Pharmacy Committee Research Articles

PNS144 Trends in US Payer Decision Making: Resources, Processes, Timing, and Collaborations

The objectives for this research are to: 1) understand how payers gather and organize decision resources; 2) identify and rank external influencers in reimbursement decision making; and, 3) explore internal processes for reimbursement decisions. Senior-level decision-makers (n=10) from US payer organizations (n=9) representing 206.1 million member lives were recruited in May 2020 to participate in a web survey (9 topics) and qualitative telephone interview (approximately 20 minutes). Advisers were required to have a high level of knowledge surrounding formulary decision-making, clinical pathways and medical policy development, and manufacturer contracting. Descriptive statistics (e.g. Surveymonkey ranking scores, weighted means, % of mentions) and contextual analysis were used to analyze the results. Subanalyses were conducted by payer archetype (integrated delivery network, pharmacy benefit manager, regional/national managed care organization). Payers use the following information sources most frequently: government organizations (e.g. CDC, NIH) (4.1), research at own institution (3.9), and peer-reviewed journals (3.8). Internally developed HCRU/disease costing analyses most frequently (90%) use data or survey/registry based on health plan data. The most influential organizations to payers are: CMS rules (100%), internal guidelines (100%), and KOL input (90%). Pharmacy and Therapeutics (P&T) committees are frequently comprised of pharmacy directors (100%), medical directors (90%), and independent practicing physicians (80%). A majority (60%) of P&T committees meet quarterly, most often discussing formulary management and drug-use policies (100%). Payers report that newly approved drugs are not frequently reviewed immediately upon approval (70%) and often/always delayed (50%). Only 60% report proactively communicating decisions to provider networks. Variation on decision resource sources, process, and timing exists among US payer archetypes and organizations. While more payers are beginning to rely on analysis from external organizations and their member data, the core focus still remains on gathering and analyzing clinical and safety evidence from literature and consensus-developed guidelines.

Is Real-World Evidence Used in P&T Monographs and Therapeutic Class Reviews?

Payers are faced with making coverage and reimbursement decisions based on the best available evidence. Often these decisions apply to patient populations, provider networks, and care settings not typically studied in clinical trials. Treatment effectiveness evidence is increasingly available from electronic health records, registries, and administrative claims. However, little is known about when and what types of real-world evidence (RWE) studies inform pharmacy and therapeutic (P&T) committee decisions. To evaluate evidence sources cited in P&T committee monographs and therapeutic class reviews and assess the design features and quality of cited RWE studies. A convenience sample of representatives from pharmacy benefit management, health system, and health plan organizations provided recent P&T monographs and therapeutic class reviews (or references from such documents). Two investigators examined and grouped references into major categories (published studies, unpublished studies, and other/unknown) and multiple subcategories (e.g., product label, clinical trials, RWE, systematic reviews). Cited comparative RWE was reviewed to assess design features (e.g., population, data source, comparators) and quality using the Good ReseArch for Comparative Effectiveness (GRACE) Checklist. Investigators evaluated 565 references cited in 27 monographs/therapeutic class reviews from 6 managed care organizations. Therapeutic class reviews mostly cited published clinical trials (35.3%, 155/439), while single-product monographs relied most on manufacturer-supplied information (42.1%, 53/126). Published RWE comprised 4.8% (21/439) of therapeutic class review references, and none (0/126) of the monograph references. Of the 21 RWE studies, 12 were comparative and assessed patient care settings and outcomes typically not included in clinical trials (community ambulatory settings [10], long-term safety [8]). RWE studies most frequently were based on registry data (6), conducted in the United States (6), and funded by the pharmaceutical industry (5). GRACE Checklist ratings suggested the data and methods of these comparative RWE studies were of high quality. RWE was infrequently cited in P&T materials, even among therapeutic class reviews where RWE is more readily available. Although few P&T materials cited RWE, the comparative RWE studies were generally high quality. More research is needed to understand when and what types of real-world studies can more routinely inform coverage and reimbursement decisions. This project was funded by the National Pharmaceutical Council. Hurwitz, Brown, Peters, and Malone have nothing to disclose. Graff is employed by the National Pharmaceutical Council Part of this study was presented as a poster presentation at the AMCP Managed Care & Specialty Pharmacy 2016 Annual Meeting; April 19-22, 2016; San Francisco, CA. Study concept and design were primarily contributed by Malone and Graff, along with Hurwitz and Brown. All authors participated in data collection, and data interpretation was performed by Malone, Hurwitz, and Graff, with assistance from Brown and Peters. The manuscript was written primarily by Hurwitz and Malone, along with Graff, Brown, and Peters, and revised by Malone, Brown, Peters, Hurwitz, and Graff.

