Health-system Specialty Pharmacy Research Articles

Quality improvement to evaluate and provide treatment for chronic hepatitis C postpartum

BackgroundChronic hepatitis C virus (HCV) infections are increasing among reproductive age individuals. Direct acting antivirals (DAAs) can cure HCV, but the use of DAAs is not currently recommended during pregnancy and breastfeeding. Individuals with HCV commonly have inadequate prenatal and postnatal care. ObjectivesThe purpose of our study was to demonstrate the success of a quality improvement program to increase evaluation during pregnancy and ensuring access to DAA treatment medication during the postpartum period for individuals with chronic HCV to achieve cure 12 weeks after completing therapy. The primary outcome was documented HCV cure rate compared among individuals who received immediate treatment with DAA after delivery or after weaning or a traditional approach of referral to an infectious diseases specialist or hepatologist. The secondary outcome was the proportion of infants exposed to HCV evaluated. MethodsAn interdisciplinary team developed a program to increase evaluation and HCV treatment for postpartum individuals. Individuals who received prenatal care from March 2017 to May 2021 were eligible. Individuals with chronic HCV had a laboratory evaluation before delivery, and appropriate DAAs were selected for postpartum treatment. The health system specialty pharmacy dispensed DAA prescriptions immediately after delivery to those who were not breastfeeding. Individuals who did breastfeed had the option to begin treatment after weaning. Cure was defined as a sustained viral response or undetectable HCV RNA collected 12 weeks after completing DAA treatment. ResultsWe demonstrate the success of an interdisciplinary team to ensure access to therapy for the treatment of postpartum chronic HCV. Only 3 infants (25%) with mothers referred were evaluated at our institution compared with 44% of infants (n = 10) whose mothers were treated after delivery. ConclusionAn interdisciplinary team for HCV treatment improves access to treatment therapy with DAAs leading to the cure of chronic HCV after delivery.

250: Integrated clinic partnership with health system specialty pharmacy shows statistically greater adherence to CFTR modulator than usual care

250: Integrated clinic partnership with health system specialty pharmacy shows statistically greater adherence to CFTR modulator than usual care

Health-system specialty pharmacy impact on oral chemotherapy outcomes.

240 Background: Oral chemotherapy usage has grown significantly over the years as it provides a more convenient and less invasive administrative option for patients.In 2019, 89% of large hospitals owned and operated their own Health System Specialty Pharmacies (HSSP)1.Pharmacist-led medication therapy management services are crucial to provide patient education, monitoring of medication adherence and adverse effect management. With the current vertical integration of health plans and pharmacy benefit managers (PBMs) increasing their dominance over specialty dispensing channels, HSSP are often excluded from specialty networks. The objective of this study is to compare outcomes of oncology patients filling their oral chemotherapy at Cedars Sinai Medical Center (CSMC) Specialty Pharmacy versus those who are filling their medications at outside specialty pharmacies (OSP). Methods: Electronic health records were used to conduct a retrospective chart review of patients started on oral chemotherapy at CSMC between January 2019 to January 2021. Primary endpoints included time to treatment (TTT) and proportion of days covered (PDC). Secondary endpoints included drug-related problems (DRPs) and treatment-related ED visits and hospitalizations. DRPs were categorized by severity and type of intervention. Results: There were 100 patients included in the study: CSMC group (n = 50) and OSP group (n = 50). Patients in the CMSC group had significantly shorter TTT compared to OSP group (4 days vs. 9.5 days, respectively [P < 0.0026]), as well as a higher PDC (99.5% vs 91%, respectively [P < 0.0005]). Pharmacists identified and resolved 31 DRPs in CSMC arm with 19 DRPs categorized as serious and 1 DRP categorized as life-threatening. For the OSP group, 23 preventable DRPs were identified with 12 DRPs categorized as serious and 1 DRP categorized as life-threatening. There were no treatment-related ED visits or hospitalizations in either group. Conclusions: Patients filling their oral chemotherapy at CSMC Specialty Pharmacy had significantly quicker TTT and higher adherence rates as measured by PDC. Numerous DRPs were identified for OSP patients; potential pharmacist-interventions could have led to optimized and safer medication therapy if filled at a HSSP. Continued research comparing treatment outcomes and interventions made between HSSP and OSP can create a strong argument for health plans and PBMs to consider inclusion of HSSPs into their specialty networks.

