Bodas de oro de la Sociedad Argentina de Farmacia Hospitalaria / The Argentine Society of Hospital Pharmacy ́s Golden Anniversary

Desde la década de los años sesenta, la función institucional del farmacéutico fue cambiando a expensas del desarrollo de la industria farmacéutica, orientando su objetivo hacia el paciente. Esto llevó a un cambio radical en la profesión, y particularmente, en las instituciones asistenciales. En la Argentina, fue un grupo de profesionales de la Cátedra de Farmacotecnia, de la FFyB (UBA), quienes comenzaron a promover las ideas del nuevo paradigma de la Farmacia Hospitalaria. Estos pioneros formaron, el 24 de octubre de 1969, la Sociedad Argentina de Farmacéuticos de Hospital (SAFH). Desde el inicio se comenzó a difundir y fomentar el intercambio del nuevo modelo en las instituciones asistenciales y se impulsaron los conceptos que hoy son una realidad en los establecimientos sanitarios del país, como la residencia farmacéutica, la esterilización, las especialidades farmacéuticas, la nutrición parenteral, el fraccionamiento de citostáticos, la farmacovigilancia y la farmacia clínica entre otros. Poco a poco, este paradigma fue extendiéndose por los hospitales argentinos, en especial en la Ciudad de Buenos Aires, donde el Hospital de Niños fue parte de esa transformación

In the early sixties the institutional role of the pharmacist was changing at the expense of the development of the pharmaceutical industry; orienting its objective towards the patient. This led to a radical change in the profession, particularly in healthcare institutions. In Argentina it was a group of professionals from the FFyB Chair of Pharmacotechnics (UBA) who began to promote the ideas of the new paradigm of Hospital Pharmacy. These pioneers formed, on October 24, 1969, the Argentine Society of Hospital Pharmacists (SAFH). From the first moments, the exchange of the new model in healthcare institutions began to be disseminated and promoted and promoted the concepts that today are a reality in the country's health establishments such as pharmaceutical residence, sterilization, pharmaceutical specialties, parenteral nutrition, cytostatic fractionation, pharmacovigilance and clinical pharmacy among others. Gradually this paradigm was spreading through hospitals in Argentina, particularly in the City of Buenos Aires and Hospital de Niños was part of that transformation

Clozapine-associated neutropenia and agranulocytosis in Argentina (2007-2012).

The risks of severe leukopenia and agranulocytosis have varied over time and among geographical regions and cultures, with little information available on South American populations. Accordingly, we reviewed and analyzed data from a 6-year experience monitored by an Argentine national registry to which reporting of adverse events reports is required. We analyzed data for 2007-2012 from the pharmacovigilance program of the Argentine drug-regulatory agency (ANMAT) using standard bivariate and multivariate statistical methods and survival analysis. We identified 378 cases of adverse hematological events over 6 years among an average of 12 305 individuals/year treated with clozapine (308±133 mg/day) to estimate the mean annualized rates of leukopenia [0.19 (95% confidence interval [CI] 0.11-0.27)], neutropenia [0.38 (95% CI 0.34-0.43)], and agranulocytosis [0.05 (95% CI 0.02-0.08)] % per year [median latency 2 (95% CI 1.3-2.1) months]; fatalities related to agranulocytosis averaged 4.2 (95% CI 0.0-9.2) per 100 000 treated individuals/year. Factors associated significantly and independently with agranulocytosis were female sex, older age, and use of other drugs in addition to clozapine. With monitoring by international standards, recent risks of clozapine-associated agranulocytosis in Argentina were lower, but fatality rates were higher than that in other regions of the world. Risk factors include the use of multiple psychotropic drugs, female sex, and older age.

[Risk minimization evolution of agranulocytosis caused by the administration of pharmaceutical products containing Clozapine in Argentina]. / Evolución de la minimización del riesgo de producir agranulocitosis por la administración de especialidades medicinales que contienen clozapina en Argentina.

