Burgunda V. Sweet

Impact of drug shortages on U.S. health systems

PURPOSE A study was performed to quantify the personnel resources required to manage drug shortages, define the impact of drug shortages on health systems nationwide, and assess the adequacy of information resources available to manage drug shortages. METHODS An online survey was sent to the 1322 members of the American Society of Health-System Pharmacists who were identified as directors of pharmacy. Survey recipients were asked to identify which of the 30 most recent drug shortages listed affected their health system, to identify actions taken to manage the shortage, and to rate the impact of each shortage. Employees responsible for completing predefined tasks were identified, and the average time spent by each type of employee completing these tasks was estimated. Labor costs associated with managing shortages were calculated. RESULTS A total of 353 respondents completed the survey, yielding a response rate of 27%. Pharmacists and pharmacy technicians spent more time managing drug shortages than did physicians and nurses. There was a significant association between the time spent managing shortages and the size of the institution, the number of shortages managed, and the institutions level of automation. Overall, 70% of the respondents felt that the information resources available to manage drug shortages were not good. The labor costs associated with managing shortages in the United States is an estimated

Drug Shortages: A Complex Health Care Crisis

216 million annually. CONCLUSION A survey of directors of pharmacy revealed that labor costs and the time required to manage drug shortages are significant and that current information available to manage drug shortages is considered suboptimal.

Cidofovir for the treatment of recurrent respiratory papillomatosis: A review of the literature

National tracking of drug shortages began in 2001. However, a significant increase in the number of shortages began in late 2009, with numbers reaching what many have termed crisis level. The typical drug in short supply is a generic product administered by injection. Common classes of drugs affected by shortages include anesthesia medications, antibiotics, pain medications, nutrition and electrolyte products, and chemotherapy agents. The economic and clinical effects of drug shortages are significant. The financial effect of drug shortages is estimated to be hundreds of millions of dollars annually for health systems across the United States. Clinically, patients have been harmed by the lack of drugs or inferior alternatives, resulting in more than 15 documented deaths. Drug shortages occur for a variety of reasons. Generic injectable drugs are particularly susceptible to drug shortages because there are few manufacturers of these products and all manufacturers are running at full capacity. In addition, some manufacturers have had production problems, resulting in poor quality product. Although many suppliers are working to upgrade facilities and add additional manufacturing lines, these activities take time. A number of stakeholder organizations have been involved in meetings to further determine the causes and effects of drug shortages. A new law was enacted in July 2012 that granted the Food and Drug Administration additional tools to address the drug shortage crisis. The future of drug shortages is unknown, but there are hopeful indications that quality improvements and additional capacity may decrease the number of drug shortages in the years to come.

Retisert: Is the New Advance in Treatment of Uveitis a Good One?

Recurrent respiratory papillomatosis (RRP) is a rare but potentially severe disease caused by papillomavirus, most often types 6 and 11. The disease, which occurs in both juvenile and adult forms, is characterized by benign epithelial tumors of the airway that most frequently affect the larynx but can also spread along the entire aerodigestive tract. Recurrent respiratory papillomatosis is the most common benign neoplasm of the larynx in children and the second most frequent cause of childhood hoarseness. Standard treatment, which is palliative only, consists of surgical excision of papillomata to maintain airway patency and improve voice quality. Recurrence despite repeated surgical procedures is the rule. To date, incorporation of adjuvant treatments has not been reliably beneficial in altering the disease course. Several case series have described promising results with cidofovir, a cytosine nucleoside analog with antiviral activity. To evaluate the data available on the safety and efficacy of cidofovir for the treatment of RRP, we conducted a MEDLINE search for all case reports or series from January 1966–August 2004 describing cidofovir therapy in either adults or children with RRP. The bibliographies of qualifying articles were also searched for relevant references. In both adults and children with mild‐to‐severe RRP, intralesional administration of cidofovir directly into the site of papillomata was associated with partial‐to‐complete regression of papillomata, improvement in voice quality and airway status, and decreased need for surgery. Wide variation in intralesional cidofovir dose (2–57 mg), frequency (every 2–8 wks), and duration (4 mo−4 yrs) was found. Successful outcomes have also been reported with intravenous cidofovir, but data are limited to three case reports. Rash, headache, and precordialgia were the only adverse effects reported with intralesional cidofovir. Nephrotoxicity and neutropenia secondary to either intralesional or intravenous cidofovir were not observed. Long‐term risks associated with intralesional administration remain to be seen. Further studies are necessary to determine the most appropriate dose, frequency, and duration of therapy, and to fully characterize the safety profile of cidofovir when given intralesionally.