A survey on student pharmacists' knowledge, attitude and perceptions about drug and poison information elective rotation in Saudi Arabia

Background: Drug and poison information (DPI) elective rotation develops interns into drug information experts, educators, and policymakers. DPI is an important pharmaceutical service built on technical skills, knowledge and expertise. Aim: A pre- and post-rotation survey to assess the current knowledge, attitude and perceptions of student pharmacists about DPI rotation. Methods: Three cohorts of student pharmacists responded to the survey, which was composed of closed- and open-ended questions. Descriptive statistics, McNemar's test, and Chi-square test were utilised for data analysis. Results: Knowledge of primary resources increased from 37.2% to 85.6% at the end of the rotation. In the beginning, only 13.8% were aware of Pharmacy and Therapeutic committee related activities, and 15.9% considered identification adverse drug reactions as auxiliary responsibilities. However, the proportion increased to 82% and 83.5% by the end of the rotation. Both at the beginning and the end, student pharmacists felt the training was essential to appraise literature. Twice the number of respondents expressed that there were job opportunities in the DPI centre post-rotation compared with the pre-rotation response (p<0.001). The perception of responding to queries at their own pace was significantly reversed post-rotation (p<0.001). A significant association was found between opportunities in DPI centre and motivation to choose this rotation (p<0.05). Also, knowledge of primary resources with previous research was significantly associated (p<0.05). Conclusion: Interventions such as journal club, guest lectures and visit to the DPI centre significantly improved the knowledge, attitude and perceptions of student pharmacists towards this DPI rotation.

Cost savings of biosimilars in oncology: A single institution experience.

10 Background: Biosimilar medications have increasingly gained regulatory approvals in recent years. Numerous conditions in the fields of hematology, oncology, rheumatology, and endocrinology have a biosimilar treatment option available. Some biosimilar agents can be obtained at a significantly lower cost than reference medications. Methods: Intermountain Healthcare Oncology Pharmacy and Therapeutics (P&T) committee manages and maintains the formulary of accepted drugs. The committee consists of pharmacists, medical oncologists and oncology nurses. Biosimilar medications were approved in place of reference medications for the following: pegfilgrastim, bevacizumab, trastuzumab, and rituximab. Results: Annually, we administer about 6,450 combined doses of pegfilgastrim, bevacizumab, trastuzumab, and rituximab. Assuming 70% conversion from the reference medication to biosimilar agent, transitioning from the above listed reference medications to biosimilar would save an estimated $6.3 million annually (Table). This includes a $1.75 million savings from transitioning to rituximab alone. In addition, transitioning trastuzumab from a single dose vial to multi-dose vials is estimated to save an addition $730,000. Conclusions: Biosimilar agents can reduce the cost of oncology care to patients treated at our institution. We are utilizing biosimilar agents as part of our ongoing mission to decrease the financial toxicity of treatment for patients with cancer. [Table: see text]

S3205 Development, Testing, and Implementation of an Opioid-Sparing Proactive Pain Control Order Set for Hospitalized Adults With IBD

INTRODUCTION: In patients with inflammatory bowel disease (IBD), opioid-use is associated with an increased risk of poor quality of life, infection and death, yet opioids remain commonly prescribed. Many patients are first exposed to opioids during a hospitalization and continue them after hospital discharge. Therefore, opioid reduction strategies in hospitalized patients with IBD are desirable. We aimed to develop an opioid-sparing pain control strategy for hospitalized adults with IBD. METHODS: We conducted a systematic literature review and presented it to a panel of pharmacists, IBD specialists, and pain specialists to identify non-opioid medication regimens for pain in IBD. The panel iteratively developed an algorithm for scheduled and as-needed therapies to treat mild, moderate, and severe pain in patients with IBD. This protocol was used in a limited number of patients to assess feasibility and obtain patient feedback. Based on feedback, small changes were made. The final algorithm was presented to the pharmacy & therapeutics committee, and programmed as a 1-click order set within the electronic health record (Epic®). RESULTS: We developed an algorithm that includes scheduled acetaminophen, celecoxib, gabapentin, and as-needed lorazepam and hydromorphone tailored to mild, moderate and severe pain (Table 1). This algorithm was accepted and approved by a multidisciplinary therapeutics committee, and developed into a single-click electronic order set. CONCLUSION: We developed an evidence-based opioid-sparing algorithm for pain control in hospitalized patients with IBD. This proactive approach using scheduled non-opioid pain medications and as-needed opiates has the potential to both improve pain and reduce opioid use in the hospital. Testing of this proactive algorithm against usual care in a randomized, controlled trial is warranted.Table 1.: Proactive Inpatient Narcotic-Sparing Protocol

PNS63 A Cross-Sectional Study About Medications Wastage In Saudi Arabia

This study aimed to investigate the main reasons behind medication wastage and how the issue is perceived by healthcare workers. A questionnaire was sent out via email to healthcare professionals working in pharmacy and supply chain departments. The data collection took three months to complete then analyze by descriptive statistics. The sample consisted of 123 participants. Around 92% of respondents believed that ideally internal committees should calculate actual annual requirements considering both medicine consumption in the previous year and amount wasted. About 91% of respondents asserted that procurement of medicines should not be solely based on the demands of contracted doctors except in some rare cases, for limited amounts. Almost 65% of the participants believed that medicines should preferably be prescribed for no more than two months; 75% of the participants thought the pharmacy and therapeutics committee should consider drug efficacy and price when planning to add a new medicine to the hospital formulary. Nearly 58.5% of the respondents believed that inspectors should carry out stock monitoring and hospital inspections every three months. This study concluded that medication wastage results in immense resource drainage and represents a significant burden to healthcare institutions. Stakeholders should promote awareness about medication wastage on a top priority basis. One of the suggested solutions is to minimize the amount of medications in prescriptions and accurately estimate drug requirements at healthcare facilities. Additionally, frequent reviews should be conducted to ensure that the best medicines are stocked in each therapeutic group based on efficacy, safety, and price.

