Michigan Pharmacists Transforming Care and Quality: Developing a Statewide Collaborative of Physician Organizations and Pharmacists to Improve Quality of Care and Reduce Costs.

BACKGROUND: Inappropriate drug use, increasing complexity of drug regimens, continued pressure to control costs, and focus on shared accountability for clinical measures drive the need to leverage the medication expertise of pharmacists in direct patient care. A statewide strategy based on the collaboration of pharmacists and physicians regarding patient care was developed to improve disease state management and medication-related outcomes. PROGRAM DESCRIPTION: Blue Cross Blue Shield of Michigan (BCBSM) partnered with Michigan Medicine to develop and implement a statewide provider-payer program called Michigan Pharmacists Transforming Care and Quality (MPTCQ), which integrates pharmacists within physician practices throughout the state of Michigan. As the MPTCQ Coordinating Center, Michigan Medicine established an infrastructure integrating clinical pharmacists into direct patient care within patient-centered medical home (PCMH) practices and provides direction and guidance for quality and process improvement across physician organizations (POs) and their affiliated physician practices. The primary goal of MPTCQ is to improve patient care and outcomes related to Medicare star ratings and HEDIS measures through integration of clinical pharmacists into direct patient care. The short-term goal is to adopt and modify Michigan Medicine's integrated pharmacist practice model at participating POs, with the long-term goal of developing a sustainable model of pharmacist integration at each PO to improve patient care and outcomes. Initially, pharmacists are delivering disease management (diabetes, hypertension, and hyperlipidemia) and comprehensive medication review services with future plans to expand clinical services. OBSERVATIONS: In 2015, 10 POs participated in year 1 of the program. In collaboration with the MPTCQ Coordinating Center, each PO identified 1 "pharmacist transformation champion" (PTC). The PTC implemented the integrated pharmacist model at 2 or 3 practice sites with at least 2 practicing physicians per site. IMPLICATIONS: MPTCQ is a unique collaboration between a large academic institution, physician organizations, a payer, and a statewide coordinating center to improve patient care and address medication-related challenges by integrating pharmacists into a PCMH network. Pharmacists can actively provide their medication expertise to physicians and patients and optimize quality measure performance. DISCLOSURES: This project was funded by Blue Cross Blue Shield of Michigan. Choe and Spahlinger are employees of Michigan Medicine. Tungol Lin, Kobernik, Cohen, Qureshi, Leyden, and Darland are employees of Blue Cross Blue Shield of Michigan. At the time of manuscript preparation, Share and Wesolowicz were employees of Blue Cross Blue Shield of Michigan. Study concept and design were primarily contributed by Choe, along with the other authors. Choe, Tungol Lin, and Kobernik collected data, and data interpretation was performed by Choe, Tungol Lin, Cohen, and Wesolowicz. The manuscript was written primarily by Choe, along with Tungol Lin and assisted by Kobernik, Cohen, Leyden, and Qureshi. The manuscript was revised by Leyden, Spahlinger, Share, and Darland. Material from this manuscript was previously presented as an education session at the 2016 AMCP Managed Care & Specialty Pharmacy Annual Meeting; April 19-22, 2016; San Francisco, California.

Effectiveness of a Retrospective Drug Utilization Review on Potentially Unsafe Opioid and Central Nervous System Combination Therapy.

BACKGROUND: Drug overdose deaths are the leading cause of unintentional death in the United States, and opioid-related mortality is the primary contributor (75.2%). Among opioid-related mortalities, opioids are most commonly taken with benzodiazepines (30.1%) and antidepressants (13.4%). The utility of a retrospective drug utilization review (DUR) program initiated by a commercial health plan for members taking potentially unsafe opioid and central nervous system (CNS) combination therapy is currently unknown. OBJECTIVE: To determine the effectiveness of a retrospective DUR program on potentially unsafe opioid and CNS combination therapy. METHODS: This research is a pre-post study utilizing pharmacy claims data from 2.6 million commercially insured members enrolled in a health plan in the Midwest. Members were required to be at least aged 18 years as of August 30, 2013, and continuously enrolled from May 2, 2013, through February 15, 2014. Members with 1 or more paid claims for an opioid at least 200 morphine equivalent dose (MED) daily and a concur- rent supply of another opioid, benzodiazepine, or antidepressant from May 2, 2013, through August 30, 2013 (120-day preintervention period) were targeted for the retrospective DUR program. These exclusion criteria were applied: members belonging to commercial groups requiring permission on claims data analyses, missing or invalid prescriber information, or presence of pharmacy claims indicating human immunodeficiency virus or acquired immunodeficiency syndrome during the 2 years prior to the pre-intervention period. Prescribers of high-dose opioids received a mailing (intervention) containing a member-specific letter, medication profile, and satisfaction survey to determine the prescriber-perceived clinical value of the program. To assess the effectiveness of the retrospective DUR program, criteria was reapplied to identify members still meeting criteria 120 days postintervention (February 15, 2014). Paired samples t-test was used to compare pre-post results. RESULTS: Of 2,236,243 eligible members aged 18 years and older, 980 met DUR criteria. Prescribers for these members subsequently received a mailing regarding potentially unsafe opioid and CNS combination therapy. A total of 671 prescribers were sent a mailing regarding these 980 members. Among the 980 members meeting DUR criteria, distribution of prescriber specialty was family medicine (25.9%), physical medicine and rehabilitation (14.4%), internal medicine (13.0%), pain (9.2%), anesthesiology (7.0%), other (8.8%), and unknown (21.7%). High-dose opioids most commonly identified by the DUR were oxycodone extended release (27.6%), morphine sulfate extended release (17.7%), and fentanyl patch (13.1%). After reapplying DUR criteria to identify members still meeting criteria 120 days after the DUR, 528 members remained, representing a 28.1% reduction in high-risk opioid use. Survey response rate was 23.6% (231 of 980 surveys returned). The majority (62.3%) of respondents reported that this retrospective DUR program was useful in their daily practice. CONCLUSIONS: A 28.1% reduction in potentially unsafe opioid and CNS combination therapy was observed after implementing a retrospective DUR program targeting high-risk opioid use. Among members remaining high risk after the DUR, the change in total unique opioids and total daily MED was nonsignificant. Members remaining at high risk after the DUR can be targeted for further interventions such as care management and member education regarding fraud, waste, and abuse. A majority of prescribers (90.5%) self-report using their states' prescription monitoring programs when prescribing controlled substances.

