Paediatric galenics: a challenge and an opportunity proposed by A.P.P.A.® Project for Developing Countries

The goal of any health care system is to provide universal access to appropriate, efficient, effective and quality services in order to improve and promote people’s health. Based on Alma-Ata Declaration of 1978 “the Primary Health Care (PHC) … forms an integral part both of the country’s health system, of which it is the central function and main focus, and of the overall social and economic development of the community. It is the first level of contact… with the national health system, bringing health care as close as possible to where people live and work, and constitutes the first element of a continuing health care service.” The ultimate goal of PHC is better health for all. Despite the relevance of PHC, most of the developing Countries (DC) have not been able to commit to a full integration of all the essential elements and principles of PHC. Currently, 70% of health costs in DC are spent on about the 30% of the population. In the international health context the difficulty of access to adequate basic health resources is in addition to the wide presence on the market of counterfeit medicines. The existence on the market of these products is reflected in a imbalance of health conditions among Countries in the developing world and the rest of the world. Targeted interventions about information, prevention and check can reduce the phenomenon. In this context the non-profit organization Aid Progress Pharmacist Agreement operates. Its main activity is the A.P.P.A.® Project. The Project, started in 2005, is the result of the cooperation between the Pharmacy Faculty (Turin) and local Pharmacists. The Project is in agreement with the International Health Cooperation principles and it complies both with Italian and guest Countries laws. Objectives: • realizing galenic lab in hospitals located in DC with the aim of preparing medicinal products which comply with adequate quality requirements, first of all to fight the widespread phenomenon of counterfeit in DC; • customizing the dosages and pharmaceutical forms according to the actual needs of patients; • employing local staff, teaching them a “new job” in order to open suitable school; • minimizing the financial commitment necessary to prepare these medicines. The Project is structured in six phases, through which it is possible to obtain an effective and functional lab: from a preliminary study of local needs up to a constantly and accurate control of the prepared galenics by analysis in the laboratories of University of Turin. The most important results showed that several Projects are going on: two in Cameroun, two in Madagascar, two in Angola, one in Tchad and one in Haiti. Due to the different socio-economic conditions each lab is a reality different from the others, always without forgetting the goal of opening labs to produce quality medicinal products. For each lab a specific handbook has been studied: each of them reflects the different local needs. For this reason, in the last two labs carried out in Angola and Haiti, it was necessary to introduce several formulations for pediatric use because the number of young patients is high and the availability of preparations designed for them is limited. For example suppository and liquid preparations for oral use must be prepared; in particular liquid preparations allow a simple modulation of the amount in function of the weight of several children afferent to the hospital. The preparation studied and formulated until today for pediatric use are: • Solutions: captopril, furosemide • Suspension: amoxicillin, carbocysteine, chloramphenicol, erythromycin, magnesium and aluminum hydroxide, metronidazole, vitamin B complex • Syrups: ascorbic acid, carbocysteine, ibuprofen, iron sulphate, paracetamol, potassium canrenoate, propranolol, quinine, ranitidine, salbutamol, vitamin B6 • Drops: nifedipine, quinine, ranitidine, salbutamol, vitamin B6 • Suppositories: paracetamol For each preparation specific tests were performed to verify the quality and also the stability under different environmental conditions, in accordance with the EMA guidelines. All formulations have proved to be stable in “Accelerated” conditions (T=40±2 °C, UR 60±5%) for 3 month, in “Refrigerated” conditions (T=5±3 °C) and “Standard” conditions (T=25±2 °C, UR 60±5%) for 12 months. The main goal is that the studied preparations could therefore be preserved in complete safety at homes even if these houses, as often happens in DC, are not equipped with air conditioners or refrigerators.