Ferric Derisomaltose.

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433.

Strategies Implemented by Public Institutions to Approach the Judicialization of Health Care in Brazil: A Systematic Scoping Review

BackgroundThe judicialization of health care is a social claim concerning the right to the access to health care. It usually occurs due to gaps in public policy or failures in its application. In Brazil, several public institutions have implemented strategies to approach this phenomenon. However, these strategies have not yet been systematized into functional categories.ObjectiveTo categorize and analyze the strategies implemented by public institutions in Brazil to approach the judicialization of health care.MethodA systematic scoping review was developed following the method proposed by the Joanna Briggs Institute. The descriptor ‘judicialization of health’ was used to conduct the searches for studies in 18 electronic databases and other types of documents in the gray literature until March 2019. Documents containing the reports of strategies implemented in public institutions to approach the judicialization of health care in Brazil were included. Two independent reviewers assessed the eligibility of the documents and extracted the data. The strategies identified were categorized using definitions from the World Health Organization and existing Brazilian legislation.ResultsSeventy eight implemented strategies were identified and organized into nine categories: i. Technical support to the judiciary; ii. State health committees; iii. Organization of assistance; iv. Compliance with court orders, v. Computerized information systems; vi. Administrative proceeding; vii. Defense of the public authority; viii. Pharmacy and therapeutics committee; ix. Alternative dispute resolution. These categories are not mutually exclusive and often act in concert or complement each other’s activities. They represent services either existing or provided for in legal provisions by the public administration to meet various types of demands.ConclusionsThe categories proposed to approach the judicialization of health care represent some of the recommendations for qualifying public administration or are provided for in Brazilian legislation, or both. The existence of recommendations and legislation facilitate, but do not guarantee, the implementation of strategies by public institutions.

Indirect comparison of glucagon like peptide-1 receptor agonists regarding cardiovascular safety and mortality in patients with type 2 diabetes mellitus: network meta-analysis

BackgroundThe cardiovascular outcome trials (CVOTs) have shown that glucagon like peptide-1 receptor agonists (GLP1RAs) have varying degrees of cardiovascular (CV) safety in patients with type 2 diabetes mellitus (T2DM.) The lack of any head-to-head comparative trials among GLP1RAs urged the need for an indirect comparison of these agents. Therefore, this study was conducted to indirectly compare the CV safety and mortality effects among different GLP1RAs in patients with T2DM using network meta-analysis (NMA).MethodsMedline was searched to identify GLP1RA CVOTs to date. The outcomes of interest were CV death, myocardial infarction (IM), stroke, and death from any cause. An NMA with binomial likelihood logit link model was used for the binary outcomes. We conducted both fixed effects and random effects models for each outcome, and selected the best model based on the deviance information and the average posterior residual deviance. This NMA was reported in accordance with the preferred reporting items for systematic reviews and meta-analyses (PRISMA-NMA).ResultsA total of seven GLP1RA CVOTs were included having 56,004 patients. The NMA results showed that oral semaglutide was statistically better than exenatide (OR 0.47, 95% CI 0.21–0.99), dulaglutide (OR 0.46, 95% CI 0.20–0.97), albiglutide (OR 0.45, 95% CI 0.19–0.97), lixisenatide (OR 0.43, 95% CI 0.19–0.92) in reducing CV death events. No significant differences were detected between most of the treatments regarding reducing death from any cause, MI and stroke events. The ranking results showed that oral semaglutide had the highest probability to be ranked first (> 90%) in reducing CV death and death from any cause. Moreover, once weekly semaglutide had the highest probability to be ranked first in reducing MI and stroke events.ConclusionThe GLP1RAs have shown significant benefits in terms of CV safety. The indirect comparison and ranking probability results have shown that one weekly semaglutide and oral semaglutide seems to be the preferred option in patients with T2DM and established or at high risk of CVD. This result can aid health care providers, pharmacy and therapeutics committees in hospitals, and insurance companies when deciding which GLP1RA to start or add to their formulary.

Is P&T Ready to Add Rapid Cycle Analytics to Formulary?

