Formulary Systems Research Articles

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Drug provision is one of the health care key problems in many countries, including Armenia. The World Health Organization is implementing a policy aimed at introducing the principles of effective use of drugs in countries, offering to introduce and improve formulary systems as a tool for effective use of drugs. The formulary system is currently used in all developed countries and provides many advantages, the most important of which is the improvement of health care quality. Formulary list of drugs include only those drugs that are proven effective, safe, high quality and cost-effective, facilitating the work of the prescribers, decreasing medical errors and the complications of pharmacotherapy, thus improving public health indicators. Thus, the formulary system is an effective mechanism, that allows using drugs effectively, reduces the costs of their acquisition and, consequently, improves drugs provision to the population. Therefore, its introduction in health facilities of Armenia will be one of the most effective steps to have positive changes in the health care system.

Exploring perspectives on antimicrobial stewardship: a qualitative study of health managers in Kenya

BackgroundAntimicrobial resistance is a significant public health concern with the establishment of antimicrobial stewardship in hospitals being increasingly obligatory. Perspectives and insights of health managers on antimicrobial stewardship (AMS), complementary health services and building blocks are imperative towards implementation of robust AMS programs. This study aimed to understand perspectives of hospital managers on AMS and identify areas of management engagement while addressing potential blockades to change.MethodsA cross-sectional, qualitative, multicenter study was conducted in three hospitals in Kenya. Key-informant interviews on perspectives on AMS were administered to hospital managers. Qualitative data was captured using audio tapes and field notes, transcribed and managed using NVivo 12 software. An iterative process was used to develop the thematic framework and updated in two rounds of iteration analysis. Analysis charts for each emergent theme were developed and categorized across all participants.ResultsPerspectives on AMS are described in five thematic categories; Importance of antimicrobial stewardship and the role of medicines and therapeutics committee, availability of antimicrobial formulary and usage surveillance systems, laboratory competency and recommendations for infection prevention and management, educational resources and communications channels available, building blocks and low-lying fruits for Antimicrobial Stewardship Committees. The role of stewardship collaboration in diagnosis and antimicrobial prescription was alluded to with managers indicating a growing rise in occurrence of antimicrobial resistance. There lacked contextualized, hospital specific antimicrobial formulary and adequate laboratory competency. Staff training and communication channels were available in varying capacity across the three hospitals. Building blocks identified include medicines and therapeutics committee, education, and training platforms (Continuous Medical Education and Continuous Professional Development activities) and hospital leadership commitment.ConclusionsThe practice of antimicrobial stewardship is not implemented and well developed as demonstrated by lack of core AMS complementary health services. However, the health managers are aware of the fundamental importance of antimicrobial stewardship programs and the vast benefits of implementation and institutionalization of AMS to hospitals and their clients. The findings underpin the importance of understanding and incorporating perspectives of health managers on existing contextual mechanisms that can be leveraged on to establish robust AMS programs in the fight against antimicrobial resistance.

PRACTITIONER UPDATE.

OBJECTIVE: To review the development and implementation of prescription formularies by managed care organizations, identify their current applications, and recognize future trends in the managed care pharmacy environment. DATA SOURCES: Current journal articles and texts regarding the use of formularies and the managed care environment. DATA SYNTHESIS: Not applicable. CONCLUSION: Formulary systems have proven to be a valuable means to control the pharmacy benefit and can be expected to expand in both scope and sophistication.

ASHP national survey of pharmacy practice in hospital settings: Prescribing and transcribing-2016.

