Managing conflicts of interest in pharmacy and therapeutics committees: A proposal for multicentre formulary development.

WHAT IS KNOWN AND OBJECTIVE: While many countries have central agencies responsible for formulary development, within the United States, each hospital, health care system, or insurance provider has their own pharmacy and therapeutic committee, leading to both inefficiencies and inequalities across formularies. The number and variety of processes within pharmacy and therapeutic committees also increases the likelihood that conflicts of interest will influence the development of formularies. We sought to determine how such influences could be reduced by reviewing international evidence related to the presence and harms of conflicts of interest in formulary development. METHODS: Several approaches have been taken to reduce the influence of conflicts of interest in pharmacy and therapeutics committee processes, including include disclosure, recusal, exclusion, universal consideration and dual committees. The feasibility of each of these approaches is considered in the context of the United States. RESULTS AND DISCUSSION: A proposal is drawn from the discussion of various approaches to conflicts of interest in pharmacy and therapeutics committees: multicenter formulary development. WHAT IS NEW AND CONCLUSION: Multicentre formulary development, where resources are pooled across institutions, may lead to a reduction in the influence of conflicts of interest in pharmacy and therapeutics committee processes in the United States, increasing the chances of including the most safe, efficacious and cost-effective drugs on formularies.

[Analysis of the selection process for new drugs in a tertiary hospital 2004-2007]. / Análisis del proceso de selección de nuevos medicamentos en un hospital terciario. Años 2004-07.

OBJECTIVE: The purpose of this study is to describe the structure of the CFyT, the Pharmacy and Therapeutics Committee, and a tertiary hospital's selection process for new drugs. MATERIAL AND METHODS: All annals of the P&TC and the New Drug Incorporation Guides (GINF) to incorporate new drugs received at Hospital Virgen del Rocío between 2004 and 2007 were reviewed. We carried out a descriptive study which collected variables having to do with the drug (drug type, type of register, route of administration and legal category), the petitioner (responsible division, professional category and request type) and the result of the evaluation (final decision, elapsed time between the request and the decision). RESULTS: Of the 72 requested drugs, 45 (62.5%) were approved: six as equivalent treatments, 36 (80%) with specific recommendations, and three (4.2%) with no restrictions. Twelve drugs (81.1%) were not included due to insufficient evidence of their effectiveness compared with the current treatment. The most frequently-requested drug type was the antineoplastics, most commonly requested by Oncology and Haematology divisions. We highlight the fact that many of the petitioners included clinical trials (97.2%) and data referring to costs (84.7%). CONCLUSIONS: There is a high level of compliance with the GINF guide in our centre, which guarantees that the P&TC's final decision is based on scientific evidence.

Pharmacy and therapeutics committees strategy to address olmesartan safety issues at a primary care level.

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

Off-label use of drugs in pain medicine and palliative care: an algorithm for the assessment of its safe and legal prescription.

Off-label medication use is common practice, particularly in difficult to treat patients who have already tried commonly accepted medication unsuccessfully. Health authorities try to regulate this practice to protect the patient's safety and to prevent over consumption of new and more expensive drugs. Justified off-label drug use requires a thorough assessment. Physicians, in cooperation with formulary committees, need tools to structure this assessment. The evaluation algorithm for off-label prescription we present here, to be used after identification of a planned off-label application, consists of four steps. Step 1 indicates the extent of the problem and the need for further investigation. Step 2 is the decisional process evaluating the necessity of off-label use in identified prescriptions and confirmation as to what extent it needs further investigation. In step 3, the scientific knowledge to support the proposed off-label use is gathered in a short or extensive evaluation trajectory. The short trajectory consists of assembling the information approved in other countries or in accepted guidelines and textbooks, whereas the extensive trajectory is necessary when the indication, route, or formulation is not approved nationally or internationally. Assessment needs to be based on a literature research on the clinical and pharmacological information of the product. Step 4 is the acceptance or rejection of the off-label use of the drug for the indication at hand. Those four steps need to be carefully documented. Treatment outcome will then be closely monitored, documented, and made available to professionals, thus allowing for regular update of recommendations. This algorithm can help formulary committees to develop a strategy for evaluating off-label prescriptions in well-defined conditions, and help healthcare providers to develop protocols and guidelines.

