Search

Background South Africa faces a heavy burden of disease, which impacts resource allocation. The needs of South Africa require efficient translation into pharmaceutical expenditure for medicine provision, to ensure availability of medicines. Given that South Africa faces various challenges with medicine provision accompanied by rising pharmaceutical expenditure, this study aimed to report on the considerations and methods used to determine the healthcare budget for South Africa, and how it is translated into pharmaceutical expenditure for medicines provision on the Standard Treatment Guidelines and Essential Medicines List and non-essential medicines in the public sector. Method Qualitative, semi-structured interviews guided by a discussion guide were conducted with seven pharmaceutical officials involved in the budget and resource allocation process, between October 2019 and March 2020. Interviews were recorded and transcribed verbatim. Once the interviews were coded by the first author they were verified by the other authors. Data were thematically analysed. Results This study depicted the knowledge and participation of pharmaceutical services in the budget process. The National and Provincial Department of Health have improved pharmaceutical budgeting by making strides towards a collaborative, informed, and more evidence-based approach. Pharmaceutical services have roles in advising on requirements; commenting where necessary, constantly monitor and taking accountability for their budget. The main considerations that determined the budget included population size and growth, historical expenditure, the extra heavy burden of disease and incidence rate, demand data and forecasting. The local and provincial pharmacy and therapeutics committee play a vital role in monitoring the budget and expenditure; ensuring adherence to guidelines; controlling the extent to which non-Essential Medicine List items are used and advising accordingly. Conclusion This was the first study to report on the decision and thought processes of the healthcare budget and its translation into pharmaceutical expenditure for medicine provision in South Africa. Many factors were considered to inform the budget, with the Standard Treatment Guideline and Essential Medicines List being the principal guide for medicine provision. This process was well-controlled and monitored by the pharmaceutical therapeutics committee. Documenting the South African experience can assist other countries in their budget decisions for medicines.

Cannabidiol (CBD) oil has been gaining popularity as a natural alternative for numerous disease states. CBD is a phytocannabinoid obtained from the Cannabis sativa plant. Unlike its relative tetrahydrocannabinol (THC), CBD does not activate CB1 receptors in the brain and therefore lacks psychotropic effects (1). Instead, this substance is thought to work on the G-protein coupled receptor, endothelial cannabinoid receptor, and serotonin-1A receptors, among others. Diabetes is the seventh leading cause of death and affects >30 million people in the United States (2). CBD has been investigated, mostly in animal models, for its ability to help treat diabetes. It is theorized that cannabis has desirable effects on hyperglycemia through its anti-inflammatory and antioxidant properties (3). The endocannabinoid system modulates food intake and energy homeostasis by activating cannabinoid receptors. Modulation of these receptors with CBD has the possibility to reduce body weight and A1C in people with diabetes. In one study using mouse models, CBD was shown to significantly reduce the incidence of diabetes in these mice (4). This was shown by a significant decrease in pancreatic islets production of destructive insulitis and inflammatory cytokine production. The potential to use CBD as a method to treat diabetes reveals the need for studies and case reports. The following case illustrates the initiation of CBD in a patient with type 2 diabetes. A 62-year-old Hispanic obese man (weight 113 kg, BMI 39 kg/m2) with a history of type 2 diabetes for 11 years began taking CBD oil to control his blood glucose in place of insulin degludec. Initiation of this product was independent of his clinician’s recommendation and based on the patient’s personal review of information that suggested CBD was beneficial for people with type 2 diabetes. As shown in Table 1, the week before the patient’s initiation of CBD, …

Background: Unlicensed medication use (off label use) is common in pediatrics practice. There are more than 75% of drugs which approved for using in adults, data of efficacy and safety in pediatric population is not completely available, and missed data might be due to some reasons mainly ethical consideration. Our study aimed to assess practicing of using of unlicensed medication in pediatrics at major tertiary care hospital in Saudi Arabia. Methods: A retrospective review of pediatrics prescriptions that were prescribed as unlicensed medication use by collection of all unlicensed use forms that known as form B which approved by pharmacy and therapeutics (P&T) committee at Prince Sultan Military Medical city (PSMMC). Data collection stared from January 2018 until the end of 2020. Children up to 14 years of age and administered at least one medication were eligible to participate in the study. Results: The total collected off label prescriptions (both in and out patients) was 128 from January 2018 till end of 2020. Prescription for females were 39.84% while their male counterparts were 60.16%. Ophthalmology, Oncology and both Otorhinolaryngology and general pediatrics were the most frequent specialties prescribed unlicensed medications by 34.38%, 19.53% and 8.59% respectively. Overall, unlicensed medicine use was highest (33.6%) for products belong to monoclonal antibodies class. Surgical intervention was the commonest indication for using unlicensed medication (35.94%) followed by infectious diseases treatment (14.06%). Represented as the cumulative off-label frequency percentage, the most common reason of off-label use was by indication (35.94%), frequency (33.18%), Dose (19.82%), while for the route was almost (11.06%). The highest frequency of off label prescriptions according to pharmacological class split by gender and age category showed significance level of 0.045 in males and 0.001 in infants respectively. Conclusion: Class variability of unlicensed medications in this study, sought us to confirm that physician using this therapeutic option yet ethically, but in a disorganized manner. Thus, prescribing unlicensed drugs specifically in pediatric needs to be better validated by current and new evidence. The findings of this study call for further research across the kingdom to start off label legislation process under SFDA authority. Current off-label dosage amounts pose concerns about drug safety exceptionally in children.

Drug shortages have significantly affected the ability to provide care at pediatric institutions, particularly in the inpatient and critical care settings. The coronavirus disease 2019 (COVID-19) pandemic highlighted additional challenges with drug supply chains. A working group consisting of pharmacy management, clinical pharmacists, and pharmacy buyers met regularly at the beginning of the COVID-19 pandemic. In collaboration with medical staff leadership and the Pharmacy and Therapeutics Committee, we developed a pediatric critical drug list to track essential medications for targeted monitoring. We created an inventory model with easily modifiable input variables related to patient and hospital data. This model was aligned across affiliate health care systems to increase transparency of our hospital's surge capacity for managing patients with COVID-19. Here, we share our framework for modeling drug inventory management at a freestanding children's hospital during a global pandemic.

