Mozambique has a population of 27 million. Malaria, TB, and AIDS are among the common causes of death and illness in the country. Approximately six million cases of malaria are reported each year, and there is an estimated incidence rate of 431 cases of TB (all forms) per 100,000 people. An HIV seroprevalence of 16% places Mozambique 19th among the world’s 22 high-burden countries. In 2006, an external evaluation of the pharmaceutical sector provided a clear assessment, and a roadmap to improve the pharmaceutical sector in Mozambique was developed. SIAPS supported the National Pharmacy Directorate (DNF) and the National Directorate of Medical Assistance to improve regulatory systems and appropriate medicine use.
Establishing Drug and Therapeutics Committees
SIAPS developed and implemented a Drug and Therapeutics Committee (DTC) orientation program that provided an overview of a DTC’s roles and responsibilities. SIAPS provided technical assistance and supported the Hospital Pharmacy Department (HPD) in overseeing activities of all DTCs to strengthen their capacity and operations at the central and provincial levels. The HPD conduct supportive supervisions for nine central and province hospitals. SIAPS also supported the design and piloting of SOPs for medicine use studies.
Revising the Essential Medicines List
SIAPS supported the DNF to develop and institutionalize the NEML revision mechanism by following the standardized criteria, engaging stakeholders, and promoting ethical practices, leading to improve efficiency, transparency, and accountability in the medicines selection process. SIAPS built the technical expertise of Ministry of Health (MoH) staff and specialists by training them on the EML revision process to ensure a common understanding of the concept of an essential medicines program and the process of developing an EML; the concepts and evidence-based practices used in selecting medications for an EML; and conducting evidence-based medicine selection in accordance with WHO principles.
Strengthening the Medicines Marketing Authorization System
SIAPS supported the implementation of Pharmadex, which was customized to meet the country’s requirements, and 4,248 dossiers were processed and archived. SIAPS also provided support to build the DNF’s technical capacity for common technical documents.
Strengthening the DNF’s M&E System
SIAPS supported the DNF to establish an M&E system. Through a desk review of key documents and interviews with key personnel, and taking into account the perspective of WHO and SADC, a set of core performance indicators was selected and a performance monitoring plan, reports, and forums for reviewing data were developed. SIAPS organized a multisectoral workshop to build capacity and develop a clear path forward to foster evidence-based decision making at all levels in the department. Technical assistance was provided to perform a data quality assessment and improve the DNF databases, and the data quality assessment was extended to the province level.
Developing a Pharmacovigilance System
SIAPS trained health professionals, Hospital Therapeutics and Pharmacy Committees, and students on identifying and reporting adverse drug reactions.
Improving Pricing Regulation
SIAPS reviewed the current medicine pricing regulatory framework and enforcement capabilities and laid the groundwork for a sustainable and transparent regulatory system for improved access.
SIAPS collaborated with the DNF and other partners to implement a package of activities focused on improving awareness and understanding of AMR, including:
- A two-day workshop to train journalists on their role in combating AMR, starting with raising awareness and understanding of the strategic action
- A two-day workshop for 25 representatives of different health disciplines in universities to establish the role of universities in combating AMR
- The first three of a set of educational spots about AMR to raise public awareness and understanding, warn of its dangers, and trigger behavior change
- A total of 781 staff (out of the life-of-project target of 680), including 463 DTC strategy implementers, were trained on pharmaceutical management, and the 13 sites implemented medicine safety activities and pharmacovigilance
- Seventy medication error studies, 13 ABC/VEN analyses, and 28 prescribing studies were conducted
- Five DTCs developed or implemented treatment/prophylaxis guidelines and formularies; four developed rational medicine use policies; and three conducted in-service trainings on rational medicine use or DTC responsibilities
- Seven hospitals designed, implemented, and evaluated interventions to address low levels of compliance with national prescribing guidelines
- Hospital health technicians working in emergency care in Quelimane Provincial Hospital were trained on how to manage the facility’s most frequently diagnosed diseases
- Interventions at Lichinga Provincial Hospital improved the transcription of therapeutics information from clinical diaries to the therapeutic chart by 14.9% and compliance with standard treatment guidelines for all patient encounters by 19.5%
- In Jose Macamo General Hospital, the average completeness of relevant information in prescriptions improved from 51% in January 2016 to 72% in June 2016
- After conducting aggregate consumption studies, the Chimoio Provincial Hospital DTC regulated the use of ferrous sulfate and iron in the hospital, trained prescribers how to treat anemia, and closely monitored the prescription and consumption of ferrous sulfate with folic acid. After one month, consumption of the medication decreased by 10% and remained below 10% for the next four months.
Medicines Marketing Authorization System
Through the implementation of Pharmadex, the average registration process (submission, screening, review, and final decision) decreased from 400 to 176 days.
The EML committee was institutionalized with defined roles and responsibilities and approved Terms of Reference for the selection committee. SIAPS has trained 75 MoH staff on the EML process. The DNF developed and institutionalized a system to regularly update of the EML based on international standards.
Fifteen journalists from local newspapers and radio and television stations were trained on AMR. Since the training, an AMR newspaper article reached an estimated 80,000 readers. Three live radio interviews on AMR were conducted, and a DNF website article on the training had nearly 25,000 views. At the end of the AMR workshop, data were compiled to develop guidelines to help universities develop a joint action plan based on the one-health approach; SIAPS will support the drafting of the guidelines.
The support to DTCs and the EML system has contributed to building individual and institutional capacity and sustainability of regulatory and rational use interventions in Mozambique. The medicine registration system has been streamlined with the implementation of Pharmadex. Strengthening DTCs, the EML, and medicines market authorization will contribute to the USG National Strategy and Action Plan for Combating Antibiotic-Resistant Bacteria, which aims to strengthen regulatory and supply chain systems that ensure the quality, safety, and efficacy of antibiotics used in low- and middle-income countries.
- Implementing a Computerized Medicine Registration System in Mozambique
- Systems Requirements for Computerized Medicine Registration, Mozambique Ministry of Health
- Strengthening Drug and Therapeutics Committees to Promote Rational Medicine Use in Mozambique
- Mozambique Drug and Therapeutics Committee Workshop and Field Activities
- Mozambique Drug and Therapeutics Committee Workshop: Technical Report
- Strengthening capacity for Monitoring and Evaluating Mozambique’s regulatory System
- Maputo Provincial Hospital DTC Training Technical Report
- Training the Mozambican Pharmacy Department on the Use of Pharmadex
 Country cooperation strategy; http://apps.who.int/iris/bitstream/10665/135983/1/ccs_moz.pdf?ua=1