The results of the 2016 ASHP national survey of pharmacy practice in hospital settings are presented. A stratified random sample of pharmacy directors at 1,315 general and children's medical-surgical hospitals in the United States were surveyed using a mixed-mode method offering a choice of completing a paper survey or an online survey. IMS Health supplied data on hospital characteristics; the survey sample was drawn from IMS's hospital database. The survey response rate was 29.8%. Drug policy development by pharmacy and therapeutics committees continues to be an important strategy for improving prescribing. Strict formulary systems are maintained in 63.0% of hospitals, and 89.7% of hospitals use clinical practice guidelines that include medications. Pharmacists have the authority to order laboratory tests in 89.9% of hospitals and order medications in 86.8% of hospitals. Therapeutic interchange policies are used in 89.2% of hospitals. Electronic health records (EHRs) have been implemented partially or completely in most hospitals (99.1%). Computerized prescriber-order-entry systems with clinical decision support are used in 95.6% of hospitals, and 92.6% of hospitals have barcode-assisted medication administration systems. Transitions-of-care programs are increasing in number, with 34.6% of hospitals now offering discharge prescription services. Pharmacists practice in 39.5% of hospital ambulatory or primary care clinics. The most common service offered by pharmacists to outpatients is anticoagulation management (26.0%). When pharmacists practice in ambulatory care clinics, 64.5% have prescribing authority through collaborative practice agreements. Pharmacists continue to expand their role in improving the prescribing of medications in both hospital and outpatient settings. The adoption of EHRs and medication-use technologies has contributed to this growth.

ASHP national survey of pharmacy practice in hospital settings: Prescribing and transcribing-2013.

The results of the 2013 ASHP national survey of pharmacy practice in U.S. hospital settings are presented. A stratified random sample of pharmacy directors at 1433 general and children's medical-surgical hospitals was surveyed by mail. IMS Health supplied data on hospital characteristics; the survey sample was drawn from IMS's hospital database. In this national probability sample survey, the response rate was 28.9%. Drug policies developed by pharmacy and therapeutics committees continue to be an important strategy for improving prescribing. Strict formulary systems were maintained in 60.4% of hospitals, and 77% used clinical practice guidelines that included medications. Direct clinical services by pharmacists are becoming a more important way to identify and resolve medication-related problems with prescribing. Therapeutic interchange policies were used in 87.2% of hospitals, and pharmacist consultation to improve prescribing was common. Pharmacists most commonly provided consultations to prescribers for dosage adjustment (98.3%), drug information (93.2%), recommendations for antibiotic therapy (91.7%), and pharmacokinetics (91.5%). Electronic health records (EHRs) have been implemented partially or completely in most hospitals (92.6%). Computer prescriber-order-entry systems with clinical decision support were used in 65.2% of hospitals, 80% had barcode-assisted medication administration systems, 80.8% had smart infusion pumps, and 93.9% had electronic medication administration records. EHRs were used in 60.7% of outpatient clinics, with electronic prescribing to outpatient pharmacies used in 59.6% of hospitals. Pharmacists practiced in 27.1% of hospital ambulatory or primary care clinics, which is an increase from 18.1% compared with 2010. The most common service offered by pharmacists to outpatients was anticoagulation management (63.5%). The percentage of hospitals using performance metrics increased from 58.7% in 2010 to 68.7%. Pharmacists continue to expand their role in improving the prescribing of medications in both the hospital and outpatient settings. The adoption of EHRs and medication-use technologies has contributed to this growth.

Oxycodone/Naloxone: role in chronic pain management, opioid-induced constipation, and abuse deterrence.

