Aprendizado de máquina nos serviços farmacêuticos: uma revisão integrativa / Machine learning in pharmaceutical services: an integrative review

A crescente digitalização e aplicação de inteligência artificial (IA) em problemas complexos do mundo real, tem potencial de melhorar os serviços de saúde, inclusive da atuação dos farmacêuticos no processo do cuidado. O objetivo deste estudo foi identificar na literatura científica, estudos que testam algoritmos de aprendizado de máquina (Machine Learning ­ ML) aplicados as atividades de farmacêuticos clínicos no cuidado ao paciente. Trata-se de uma revisão integrativa, realizada nas bases de dados, Pubmed, Portal BVS, Cochrane Library e Embase. Artigos originais, relacionados ao objetivo proposto, disponíveis e publicados antes de 31 de dezembro de 2021, foram incluídos, sem limitações de idioma. Foram encontrados 831 artigos, sendo 5 incluídos relacionados as atividades inseridas nos serviços de revisão da farmacoterapia (3) e monitorização terapêutica (2). Foram utilizadas técnicas supervisionadas (3) e não supervisionadas (2) de ML, com variedade de algoritmos testados, sendo todos os estudos publicados recentemente (2019-2021). Conclui-se que a aplicação da IA na farmácia clínica, ainda é discreta, sinalizando os desafios da era digital.

The growing application of artificial intelligence (AI) in complex real-world problems has shown an enormous potential to improve health services, including the role of pharmacists in the care process. Thus, the objective of this study was to identify, in the scientific literature, studies that addressed the use of machine learning (ML) algorithms applied to the activities of clinical pharmacists in patient care. This is an integrative review, conducted in the databases Pubmed, VHL Regional Portal, Cochrane Library and Embase. Original articles, related to the proposed topic, which were available and published before December 31, 2021, were included, without language limitations. There were 831 articles retrieved 5 of which were related to activities included in the pharmacotherapy review services (3) and therapeutic monitoring (2). Supervised (3) and unsupervised (2) ML techniques were used, with a variety of algorithms tested, with all studies published recently (2019­2021). It is concluded that the application of AI in clinical pharmacy is still discreet, signaling the challenges of the digital age.

Pharmaceutical care- urgency: Proposing a practical clinical framework for pharmacy students.

BACKGROUND AND PURPOSE: Prioritizing a drug therapy problem (DTP) during an experiential placement is challenging for some pharmacy students, suggesting a gap in pre-placement preparedness and the need to modify existing resources. A modified DTP prioritizing framework is proposed to enhance clinical reasoning and increase students' confidence in performing this important step in the pharmaceutical care process. EDUCATIONAL ACTIVITY AND SETTING: Students' baseline DTP prioritizing capability was assessed in an informal focus group consisting of pharmacy students and experienced hospital pharmacy preceptors. Participants ranked the urgency for addressing 47 common medical conditions and selected a time frame to resolve the DTP. Participants also provided feedback on a proposed DTP prioritizing framework. A modified, student-focused DTP prioritizing framework, incorporating elements of curricular knowledge, principal elements of urgency, and time frame for taking action to resolve the identified DTP is described. FINDINGS: Students' DTP urgency rankings were heterogeneous and showed greater deviation from the anticipated ranking (R = 0.61) compared to the pharmacist cohort (R = 0.807), reinforcing our view of the need for a modified DTP prioritizing framework for students. In qualitative terms, students felt the framework's focus on curricular knowledge would contribute to the development of expertise. Preceptors felt the framework reflected their usual practice and would help guide discussions with students. SUMMARY: The modified DTP prioritizing framework, described in this article, may be utilized both to enhance student success and preceptor development in the experiential setting.

Pharmacovigilance: an evaluation on the practice of pharmacists acting in pharmacies and drugstores

Abstract Pharmacists acting in pharmacies and drugstores stores are some of the most accessible healthcare providers and the last to intervene before the patient takes their medicine. This puts the pharmacist in a position of authority that should be harnessed for the benefit of health. Thus, this professional is strategic for performing pharmacovigilance. Our objective of this study was to interrogate the practice of pharmacists in relation to pharmacovigilance activities, and to identify difficulties and possible stimuli for the improvement these activities in pharmacies and drugstores. The information was collected through an online questionnaire via Survey Monkey®. The data were analyzed statistically using SPSS software. Responses were received from 5174 pharmacists: mostly young women within five years of graduation and experience in pharmaceutical retail. 81% of them reported having identified suspected substandard medicines, but only 16% used the Brazilian notification system Notivisa. More than 85% of pharmacists agreed with the importance of pharmacovigilance and the recognition of reporting services as part of pharmacist duties and pharmaceutical care. The main barriers to making notifications were the lack of access and knowledge about Notivisa. Pharmacists agreed that simplifying the system would be a stimulus for notifications, and requested more feedback from notifications, as well as material and courses to understand the notification process. Pharmacists have important data to feed into pharmacovigilance systems, recognize their responsibilities and are willing to contribute, but still demonstrate low compliance. Simplification of the system and training on it are likely to increase notifications.

