Preparing for the market entry of adalimumab biosimilars in the US in 2023: A primer for specialty pharmacists.

PURPOSE: The impact of the market entry of adalimumab biosimilars on clinical practices and specialty pharmacies is explained. A roadmap is also provided for how pharmacists can successfully navigate this landscape. SUMMARY: Biosimilars have previously been introduced as a mechanism to help curb biologic expenditures, with biosimilars undergoing an abbreviated regulatory approval process that focuses on biosimilarity and generating product competition. Adalimumab is currently the leading product in the biologics market, generating approximately $20 to $30 billion in sales worldwide consecutively from 2019 to 2021. Many adalimumab biosimilars are slated to enter the market in 2023 and become available for patient use. However, compared to other biosimilars, adalimumab biosimilars have several unique considerations, such as interchangeability and concentration, that will impact pharmacy practices and workflows. Because pharmacists embedded in clinical practices and specialty pharmacies will be significantly involved in the processes relating to adalimumab biosimilar implementation, adoption, and use, a primer on understanding the various adalimumab biosimilar products available and considerations surrounding these products with regard to workflow and patient use is critical. Several resources are also provided to help pharmacists successfully navigate the adalimumab biosimilar landscape. CONCLUSION: The biosimilar landscape continues to evolve, and 2023 will see the launch of several adalimumab biosimilar products, which vary with regard to formulation, concentration, and interchangeability status. Pharmacists are well positioned to educate providers and patients about this landscape and help implement an efficient workflow to support adalimumab biosimilar adoption and use.

A safe in-home disposal system with every opioid prescription? Food and Drug Administration is considering a potential new Risk Evaluation and Mitigation Strategy that could impact pharmacists.

Misuse of prescription opioids contributes to the ongoing crisis of opioid-related overdose and deaths in the United States. The failure of patients and caregivers to safely dispose of unused opioids contributes to the problems. In 2018, Public Law 115-271 provided U.S. Food and Drug Administration (FDA) authority to mandate a Risk Evaluation and Mitigation Strategy (REMS) for safe disposal packaging or safe disposal solutions for opioid analgesic medications. FDA has been collaborating with stakeholders to determine whether a new REMS is needed. A new or revised opioid REMS could substantially affect opioid packaging, pharmacist roles and services, and dispensing activities such as education, counseling, and product distribution. The pharmacy profession has provided limited input to FDA regarding a potential new or revised opioid REMS. In this commentary, we aim to (1) provide awareness and raise questions on pertinent issues regarding opioid use and safe home disposal, (2) offer considerations for regulators on needed research in the development and assessment of a new REMS, and (3) highlight actions for pharmacist engagement in patient care services to promote safe use and safe home disposal of opioids. Consideration of a potential mandate regarding enhanced safety packaging or safe disposal solutions for opioids presents opportunities to revisit professional roles and engage proactively with FDA and other stakeholders. We hope this commentary stimulates timely feedback by pharmacy leaders, researchers, and practitioners on whether and how options for safe home disposal of opioids should be included in a REMS in contemplation of potential benefits, unintended consequences, expanded professional roles, timeline, assessment of program effectiveness, and adequate compensation. We support a shared opioid REMS that funds the counseling of patients and caregivers on safe opioid use and safe home opioid disposal options and provides appropriate education and products to facilitate that disposal.

A pharmacist-managed virtual consult service for patients with rheumatologic conditions requiring specialty or infused medications.

PURPOSE: To describe a pharmacist-managed virtual consult service practice model for rheumatology patients and evaluate its initial impact on compliance with institutional critical care guidelines for biologic response modifiers (BRMs). SUMMARY: Pharmacologic care of patients with rheumatologic conditions often revolves around the use of BRMs. While these drugs are generally well tolerated, nearly all of them carry risks for serious adverse events. The severity of these possible problems necessitates a thorough initial and ongoing clinical workup. Based on results of a needs assessment, a virtual consult service was introduced at the University of Illinois Hospital and Health Sciences System (UI Health) in August 2018 to integrate clinical, specialty pharmacy, and therapeutic infusion services for proactive medication and safety management of patients with rheumatologic conditions requiring treatment with BRMs. The consult service was managed by an embedded clinical pharmacist and a postgraduate year 1 specialty pharmacy resident, who evaluated each request for therapy appropriateness prior to submission for insurance approval. CONCLUSION: Forty-one percent of the pharmacy benefit consult orders required a pharmacist intervention prior to referral to the specialty pharmacy. All consults (100%) adhered to the safety management guidelines for BRMs after review by the pharmacist. The pharmacist-managed virtual consult service is a novel practice model in specialty pharmacy that permits pharmacists to manage multiple patients simultaneously, virtually, and with optimal impact on medication selection and management at or before the point of prescribing.

