Rational drug use in hospital settings - areas that can be changed.

Irrational use of drugs occurs at all levels of healthcare. This phenomenon can also be observed in hospitals. Irrational use of a drug contributes to a decrease in the patient's quality of treatment and often causes negative health consequences. For this reason, it is essential to consider methods that can be introduced in hospitals to increase the safety and effectiveness of the drugs used. The article presents selected methods of rationalization of drug management that can be used in hospitals.

Insights on developing a field hospital formulary and medication distribution process in preparation for a second surge of COVID-19 cases.

PURPOSE: The coronavirus disease 2019 (COVID-19) pandemic has caused health systems across the country to plan for field hospitals to care for patients outside of traditional healthcare settings in the event of a second surge. Here we describe key considerations for the implementation of pharmacy operations and a field hospital formulary at an offsite location within a 2-week time frame. SUMMARY: Development of an offsite field hospital formulary is first dependent on the location and patient population defined for the field hospital. Creation of a limited formulary for a planned field hospital in Michigan involved reviewing physical space limitations and drug distribution workflows, assessing current prescribing trends, creating drug categories, and creating formulary guidelines to limit formulary options in each therapeutic category. Ultimately, our institution developed a 140-medication field hospital formulary, a process to enable appropriate use of nonformulary drugs, and a mixed operations model including automated dispensing cabinets and a manual cart-fill process. Although the institution did not have to open the field hospital, the process used for developing the formulary and determining distribution models will allow for an immediate implementation if a second surge occurs. CONCLUSION: A methodical approach to developing limited formularies and pharmacy operations in a field hospital setting will allow health systems to establish efficient and effective medication distribution services in the event of a second surge of COVID-19 cases.

Dynamic pharmacy leadership during the COVID-19 crisis: Optimizing patient care through formulary and drug shortage management.

PURPOSE: The coronavirus disease 2019 (COVID-19) pandemic has created unprecedented challenges for health systems around the world. We describe our approach to adapting the pharmacy leadership structure to address critical medication shortages through innovative data analysis, procurement strategies, and rapid implementation of medication policy. SUMMARY: Yale New Haven Health deployed a system incident management command structure to effectively respond to the COVID-19 crisis. System pharmacy services adopted a similar framework to enable efficient communication and quick decision-making in key domains, including drug procurement and policy. By refining a model to project health-system medication needs, we were able to anticipate challenges and devise alternative treatment algorithms. By leveraging big data and creating a system knowledge base, we were able to consolidate reporting and coordinate efforts to ensure system success. Various procurement strategies were employed to ensure adequate supply, including frequent communication with our wholesaler, sourcing direct from suppliers, outsourcing of sterile products compounding to registered 503B outsourcing facilities, and acquisition of active pharmaceutical ingredients for compounding of essential medications. Strategic positioning of pharmacists within the health system's incident command response teams and rapid adaption of drug use policy governance fueled accelerated response and nimble implementation. Communication was streamlined and executed via multiple outlets to reach a broad audience across the health system. CONCLUSION: With medication shortages posing a threat to patient care, dynamic pharmacy leadership proved essential to providing patient care at the height of the COVID-19 pandemic. System alignment and the rapid adaption of the existing framework for drug shortage management and medication use policy were crucial to success in crisis response.

Impact of a change of bronchodilator medications in a hospital drug formulary on intra- and out-of-hospital drug prescriptions: interrupted time series design with comparison group.