Antimicrobial stewardship.

Antimicrobial stewardship is a key component of a multifaceted approach to preventing emergence of antimicrobial resistance. Good antimicrobial stewardship involves selecting an appropriate drug and optimizing its dose and duration to cure an infection while minimizing toxicity and conditions for selection of resistant bacterial strains. Studies conducted over the years indicate that antibiotic use is unnecessary or inappropriate in as many as 50% of cases in the United States, and this creates unnecessary pressure for the selection of resistant species. Because the pharmaceutical industry pipeline for new antibiotics has been curtailed in recent years, and it may be > or = 10 years before important new antibiotics to treat certain resistant bacteria find their way to market, a premium has been set on maintaining the effectiveness of currently available agents. Several strategies, including prescriber education, formulary restriction, prior approval, streamlining, antibiotic cycling, and computer-assisted programs have been proposed to improve antibiotic use. Although rigorous clinical data in support of these strategies are lacking, the most effective means of improving antimicrobial stewardship will most likely involve a comprehensive program that incorporates multiple strategies and collaboration among various specialties within a given healthcare institution. Computer-assisted software programs may be especially useful in implementing these comprehensive programs. The antimicrobial stewardship program at the Hospital of the University of Pennsylvania, which has been shown to improve appropriateness of antibiotic use and cure rates, decrease failure rates, and reduce healthcare-related costs, is used as an example in support of this multifaceted, multidisciplinary approach. At this time, data from well-controlled studies examining the effect of antibacterial stewardship on emergence of resistance are limited, but available data suggest that good antibiotic stewardship reduces rates of Clostridium difficile-associated diarrhea, resistant gram-negative bacilli, and vancomycin-resistant enterococci.

Análisis del cumplimiento del plan de consumo de los medicamentos de alto costo. Matanzas. 2012-2017 / Analysis of the fulfillment of the consumption plan of high cost medications. Matanzas. 2012 - 2017

RESUMEN Introducción: los medicamentos de alto costo son medicamentos nuevos, altamente específicos y utilizados en condiciones clínicas complejas, como el tratamiento de algunos tipos de cáncer; enfermedades que comprometen el sistema inmunológico, enfermedades inflamatorias o infecciosas. Objetivo: determinar cumplimiento del plan de consumo de los medicamentos de alto costo en la provincia de Matanzas, en el quinquenio 2012-2017. Materiales y métodos: estudio descriptivo, observacional de seguimiento sobre el cumplimiento del plan de consumo de los medicamentos de alto costo, en la población matancera del año 2012 al 2017. Se analizó el universo de medicamentos incluidos en esta categoría, a partir de la base de datos de suministro de medicamentos que emplea la Empresa Comercializadora de Medicamentos. Se identificaron las variables estudiadas. Resultados: en todo el período de estudio se observó un incremento creciente de los medicamentos de alto costo, en el 88,9 % de ellos el consumo ha estado por encima de la planificación realizada por la provincia. Los costos se incrementaron en un 233 % y además en las prescripciones realizadas de estos productos, se encontraron problemas como escaques vacíos, antibióticos sin impresión diagnóstica y omisión de la forma de presentación del medicamento y/o dosis indicada. Conclusiones: el consumo de muchos medicamentos de alto costo fue mayor que la planificación realizada en la provincia de Matanzas, durante el período analizado. Implicó un incremento significativo del presupuesto destinado a estos fines y se detectaron dificultades en el cumplimiento de lo establecido en las prescripciones de dichos medicamentos (AU).