Purpose: The intent of this article is to evaluate a novel approach, using rapid cycle analytics and real world evidence, to optimize and improve the medication evaluation process to help the formulary decision making process, while reducing time for clinicians. Summary: The Pharmacy and Therapeutics (P&T) Committee within each health system is responsible for evaluating medication requests for formulary addition. Members of the pharmacy staff prepare the drug monograph or a medication use evaluation (MUE) and allocate precious clinical resources to review patient charts to assess efficacy and value. We explored a novel approach to evaluate the value of our intravenous acetaminophen (IV APAP) formulary admittance. This new methodology, called rapid cycle analytics, can assist hospitals in meeting and/or exceeding the minimum criteria of formulary maintenance as defined by the Joint Commission Standards. In this particular study, we assessed the effectiveness of IV APAP in total hip arthroplasty (THA) and total knee arthroplasty (TKA) procedures. We assessed the correlation to same-stay opioid utilization, average length of inpatient stay and post anesthesia care unit (PACU) time. Conclusion: We were able to explore and improve our organization's approach in evaluating medications by partnering with an external analytics expert to help organize and normalize our data in a more robust, yet time efficient manner. Additionally, we were able to use a significantly larger external data set as a point of reference. Being able to perform this detailed analytical exercise for thousands of encounters internally and using a data warehouse of over 130 million patients as a point of reference in a short time has improved the depth of our assessment, as well as reducing valuable clinical resources allocated to MUEs to allow for more direct patient care. This clinically real-world and data-rich analytics model is the necessary foundation for using Artificial or Augmented Intelligence (AI) to make real-time formulary and drug selection decisions.

Pharmacy and Therapeutics Committee Preparedness Plan for COVID-19.

As the Pharmacy and Therapeutics (P&T) committee acts as an advisory committee on therapeutic options, it is important during pandemics, such as the current Coronavirus disease 2019 pandemic, to quickly search the evidence, be able to select the most appropriate therapies despite the limited evidence, and make appropriate decisions related to which drugs to procure and stock. Potential therapies and recommendations to the P&T committee at a large healthcare institution as means of a preparedness plan are reviewed here.

Care Right Where You Are: Treating in Place to Avoid an Emergency Department Visit or Hospitalization

Care Right Where You Are: Treating in Place to Avoid an Emergency Department Visit or Hospitalization

Is it time to consider a medical marijuana policy?

As more and more states approve the use of medical marijuana, hospitals will surely be admitting patients who rely on cannabis for medicinal purposes. Upon admission, institutions will be faced with the decision to allow patients to continue their cannabis as an inpatient or disallow its use for fear of legal repercussions. Therefore, careful planning and the development of policies to guide clinicians are needed as use of medical cannabis becomes more widespread. “There is an ever-increasing amount of research linking cannabis to positive treatment outcomes,” Benjamin Caplan, MD, founder of CED Clinic in Massachusetts, told Pharmacy Today. “The efficacy of cannabis, particularly when it is used as a component of a treatment plan for chronic pain, and its potential to be a replacement for opioids, makes it especially appealing to use in select patients,” he said. “Unfortunately, there are very few hospitals in the United States that formally embrace cannabis as a helpful option for their patients.” Caplan explained that as long as cannabis remains a Schedule 1 substance per the Controlled Substance Act, many hospitals fear they may violate federal rules that prohibit them from having these types of substances on the premises. “Hospitals and their clinicians face conflict, either to condone the use of cannabis for their patients’ well-being, yet violate and risk losing their federal contracts, or to withhold the medicine from patients and uphold their formal obligations, suffering potential risk and ethical liability to their patients,” Caplan said. To address the issue of medical cannabis in the hospital setting, the Minnesota Hospital Association (MHA) has released three sample policies that may be useful to facilities and clinicians. The sample templates, available online, focus on the following three scenarios: 1) not allowing use of medical cannabis in the hospital; 2) allowing its use and administration by patients; or 3) allowing its use and administration by nurses. MHA noted that committees such as the pharmacy and therapeutics committee, physician committees, legal committees, and/or executive committees should all work together to determine appropriate processes for patients using medical cannabis. Decisions may be based on patient characteristics and needs, as well as staff and legal considerations. There is no single standard for all Minnesota hospitals, with some prohibiting its use and others allowing it only in select situations. They key is that policies are put in place to guide clinicians before they encounter these patients. Caplan stressed that misconceptions and misinformation about cannabis have permeated both the popular and medical cultures for decades. He described the mountain of scientific literature and data that exist today in support of its abundant medicinal qualities, of which many clinicians seem to be unaware. He also commented on some of the safety considerations associated with cannabis use, such as select drug–drug interactions and effects on metabolism and the heart. “Plant cannabinoids are degraded by the cytochrome P450 hepatic enzymes, and as with other medications that are processed hepatically, the presence of enzyme regulators, whether inhibitors or activators, affects the duration and strength of plant cannabinoids,” Caplan said. “Generally speaking, patients taking medications or foods that inhibit cytochrome P450 may have prolonged or stronger effects from the same cannabis consumed without enzymatic inhibition, whereas enzyme activators will have the opposite results.” In addition to drug–drug interactions that may be affected by hepatic degradation, Caplan noted that chronotropic effects and cannabis’s activation of cardiomyocytes deserve consideration. “While the majority of cannabis patients are not at elevated risk related to its stimulating effects on normal cardiac function, patients with sensitive, damaged, or at-risk physiology would likely benefit from a cautious approach to self-medicating or guidance from a supportive expert.” Hospital pharmacists should be aware of and familiar with policies that address the use of medical cannabis in the inpatient setting. If use is allowed, pharmacists can play an essential role in parsing therapeutics, discussing appropriate use with their patients and other care team members, and evaluating patients for potential drug–drug interactions and adverse effects.