BACKGROUND: Hospital drug formularies are reduced lists of drugs designed to optimise inpatient care. Adherence to the drugs included in such formularies is not always 100% but is generally very high. Little research has targeted the impact of a change in these formularies on outpatient drug prescriptions. This study therefore sought to evaluate the impact of a change affecting bronchodilator medications in a hospital drug formulary on intra- and out-of-hospital drug prescriptions in a region in north-western Spain. Two new drugs belonging to this same class were brought onto the out-of-hospital market, overlapping with the intervention. METHODS: We used a natural before-after quasi-experimental design with control group based on monthly data. The intervention evaluated was the modification of a hospital drug formulary, which involved withdrawing salmeterol/fluticasone in order to retain formoterol/budesonide as the sole inhaled corticosteroid and long-acting beta-agonist (ICS/LABA). Using official data sources, we extracted the following dependent variables: defined daily doses (DDD) per 1000 inhabitants per day, DDD per 100 bed-days, and cost per DDD. RESULTS: Intra-hospital use showed a 173.2% rise (95% CI 47.3-299.0%) in the medication retained in the formulary, formoterol/budesonide, and a 94.9% drop (95% CI 77.9-111.9%) in the medication withdrawn from the formulary, salmeterol/fluticasone. This intervention led to an immediate reduction of 75.9% (95% CI 82.8-68.9%) in the intra-hospital cost per DDD of ICS/LABA. No significant changes were observed in out-of-hospital use. CONCLUSIONS: Although this intervention was cost-effective in the intra-hospital setting, the out-of-hospital impact of a change in the drug formulary cannot be generalised to all types of medications and situations.

Current state of opioid stewardship.

PURPOSE: The opioid epidemic continues to result in significant morbidity and mortality even within hospitals where opioids are the second most common cause of adverse events. Opioid stewardship represents one model for hospitals to promote safe and rational prescribing of opioids to mitigate preventable adverse events in alliance with new Joint Commission standards. The purpose of this study was to identify the prevalence of current hospital practices to improve opioid use. METHODS: A cross-sectional survey of hospital best practices for opioid use was electronically distributed via electronic listservs in March 2018 to examine the presence of an opioid stewardship program and related practices, including formulary restrictions, specialist involvement for high-risk patients, types of risk factors screened, and educational activities. RESULTS: Among 133 included hospitals, 23% reported a stewardship program and 14% reported a prospective screening process to identify patients at high risk of opioid-related adverse events (ORAEs). Among those with a prospective screening process, there was variability in ORAE risk factor screening. Formulary restrictions were dependent on specific opioids and formulations. Patient-controlled analgesia was restricted at 45% of hospitals. Most hospitals reported having a pain management service (90%) and a palliative care service providing pain management (67%). CONCLUSION: The absence of opioid stewardship and prospectively screening ORAEs represents a gap in current practice at surveyed hospitals. Hospitals have an opportunity to implement and refine best practices such as access to pain management specialists, use of formulary restrictions, and retrospective and prospective monitoring of adverse events to improve opioid use.

Yinning Tablet, a hospitalized preparation of Chinese herbal formula for hyperthyroidism, ameliorates thyroid hormone-induced liver injury in rats: Regulation of mitochondria-mediated apoptotic signals.

ETHNOPHARMACOLOGICAL RELEVANCE: Hyperthyroidism is closely associated with liver injury. The preliminary clinical observation suggests that Yinning Tablet, a hospitalized preparation of traditional Chinese formula for hyperthyroidism, improves not only hyperthyroidism, but also hyperthyroidism-associated liver injury. AIM: To evaluate the effect and underlying mechanisms of Yinning Tablet on thyroid hormone-induced liver injury. MATERIALS AND METHODS: Female rats were orally administered L-thyroxine (1 mg/kg) once daily for 60 days, and co-treated with the carefully identified Yinning Tablet extract (0.6-2.4 g/kg) during the last 30 days. Blood and liver variables were determined enzymatically, histologically, by ELISA, radioimmunoassay, Real-Time PCR or Western blot, respectively. RESULTS: Co-treatment with the extract attenuated L-thyroxine-induced increases in serum alanine transaminase and aspartate transaminase activities, the ratio of liver weight to body weight, cytoplasmic vacuolization in hepatocytes, infiltrated inflammatory cells and confused structures in liver tissue, accompanied by attenuation of increased serum triiodo-l-thyronine concentration and hepatic deiodinase type I overexpression in rats. Importantly, Yinning Tablet suppressed L-thyroxine-triggered hepatic Bax, cleaved caspases-3, -8 and -9 protein overexpression, and Bcl-2 protein downregulation. Furthermore, the increases in cytochrome c protein expression, Ca2+-ATPase activity and malondialdehyde content, and decreases in activities of Na+/K+-ATPase, catalase, superoxide dismutase and glutathione peroxidase, and total antioxidant capacity in liver tissue were attenuated. CONCLUSION: The present results suggest that Yinning Tablet ameliorates thyroid hormone-induced liver injury in rats by regulating mitochondria-mediated apoptotic signals. Our findings go insight into the pharmacological basis of the hospitalized preparation for treatment of hyperthyroidism-associated liver injury.

