Promoting quality use of medicines in South-East Asia: reports from country situational analyses

Background Irrational use of medicines is widespread in the South-East Asia Region (SEAR), where policy implementation to encourage quality use of medicines (QUM) is often low. The aim was to determine whether public-sector QUM is better in SEAR countries implementing essential medicines (EM) policies than in those not implementing them. Methods Data on six QUM indicators and 25 EM policies were extracted from situational analysis reports of 20 country (2-week) visits made during 2010–2015. The average difference (as percent) for the QUM indicators between countries implementing versus not implementing specific policies was calculated. Policies associated with better (> 1%) QUM were included in regression of a composite QUM score versus total number of policies implemented. Results Twenty-two policies were associated with better (> 1%) QUM. Twelve policies were associated with 3.6–9.5% significantly better use (p < 0.05), namely: standard treatment guidelines; formulary; a government unit to promote QUM; continuing health worker education on prescribing by government; limiting over-the-counter (OTC) availability of systemic antibiotics; disallowing public-sector prescriber revenue from medicines sales; not charging fees at the point of care; monitoring advertisements of OTC medicines; public education on QUM; and a good drug supply system. There was significant correlation between the number of policies implemented out of 22 and the composite QUM score (r = 0.71, r2 = 0.50, p < 0.05). Conclusions Country situational analyses allowed rapid data collection that showed EM policies are associated with better QUM. SEAR countries should implement all such policies. Electronic supplementary material The online version of this article (10.1186/s12913-018-3333-1) contains supplementary material, which is available to authorized users.


Aim of Country Situational Analysis of Medicines Management in Health Care Delivery
Effective management of medicines in health care delivery involves many functions, disciplines and stakeholders, covering the areas of supply, selection, use, regulation and policy. Generally, these functions are undertaken by a variety of different government units and other stakeholders. Often functions and fragmented due to poor coordination between these different government units and stakeholders. This, in turn, makes it difficult to plan strategically and effectively for the pharmaceutical sector. The aim of undertaking a country situational analysis of medicines in health care delivery is to gain a holistic understanding of how medicines are managed in the health care system, with respect to 5 main areassupply, selection, use, regulation and policy. By understanding how medicines are managed in the health care system, one may identify the priority problems and solutions that are likely to be effective and feasible.

What does a country situational analysis involve?
The country situational analysis involves collection of both qualitative and quantitative data over a 2-week period and is followed immediately by a 1-day national workshop for all stakeholders. At the workshop, the findings of the situational analysis are presented and validated, group work is undertaken to identify the major priority problems and solutions and recommendations are agreed in plenary discussion. The recommendations are for use by MOH and partners in planning for the sector. The aim of the situational analysis is to identify a range of priority problems and solutions, not to collect sufficient data for generalizable estimates of function, which cannot be done in only 2 weeks. Even so the data that can be collected in 2 weeks (which is all most government staff can spare) is often surprisingly extensive and not available elsewhere. This instrument can used for reviewing management of traditional medicines also.

The situational analysis should involve visits to:
 the major government departments concerned with medicines -medicines procurement & distribution, government health insurance (if there is significant population coverage), pharmacy services, medical services, drug regulation, drug policy, and any other department that is involved in medicines management and also any department of traditional medicine (if widely used in the country).
 the medical, nursing and pharmacy councils and associations (could be a joint meeting),