The use of opioids in the treatment of chronic pain is widespread; the prevalence of specific opioids varies from country to country and depends on product availability, national formulary systems, and provider preferences. Patients often receive opioids for legitimate treatment of pain conditions, but on the opposite side of the spectrum, nonmedical use of opioids is a significant public health concern. Opioids are associated with several side effects, and constipation is the most commonly reported and persistent symptom. Unlike some adverse effects associated with opioid use, tolerance does not develop to constipation. Opioid-induced constipation (OIC) is the most prevalent patient complaint associated with opioid use and has been associated with declines in various quality of life measures. OIC can be extremely difficult for patients to tolerate and may prompt patients to decrease or discontinue opioid treatment. Current management strategies for OIC are often insufficient. A prolonged-release formulation of oxycodone/naloxone (OXN) has been investigated for the treatment of nonmalignant and cancer pain and mitigation of OIC, and evidence is largely favorable. Studies have demonstrated the capability of OXN to alleviate OIC while maintaining pain control comparable to oxycodone-only regimens. There is insufficient evidence for OXN efficacy for patients with mild OIC or patients maintained on high doses of opioids, and use in these populations is controversial. The reduction of costs associated with OIC may provide overall cost effectiveness with OXN. Additionally, the presence of naloxone may deter abuse/misuse by those seeking to misuse the formulation by modes of administration other than oral ingestion. Most studies to date have occurred in European countries, and phase 3 trials continue in the United States. This review will include current therapeutic options for pain and constipation, unique characteristics of OXN, evidence related to use of OXN and its place in therapy, discussion of opioid abuse/misuse, and various abuse-deterrent mechanisms, and areas of continuing research.Electronic supplementary materialThe online version of this article (doi:10.1007/s40122-014-0026-2) contains supplementary material, which is available to authorized users.

Formulary systems and pharmacy and therapeutics committees in the Western Pacific Region: Exploring two Basel Statements

The use of formulary systems and pharmacy and therapeutics (P&T) committees in the Western Pacific Region (WPR) and the factors associated with their use were explored. Minor additions were made to a previously validated survey and reviewed by a WPR advisory committee. The Basel Statements 26 and 27 survey was made available in eight languages and sent electronically to 1989 hospital pharmacy directors through respective hospital pharmacy associations in the WPR. A total of 797 responses (40%) from 34 nations were received. Of these responses, 87% of hospitals (691 of 797) used a formulary. Also, 93% of respondents (619 of 664) indicated that their hospital had a P&T committee. However, only 44% of respondents (274 of 626) reported that more than half of their formulary medicines were linked to standard treatment guidelines. Furthermore, only 41% of hospitals (247 of 601) had a policy for off-label medication use. The pharmacy directors' perceived benefits of formularies were correlated with having more formulary medicines linked to standard treatment guidelines, basing their use on the best available evidence, and having a policy for the use of off-label medicines. A large proportion of hospitals in the WPR have implemented formularies and P&T committees. Although formularies are commonly used, their effectiveness may be limited, as formularies are often not linked to standard treatment guidelines or the best available evidence.

Assuring dietary supplement quality for cancer patients: An integrated formulary systems approach.

e20663 Background: Studies reveal up to 80% of cancer patients use some form of dietary supplements (DS). Despite the need for additional research, evidence exists that some DS may be of clinical value. In order to provide safe DS recommendations to patients, we created a Dietary Supplement Formulary Committee (DSFC). Methods: Twelve manufacturers (marketing 19 DS brands) with a reasonable reputation among providers for quality were selected. A survey tool was created to measure critical quality, GMP and FDA compliance practices; information was obtained via non-disclosure agreements; manufacturing documents were audited and compared to survey responses; FDA audit reports were obtained under Freedom of Information requests; site audits were conducted; and third party analytical testing was performed. Results: All 12 companies claimed to be operating in full compliance with FDA regulations. However, 3 had received Warning Letters from FDA for GMP violations; 2 performed a product recall within the last 5 years; 4 reported products that failed Consumerlab.com for potency or purity; 1 did not have product specifications; 1 was found by FDA to have inadequate testing; 1 was found to have a lack of sufficient controls throughout the supply chain to guard against microbiological contamination; and 2 had confirmed melamine contamination or lack of melamine testing on protein powders. Additional concerns included the use of subcontractors for certain operations, lack of stability data to support expiration dates, material discrepancies between claims and actual practice, and failure to change UPC (Universal Product Code) numbers when active ingredient formulas change. Conclusions: We observed considerable variation in the quality of DS, and in the level of compliance, which raises concerns for patient safety. One company met all quality standards. The combined use of the measures described above allowed for informed product selection. The variable quality practices identified here emphasize the need for careful formulary oversight. The USP (United States Pharmacopeial Convention), ConsumerLab.com, and the NSF International’s certification programs are current resources available to help identify quality DS.