Evaluation of the use of non-formulary oncology medications restricted to outpatient use in hospitalized patients after implementation of a criteria-for-use algorithm.

OBJECTIVE: To decrease the number of orders and total hospital spend for inpatient use of antineoplastic drugs of interest, while evaluating each case for urgent or emergent need for administration. METHODOLOGY: This study is a multicenter, retrospective, cost-evaluation, cohort study performed in five Ascension Seton hospitals in the Austin, Texas area between 1 January 2013 and 31 December 2018. Patients were identified via a dispense analysis report for the antineoplastic drugs of interest. RESULTS: An overall reduction of 56% was seen in orders processed with a 62% decrease in annual hospital spending after implementation of the criteria-for-use algorithm. When results were evaluated without including rituximab orders, a reduction of 17% was seen in orders processed with a 21% decrease in annual hospital spending. DISCUSSION AND CONCLUSION: The decreases in our primary outcomes were primarily driven by a reduction in the use of one drug, rituximab. Overall, implementation of a criteria-for-use algorithm was effective in reducing both overall number of orders and hospital spending for restricted antineoplastic agents.

Descriptive comparison of hospital formulary decisions with published oncology valuation methods.

INTRODUCTION: As cost of cancer therapy continues to increase, several organizations have developed rubrics to ascertain treatment. No studies have evaluated these methods for hospital formulary decision-making. We applied different value measurement tools to formulary decisions from one hospital system to assess their operational utility. METHODS: We evaluated four value systems: National Comprehensive Cancer Network Evidence Blocks, DrugAbacus drug pricing, European Society for Medical Oncology clinical benefit scale, and the American Society of Clinical Oncology net health benefit. Each value score or cost was assessed against our hospital formulary requests between 2012 and 2016. Formulary requests accepted and rejected were compared with respect to their relative numbers of National Comprehensive Cancer Network blocks, difference between DrugAbacus and actual cost, and European Society for Medical Oncology and American Society of Clinical Oncology scores. RESULTS: Twenty-two chemotherapy requests were included, with 20 approvals and 2 rejections. No correlation was observed between number of evidence blocks and formulary acceptance (p = 0.13). Most drugs had a higher actual price than the DrugAbacus suggested cost (p = 0.036). No significant differences were observed in European Society for Medical Oncology (p = 0.90) or American Society of Clinical Oncology (p = 0.70) scores between drugs that were accepted or rejected. When evaluating monthly cost per point of American Society of Clinical Oncology score, a numerical difference between groups was observed (median = $369.7 versus $1256.8 per point, p = 0.61). CONCLUSIONS: Existing oncology value assessment systems only variably inform hospital formulary decisions. The American Society of Clinical Oncology net health benefit score deserves further study as a method to systematically quantify the clinical safety and efficacy of formulary medication addition relative to cost.

Managing conflicts of interest in pharmacy and therapeutics committees: A proposal for multicentre formulary development.