Privileges of Pharmacist in Saudi Arabia: Administration and Management

PTB Reports,2020,6,1,7-12.DOI:10.5530/PTB.2020.6.2Published:March 2020Type:Research ArticleAuthors:Faisal Al-Otaibi, Mohamed Soliman Imam, Randa Mansour Abdel-Sattar Ahmed, Amsha Alotaibi, Asma Alotaibi, Amal Alotaibi, Wesam Alsuwaid, and Yousef Ahmed Alomi Author(s) affiliations:Faisal Al-Otaibi, Ph. D, Assistant Professor, College of Pharmacy, Pharmacy Patrice Department, Shaqra University, Saudi Arabia. Mohamed Soliman Imam, Ph. D, Assistant Professor, Dean, College of Pharmacy, Shaqra University, Saudi Arabia. Randa Mansour Abdel-Sattar Ahmed, Ph.D, Biomedical Science Department, College of Pharmacy, Shaqra University, Saudi Arabia. Amsha Alotaibi, Pharm D, Clinical Pharmacist, College of Pharmacy, Pharmacy Patrice Department, Shaqra University, Riyadh, Saudi Arabia. Asma Alotaibi, Pharm D, Clinical Pharmacist, College of Pharmacy, Pharmacy Practice Department, Shaqra University, Saudi Arabia. Amal Alotaibi, Pharm D, Clinical Pharmacist, College of Pharmacy, Shaqra University, Saudi Arabia. Wesam Alsuwaid, Pharm D, Clinical Pharmacist, College of Pharmacy, Pharmacy Practice Department, Shaqra University, Saudi Arabia. Yousef Ahmed Alomi*, BSc. Pharm, MSc. Clin Pharm, BCPS, BCNSP, DiBA, CDE, Critical Care Clinical Pharmacists, TPN Clinical Pharmacist, Freelancer Business Planner, Content Editor and Data Analyst, P.O.BOX 100, Riyadh, Saudi Arabia. Abstract:Objectives: To explore the privileges of pharmacists through the pharmacy administration and management in Saudi Arabia. Methods: This is a 4-month cross-sectional survey regarding the privileges of pharmacists in Saudi Arabia. The study consisted of two parts: the first part collected demographic information and the second part comprised a questionnaire with 28 questions divided into 4 domains. The questions were derived from previous literature and from the regulatory standards of the American Society of Health-System Pharmacists (ASHP). The four domains were as follows: privilege management and resources, pharmacist prescribing and therapeutic interchange, clinical and administration privilege and drug monitoring and healthcare education. The responses were obtained using a 5-point Likert response scale system with close- and open-ended questions. The survey questionnaire was distributed in an electronic format to the hospital’s director of pharmacy of each hospital in Saudi Arabia. In this study, we analyzed pharmacist’s privilege in Saudi Arabia with regard to the pharmacy administration and management. All data were obtained through the Survey Monkey system. Results: The survey was distributed to 36 hospitals. The administration-related elements of pharmacist privilege with maximum score were policies and procedures of pharmacist’s privilege (3.88 (77.6%)) followed by the vision of pharmacist privilege (3.57 (71.4%)) and pharmacist privilege in the job description (3.56 (71.2%)). The average score of pharmacist privilege in the hospital committees was 3.47 (69.40%). Most of the committees having pharmacist privilege was the patient or medication safety committee (4.09 (81.8%)) followed by the pharmacy and therapeutic committee (4.06 (81.2%)) and quality management committee (4.06 (81.2%)). The average score of pharmacist privilege in the teams was 3.44 (68.85%). The majority of the teams having pharmacist privilege was antibiotics team (4.25 (85%)) followed by anticoagulation team (3.86 (77.2%)) and IV therapy team (3.81 (76.2%)). Conclusion: The privileges of a pharmacists is inadequate in the Kingdom of Saudi Arabia. Future programs should target to improve the healthcare system and expand pharmacists’ role in the hospital practice. This might improve the pharmaceutical care services and patient outcomes and prevent drug-related problems and unnecessary economic expenditure on the healthcare practice in Saudi Arabia. Keywords:Administration, Management, Pharmacist, Privileges, Saudi ArabiaView:PDF (213.19 KB) PDF PDF Images Responders’ experiences of pharmacy practice

Top Evidentiary Gaps in Managed Care Pharmacy: A Research Agenda.