Clinical pharmaceutical services in primary health care of the Federal District: Performance frequency and conditioning factors

Abstract Pharmaceutical services correspond to a set of actions that aim to guarantee the integral access and rational use of drugs by the population. In this sense, this study aimed to identify the frequency and conditioning factors for clinical services of primary care in the Federal District, Brazil. A quantitative cross-sectional study was conducted, in which 34 pharmacists were interviewed. The most frequently developed clinical pharmaceutical services were dispensing, pharmaceutical guidance for users, and technical-pedagogical activities for the health team. There is a greater frequency of operation of clinical services by pharmacists working in pharmacies with physical infrastructure, with better levels of adequacy, greater support from management and health staff, and the inclusion in Family Health Support Nucleus activities. Although the clinical pharmaceutical services in primary care are incipient, the study raises important data for the reorientation and qualification of these actions.

Percepção de farmacêuticos na implantação do Cuidado Farmacêutico na Atenção Básica / Pharmacists' perceptions on the implementation of Pharmaceutical Care in Primary Care

Resumo O artigo descreve a percepção de 10 farmacêuticos da Atenção Básica (AB) de uma região do município de São Paulo que participaram do processo de implantação do Cuidado Farmacêutico. A partir de uma pesquisa qualitativa com grupos focais e abordagem descritiva, os conteúdos foram analisados utilizando-se a Análise de Conteúdo. Das 52 unidades de registro organizadas em 10 categorias, resultaram três sínteses sobre o processo de implantação do CF. Nesse contexto, foi possível descrever o papel do farmacêutico na AB após a implantação dos serviços clínicos, de modo a identificar suas percepções, dificuldades e avanços. Os resultados demonstraram aspectos positivos, além da necessidade de uma mudança gradual no perfil e nas competências dos farmacêuticos para o desenvolvimento de serviços clínicos, ultrapassando os limites da categoria e dependendo do trabalho em equipe realizado na AB. Logo, os resultados promovem os diferentes papéis dos atores envolvidos nesta prática (usuários, equipe de saúde, gestores e farmacêuticos) e valorizam novas formas de cuidado no SUS.

Abstract The article describes the perception of 10 pharmacists from the Primary Health Care (PHC) of a region in the municipality of São Paulo that participated in the process of implementing the Pharmaceutical Care (PC). Based on qualitative research with focus groups and descriptive approach, contents were reviewed using the Content Analysis. The 52 registration units organized in 10 categories resulted in three summaries about the PC implementation process. In this context, we could describe the role of pharmacists in PHC after the implementation of clinical services, in order to identify their perceptions, difficulties and advances. Results unveiled positive aspects, besides the need for gradual change in the profile and competences of pharmacists to develop clinical services, extrapolating the category boundaries, and depending on the teamwork performed at PHC. Therefore, results promote the different roles of the players involved in this practice (users, health team, managers, and pharmacists), and value new forms of care in the Brazilian Health System (SUS).

Pharmaceutical services in primary health care: dissatisfaction among users, managers and pharmacists

Abstract To assess the performance indicators for pharmaceutical services (PS) in primary health care (PHC), the level of satisfaction with pharmacy services among users and managers / pharmacists' impressions in relation to the findings were evaluated. The study used mixed methods, including a retrospective and descriptive study of the performance indicators for PS in PHC, an observational study on the level of satisfaction and a qualitative study of users' perception of pharmacy services at Health Units. Managers and pharmacists' impressions of the study results were also collected. Only 44.4% of pharmacies had a full-time pharmacist. From the establishments visited, 5.3% did not have an air-conditioned environment, and only 33.3% of the items essential to the Good Practices of Storage of Medicines and Supplies criteria were fulfilled. Although 77.9% of the prescribed medicines were dispensed, it did not reach the 80% standard. The satisfaction level of users was 3.2±0.6, indicating dissatisfaction with pharmacies' services. By means of an evaluation of each item within the questionnaire, it was possible to observe that variables related to pharmaceutical care presented low scores in relation to other domains, thus evidencing the fragility of the pharmaceutical- patient relationship in users' perception. Managers and pharmacists suggested that these results were related to the inadequate physical infrastructure of pharmacies, work overload, lack of recognition and undervaluation of pharmacists, lack of interaction within the PHC team, high turnover of pharmacists, and lack of PS prioritization by the administration. PS in PHC has structural and organizational weaknesses that require changes. In general, users are dissatisfied with pharmacies' services, especially with pharmaceutical care.