WHAT IS KNOWN AND OBJECTIVE: While many countries have central agencies responsible for formulary development, within the United States, each hospital, health care system, or insurance provider has their own pharmacy and therapeutic committee, leading to both inefficiencies and inequalities across formularies. The number and variety of processes within pharmacy and therapeutic committees also increases the likelihood that conflicts of interest will influence the development of formularies. We sought to determine how such influences could be reduced by reviewing international evidence related to the presence and harms of conflicts of interest in formulary development. METHODS: Several approaches have been taken to reduce the influence of conflicts of interest in pharmacy and therapeutics committee processes, including include disclosure, recusal, exclusion, universal consideration and dual committees. The feasibility of each of these approaches is considered in the context of the United States. RESULTS AND DISCUSSION: A proposal is drawn from the discussion of various approaches to conflicts of interest in pharmacy and therapeutics committees: multicenter formulary development. WHAT IS NEW AND CONCLUSION: Multicentre formulary development, where resources are pooled across institutions, may lead to a reduction in the influence of conflicts of interest in pharmacy and therapeutics committee processes in the United States, increasing the chances of including the most safe, efficacious and cost-effective drugs on formularies.

Impact of removal and restriction of me-too medicines in a hospital drug formulary on in- and outpatient drug prescriptions: interrupted time series design with comparison group.

BACKGROUND: The study covered in- and out-of-hospital care in a region in north-western Spain. The intervention evaluated took the form of a change in the hospital drugs formulary. Before the intervention, the formulary contained four of the five low molecular weight heparins (LMWHs) marketed in Spain. The intervention consisted of withdrawing two LMWHs (bemiparin and dalteparin) from the formulary and restricting the use of another (tinzaparin), leaving only enoxaparin as an unrestricted prescription LMWH. Accordingly, the aim of this study was to evaluate the effect on in- and outpatient drug prescriptions of removing and restricting the use of several LMWHs in a hospital drugs formulary. METHODS: We used a natural, before-after, quasi-experimental design with a control group and monthly data from January 2011 to December 2016. Based on data drawn from official Public Health Service sources, the following dependent variables were extracted: defined daily doses (DDD) per 1000 inhabitants per day (DDD/TID), DDD per 100 stays per day, and expenditure per DDD. RESULTS: The two compounds that were removed from the formulary registered an immediate decrease at both an intra- and out-of-hospital level (66.6% and 55.6% for bemiparin and 73.0% and 92.2% for dalteparin, respectively); similarly, the compound that was restricted also registered an immediate decrease (36.1% and 9.0% at the in- and outpatient levels, respectively); in contrast, the remaining LMWH (enoxaparin) registered an immediate, significant increase at both levels (44.9% and 32.6%, respectively). The intervention led to an immediate reduction of 6.8% and a change in trend in out-of-hospital cost/DDD; it also avoided an expenditure of €477,317.1 in the 21 months following the intervention. CONCLUSIONS: The results indicate that changes made in a hospital drugs formulary towards more efficient medications may lead to better use of pharmacotherapeutic resources in its health catchment area.

The impact of formulary restriction on the relative consumption of carbapenems in intensive care units at an academic medical center.

Antipseudomonal carbapenems are an important target for antimicrobial stewardship programs. We evaluated the impact of formulary restriction and preauthorization on relative carbapenem use for medical and surgical intensive care units at a large, urban academic medical center using interrupted time-series analysis.

Use of non-formulary high-cost medicines in an Australian public hospital.