IMPACT OF A CLINICAL PHARMACIST AND SPECIALTY PHARMACY SERVICES ON TREATMENT OUTCOMES IN AN IDIOPATHIC PULMONARY FIBROSIS SPECIALITY CLINIC

TOPIC: Diffuse Lung Disease TYPE: Original Investigations PURPOSE: Evaluate the impact of an idiopathic pulmonary fibrosis (IPF) clinical pharmacist and specialty pharmacy services on patient outcomes. METHODS: This is a retrospective chart review evaluating patients prescribed anti-fibrotic treatment with nintedanib (Ofev®) or pirfenidone (Esbriet®) at an interstitial lung disease (ILD) specialty clinic from the period of 9/2016-1/2021. Clinical outcomes evaluated include time to treatment discontinuation, adverse event management, and markers of IPF progression. Non-clinical outcomes including assessment for appropriate adherence as indicated by proportion of days covered (PDC) of ≥80%, time to anti-fibrotic treatment initiation following pharmacy receipt of prescription (turnaround time), patient financial obligation, and financial assistance provided will also be evaluated. Data will be summarized using descriptive statistics and compared to available data from anti-fibrotic clinical trials, internal data, and other relevant literature. RESULTS: Chart review for this research is in process as of current. Preliminary results suggest that most patients managed by the IPF pharmacist and specialty pharmacy (n = 31) with 3 or more anti-fibrotic prescription fills maintained appropriate adherence as evidenced by a PDC ≥80% in 83% (n = 26) of patients. Patients with a PDC of <80% (n = 5) were reviewed for clinically appropriate reasons for exclusion with 60% (n = 3) ultimately being excluded from PDC calculation for having a clinically appropriate reason for non-adherence. The average prescription turnaround time was 1.94 days (range 1-13 days). Data will be reviewed to obtain additional outcomes as indicated in the methods section and is expected to be completed ~6/2021. CONCLUSIONS: Though this chart review is still in process, preliminary results from anti-fibrotic dispensing data indicate that the majority (92.8%) of patients achieved appropriate adherence to medication therapy with a PDC of ≥80% following exclusion for clinically appropriate reasons for non-adherence such as medication adjustment for toxicity. Additionally, results showed that patients who receive anti-fibrotic prescriptions through the internal specialty pharmacy generally received their medications in 2 days or less, indicating only minimal delays in treatment initiation. Though data review is not final as of current, preliminary review suggests that patients who were not managed by the internal specialty pharmacy and IPF pharmacist were more likely to have a PDC of <80%, indicating potential issues with adherence in this population. Further data review will elucidate the benefits of including an IPF-focused clinical pharmacist and integrated specialty pharmacy in the multi-disciplinary management of IPF patients. CLINICAL IMPLICATIONS: Results will be used to aid in elaborating on the role of an IPF-focused clinical pharmacist in the multi-disciplinary management of IPF patients, lead to further generalized research into the impacts of a pharmacist within an ILD/Pulmonary clinic, and will highlight the importance of collaboration between an IPF-focused clinical pharmacist and an integrated health-system specialty pharmacy. DISCLOSURES: No relevant relationships by Charles Bodreau, source=Web Response No relevant relationships by Said Chaaban, source=Web Response No relevant relationships by Stephen Hobbs, source=Web Response No relevant relationships by Thom Platt, source=Web Response

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

Results of the first ASHP National Survey of Health-System Specialty Pharmacy Practice are presented. 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. 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. The health-system specialty pharmacy represents an integrated advanced practice model that incorporates specialty medication-use management across the continuum of care.

Charting a course for health-system specialty pharmacy.

Charting a course for health-system specialty pharmacy.

Impact of a pharmacy technician and pharmacist on time to inhaled tobramycin therapy in a pediatric cystic fibrosis clinic.

