Background Fungal infections are rare complications of injections for treatment of chronic pain. In September 2012, we initiated an investigation into fungal infections associated with injections of preservative-free methylprednisolone acetate that was purchased from a single compounding pharmacy. Methods Three lots of methylprednisolone acetate were recalled by the pharmacy; examination of unopened vials later revealed fungus. Notification of all persons potentially exposed to implicated methylprednisolone acetate was conducted by federal, state, and local public health officials and by staff at clinical facilities that administered the drug. We collected clinical data on standardized case-report forms, and we tested for the presence of fungi in isolates and specimens by examining cultures and performing polymerase-chain-reaction assays and histopathological and immunohistochemical testing. Results As of October 19, 2012, more than 99% of 13,534 potentially exposed persons had been contacted. As of December 10, there were 590 reported cases of infection in 19 states, with 37 deaths (6%). As of November 26, laboratory evidence of Exserohilum rostratum was present in specimens from 100 case patients (17%). Additional data were available for 386 case patients (65%); 300 of these patients (78%) had meningitis. Case patients had received a median of 1 injection (range, 1 to 6) of implicated methylprednisolone acetate. The median age of the patients was 64 years (range, 16 to 92), and the median incubation period was 20 days (range, 0 to 120); 33 patients (9%) had a stroke. Conclusions Analysis of preliminary data from a large multistate outbreak of fungal infections showed substantial morbidity and mortality. The infections were associated with injection of a contaminated glucocorticoid medication from a single compounding pharmacy. Rapid public health actions included prompt recall of the implicated product, notification of exposed persons, and early outreach to clinicians.
Background Hospitalisation often leads to increased medication regimen complexity for older patients; increased complexity is associated with medication non-adherence. There has been little research into strategies for reducing the impact of hospitalisation on medication regimen complexity. Objective To investigate the impact of pharmacist medication review, together with an educational intervention targeting clinical pharmacists and junior medical officers, on the increase in medication regimen complexity that occurs during hospitalisation. Setting Two acute general medicine wards and two subacute aged care (geriatric assessment and rehabilitation) wards at a major metropolitan public hospital in Melbourne, Australia. Methods A before-after study involving patients aged 60 years and over was undertaken over two 5-week periods. During the pre-intervention period patients received usual care. During the intervention period, clinical pharmacists were encouraged to review patients' medication regimen complexity prior to discharge, and make recommendations to hospital medical officers to simplify regimens. Prior to the intervention period, pharmacists attended an interactive case-based education session about medication regimen simplification, and completed an assessment task. A similar, but briefer, education session was delivered to junior medical officers. Main outcome measure The primary endpoint was change in medication regimen complexity index (MRCI) score (a validated measure of regimen complexity) between admission and discharge for regularly scheduled long-term medications, adjusted for age, length of hospital stay, number of medications and regimen complexity prior to admission. Results Three hundred ninety-one patients were included (mean age 80.6 years, mean 7.4 regularly scheduled long-term medications on admission). The mean increase in MRCI score between admission and discharge was significantly smaller in the 205 intervention patients than in the 186 usual care patients (2.5 vs. 4.0, p = 0.02; adjusted difference 1.6, 95 %CI 0.3, 2.9). The intervention had greatest impact in patients discharged from subacute wards (mean adjusted difference: 2.7), not using a dose administration aid after discharge (mean adjusted difference: 2.6), and not discharged to a residential care facility (mean adjusted difference: 1.9). Mean differences in MRCI scores were equivalent to ceasing one to two medications. Conclusion An educational intervention and clinical pharmacist medication review reduced the impact of hospitalisation on the complexity of older patients' medication regimens.
