ABSTRACT
BACKGROUND: Alcohol interventions are important to the developing public health role of community pharmacies. The Medicines and Alcohol Consultation (MAC) is a new intervention, co-produced with community pharmacists (CPs) and patients, which involves a CP practice development programme designed to integrate discussion of alcohol within existing NHS medicine review services. We conducted a pilot trial of the MAC and its delivery to investigate all study procedures to inform progression to a definitive trial. METHODS: This cluster pilot RCT was conducted in 10 community pharmacies in Yorkshire, UK, with a CP from each who regularly conducted Medicine Use Review (MUR) and New Medicine Service (NMS) consultations. Randomisation was conducted using a secure remote randomisation service. Intervention CPs (n = 5) were trained to deliver the MAC in MUR/NMS consultations. Control CPs (n = 5) provided these services as usual. Consecutive MUR/NMS patients were asked by CPs to participate, screened for eligibility (consumption of alcohol at least twice per week), and baseline data collected for those eligible. A two-month follow-up telephone interview was conducted. Blinding of CPs was not possible, but patients were blinded to the alcohol focus of the trial. Primary outcomes were total weekly UK units (8 g of ethanol per unit) of alcohol consumption in the week prior to follow-up, and confidence in medications management. Trial procedures were assessed by recruitment, attrition, and follow-up rates. RESULTS: 260 patients were approached by CPs to take part in the trial, 68% (n = 178) were assessed for eligibility and 30% (n = 54) of these patients were eligible. Almost all eligible patients (n = 51; 94%) consented to participate, of whom 92% (n = 47) were followed-up at 2 months; alcohol consumption was lower in the intervention arm and confidence in medication management reduced slightly for both groups. Exploration of recall issues at follow-up showed a high level of agreement between a two-item quantity/frequency measure and 7-day guided recall of alcohol consumption. CONCLUSIONS: The pilot trial demonstrates the feasibility of implementing the MAC in community pharmacy and trial recruitment and data collection procedures. However, decommissioning of MURs means that it is not possible to conduct a definitive trial of the intervention in this service. TRIAL REGISTRATION: ISRCTN57447996.
Subject(s)
Alcohol Drinking/prevention & control , Community Pharmacy Services/organization & administration , Drug Utilization Review/organization & administration , Aged , Aged, 80 and over , Feasibility Studies , Female , Humans , Male , Middle Aged , Pilot Projects , Referral and Consultation , United KingdomABSTRACT
BACKGROUND: In-hospital medication reviews are regularly performed. However, discontinuity in care could occur because secondary care providers lack insight into the outpatient history. Furthermore, for the implementation or follow-up of some medication review-based interventions, the help of primary care providers is essential. This requires interprofessional collaboration between secondary and primary care. Therefore, the aim of this qualitative study was to gain insight into the perceptions of primary and secondary care providers on interprofessional collaboration on medication reviews in hospitalised patients. METHODS: Ten face-to-face semi-structured interviews and three focus group discussions were conducted with 20 healthcare providers from three hospitals and community health services. The interviews were aimed at exploring general practitioners', community pharmacists', geriatricians', and hospital pharmacists' experiences, attitudes, and views of interprofessional collaboration. Focus groups consisted of representatives of all professional groups. Through group discussion, interprofessional collaboration was explored by addressing three main questions: 1) What are the benefits of in-hospital medication reviews? 2) What are the barriers to in-hospital medication reviews from an interprofessional collaboration perspective? 3) Given the barriers mentioned, how should this interprofessional collaboration between primary and secondary care be designed? Data were analysed using a thematic-content approach. RESULTS: The need for in-hospital medication reviews was underlined due to their many benefits, such as reducing potentially preventable re-admissions. Barriers regarding interprofessional collaboration between primary and secondary care can be subdivided into three main themes: 1) defining in-hospital medication reviews (e.g., lack of clear goals), 2) execution of medication reviews (e.g., hospital setting is dynamic), and 3) follow-up after discharge (e.g., unclear instructions). Care providers suggested solutions for each of the barriers mentioned, for example, by using supportive staff in order to overcome the gap between primary and secondary care providers and making clear agreements on proper means of communication. CONCLUSION: Primary and secondary care providers recognise the importance of in-hospital medication reviews and the need for interprofessional collaboration. To create satisfying interprofessional collaboration, conditions should be met on defining in-hospital medication reviews across settings and involving both primary and secondary care providers in implementing medication reviews and organising their follow-up.