Cystic fibrosis (CF) patients who grow Pseudomonas aeruginosa on respiratory culture are commonly prescribed inhaled tobramycin (TIS) to eradicate the organism. The objective of this study was to determine the impact of a pharmacy technician/pharmacist team, in conjunction with an integrated health-system specialty pharmacy (IHSSP), on the time from positive culture to prescribing and access to TIS in a pediatric CF clinic. A retrospective study of CF patients positive for P. aeruginosa who were prescribed TIS for eradication. The study included 20 patients in the pregroup and 42 patients in the postgroup. Total median (interquartile range) days from positive culture to TIS being shipped to the patient from the pharmacy was significantly different: 15 (10.25-21) days in the pregroup and 9 (7-14) days in the post groups (p = .005). The time from positive culture to TIS prescribing was significantly different: 6 (5-12.75) days in the pregroup and 5 (3.75-6) days in the postgroup (p = .01). In the postgroup median time from prescription to the patient receiving the TIS was significantly different between the two groups 2 (2-5) days IHSSP group versus 6 (3-9) external specialty pharmacy group (p = .003). Time from prescription to prior authorization approval was the same in both groups. The addition of the pharmacy team reduced time from culture to TIS being received by the patient. Patients able to fill at the IHSSP received their medication sooner than an external specialty pharmacy. The study shows the benefit of an integrated pharmacy model in conjunction with an IHSSP.

Adherence and persistence in patients with rheumatoid arthritis at an integrated health system specialty pharmacy.

BACKGROUND: Disease-modifying anti-rheumatic drugs (DMARDs) improve symptoms and delay progression of rheumatoid arthritis (RA), but adherence is often sub-optimal and many patients change medication (either "switching" to a medication with a different mechanism of action or "cycling" to a medication with the same mechanism of action) during the first year of therapy. Some integrated health-system specialty pharmacies embed pharmacists in clinics to help patients access and adhere to specialty medication. OBJECTIVE: This study assessed DMARD switching, cycling, adherence, and persistence at an outpatient rheumatology clinic with an integrated health-system specialty pharmacy. METHODS: We conducted a retrospective cohort study of adults with RA, naïve to biologic or targeted synthetic DMARDs, who filled ≥ 2 biologic or targeted synthetic DMARD prescriptions within 12 months. Adherence was measured using proportion of days covered (PDC); persistence was computed at 12 months. Univariate analyses compared adherence and persistence between patients with and without a medication change. Ordinal logistic regression examined whether PDC was associated with patient age, gender, race, insurance type, and medication change. RESULTS: We included 772 patients: 79% female/21% male, 89% White/11% non-White, median age 56 years (interquartile range = 48-63). Most patients (84%) did not change medication during the study period, 5% cycled medication one or more times (but did not switch), 9% switched medication one or more times (but did not cycle), and 2% of patients both switched and cycled during the study period. Median PDC of the sample was 0.94 and 73% of patients were persistent. Patients with a medication change had lower PDC than those without (0.89 vs 0.95, P = 0.004), but rate of persistence did not significantly differ between groups (77 vs 72%, P = 0.300). Odds of higher PDC was more likely for men (Odds ratio [OR] = 1.82, 95% confidence interval [CI]: 1.34-2.48, P < 0.001) and less likely for patients who changed medication (OR = 0.65, CI: 0.47-0.91, P = 0.011); age, race, and insurance type were not significant. CONCLUSIONS: Patients with RA demonstrated high medication adherence and persistence, and low rates of switching and cycling. Findings support evidence that integrated health-system specialty pharmacies with clinical pharmacists embedded in outpatient clinics help patients overcome barriers to medication adherence to persist on therapy. DISCLOSURES: This study was funded by Sanofi, Inc. James and J. Choi were employed by Sanofi, Inc., at the time of this study. Peter, Zuckerman, DeClercq, L. Choi, and Tanner, received research funding from Sanofi, Inc., for work on this study. Tanner has also received advisory board/speaker bureau fees from Pfizer, Regeneron, and Sanofi-Aventis. This study was presented as a poster at AMCP Nexus in October 2019 at National Harbor, MD.

Analyzing the costs of developing and operating an integrated health-system specialty pharmacy: The case of a centralized insurance navigation process for specialty clinic patients.