What is known and Objective: Older hospital inpatients are often prescribed complex multi-drug regimens; increased regimen complexity is associated with poorer medication adherence and treatment outcomes. There has been little research into methods for reducing regimen complexity. The objective of this study was to explore the feasibility of incorporating medication regimen simplification into routine clinical pharmacist care for older hospital inpatients and identify barriers to regimen simplification at a major teaching hospital. Methods: Following an educational intervention, clinical pharmacists were encouraged to minimize regimen complexity for their patients by identifying potential simplifications during routine medication regimen reviews (e.g. medication chart reviews, discharge prescription reviews) and discussing these changes with hospital doctors and patients. Pharmacists completed a data collection form for patients aged 60 years or above discharged from their wards during the study period (n = 205; mean age, 81·3 years), indicating whether they had reviewed the patient’s medication regimen complexity (and if not why), whether any changes to simplify the regimen were identified, and whether changes were successfully implemented (and if not why). Results and Discussion: Pharmacists reviewed medication regimen complexity for 173/205 (84·4%) patients and identified 149 potential changes to reduce regimen complexity for 79/173 (45·7%) reviewed patients. Ninety-four (63·1%) changes were successfully implemented in 54/205 (26·3%) patients. Regimens were simplified more often for patients discharged from subacute aged care (geriatric assessment and rehabilitation) wards compared with acute general medicine wards. The most commonly cited reason for not reviewing regimen complexity and not implementing identified simplification-related changes was ‘lack of time’. Non-acceptance of pharmacist recommendations by patients or doctors were other common reasons for not implementing changes. What is new and Conclusion: This is the first study to explore pharmacist-led medication regimen simplification and barriers to regimen simplification in the hospital setting. It demonstrates that simplification of older inpatients' regimens is feasible when training in regimen simplification is provided. The main barrier to regimen simplification appears to be lack of pharmacist time.
ABSTRACT Compounding pharmacies serve a critical role in modern health care to meet special patient care needs. While the Food and Drug Administration (FDA) has clearly delineated jurisdiction over drug companies and products manufactured under Good Manufacturing Practice (GMP) regulations to ensure quality, potency and purity, compounding pharmacies are regulated by the State Boards and are not registered by the FDA. In the recent years, some compounding pharmacies acted like a manufacturer, preparing large amounts of injectable drugs with interstate activities. Multiple outbreaks have been linked to compounding pharmacies, including a recent outbreak of fungal meningitis related to contaminated methylprednisolone, exposing more than 14,000 patients in multiple states. This tragedy underscores the urgency of addressing safety related to compounding pharmacies. There is a call for action at the federal and state levels to set minimum production standards, impose new labeling conditions on compounded drugs, and require large scale compounders be regulated by the FDA. “Industrial” compounding must come under FDA oversight, require those pharmacies to meet GMP standards, and ensure quality and safe products for patient use. Moreover, compliance with the Institute for Safe Medication Practices 2011 recommendations that any type of sterile compounding must be in compliance with the United States Pharmacopoeia Chapter 797 guidelines will reduce the risk of patient harm from microbial contamination. Finally, other critical factors that require close attention include addressing injectable products compounded in hospitals and other outpatient healthcare centers. The FDA and State Boards of Pharmacy must be adequately funded to exercise the oversight effectively.
- Pain practice : the official journal of World Institute of Pain
- Published almost 5 years ago
Compounding pharmacies play an increasing and increasingly important role in our healthcare system, but recent media attention has exposed limited regulatory control over these organizations at the same time their role is expanding. Compounding pharmacies are not regulated in the same manner as pharmaceutical companies and are governed largely by Chapter <797>, a monograph on the pharmaceutical compounding of sterile products, issued but not enforced by the U.S. Pharmacopeial Convention. Not all states require adherence to Chapter <797>, and those that do may choose not to enforce it stringently. Furthermore, Chapter <797> is not a strong standard-for example, it does not require documentation of drug lot numbers or cross-references for patient identification. Thus, there have long been many potential quality issues associated with compounding pharmacies. As these compounding pharmacies provide important products and services, better regulation is urgently needed. Moreover, clinicians should be better aware that some injectable products they use may have been prepared by a compounding pharmacy.
Our aim was to explore how members of community pharmacy staff perceive and experience the role of procedures within the workplace in community pharmacies.
Impact of pharmacist integration in a pediatric primary care clinic on vaccination errors: A retrospective review
- Journal of the American Pharmacists Association : JAPhA
- Published over 3 years ago
OBJECTIVE To measure the impact of ambulatory clinical pharmacist integration in a pediatric primary care clinic on vaccination error rates and to evaluate missed opportunities. METHODS A retrospective, quasi-experimental review of electronic medical records of visit encounters during a 3-month period compared vaccine error rates and missed opportunities between two pediatric residency primary care clinics. The intervention clinic has a full-time ambulatory clinical pharmacist integrated into the health care team. Pharmacy services were not provided at the comparison clinic. A vaccine error was defined as follows: doses administered before minimum recommended age, doses administered before minimum recommended spacing from a previous dose, doses administered unnecessarily, live virus vaccination administered too close to a previous live vaccine, and doses invalid for combinations of these reasons. RESULTS 900 encounters were randomly selected and reviewed. The error rate was found to be 0.28% in the intervention clinic and 2.7% in the comparison clinic. The difference in error rates was found to be significant (P = 0.0021). The number of encounters with greater than or equal to one missed opportunity was significantly higher in the comparison clinic compared with the intervention clinic (29.3% vs. 10.2%; P <0.0001). CONCLUSION The pediatric primary care clinic with a pharmacist had reductions in vaccination errors as well as missed opportunities. Pharmacists play a key role in the pediatric primary care team to improve the appropriate use of vaccines.