Research agendas play valuable roles in clearly identifying high-priority topics that reflect potential to improve health care quality. The purpose of this report is to present work completed by the Academy of Managed Care Pharmacy (AMCP) and AMCP Foundation Joint Research Committee. This committee set forth to develop a research agenda for our 2 organizations that focuses on critical evidence needs in managed care pharmacy. This document reviews results from 2 surveys that were conducted to better understand unmet research needs within managed care pharmacy and to inform professional efforts of managed care pharmacists. The first survey collected qualitative data from key opinion leaders (KOLs) regarding the top evidentiary gaps in managed care pharmacy and barriers to closing those gaps. The second survey was sent to AMCP members and AMCP Foundation stakeholders, used a mixed methods quantitative-qualitative design, and incorporated concepts from initial KOL responses. The key outcome from these proceedings is the research agenda, which identifies and prioritizes 4 evidentiary gaps in managed care pharmacy: (1) real-world evidence to inform managed care pharmacy decision making, (2) value-based models in managed care pharmacy to address total cost of care, (3) impact of benefit design or utilization management strategies on patient outcomes, and (4) impact of direct patient care services provided by managed care pharmacy on patient outcomes. The agenda was intended to be broad and will evolve over time. AMCP and the AMCP Foundation hope that this research agenda inspires the AMCP membership, researchers, and funding agencies to close these gaps in knowledge and understanding. DISCLOSURES: Chairs and members of the Joint Research Committee oversaw and conducted the work outlined in this report with the support of AMCP and the AMCP Foundation. No outside funding was received. Gembarski, Couto, Wilson, and Eichenbrenner declare no conflicts of interest, real or apparent, with any product or service mentioned in this report. Gembarski is employed by BCBS Michigan; Couto is employed by Cigna; Wilson is employed by HealthCore, a wholly owned subsidiary of Anthem; and Eichenbrenner is employed by the AMCP Foundation.

Role and Structure of Pharmacy and Therapeutic Committee concern to Pharmacist: Short Review

Role and Structure of Pharmacy and Therapeutic Committee concern to Pharmacist: Short Review

Bacillus Calmette-Guérin Packaged for Percutaneous Vaccination Can Be Safely Used for Intravesical Instillation in Patients with Urothelial Carcinoma of the Bladder.

Bacillus Calmette-Guérin production is limited worldwide with stuttering shortages affecting patient access. Our institution received 50 vials of bacillus Calmette-Guérin labeled for percutaneous administration, and upon discussion with our clinical team and approval by the Pharmacy and Therapeutics Committee we used the percutaneous formulation in place of the intravesical formulation. We report our experience. Between February and April 2019 patients were treated with a third of a vial dose either with percutaneous or intravesical bacillus Calmette-Guérin. American Urological Association Symptom Score and Quality of Life survey and an additional 6-question survey (querying presence of suprapubic pain, hematuria, fevers, malaise, skin rashes, testicular/groin pain) were administered. Statistical analyses comparing the 2 groups were performed with SPSS version 22 software. A total of 30 patients with 73 intravesical instillations were evaluated with 34 patients receiving intravesical and 39 percutaneous bacillus Calmette-Guérin. We found no significant differences when comparing intravesical vs percutaneous bacillus Calmette-Guérin groups in terms of American Urological Association Symptom Score (6.1 vs 6.9, p=0.177), Quality of Life score (1.3 vs 1.7, p=0.132), fevers (2.9% vs 0%, p=0.300), hematuria (14.7% vs 2.8%, p=0.075), suprapubic pain (10.1% vs 4.3%, p=0.129), skin rashes (1.4% vs 0%, p=0.307) and feeling of general fatigue and malaise (15.7% vs 8.6%, p=0.126). Intravesical instillation of percutaneous bacillus Calmette-Guérin appears to be a safe alternative to intravesical bacillus Calmette-Guérin during times of shortage. Development of additional strains, use of alternative intravesical therapies and incentivizing bacillus Calmette-Guérin production through policy change and/or alternative funding may also help avoid bacillus Calmette-Guérin supply shortages in the future.

National Survey of Pharmacy and Therapeutic Committee in Saudi Arabia: Formulary Management System