Direct and indirect costs related to the growth of specialty pharmacy services and the insurance navigation process for specialty clinic patients are discussed, and development and implementation of a pharmacy-driven and system-wide prior authorization (PA) processing center within a health system are described. Expensive specialty drugs require PA. Due to the concentration of specialists, health systems with multiple specialties experience higher PA burden and resulting care delays. Although clinic staff typically handle PA requests, health-system specialty pharmacies are well positioned to support patients, clinic staff, and physicians by assuming responsibility for the PA process entirely. University of Utah Health established its Pharmacy Ambulatory Clinical Care Center (PAC3) to centralize PA processing for selected specialty and primary care clinics within the health system. In fiscal year 2019, the PAC3 team (10 pharmacy technician and 1.5 pharmacist full-time equivalents) completed over 13,000 PAs. The pharmacy labor cost increase was significant; however, the benefits gained from increased services, quality, and financial strength surpassed all costs associated with the implementation and maintenance of the pharmacy operation. Other tangible benefits included decreased delays in therapy initiation, increased patient satisfaction, increased clinic visits, and increased staff and provider satisfaction and engagement. Increased PA requests associated with specialty drugs have placed considerable stress and staff burden on specialty clinics within health systems. However, development and implementation of an efficient PA processing infrastructure within a health-system specialty pharmacy may reduce the burden, increase financial strength, and improve the patient experience.

Development, implementation, and evaluation of a health outcomes and research program at an integrated health-system specialty pharmacy.

Health-system specialty pharmacies (HSSPs) provide high-quality, efficient, and collaborative care to patients receiving specialty therapy. Despite proven benefits of the integrated model, manufacturer and payer restrictions challenge the viability and utility of HSSPs. Vanderbilt Specialty Pharmacy developed a health outcomes and research program to measure and communicate the value of this model, drive improvement in patient care delivery, and advocate for recognition of HSSP pharmacists' role in patient care. The purpose of this descriptive report is to describe the development and results of this program. The health outcomes and research program began as an initiative for pharmacists to evaluate and convey the benefits they provide to patients, providers, and the health system. Early outcomes data proved useful in communicating the value of an integrated model to key stakeholders and highlighted the need to further develop research efforts. The department leadership invested resources to build a research program with dedicated personnel, engaged research experts to train pharmacists, and fostered internal and external collaborations to facilitate research efforts. As of March 2021, the health outcomes and research program team has published 33 peer-reviewed manuscripts, presented 88 posters and 7 podium presentations at national conferences, and received 4 monetary research awards. Further, the program team engages other HSSP teams to initiate and expand their own health outcomes research in an effort to empower all HSSPs in demonstrating their value. The health outcomes and research program described has pioneered outcomes research among HSSPs nationwide and has proven valuable to specialty pharmacists, the health system, and key specialty pharmacy stakeholders.

Effect of clinical pharmacist interventions on cost in an integrated health system specialty pharmacy.

BACKGROUND: Patients who are prescribed specialty medications require close monitoring, including assessment of laboratory parameters, toxicities, and adherence. Specialty pharmacies integrated within a health system are able to access records, assess therapy, and efficiently communicate with prescribers. OBJECTIVE: To analyze interventions made by clinical pharmacists within the Cleveland Clinic Specialty Pharmacy (CCSP) regarding cost avoidance for the health care system and improvements in patient safety. METHODS: This was a retrospective, observational study that analyzed pharmacist interventions regarding specialty hematology/oncology medications. Interventions were measured with pharmacist documentation within the electronic health record (EHR). The primary endpoint was the cost-avoidance effect of clinical pharmacist interventions resulting from pharmacist access to the EHR. Secondary endpoints included pharmacist interventions that led to additional ancillary or supportive care, time taken to perform interventions, total interventions according to new or refill status, and total interventions performed according to insurance subtype. RESULTS: 547 interventions were identified during the study period, with a total cost avoidance of $1,508,131. The intervention with the highest overall cost savings was discontinuation of therapy ($290,091). The highest cost savings, based on intervention type, was lack of follow-up ($30,892). The medication with the highest overall cost savings was abiraterone ($273,160). Gilteritinib was associated with the highest cost saving per intervention ($28,350). The indication with the highest overall cost savings was prostate cancer ($402,601), while cutaneous T-cell lymphoma had the highest cost savings per intervention ($25,424). CONCLUSIONS: CCSP pharmacist interventions led to significant overall cost savings to the health care system. Although not measured in this study, it is reasonable to expect that decreased medication use may also translate into less financial burden for patients, as well as for pharmacy benefit managers. Access to the EHR and integration within the health care system may have facilitated the cost savings. DISCLOSURES: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors have no conflicts of interest to disclose.

Inclusion in limited distribution drug network reduces time to dalfampridine access in patients with multiple sclerosis at a health-system specialty pharmacy.

