A major output of the Project is the development and approval of a hospital policy for Ulaanbaatar city which will direct changes in the way Ulaanbaatar city hospitals are financed, managed, organized and deliver services. The policy was intended to cover private sector participation, governance and autonomy issues and future public sector investment. MOHS working group with the support from Project consultants developed a draft policy, which was discussed and commented in 2012 by a high level strategic planning committee.
In June 2012, the MOH decided to extend the document to cover hospitals nationwide and the policy document underwent extensive discussion and review at the ministry level throughout 2013. A shorter version of a "Hospital Care Development Policy" document was approved through a ministerial order in February 2014. Strategic plan for Hospital Care Development Policy was approved by the Ministerial order #181 in May 2015. The hospital policy and the strategic plan are supported by specific covenants of the grant agreement.
In March 2012 a review of the current capital planning system was carried out by an international consultant. An assessment of public infrastructure and equipment in Ulaanbaatar was carried out covering 37 hospitals of various types. The assessment intended to provide a basis for estimation of infrastructure investment needs and contribute to a strategic development plan to reform the hospital sector in Ulaanbaatar. Capital planning procedures developed by international consultant and the assessment of the infrastructure investments needs of the Government are available. As a next step, by the end of 2015, the MOH will define the future capital planning system which would address institutional, human resources, information technology, financial requirements and investments to restructure and develop the hospital sector, as well as the types of processes needed.
The development of a model multifunctional general hospital in Songinokhairkhan district is intended to assist in the ongoing health and hospital sector reform by instituting best management practices, organizational processes, and restructured clinical services. The original plan was to renovate the existing hospital and have a restructured facility operational by June 2015. In 2012 the government requested additional funding of $25 million as a concessional loan for a new hospital, instead of renovating and appending new wings to the existing structure. The FHSDP-AF, the additional loan, became effective on 14 June 2013.
The Project has engaged SIMED (the Netherlands), an international hospital planning and design consulting firm, to develop the concept design and functional requirements, and Junglim Architecture Co.,Ltd (Republic of Korea) for the development of engineering and architectural design of model multifunctional general hospital in Songinokhairkhan district. Architectural detailed design of the demonstration hospital, which was developed by Junglim Architecture Co.,Ltd, was approved by the joint MOHS/UB City working group in May 2015 and is currently pending State expertise approval. Technical conditions for external heating, external electricity, external communications, external water supply and sewerage were approved by respective agencies in June 2015. Bidding document for the construction of the demonstration hospital is under preparation. The construction work will take place in 2016-2018.
The WHO has agreed to support hospital experts (4 months input to be split between developing the Songinokhairkhan hospital development plan and developing and introducing internal operating plan and new policies and procedures). The MOH will finalize the Songinokhairkhan hospital development plan by the end of 2015.
Licensing issues were addressed largely as a result of the Third Health Sector Development Project (THSDP) through ministerial orders (no. 143, 145) in April 2013 on regulating public and private health organizations. These orders included recommendations on certificates of need, licensing and regulatory frameworks for both public and private hospitals and clinics and other healthcare facilities.
International consultants reviewed the postgraduate training system and proposed a draft institutional framework to address system limitations. At a consensus meeting, the Ministry of Education, the Ministry of Health and Sports, hospitals and teaching universities agreed on the recommendations to extend the period of specialty training; to remunerate residents undergoing specialist training; to adopt the revised curricula; and to define the legal basis for medical education in the Health Law. But the issue of the institutional base for organizing postgraduate education has still not been agreed. The OPM and WHO consultants have proposed in-service hospital based training as the most preferred approach for improved specialty training. However, major stakeholders have not reached a consensus on this issue and this issue could be resolved only by improving respective laws and regulations (the Health law, the Law on Higher Education). Framework for establishing institution for governing and implementing postgraduate medical specialty training is included in the draft hospital care law in May, 2015.
Project consultants reviewed residency training program and curricula in four clinical areas (internal medicine, general surgery, obstetrics-gynaecology and paediatrics); recommendations for improvement were discussed and agreed by working groups comprised of specialists in these clinical areas. The postgraduate training for nurses was also reviewed by consultants, and training curricula for nursing streams were reduced from 26 to 9 with a strong emphasis on in-service training in the hospital. The trainers curriculum was developed to improve leadership skills in senior nurse managers (nurse director, chief nurse and ward manager). Translation rights for medical textbooks on internal medicine, general surgery, obstetrics-gynaecology and paediatrics were obtained from publishers in May 2015.