International Journal of Pharmacology and Clinical Sciences,2019,8,4,227-231.DOI:10.5530/ijpcs.2019.8.50Published:December 2019Type:Research ArticleAuthors:Yousef Ahmed Alomi, Sultan Mohammed Al-Jarallah, Rasha Abdelsalam Elshenawy, and Faiz A Bahadig Rph Author(s) affiliations:Yousef Ahmed Alomi*, The Former General Manager of General Administration of Pharmaceutical Care, The Former Head, National Clinical Pharmacy and Pharmacy Practice, The Former Head, Pharmacy R & D Administration, Ministry of Health, Riyadh, SAUDI ARABIA. Sultan Mohammed Al-Jarallah, Head, Ambulatory Care Pharmacy, Oncology and Hematology Clinical Pharmacist, Pharmaceutical Care Department, Security Forces Hospital, Riyadh, SAUDI ARABIA. Rasha Abdelsalam Elshenawy, BCS. Pharm. BCPS (AQ-ID), CPHQ, M.Sc., TQM (AUC), SIDP, CEO of FADIC, Ministry of Health, Makkah, SAUDI ARABIA. Faiz A Bahadig Rph, Informatics Pharmacist, Pharmaceutical Care Department, King Abdulaziz Medical City-WR-Jeddah, Ministry of National Guard, SAUDI ARABIA. Abstract:Objective: Formulary management is an integrated patient care process which enables physicians, pharmacists and other healthcare professionals to work together to promote clinically sound cost-effective medication therapy and positive therapeutic outcomes. Effective use of healthcare resources can minimize overall medical costs, improve patient access to more affordable care and provide an improved quality of life. A formulary not only includes a list of medications and medication-associated products but also includes medication-use policies, important ancillary drug information, decision support tools and organizational guidelines. Therefore, in this study, we aimed to provide the guiding principles for the Formulary Management System at Ministry of Health (MOH) hospitals in Saudi Arabia. Methods: This is a 4-month cross-sectional national survey of Pharmacy and Therapeutic Committee at MOH hospitals in Saudi Arabia. The survey consisted of two parts: the first part collected demographic information and the second part contained 93 questions divided into four domains. The scope, structure and responsibilities, the formulary management system, the evaluation of drug formulary and decision-making and the committee meetings organization and management. The electronic survey was distributed to 50 drug information centers at MOH hospitals. It analyzed the formulary management system at MOH hospitals in Saudi Arabia through Survey Monkey system. Results: A total of 50 drug information centers responded to our questionnaire. The statement with highest score was related to the committee formulary system of medications usage through ensuring the safety of prescribing, distribution, administration and monitoring of medications (3.8); the process for managing drug product shortages (3.76); and the medications are requested for the addition or deletion from the drug formulary (3.68). Most of the hospitals had an open drug formulary (30 (60%)), with remaining responders having closed drug formulary (20 (40%)) with the total number of medications in the drug formulary (300–899) at 32 (64%) of the responded hospitals. The average score of type of method related to drug usage evaluation statements was 3.36, with the statement with high average score was review of medication error report (3.94) and review of medication sentinel incident reports (3.48), whereas the statement with lowest score was an investigational drug therapy approved (2.88). Conclusion: Two-thirds of the hospitals had open drug formulary. Drug utilization evaluation system should review for the majority of the hospital. update the formulary management system required with close monitoring for all MOH hospitals in Saudi Arabia. Keywords:Formulary Management System, Ministry of Health, National Pharmacy and Therapeutic Committee, Saudi ArabiaView:PDF (202.75 KB) PDFClick here to download the PDF file. Images National Survey of Pharmacy and Therapeutic Committee in Saudi Arabia: Formulary Management System

National Survey of Pharmacy and Therapeutic Committee in Saudi Arabia: Evaluation of Drug Formulary and Decision-Making

International Journal of Pharmacology and Clinical Sciences,2019,8,4,232-236.DOI:10.5530/ijpcs.2019.8.51Published:December 2019Type:Research ArticleAuthors:Yousef Ahmed Alomi, Sultan Mohammed Al-Jarallah, Rasha Abdelsalam Elshenawy, and Faiz A Bahadig Rph Author(s) affiliations:Yousef Ahmed Alomi*, The Former General Manager of General Administration of Pharmaceutical Care, The Former Head, National Clinical Pharmacy and Pharmacy Practice, The Former Head, Pharmacy R & D Administration, Ministry of Health, Riyadh, SAUDI ARABIA. Sultan Mohammed Al-Jarallah, Head, Ambulatory Care Pharmacy, Oncology and Hematology Clinical Pharmacist, Pharmaceutical Care Department, Security Forces Hospital, Riyadh, SAUDI ARABIA. Rasha Abdelsalam Elshenawy, BCS. Pharm. BCPS (AQ-ID), CPHQ, M.Sc., TQM (AUC), SIDP, CEO of FADIC, Ministry of Health, Makkah, SAUDI ARABIA. Faiz A Bahadig Rph, (BSC-Pharm, MBA), Informatics Pharmacist, Pharmaceutical Care Department, King Abdulaziz Medical, City-WR-Jeddah, Ministry of National Guard, SAUDI ARABIA. Abstract:Objective: Ministry of Health (MOH) hospitals in Saudi Arabia should develop, organize and administer a formulary system that follows the principles to optimize patient care by ensuring access to clinically appropriate, safe and cost-effective medications. This can be achieved through the Pharmacy and Therapeutic Committee’s (PTC) role in the evaluation of hospital’s drug formulary and decision-making. The primary purposes of the PTC are policy development, communication and education and formulary management. Therefore, in this study, we aimed to explore the hospital drug formulary evaluation and decision-making at MOH hospitals in Saudi Arabia. Methods: This is a 4-month cross-sectional national survey of PTC at MOH hospitals in Saudi Arabia. The survey consisted of two parts: the first part collected demographic information and the second part consisted on 93 questions divided into four domains. An electronic survey was distributed to all drug information centers at MOH hospitals and analyzed the evaluation of drug formulary and decision-making through the Survey Monkey system. Results: A total of 50 drug information centers responded to the questionnaire (100%). Restricted drug usage (3.88), new drug entities (3.74), new dosage form (3.6) and new strength (3.6) were the majority of the requests for inclusion in the formulary. A total of 1-3 medications were evaluated monthly by the PTC at 41 (82%) hospitals. Most of the healthcare providers were allowed to request for the addition or deletion of medications: PTC members 38 (76%), attending medical staff 35 (70%), pharmacy staff 10 (20%) and formulary subcommittees 10 (20%). The formal economic analysis of the drug formulary revision was rarely or never conducted at 26 (42%) hospitals. The responsible person for the economic evaluation was drug information pharmacist (21 (42%)), pharmacy department (nonspecific) (17 (34%)) and the pharmacy and medical department (14 (28%)). Conclusion: Evaluation of hospital’s drug formulary and decision-making was not adequate at the majority of the hospitals. Education and training about drug evaluation with an emphasis on cost analysis and impact are mandatory. An electronic addition new medications with close formulary is required with close monitoring for all MOH hospitals in Saudi Arabia. Keywords:Decision-Making, Drug Formulary, Evaluation, Ministry of Health, National Pharmacy and Therapeutic Committee, Saudi ArabiaView:PDF (202.48 KB) PDFClick here to download the PDF file. Images The formulary management system.