BACKGROUND: Dalfampridine improves walking speed in patients with multiple sclerosis (MS), but accessing specialty medications such as dalfampridine can be hindered by insurance restrictions, high costs, and limited distribution networks (LDNs) imposed by manufacturers. Some integrated health-systems specialty pharmacies (HSSPs) embed pharmacists in clinics and dispense medications from their internal pharmacies if included within the LDN. OBJECTIVE: To assess access to dalfampridine in patients at an HSSP before and after gaining admission to the LDN. METHODS: This study was conducted at Vanderbilt Specialty Pharmacy (VSP), an integrated HSSP at Vanderbilt University Medical Center (VUMC) with 2 clinical pharmacists embedded in the MS clinic. VSP gained access to the dalfampridine LDN on May 1, 2018, at which time the embedded pharmacists began to manage the comprehensive therapy initiation process. We performed a retrospective review of adult patients with MS who were prescribed dalfampridine from March 2010 to December 2018. Eligible prescriptions were new starts (no previous use) or restarts (after previous use and discontinuation). Prescriptions were classified as pre-VSP and post-VSP, which differentiates before and after VSP gained access to dispense dalfampridine. Study outcomes were insurance approval, initiation of therapy, and time from treatment decision to medication access. We used a proportional odds logistic regression model for time to medication access using the following covariates: pre-VSP versus post-VSP time period, insurance prior authorization (PA) denied versus approved/not needed, and baseline timed 25-foot walk. RESULTS: We included 262 patients and 290 prescriptions (260 pre-VSP and 30 post-VSP). In pre-VSP and post-VSP prescriptions, 97% were approved by insurance, and 93% of patients started therapy. Median time to medication access was 22 days (IQR = 11-45) for pre-VSP prescriptions and 1 day (IQR = 0-3) for post-VSP prescriptions. In the proportional odds logistic regression model, the odds of having a longer medication access time were significantly higher for pre-VSP prescriptions (OR = 83.219, P < 0.001) and prescriptions whose PA was initially denied (OR = 9.50, P < 0.001); 25-foot walk time was not significant (OR = 0.95, P = 0.277). CONCLUSIONS: After obtaining access to dispense dalfampridine, the time to access therapy was reduced, suggesting that LDNs delay patient access to therapy at HSSPs. DISCLOSURES: No funding was provided for this study. The authors have no conflicting interests to disclose. Preliminary results have been previously presented at the American Society of Health-Systems Pharmacy Midyear Meeting in December 2019, the Vanderbilt Health Systems Specialty Pharmacy Outcomes Research Summit in August 2020, and the National Association of Specialty Pharmacy Annual Meeting in September 2020.

Rheumatoid arthritis medication adherence in a health system specialty pharmacy.

To assess adherence to specialty medications for rheumatoid arthritis (RA) at an integrated health system specialty pharmacy (HSSP) and identify characteristics associated with adherence. Single-center, retrospective cohort study. Study patients were adults with RA who filled at least 3 prescriptions for biologic disease-modifying antirheumatic drugs (bDMARDs) between July 1, 2016, and June 30, 2017, at an integrated HSSP. Data were collected from pharmacy claims and electronic health records. The primary outcome, adherence, was measured using proportion of days covered (PDC). Proportional odds logistic regression was used to test association between PDC and age, gender, race, insurance type, and out-of-pocket costs. We included 675 patients: 77% were female, 90% were White, 29% were naive to treatment at initial dispensing, 60% held commercial insurance, and the median age was 56 years. Median (interquartile range [IQR]) patient out-of-pocket cost per fill was $1.50 ($0-$5). Median (IQR) PDC was 0.95 (0.84-1.00); 80% of patients achieved PDC of 0.80 or higher. Higher adherence was more likely in patients who were male (odds ratio [OR], 1.58; 95% CI, 1.15-2.18; P = .005], naive to specialty medication treatment (OR, 3.04; 95% CI, 2.21-4.18; P < .001), and older in age (per 10 years: OR, 1.17; 95% CI, 1.04-1.32; P = .008), and adherence had a significant nonlinear association with average cost per fill (P = .006); associations with race and insurance type were not significant. At an integrated HSSP, patients with RA paid low out-of-pocket costs for bDMARD therapy and achieved high treatment adherence. Data suggest that integrated HSSPs assist patients in removing financial barriers to treatment.

Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial.