ASHP National Survey of Health-System Specialty Pharmacy Practice-2020.

PURPOSE: Results of the first ASHP National Survey of Health-System Specialty Pharmacy Practice are presented. METHODS: A sample of 230 leaders in health-system specialty pharmacies were contacted by email and invited to participate in a survey hosted using an online survey application. The survey sample was compiled from ASHP member lists, through review of data from other ASHP surveys indicating the presence of specialty pharmacies, and by outreach to ASHP member organizational leaders. RESULTS: The response rate was 53.0%. Most health-system specialty pharmacies dispense 30,000 or fewer specialty prescriptions per year, have an annual revenue of $100 million or less, are part of an entity eligible to participate in the 340B Drug Pricing Program, operate 1 specialty pharmacy location, have at least 1 specialty pharmacy accreditation, dispense nonspecialty medications in addition to specialty medications, and employ an average of 13 pharmacists and 15 technicians. More than two-thirds of health-system specialty pharmacies (68.8%) dispense no more than half of the prescriptions written by their providers due to payer network restrictions or limited distribution drugs. The health-system specialty pharmacy practice model includes access to the electronic health record (100% of respondents), pharmacists and technicians dedicated to specific clinics (64.9% and 57.7%, respectively), specialty pharmacist involvement in treatment decisions and drug therapy selection prior to the prescription being written (64.9%), and documenting recommendations and progress notes in patients' electronic health record (93.4%). Most health-system specialty pharmacies (83.3%) offer experiential or formal education in specialty pharmacy. Top challenges that survey respondents expected to face in the next year included restricted access to payer networks and limited distribution drugs, 340B Drug Pricing Program changes, and shrinking reimbursement from payers. CONCLUSION: The health-system specialty pharmacy represents an integrated advanced practice model that incorporates specialty medication-use management across the continuum of care.

A comparison of medication access services at 340B and non-340B hospitals.

BACKGROUND: For patients that face barriers to filling their prescriptions, the availability of medication access services at their site of care can mean the difference between receiving prescribed drug therapy, and undue interruptions in care. Hospitals often provide medication access services that are not reimbursed by payers; however, they can be challenging to sustain. The 340B Drug Pricing Program allows covered entities to generate savings through discounted pricing for certain outpatient medications, which can then be used to provide more comprehensive services, including medication access services. OBJECTIVE: To characterize medication access services provided at hospitals that participate in the 340B Drug Pricing Program compared to hospitals that do not participate in the 340B Program. METHODS: Primary questionnaire response data was collected from a national sample of Directors of Pharmacy at non-federal acute care hospitals from March 2019 to May 2019. American Hospital Association Data Viewer was used to collect demographic information on 1,531 hospitals. Hospitals were excluded if they had 199 beds or fewer, did not have a unique Medicare provider ID, were federally owned, were located outside the continental U.S., or were non-acute care hospitals that served niche patient populations. This study utilized a proportional stratified sampling strategy to administer an electronic questionnaire to 340B and non-340B hospitals to assess the number and type of medication access service offerings. A final randomized sample of 500 hospitals were administered the questionnaire, and data was collected through recorded responses in Qualtrics software. RESULTS: 340B hospitals provided a significantly higher average number of medication access services compared to non-340B hospitals (6.20 vs. 3.91, p = 0.0001), adjusted for differences in hospital size and ownership type. For all nine medication access services that were assessed, a higher percentage of 340B hospitals reported providing the service compared to non-340B hospitals. This difference was statistically significant for six out of nine programs assessed. CONCLUSIONS: 340B hospitals provided more medication access services, on average, than comparably sized non-340B hospitals, suggesting that hospitals participating in the 340B Drug Pricing Program may be better positioned to create and administer programs that support medication access services.

National trends in prescription drug expenditures and projections for 2020.

PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2020 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2020 were reviewed, including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for specialty drugs, biosimilars, and diabetes medications. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2020 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2019, overall US pharmaceutical expenditures grew 5.4% compared to 2018, for a total of $507.9 billion. This increase was driven to similar degrees by prices, utilization, and new drugs. Adalimumab was the top drug in US expenditures in 2019, followed by apixaban and insulin glargine. Drug expenditures were $36.9 billion (a 1.5% increase from 2018) and $90.3 billion (an 11.8% increase from 2018) in nonfederal hospitals and clinics, respectively. In clinics, growth was driven by new products and increased utilization, whereas in hospitals growth was driven by new products and price increases. Several new drugs that will likely influence spending are expected to be approved in 2020. Specialty and cancer drugs will continue to drive expenditures. CONCLUSION: For 2020 we expect overall prescription drug spending to rise by 4.0% to 6.0%, whereas in clinics and hospitals we anticipate increases of 9.0% to 11.0% and 2.0% to 4.0%, respectively, compared to 2019. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.

National trends in prescription drug expenditures and projections for 2019.

PURPOSE: Historical trends and factors likely to influence future pharmaceutical expenditures are discussed, and projections are made for drug spending in 2019 in nonfederal hospitals, clinics, and overall (all sectors). METHODS: Drug expenditure data through calendar year 2018 were obtained from the IQVIA National Sales Perspectives database and analyzed. New drug approvals, patent expirations, and other factors that may influence drug spending in hospitals and clinics in 2019 were also reviewed. Expenditure projections for 2019 for nonfederal hospitals, clinics, and overall (all sectors) were made through a combination of quantitative analyses and expert opinion. RESULTS: U.S. prescription sales in calendar year 2018 totaled $476.2 billion, a 5.5% increase from 2017 spending. The top 3 drugs by expenditures were adalimumab ($19.1 billion), insulin glargine ($9.3 billion), and etanercept ($8.0 billion). Prescription expenditures in nonfederal hospitals totaled $35.8 billion, a 4.8% increase from 2017. Expenditures in clinics in 2018 increased by 13.0% to $80.5 billion. The increase in spending in nonfederal hospitals was largely driven by new products and increased utilization of existing products. The list of the top 25 drugs by expenditures in nonfederal hospitals and clinics was dominated by specialty drugs. CONCLUSION: We predict continued moderate growth of 4-6% in overall drug expenditures (across the entire U.S. market). We expect the clinic sector to continue to experience high (11-13%) growth in drug spending in 2019. Finally, for nonfederal hospitals we anticipate growth in the range of 3-5%. These estimates are at the national level. Health-system pharmacy leaders should carefully examine local drug utilization patterns to determine their own organization's anticipated spending in 2019.

National trends in prescription drug expenditures and projections for 2018.

PURPOSE: Historical trends and factors likely to influence future pharmaceutical expenditures are discussed, and projections are made for drug spending in 2018 in nonfederal hospitals, clinics, and overall (all sectors). METHODS: Drug expenditure data through calendar year 2017 were obtained from the IQVIA (formerly QuintilesIMS) National Sales Perspectives database and analyzed. New drug approvals, patent expirations, and other factors that may influence drug spending in hospitals and clinics in 2018 were also reviewed. Expenditure projections for 2018 for nonfederal hospitals, clinics, and overall (all sectors) were made based on a combination of quantitative analyses and expert opinion. RESULTS: Total U.S. prescription sales in the 2017 calendar year were $455.9 billion, a 1.7% increase compared with 2016. The top drug based on expenditures was adalimumab ($17.1 billion), followed by insulin glargine and etanercept. Prescription expenditures in nonfederal hospitals totaled $34.2 billion, a 0.7% decrease in 2017 compared with 2016. Expenditures in clinics increased 10.9%, to a total of $70.8 billion. The decrease in spending in nonfederal hospitals was driven by lower utilization. The top 25 drugs by expenditures in nonfederal hospitals and clinics were dominated by specialty drugs. CONCLUSION: We project a 3.0-5.0% increase in total drug expenditures across all settings, a 11.0-13.0% increase in clinics, and a 0.0-2.0% increase in hospital drug spending in 2018. Health-system pharmacy leaders should carefully examine their own local drug utilization patterns to determine their own organization's anticipated spending in 2018.

Implementation of a New Clinic-Based, Pharmacist-Managed PCSK9 Inhibitor Consultation Service.