Subject(s)
Drug Utilization Review/organization & administration , Hospitalization , Interprofessional Relations , Primary Health Care/organization & administration , Secondary Care/organization & administration , Attitude of Health Personnel , Cooperative Behavior , Female , Focus Groups , General Practitioners/psychology , General Practitioners/statistics & numerical data , Geriatricians/psychology , Geriatricians/statistics & numerical data , Humans , Male , Pharmacists/psychology , Pharmacists/statistics & numerical data , Qualitative ResearchABSTRACT
PURPOSE: Many elderly are concerned about falling transfer to assisted living facilities (ALF). Previous literatures studied the medication use and falls in the community, hospitals, or nursing homes, with scanty data about ALF. Therefore, the aim of the current case-control study was to assess the relation between medication use and falls among elderly in ALF. METHODS: A matched case-control study was conducted. The study was conducted in ALF in Cairo, Egypt. The study participants were 188 individuals; they were subdivided into two groups: fallers and nonfallers; timed up and go test (TUGT) was performed by all subjects. Medication data were collected according to the fall risk-increasing drugs list and the list of drugs that cause or worsen orthostatism. Other fall risk factors, as suggested by American Geriatric Society, were assessed. RESULTS: The use of vasodilators, diuretics, alpha blockers, opioids, antipsychotics, and sedative hypnotics were more common in fallers than in nonfallers (P < 0.001, P = 0.03, P < 0.001, P = 0.013, P < 0.001, and P < 0.001, respectively). Vasodilators, alpha blockers, and antipsychotics were significant predictors of falls even after adjustment for the possible confounding factors. Vasodilators, alpha blockers, opioids, sedative hypnotics, and recent dose changes in oral hypoglycemics were significant predictors of higher TUGT after adjustment for the possible confounding factors. CONCLUSION: The current study supported the risk of psychotropic and cardiovascular medications, with especial emphasis on vasodilators, alpha blockers, and antipsychotics, with raising concern about opioids, sedative hypnotics, and recent dose change in oral hypoglycemics.
Subject(s)
Accidental Falls/statistics & numerical data , Assisted Living Facilities/statistics & numerical data , Cardiovascular Agents/adverse effects , Postural Balance/drug effects , Psychotropic Drugs/adverse effects , Accidental Falls/prevention & control , Aged , Aged, 80 and over , Assisted Living Facilities/organization & administration , Assisted Living Facilities/standards , Case-Control Studies , Drug Utilization Review/organization & administration , Drug Utilization Review/standards , Egypt , Female , Geriatric Assessment/statistics & numerical data , Humans , Male , Middle Aged , Risk Factors , Time and Motion StudiesABSTRACT
BACKGROUND: Collaborative medication review (CMR) practices for older adults are evolving in many countries. Development has been under way in Finland for over a decade, but no inventory of evolved practices has been conducted. The aim of this study was to identify and describe CMR practices in Finland after 10 years of developement. METHODS: An inventory of CMR practices was conducted using a snowballing approach and an open call in the Finnish Medicines Agency's website in 2015. Data were quantitatively analysed using descriptive statistics and qualitatively by inductive thematic content analysis. Clyne et al's medication review typology was applied for evaluating comprehensiveness of the practices. RESULTS: In total, 43 practices were identified, of which 22 (51%) were designed for older adults in primary care. The majority (n = 30, 70%) of the practices were clinical CMRs, with 18 (42%) of them being in routine use. A checklist with criteria was used in 19 (44%) of the practices to identify patients with polypharmacy (n = 6), falls (n = 5), and renal dysfunction (n = 5) as the most common criteria for CMR. Patients were involved in 32 (74%) of the practices, mostly as a source of information via interview (n = 27, 63%). A medication care plan was discussed with the patient in 17 practices (40%), and it was established systematically as usual care to all or selected patient groups in 11 (26%) of the practices. All or selected patients' medication lists were reconciled in 15 practices (35%). Nearly half of the practices (n = 19, 44%) lacked explicit methods for following up effects of medication changes. When reported, the effects were followed up as a routine control (n = 9, 21%) or in a follow-up appointment (n = 6, 14%). CONCLUSIONS: Different MRs in varying settings were available and in routine use, the majority being comprehensive CMRs designed for primary outpatient care and for older adults. Even though practices might benefit from national standardization, flexibility in their customization according to context, medical and patient needs, and available resources is important.