Profile of pharmaceutical interventions of a pharmacotherapeutic follow-up model for diabetic patients in a community pharmacy

Abstract The insertion of Pharmaceutical Care in Primary Health Care (PHC) improves patients' clinical outcomes and quality of life. Pharmacotherapeutic follow-up can contribute to the management of chronic diseases such as diabetes, promoting better glycemic control and adherence to therapy. This study aimed to assess the Drug-therapy Problems (DTPs) and Pharmacist Interventions (PIs) on the pharmacotherapeutic management in patients with type 2 diabetes mellitus (T2DM) in a community pharmacy. A quantitative, retrospective, and cross-sectional study was conducted in a Pharmaceutical Care Program within the PHC in Juiz de Fora (Minas Gerais, Brazil). Inclusion criteria were patients with T2DM above 18, who attended at least three pharmaceutical consultations between July 2016 and October 2018 and presented two or more glycated hemoglobin tests. The study group (n = 17) was largely composed of women (65%), elderly (76%), sedentary (72%), and obese people (52%). The resolution was achieved in 79% of the DTPs identified (n = 115). Most of DTPs were related to administration and adherence to pharmacotherapy (46%). 60% of the 437 PIs involved the provision of information and counseling. In other words, accessible interventions lead to high resolvability. Therefore, clinical actuation of pharmacists could improve the prognosis in diabetes treatment

Exploring Work Satisfaction and Characteristics of Iraqi Pharmacist Workforce

Abstract The objectives of this study were to describe work characteristics of Iraqi pharmacists, to compare pharmacist job satisfaction between private and public sectors and to assess factors influencing job satisfaction level. This cross-sectional study of pharmacists, their work sites and work satisfactions used an electronic questionnaire that was posted on Facebook pharmacy professional group from June to September 2018. The participants included pharmacists from all 18 Iraqi provinces. We used multiple linear regression to identify predictors of general job satisfaction among 13 pharmacist characteristics. We received 658 usable surveys. Approximately half (47.24%) of respondents indicated dissatisfaction with their primary workplace. Job performance, patient contact, satisfaction with manager, income and expectation satisfactions were significantly related with work satisfaction. Pharmacists working in the private sector had significantly more control over their workplace and higher satisfaction with manager, income and general satisfactions compared to those working in public sector. Pharmacists work in diverse settings across the public healthcare system, community pharmacies, private drug bureaus and academia. About half of them are dissatisfied with their primary workplace. The private sector has more satisfaction rate compared to the public sector. Thus, officials need to improve job environments in the public sector.

Alternative mechanisms for delivery of medication in South Africa: A scoping review.

BACKGROUND: The number of people in South Africa with chronic conditions is a challenge to the health system. In response to the coronavirus infection, health services in Cape Town introduced home delivery of medication by community health workers. In planning for the future, they requested a scoping review of alternative mechanisms for delivery of medication to patients in primary health care in South Africa. METHODS: Databases were systematically searched using a comprehensive search strategy to identify studies from the last 10 years. A methodological guideline for conducting scoping reviews was followed. A standardised template was used to extract data and compare study characteristics and findings. Data was analysed both quantitatively and qualitatively. RESULTS: A total of 4253 publications were identified and 26 included. Most publications were from the last 5 years (n = 21), research (n = 24), Western Cape (n = 15) and focused on adherence clubs (n = 17), alternative pick-up-points (n = 14), home delivery (n = 5) and HIV (n = 17). The majority of alternative mechanisms were supported by a centralised dispensing and packaging system. New technology such as smart lockers and automated pharmacy dispensing units have been piloted. Patients benefited from these alternatives and had improved adherence. Available evidence suggests alternative mechanisms were cheaper and more beneficial than attending the facility to collect medication. CONCLUSION: A mix of options tailored to the local context and patient choice that can be adequately managed by the system would be ideal. More economic evaluations are required of the alternatives, particularly before going to scale and for newer technology.