- Journal of the American Pharmacists Association : JAPhA
- Published over 3 years ago
OBJECTIVE To assess the design and implementation of influenza vaccination clinics across campus, assess participant satisfaction with the pharmacist-led clinics, and educate and increase visibility of the role of pharmacists as vaccinators. SETTING University of Oklahoma Health Sciences Center (OUHSC), a comprehensive health sciences center. PRACTICE INNOVATION The College of Pharmacy on the OUHSC campus developed and implemented a vaccination program to increase influenza vaccination of OUHSC employees. MAIN OUTCOME MEASURES Number of employees receiving influenza vaccination, employee satisfaction with the pharmacist-led clinics, and employee awareness of the pharmacist’s role in vaccination. RESULTS Reported OUHSC employee influenza vaccination rates increased from approximately 35% before implementation of the pharmacy-based program to 54% in 2012 after implementation. The increase was attributed to maintaining no out-of-pocket costs for employees, offering various clinic locations, and using media resources to educate employees about influenza infection and vaccination. Employees reported high satisfaction with the influenza vaccination clinics and with receiving vaccinations from pharmacists and student pharmacists. In the first 2 years of the program, the percentage of surveyed employees “very familiar” with the pharmacist’s role in vaccinations increased from 23% to 66%. CONCLUSION A college of pharmacy on a large health sciences center developed and successfully implemented an influenza vaccination program, providing an accessible and convenient route for influenza prevention to employees, as well as enhanced the visibility of pharmacists as vaccination providers.
Assessment of Community Pharmacists' Counseling Practices With Simulated Patients Who Have Minor Illness: A Pilot Study
- Simulation in healthcare : journal of the Society for Simulation in Healthcare
- Published over 2 years ago
A community pharmacist (CP) must provide counseling to consumers of nonprescription medicines and promote responsible self-medication. Previous studies indicate no available statistics on the proportion of pharmacies that provide cognitive services in Brazil. Furthermore, few studies have explored CPs' performance regarding patient-centred cognitive services in community pharmacies. Thus, quality improvement initiatives are needed for the responsible provision of self-medication to fully integrate Brazilian CPs into patient-centred cognitive services. Consequently, the present study’s aim was to assess CPs' performance in the management of cases with minor symptoms using nonprescription medicines.
Background In France, community pharmacists do not have free access to patients' lab results, and it is therefore impossible for them to identify patients with renal impairment. Objective (1) to evaluate the ability of community pharmacists (CPs) to identify drug related problems (DRP) in patients at risk for or suffering from renal impairment; (2) to evaluate the proportions of recommendations by CPs that lead to a modification by GP. Setting A prospective and observational study involving 24 community pharmacists in France. Methods Following special training, community pharmacists were asked to select 52 patients with the following characteristics: ≥65 years of age; prescribed at least two diabetic and/or antihypertensive drugs. Serum creatinine value was obtained for each patient and glomerular filtration rate estimated (eGFR) with the aMDRD formula. Those with a eGFR 60 ml/min/1.73 m² were considered having chronic kidney disease (CKD). Data was collected concerning whether the community pharmacists identified drug related problems and tried to inform the GP who prescribed the medications. Identified DRP were reviewed by a team of nephrologists and hospital clinical pharmacists. Primary outcome The proportion of CKD patients and those without serum creatinine monitoring, the number of drug related problems identified by community pharmacists, and the proportion of drug related problems resolved by the community pharmacists intervention to the GP. Results Of the total 791 patients identified, 180 (22.8 %) exhibited CKD, and 57 (7.2 %) had not undergone serum creatinine monitoring. Among the 1297 drugs prescribed, 260 had to be adapted to eGFR. The proportion of DRP was 21.5 % (56/260), of which 40 % (20) were identified by community pharmacists. Once the GP was informed, 33.3 % (6/18) of DRP were resolved. Conclusion Community pharmacists identified 40 % of DRP related to CKD prescriptions, leading to prescription modification by GPs in a third of the cases. These interventions are likely to decrease drug-related morbidity and mortality.