Subject(s)
Drug Utilization Review/organization & administration , Polypharmacy , Aged , Ambulatory Care , Female , Finland , Humans , Male , Practice Patterns, Physicians'/statistics & numerical dataABSTRACT
Widespread veterinary use of antimicrobials might contribute to the increasing burden of antimicrobial resistance. Despite many successful efforts to reduce veterinary antimicrobial use in the Netherlands, antimicrobial use on a substantial number of farms has remained relatively high over the past few years. Farm-specific solutions are required to further lower antimicrobial use on these farms. Reducing the burden of animal diseases at the farm level by means of a structured approach to animal health planning could be promising. This intervention study aimed to evaluate the main effects of an animal health planning program developed by an advisory team consisting of a dairy farmer, his veterinarian, and his feed adviser under the guidance of a professional facilitator. During an initial farm visit, the advisory team developed a farm-specific animal health planning program with support from the facilitator. After 1 yr, the effects of this program on animal health, production parameters, and antimicrobial use were evaluated and compared with control farms that did not have a facilitated animal health planning program. Antimicrobial use on intervention farms was significantly reduced between the start and the end of the study period; however, no significant differences in the rate of reduction between the intervention and control groups could be observed (-19% and -14%, respectively). Reduced antimicrobial use did not result in negative effects on animal health and production parameters during the study period in both groups. On intervention farms, a significant positive relationship was found between the percentage of completed action points at farm level and the percentage reduction in antimicrobial use. The level of compliance with action points and the quality of collaboration between farmer and advisers were positively associated with the accomplishment of corresponding objectives. However, the total number of objectives was negatively associated with the level of compliance with action points and tended to be negatively associated with the percentage reduction in antimicrobial use at farm level. Gradually reducing antimicrobial use without adverse effects on animal health and productivity is possible by adjusting management practices in a team effort. Fostering good collaboration among farmer, veterinarian, and feed adviser and focusing on a limited number of objectives have positive effects on the outcomes of the animal health planning program and antimicrobial use.
Subject(s)
Advisory Committees/organization & administration , Anti-Bacterial Agents , Dairying , Drug Utilization Review/organization & administration , Health Planning/organization & administration , Animals , Netherlands , Program Evaluation , VeterinariansABSTRACT
Recent changes in regulations by the Centers for Medicare & Medicaid Services require long-term care facilities to meet specific requirements on antibiotic stewardship, promoting the appropriate use of antibiotics and antimicrobials. The goal is to improve patient outcomes and decrease the spread of infections caused by multi-drug-resistant organisms. Consultant pharmacists can help facility personnel implement policies and procedures for effective antibiotic stewardship, assist prescribers and facility staff in understanding how to use the facility's antibiogram, find appropriate resources, and provide facility personnel with feedback on their antimicrobial stewardship efforts.
Subject(s)
Anti-Bacterial Agents/administration & dosage , Homes for the Aged/organization & administration , Inappropriate Prescribing/prevention & control , Nursing Homes/organization & administration , Pharmacists/organization & administration , Anti-Bacterial Agents/therapeutic use , Consultants , Drug Utilization Review/organization & administration , Homes for the Aged/standards , Humans , Infection Control/organization & administration , Inservice Training , Microbial Sensitivity Tests , Nursing Homes/standards , Practice Guidelines as Topic , WorkflowABSTRACT
OBJECTIVE: To assess pharmacists' impact on optimizing pharmacotherapy among geriatric patients. DESIGN: Single-site, prospective, quality-improvement project. SETTING: Primary care at a Veterans Affairs medical center. PARTICIPANTS: Thirteen males 75 years of age and older were included. INTERVENTIONS: Recommendations were made by pharmacists to optimize prescribing. MAIN OUTCOME MEASURES: Differences between specific instances of suboptimal prescribing before and after pharmacists' recommendations, the percentage of pharmacists' recommendations accepted, and the top most commonly prescribed psychotropic medications and their most common indications. RESULTS: Sixty-three recommendations were made by pharmacists, and 48% of these recommendations were accepted by providers. There was a 27% reduction of the use of high-risk medications, a 44% reduction of omissions of care, and a 74% reduction of incomplete medication monitoring after pharmacists' recommendations. The most commonly prescribed psychotropic medications were zolpidem (31%), lorazepam (23%), and clonazepam and temazepam (each 15%). The most common indications for these medications were anxiety and insomnia (each 46%), with 8% of patients having an indication for both. CONCLUSION: Pharmacists' recommendations improved geriatric pharmacotherapy by decreasing the overall instances of suboptimal prescribing.