BackgroundThe effectiveness of specialty medications in complicated clinical conditions depends on adherence to therapy. However, specialty medications pose unique barriers to adherence.ObjectiveThis study aims to determine whether pharmacist interventions improve specialty medication adherence.MethodsThis is a single-center, pragmatic, randomized controlled trial ongoing since 10 May 2019 at an integrated health system specialty pharmacy. This study evaluates usual care compared with usual care plus patient-tailored adherence interventions. Study design and procedures were informed by focus groups with patients and specialty pharmacists. Patients at Vanderbilt Specialty Pharmacy with a proportion of days covered (PDC) < 90% in the previous 4 months are identified by a daily query of the electronic pharmacy database. A pharmacist reviews these patients’ electronic health records to identify and exclude ineligible patients. Eligible patients are randomized evenly to the control or intervention arm and stratified by historical clinic nonadherence rates. Patients randomized to the intervention arm undergo a baseline assessment to clarify reasons for nonadherence and subsequently receive patient-tailored interventions based on their specific reasons. Interventions and follow-up are provided at the discretion of the intervening pharmacist. The primary outcome is PDC calculated at 8 months post-enrollment. Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum.DiscussionThis trial will evaluate the effect of patient-tailored interventions on specialty medication adherence and will inform how often and why patients are misidentified as nonadherent.RegistrationThe trial was deemed a quality improvement initiative by the Vanderbilt University Institutional Review Board. It was registered in ClinicalTrials.gov (NCT03709277) on 17 October 2018.Electronic supplementary materialThe online version of this article (10.1007/s40801-020-00213-8) contains supplementary material, which is available to authorized users.

Development of a quality measures tool for the utilization of tyrosine kinase inhibitors in non-small cell lung cancer: An integrated specialty pharmacy initiative.

Tyrosine kinase inhibitors, commonly prescribed for non-small cell lung cancer, are efficacious but pose safety risks that can diminish quality of life. Quality measures to ensure appropriate utilization and monitoring of tyrosine kinase inhibitors are needed to reduce unnecessary healthcare costs and maximize therapeutic benefit. With integrated clinical and pharmaceutical care services, a health-system specialty pharmacy is the ideal setting for quality measures development. The purpose of this initiative was to develop a tool to assess quality in the utilization of tyrosine kinase inhibitors in non-small cell lung cancer by engaging multiple key stakeholder perspectives to identify the fundamental elements of high-quality clinical and specialty pharmacy care. Quality measures for the utilization of tyrosine kinase inhibitors in non-small cell lung cancer were developed by conducting package insert, guideline, and literature review followed by integrating feedback from key stakeholder groups through individual conversations and a structured assessment. The finalized guide assesses safety, efficacy, persistence, and patient-reported outcomes using defined clinical and specialty pharmacy measures. Most stakeholders agreed that the proposed measures were relevant as well as accurate and expressed support for implementation. The proposed tool provides a framework for specialty pharmacies to deliver quality care in the use of tyrosine kinase inhibitors for the treatment of non-small cell lung cancer. Further work is needed to implement and validate this tool.

The Effect of an Integrated Health System Specialty Pharmacy on HIV Antiretroviral Therapy Adherence, Viral Suppression, and CD4 Count in an Outpatient Infectious Disease Clinic.