Hypoglycemia has been a barrier to A1C attainment in people with diabetes (1). It is well known that a glucocentric approach with intensive control reduces microvascular complications, but at what cost? Worse clinical outcomes, increased risk of severe hypoglycemia, and heavier treatment burden can result from aggressive efforts to lower A1C (2). People with diabetes also tend to experience more stress as a result of fear of hypoglycemia, higher costs of care, and increased prevalence of polypharmacy—especially for those with type 2 diabetes of longer duration. New medication classes (e.g., sodium–glucose cotransporter 2 inhibitors and glucagon-like peptide 1 receptor agonists) are providing impetus for replacing the glucocentric treatment paradigm with an individualized multifactorial approach (2). Traditional glucagon kits have long been available for the ambulatory treatment of patients with hypoglycemia. However, these kits have disadvantages. Their complicated multistep injection procedure can be difficult to perform. Additionally, the use of glucagon must be taught to the family members, friends, or caregivers because it is administered by someone else when a person with diabetes is unconscious or otherwise incapacitated by severe hypoglycemia (3). For these reasons, glucagon is undertaught and underutilized (3). Two new glucagon formulations offer potentially easier delivery. The purpose of this article is to review all available glucagon formulations, discussing the associated literature and possible new directions for the treatment of hypoglycemia. The American Diabetes Association has adopted a three-level classification of hypoglycemia. Level 1 is a glucose concentration

The digitalization of health and medicine and the growing availability of electronic health records (EHRs) has encouraged healthcare professionals and clinical researchers to adopt cutting-edge methodologies in the realms of artificial intelligence (AI) and big data analytics to exploit existing large medical databases. In Hospital and Health System pharmacies, the application of natural language processing (NLP) and machine learning to access and analyze the unstructured, free-text information captured in millions of EHRs (e.g., medication safety, patients’ medication history, adverse drug reactions, interactions, medication errors, therapeutic outcomes, and pharmacokinetic consultations) may become an essential tool to improve patient care and perform real-time evaluations of the efficacy, safety, and comparative effectiveness of available drugs. This approach has an enormous potential to support share-risk agreements and guide decision-making in pharmacy and therapeutics (P&T) Committees.

Gastroparesis is characterized by delayed gastric emptying in the absence of mechanical obstruction. This complication is associated with uncontrolled diabetes, contributing to approximately one-third of all gastroparesis cases (1–3). Gastroparesis is more prevalent in patients with type 1 diabetes than in those with type 2 diabetes (4). The 10-year cumulative incidence of diabetic gastroparesis has been estimated to be 5.2% in patients with type 1 diabetes and 1% in those with type 2 diabetes (5,6). The prevalence of diabetes-associated gastrointestinal symptoms is 5–12% (7,8). In a study by Jung et al. (9) conducted in Olmsted County, MN, the prevalence of gastroparesis was about 5% in patients with type 1 diabetes and 1% in type 2 diabetes (9). In the same study, the age-adjusted incidence rate of gastroparesis was 2.4/100,000 person-years in men and 9.8/100,000 person-years in women (9). Gastroparesis, a form of autonomic neuropathy, is most commonly seen in people who have had diabetes for >10 years and who have already developed other microvascular complications (10). Once the symptoms from gastroparesis begin, they typically persist and are stable over 12–25 years; this is true even when blood glucose levels have been controlled (11). The most common symptoms are early satiety, nausea, bloating, abdominal pain, and vomiting. In terms of prognosis, a recent study published by Chang et al. (12) found no association between delayed gastric emptying and increased mortality over a 25-year period. Although there is no evidence to date that diabetic gastroparesis increases mortality, this complication substantially impairs all aspects of life (13). Although still not fully elucidated, the suggested pathophysiology of diabetic gastroparesis includes poor glycemic control, sympathetic vagal neuropathy, Cajal interstitial cell abnormalities, and loss of neuronal nitric oxide synthase (nNOS) (3,14). The loss of interstitial cells …

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.

Background Olmesartan, an antihypertensive drug, has been associated with a severe and potentially life-threatening sprue-like enteropathy, consisting of a serious, chronic diarrhoea and malabsorption syndrome. Treatment with this drug should be discontinued if patients develop such symptoms. Objective To retrospectively determine the reduction in olmesartan prescription following a strategy promoted by pharmacy and therapeutics committees within daily clinical practice to manage updated safety information on olmesartan. Setting Three primary healthcare centres. Method In May 2016, local pharmacy and therapeutics committees integrated by general practitioners, nursing staff and clinical pharmacists sent information about olmesartan safety issues to general practitioners, together with an individual list of their patients who were then being treated with olmesartan. Moreover, information about dose equivalents between angiotensin II receptor blockers and angiotensin II receptor blockers versus angiotensin-converting-enzyme inhibitors was also attached. The strategy aimed to promote individual benefit/risk assessment by general practitioners of the continuation of olmesartan treatment as a means to achieving a decrease in the risk of sprue-like enteropathy. The investigation team retrospectively reviewed the clinical records. Main outcome measure Reduction of olmesartan prescription. Results Olmesartan was discontinued in 44.4% of patients (197/444) in the year after the safety alert e-mail. In their medical records general practitioners registered that, after informing about olmesartan safety warnings, in four cases (0.9%), patients reported gastrointestinal symptoms. Conclusion A multidisciplinary strategy implemented to promote individual benefit/risk assessment regarding continuation of olmesartan treatment showed an important reduction in olmesartan prescriptions 1 year later.

What is known and Objective: Scoping reviews are a valuable evidence synthesis methodology. They can be used to map the evidence related to any topic to allow examination of practice, methods, policy and where (and how) future research could be undertaken. As such, they are a useful form of evidence synthesis for pharmacy clinicians, researchers and policymakers to review a broad range of evidence sources. Comment: This commentary presents the most comprehensive and up to date methodology for scoping reviews published by Joanna Briggs Institute (JBI). This approach builds upon two older approaches by Arksey and O'Malley, and Levac. To assist reviewers working in the field of pharmacy with planning and conducting scoping reviews, this paper describes how to undertake scoping reviews from inception to publication with specific examples related to pharmacy topics. What is new and conclusion: The JBI scoping review methodology is a valuable evidence synthesis approach to the field of pharmacy and therapeutics. This approach can assist pharmacy clinicians, researchers and policymakers to gain an understanding of the extant literature, to identify gaps, to explore concepts, characteristics and to examine current practice. Refereed/Peer-reviewed

Glucagon-like peptide 1 (GLP-1) receptor agonists are a safe and effective treatment option for patients with type 2 diabetes (1). Selective activation of the GLP-1 receptor causes glucose-dependent insulin secretion, resulting in a very low risk of hypoglycemia (2). The additional mechanism of slowing gastric emptying has resulted in reliable weight loss with this class of antihyperglycemic medications (3). In addition, multiple agents in this drug class (semaglutide, liraglutide, and dulaglutide) have been proven to reduce the risk of cardiovascular events (4). Furthermore, the possibility of once-weekly dosing for glycemic control in type 2 diabetes has been realized with some GLP-1 receptor agonists (semaglutide, exenatide extended-release, and dulaglutide) as a result of albumin binding that decreases renal clearance and protects against metabolic degradation by the dipeptidyl peptidase-4 enzyme (2). Poor adherence to pharmacologic therapy is well documented in patients with type 2 diabetes and is linked to inadequate glycemic control (based on the American Diabetes Association’s general A1C goal of 10%) and injection-site reactions (>1%) (1,7). General injection-site reactions (e.g., erythema, pain, or rash) have been reported with all of the commercially available GLP-1 receptor agonists (i.e., exenatide, lixisenatide, liraglutide, dulaglutide, and semaglutide) (8–13). However, post-marketing reports have revealed that exenatide extended-release, specifically, may cause more alarming injection-site …