ABSTRACT Introduction: high cost medications (HCM) are new highly specific medications and used in complex clinical conditions as in treatment of some types of cancer, diseases that compromise the immunological system, inflammatory or infections disorders. Objective: to determine the fulfillment of the consumption plan of high-cost medications in the province of Matanzas in the period 2012-2017. Materials and methods: a descriptive, observational, follow up study on the fulfillment of the consumption plan of high-cost medication by the population of Matanzas2012 year to 2017. The universe of drugs included in this category was analyzed on the bases of the drug-supplying database used by the Drug Commercializing Enterprise (ENCOMED in Spanish). The studied variables were identified. Results: it was observed a growing increase of high-cost drugs use during all the period; in 88.9 % of them the consumption has been above the planning made in the province. The costs increased in 233 %, and besides that in the prescriptions made of these drugs there were found problems like empty boxes, antibiotics without diagnostic impression and omissions of the drug presentation forms and/or the prescribed doses. Conclusions: the consumption of many high-cost drugs was higher than the planning made in the province of Matanzas for the analyzed period. It implied a significant increase of the budget destined for these aims and difficulties were found in the fulfillment of the terms for prescribing these drugs (AU).

La mortalidad del primer cuatrimestre de 2020 en la pandemia por COVID-19. Análisis del Comité de Mortalidad del Hospital Central de la Defensa «Gómez Ulla», Madrid / Mortality in the first four months of 2020 in the COVID-19 pandemic. Analysis of the Mortality Committee of the Hospital Central de la Defensa «Gómez Ulla», Madrid

INTRODUCCIÓN: En diciembre de 2019, Wuhan, China, tuvo un brote de la enfermedad COVID-19, causado por el síndrome respiratorio agudo severo coronavirus 2 (SARS-CoV-2). La enfermedad en poco tiempo se convirtió en pandemia. Los factores de riesgo asociados a su mortalidad están aún por determinar. El Comité de Mortalidad estudia los fallecimientos hospitalarios con el objetivo principal de reducir las muertes evitables. OBJETIVOS: Describir las características de comorbilidad y demográficas de los exitus del primer cuatrimestre de 2020 en el Hospital Central de la Defensa y su relación con COVID-19. MATERIAL Y MÉTODOS: Estudio transversal, descriptivo, observacional y retrospectivo. Datos clínicos y demográficos de los exitus en relación a la presencia de COVID-19. RESULTADOS: De 371 fallecidos, 271 COVID-19 positivos y 100 COVID-19 negativos. Casi 1,8 veces más de la mortalidad esperada en el cuatrimestre (208 a 371). Edad media de los grupos 80 y 84 años, rango entre 35 y 104 años. Estancia hospitalaria en COVID-19 positivos del 10,1% frente a 5,5% en COVID-19 negativos. Exitus extranjeros menor de 70 años 80%. Lugar del exitus: planta hospitalaria (84%). Puntuación media del índice de Charlson: 4 puntos (intercuartil, 2-6), 53% supervivencia estimada a 10 años. Comorbilidades más frecuentes: HTA (70,5%); DM (36,5%); Oncológico (31%); Neumonía (86,7%). Mal estado general al ingreso (81,9%). CONCLUSIONES: La variable con mayor potencia relacionada con la mortalidad fue la edad avanzada. Otro grupo, sin comorbilidades, menor de 51 años, presentó evolución fatal. A pesar de la dificultad para establecer la tasa de mortalidad real por COVID-19, la diferencia entre los exitus esperados y los registrados por el Comité de Mortalidad Hospitalario constituye el valor más aproximado

INTRODUCTION: In December 2019, Wuhan, China had an outbreak of the COVID-19 disease, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease quickly turned into a pandemic. The risk factors associated with its mortality are yet to be determined. The Mortality Committee studies hospital deaths with the main objective of reducing preventable deaths. OBJECTIVES: To describe the comorbidity and demographic characteristics of the deaths from the first four-month period of 2020 at the Central Defense Hospital and their relationship with COVID-19. MATERIAL AND METHODS: Cross-sectional, descriptive, observational and retrospective study. Clinical and demographic data of deaths in relation to the presence of COVID-19. RESULTS: Of 371 deceased, 271 positive COVID-19 and 100 negative COVID-19-. Almost 1.8 times more than the expected mortality in the four-month period (208 to 371). Average age of the groups 80 and 84 years, range between 35 and 104 years. Hospital stay at positive COVID-19 10.1% compared to 5.5% at negative COVID-19. Foreign exitus under 70 years 80%. Exit location: hospital plant (84%). Average Charlson index score: 4 points (interquartile, 2-6), 53% estimated survival at 10 years. Most frequent comorbidities: HTN (70.5%); DM (36.5%); Oncological (31%); Pneumonia (86.7%). Poor general condition at admission (81.9%). CONCLUSIONS: The variable with the greatest power related to mortality was advanced age. Another group, without comorbidities, younger than 51 years, presented fatal evolution. Despite the difficulty in establishing the actual mortality rate from COVID-19, the difference between the expected deaths and those recorded by the Hospital Mortality Committee constitutes the most approximate value