BACKGROUND: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors alirocumab and evolocumab were approved by the FDA in 2015. In anticipation of provider interest and a potential increase in referrals to the on-site specialty pharmacy, we created a pharmacist-managed consultation service. PROGRAM DESCRIPTION: The development of a clinic-based pharmacist-managed consultation service for the management of the PCSK9 inhibitor agents alirocumab and evolocumab is described. Key implementation steps included (a) creation of a pharmacy team and collaboration with cardiology; (b) completion of a needs assessment; (c) service creation; (d) collaboration with the on-site specialty pharmacy; (e) development of an electronic consult order and consult pool; (f) personnel training; and (g) service approval and marketing. The service development occurred over 9 months (July 2015-April 2016) and was implemented hospital-wide in May 2016. OBSERVATIONS: The University of Illinois Hospital and Health Sciences System PCSK9 inhibitor consultation service successfully integrated the benefits of a clinical review process, information technology capabilities of an electronic medical record system, and collaboration with the on-site specialty pharmacy to provide a comprehensive service that aimed to facilitate appropriate medication management from prescribing to patient administration and provide monitoring for this class of specialty medications. IMPLICATIONS/RECOMMENDATIONS: The PCSK9 pharmacist-managed consultation service provides a method for complex therapies to be managed comprehensively through the collaboration of ambulatory care clinics and outpatient specialty pharmacies. DISCLOSURES: No outside funding supported this study. Groo reports speaker bureau fees from Pfizer and Bristol-Myers Squibb. The other authors have nothing to disclose. All the authors contributed to study concept and design. Atande took the lead in data collection, and data interpretation was performed by Groo and Atanda. The manuscript was written by Atanda and revised by all the authors.

National trends in prescription drug expenditures and projections for 2017.

PURPOSE: Historical trends and factors likely to influence future pharmaceutical expenditures are discussed, and projections are made for drug spending in 2017 in nonfederal hospitals, clinics, and overall (all sectors). METHODS: Drug expenditure data through calendar year 2016 were obtained from the QuintilesIMS National Sales Perspectives database and analyzed. Other factors that may influence drug spending in hospitals and clinics in 2017, including new drug approvals and patent expirations, were also reviewed. Expenditure projections for 2017 for nonfederal hospitals, clinics, and overall (all sectors) were made based on a combination of quantitative analyses and expert opinion. RESULTS: Total U.S. prescription sales in the 2016 calendar year were $448.2 billion, a 5.8% increase compared with 2015. More than half of the increase resulted from price hikes of existing drugs. Adalimumab was the top drug overall in 2016 expenditures ($13.6 billion); in clinics and nonfederal hospitals, infliximab was the top drug. Prescription expenditures in clinics and nonfederal hospitals totaled $63.7 billion (an 11.9% increase from 2015) and $34.5 billion (a 3.3% increase from 2015), respectively. In nonfederal hospitals and clinics, growth in spending was driven primarily by price increases of existing drugs and increased volume, respectively. CONCLUSION: We project a 6.0-8.0% increase in total drug expenditures across all settings, an 11.0-13.0% increase in clinics, and a 3.0-5.0% increase in hospital drug spending in 2017. Health-system pharmacy leaders should carefully examine their own local drug utilization patterns to determine their own organization's anticipated spending in 2017.

National trends in prescription drug expenditures and projections for 2016.

PURPOSE: Historical trends and factors likely to influence future pharmaceutical expenditures are discussed, and projections are made for drug spending in 2016 in nonfederal hospitals, clinics, and overall (all sectors). METHODS: Drug expenditure data through calendar year 2015 were obtained from the IMS Health National Sales Perspectives database and analyzed. Other factors that may influence drug spending in hospitals and clinics in 2016, including new drug approvals and patent expirations, were also reviewed. Expenditure projections for 2016 were based on a combination of quantitative analyses and expert opinion. RESULTS: Total U.S. prescription sales in the 2015 calendar year were $419.4 billion, which was 11.7% higher than sales in 2014. Prescription expenditures in clinics and nonfederal hospitals totaled $56.7 billion (a 15.9% increase) and $33.6 billion (a 10.7% increase), respectively, in 2015. In nonfederal hospitals, growth in spending was driven primarily by increased prices for existing drugs. The hepatitis C combination drug ledipasvir-sofosbuvir was the top drug overall in terms of 2015 expenditures ($14.3 billion); in both clinics and nonfederal hospitals, infliximab was the top drug. Individual drugs with the greatest increases in expenditures in 2015 were specialty agents and older generics; these agents are likely to continue to influence total spending in 2016. CONCLUSION: We project an 11-13% increase in total drug expenditures overall in 2016, with a 15-17% increase in clinic spending and a 10-12% increase in hospital spending. Health-system pharmacy leaders should carefully examine local drug utilization patterns in projecting their own organization's drug spending in 2016.