Project consultants assessed hospital management training in Mongolia. Among the limited number of institutions which provide management training with various degrees of quality, the program offered by the School of Public Health of the Mongolian National Medical Science University was preferred for institutionalization as the hospital management training. The School of Public Health in association with the Association of Public Health Specialists and Management Academia developed a training curriculum, which was approved by MOH. The hospital managers training was organized in September 2013, and the training of the first batch of 25 managers (with 20 female participants 80%) was undertaken between October 2013 and January 2014, and the second batch of 25 was undertaken in May 2015. The hospital managers training curricula consists of 6 modules and is based on an enquiry-based learning approach. The participants are expected to have hands-on experience in hospital management.
Output 3.1. and 3.2.
The Project's aim is to establish a drug regulatory authority and strengthen regulatory functions to improve coordination and quality. An amended drug law passed in 2010 includes provision for the establishment of a Drug Regulatory Agency (DRA) with 10 regulatory functions under MOH. The core of a new DRA with 18 staff was established in 2011 in the Drug Regulatory Division of the Department of Health (DOH/DRD). It was abolished in September 2012. Currently only 8 of the regulatory staff have been retained in the MOH Pharmaceuticals and Medical Devices Division (PMDD).
OPM provided technical assistance to initiate the DRA including a draft strategic plan, concept note, organizational structure and financing arrangements, and assistance with a draft medicines bill.
In strengthening regulatory functions, the OPM consultants have trained and mentored the original DOH/DRD staff and the interim regulatory staff in PMDD; several technical guidelines have been revised and approved (Good Manufacturing Practice, Good Distribution Practice and Good Pharmacy Practice). A baseline review of drug regulatory functions was undertaken using the WHO methodology in late 2011 and results were presented to relevant stakeholders. Mongolia s score of 46.9% in drug regulation show the need to strengthen drug regulatory functions. A team of local experts under WHO international experts guidance conducted a nationwide survey on the prevalence of unsafe drugs in the market in 2012. The survey revealed that 29% of medicines circulating in Mongolia are illegal (unregistered) or substandard. Project consultants developed and revisited drug regulatory procedures and some of them (registration procedures, adverse drug reaction reporting) were approved by MOH. A new National Medicines Policy, developed with technical support of OPM, endorsed by the Cabinet and ratified by the Parliament in October 2014, was the foremost achievement of this component. The National Medicines Policy covers core areas in medicine regulation such as medicines quality and safety, rational use, access, provision, distribution, and governance. The Project aim of establishing a website on the DRA and drug governance, along with an E-library was postponed until a DRA is established. The Project is assisting MOH in upgrading the drug regulatory database LICEMED that would lead to improved quality data base of registered products, licensed providers, and specialists available online.
A one-day conference on strengthening drug safety and human resource development with 70 representatives from MOHS, MOF, GASI, NUMSM, city department of health, center for health development, health insurance department at SSIGO, pharmaceutical and medical professional associations, health department and of general hospital Songinokhairkhan district, and representatives from international agencies was organized on 13 May 2015. During the conference the key implementing parties were informed about OPM project accomplishments, lessons and further recommendations from the project to ensure sustainability and collaboration.
Upgrading and strengthening of the Drug Control Laboratory (DCL) of the GASI is an important element for drug safety, and steady progress has been made in this field. The DCL moved to the new building built with the support of the Government of PRC in January 2013; new equipment provided by the Project was installed in November 2013 with on the job training from supplier companies. OPM consultants developed a Strategic Plan and ISO-17025 Accreditation Action Plan which were approved by DCL. For preparation of the lab accreditation, SWOT analyses and baseline Good Laboratory Practice assessment of the medicine laboratory were conducted in January 2013. Project consultants developed a laboratory quality management system including quality manual, standard operational procedures, record and reporting forms for the DCL. The Mongolian Agency for Standardization and Metrology has accredited DCL with ISO-17025 during a national assessment.
The Project aims for GMP are to upgrade standards, inspectorate, regulations and manufacturer capabilities with a target of at least five local drug manufacturers certified at international GMP standards by 2015. Project consultants conducted a gap analysis against the WHO GMP Guidelines and developed a new national GMP standard (MNS 5524:2014) which was approved by the Mongolian Agency for Standardization and Metrology. A GMP certification procedure was developed and approved by MOH.