Subject(s)
Drug Utilization Review/organization & administration , Pharmacists/organization & administration , Pharmacy Service, Hospital/organization & administration , Quality Improvement/organization & administration , Aged , Aged, 80 and over , Antidepressive Agents/administration & dosage , Antidepressive Agents/adverse effects , Benzodiazepines/administration & dosage , Benzodiazepines/adverse effects , Drug Monitoring/methods , Drug-Related Side Effects and Adverse Reactions/prevention & control , Female , Humans , Hypnotics and Sedatives/administration & dosage , Hypnotics and Sedatives/adverse effects , Male , Prospective Studies , Risk Factors , United States , United States Department of Veterans AffairsABSTRACT
BACKGROUND: Restricted use of third-generation cephalosporins and fluoroquinolones has been linked to a reduced incidence of hospital-acquired infections with multidrug-resistant bacteria. We implemented an intensified antibiotic stewardship (ABS) programme in the medical service of a university hospital center aiming at a reduction by at least 30% in the use of these two drug classes. METHODS: The ABS programme was focused on the 300-bed medical service. Prescription of third-generation cephalosporins was discouraged, whereas the use of penicillins was encouraged. Monthly drug use density was measured in WHO-ATC defined and locally recommended daily doses (DDD and RDD) per 100 patient days, to evaluate trends before (01/2008 to 10/2011) and after starting the intervention (1/2012 to 3/2013). The effect was analysed using interrupted time-series analysis with six non-intervention departments as controls. RESULTS: Following initiation of the ABS intervention, overall antibiotic use in the medical service declined (p < 0.001). There was a significant intervention-related decrease in the use of cephalosporins and fluoroquinolones (p < 0.001) outperforming the decreasing baseline trend. Trend changes observed in some of the control departments were smaller, and the difference between trend changes in the medical service and those in control departments were highly significant for overall use and cephalosporin use reductions (p < 0.001) as well as for the increasing use of penicillins (p < 0.001). Mean use density levels (in RDD per 100 patient days) dropped for cephalosporins from 16.3 to 10.3 (-37%) and for fluoroquinolones from 17.7 to 10.1 (-43%), respectively. During the same period, the use of penicillins increased (15.4 to 18.2; 18%). The changes in expenditures for antibiotics in the medical service compared to control services minus programme costs indicated initial net cost savings likely to be associated with the programme. CONCLUSION: An intensified ABS programme targeting cephalosporin und fluoroquinolone use in the setting of a large academic hospital is feasible and effective. The intervention may serve as a model for other services and hospitals with a similar structure and baseline situation.