National Survey of Pharmacy and Therapeutic Committee in Saudi Arabia: Meetings, Organization, and Management

International Journal of Pharmacology and Clinical Sciences,2019,8,4,237-241.DOI:10.5530/ijpcs.2019.8.52Published:December 2019Type:Research ArticleAuthors:Yousef Ahmed Alomi, Sultan Mohammed Al-Jarallah, Rasha Abdelsalam Elshenawy, and Faiz A Bahadig Rph Author(s) affiliations:Yousef Ahmed Alomi*, The Former General Manager of General Administration of Pharmaceutical Care, The Former Head, National Clinical Pharmacy and Pharmacy Practice, The Former Head, Pharmacy R & D Administration, Ministry of Health, Riyadh, SAUDI ARABIA. Sultan Mohammed Al-Jarallah, Head, Ambulatory Care Pharmacy, Oncology and Hematology Clinical Pharmacist, Pharmaceutical Care Department, Security Forces Hospital, Riyadh, SAUDI ARABIA. Rasha Abdelsalam Elshenawy, BCS. Pharm. BCPS (AQ-ID), CPHQ, M.Sc., TQM (AUC), SIDP, CEO of FADIC, Ministry of Health, Makkah, SAUDI ARABIA. Faiz A Bahadig Rph, Informatics Pharmacist, Pharmaceutical Care Department, King Abdulaziz Medical City-WR-Jeddah, Ministry of National Guard, SAUDI ARABIA. Abstract:Objective: Pharmacy and Therapeutic Committee (PTC) is required for the effective running of a hospital. In the beginning, there was no such concept of drug committee, but with the advent of time, the need for an effective PTC started increasing. In the PTC, the pharmacist, physicians and nurses play an important role, in addition to the presence of an administrative. This study aims to explore the importance of having effective meetings organization and management of PTC at Ministry of Health (MOH) hospitals in Saudi Arabia. The purpose of this study was to explore the meetings organization and management of PTC at MOH hospitals in Saudi Arabia. Methods: This is a 4-month cross-sectional national survey of PTC at MOH hospitals in Saudi Arabia. The survey consisted of two parts: the first part collected demographic information and the second part consisted of 93 questions divided into four domains: Domain 1: the scope, structure and responsibilities; domain 2: the formulary management system; domain 3: evaluation of drug formulary and decision-making; and domain 4: organization and management of committee meetings. This questionnaire was prepared in an electronic format and was distributed all drug information centers at MOH hospitals. It analyzed organization and management of committee meetings through Survey Monkey system. Results: A total of 50 drug information centers responded to the questionnaire (100% response rate). The person leads the discussion in PTC was a Chairman of the Committee (29 (58%)), Chief of Pharmacy (13 (26%)) and Director of Drug Information (3 (6%)). The number of scheduled meetings per year (1–4) was 18 (36%) per hospital with a duration (1-2 hrs) at 48 (96%). Most of discussions were related to medications of infectious diseases (26 (52%)) and cardiovascular diseases (21 (42%)). Most of the challenging recommendations that needed implementation was a lack of resources (37 (74%)), lack of hospital administrator support (23 (46%)) and lack of pharmacist role (18 (36%)). Conclusion: The PTC is a demanding scientific resource and administrative support. Total quality management system, workload analysis, positive outcomes of PTC were lacking. Special education and training needs to be provided to all the healthcare providers with hospital administrator’s support. Keywords:Meetings, Ministry of Health, National Pharmacy and Therapeutic Committee, Organization and Management, Saudi ArabiaView:PDF (202.45 KB) PDFClick here to download the PDF file. Images Assessment of PTC meetings.