Adherence to antiretroviral (ARV) therapy is critical in order to achieve and maintain viral suppression and improve immune function. Clinical pharmacists and pharmacies focused on human immunodeficiency virus (HIV) have demonstrated the ability to increase ARV medication adherence and subsequently have a positive effect on these lab markers. To evaluate the effect of an integrated health system specialty pharmacy service with a clinic-embedded, HIV-trained pharmacist and pharmacy technician on ARV medication adherence rate, viral load, and CD4 count. This was a single-center, retrospective cohort study conducted from August 7, 2017, to June 30, 2018, at an indigent outpatient infectious disease clinic within Atrium Health (AH), a not-for-profit health system based in Charlotte, NC. The intervention group (opt-in group) received HIV patient care that involved the health system specialty pharmacy service. Once a patient was enrolled in the specialty pharmacy service, medication reconciliation was completed by the pharmacist, financial assistance and prior authorizations were completed if needed; prescriptions were delivered to the patient; and monthly refills calls were conducted to assess adherence, tolerability, and medication changes. The control group (opt-out group) received HIV patient care that did not incorporate the health system specialty pharmacy. The primary endpoints were medication adherence, viral suppression, and CD4 counts. Within-group comparisons from baseline to follow-up were made along with group-to-group comparisons. Adherence was calculated using medication possession ratio. For those patients using Atrium Health Specialty Pharmacy Service (AH SPS; n = 46), the overall median adherence rate was higher at 100% versus only 94% for those patients (n = 50) that opted out of the service (P < 0.01). All but 3 patients (21.7% at baseline vs. 6.5% at follow-up, P = 0.03) using AH SPS reached viral suppression, and all but 1 had improved immune function with a CD4 count of 200 or greater by the end of the observation period (P = 0.03). The change in viral suppression and CD4 count of 200 or greater was not statistically improved between baseline and follow-up in those opting out of using AH SPS. When comparing the 2 groups at reaching these endpoints, there was no statistically significant difference in viral suppression and CD4 count. AH SPS was able to demonstrate improved ARV adherence in those patients using an integrated specialty pharmacy with an embedded pharmacy team, coordinated monthly medication delivery, and refill reminder and adherence calls. This in turn led to improved viral suppression and immune markers by the end of the observation window for patients using AH SPS. No outside funding supported this study. The authors have nothing to disclose.

An Integrated Health-System Specialty Pharmacy Model for Coordinating Transitions of Care: Specialty Medication Challenges and Specialty Pharmacist Opportunities.

Adherence and persistence to specialty medications are necessary to achieve successful outcomes of costly therapies. The increasing use of specialty medications has exposed several unique barriers to certain specialty treatments’ continuation. Integrated specialty pharmacy teams facilitate transitions in sites of care, between different provider types, among prescribed specialty medications, and during financial coverage changes. We review obstacles encountered within these types of transitions and the role of the specialty pharmacist in overcoming these obstacles. Case examples for each type of specialty transition provide insight into the unique complexities faced by patients, and shed light on pharmacists’ vital role in patient care. This insightful and real-world experience is needed to facilitate best practices in specialty care, particularly in the growing number of health-system specialty pharmacies.

Impact of health-system specialty pharmacy services on medication adherence in pediatric patients with cystic fibrosis

Background: Specialty medications represent a growing part of the pharmacological management of chronic disease states such as cystic fibrosis (CF). The management of CF in the pediatric population is complex, as it involves multiple medications and treatment success is largely determined by adherence to the care plan. There is often a delay between prescribing of specialty medications and initiation of therapy in the pediatric CF population. Health-system specialty pharmacy services provide significant benefits when compared to external specialty pharmacies, including direct access to the medical record, collaboration with the healthcare team, continuous patient education and continuity of care. Aims: The objective of this initiative was to assess the impact of Outpatient Pharmacy Services at Yale New Haven Health (OPS), a health system specialty pharmacy, on medication adherence in pediatric patients with CF. Methods: A prospective review of 65 pediatric patients with CF seen by the pharmacist in a health-system CF clinic over 6 months was conducted for medication adherence and compared to a retrospective cohort. Education about the health-system specialty pharmacy services was provided to patients through the following methods: invitation letter, informational pamphlets distributed in clinic and direct education by the clinic pharmacist. A clinic workflow was implemented to streamline the referral process. Primary endpoints include: medication possession ratio (MPR), proportion of days covered (PDC), and percentage of prescriptions sent to and filled by the OPS. Results: A total of 65 pediatric CF prescriptions were written from September 2017 to February 2018, with only 7.7% of the prescriptions sent to OPS prior to implementation of the clinic workflow. The MPR and PDC in this retrospective cohort were 0.85 and 0.75 respectively. From September 2018 to February 2019 the number of prescriptions for all medications written was 304, with 32.9% sent to OPS and a fill rate of 89%. The MPR and PDC for that year were 0.86 and 0.80 respectively. Conclusions: This single-center review that assessed the impact of specialty pharmacy services on pediatric patients with CF in a large health system demonstrated improved and sustained patient medication adherence. The increase in utilization of OPS led to an increase in prescriptions received and filled by the health-system specialty pharmacy.