Clozapine is an antipsychotic medication used in the treatment of schizophrenia. Compared to other drugs, Clozapine has shown remarkable advantages. However, its use entails a serious risk of causing hematologic alterations (including granulocytopenia/agranulocytosis). Such alterations may result in death if they are not detected early. Clozapine was recalled from the worldwide market and it was reintroduced some years later, but a mandatory hematologic monitoring program was implemented. The program was established in Argentina by ANMAT's regulation 935/00. It helped to monitor of the use of the drug. Currently, the incidence of agranulocytosis in our country is lower than the international incidence rates.

Uso de oseltamivir durante la pandemia de gripe a (H1N1): análisis de las reacciones adversas reportadas al sistema nacional de farmacovigilancia de ANMAT / Use of oseltamivir during influenza A (H1N1) pandemic: analysis of adverse reactions reported to the ANMAT national pharmacovigilance system

INTRODUCCIÓN: Oseltamivir es un medicamento antiviral usado para profilaxis y tratamiento de la gripe. Sus efectos adversos son conocidos a través de los ensayos clínicos y por la experiencia adquirida en la última epidemia de gripe aviar. Dentro de las reacciones más graves se han reportado casos de anafilaxia, eventos cutáneos y manifestaciones psiquiátricas como alucinaciones, delirium e ideación suicida. OBJETIVO: en julio de 2009, el departamento de Farmacovigilancia de ANMAT lanzó el Plan Nacional de Farmacovigilancia para Drogas Antivirales con el objetivo de recolectar mayor información de seguridad de estos medicamentos durante su uso masivo, con especial atención a las manifestaciones cutáneas, hepáticas y neuropsiquiátricas. MÉTODOS: se analizaron todas las notificaciones recibidas durante junio - noviembre de 2009. Los datos considerados fueron: sexo, edad, notificador, modalidad terapéutica, severidad, clasificación delefecto adverso principal e imputabilidad asignada. RESULTADOS: serecibieron 179 notificaciones, la mayoría asociadas a la modalidad tratamiento. Las reacciones adversas más reportadas involucraron al sistema gastrointestinal, siendo en su mayoría leves y autolimitadas. Con respecto a los casos psiquiátricos reportados, su severidad y variabilidad obliga a prestar especial atención a estas notificaciones. Se reportaron además casos de prolongación del Intervalo QTc, evento no descripto previamente en la literatura. CONCLUSIÓN: Dada la escasa experiencia en la Argentina y el estrecho perfil de seguridad de este fármaco, es indispensable continuar con una vigilancia activa del mismo.

INTRODUCTION: Oseltamivir is an antiviral drug used for profhylaxis and treatment of influenza. Adverse effects are known through clinical trials and in large part by the experience gained after its use in the last outbreak of avian influenza in Asia. Among the most serious reactions are reported cases of anaphylaxis, cutaneous events and psychiatric symptoms such as hallucinations, delirium and suicidal behaviour. OB JECTIVE: in line with various international regulatory authori ties, during July 2009, the ANMAT through Pharmacovigilance Department launched the National Pharmacovigilance Plan for antiviral drugs used for prophylaxis and treatment of the pandemic H1N1 influenza virus. The plan called for reporting any signs or symptoms, paying particular attention to the cutaneous, hepatic and neuropsychiatric symptoms. METHOD:we analyzed all reports received during June to November 2009. The data considered were: sex, age, notifier, therapeutic modality, severity, classification of main side effect and imputation assigned. RESULTS: 179 notifications were received, most associated with treatment modality. As can be seen world wide, in Argentina, the great majority of reported adverse reactions involve the gastrointestinal system, being mostly mild and self-limiting. Given the variability and severity of psychiatric cases reported it is very important to pay close attention to these reports. Reported cases include the QTc interval prolongation, an event not previously described in the literature. CONCLUSIONS: it is essential to continu e with proactive monitoring of this drug because of the limited current experience and the benefits/ risks ratio of the safety profile of this drug.