Sterile compounding: clinical, legal, and regulatory implications for patient safety.

BACKGROUND: Poor compounding practices by the New England Compounding Center resulted in the 2012-2013 fungal infections outbreak. Contaminated injectable methylprednisolone led to the diagnosis of fungal infections in 751 patients and 64 deaths. In the United States, pharmacy compounding has traditionally been regulated by state boards of pharmacy rather than the FDA. To minimize safety risks related to pharmacy compounding, the Drug Quality and Security Act (DQSA) was signed into law November 27, 2013, to improve regulation of compounding pharmacies. OBJECTIVES: To (a) review the literature regarding clinical, legal, and regulatory implications of pharmacy compounding for patient safety during the 2012-2013 fungal infections outbreak and (b) discuss strategies that managed care organizations (MCOs) can use to promote safe compounding practices.  METHODS: A literature search was conducted via PubMed for original articles on fungal infections related to drug compounding published October 2012 to March 2014. Specific search terms included "drug compounding and fungal infection" and "fungal meningitis outbreak." The FDA website was also utilized for material related to the Food, Drug, and Cosmetic Act and the DQSA.  RESULTS: Four articles met inclusion criteria. The 2012-2013 fungal infections outbreak was attributed to 3 lots of preservative-free methylprednisolone acetate, which comprised 17,675 vials distributed to 76 facilities across 23 states. Median incubation period (from time of last injection to initial diagnosis) was 47 days, ranging from 0 to 249 days. According to the FDA, a total of 30 recalls regarding compounded products were issued by pharmacies during March through December 2013. CONCLUSIONS: Pharmacy compounding has the potential for significant safety risks. The purpose of the DQSA is to improve regulation of compounding pharmacies. Since registration as an outsourcing facility is voluntary, uncertainty still remains regarding advancement in safe compounding practices. MCOs can employ multiple strategies to ensure patient safety and promote appropriate drug therapy.

Formulary management of 2 new agents: lorcaserin and phentermine/topiramate for weight loss.

BACKGROUND: Obesity may lead to the development of multiple chronic disease states, including hypertension, dyslipidemia, and type 2 diabetes mellitus. Over a half billion adults worldwide are affected by obesity, and more than two-thirds of adults are either obese or overweight in the United States. Diet and exercise have been the mainstays of treatment in this population; however, once failed, noninvasive, long-term effective treatment modality is lacking, and medications may potentially fill the void. Lorcaserin and phentermine/topiramate were approved by the FDA in June 2012 and July 2012, respectively, as adjuncts to diet and exercise for chronic weight management of obese (body mass index [BMI] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) individuals with comorbidities. OBJECTIVE: To review the phase 3 trials of lorcaserin and phentermine/topiramate and provide managed care considerations that may be taken into account as a result. METHODS: A MEDLINE review was performed for articles published and available through September 17, 2012, using keywords "lorcaserin" or "phentermine/topiramate" with an emphasis on phase 3 trials. The literature search was limited to randomized controlled trials in humans published in the English language. Additional information on lorcaserin from its FDA review was obtained from the FDA website. RESULTS: 5 pivotal phase 3 trials were identified: 3 for lorcaserin and 2 for phentermine/topiramate. Both agents demonstrated a statistically significant higher proportion of individuals who lost ≥ 5% of body weight, as well as higher mean weight loss when compared with placebo. Safety concerns for lorcaserin include cardiac valvulopathy and increased risk of psychiatric, cognitive, and serotonergic adverse effects. Teratogenicity and increased heart rate are major safety concerns regarding phentermine/topiramate. CONCLUSIONS: Health care decision makers have many factors to consider when developing strategies to fight obesity. Despite a great need for new therapies to treat obesity, medications used for weight loss have significant side-effect profiles and contraindications that may limit therapy. An appropriate utilization management strategy is needed.