacotherapeutic approaches. Despite the high costs of many antifungal agents recommended for the treatment of candidemia, unambiguous clinical evidence to guide treatment selection does not exist. This article reviews the clinical and economic burdens of candidemia, describes candidemia cost drivers and discusses existing pharmacoeconomic data regarding the cost-effectiveness of candidemia rapid identification and treatment approaches.
Lofland JH, Gagne JJ, Pizzi LT, Rupnow M, Silberstein SD. Impact of topiramate migraine prophylaxis on workplace productivity: results from two US randomized, double-blind, placebo-controlled, multicenter trials. J Occup Environ Med. 2007;49 (3) :252-7.Abstract
OBJECTIVE: We conducted this study to determine whether topiramate at 100 mg/d for the treatment of migraine headache is associated with improved productivity in the workplace. METHODS: Results were derived from two randomized, double-blind, placebo-controlled trials among migraineurs. The number of hours of absenteeism (A), presenteeism (P), and total lost productivity (TLP) (A + P) were calculated. Results were not adjusted for multiplicity. RESULTS: A total of 325 (162 in the topiramate group and 163 in the placebo group) of 449 subjects were included. Per person mean monthly A rate was only significantly less for individuals within the topiramate group (1.0 hours per person) versus those in the placebo group (1.5 hours per person) for month 3 (P < 0.05). Per person mean P and TLP rates were significantly lower for individuals in the topiramate group versus those in the placebo group for months 1 through 5 (P < 0.05). CONCLUSIONS: Findings suggest that topiramate, compared with placebo, is associated with decreased workplace presenteeism and TLP.
Gagne JJ, Leas B, Lofland JH, Goldfarb N, Freitag F, Silberstein S. Quality of care measures for migraine: a comprehensive review. Dis Manag. 2007;10 (3) :138-46.Abstract
Migraine headache is a highly prevalent, chronic, episodic disorder that is associated with high direct and indirect costs. Migraine headache impacts not only patients, but also their employers due to substantial decreases in workplace productivity. Despite the prevalence and clinical and economic burdens of migraine, no national efforts to develop and implement standardized measures of quality of care have been made. The objective of this study was to collect and report on existing quality of care measures for migraine that could be suitable for quality measurement at the health-plan level. Published literature, the Agency for Healthcare Research and Quality's National Quality Measure Clearinghouse, and resources available from quality organizations (eg, the National Committee for Quality Assurance) were examined to identify existing quality indicators that can be used to assess the quality of care delivered to migraine sufferers at the health-plan level. Among the results of the study were the following: Quality of care measures for migraine include patient-reported measures and non-patient reported, diagnosis-related, prevention-related, and treatment-related indicators. Most existing measures have been developed by the Institute for Clinical Systems Improvement or summarized and reported by the RAND Corporation. Few of these measures can be used to assess migraine quality of care at the health-plan level. In conclusion, many measures exist, but they are not intended for use at the health-plan level. Incorporation of valid and reliable quality of care measures may increase the ability of migraine disease management programs to conform to clinical care guidelines. Significant effort is needed to determine what and how to measure quality among health plans to improve the quality of care delivered to individuals with migraine.