Subject(s)
Anti-Bacterial Agents/administration & dosage , Cephalosporins/administration & dosage , Drug Utilization Review/organization & administration , Drug Utilization/standards , Fluoroquinolones/administration & dosage , Academic Medical Centers/organization & administration , Academic Medical Centers/standards , Cross Infection/drug therapy , Cross Infection/prevention & control , Drug Utilization/statistics & numerical data , Drug Utilization Review/standards , Humans , Incidence , Tertiary HealthcareABSTRACT
BACKGROUND: Prescription drug abuse has prompted considerable concern. We evaluated a retrospective drug utilization review program to reduce controlled substance use among individuals with high-risk utilization. METHODS: We analyzed pharmacy claims from a large pharmaceutical benefits manager. For each eligible member, we calculated a controlled substance score based on the number and type of claims, prescribers and pharmacies, and utilization patterns over three months. Two state health plans sent controlled substance letters to prescribers of members meeting or exceeding a plan- and pre-specified controlled substance score. Two different state health plans did not send such letters. We used a difference-in-difference design and generalized estimating equations to quantify the impact of the program on the mean difference in reduction of the controlled substance score over six months. RESULTS: Eligible members in the intervention and comparison states had similar baseline mean controlled substance scores (19.0 vs. 18.6, p = 0.36). Adjusting for individuals' age, sex and pharmacy risk group score, reductions in the mean controlled substance score were greater in the intervention than comparison cohort (5.67 vs. 4.31, p = 0.01), corresponding with a 34.0% reduction in the intervention cohort compared to a 25.5% reduction in the comparison cohort. Changes were driven primarily by reductions in the number of controlled substance claims filled (30.5% vs. 23.1%, p = 0.01), as well as by a non-statistically significant trend towards reductions in the number of prescribers and pharmacies used (26.9% vs. 20.1%, p = 0.07). CONCLUSIONS: Retrospective drug utilization review programs may reduce controlled substance scores and claims among individuals with patterns suggesting high-risk utilization.
Subject(s)
Controlled Substances/administration & dosage , Drug Utilization Review/organization & administration , Practice Patterns, Physicians'/standards , Prescription Drugs/administration & dosage , Adolescent , Adult , Aged , Controlled Substances/adverse effects , Female , Humans , Insurance, Pharmaceutical Services/statistics & numerical data , Male , Middle Aged , Prescription Drugs/adverse effects , Program Evaluation , Retrospective Studies , Risk , United States , Young AdultABSTRACT
OBJECTIVES: Antimicrobial stewardship programs are recommended to reduce antimicrobial resistance by reducing inappropriate use of antimicrobials. We implemented an antimicrobial stewardship program and aimed to evaluate its effect on broad-spectrum antimicrobial use. DESIGN, SETTING AND PARTICIPANTS: Observational study with historical control using interrupted time series analysis conducted in a tertiary referral hospital. Hospital inpatients prescribed restricted antimicrobials for non-standard indications, where approval had expired or without approval. INTERVENTION: Baseline period of 30 months immediately followed by an 18-03 intervention period commencing January 2011. MAIN OUTCOME MEASURES: Number and type of interventions made by antimicrobial stewardship team; monthly rate of use of broad-spectrum antimicrobial agents (in defined daily doses/1000 occupied bed-18s). RESULTS: The antimicrobial stewardship team made 1104 recommendations in 779 patients during the 18-03 intervention period. In 64% of cases, the recommendation was made to cease or de-escalate the antimicrobial therapy, or to change from intravenous to oral therapy. The introduction of the intervention resulted in an immediate 17% (95% CI, 13%-20%) reduction in broad-spectrum antimicrobial use in the intensive care unit and a 10% (95% CI, 4%-16%) reduction in broad-spectrum antimicrobial use outside the intensive care unit. Reductions were particularly seen in cephalosporin and glycopeptide use, although these were partially offset by increases in the use of ß-lactam-ß-lactamase inhibitors. CONCLUSIONS: The introduction of an antimicrobial stewardship program, including postprescription review, resulted in an immediate reduction in broad-spectrum antimicrobial use in a tertiary referral centre. However, the effect of this intervention reduced over time.
Subject(s)
Anti-Infective Agents/therapeutic use , Drug Prescriptions/statistics & numerical data , Drug Utilization Review/organization & administration , Drug Utilization/trends , Australia , Case-Control Studies , Drug Resistance, Microbial , Female , Hospitals, Teaching , Humans , Male , Program Development , Program Evaluation , Quality ImprovementABSTRACT
Antithrombotic therapies, especially anticoagulants, are high-risk medications with increased potential for adverse events. The development and implementation of a well-functioning, designated, multidisciplinary anticoagulation stewardship program (MASP), tailored to each hospital-center's needs, has the primary objectives of improving patient-centered outcomes, minimizing undesirable anticoagulation-related adverse events and minimizing hospital length of stay (LOS) and other patient-related costs. Such stewardship programs are pivotal in supporting busy clinicians with consultation on challenging clinical case scenarios, ensuring appropriate use of valuable healthcare resources, achieving compliance with anticoagulant-associated accreditation standards, and positively impacting patient-specific morbidity/mortality outcomes. Herein, we review and discuss the critical need for antithrombosis stewardship and the benefit of formalized MASP in optimizing use of antithrombotic therapies.