The role of pharmacoeconomic guidelines for formulary approval: the Australian experience.

This paper provides a review and critique of the recently introduced Australian Guidelines for the Presentation of Submissions to the Pharmaceutical Benefits Advisory Committee (Guidelines), which require pharmaceutical companies seeking recommendation for national formulary listing and subsidization to provide a detailed economic analysis to support their case. As Australia is the first country to mandate such a requirement, it is important not only to consider the details of the Guideline's requirements for economic analysis and the expectations of the authors, but also to consider, from both theoretical and practical perspectives, whether the Guidelines are appropriate for drug evaluation purposes. Although the Guidelines have raised the level of awareness of the need to integrate economic analysis into the formulary approval process, their contribution as a model for other jurisdictions must be qualified by the prescriptive and unduly narrow view that is taken of allowable analytical techniques. By forcing drug evaluations into a straightjacket, the Guidelines run the risk of undermining the credibility and contribution of economic analysis to formulary decisions.

Clinical guidelines and pharmacist intervention program for HIV-infected patients requiring granulocyte colony-stimulating factor therapy.

Guidelines, implemented by clinical pharmacists, were developed by the pharmacy and therapeutics subcommittee on a dedicated service caring for hospitalized patients with human immunodeficiency virus infection or the acquired immunodeficiency syndrome (AIDS) who required granulocyte colony-stimulating factor (G-CSF) therapy. Drug use and evaluation was conducted on all patients with AIDS who were prescribed G-CSF, and education was provided to medical house staff. Clinical data from chart review and laboratory and billing data bases of the hospital medical information system were compared for the 9-month intervention period (IP) with data from the 9-month preintervention period (PIP). Comparing the IP and PIP, the mean number of G-CSF doses (0.29 vs 0.51) and pharmacy costs per day ($112 vs $200) decreased, with no change in the number of patients requiring G-CSF. The 1.3 pharmacist interventions per patient resulted in a decrease to 2.4 doses per admission from a baseline of 5.9 (p<0.0001). Mean hospital stay (11.9 vs 13.8 days) and mean number of days of neutropenia did not differ for IP and PIP groups. Effectively implemented pharmacist-based interventions can decrease hospital costs without increasing patient morbidity.

Access to new cardiovascular therapies in Canadian hospitals: a national survey of the formulary process.

BACKGROUND: Access to new therapies in hospitals depends upon both clinical trial evidence and local Pharmacy and Therapeutics (P&T) committee approval. The process of formulary evaluation by P&T committees is not well-understood. OBJECTIVES: To describe the formulary decision-making process in Canadian hospitals for cardiovascular medications recently made available on the Canadian market. METHODS: Postal survey of hospital pharmacy directors in all Canadian hospitals with more than 50 beds. Target drugs included abciximab, enoxaparin, dalteparin, clopidogrel, eptifibatide and tirofiban. RESULTS: Of 428 surveys mailed, responses were received from 164 P&T committees representing 350 hospitals for an effective response rate of 82%. While physicians make up the largest proportion of committee membership, pharmacists play an influential role. Information most commonly cited as influencing formulary decisions included published clinical trials (97%), regional guidelines (90%), pharmacoeconomic data (84%), decisions at peer hospitals (73%) and local opinion leaders (60%). However, this information was often not required on formulary applications. Approval timelines varied widely for target medications but there were no regional, hospital or P&T committee characteristics that were independent predictors of early formulary application or approval. CONCLUSIONS: There is wide variability in the time taken for Canadian institutions to adopt new cardiovascular therapies, which is not explained by regional, hospital or P&T committee characteristics. Standardization of the formulary application and evaluation processes, including sharing of information amongst institutions, would lead to broader understanding of the applicable issues, more objectivity and improved efficiency.

