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Functional Comparison of Electronic Medicines Registration Systems

In November 2016, SIAPS offered technical assistance to DPMED to optimize the current medicine registration system, potentially by using the web-based medicine registration tool Pharmadex. After the assessment at DPMED in August 2017, SIAPS found that the SIGIP-ARP system in place was a software recommended for the regional West African Economic and Monetary Union (WAEMU) member states and was preferred by DPMED. Hence, it was jointly resolved to strengthen the system already in place. A server room was setup and a rack server installed to hold the current and any other future systems for DPMED (e.g., inspection software). SIGIP-ARP was modified to improve its performance, which has enabled DPMED to do concurrent data entry of registration applications. DPMED is currently progressing on this task, and SIGIP-ARP can generate monitoring reports, which the director can use for management purposes. DPMED has yet to develop monitoring and evaluation indicators to track the data entry.

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Implementing an TB/HIV Active Surveillance System in Swaziland

SIAPS supported the Swaziland Ministry of Health (MOH) in mobilizing key stakeholders from the Swaziland National AIDS Program and the National Tuberculosis Control Program to introduce and implement an active surveillance system for patients on ARVs and anti-TB treatment. SIAPS provided technical assistance to MOH’s National Pharmacovigilance Unit (NPVU) to develop the protocol and tools to implement the system, as well as to develop a system for recruiting patients at the HIV and TB sites.

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Strengthening Regulatory Systems to Improve Access to Safe, Effective, and Quality Medicines

SIAPS technical support has helped strengthen the capacity of the national registration committee and streamline medicines registration. As a result, the number of registered medicines has increased from 200 in 2010 to over 3,000 in 2014; 72% of the medicines included on DRC’s essential medicines list currently have at least one product registered, up from 44% in 2011. The backlog of applications has been completely eliminated and the time taken to process a new application has been reduced from a peak of 85 days in 2013 to 64 days at the end of 2014.

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Guidance for Planning the Introduction of New Reproductive, Maternal, Newborn, and Child Health Medicines and Supplies

The purpose of this document is to provide guidance to program managers in ministries of health at national and sub-national levels as well as personnel in other interested organizations on actions to take and factors to consider when expanding access to essential RMNCH commodities. While this document focuses on RMNCH medicines and supplies, it may be used as a guiding document and planning tool for other essential medicines and supplies. This guide addresses several pharmaceutical management issues (pharmaceutical policies, effective medicine management, strengthening regulatory systems, information needs, and product quality and safety practices) that are often overlooked when considering the introduction of new products. The systems strengthening approach described in this document focuses on governance, human resources, information systems, financing, and service delivery, with the provision of medical products cutting across these sub-systems. The goal of this guidance document is to assist managers to systematically plan for the successful introduction of new medicines and supplies by harmonizing and aligning efforts among all stakeholders involved in the process.

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Analysis of the Regulatory Capacity to Assure the Quality of Antimalarial Medicines in Selected Countries of the Greater Mekong Subregion of Asia

SIAPS conducted a review of regulatory and quality assurance efforts in the GMS with the following objectives—

  • To inform PMI of past and current initiatives to improve the capacity of the region to combat counterfeit, substandard, and banned antimalarial medicines
  • To understand the current barriers to effective medicine quality control for malaria
  • To recommend specific areas of focus or interventions to further improve regional and country capacity to combat counterfeit, substandard, and banned or illegal antimalarial medicines
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Assessment of the Medicines Regulatory System in Angola: Report

The Ministry of Health (Ministério da Saúde; MINSA)’s National Directorate of Medicines and Equipment (Direccao Nacional de Medicamentos e Equipamentos; DNME) is responsible for regulating medicines and other pharmaceutical products in Angola in collaboration with the Inspectorate General of Health (Inspecção-Geral da Saúde; IGS). Preliminary reports indicated that the regulatory system was not fully functional or operating effectively and thus needed assistance.

As a first step toward providing technical support and identifying additional sources of assistance to strengthen the regulatory system, the USAID-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program, which has been providing support to the DNME since 2005 in pharmaceutical management, particularly supply chain management, conducted an assessment of the system and DNME’s capacity to implement it.

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Tips for Lowering Pharmacy Temperatures to Maintain Good Medicine Quality

Pharmacies that serve health clinics located in tropical areas need infrastructure that will help lower their inside air temperature.

It is very important that medicines are stored below 30°C, remembering that certain medicines must be stored at temperatures below 25°C. Higher temperatures tend to change medicine quality, which can make them less effective.

This guide provides instruction on simple and inexpensive modifications of pharmacy stores to reduce the inside air temperature by up to 4°C.

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Were Medicine Quality and Pharmaceutical Management Contributing Factors in Diminishing Artemisinin Efficacy in Guyana and Suriname?

Pribluda VS, Evans L, Barillas E, Marmion J, Lukulay P, Chang J. Were medicine quality and pharmaceutical management contributing factors in diminishing artemisinin efficacy in Guyana and Suriname? Malaria Journal. 2014;13:77.

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Substandard and Counterfeit Antimicrobials: Recent Trends and Implications to Key Public Health Interventions in Developing Countries

Tadeg H, Berhane Y. Substandard and counterfeit antimicrobials: recent trends and implications to key public health interventions in developing countries. East Afr J Public Health. 2012;9(2):85-9.

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