Subject(s)
Anticoagulants , Drug Utilization Review , Hospitals , Humans , Anticoagulants/therapeutic use , Fibrinolytic Agents/therapeutic use , Drug Utilization Review/organization & administration , Hospital AdministrationABSTRACT
Many consultant pharmacists are moving beyond their federally defined role of reviewing resident charts in nursing facilities. They are taking on an expanded role, not only to provide the best possible care, but also to ensure that the spending for medications supports these efforts. This is increasingly important, given the 11% cut in Medicare effective October 1, 2011, which is forcing nursing facilities to operate even more efficiently and effectively. Involvement of the consultant pharmacist in medication finances requires knowledge in several new areas that include the dialysis-medication bundling, vaccine coverage, and responsibility for off-label use of medications. While the financial management of medications is an opportunity for the consultant pharmacist, it is only the first of many. Additional opportunities for consultant pharmacists will develop as nursing facilities become accountable for clinical outcomes-including readmissions-that will impact both hospital referrals to nursing facilities and Medicare payments. Appreciating these opportunities and gaining knowledge and expertise is critical to consultant pharmacists playing a lead role in the nursing facility. Consultant pharmacists need financial management expertise to become able to deal with ongoing changes.
Subject(s)
Drug Utilization Review/organization & administration , Nursing Homes/economics , Pharmaceutical Services/organization & administration , Pharmacists/organization & administration , Consultants , Drug Utilization Review/economics , Humans , Medication Therapy Management/economics , Medication Therapy Management/organization & administration , Nursing Homes/organization & administration , Professional RoleSubject(s)
Drug Approval/organization & administration , Drug Utilization Review/organization & administration , Lung Neoplasms/drug therapy , Piperazines/therapeutic use , Societies, Medical , Acrylamides , Aniline Compounds , Antineoplastic Agents/therapeutic use , Evidence-Based Medicine , Germany , Humans , Internationality , Treatment OutcomeABSTRACT
BACKGROUND: In 2004, the Georgia Medicaid program implemented a prior authorization (PA) policy for certain atypical antipsychotic agents, resulting in an average savings of $2.7 million per year. OBJECTIVE: To determine whether implementation of a PA policy for atypical antipsychotic drugs increased health-care utilization in the Georgia Medicaid program from July 2003 to April 2006. METHODS: A single cohort observational study employing segmented regression and time series analysis was conducted to determine health-care services utilization, including emergency department (ED) visits, outpatient office visits, hospital admissions, and length of stay (LOS). Study subjects included continuously eligible adult Georgia Medicaid recipients with a schizophrenia-related diagnosis and documented use of an atypical antipsychotic medication (N = 12,120). Where applicable, analysis of a noncontinuously eligible population was also performed to investigate disenrollment bias in study results. RESULTS: A significant decline in post-policy trend for the average number of ED visits (absolute difference -0.042 per member per month (PMPM); relative difference -20.92%) and average number of hospital admissions PMPM (absolute difference -0.010 PMPM; relative difference -22.27%) was observed at the end of the study period. Baseline and pre-policy trends were found to be significant predictors for both endpoints. Significant models were not identified for average outpatient office visits PMPM or average LOS per admission. CONCLUSIONS: In contrast to other published studies on PA for atypical antipsychotics, patient outcomes improved after the initiation of the policy. To the extent that medical utilization reflects patient health outcomes and health status, the results of this study indicate that the PA program has potentially improved the health of schizophrenic patients in Georgia and lowered program costs.