Butterbur: An alternative therapy for migraine prevention

Objective: To review the use of corticosteroids for the treatment of uveitis, with a focus on the pharmacology, efficacy, and safety of a newer delivery device, Retisert. Data Sources: A PubMed/MEDLINE search from 1950 through February 2007 was conducted, and manufacturer-provided data were reviewed. Study Selection And Data Extraction: Animal studies and Phase II and III clinical trials evaluating the safety and efficacy of Retisert for the treatment of uveitis were considered. The data were extracted from Pub Med/MEDLINE using the search terms fluocinolone acetonide, corticosteroids, intravitreal implant, uveitis, ocular steroids, and Retisert. Data Synthesis: The findings of the clinical studies showed, with use of Retisert, a reduction in the recurrence of uveitis, improvement in visual acuity, and a decreased need for adjunctive therapy with corticosteroids and immunosuppressant agents, There are currently no studies directly comparing Retisert with other treatment options. The most commonly reported adverse events (ADEs) in clinical trials included cataracts, increased intraocular pressure, post-procedural complications associated with implant insertion, and ocular pain. Other ocular ADEs included decreased visual acuity, glaucoma, blurred vision, an abnormal sensation in the eye, eye irritation, and a change in tearing. These ADEs are similar to those seen with chronic corticosteroid therapy delivered by other ocular routes. Conclusions: Retisert implants have been shown to deliver sufficient drug for a longer period of time compared with the traditional steroid delivery methods. Promising efficacy results show a significant reduction in recurrence rate and improvement in visual acuity for approximately 3 years after implant. However, the drug carries the risks associated with the implant procedure and with chronic exposure of the eye to steroids. Until more data on the long-term safety are known, Retisert should be reserved for patients who are no longer tolerant of or responsive to more traditional treatment modalities.

Melatonin: an option for managing sleep disorders in children with autism spectrum disorder.

Petasites hybridus, more commonly known as butterbur, is a member of the Asteraceae family.[1][1]–[4][2] This perennial shrub, which can grow to a height of 3 ft, has a creeping, horizontal rhizome, lilac-pink flowers, and broad leaves that can approach 3 ft in diameter (figure).[1][1],[3][3]–[5

Improving investigational drug service operations through development of an innovative computer system

Sleep disorders arise from a variety of causes and are thought to affect 20–30% of typically developing (i.e., non-special-needs) children.[1][1] This frequency increases to up to 80% in children with neurodevelopmental disorders such as autism spectrum disorder (ASD).[1][1]–[3][2] A broad 2006

Career placement of doctor of pharmacy graduates at eight U.S. Midwestern schools

PURPOSE The development of a computerized system for protocol management, dispensing, inventory accountability, and billing by the investigational drug service (IDS) of a university health system is described. SUMMARY After an unsuccessful search for a commercial system that would accommodate the variation among investigational protocols and meet regulatory requirements, the IDS worked with the health-system pharmacys information technology staff and informatics pharmacists to develop its own system. The informatics pharmacists observed work-flow and information capture in the IDS and identified opportunities for improved efficiency with an automated system. An iterative build-test-design process was used to provide the flexibility needed for individual protocols. The intent was to design a system that would support most IDS processes, using components that would allow automated backup and redundancies. A browser-based system was chosen to allow remote access. Servers, bar-code scanners, and printers were integrated into the final system design. Initial implementation involved 10 investigational protocols chosen on the basis of dispensing volume and complexity of study design. Other protocols were added over a two-year period; all studies whose drugs were dispensed from the IDS were added, followed by those for which the drugs were dispensed from decentralized pharmacy areas. The IDS briefly used temporary staff to free pharmacist and technician time for system implementation. Decentralized pharmacy areas that rarely dispense investigational drugs continue to use manual processes, with subsequent data transcription into the system. Through the universitys technology transfer division, the system was licensed by an external company for sale to other IDSs. CONCLUSION The WebIDS system has improved daily operations, enhanced safety and efficiency, and helped meet regulatory requirements for investigational drugs.

Oral acetylcysteine for neuropsychiatric disorders

Objective. To characterize postgraduation placement plans of 2013 doctor of pharmacy (PharmD) graduates. Methods. A cross-sectional survey of PharmD graduates from 8 midwestern colleges of pharmacy was designed to capture a comprehensive picture of graduating students’ experiences and outcomes of their job search. Results. At graduation, 81% of 2013 respondents had postgraduate plans, with approximately 40% accepting jobs and 40% accepting residencies or fellowships. Eighty-four percent of graduates reported being pleased with offers received, and 86% received placement in their preferred practice setting. Students perceived that securing residencies was more difficult than securing jobs. Students who participated in key activities had a nearly sevenfold increase in successful residency placement. Conclusion. While the demand for pharmacists decreased in recent years, responses indicated successful placement by the majority of 2013 graduates at the time of graduation.

Outcomes of an Erythropoietic Growth Factor Interchange Program in Hospitalized Chronic Hemodialysis Patients

Food and Drug Administration (FDA)–approved formulations of acetylcysteine have been used for many years for the treatment of acetaminophen overdose, among other indications. In recent years there has been growing interest in the use of over-the-counter (OTC) dietary supplements composed of or