The Project aimed to upgrade the GASI medicines inspectorate, guide inspections and company certifications. GASI inspectors were involved in GMP assessments by the international GMP consultant, and invited to all GMP trainings. According to the OPM consultants, GASI inspection procedures are not compatible with WHO Good Inspection guidelines and the methods of GASI s GMP inspection are problematic. The MOH will engage GMP qualification experts from WHO in the first part of 2015 to get professional opinion in regard to the existing quality management system for GMP inspection (under GASI).
OPM consultants assisted in developing manufacturer capabilities to upgrade facilities and train personnel. Training on GMP principles and good practices was done in 2012-2014 with participants from local drug manufacturers (production and quality control managers), medicines control laboratory and pharmaceutical associations. Consultants have also conducted a regular assessment in the 7 most promising local drug manufacturers since 2011 to support them to be certified by the upgraded GMP standard.
WHO GMP inspector worked in April 2015 to assess quality system of Mongolian GMP inspectorate and implement joint inspection with GASI inspectors for drug manufacturers assessed by FHSDP consultants previously. This GMP assessment of the selected companies confirmed that some potential facilities have made a progress, particularly in terms of green sites' (new construction), however there are still gaps in key areas especially control of active ingredients, HVAC qualification, classification of production areas, utilities and validation of sterilization cycles and other key processes such as cleaning of equipment. None of its licensed companies is meeting international GMP and therefore this situation poses severe (reputational) risk on the government. Options were discussed and it was agreed by the stakeholders that a GMP road map' for Mongolia to reach acceptable GMP standards (for initially 5 sites) by 2018 and further (10 sites) by 2020.
GMP international consultant recruited by the Project reviewed the quality manual of GASI to see if some sections had to be changed or improved. Several aspects of the roadmap for the GMP implementation, as defined after the WHO inspection, were discussed. Recommendations to progress on the GMP implementation in the local manufacturers were made and these recommendations reflected in the draft GMP implementation program of MOHS for 2015-2020.
The aim is to establish a basis for monitoring and reporting on adverse drug reactions to increase awareness of the problem and to institute preventive and corrective measures in hospitals. MOHS with support of project consultants developed and approved in 2013 a National Pharmacovigilance strategy and a ministerial order on Procedure on adverse drug reaction reporting and periodic safety update report of medicine. Trainings for medical professionals and members of hospital drug committees were conducted in 2013-2014. The number of reported ADRs has increased 4-times since the ADR training and publication of the ADR reporting manual. Twenty ADR case reports were filed in Vigibase (the global ADR database in Uppsala, Sweden) enabling Mongolia to attain full membership in the WHO International Drug Monitoring Programme.
Trainings on adverse drug reaction reporting activity and its significance for drug therapeutic committee members of hospitals and pharmacists of Tuv and Dornogovi aimags were organized in June 2015.
The objective of this output was to achieve strengthened drug safety governance functions at MOH with a pharmaceutical management information system. In 2010, WHO conducted a Country case study on Good Governance in the Pharmaceutical Sector in Mongolia. The results showed a moderate vulnerability to corruption with 6.169 and 6.208 ratings , meaning that registration, promotion, inspection, selection and procurement of medicines in Mongolia are conducted according with specific rules and legal acts. But violations are not properly punished even though the legal acts provide necessary provisions; there is no system for enabling the public to have equal and accessible information; and availability and accessibility of the instructions for the members of the drug registration, selection and tendering committees are insufficient. Project has initiated a review of a good governance of the pharmaceutical sector using WHO Good Governance Medicines Framework process in 2012. The MOH built the principles of a Good governance functions into the National Medicines Policy, approved by Parliament in October 2014. Project consultants assessed the current strategy to fight against illegal, counterfeit and/or substandard drugs and introduced recommendations to MOH, along with results of the national counterfeit drug survey undertaken in 2012. The MOH approved the anti-counterfeiting strategy in 2012.
Pharmacovigilance workshop on Regulation issues of safety of registered medicines for 100 representatives of pharmaceutical procuring company and drug manufacturers of UB city was organized in June 2015. The participants were introduced about issues related with reporting the periodic safety update information of procured or produced medicines by pharmaceutical companies. Handbook for periodic safety updates report (92 pages) was developed by Pharmacovigilance consultant, 500 copies were published and used as a training reference for Pharmacovigilance workshop.