Subject(s)
Antipsychotic Agents/administration & dosage , Drug Utilization Review/legislation & jurisprudence , Government Programs , Health Services/statistics & numerical data , Program Evaluation , Schizophrenia/drug therapy , Adolescent , Adult , Aged , Antipsychotic Agents/economics , Cohort Studies , Drug Utilization Review/organization & administration , Drug Utilization Review/statistics & numerical data , Female , Georgia , Government Programs/economics , Government Programs/legislation & jurisprudence , Government Programs/organization & administration , Health Services/legislation & jurisprudence , Humans , Male , Medicaid/economics , Medicaid/organization & administration , Mental Health Services/economics , Mental Health Services/legislation & jurisprudence , Mental Health Services/statistics & numerical data , Middle Aged , Regression Analysis , Reimbursement Mechanisms/legislation & jurisprudence , Reimbursement Mechanisms/organization & administration , Schizophrenia/economics , Schizophrenia/therapy , United States , Young AdultABSTRACT
PURPOSE: Serious adverse drug event (sADE) reporting to Institutional Review Boards (IRB) is essential to ensure pharmaceutical safety. However, the quality of these reports has not been studied. Safety reports are especially important for cancer drugs that receive accelerated Food and Drug Administration approval, like imatinib, as preapproval experience with these drugs is limited. We evaluated the quality, accuracy, and completeness of sADE reports submitted to an IRB. EXPERIMENTAL DESIGN: sADE reports submitted to an IRB from 14 clinical trials with imatinib were reviewed. Structured case report forms, containing detailed clinical data fields and a validated causality assessment instrument, were developed. Two forms were generated for each ADE, the first populated with data abstracted from the IRB reports, and the second populated with data from the corresponding clinical record. Completeness and causality assessments were evaluated for each of the two sources, and then compared. Accuracy (concordance between sources) was also assessed. RESULTS: Of 115 sADEs reported for 177 cancer patients to the IRB, overall completeness of adverse event descriptions was 2.4-fold greater for structured case report forms populated with information from the clinical record versus the corresponding forms from IRB reports (95.0% versus 40.3%, P < 0.05). Information supporting causality assessments was recorded 3.5-fold more often in primary data sources versus IRB adverse event descriptions (93% versus 26%, P < 0.05). Some key clinical information was discrepant between the two sources. CONCLUSIONS: The use of structured syndrome-specific case report forms could enhance the quality of reporting to IRBs, thereby improving the safety of pharmaceuticals administered to cancer patients.
Subject(s)
Adverse Drug Reaction Reporting Systems/statistics & numerical data , Adverse Drug Reaction Reporting Systems/standards , Professional Staff Committees , Adverse Drug Reaction Reporting Systems/organization & administration , Antineoplastic Agents/adverse effects , Benzamides , Clinical Trials as Topic , Drug Utilization Review/organization & administration , Drug Utilization Review/standards , Drug Utilization Review/statistics & numerical data , Fractures, Bone/chemically induced , Heart Failure/chemically induced , Humans , Imatinib Mesylate , Infections/chemically induced , Neoplasms/drug therapy , Piperazines/adverse effects , Product Surveillance, Postmarketing/standards , Product Surveillance, Postmarketing/statistics & numerical data , Pulmonary Edema/chemically induced , Pyrimidines/adverse effects , Time FactorsABSTRACT
OBJECTIVE: To explore pharmacists' views on managing patients with chronic illness; to understand the incentives and barriers they perceive and the solutions they propose to overcome these barriers. SETTING: Hospital pharmacists, with experience in managing people with chronic illnesses, working in western Sydney, Australia, were interviewed during June and July 2008. METHOD: A qualitative study involving group and individual interviews using a semi-structured interview guide. RESULTS: Hospital pharmacists identified lack of communication between different healthcare providers and with patients as a contributing factor to lack of continuity of care and this was perceived as a major barrier in managing patients with chronic illnesses. Pharmacists were also concerned about the effects of medication costs, and poor patient knowledge regarding their disease and medications, and the effects on adherence. Suggested solutions included taking a teamwork approach in the management of chronic illness and providing more information to patients to improve adherence. CONCLUSION: The identified incentives and barriers have provided valuable information on what pharmacists face in managing patients with chronic illness. Most of the solutions suggested by them have been tested and proven unsuccessful. Develop successful health policy to address the identified barriers remains a challenge.