Getting clinical trial results into practice: design, implementation, and process evaluation of the ALLHAT Dissemination Project.

Conventional dissemination of clinical trial results has inconsistent impact on physician practices. A more comprehensive plan to influence determinants of prescribing practices is warranted. To report the response from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial to the National Heart, Lung, and Blood Institute's requirement for dissemination and evaluation of trials with potential immediate public health applicability. ALLHAT's dissemination plan had two-components: (1) a traditional approach of media coverage, scientific presentation, and publication; and (2) a theory-based approach targeting determinants of clinician behavior. Strategies included: (1) academic detailing, in which physicians approach colleagues regarding blood pressure management, (2) direct patient messages to stimulate communication with physicians regarding blood pressure control, (3) approaches to formulary systems to use educational and economic incentives for evidence-based prescription, and (4) direct professional organization appeals to clinicians. One hundred and forty-seven Investigator Educators reported 1698 presentations to 18,524 clinicians in 41 states and the District of Columbia. The pre- and post-test responses of 1709 clinicians in the face-to-face meetings indicated significant changes in expectations for positive patient outcomes and intention to prescribe diuretics. Information was mailed to 55 individuals representing 20 professional organizations and to eight formulary systems. Direct-to-patient messages were provided to 14 sites that host patient newsletters and Web sites such as health plans and insurance companies, 62 print mass media outlets, and 12 broadcast media sites. It was not within the scope of the project to conduct a randomized trial of the impact of the dissemination. However, impact evaluation using quasi-experimental designs is ongoing. A large multi-method dissemination of clinical trial results is feasible. Planning for dissemination efforts, including evaluation research, should be considered as a part of the funding and design of the clinical trial and should begin early in trial planning.

Ordering Off the Menu: Assessing Compliance with a Nonformulary Medication Policy

Use of nonformulary medications (NFMs) may create added costs and potential safety issues. Institutional policies can support compliance with formulary systems and address these issues. However, periodic review is needed to assess the effectiveness of NFM policies. To evaluate NFM use at a large university medical center and assess for compliance with the established policy as well as for prescribing errors, procurement procedures, and delivery times. All new medication orders entered as NFM in the computerized order entry system during a 6-week period were evaluated and followed until administration of the first NFM dose. Orders were categorized as NFMs, formulary medications (FMs), or the patient's own medications. Each order was evaluated to determine the prescriber, service and location of the patient, and any prescribing errors. Additional information, such as the indication, location where the medication was obtained, and the delivery time, was obtained through patient chart review and the pharmacist intervention database. A total of 237 orders were entered as nonformulary; 72 (30%) were FMs and 165 (70%) were NFMs. Of the 165 NFM orders, 71 (43%) were orders for the patient's own medication. Of the remaining 94 NFMs, only 39% met the institution's established policy criteria. Overall, 28% of all orders entered as nonformulary had a prescribing error. Of these, 49% were incorrect dosages and 33% were misspelled orders. Seventy percent of NFMs were obtained from the institution's standard locations. The institution's nonformulary turnaround time was achieved with 96% of NFMs. The majority of NFM orders did not meet the institution's established criteria and these orders frequently contained prescribing errors. Routine assessment of NFM use and policy compliance can present opportunities for improvement.

Cost-effectiveness analysis and the formulary decision-making process.

Faced with high drug expenditures in an environment of cost containment, drug formulary systems, particularly in managed care, have become more dependent on pharmacoeconomic evaluations to assess the value of new products. Within pharmacoeconomics (PE), cost-effectiveness analysis (CEA) is the most commonly used method. However, current methodological concerns about CEA have limited its practical contribution to the formulary process. Advances in analysis are likely to improve the relevance of CEA over time. The purpose of this paper is to review CEA, its limitations, and its applications in formulary decision making in order to promote greater utility of CEA for managed care pharmacists. Enhancements to CEA, such as the development of modeling software, rank-order stability analysis, cost-consequence analysis (CCA), and budget impact analysis are discussed. A combined method of CCA-CEA and standardized guidelines are suggested to improve the impact of CEA in the drug formulary process. Along with advances in its methodology and relevant standardized guidelines, CEA will gain increased importance in formulary decision making, helping to assure the goal of cost containment while ensuring quality of care.