The role of pharmacies in haematopoietic stem cell transplantation process: A nationwide survey by Gruppo Italiano Trapianto di Midollo Osseo.

WHAT IS KNOWN AND OBJECTIVE: The aim of this survey, conducted by the Gruppo Italiano per il Trapianto di Midollo Osseo (GITMO), was to evaluate the involvement of pharmacists in the haematopoietic stem cell transplant (HSCT) program in Italian adult and paediatric centres. METHODS: A 63-item online questionnaire was developed and sent to the Italian Transplant Programs on behalf of GITMO. RESULTS AND DISCUSSION: Overall, 54.7% of the Italian HSCT centres participated in the survey (88.5% adult, 7.7% paediatric, 3.8% mixed), of which 50% were in public hospitals and 50% affiliated with public universities. Just over 80% declared that a pharmacist is involved in the HSCT centre, and 86.5% reported the presence of a documentation system to signal of adverse events, accessible by physicians, nurses and pharmacists in 57.7%. Chemotherapy drugs were centralized in the pharmacy in 98.1% of HSCT centres, while parenteral nutrition was centralized in 55.8%. The use of off-label drugs was authorized by an internal committee and by the regional health authorities in 88.5% of the centres. On univariate analysis, few statistically significant differences were found on response frequencies between public hospitals and university centres or between HSCT centres performing only autologous stem cell transplantation versus other centres performing autologous and allogeneic stem cell transplantation. WHAT IS NEW AND CONCLUSION: This survey suggests that there is good collaboration between pharmacists and physicians and nurses in Italian HSCT transplantation centres. The enhancement of pharmacists dedicated to HSCT programs could improve some problems, for example, the centralization of parenteral nutrition.

Prevalence of drug-drug interactions in sarcoma patients: key role of the pharmacist integration for toxicity risk management.

BACKGROUND: The risk of drug-drug interactions (DDI) has become a major issue in cancer patients. However, data in sarcoma patients are scarce. We aimed to evaluate the frequency and the factors associated with DDI with antitumor treatments, and to evaluate the impact of a pharmacist evaluation before anticancer treatment. PATIENTS AND METHODS: We performed a retrospective review of consecutive sarcoma patients starting chemotherapy (CT) or Tyrosine kinase inhibitor (TKI). A pharmacist performed medication reconciliation and established an early toxicity risk assessment. Potential DDI with antitumor drugs were identified using Micromedex electronic software. RESULTS: One hundred and twenty-two soft-tissue and 80 bone sarcoma patients (103 males, median age 50 years,) were included before CT (86%) or TKI (14%). The median number of medications was 3; 34 patients (22% of patients with medication reconciliation) reported complementary medicine use. 37 potential DDI classified as major, were identified (12% of the 243 pre-therapeutic assessments). In multivariate analysis, TKI (p < 0.0001), proton pump inhibitor (p = 0.026) and antidepressant (p < 0.001) were identified as risk factors of DDI (p < 0.02). Only marital status (p = 0.003) was associated with complementary medicine use. A pharmacist performed 157 medication reconciliations and made 71 interventions among 59 patients (37%). In multivariate analysis, factors associated with pharmacist intervention were: complementary medicines (p = 0.004), drugs number (p = 0.005) and treatment with TKI (p = 0.0002) CONCLUSIONS: Clinical interventions on DDI are more frequently required among sarcoma patients treated with TKI than CT. Multidisciplinary risk assessment including a medication reconciliation by a pharmacist could be crucial to prevent DDI with TKI.

Impact of medication therapy management service on selected clinical and humanistic outcomes in the ambulatory diabetes patients of Tikur Anbessa Specialist Hospital, Addis Ababa, Ethiopia.