National trends in prescription drug expenditures and projections for 2015.

PURPOSE: An analysis of trends in U.S. pharmaceutical spending is presented, including projections for drug expenditures in nonfederal hospital and clinic settings in 2015. METHODS: Prescription drug expenditure data through September 2014 were obtained from the IMS Health National Sales Perspectives database and were analyzed descriptively. Other factors that may influence prescription spending in hospitals and clinics in 2015, including new drug approvals and patent expirations, were analyzed. Expenditure projections were based on a combination of quantitative and qualitative analyses and expert opinion. RESULTS: Total prescription sales for the 12 months ending September 30, 2014, were $360.7 billion, 12.2% higher than during the previous 12 months. With $6.6 billion in expenditures in the first 9 months of 2014, sofosbuvir topped the overall list of drugs based on sales, followed by aripiprazole and insulin glargine. Pharmaceutical spending by clinics and nonfederal hospitals rose by 13.3% and 4.0%, respectively. For the first 9 months of 2014, the top drugs based on expenditures were infliximab, pegfilgrastim, and epoetin alfa in clinics and infliximab, rituximab, and pegfilgrastim in hospitals. Specialty drugs continued to constitute an increasing portion of drug expenditures and will contribute to higher expenditures in 2015. CONCLUSION: Growth in U.S. prescription drug expenditures is expected to continue to increase in 2015. The projected increases in total drug expenditures are 7-9% across all settings, 12-14% in clinics, and 5-7% in hospitals. Health-system pharmacy leaders should carefully examine their own local drug utilization patterns to determine their own organization's anticipated spending in 2015.

Integrated clinical and specialty pharmacy practice model for management of patients with multiple sclerosis.

PURPOSE: An integrated clinical and specialty pharmacy practice model for the management of patients with multiple sclerosis (MS) is described. SUMMARY: Specialty medications, such as disease-modifying therapies (DMTs) used to treat MS, are costly and typically require special administration, handling, and storage. DMTs are associated with high rates of nonadherence and may have associated safety risks. The University of Illinois Hospital and Health Sciences System developed an MS pharmacy practice model that sought to address the many challenges of coordinating care with multiple entities outside the health system. Several key features of the integrated model include a dedicated clinical pharmacist on the MS specialty team, an integrated specialty pharmacy service, direct access to the electronic medical record, and face-to-face interaction with patients. Through the active involvement of the neurology clinical pharmacist and an onsite specialty pharmacy service, targeted assessments and medication and disease education are provided to the patient before DMT initiation and maintained throughout therapy. In addition, the regular point of contact and refill coordination encourages improved compliance, appropriate medication use, ongoing safety monitoring, and improved communication with the provider for quicker interventions. This fosters increased accessibility, convenience, and patient confidence. Improving patient outcomes--the priority goal of this service model--will be assessed in future planned studies. Through this new practice model, providers are empowered to incorporate specialty medication management into transitions in care, admission and discharge quality indicators, readmissions, and other core measures. CONCLUSION: An integrated pharmacy practice model that includes an interdisciplinary team of physicians, nurses, and pharmacists improved patient compliance with MS therapies.

Medicare Part D research highlights and policy updates, 2013: impact and insights.

BACKGROUND: Since its implementation in 2006, Medicare Part D has evolved from a program that offered basic access to covered drugs for beneficiaries to one that has the potential to affect patient outcomes. OBJECTIVES: The purpose of this article was to highlight key research findings on Medicare Part D published in 2012 and major public policy initiatives for Part D for 2013. METHODS: PubMed/MEDLINE was searched for research studies on Part D published in 2012 in biomedical/scientific, peer-reviewed, English-language journals. For policy updates, sources included the Federal Register, the 2013 Final Call Letter, guidance from the Centers for Medicare and Medicaid Services, and 2012 publications on Part D policy identified in PubMed. RESULTS: Part D has been associated with higher medication use and lower out-of-pocket (OOP) costs of many long-term medications; however, differences within subgroups of beneficiaries have been observed. Studies on health outcomes have been inconclusive. Part D policy changes in 2013 have addressed problems with the benefit, namely coverage of benzodiazepines and barbiturates; reducing coinsurance in the coverage gap; reducing fraud, waste, and abuse; medication therapy management program standardization; and an expanded appeals process. CONCLUSIONS: Research continues to suggest that Part D is effective in increasing medication utilization and lowering OOP costs. Further work is needed to clarify the effects of Part D on nondrug health care service utilization and health outcomes. Policy changes for 2013 addressed specific improvements in the Medicare Part D benefit while potentially generating cost-savings for Medicare and Medicaid. Future challenges include alleviating access burden to medications during the phase-out of the coverage gap, minimizing disparities among Part D beneficiaries, and coordinating the Part D benefit with Medicare parts A and B via Medicare Accountable Care Organizations. A more integrated and coordinated Medicare benefit among all of its components would benefit overall health outcomes and increase cost-savings.