Alternate financial incentives in multi-tiered formulary systems to improve accountability for outcomes.

Drug manufacturer rebates paid to health plans and pharmacy benefit management companies have come under increased public scrutiny. Over the past several years, numerous articles have appeared in the literature encouraging a shift to a more quality-based decision-making process for health plan drug formularies. To propose a new basis for formulary placement decisions that would include consideration of health-plan-specific measures (clinical outcomes, total cost, adherence, and appropriateness of care) and align incentives for health plans, physicians, pharmacists, and pharmaceutical companies to promote high-quality care. The proposed approach builds on key components of the Pharmacy's Framework for Drug Therapy Management in the 21st Century and the Academy of Managed Care Pharmacy's Format for Formulary Submission, including a focus on patient outcomes and evidence-based decision making. The proposed approach would lessen the influence of drug manufacturer rebates on formulary placement by shifting the focus to appropriateness of care, clinical outcomes, patient adherence, and total cost of care. Pharmaceutical manufacturers would benefit from the focus on adherence to drug therapy and total cost of care. Health plans and pharmacy benefit management companies would gain in that they may be able to reduce efforts in drug utilization review as pharmaceutical manufacturers are given incentives to market their drugs more appropriately. Physicians and pharmacists would benefit because the rebate money would be used to provide quality-based financial incentives related to adherence and appropriate use of drugs. The implementation of this approach would be difficult and require cooperation from employers, pharmacists, pharmaceutical manufacturers, health plans, and pharmacy benefit management companies. Aspects of this approach could be incorporated into existing pharmacy benefit management processes to encourage the delivery of high-quality health care.

Prior Authorization Programs: A Critical Review of the Literature

OBJECTIVE: Though prior authorization (PA) programs are widely used in the managed care pharmacy environment, some stakeholders question whether these programs are effective. The objective of this article is to critically examine the effect of PA programs on health-related outcomes. DATA SOURCES: A computer-aided search of the literature was conducted using several online databases to find studies that have evaluated PA programs. Other sources of information used were reference lists, authors of previous studies, and meeting abstracts. STUDY SELECTION: In order for a study to be included in our analysis, it had to (1) appear in the peer-reviewed literature and (2) investigate the effects of a PA program on specified drugs. We excluded papers that studied the effectiveness of formulary systems, of which PA may be a component. DATA EXTRACTION: From each study evaluated, we extracted data related to the study design and to the effect of the PA program on economic, clinical, and humanistic outcomes. DATA SYNTHESIS: Six studies met our criteria. Overall, PA programs appear to be effective at reducing drug-related costs. There is some evidence that they reduce non drug-related costs but little evidence that they have a positive impact on clinical or humanistic outcomes. None of the studies had a randomized, controlled design; most of the studies had severe methodological limitations. CONCLUSION: Rigorously designed studies are urgently needed in order to evaluate the effects of PA on health related outcomes.

The Hospital Drug Formulary System: Just a Leftover? Opinions of a Tired but Still Committed Formulary System Manager

Irecently came across some minutes of the Pharmacy and Therapeutics Committee at our hospital in which the topic of formulary systems was being hotly debated. One member was quoted as saying that “a hospital formulary is too confining and would limit doctors on their choice of drugs”; another stated that “it has value as an educational aid and reference”, and yet another suggested that “it would eliminate some useless drugs and probably decrease drug costs”. The date on those minutes was January 16, 1959, and this documentation marked the birth of the formulary system at Vancouver General Hospital. Amazingly, over 40 years later, the controversy about hospital formulary systems continues. A few decades later, and after more than 10 years of personal experience working on drug management at this institution, I believe that a well-controlled drug formulary system is still and will continue to be a critical element of responsible acute care hospital pharmacy practice. As the godfather of pharmaceutical care has said, “I personally would much rather practice, and receive care, in a hospital with a well-managed formulary system than in one without”. 1 However, like