SUMMARY The 1-month drug-dispensing limit is a common drug utilization tool used by state Medicaid agencies to control spending. Since the beginning of the COVID-19 pandemic, many states relaxed the 1-month dispensing limit restriction in order to align with social distancing recommendations. Yet, some states have not relaxed this limit and have differed substantially regarding the policies that have been implemented. Among states that relaxed the 1-month supply limit, determining which chronic disease drugs qualified for this extension can be challenging for patients and clinicians. As more commercial and Medicare insurance beneficiaries are offered 90-day drug supplies, the 30-day drug supply limit with Medicaid has become a health equity issue, since many individuals insured by Medicaid have already experienced a disproportionate impact from and remain at high risk for severe COVID-19 disease. Thus, we propose policy solutions to ensure that Medicaid beneficiaries have safe and uninterrupted access to chronic disease medications during and beyond the COVID-19 pandemic. DISCLOSURES: No funding was received for this work. Alpern has received funding from Arnold Ventures for research related to the use and spending of off-patent drugs, unrelated to this work, and is a member of the Pharmacy and Therapeutics Committee at Regions Hospital, St. Paul, MN. DeSilva has received CDC support for work on Vaccine Safety Datalink, VISION network, and Center of Excellence for Newcomer Health, unrelated to this work. Chomilo is Medicaid Medical Director for the State of Minnesota's Department of Human Services.

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.

PurposeAn overview of therapeutic oncology biosimilars, the U.S. biosimilars regulatory pathway, and the clinical development of selected biosimilar products is provided, including discussion of considerations in adopting biosimilars into oncology practice.SummaryBiosimilars are biologic agents that are highly similar to and have no clinically meaningful differences from an approved reference product in terms of safety, purity, and potency. There is a large market for cancer biologics, and approval of biosimilars has the potential to increase access to care and reduce costs. An abbreviated regulatory pathway for the development and approval of biosimilars defines a stepwise approach to demonstrating biosimilarity and conducting clinical comparative trials to confirm equivalent pharmacokinetics, efficacy, safety, and immunogenicity to the reference product. Three therapeutic biologics (bevacizumab, trastuzumab, and rituximab) have been used extensively in the treatment of a variety of cancers and are targets for biosimilar product development. Preclinical and clinical experience with 2 recently approved biosimilars to bevacizumab and trastuzumab is reviewed. Challenges faced by pharmacy and therapeutics committees when considering oncology biosimilars for formulary inclusion are discussed.ConclusionIncreased adoption of biosimilars could potentially lower treatment costs and improve access to biologics for patients with cancer. Key considerations in formulary review of biosimilars include the quality and quantity of data from comparative clinical trials, economic factors, manufacturer reliability, and challenges associated with incorporating biosimilars into practice.

Background Clinicians play an important role in containing pharmaceutical spending at the patient level, as well as ensuring efficacy and quality outcomes, yet little research has examined how to achieve this goal. Measures Using auditing and feedback (A&F) as part of a Pharmacy and Therapeutics (P&T) Committee, we evaluated our community-based hospice program's prescribing habits for opioids, antipsychotics, and antidepressants and calculated oral pharmaceutical prescription costs per-patient-day. Quality of care was reflected by patient pain scores in electronic medical records. Intervention Our P&T Committee adopted an A&F approach to monitor and assess provider prescribing habits and cost. An already-existing pain quality improvement program assessed care quality. Outcomes Pain relief either improved or was maintained while medication costs were reduced by over $1.00 per-patient-day from 2010 to 2011. Conclusions/Lessons Learned An active, hospice P&T Committee featuring A&F can significantly affect medication costs for a hospice program while maintaining or improving patient outcomes.

Andexanet alfa, a recombinant modified human "decoy" factor Xa (FXa) protein, is the first and only available antidote approved by the Food and Drug Administration to manage life-threatening or uncontrolled bleeding associated with the anti-Xa agents. It binds to direct and indirect anti-Xa oral anticoagulants with high specificity to reverse their inhibitory effects and restore the activity of FXa. Andexanet alfa is administered via two different dosing regimens, standard and high dose, based on the specific FXa inhibitor, dose, and time since the patient's last dose of FXa inhibitor. The approval for andexanet alfa is supported by data from two phase 3 studies (ANNEXA-A, ANNEXA-R) and preliminary data from the phase 3b/4 ANNEXA-4 trial. The first study found that andexanet alfa rapidly reduced anti-Xa activity by 92%-94% in healthy volunteers taking apixaban or rivaroxaban. The ANNEXA-4 study found that the median anti-Xa activity decreased by 89%-93% in patients with major bleeding taking apixaban or rivaroxaban. However, thrombotic events occurred in 12 of 67 patients (18%) during the 30-day follow-up in ANNEXA-4. Additionally, only 40% of patients had restarted anticoagulation and, in this group, the rate of thrombotic events was 12%. Four patients had a thrombotic event within 3 days after andexanet alfa treatment. The wholesale acquisition cost of the standard dose regimen is $24,750, and the high-dose regimen is $49,500. The estimated annual drug budget of treating 10-100 patients ranges from $248K to $495M. Effective October 1, 2018, Medicare will provide an add-on payment for andexanet alfa of up to $14,063 per qualifying case to Inpatient Prospective Payment System-participating acute care hospitals. In this formulary review for a health system's pharmacy and therapeutics committee, andexanet alfa clinical trials and medication package insert were summarized and, after consulting with clinical experts from our institutions, practical recommendations for use were generated to ensure appropriate and safe use of this agent.

Individuals with type 1 diabetes represent only ∼6% of all patients with diabetes in the United States and require characteristically complex treatment modalities (1). Autoimmune pancreatic β-cell destruction ultimately results in an absolute insulin deficiency, the presence of autoimmune markers, and little to no residual C-peptide (2,3). Additionally, pancreatic α-cell dysfunction is present, resulting in excess glucagon in both the fasting and postprandial states, and the gastric emptying rate is altered in many patients. Exogenous insulin serves as the foundation of therapy for type 1 diabetes and is commonly delivered via a multiple-dose regimen or an insulin pump. The two most common adverse effects associated with insulin use are hypoglycemia and weight gain. Recent data suggest that 68% of people with type 1 diabetes are overweight or obese and that severe hypoglycemia occurs at a rate of 9–20% (4). The latter complication is considered a limiting factor to achieving glycemic targets in the type 1 diabetes population. Indeed, the average A1C for adults ≥18 years of age with type 1 diabetes in the United States was 7.9% in 2015, a value well above the target of 7% recommended by the American Diabetes Association for most adult patients. Further complicating matters, diabetic ketoacidosis (DKA) occurs at a rate of 10% per year in some age-groups (4). Overall, these data suggest a need for adjunctive therapies for type 1 diabetes that reduce the risk for hypoglycemia and weight gain. While β-cell dysfunction is clearly a therapeutic focus for all types of diabetes, multiple other pathways of hyperglycemia present opportunities for alternate treatment modalities that may assist in achieving glycemic targets (5). The ideal pharmacotherapy regimen for a patient with type 1 diabetes would not only target the β-cell dysfunction, but also decrease blood glucose through hyperglycemic pathways independent of β-cell …