Improvement in safety monitoring of biologic response modifiers after the implementation of clinical care guidelines by a specialty.

BACKGROUND: Tumor necrosis factor (TNF)-alpha inhibitors and other biologic response modifiers (BRMs) are frequently used to treat a variety of inflammatory diseases. Use of these agents may increase risk of serious infections, malignancies, and other complications such as worsening symptoms of heart failure or demyelinating disease. Because of these risks, a baseline assessment and routine monitoring have been recommended, but standardized guidelines for monitoring have yet to be established. OBJECTIVE: To measure the compliance with the recommended safety monitoring in the Clinical Care Guidelines for BRMs at the University of Illinois Hospitals and Health Sciences System (UI Health). METHODS: The Clinical Care Guidelines for BRMs was developed by a committee of pharmacists, nurses, and physicians based on an assessment of published literature and medication labeling. The guidelines included recommendations for safety monitoring prior to BRM therapy, such as the tuberculosis (TB) test, Hepatitis B surface Antigen (HBsAg) test, liver function test (LFT), complete blood count (CBC), up-to-date vaccinations, risk assessment for cancer, pregnancy testing, monitoring for contraindications with concomitant medications, concomitant disease state risk assessment, and patient education. The guidelines were introduced to UI Health in February 2012 by a systemwide email and by in-services given by the health system's Specialty Pharmacy Service. In-services were given in the clinics known to generate large numbers of BRM orders (e.g., gastroenterology and rheumatology) and at the outpatient center for infused therapies. The purpose of the in-services was to introduce providers to the guidelines and encourage their compliance. To ensure that guideline requirements were met when BRMs were ordered, a process was established to identify BRM orders, assess the orders for compliance with 4 of the safety monitoring tests from the guidelines (TB, HBsAg, LFT, and CBC), and make interventions. When necessary, Specialty Pharmacy Services coordinated with the pharmacists and other providers in the clinic to order lab tests and ensure they were completed prior to the start of therapy. Feedback was provided during the study to proactively improve compliance with the guidelines. After completion of the study, a report containing outpatient prescription orders for BRMs (abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, and tocilizumab) from August 2011 through July 2012 was generated from the electronic medical record. Retrospective analyses of completion of safety monitoring were conducted for patients administered BRM treatment. Completion rates were compared before and after implementation of guidelines in February 2012. Completion was considered to have occurred when all 4 safety monitoring tests had been conducted -TB (unless known to be positive from a previous test), HBsAg, LFT, and CBC. Completion data from August 2011 through January 2012 were before the guidelines were implemented, and data from February 2012 through July 2012 were after the guidelines. Chi square analyses were performed on completion frequencies in the patients before and after the guidelines were implemented. RESULTS: Of the 320 unique patient BRM orders evaluated in this study, 195 (61%) were generated in the Rheumatology clinic, 99 (31%) in the Gastroenterology clinic, 21 (6.5%) in the Dermatology clinic, and 5 (1.5%) in the Transplant clinic. Before the guidelines were implemented, 54 ( 31%) of 173 patient orders complied with the safety monitoring by having all 4 clinical tests performed at the appropriate time points. After guideline implementation, 88 (60%) of 147 patient orders were compliant and had all 4 clinical tests conducted, which represents a statistically significant improvement in the rate of compliance (Pearson chi square = 26.43, degrees of freedom (df) = 1, P less than 0.0001). This significant improvement in compliance rates after guideline implementation was observed in both the new patient group and the patients with continuing prescription orders/treatment changes. There was also an improvement in patients whose prescriptions were dispensed by UI Health and to a lesser degree those whose prescriptions were dispensed by an outside pharmacy. When the new patient group was analyzed separately (n = 92), 50 patients were treated before the guidelines were implemented, and 42 patients were treated after the guidelines were implemented. Compliance rates with safety monitoring in these 2 groups were 52% pre-implementation and 83% post-implementation, which represented a statistically significant improvement in compliance (Pearson chi square = 10.03, df=1, P = 0.0015). Similar results were observed in the second patient subgroup with continuing prescription orders/treatment change (n = 228). A total of 123 patients were treated before the guidelines were implemented, and 105 were treated after the guidelines were implemented. Compliance rates were 23% pre-implementation compared with 50% post-implementation, which represented a statistically significant improvement in compliance (Pearson chi square = 18.99, df = 1, P less than 0.0001). CONCLUSION: Given the widespread and long-term use of BRMs, safety monitoring and management should be an important part of a comprehensive medication management program for their use. A coordinated effort may have a significant impact on compliance with safety monitoring guidelines.