BACKGROUND: Diabetes mellitus (DM) patients are at increased risk of developing drug therapy problems (DTPs). The patients had a variety of comorbidities and complications, and they were given multiple medications. Medication therapy management (MTM) is a distinct service or group of services that optimize therapeutic outcomes for individual patients. The study assessed the impact of provision of MTM service on selected clinical and humanistic outcomes of diabetes patients at the diabetes mellitus clinic of Tikur Anbessa Specialized Hospital (TASH). METHODS: A pre-post interventional study design was carried out at DM clinic from July 2018 to April 2019. The intervention package included identifying and resolving drug therapy problems, counseling patients in person at the clinic or through telephone calls, and providing educational materials for six months. This was followed by four months of post-intervention assessment of clinical outcomes, DTPs, and treatment satisfaction. The interventions were provided by pharmacist in collaboration with physician and nurse. The study included all adult patients who had been diagnosed for diabetes (both type I & II) and had been taking anti-diabetes medications for at least three months. Patients with gestational diabetes, those who decided to change their follow-up clinic, and those who refused to participate in the study were excluded. Data were analyzed using Statistical Package for the Social Sciences (SPSS). Descriptive statistics, t-test, and logistic regressions were performed for data analyses. RESULTS: Of the 423 enrolled patients, 409 fulfilled the criteria and included in the final data analysis. The intervention showed a decrease in average hemoglobin A1c (HbA1c), fasting blood sugar (FBS), and systolic blood pressure (SBP) by 0.92%, 25.04 mg/dl, and 6.62 mmHg, respectively (p<0.05). The prevalence of DTPs in the pre- and post-intervention of MTM services was found to be 72.9% and 26.2%, respectively (p<0.001). The overall mean score of treatment satisfaction was 90.1(SD, 11.04). Diabetes patients of age below 40 years (92.84 (SD, 9.54)), type-I DM (93.04 (SD, 9.75)) & being on one medication regimen (93.13(SD, 9.17)) had higher satisfaction score (p<0.05). CONCLUSION: Provision of MTM service had a potential to reduce DTPs, improve the clinical parameters, and treatment satisfaction in the post-intervention compared to the pre-intervention phase.

Effects of a pharmacist-managed anticoagulation outpatient clinic in Taiwan: evaluation of patient knowledge, satisfaction, and clinical outcomes.

Objective: The study aimed to evaluate the improvement of patient knowledge of warfarin use, satisfaction with pharmacists, and the quality of international normalized ratio (INR) control after the implementation of an anticoagulant clinic (ACC) service.Methods: This was a prospective single-group pre- and post-comparison study. Patients who were at least 20 years of age and participated in a pharmacist-managed ACC service were enrolled from February 2012 to September 2015. Each participant completed a self-administered questionnaire before and after the ACC service to evaluate changes in warfarin knowledge. Another questionnaire was distributed after the ACC to evaluate participants' satisfaction with the pharmacist service in the ACC. The INR levels before and after the ACC intervention were obtained to calculate the proportion of time spent in the therapeutic INR range (time in therapeutic range, TTR). Paired t-tests were used to compare changes in participants' knowledge related to warfarin use. Multiple linear regressions were performed to explore the predictors associated with the participants' knowledge scores and TTR after the ACC intervention.Results: One hundred and forty-eight participants were enrolled in this study. A significant improvement (31.5%,p<0.001) in the knowledge of warfarin use was observed at the end of the ACC intervention. The interaction between warfarin and food was the most confusing factor for participants in warfarin use. More than 95% of the participants perceived a positive value of the pharmacist-managed ACC service. However, the consultation fee was the least satisfactory of the ACC service. The average TTR increased from 51.0±34.3% to 78.6±24.5% (p<0.001) after the ACC service was implemented. Participants' education levels and baseline knowledge scores were significant determinants associated with the knowledge improvement in the appropriate warfarin use (p<0.001).Conclusions: A pharmacist-managed ACC improved patient knowledge of warfarin use and INR control, and led to high satisfaction with the pharmacist service in the ACC in Taiwan. Pharmacists should focus on patients with lower education levels to facilitate their understanding of the appropriate warfarin use for better health outcomes.

Perspectives of nurses' role in interprofessional pharmaceutical care across 14 European countries: A qualitative study in pharmacists, physicians and nurses.

OBJECTIVES: To understand healthcare professionals' experiences and perceptions of nurses' potential or ideal roles in pharmaceutical care (PC). DESIGN: Qualitative study conducted through semi-structured in-depth interviews. SETTING: Between December 2018 and October 2019, interviews were conducted with healthcare professionals of 14 European countries in four healthcare settings: hospitals, community care, mental health and long-term residential care. PARTICIPANTS: In each country, pharmacists, physicians and nurses in each of the four settings were interviewed. Participants were selected on the basis that they were key informants with broad knowledge and experience of PC. DATA COLLECTION AND ANALYSIS: All interviews were conducted face to face. Each country conducted an initial thematic analysis. Consensus was reached through a face-to-face discussion of all 14 national leads. RESULTS: 340 interviews were completed. Several tasks were described within four potential nursing responsibilities, that came up as the analysis themes, being: 1) monitoring therapeutic/adverse effects of medicines, 2) monitoring medicines adherence, 3) decision making on medicines, including prescribing 4) providing patient education/information. Nurses' autonomy varied across Europe, from none to limited to a few tasks and emergencies to a broad range of tasks and responsibilities. Intended level of autonomy depended on medicine types and level of education. Some changes are needed before nursing roles can be optimised and implemented in practice. Lack of time, shortage of nurses, absence of legal frameworks and limited education and knowledge are main threats to European nurses actualising their ideal role in PC. CONCLUSIONS: European nurses have an active role in PC. Respondents reported positive impacts on care quality and patient outcomes when nurses assumed PC responsibilities. Healthcare professionals expect nurses to report observations and assessments. This key patient information should be shared and addressed by the interprofessional team. The study evidences the need of a unique and consensus-based PC framework across Europe.