Introduction In the European Union companies only need to demonstrate that the risk-benefit balance of the new drug is favourable to obtain the authorization to sell new drugs. Hence a comparison with available treatments, a cost-effectiveness analysis and the place in the therapy of the new drug are not required. Therefore, it is necessary to carry out these analyses in an additional study. In Spain there is no national government agency, which conducts a centralized evaluation and makes decisions on funding and are the Pharmacy and Therapeutics committees that take mandatory decisions for the entire region. Objectives To identify all drug assessments and health technology assessment reports of the enzymatic replacement treatments for the four LSD considered in this study, including Mucopolysaccharidosis (MPS), Gaucher, Fabry and Pompe disease at the national, regional and hospital level; and to summarize the efficacy in terms of outcome measures, adverse events, economic impact and final recommendations and indicate potential improvements. Methods 19 reviews at the regional and hospital level and one therapeutic positioning report at national level for MPS were considered for this. Results In general, the drugs evaluated in LSD have proved to be effective in the most frequent clinical forms of disease. However, there are clinical phenotypes that still do not have available an effective treatment. Conclusions It is expected that new therapies, such as intrathecal therapies or gene therapy could be evaluated in the different types of LSD demonstrating positive effects, especially in the previous phenotypes.

Purpose A novel value-based approach to evaluate costly specialty drugs for formulary addition was developed. Summary In February 2016, Stanford Health Care launched the specialty drug subcommittee (SDSC), a subcommittee of the pharmacy and therapeutics committee, responsible for the formulary review of specialty pharmaceuticals. A process was developed for value-based review that includes not only consideration of clinical trial data and institutional acquisition costs but also internal patient outcomes and a cost-effectiveness model using internal financial data. A Markov model was developed to assess the value of trabectedin, which was approved for formulary addition in April 2016, relative to the addition of dacarbazine. The economic model and internal patient outcome analysis were presented to the prescribing oncologist and the SDSC for review. Internal data revealed that fewer patients than had been estimated received trabectedin, with outcomes significantly worse than those observed in the clinical trial leading to Food and Drug Administration approval. In the cost-effectiveness model, trabectedin had higher costs and poorer outcomes compared with dacarbazine. Based on the economic model, low utilization, and real-world outcomes, trabectedin was removed from formulary and a restrictive treatment pathway for nonformulary use, developed by the primary prescriber, was implemented. This process has since been applied to 11 more specialty drugs. Conclusion Internal cost-effectiveness models in combination with real-world patient outcomes data can be effective formulary management tools. Engagement and collaboration with the requesting provider are key to developing thoughtful treatment pathways.

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.

Canagliflozin is a member of the sodium–glucose cotransporter 2 (SGLT2) inhibitor class and is approved by the U.S. Food and Drug Administration (FDA) for use in patients with type 2 diabetes as an adjunct to diet and exercise to improve glycemic control. Canagliflozin works by inhibiting SGLT2 in the proximal renal tubules, causing a reduction of filtered glucose reabsorption, lowering of the renal threshold for glucose, and increasing urinary glucose excretion (1). The American Diabetes Association (ADA) Standards of Medical Care in Diabetes—2017 (2) and the American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) (3) recommend SGLT2 inhibitors as add-on to metformin for patients with type 2 diabetes uncontrolled after 3 months of metformin use. The ADA lists the SGLT2 inhibitors as investigational agents for patients with type 1 diabetes because of the risk of diabetic ketoacidosis (DKA). Despite concerns for DKA in patients with type 2 diabetes treated with an SGLT2 inhibitor, a clinical review by an expert panel found that DKA occurred infrequently and recommended no change to their labeling (4). Although SGLT2 inhibitors are not FDA-approved for use in patients with type 1 diabetes, providers have prescribed these agents for off-label use in this patient population. Glycemic variability may be problematic in patients with type 1 diabetes; therefore, adding an SGLT2 inhibitor can assist in not only improving glycemic control but also reducing glycemic fluctuations. Although adding an SGLT2 inhibitor to insulin may increase the risk of hypoglycemia, the potential to reduce the need for increasing insulin doses may moderate this effect. Patients with type 1 diabetes uncontrolled with insulin therapy who are overweight/obese and have hypertension may benefit from the addition of an SGLT2 inhibitor because these medications help to lower A1C values and can reduce both weight and blood pressure. Several studies have …

Background and importance Special drug prescriptions and authorisation by the hospital medical director is a necessary but time consuming activity that could even delay the start of treatment in some cases. To avoid documents and improve traceability, since 2014 our third level hospital is using an internal application (Rafpharma). This works as a mailbox: the treatment request for a specific patient is created by the physician, his head of the service agrees, the pharmacy service assesses the suitability and the medical director (MD) authorises/denies the treatment requested. Aim and objectives To optimise the individualised special treatments requests circuit. Material and methods A multidisciplinary working team (MWT) was created, including five hospital pharmacists, the head of the pharmacy department (PD), an internal medicine physician, the hospital MD and a hospital informatic, aimed at analysing all requests, identifying inefficiencies and proposing solutions to optimise the circuit. Results Nine work team meetings were held between February and June 2018. Each of the 1641 requests in 2017 were analysed. The main causes reducing the efficiency of the system were: high volume of requests, time spent in the application and lack of knowledge by the persons involved. With the aim of improving the efficiency of the system, the working group implemented the following measures. Reduced the number of treatments that required authorisation from the MD, with the agreement of the pharmacy and therapeutics committee (FTC). This was possible by avoiding the need for special requests for certain drugs, affecting 39% of all the requests; encouraging three medical services to request approval for off–label use by the FTC, of which two did; and finally the group recommended that several medical services make a formal request to include 11 drugs in the hospital (only 3 have been requested). Optimisation of Rafpharma application by the informatic department. Development of Rafpharma user protocols by user profile. Planning of specific training sessions in the departments involved. Conclusion and relevance The optimisation process of the individualised request circuit led to improvement in the three main problems detected. The group reduced the circuit´s workload by nearly 40%. The creation of MWTs makes approaching any key process from all points of view possible, allowing proposals to be made for optimisation agreed upon. References and/or acknowledgements Conflict of interest No conflict of interest