Do Institutional Formulary Systems Conflict with the Provision of Pharmaceutical Care

Almost all pharmacists working in Canadian hospitals and health-care institutions practice in a setting where a drug formulary specifies the medications available for treating patients. The drug formulary can be defined as a continually revised compilation of medications reflecting the current clinical judgement of local staff regarding the medications necessary to treat the local patient population. The formulary system is the method whereby physicians, pharmacists, and other members of the health-care team work to select the medications considered most useful for patient care and thereby ensure quality drug use while controlling costs. 1 “Pharmaceutical care is the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life. Pharmaceutical care involves the process through which a pharmacist cooperates with a patient and other professionals in designing, implementing, and monitoring a therapeutic plan that will produce specific therapeutic outcomes for the patient.” 2 Yet restriction of the choice of drug therapy to a limited number of therapeutic options could theoretically conflict with optimal drug therapy for individual patients. Is it reasonable that we, as practitioners attempting to achieve specific therapeutic outcomes for individual patients, are limited in our choice of therapies because of a restrictive formulary? The “knee-jerk” response to this question would be that clinicians should not be limited in their therapeutic choices by a formulary, but a more holistic view of care lessens the potential for conflict between the formulary system and pharmaceutical care. The goals of the formulary system are consistent with the goals of pharmaceutical care. Formularies are established to ensure the availability of the drug therapies used to treat the conditions experienced by the patients served by the institution. The decision to add a drug to the institution’s formulary should be based on scientific data that have been evaluated impartially by clinicians familiar with anticipated therapeutic indications and alternative therapies. By assessing other available therapies, the formulary addition process minimizes redundant therapeutic options. This will reduce the costs of inventory management, drug storage and preparation, and staff education. The formulary evaluation process also prompts reevaluation of existing therapies in terms of more recent advances so that potentially outdated or toxic therapies can be

Drug formulary systems not widely used in Hong Kong

Drug formulary systems not widely used in Hong Kong

Managing the Pharmacy Benefit: The Formulary System

OBJECTIVE: To review the development and implementation of prescription formularies by managed care organizations, identify their current applications, and recognize future trends in the managed care pharmacy environment. DATA SOURCES: Current journal articles and texts regarding the use of formularies and the managed care environment. DATA SYNTHESIS: Not applicable. CONCLUSION: Formulary systems have proven to be a valuable means to control the pharmacy benefit and can be expected to expand in both scope and sophistication.

The expanding role of pharmacy and therapeutics committees. The 1990s and beyond.

Traditionally, pharmacy and therapeutics (P&T) committees have been responsible for overseeing the drug use process, using formulary systems to control drug costs. Primarily, these committees act in an advisory capacity as policy-recommending bodies within healthcare systems, for the specific purpose of promoting rational drug therapy. Methodologies utilised by these committees include drug use evaluation, medical staff education, continuous quality improvement, formulary restriction and therapeutic interchange. Future roles of P&T committees will include the evaluation of clinical outcomes information, including quality-of-life issues, to establish policies governing the use of drugs at all levels and in all types of healthcare.

Hospital formularies: moving towards extinction or evolution?

Since their introduction, drug formularies and formulary systems have gone through many changes. However, at present, even greater changes are underway as a result of the reorganisation of the US healthcare system. They are no longer simply a means of adding, deleting or restricting the use of drugs, but are one of several appropriate-use strategies that can be used to standardise the quality of drug use and to assist in the management of medical outcomes. The evolution of hospital formularies and ways to develop, refine and implement effective appropriate-use programmes were presented during the 1996 Annual Meeting of the American Society of Health-System Pharmacists [ San Diego, US; June 1996 ].

Use a proactive focus for formulary systems

Use a proactive focus for formulary systems