Clinical outcomes of pharmaceutical care intervention in HIV positive patients with hypertension: A randomized controlled study.

WHAT IS KNOWN AND OBJECTIVE: Pharmaceutical care (PC) has been shown to improve clinical outcomes in hypertensive patients as well as in people living with HIV (PLWHV). The objective of this study was to evaluate the impact of PC on blood pressure (BP) control, viral load and adherence to medications in hypertensive PLWHV. METHODS: This was a prospective, randomized controlled study conducted in the University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria. Eligible ambulatory patients were randomized equally to two study arms. The control arm (CA) received the traditional care offered at the HIV clinic; the intervention arm (IA) received the traditional care in addition to PC by the research pharmacist, which included structured education/counselling. BP and self-reported medication adherence were measured at baseline, 6 months and 12 months. Viral load was obtained at baseline and after 12 months. Data were analysed with spss, version 25.0. RESULTS AND DISCUSSION: Of the 206 participants initially randomized, 182 (91 in each study arm) completed the 12-month follow-up. No significant differences existed in both arms concerning socio-demographic/clinical characteristics of participants at baseline (p > 0.05). After 12 months, BP control was significantly higher in the IA (53.4% vs. 25.2%; p < 0.001, adjusted odds ratio, aOR = 3.20 (95% CI 1.59-6.44). Systolic BP reduced by 0.9 mmHg from baseline in the CA (p = 0.668) and by 16.67 mmHg from baseline value in the IA (p < 0.001). Diastolic BP increased by 1.9 mmHg in the CA (p = 0.444), but reduced by 7.0 mmHg in the IA (p < 0.001). No significant differences were observed in the change from baseline in the proportion with undetectable plasma viral load (UPVL) in both groups (p > 0.05). PC led to an increase in mean adherence to antiretroviral drugs (Δ = 0.55; p = 0.015), and an increase in mean adherence to antihypertensive drugs (Δ = 2.32; p < 0.001) in the IA. WHAT IS NEW AND CONCLUSION: To our knowledge, this is the first prospective randomized controlled study evaluating the impacts of PC on clinical outcomes in hypertensive PLWHV with a 12-month follow-up. Our results show that PC significantly improved BP control and adherence to antiretroviral and antihypertensive medications, but had no significant effect on viral load in HIV positive patients with hypertension. Providers of care for PLWHV should leverage the established HIV treatment successes for promoting adherence to treatment for common comorbidities like hypertension in PLWHV in order to improve clinical outcomes.

AMCP Partnership Forum: Preparing for and managing rare diseases.

Despite the opportunity for large health gains, there are many challenges associated with rare disease therapies. Among these are striking the appropriate balance between the urgency to respond to patient needs with the uncertainty that is often inherent in rare disease therapy datasets leading to concerns with developing and interpreting clinical data; uncertainty around financial impact, value determination, and affordability; and variation in approach to coverage and potential effects on access. To discuss these challenges and opportunities to address them, AMCP held a virtual multidisciplinary stakeholder forum on September 8-10, 2020. Forum participants represented diverse sectors of the health care industry, including integrated delivery systems, health plans, pharmacy benefit managers, employer groups, biopharmaceutical companies, patient advocacy organizations, health policy researchers, and consulting firms; they evaluated strategies to plan for and manage rare disease therapies and recommended best practices and next steps. DISCLOSURES: This forum was sponsored by the following: AstraZeneca, Dicerna, Genentech, National Pharmaceutical Council, Novo Nordisk, Pfizer, Precision Value, Sanofi, Sarepta Therapeutics, Seattle Genetics, Spark Therapeutics, and Takeda. These proceedings were prepared as a summary of the forum to represent common themes; they are not necessarily endorsed by all attendees nor should they be construed as reflecting group consensus.

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.