Background and importance In our country, considerable progress has been made in recent years since the establishment of the clinical therapeutic position reports (TPR) in 2013, but more research is needed about their impact on decision making. Aim and objectives To determine the value of immunotherapy for cancer therapeutic positioning reports (ITc-TPR) in clinical practice. Material and methods A nationwide survey was designed for hospital pharmacists and clinical oncologists of the ITc-TPR, published between May 2013 and March 2020. The main variables collected were: sociodemographics of the hospitals and health professionals, approval criteria and variables related to the acceptance of the ITc-TPR recommendations. Results During the study period, 46 ITc-TPR of 22 active substances were published. 27 health professionals answered the survey, 81.5% hospital pharmacists and 18.5% oncologists, ascribed to 24 hospitals in the national territory. 33.3% of the professionals had participated in the development of some TPR-ITc. In 45.8% of hospitals, incorporation of ITc was decided at the regional level, and in 66.7% of hospitals the drug and therapeutic indication with ITc-TPR published should be re-evaluated by the pharmacy and therapeutics hospital commission. In 50%, the authorised indications were the same as those of the ITc-TPR and 70.8% followed the recommendations of the ITc-TPR. 48.1% of the professionals who responded to the survey believed that ITc-TPR have eliminated barriers for access of patients to ITc, have decreased the variability of clinical care and promoted equity in the national territory. 66.7% believed the incorporation of the drug into clinical practice was faster if there was a published ITc-TPR. The main limitations for patients to access ITc were: not financed by the national health system (55.6%), high cost (37.1%) and the restrictions at the autonomic level (29.6%). The aspects of the ITc-TPR that should be improved were: pharmacoeconomic evaluation (66.7%), conclusions useful for clinical practice (70.4%), a single evaluation at the national level (70.4%) and decisions binding (80.5%). Conclusion and relevance ITc-TPR is a useful and well established tool at the national level for the positioning of a new drug. The results of the survey will allow the development of strategies to improve ITc-TPR. References and/or acknowledgements Acknowledgements: AEMPS, GEDEFO, participants, directors, teachers and tutors of Master Inmunoterapia del Cancer. Conflict of interest No conflict of interest

Background and importance It is very important to analyse the dispensing conditions of all drugs outside the hospital guide in order to update the pharmacotherapeutic guide when appropriate, and thus minimise out-of-guide prescriptions when there is insufficient evidence. Aim and objectives To evaluate prescriptions for drugs not included in the pharmacotherapeutic guide to advise the medical director on their approval. Material and methods Data were collected for all medications not included in the pharmacotherapeutic guide requested from the hospital pharmacy service throughout the year. Analysis of the data was carried out, differentiating two types of situations: (a) medications not susceptible to therapeutic exchange; and (b) medications of low therapeutic usefulness (LTU) according to the pharmacotherapeutic guide of the Murcian Health Service. The characteristics of LTU drugs were: (a) their therapeutic usefulness had not been proven in clinical studies carried out under adequate conditions; (b) insufficient benefit–risk ratio; (c) associations not recommended, such as those in which the combination of two or more drugs does not provide any advantage over the administration of the drugs separately or those that include a drug of low therapeutic utility. Results 66 treatments with medications not included in the guide were collected, corresponding to 40 different patients, for a total of 190 dispensations. 52 (79%) were not interchangeable and 14 (21%) were LTU drugs. Three pharmacological groups accounted for 33.3% of all treatments: urinary antispasmodics, antidepressants (both 12.1%) and antiasthmatics (9.1%). Conclusion and relevance Most of the expenditure on drugs not included in the hospital guide was from the acquisition of drugs for which it was assumed that there was no other interchangeable option in the pharmacotherapeutic guide. Three pharmacological groups accounted for a third of the total cost of these drugs. For this reason, the actions in these groups should be prioritised, proposing their replacement, whenever possible, and evaluating the possibility of including them in the hospital guide, thereby reducing the cost of acquisition. In view of the results, the pharmacy and therapeutics commission decided to include one of the antidepressants in the hospital guideline due to its cost–benefit. It might be advisable to reinforce the pharmacist’s interventions in this regard to instil in prescribers the importance of adjusting the treatment to the hospital guidelines. References and/or acknowledgements Conflict of interest No conflict of interest

Background and importance Intravenous immunoglobulin (IVIG) is a blood product used for replacement therapy and immunomodulation in various conditions. Its use is usually restricted to situations with clinical benefit and established evidence, due to the drug’s production method and high economic value. Recently, the Portuguese National Pharmacy and Therapeutics Committee (NPTC) released guidance for a more evidence based IVIG use approach.¹ Aim and objectives To characterise the IVIG prescription profile in our institution; to assess if IVIG is prescribed and used in accordance with guidance No 8, May 2020, from NPTC and the National Medicines Formulary (NMF); and to evaluate the impact of IVIG consumption on the hospital’s financial budget. Material and methods All IVIG prescriptions from January 2018 to May 2020 were analysed. Indications, doses, infusion rates (IR) and adverse reactions (AR) were registered in an Excel spreadsheet. The indications were classified as either on or off-label, regarding their inclusion in the aforementioned guidance and as per the NMF. The economic impact was calculated from the average price, using SGICM-GLINTT pharmacy software. Results The study included 131 prescriptions, of which 92.4% conformed to the NMF: 60.3% were replacement therapy, 31.2% immunomodulation cases and the remaining 8.5% were off-label (of these, 64% had probable benefit). The most prevalent indications were chronic inflammatory demyelinating polyradiculopathy (39%) and MyD88 deficiency (31%). Doses and IR were as indicated. There were recorded AR. IVIG accounted for 1.21% of the institution’s total medication expenses. Conclusion and relevance IVIG was mostly used for approved indications. Doses and IR were within the recommended range and no AR were reported, suggesting that the administrations was well tolerated. Off-label use, although characterised by limited expression and for indications with probable benefit, included indications not mentioned in the guidance. In this study, hospital prescriptions showed a low level of compliance with the NPTC guidance; therefore, an institutional protocol should be developed for a more evidence based approach to IVIG use. Locally, the annual expenses for IVIG (1.21%), a value way below the national average (2.83%), may be due to the smaller size and complexity of the hospital and slight off-label use. References and/or acknowledgements Comissao Nacional de Farmacia/Terapeutica. (2020). Recomendacao sobre utilizacao de IgHN. Orientacoes Comissao Nacional Farmacia/Terapeutica. Conflict of interest No conflict of interest

The chapter is initiated with basic data, particularly with the concepts of nanoparticle, nanomineral and nanomaterial. Nanostrutured materials based on nanoparticles constitute fundamental components of the human body. In the natural environment, the nanoparticles of origin both geogenic and anthropogenic are everywhere, in the soil, in the air, and in the water, and when they interact with the human body, they can be incorporated, and in some circumstances, they can be toxic. Nanominerals and nanomaterials are prepared to be used, for example, in pharmacy, cosmetics, and medicine. Nanoparticles are potential nanocarriers for direct cell/tissue delivery of therapeutic or diagnostic compounds. Clay and clay minerals are good examples of nanomaterials and nanominerals. The so-called organoclays are biocomposites very important in various technologies such as biosensors, regenerative medicine, and tissue engineering. Within the nanominerals, which are the devices or “machines” small enough to “travel” inside the human body to provide health benefits, some which are important in regenerative medicine/tissue engineering deserve particular reference and description. Bioactive ceramics and glasses to make prostheses can be implanted to replace and repair diseased or damaged body parts. The chapter ends with the report and discussion of both toxicity and regulation of nanominerals and nanomaterials.