Priority setting in a hospital drug formulary: a qualitative case study and evaluation.

Dramatically rising costs for new drugs are posing major challenges for hospital budgets. In response to these pressures, hospitals must set priorities for which drugs they will list on their formularies. While there have been studies relevant to decision making in hospitals regarding drugs, none have described how priority setting for drugs in hospitals is done and evaluated it against a framework of how it should be done. In this paper we describe the process of priority setting for new drugs in a hospital formulary and evaluate it using a leading conceptual framework for healthcare priority setting--Daniels and Sabin's 'accountability for reasonableness'. The findings from this study provide an evidence base for developing strategies to improve this hospital's priority setting regarding its drug formulary. The process we utilized here, describing using case study methods and evaluating using 'accountability for reasonableness', is a generalizable process for improving the fairness of priority setting in hospital drug formularies.

Using multidose eyedrops in a health care setting: a policy and procedural approach to safe and effective treatment of patients.

IMPORTANCE: Quality and safety of eyedrop use for patients treated in a health care setting play a vital role in the delivery of health care. OBJECTIVE: To describe the development of a policy and procedural approach to the use of multidose eyedrops in multiple patients, approved and accepted by The Joint Commission in compliance with preferred practice standards in ophthalmology, the safe handling and administration of multidose eyedrops, and cost benefits of a multidose eyedrop approach. DESIGN, SETTING, AND PATIENTS: Using a policy and procedural approach, we petitioned The Joint Commission for approval and evaluated the cost benefits of implementation of a multidose process for eyedrop administration in patients undergoing surgery and treatment at the Utah Valley Regional Medical Center, Provo. RESULTS: The Joint Commission approved our policy and procedural approach, implemented in April 2012. Cost savings to both patients and the facility were significant. Costs to patients undergoing a single cataract operation were decreased as much as $283.85. Costs to the facility were decreased by $330.91 per cataract case. CONCLUSIONS AND RELEVANCE: Approval of our policy and processes indicates that The Joint Commission validates our policy and its adherence to accepted preferred practice guidelines of safe handling and administration of multidose eyedrops and establishes precedence that may be followed by other eye care facilities and health care organizations in the future. Our policy provides a safe and effective process for administering eyedrop medications to patients as well as controlling excessive health care costs to both patients and health care facilities.

Valoración de los comités farmacoterapéuticos en policlínicos / Assessment of Therapeutic Drug Committees at Polyclinics

Introducción: El uso inadecuado de los medicamentos provoca falta de eficacia terapéutica, aparición de reacciones adversas prevenibles y aumento del gasto sanitario. Objetivos: Valorar la composición y el funcionamiento de los comités farmacoterapéuticos de los policlínicos del municipio Boyeros e identificar factores que pueden afectar su funcionamiento. Métodos: Estudio descriptivo, transversal. El universo estuvo constituido por los siete comités farmacoterapéuticos del municipio; se exploraron variables como cargo y profesión de los presidentes y secretarios, miembros permanentes, cantidad de actas de reunión, funciones que realizan, productos de su gestión; esta información se obtuvo por entrevista al presidente del comité y por la revisión de las actas de reuniones efectuadas en el año. Además, se realizó un grupo focal con los presidentes y secretarios de los comités farmacoterapéuticos, entre otros integrantes, cuyos criterios se agruparon según su frecuencia.m Resultados: Predominó la composición inadecuada (71,5 por ciento); todos los presidentes eran médicos, un secretario era enfermera de profesión; existió poca participación de Pediatría (71,4 por ciento), Ginecoobstetricia (42,9 por ciento), Medicina General Integral (28,5 por ciento). El funcionamiento se valoró mal (57,1 por ciento) y regular (42,9 por ciento); sólo 42,9 por ciento tenía entre 9 y 12 actas de reuniones. Se identificó poca percepción de los directores de la importancia del comité, falta de capacitación de sus integrantes y la necesidad de que un profesional asuma esa actividad como única tarea en la institución. Conclusiones: Se identificó que la composición y el funcionamiento de los comités farmacoterapéuticos en el municipio Boyeros no fueron adecuados, lo que también fue reconocido por sus miembros(AU)