Subject(s)
Attitude of Health Personnel , Chronic Disease/therapy , Drug Utilization Review/organization & administration , Health Knowledge, Attitudes, Practice , Pharmacists/organization & administration , Pharmacy Service, Hospital/organization & administration , Adult , Australia , Continuity of Patient Care/organization & administration , Drug Costs , Home Care Services/organization & administration , Humans , Interprofessional Relations , Interviews as Topic , Middle Aged , Patient Care Team/organization & administration , Patient Compliance , Patient Education as Topic , Pharmacists/psychology , Professional-Patient Relations , Qualitative ResearchABSTRACT
PURPOSE: The opioid epidemic continues to result in significant morbidity and mortality even within hospitals where opioids are the second most common cause of adverse events. Opioid stewardship represents one model for hospitals to promote safe and rational prescribing of opioids to mitigate preventable adverse events in alliance with new Joint Commission standards. The purpose of this study was to identify the prevalence of current hospital practices to improve opioid use. METHODS: A cross-sectional survey of hospital best practices for opioid use was electronically distributed via electronic listservs in March 2018 to examine the presence of an opioid stewardship program and related practices, including formulary restrictions, specialist involvement for high-risk patients, types of risk factors screened, and educational activities. RESULTS: Among 133 included hospitals, 23% reported a stewardship program and 14% reported a prospective screening process to identify patients at high risk of opioid-related adverse events (ORAEs). Among those with a prospective screening process, there was variability in ORAE risk factor screening. Formulary restrictions were dependent on specific opioids and formulations. Patient-controlled analgesia was restricted at 45% of hospitals. Most hospitals reported having a pain management service (90%) and a palliative care service providing pain management (67%). CONCLUSION: The absence of opioid stewardship and prospectively screening ORAEs represents a gap in current practice at surveyed hospitals. Hospitals have an opportunity to implement and refine best practices such as access to pain management specialists, use of formulary restrictions, and retrospective and prospective monitoring of adverse events to improve opioid use.
Subject(s)
Analgesics, Opioid/administration & dosage , Drug Utilization Review/organization & administration , Pain Management/methods , Pain/drug therapy , Analgesia, Patient-Controlled/standards , Analgesics, Opioid/therapeutic use , Cross-Sectional Studies , Drug Utilization Review/standards , Electronic Health Records , Formularies, Hospital as Topic , Hospital Bed Capacity , Humans , Inservice Training/organization & administration , Ownership , Pain Management/standards , Practice Patterns, Physicians' , Risk Factors , SpecializationABSTRACT
DISCLOSURES: No funding supported the writing of this article. The author has nothing to disclose.
Subject(s)
Community Pharmacy Services/economics , Insurance, Pharmaceutical Services/economics , Prescription Drugs/economics , Reimbursement Mechanisms , Community Pharmacy Services/organization & administration , Cost-Benefit Analysis , Counseling/economics , Counseling/organization & administration , Drug Costs , Drug Utilization Review/economics , Drug Utilization Review/organization & administration , Prescription Drugs/therapeutic useABSTRACT
Antimicrobial stewardship programmes (ASP) are aimed at optimising antimicrobial utilization. However, only few studies have focused on paediatric intensive care units (PICU), where inappropriate antibiotic use occurs frequently. We assessed the effect and safety of a once weekly paediatric infectious disease (PID) ward round with prospective audit and feedback on antibiotic consumption in a multidisciplinary PICU. This study was conducted within 6-months periods before and after the implementation of a weekly PID-ward round. Antimicrobial management and two main recommendations per patient were discussed and documented. The primary outcome was antimicrobial utilization, measured by days of therapy (DoT) and length of therapy (LoT) per 1000 patient days (PD) for all PICU stays. Secondary outcomes included PICU mean length of stay, total mortality, infection-related mortality and cost of therapy. 1964 PD were analyzed during the pre- and 1866 PD during the post-implementation phase. Adherence to the recommendations was 79%. An 18% reduction of DoT/1000 PD was observed in the post-implementation period (p = 0.005). LoT/1000 PD decreased by 11% (p = 0.09). Meropenem and vancomycin usage were reduced by 49% (p = 0.07) and 56% (p = 0.03), respectively. We conclude, that a once weekly PID-ward round with prospective audit and feedback is safe and effective and reduces antibiotic consumption in PICUs.