Entrustable professional activities (EPAs) denote activities and tasks students should be able to perform by graduation irrespective of their practice setting. Formulary decision-making includes several core EPA related skills, such as utilization of drug information, written, and verbal skills. The objective of this study was to describe an EPA supporting task aimed at improving utilization of evidence-based medicine skills and its impact on student self-perceived confidence, rating of skills needed, and competence.Teams comprised of six to seven students were assigned a drug and instructed to complete the following activities: (1) background literature search, (2) drug monograph, (3) five-min presentation to simulate a live pharmacy and therapeutics (PT) committee meeting, and (4) vote on a formulary drug in each drug class. Students completed a pre/post five-point Likert scale self-efficacy survey and a perceived importance survey. A scoring rubric assessed monograph and presentation elements (max points 30). Survey items were analyzed using Wilcoxon signed-rank test. Descriptive statistics were used for assignment grades.One hundred ninety students completed the pre/post self-efficacy and perceived importance survey. Confidence showed statistically significant improvement (P.001) in nine target skill areas. In ranking importance, all 12 assessed skills exhibited a statistically significant increase following the activity.A mock PT activity represents an innovative way to evaluate an EPA supporting task that allows students to improve their evidence-based analysis, written, and verbal communication skills.

Diabetes prevalence continues to rise in the United States, affecting more than 30 million people (9.4% of the population) in 2015 (1). Diabetes is expensive in terms of both direct medical costs and indirect costs of disability, lost work productivity, and premature death. The estimated cost of diabetes in the United States was $245 billion in 2012 (2). Optimizing care by facilitating glycemic control, patient education, preventive health screenings, and adherence to the treatment regimen have been suggested as methods to decrease the cost of this disease (3). There are inequalities in the disease burden of diabetes in the United States. The prevalence, incidence, and complications rates of diabetes are higher in non-Hispanic black, Hispanic, and American Indian/Alaska Native populations (4,5). Minority, low-income, and uninsured people have a higher risk for omissions of recommended diabetes prevention services (6). Furthermore, people who are non-English–speaking may experience barriers to effective diabetes medication management, including prohibitive costs of medications, hindered communication, knowledge deficits, and difficulties in understanding (7). The American Diabetes Association consistently identifies the promotion of health equity for populations disparately affected by diabetes as an advocacy priority (8). Federally Qualified Health Centers (FQHCs) provide primary care, behavioral health services, dental care, and other health care services to medically underserved populations. These safety-net clinics work to reduce barriers to health and health care in low-income populations disproportionately affected by chronic disease by increasing access to health care providers and medications (9,10). In 2016, FQHCs provided care to more than 26 million patients, more than half of whom had an income below the federal poverty level. The Health Resources and Services Administration (HRSA) reported in its 2016 health center data report that 32.1% of the more than 2 million patients with diabetes receiving care at FQHCs had …

Glucagon-like peptide 1 (GLP-1) receptor agonists are relatively new additions to the treatment options available for type 2 diabetes. These agents provide glycemic control by increasing glucose-dependent insulin secretion, decreasing inappropriate glucagon secretion, slowing gastric emptying, and increasing satiety (1). The GLP-1 receptor agonists are an attractive treatment option because they are associated with weight loss and have a low risk of hypoglycemia. However, their use is limited in some patients because of gastrointestinal adverse effects (nausea, vomiting, diarrhea), cost, and their subcutaneous route of administration (1). There are currently six GLP-1 receptor agonists approved for use in the United States: exenatide (Byetta), 2005; liraglutide (Victoza), 2010; exenatide XR (Bydureon), 2012; albiglutide (Tanzeum), 2014; dulaglutide (Trulicity), 2014; and lixisenatide (Adlyxin), 2016. Many differences exist within this class of medications, including efficacy and safety profiles, dosing schedules, and preparation and administration requirements, making product selection and use potentially confusing for both health care professionals (HCPs) and patients. Dosing schedule is one important consideration when comparing GLP-1 receptor agonists. Whereas three of the GLP-1 receptor agonists are available in multi-use, disposable pen devices and are given either twice daily (exenatide) or once daily (liraglutide and lixisenatide), the other three GLP-1 receptor agonists are once-weekly formulations available in single-use, disposable pen devices (albiglutide [2], dulaglutide [3], and exenatide XR [4]). Once-weekly products may offer the advantage of better adherence and ease of use compared to once- or twice-daily medications. In clinical studies, adherence to treatment and treatment satisfaction significantly increased with once-weekly GLP-1 receptor agonists compared to once- or twice-daily GLP-1 receptor agonists (5–7). In comparing efficacy and safety of the once-weekly agents, meta-analyses and head-to-head trials demonstrate that dulaglutide showed the greatest reduction in A1C compared with other once-weekly GLP-1 receptor agonists, …

Background: The use of antibiotic drugs (ABX) in hospitals, and especially in intensive care units (ICU), is widespread. The early administration of ABX therapy can improve survival rates. The influence and impact of the ABX are observed in the patients who receive them (clinical response, course) and in the ecosystem surrounding the patient (hospital flora). Aim of the review: The objective of this review is to identify strategies that reduce or limit the appearance and transmission of multidrug-resistant microorganisms. This identification can then develop a rational use of the ABX plan in the ICU. Method: The following databases were queried; Medline, Embase, The Cochrane Library, and the Centre for Reviews and Dissemination (University of York), asking the questions in PICO format to evaluate the efficacy and safety of several interventions: A) Therapeutic de-escalation; B) Cycling of ABX and; C) Early antibiotic treatment. Results: A) In therapeutic de-escalation of 98 studies identified, three studies that met the inclusion criteria were analyzed. B) Two studies comparing antibiotic cycling versus other interventions were selected. C) No studies have been found with sufficiently robust methodological designs that address the ABX early treatment. There is no strong evidence to indicate which of the different antibiotic interventions (therapeutic de-escalation, cycling of ABX and preemptive treatment) is more effective in reducing antibiotic resistance in ICU patients. There is insufficient evidence that de-escalation of antimicrobial agents is effective against resistance. In patients admitted to the ICU with a low prevalence of fluoroquinolones resistance, increased exposure to this class of antibiotics, using antibiotic cycling, increases the emergence of resistant strains. Conclusion: Despite the fact that no prospective studies were identified in this SR, rationale and day-to-day clinical practice experience suggest that multidisciplinary participation of different specialists in ABX's Infection and Policy Commission (or the ABX Commission), or the Pharmacy and Therapeutics Committee, might improve the development and application of these strategies.