Medicare part D research and policy highlights, 2012: impact and insights.

BACKGROUND: In the 6 years since the implementation of Medicare Part D in the United States, the program has been reported to improve quality, offer better beneficiary protections, and lower drug costs. OBJECTIVE: The purpose of this article was to highlight the latest key peer-reviewed research findings on Medicare Part D and major public policy initiatives for Part D for 2012. METHODS: PubMed was searched for studies on Medicare Part D published in 2011 in biomedical/scientific, peer-reviewed, English-language journals. For the policy update, sources included the Federal Register, the Medicare Prescription Drug Benefit Manual, the 2012 Final Call Letter, and guidance from the Centers for Medicare and Medicaid Services. RESULTS: Medicare Part D has been associated with increased medication utilization, reduced out-of-pocket expenditures, and an overall decrease in cost-related non-adherence and nonpersistence. Its impact on reduction in non-drug utilization of health services has been more apparent after the transition year in 2006 and among subsets of Medicare beneficiaries. Recent policy changes promise to make Part D more user-friendly, simplify choice, and offer greater protection to beneficiaries. The coverage gap will phase out by 2020. Both the quality rating system for prescription drug plans and medication therapy management programs were enhanced. CONCLUSIONS: Although Part D was designed to improve drug benefits, improvements may be needed in plan selection and simplification, quality assessment (especially with regard to long-term impact and health outcomes), evidence-based improvements in medication therapy management, and disparities among priority subpopulations. Medicare Parts A, B, and D could be coordinated to offset costs by increasing medication expenses and decreasing expenses for nonprescription medical services, thereby improving the overall cost-effectiveness of the Medicare program.

Medicare Part D and quality of prescription medication use in older adults.

In 2006, the US Centers for Medicare and Medicaid Services implemented Medicare Part D to provide outpatient prescription drug insurance to disabled and older adults. In creating Part D, a key provision to address quality included medication therapy management (MTM) programmes designed to increase proper and safe use of medications among targeted Part D beneficiaries. A preponderance of evidence shows that Part D has increased medication affordability and accessibility; however, what remains less clear is whether it has improved the quality of medication use and optimized health outcomes. Now in its sixth year, Part D is undergoing its first major revision, with the gradual elimination of the coverage gap by 2020. Therefore, now is a good time to review the accumulated evidence on the impact of Part D and MTM programmes on the quality of medication use to help inform future policy decisions and research directions. In this review, we found that Part D's net effect on quality of medication use has mainly been positive. Cost-related medication nonadherence improved moderately and there were fewer than expected treatment interruptions. However, vulnerable subgroups, such as sicker and dual-eligible beneficiaries, experienced lags in improvement. Beneficiaries who entered the coverage gap consistently experienced interruptions and displayed worsening medication adherence after entering the gap, with generic-only gap drug coverage offering limited benefit. Such findings can serve as baseline information as the coverage gap phases out. Limited availability of data is the greatest barrier to research into Part D. Part D's overall effect on health outcomes and adverse medical events, such as hospitalizations, is inconclusive because of inadequate evidence to date. Similarly, no evaluation of quality of medication use is available with respect to utilization management strategies and MTM programmes delivered under Part D. Future research will need to further examine the added value of Part D and address whether Part D optimizes health outcomes in the Medicare population. As the current economic recession increases the pressure to cut costs, the effect of future spending restrictions, such as restrictions on coverage subsidies, will also be of special concern.