Introducción: El uso inadecuado de los medicamentos provoca falta de eficacia terapéutica, aparición de reacciones adversas prevenibles y aumento del gasto sanitario. Objetivos: Valorar la composición y el funcionamiento de los comités farmacoterapéuticos de los policlínicos del municipio Boyeros e identificar factores que pueden afectar su funcionamiento. Métodos: Estudio descriptivo, transversal. El universo estuvo constituido por los siete comités farmacoterapéuticos del municipio; se exploraron variables como cargo y profesión de los presidentes y secretarios, miembros permanentes, cantidad de actas de reunión, funciones que realizan, productos de su gestión; esta información se obtuvo por entrevista al presidente del comité y por la revisión de las actas de reuniones efectuadas en el año. Además, se realizó un grupo focal con los presidentes y secretarios de los comités farmacoterapéuticos, entre otros integrantes, cuyos criterios se agruparon según su frecuencia. Resultados: Predominó la composición inadecuada (71,5 percent); todos los presidentes eran médicos, un secretario era enfermera de profesión; existió poca participación de Pediatría (71,4 percent), Ginecoobstetricia (42,9 percent), Medicina General Integral (28,5 percent). El funcionamiento se valoró mal (57,1 percent) y regular (42,9 percent); sólo 42,9 percent tenía entre 9 y 12 actas de reuniones. Se identificó poca percepción de los directores de la importancia del comité, falta de capacitación de sus integrantes y la necesidad de que un profesional asuma esa actividad como única tarea en la institución. Conclusiones: Se identificó que la composición y el funcionamiento de los comités farmacoterapéuticos en el municipio Boyeros no fueron adecuados, lo que también fue reconocido por sus miembros(AU)

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

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Impact of a faculty orientation and development committee.

This paper describes the faculty enrichment activities and outcomes of a faculty orientation and development committee at a college of pharmacy. The committee used a continuous quality improvement (CQI) framework that included needs assessment, planning and implementation of programs and workshops, assessment of activities, and evaluation of feedback to improve future programming. Some of the programs established by the committee include a 3-month orientation process for new hires and development workshops on a broad range of topics including scholarship (eg, research methods), teaching (eg, test-item writing), and general development (mentorship). Evidence of the committee's success is reflected by high levels of faculty attendance at workshops, positive feedback on workshop evaluations, and overall high levels of satisfaction with activities. The committee has served as a role model for improving faculty orientation and retention.

Regulação, circulação e distribuição da penicilina em Portugal (1944-1954) / Regulation, circulation and distribution of penicillin in Portugal (1944-1954)

Portugal foi um dos primeiros países do mundo, não participantes na II Guerra Mundial, a obter penicilina para uso civil. Em 1944 o medicamento começou a ser importado dos Estados Unidos da América pela Cruz Vermelha Portuguesa, mas como as quantidades eram escassas a sua distribuição foi confiada a uma comissão controladora constituída pela instituição. Em 1945, com o aumento da produção mundial, a penicilina foi integrada no circuito comercial de venda de medicamentos. A Comissão Reguladora dos Produtos Químicos e Farmacêuticos, fundada em 1940, enquadrada na política normalizadora do Estado Novo, com a finalidade de tutelar a atividade farmacêutica e o comércio dos medicamentos, exerceu um importante papel na regulação da venda do antibiótico. Entre 1945 e 1947 a penicilina foi importada como medicamento. A partir de 1947 a penicilina começou a ser importada como matéria-prima e em 1948 foram lançadas no mercado as primeiras especialidades farmacêuticas com penicilina preparadas em Portugal. Para garantir a qualidade dos medicamentos e minimizar a existência de produtos sem eficácia terapêutica comprovada a Comissão Reguladora dos Produtos Químicos e Farmacêuticos estabeleceu, em 1942, um laboratório para proceder à verificação analítica de medicamentos e produtos medicinais. Somente a partir de 1948, após o início da produção nacional de medicamentos com penicilina, é que o antibiótico começou a ser verificado analiticamente. A produção industrial de penicilina em Portugal surgiu em 1966. No presente artigo pretendemos demonstrar o papel da Comissão Reguladora dos Produtos Químicos e Farmacêuticos na regulamentação e no controlo da penicilina em Portugal no contexto dos outros medicamentos, bem como dar a conhecer o modo de regulação, circulação e distribuição da penicilina em Portugal nos anos 40 e 50 do século XX (AU)