Objective: To explore National Survey of Pharmacy Practice at MOH hospitals in Saudi Arabia 2016: Prescribing and medication management. Methods: It is a 4-months cross-sectional National Survey of Pharmacy Practice at MOH hospitals in Saudi Arabia. The study consisted of two parts; the demographic information and the second part contained eighty-five questions divided into eight domains drove from American Society of Health-System Pharmacists (ASHP), Saudi Pharmaceutical Society (SPS) survey, and the international standard of Joint Commission of Hospital Accreditation. The 5-point Likert response scale system was used with closed and ended questions. An electronic questionnaire was distributed to the one hundred eighty-five directors of pharmacies at MOH hospitals. The study discussed and analyzed National Survey of Pharmacy Practice at MOH hospitals in Saudi Arabia: the prescribing and medication management. Results: The survey questionnaire distributed to 185 of hospitals, the rate of reply, was 105 (56.75%) hospitals. The highest score of committee shared by the hospital pharmacy was the pharmacy and therapeutics committee (4.33), quality management committee (4.06), infection control committee (3.88), while the lowest scores were Anticoagulation committee (2.14), DUE committee (2.16) and IV therapy committee (1.99). The most therapeutic guideline available in the hospital pharmacies were antibiotics guidelines (2.91) followed by infection control (2.84) and anticoagulation guidelines (2.13). The majority formulary management method used was restricted prescribing certain expensive drugs 33 (33.1%), review of non-formulary drugs prior approval 27 (25.7%), and the closed drug formulary 14(13.3%). The most drug utilization activities used at the hospitals were Used as the basis for revision of drug-use policies and procedures 44 (41.9%) and Incorporated into medical staff credentialing considerations 27 (25.7%) The pharmacist has the privilege to write medication orders were 18 (17.1%) only. The pharmacist commonly prescribed over the counter medications 19 (57.6%) and antibiotics 15 (45.5%) through the prescription cosigned by physician 55 (52.4%). Followed by Drugs under prescribing protocol 39 (37.1%) and Medications Refill Clinic 26 (24.8%). Conclusion: The hospital seldom participated in the therapeutic guidelines, and the few pharmacists shared in essential hospital committees despite the unique role of providing medication information. Expanding pharmacy activities will improve the prescribing system, patient clinical outcomes, and prevent drug misadventures. Key word: Prescribing, Medication management, Ministry of health, Saudi arabia.

The 2008 ASHP “Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System” noted that designation of a formulary medication should reflect a determination that the medication is “appropriate for routine use” (emphasis added) in a particular patient population.[1][1] Many

Lessons learned from the creation of a multihospital health-system formulary management and pharmacy and therapeutics (PT) committee are described.A health system can create and implement a multihospital system formulary and PT committee to provide evidence-based medications for ideal healthcare. The formulary and PT process should be multidisciplinary and include adequate representation from system hospitals. The aim of a system formulary and PT committee is standardization; however, the system should allow flexibility for differences. Key points for a successful multihospital system formulary and PT committee are patience, collaboration, resilience, and communication. When establishing a multihospital health-system formulary and PT committee, the needs of individual hospitals are crucial. A designated member of the pharmacy department needs to centrally coordinate and manage formulary requests, medication reviews and monographs, meeting agendas and minutes, and a summary of decisions for implementation. It is imperative to create a timeline for formulary reviews to set expectations, as well as a process for formulary appeals. Collaboration across the various hospitals is critical for successful formulary standardization. When implementing a health-system PT committee or standardizing a formulary system, it is important to be patient and give local sites time to make practice changes. Evidence-based data and rationale must be provided to all sites to support formulary changes. Finally, there must be multidisciplinary collaboration.There are several options for formulary structures and PT committees in a health system. Potential strengths and barriers should be evaluated before selecting a formulary management process.

Diabetes is a major worldwide epidemic with >415 million individuals living with the disease. This number is expected to grow to a staggering 642 million by 2040 (1). According to the American Diabetes Association, diabetes affects 29.1 million Americans, or 9.3% of the population. Diabetes management in the United States presents several challenges: 20% of individuals with diabetes remain undiagnosed, 1.4 million new cases are diagnosed annually, and one-third of adults with diabetes are not at the general recommended A1C goal of

Complex regional pain syndrome (CRPS) is a life-altering and debilitating chronic pain condition. The authors are presenting a case study of a female who received high-dose ketamine for the management of her CRPS. The innovative treatment lies not only within the pharmacologic management of her pain, but also in the fact that she was the first patient to be admitted to our pediatric intensive care unit solely for pain control. The primary component of the pharmacotherapy treatment strategy plan was escalating-dose ketamine infusion via patient-controlled-analgesia approved by the pharmacy and therapeutics committee guided therapy for this patient. The expertise of advanced practice nurses blended exquisitely to ensure patient and family-centered care and the coordination of care across the illness trajectory. The patient experienced positive outcomes.

Background. It is estimated that >50% of all medicines are inappropriately prescribed, dispensed or sold. In 2018, the Western Cape Government Health (WCGH) Provincial Pharmacy and Therapeutics Committee (PPTC) endorsed an investigation of doxazosin use in provincial public sector healthcare facilities using a medicine-use evaluation (MUE). This was based on potential inappropriate prescribing, high usage and high costs associated with doxazosin. Objectives. To determine whether doxazosin was being prescribed in accordance with recommendations from standard treatment guidelines and essential medicines lists for hospital and primary healthcare level, as well as from the WCGH provincial code list. Methods. The study design consisted of a retrospective multicentre prescription review. The study population included all adult outpatients who were prescribed doxazosin, which was to be dispensed by the WCGH Chronic Dispensing Unit. Criteria for evaluation included indications for doxazosin administration and total daily dose prescribed. Results. The study sample comprised 171 patients. The main indication for doxazosin administration was as a fourth-line agent for the treatment of hypertension (82%). The remaining indications were not guideline approved (18%). The total daily doses identified were 4 mg (62%), followed by 8 mg (36%) and 2 mg (2%). All of these were approved dosages as per guideline recommendations. Conclusions. MUEs are an untapped resource for medication-use monitoring and practice improvement. MUEs offer a distinct, cost-effective approach to improve medicine use in all settings. This MUE revealed a relatively minor concern with doxazosin prescribing. MUEs can be beneficial to inform formulary changes and re-evaluate medication-use restrictions.

