Non available medicines (NAM). Analysis of drug information requests (2008-2010)

FONTANA, D; LASCANO, V; VEGA, E; MAZZIERI, M. R

Encuentro; 1st Annual RICiFA Meeting (International Meeting on Pharmaceutical Sciences; 2010

Introduction The lack of availability of a medicine, at the market or at the health system, is a limiting factor to achieve a therapeutic goal (1). The classical approach focused the problem on orphan drugs (OD) for rare diseases. However, the present pharmacotherpeutic scene includes other situations that lead to unavailability, such as medicines for neglected diseases, inappropriate dosage form, off-label use of a drug product, among others (2,3). Our research group proposed to study that problem from a different point of view. So, we have carried out pharmacoepidemiological studies to identify needs of non available medicines (NAM), to understand the causes and to propose interventions. Furthermore, our experience working at the Drug Information Center (CIME-UNC), has demonstrated that pharmaceutics and therapeutic information about medicines is, generally, limited, biased and outdated. To overcome these difficulties, specially detected at health institutes (HI), a NAM Database (NAM-DB) was developed in collaboration with the CIME-UNC (4,5). Objective To identify the lack of drug products and to analyze the causes of their non-availability by using the requests received at CIME-UNC during 2008-2010. Materials and methods Type of study: Observational, cross-sectional descriptive. Period: April 2008 to April 2010 Setting: CIME-UNC and HI at Córdoba. Data collection: Requests for drug information obtained from the NAM-DB. Variables: Drugs classified by ATC code (7) and situations related to non-availability. The availability of medicines was confirmed by consulting the electronic database of approved drugs by ANMAT (6) and also by direct contact with the authorized laboratory. NAMs were compared with drug requested to ANMAT for Compassionate Use in the same period and OD list of FDA and EMA. Data processing: Microsoft Excel 2007 Results 134 information requests about NAM were received, which met 48 drugs. From those, 87 were confirmed as strictly NAM. About the consultants, 39 (54.9% of requests) were physicians, 22 were pharmacists (31.0%), 9 were patients (1.4%) and 1 nurse made the 12.7% of requests. Same requests were made by more than one professional. According to the ATC code, the main groups involved were: -A: 18.4% (n=16) -C: 18.4% (n=16) -J: 13.8% (n=12) -N: 9.2% (n=8) Furthermore, the following situations of non-availability were detected: -Non marketed drugs: 58.6% (n=51). -Adjusting dosage form: 29.9% (n=26). -Off-label use: 11.5% (n=10). The 22% (n=19) of NAMs identified coincided with a requested drug to ANMAT for Compassionate Use. The 28% (n=24) and 7% (n=6) are included in OD list of FDA and EMA, respectively Conclusions Drug information requests were useful to identifying NAM and non-availability situations. The types of situations were similar to those found in previous studies. Group A (alimentary tract and metabolism) was the most frequently involved. The collaborative approach allowed the resolution of requests with evidence based information in time. The importance and benefits of interacting between HI and the University was demonstrated. Acknowledgments Secretaría de Ciencia y Tecnología de la Universidad Nacional de Córdoba. (SeCyT-UNC). Secretaría de Extensión Universitaria de la Universidad Nacional de Córdoba (SEU-UNC). Centro de de Información sobre Medicamentos de la Universidad Nacional de Córdoba (CIME-FCQ-UNC). Sección de Comercio Exterior. Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT) References: 1) OMS. Estrategia farmacéutica de la OMS 2004-2007. Lo esencial son los países. Documento WHO/EDM/2004.2. OMS. 2004 2) Fontana D, Uema S, Mazzieri MR. Medicamentos huérfanos: una revisión necesaria para un problema sanitario no resuelto. Acta Farmacéutica Bonaerense 2005;24(1):123-9. 3) Fontana D, Uema S, Mazzieri MR. Medicamentos huérfanos: una definición. Acta Farmacéutica Bonaerense 2005;24(3):449-52. 4) Lascano VM, Fontana D, Vega EM, Mazzieri MR. Base de datos de medicamentos no disponibles en Argentina. En: VIII Congreso Argentino de Farmacia Hospitalaria. 2008. 5) Lascano V, Fontana D, Vega EM, Mazzieri MR. Necesidad de información sobre medicamentos no disponibles (MND) en Córdoba. En: III Congreso Nacional de Extensión Universitaria. 2009. 6) ANMAT. Consultas sobre medicamentos. [base de datos en Internet]. Base de datos de medicamentos autorizados en Argentina. [Acceso abril 2010]. Disponible en: http://www.anmat.gov.ar/Medicamentos/basedat.asp 7) WHO Collaborating Centre for Drug Statistics Methodology [database on the Internet]. Complete ATC/DDD index 2010. [updated 2010 April]. Available: http://www.whocc.no/atcddd/indexdatabase