The impact of an integrated health-system specialty pharmacy on HIV antiretroviral therapy adherence, viral suppression and CD4 count in an outpatient ID clinic

Background: Atrium Health (AH) is a Charlotte-based not for profit hospital network that currently cares for HIV-infected patients through three outpatient ID clinics. AH recognized that novel approaches to patient care which incorporate clinical pharmacists and health-system specialty pharmacy into the practice model can help improve the HIV continuum. As a result, AH created an HIV specialty pharmacy service line that embedded an HIV-trained clinical pharmacist and pharmacy technician within one of three health-system outpatient ID clinics. Aims: This study aimed to evaluate the antiretroviral medication adherence rate, viral load, and CD4 count among patients utilizing Atrium Health Specialty Pharmacy Service (AH SPS) compared to patients that opted out of the program. Methods: This was a single-center, retrospective cohort study conducted from 7 August 2017 to 30 June 2018. All patients were already on HIV therapy at either entry or declination to the AH SPS program. The intervention group was defined as HIV patient care that incorporated AH SPS into the practice model. The control group was defined as HIV patient care that did not involve our health-system specialty pharmacy. The primary endpoints were medication adherence, viral suppression, and CD4 counts. Adherence was measured using pharmacy claims data and the Medication Possession Ratio (MPR) calculation. Baseline viral load and CD4 count at the time of entry or declination to the program was recorded as well as at the end of the observation period. Comparisons between the opt-in and opt-out groups were made. Results: For those patients using AH SPS, the overall average adherence rate was 100% versus only 89% for those patients that opted out of the service (p < 0.01). Furthermore, all but 3 patients using AH SPS reached viral suppression (p = 0.03) and all but one had improved immunefunction with a CD4 count 200 or greater by the end of the observation period (p = 0.03). The change in viral suppression and CD4 count of 200 or greater was not statistically improved between baseline and follow up in those opting out of using AH SPS. Conclusions: The AH SPS utilized an innovative practice model that fully integrated a specialty pharmacy team within an outpatient ID clinic. This novel approach to patient care significantly improved adherence which in turn lead to improved viral suppression and immune markers in patients enrolled within the program compared to those opting out.

Real-world assessment of an integrated clinical model on oral hepatitis C therapy at Southern Ohio Medical Center

Background: The area and population served by the Southern Ohio Medical Center (SOMC) is one that has been hit hard by the opioid epidemic, resulting in a very high incidence of Hepatitis C virus infected individuals. In this rural area, many patients have struggled with access to specialty healthcare. In January 2018, specialty pharmacy services were started. The main goals were to provide a valuable and personalized service to patients and increase access to specialty medications. When taken as prescribed, HCV therapies can lead to high cure rates (>95%). The program integrated a clinical pharmacist and pharmacy liaison in the infectious disease clinic to begin providing in-clinic education, 24/7 support, prior authorization assistance, financial aid assistance, refill reminders, and other services to patients. The specialty pharmacy service has assisted many local patients to obtain treatment for HCV. The following data analysis details the study design and results. Aims: The study was completed to assess the impact of the clinic-based specialty pharmacy program on medication access, affordability, and clinical outcomes for patients with HCV. Methods: The study was IRB-approved. Endpoints measured were SVR12 rates, rates of patient return for SVR12 labs, and out-of-pocket costs for patients using the SOMC Specialty Pharmacy. To be eligible for the study, patients must have started an HCV regimen written by an SOMC provider after January 1, 2018. Data was collected by reviewing patient electronic medical records and pharmacy dispensing records. Results: The study included 67 HCV patients who utilized the SOMC specialty pharmacy program to obtain treatment. Thirty-seven of the patients were male, none had liver decompensation, and 65 were treatment-naïve. By offering in-clinic specialty pharmacy services to patients, SOMC was able to remove barriers, such as cost, to improve specialty medication access and adherence. This resulted in 100% medication access and therapy completion rates for participating patients. SVR12 rates were higher than clinical trials. Finally, the average out of pocket cost to patients was found to be $0.75, with 90% of patients having zero copay. Clinical pharmacists and pharmacy liaisons played a key role in achieving this result by providing in-person education to patients, securing financial assistance for patients, and regularly following-up with patients regarding their therapy. Conclusions: Clinic-based health system specialty pharmacy programs can play a vital role in improving medication access and adherence, leading to better clinical outcomes. By offering on-site specialty pharmacy services, SOMC provides a personalized patient experience and affordable access to specialty prescriptions. These elements help ensure patients adhere to their treatment regimens over time and fully realize the benefits of their specialty medications.