Obtaining complete medication histories is imperative to treating patients effectively and avoiding unintended medication consequences. Health care providers (HCPs) receive training and learn skills to help elicit complete medical information, including but not limited to medication use, but the system falls short in some instances (1,2). In these instances, undocumented medication use can complicate patients’ treatment. Examples encompass confounding of the differential diagnosis and unforeseen medication interactions. The potential for unintended medication consequences can be increased by omissions in reporting usage of herbal, homeopathic, or over-the-counter (OTC) treatments. Although warnings about the risks of self-medicating, such as possible variability of medication effects from one person to another, date back for decades, this practice has become increasingly common (3,4). Self-medication through the use of old prescriptions or OTC products has the potential to pose problems, but self-medication via prescription sharing with other individuals—often family members or friends—is especially problematic. This practice can be dangerous because it can remain undetected for long periods of time and may be accompanied by a wide range of effects. Prescription medications are intended to be used under the supervision of licensed HCPs. The sharing of prescription medications among individuals removes pharmacists and other HCPs from the medication use process, resulting in the loss of education and instruction regarding the safe use of medications and increasing the potential for adverse effects (5,6). A survey distributed to patients in community pharmacies in New Zealand showed that, among prescription sharers, about half of prescription borrowers received written instructions with the medication, and about half of prescription lenders gave verbal instructions with the medication (7). That leaves many individuals with no instructions at all, and those who do receive instructions cannot be certain that they have received correct information because the source is not …

Purpose The implementation and maintenance of a process for adding and removing hyperlinks to medication management policies and guidelines approved by a pharmacy and therapeutics (P&T) committee into the electronic health record (EHR) are described. Summary Medication management policies and guidelines approved by the P&T committee are published on the University of Utah Health intranet, making it possible to add hyperlinks to this information within the EHR. Adding these hyperlinks allows policy and guideline information to be available to clinicians on the medication ordering, verification, and administration screens without requiring a separate search of the intranet. In a quality-improvement project, all medication management policies and guidelines posted on the intranet were reviewed for relevance to the medication ordering, verification, and administration processes. Hyperlinks to relevant policies and guidelines were implemented into the EHR for specific medications. At the beginning of the review, 100 unique drugs associated with 1 or more hyperlinks were identified. The hyperlinks referenced a total of 33 Web documents: 8 policies and 25 guidelines. There are 74 medication management policies and 78 medication management guidelines approved by the P&T committee at University of Utah Health. After investigator review, 12 of 74 policies (16%) and 41 of 78 guidelines (53%) were deemed relevant during the medication ordering, verification, and administration processes. The review and hyperlink implementation process took a total of 101 hours. A continual review process was developed to enable addition and removal of hyperlinks as appropriate. Conclusion Providing direct access to relevant medication management policies and guidelines approved by the P&T committee during the medication ordering, verification, and administration processes via hyperlinks in the EHR makes formulary information readily accessible by appropriate staff. These hyperlinks may also improve adherence to formulary information, reduce medication expenditure, and improve safety and therapeutic outcomes of medication therapy.

Este trabalho verificou os impactos econômicos e de acesso, além dos níveis de essencialidade das listas de medicamentos de uma rede hospitalar pública após a implantação de Comissões de Farmácia e Terapêutica (CFT) por meio do método de Planejamento Estratégico Situacional (PES). Foi observado uma redução de 27,8% do número total de itens, um aumento de 13,6% do percentual de itens pertencentes a Rename, de 10,5% pertencentes a lista da OMS e de 14,7% indicados por diretrizes clínicas. Em análise econômica observou-se uma redução de aproximadamente 12% dos custos da lista, demonstrando o grande potencial de contribuição para otimização dos recursos públicos.

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.

Background The X healthcare system is facing unprecedented challenges to healthcare expenditure that warrants healthcare reform and cost cutting. The pharmacy therapeutic committees (PTC) in hospitals play a pivotal role in a hospital formulary management system to ensure cost containment and to improve quality of care. Purpose Our study investigates the current PTCs’ structures, activities, variations and potential factors that might influence the decision-making of these committees within Saudi Arabian hospitals. Material and methods The study was conducted in governmental and private hospitals in X from May to July 2018 using a mixed-methods approach consisting of a quantitative, questionnaire-based study followed by a qualitative study with a triangulation technique for data collection that involved observations as well as in-depth semi-structured interviews to generate more robust findings. Ethical approval for the study was obtained from the participating hospitals. Results One hundred and nine members were invited from seven institutions for the questionnaire: 51.47% responded. For the qualitative interview, 25 members were required to reach data saturation. All PTCs had policies and procedures outlining the committee’s activities, and an approved committee formation order. Most of the PTCs (45, 88.2%) conduct their meetings every month, and all their activities complied with CBAHI’s accreditation minimum requirements. The greatest challenges reported, were time restraints on PTC activities (seven, 28%), lack of awareness of their function in committee, evidence-based evaluation and budget restraints (five, 20%), and the stock monitoring system and lack of expertise in pharmacoeconomics (three, 12%). Conclusion Based on our study findings, PTCs in the X health sector need to invest in standardising the functions and processes of PTCs, developing training programmes to support PTCs members in specialised aspects of formulary management, setting minimum standards for committee members’ selection and investing in stock monitoring IT solutions. Such changes may improve PTCs’ efficiency and cost cuts to align with the vision. Reference and/or acknowledgements World Health Organization 2003. Available from: http://apps.who.int/medicinedocs/pdf/s4882e/s4882e.pdf (Accessed: 1 January 2018). No conflict of interest.

Background The Pharmacy and Therapeutics Committee approved in May 2017 a protocol for the prescription of intravenous iron in order to achieve the correct use of it in the hospital, and the establishment of an iron sucrose complex as first choice in admitted patients. Purpose The objective of this study was to assess the degree of adaptation of the prescriptions to the protocol. Material and methods We conducted a retrospective observational study from May 2017 to July 2018. In order to assess the degree of adaptation of the prescriptions it was checked if the requests were received correctly completed for type of patient (inpatient or outpatient), medical service, diagnosis and cause and patient’s bodyweight, and if there were iron metabolism data (transferrin saturation, serum ferritin and iron) previous to the request.We also recorded the pharmaceutical product prescribed (ferric carboxymaltose or sucrose). Likewise, we reviewed if administered doses were correct, taking into account the theoretical deficiency calculated according to the Ganzoni formula. Dosage was considered correct if the difference between the administered dose and the theoretical deficiency did not exceed ±500 mg in ferric carboxymaltose and ±200 mg in sucrose. Results A total of 271 prescriptions were analysed (outpatients 51.3%). The internal medicine department was the main service prescriber (47.2%), followed by the gastroenterology department (21.8%). The principal medical diagnosis was anaemia. The cause was unknown in 35.5% of patients. Concerning the three main reasons for prescription, in descending order they were: need for fast iron replenishment (56.5%), inefficiency or intestinal malabsorption syndromes (14.7%) and intolerance to oral iron or impossibility to an oral regimen (11.4%) The reasons were unknown in 4.1%. Data of iron metabolism was not available in 34.7% of requests. Ferric carboxymaltose was the pharmaceutical product chosen in most of the patients (54.6%), of which 62% were outpatients. The total dose administered did not match the theoretical deficiency calculated in 41.3% of cases. Conclusion The lack of data in many orders received in the pharmacy department makes it difficult to verify the appropriateness of the prescription to the protocol in many cases. This highlights that protocolisation is a dynamic process which requires a continuous assessment to ensure its utility. Ferric carboxymaltose was used more frequently in iron replenishment in outpatients and iron sucrose in hospitalised patients. References and/or acknowledgements No conflict of interest.