Portugal did not participate in World War II but was one of the first countries in the world to receive penicillin for civilian use. The Portuguese Red Cross began to import the antibiotic from the United States of America in 1944 and appointed a controlling committee to oversee its distribution, due to the small amount available. In 1945, as world production increased, penicillin began to be distributed through the normal channels. An important role in its regulation was played by the official department responsible for controlling pharmaceutical and chemical products in Portugal, the Comissão Reguladora dos Produtos Químicos e Farmacêuticos (Regulatory Committee for Chemical and Pharmaceutical Products). Penicillin was imported as a raw material from 1947 and the first medicaments containing penicillin, prepared in Portugal, were released into the commercial circuit in 1948. A laboratory had been established in 1942 by the Comissão Reguladora for the analytical verification of medicaments and medicinal products with the aim of certifying their quality and minimizing the number of products with no attested therapeutic efficacy. The number of medicaments analysed by this laboratory increased substantially from 72 in the year of its foundation (1942) to 2478 in 1954, including, after 1948, medicaments containing penicillin. The aim of the present paper was to elucidate the role of the Comissão Reguladora dos Produtos Químicos e Farmacêuticos in regulating and controlling the distribution of penicillin in Portugal during the 1940s and 1950s

The role of curriculum committees in pharmacy education.

OBJECTIVE: To conduct a follow-up survey of curriculum committee chairs in US colleges and schools of pharmacy to describe current committee structures and functions and determine whether changes have occurred over time. METHODS: A descriptive cross-sectional study design using a 30-item survey instrument regarding the structure, function, and charges of curriculum committees was sent to 100 curriculum committee chairs. Several new variables were added to the questionnaire to explore the use of systematic reviews, oversight of experiential education, and the impact of accreditation standards on work focus. RESULTS: Eighty-five chairs responded. Curriculum committees are on average 1 person larger, less likely to have a student vote, more likely to have formal charges, and more likely to be involved in implementing an outcomes-based curriculum compared with 1994. Committees have shifted their work focus from review of curricular content to curricular revision. CONCLUSIONS: Curriculum committees continue to evolve as they respond to changes in pharmacy education and accreditation standards.

Variability in activity and results from drug assessments by pharmacy and therapeutics committees in Spanish hospitals.

OBJECTIVE: To quantify the Spanish Pharmacy and Therapeutics Committees (P&TC) activity with regard to assessing and selecting drugs and describing variability in decisions made to include them. METHOD: Descriptive, cross-sectional study based on a questionnaire aimed to 513 hospitals with more than 75 beds. We included questions referring to the P&TC resolutions, the therapeutic positioning and assessment reports. Recruitment was carried out between November 2007 and January 2008. Variability among P&TC conclusions were presented in five categories or levels of coincidence. RESULTS: One hundred and seventy-five hospitals participated, with a response rate of 34% (54% of beds). The mean (SD) number of drug-indications assessed per hospital was 10.35 (7.45). The proportion of assessments that conclude with drug inclusion or rejection was 75.3 and 21.4%, respectively. 16.2% concluded with therapeutic equivalence. Conditions for use were established for 64% of them, and 33% were included in a clinical guide. With regard to variability, 81.0% of assessments coincided with the conclusion to include or reject the drug. A contradictory decision was made for 19.0%. CONCLUSIONS: Drug assessment and selection activity in hospitals involve an amount of work. The proportion of drugs approved is similar in different types of hospitals. There is extensive variability as regards deciding upon inclusion and is similar to studies conducted in other countries. They indicate that a standardising methodology would be recommendable.