Background Clinicians prescribe high-cost medicines for rare diseases and nonapproved indications when conventional therapies have failed. Objective To examine the use of non-formulary high-cost medicines at an Australian public hospital. Methods Retrospective audit of individual patient use applications for nonformulary medicines costing more than $5000 AUD per year at a large tertiary referral hospital in Adelaide, South Australia over a 12-month study period from January 2015 to December 2015. Main outcome measures Total cost of non-formulary high-cost medicines, medication class, indications for use, level of supporting evidence and proposed monitoring outcomes. Results Eighty-seven individual patient use applications were examined. All except one were approved, at a total cost of $1,339,203 AUD. The most common drug classes were anti-CD20 (n = 33, 38%), combined antiretrovirals (n = 10, 11%) and TNF-alpha antagonists (n = 10, 11%). There were 56 indications for these medicines with the majority being inflammatory conditions (n = 52, 60%), followed by infections (n = 14, 16%) and malignancies (n = 14, 16%). Of the first-time individual patient use applications (n = 63), there were 25 applications (40%) that provided a case series as supporting evidence. Approximately half of new individual patient use applications (n = 32) proposed an objective monitoring outcome, but few (n = 13, 21%) contained sufficient information to allow a third party to determine efficacy of the medication. Conclusions Non-formulary high-cost medicines are being used for a broad range of indications based largely on low levels of evidence. Prospective definition of an adequate response to treatment and reporting of these outcomes is required to improve the evidence-base and to aid decision-making for subsequent treatment courses.

Economic Outcomes Associated with Safety Interventions by a Pharmacist-Adjudicated Prior Authorization Consult Service.

BACKGROUND: The establishment of a formulary management system ensures that health care professionals work together in an integrated patient care process to promote clinically sound, safe, and cost-effective medication therapy. Pharmacists have a foundational role within this system. A pharmacist-adjudicated prior authorization drug request (PADR) consult service has the potential to optimize drug therapy by decreasing medication misuse, minimizing adverse drug events (ADEs), and preventing medication errors. OBJECTIVES: To (a) determine cost avoidance associated with pharmacist-adjudicated PADR safety interventions within the Durham Veterans Affairs Health Care System and (b) evaluate cost savings associated with pharmacist-adjudicated PADRs not approved due to a safety intervention, evaluate cost avoidance and direct cost savings based on clinical specialty of pharmacist adjudicating PADR, and characterize severity of avoided ADEs. METHODS: Pharmacist-adjudicated PADRs not approved between July 1, 2016, and June 30, 2017, because of safety interventions were retrospectively reviewed. Cost avoidance was determined by multiplying the probability of ADE occurrence in the absence of PADR safety intervention by the estimated cost avoided based on the type of intervention. Direct cost savings was calculated by totaling the cost of requested medications not approved for each PADR and subtracting the cost of recommended alternative therapies and cost of pharmacist PADR review. All potential ADEs avoided were reviewed by a panel of 3 clinical pharmacists to validate ADE classification and ADE probability and severity scores. Descriptive statistics were used for all analyses. RESULTS: Of the 910 PADRs that were not approved during the study period, 96 met inclusion criteria. Pharmacist-adjudicated PADR safety interventions resulted in a total cost avoidance of $24,485.34 (mean = $255.06) and a direct cost savings of $288,695.63 (mean = $3,007.25). The practice settings of anticoagulation and infectious diseases PADRs resulted in the largest contribution to cost avoidance and direct cost savings, respectively. Prevented ADEs were classified as major for 64.6% of the PADRs. CONCLUSIONS: Pharmacist-adjudicated PADR safety reviews resulted in substantial economic benefit and prevention of major ADEs. This analysis supports the pharmacist's role in a formulary management system to optimize medication therapy. DISCLOSURES: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for profit sectors. The authors have nothing to disclose.

Drug formulary decision-making: Ethnographic study of 3 pharmacy and therapeutics committees.

PURPOSE: An ethnographic study of 3 pharmacy and therapeutics (P&T) committees was conducted to characterize the process by which evidence is weighted and decisions are made. METHODS: We recorded discussions and conducted an analysis of the transcripts from the 3 P&T committees for a 1-year period. We examined the content and ideas expressed during deliberations and synthesized themes to give a broader picture of the issues arising. Committee discussions were transcribed and the segments of each meeting that addressed any new formulary additions were then analyzed. Using constant comparison method, we generated a series of topic codes to characterize and classify that portion of the discussion. RESULTS: At 26 meetings across the 3 sites, 24 new drug formulary additions were discussed. A total of 1,093 discussion segments were identified and mapped to 7 broad categories related to discussion of evidence of need, efficacy/indications, safety, misuse potential, cost issues, committee decision-making issues, and discussion related to operationalizing use and implementation at the local institution. Overall, the leading category of discussion was efficacy/indications followed by evidence of need, operational issues, and cost issues, with some variation by site. The committees devoted substantially greater portions of their discussion to the logistics of using the drugs in their institutions than they did safety issues. We identified wide variations in specific drugs being considered and the relative amount of time devoted to various issues related to these drugs being discussed. We found discussions generally did not follow a systematic, standardized, rigorous, and reproducible approach. Discussions tended to be more idiosyncratic, individualized, varying from drug to drug, and at times devoted to a variety of tangential issues raised by committee members. CONCLUSION: P&T committee discussions at all 3 sites tended to be idiosyncratic and individualized, varying from drug to drug, and at times devoted to a variety of issues more tangentially raised by committee members. All spent less time talking about drug safety, in each case roughly half the time that they devoted to discussions of efficacy.

The effectiveness of formulary restriction and preauthorization at an academic medical center.

The impact of formulary restriction and preauthorization (FRPA) on prescribing trends was examined over a 5-year period at an academic medical center. Ordinary least squares regression was used to identify hospital units demonstrating statistically significant trends in prescription of restricted agents. Significant decreases in restricted drug use were seen on 2 of 7 medicine units subject to FRPA, whereas a significant increase was seen in 1 of 4 surgical units subject to FRPA.

Use of economic predictions to make formulary decisions.

PURPOSE: The accuracy of cost savings and reimbursement predictions for medications added to an academic medical center formulary was assessed. METHODS: Formulary changes over a 5-year period were reviewed by the investigators. Medications were included if the medication was added to formulary and the monograph included cost savings or reimbursement data that indicated a positive net margin. The primary endpoints were percent predicted cost savings and net margin per medication based on medication cost only. Secondary endpoints included the percent of medications with at least 100% predicted cost savings or net margin and evaluation of median percent predicted savings or net margin individually. RESULTS: The pharmacy and therapeutics committee reviewed 558 formulary agenda items, 184 of which were selected for further analysis. In total, 19 medications were identified as having a predicted monetary advantage. The endpoints of percent predicted cost savings and net margin yielded a median of 76.5% (range 72.9-188.71%) (n = 3) and 148.2% (IQR 108.9-543.3%) (n = 16), respectively. For 13 (68%) of 19 medications, the percent predicted cost savings or net margin was at least 100%. CONCLUSION: Economic predictions utilized for formulary management at an academic medical center generated net positive monetary value for medications where predicted cost savings or reimbursement factored into the decision to add a medication to the formulary.

Drug and therapeutics committees in Nigeria: evaluation of scope and functionality.

Introduction: Inappropriate use of medicines remains a problem, with consequences including increasing adverse drug reactions (ADRs) and prolonged hospitalizations. The Essential Medicines List and Drug and Therapeutics Committees (DTCs) are accepted initiatives to promote the rational use of medicines. However, little is known about DTC activities in Nigeria, the most populous African country. Areas covered: A cross-sectional questionnaire-based study was conducted among senior pharmacists, consultant physicians, and clinical pharmacologists in 12 leading tertiary health-care facilities across Nigeria. Expert commentary: Six (50%, 6/12) health-care facilities had existing DTCs with three (50%) having a subcommittee on antimicrobials. Seventy-five percent had infection control committees, with presence even in centers without DTCs. Chairpersons and secretaries of the DTCs were predominantly physicians (83.3%) and pharmacists (100%), respectively. Hospital formularies were available in five facilities with DTCs, while one facility without a DTC had an Essential Medicines Committee responsible for developing and updating the hospital formulary. The evaluation of ADRs was undertaken by pharmacovigilance units in nine facilities. Overall, DTCs were present in only half of the surveyed facilities and most were performing their statutory functions sub-optimally. The functioning of DTCs can be improved through government directives and mechanisms for continuous evaluation of activities.