 any NGO/partner involved in medicines management
 two provinces (regions) and in each province a visit to 1-2 facilities of each type existing in the country e.g. 1 university hospital (medical school pharmacology department and the attached hospital); 1 district/provincial/regional public health office & drug warehouse; 2 district hospitals; 2 primary health care centres; 2 sub-centres/dispensaries; 2 -3 private pharmacies; and 1 public pharmacy (not attached to health facilities, if existing). This means altogether 16-24 facilities spread over 2 provinces (regions). If traditional medicine is widely used, 2 facilities dedicated to traditional medicine may be visited.
Generally, where possible, in each situational analysis, new provinces/regions and new health facilities should be visited, not the same ones as were visited in the previous situational analysis. This is to ensure that over a period of years, the situational analysis covers as much as possible of the different geographical areas and is not limited to the most excellent facilities in the national capital. As mentioned previously, data collection is sufficient to elicit a range of problems, not conduct a generalizable survey to estimate national function.
At each facility, visits will be made to the following:  the health staff in charge of the facility to introduce the team and objectives and to ask general administrative details about the health facility;  the main pharmacy or drug store to observe drug stock availability & to ask about drug supply;  the outpatient pharmacy department to review of 30-60 prescriptions for general primary care type cases in the outpatients and to observe dispensing;  the outpatient department (from prescriptions in the pharmacy or the patient registers) to review prescribing in 30 cases of uncomplicated upper respiratory tract infection  the outpatient department to talk with the prescribers;  1-2 inpatient wards to observe how medicines are managed and dispensed.
The situational analysis should be done by a team of 4-8 government officials drawn from government bodies responsible drug supply, drug selection, drug use and quality of care, drug regulation, drug policy and health insurance. If traditional medicine is widely used in the country and there are public traditional medicines services then an additional government official from the department of traditional medicines may be invited to join the team. In addition, there should be a person in-country to coordinate the process and also an external international facilitator to supervise data collection and analysis and report writing by the government team, and to moderate discussion between different government bodies during the national workshop.

How to use this workbook tool
This workbook tool is designed such that information concerning medicines supply, selection, use, regulation and policy may be entered into the relevant sections in a systematic manner. The core sections of the workbook on drug supply, selection, use, regulation and policy, sections 1-12, will eventually form the report. The health facility, public health office/warehouse and retail pharmacy survey forms, one per health facility, sections 13-15, are   Policies to promote rational use of medicines 52 6.5.1 Monitoring and supervision of prescribing / dispensing 52 6.5.2 Standard Treatment Guidelines (STGs) 53 6.5.3 National Formulary 54 6.5.4 Drug Information Centre 54 6.5.5 Independent drug information 55 6.5.6 Drug and Therapeutics Committees 55 6.5.7 Undergraduate education on medicine use 56 6.5.8 Continuing Medical Education and medicines use 57 6.5.9 Public Education on the safe and prudent use of medicines 58 6.5.10 Generic Policies 58 6.6

When all information has been entered into sections 1-12 of the workbook and the report is being finalized, the instructions in each section, these pages on introduction and instruction, and
Summary status in medicine use since last situational analysis 59 6.7 Medicines Use: Recommendations 60 The team members consisted of:

[List the team members]
The programme involved meetings with all the major government departments and other stakeholders involved in the management of medicines and visits to health facilities in two regions. A detailed program can be seen in section 3. During the visits to public health facilities and private pharmacies, drug stores were visited to collect data on stock availability for [fill in the number] selected essential drugs and drug management, outpatient dispensaries were visited to do a prescription audit, wards were visited to review in-patient drug management, and staff were interviewed to identify health and health care factors affecting drug management.
A one-day national stakeholder workshop was held on [insert dates] where findings were discussed and recommendations developed. The participants list can be seen in section 12. The findings were presented on behalf of the team by Dr Holloway, WHO/SEARO. Group work was done by participants to develop recommendations in the areas of medicines supply, selection, use, regulation and policy.
The words "medicine" and "drug" are used interchangeably in this report.

MEDICINE SUPPLY
Medicines Supply 16

Drug availability
(1) Describe any drug availability surveys done in the last 5 years.
(2) Describe briefly end-user views on drug availability using information collected from central officials and staff at the health facilities visited. (

Allocation of budget for medicines in the public sector
Please describe allocation of budget from review of reports and interview with government staff at the centre and periphery, remembering to include the following points:

 How is the budget allocated -on the basis of population? Number of beds in hospitals?
 What is the formula for allocating resources to provinces? Districts? Health facilities?

Drug quantification in the public sector
Please describe drug quantification from review of reports and interview with government staff at the centre and periphery, remembering to include the following points:

Drug Management and Distribution in the public sector
Please describe drug distribution from review of reports and interview with government staff at the centre and periphery, remembering to include the following points:  Name of distribution agency?  Is the distribution agency public/semi-autonomous/insurance/private?  Is there an electronic drug logistic management information system operating?  Is the system a "push" or "pull" system?  What is the time-

Other Medicine Lists
Please describe other medicines lists from record review and interview with government staff at the centre and periphery.

Policies to promote rational use of medicines
For each policy in each sub-section, please summarise the information collected from record review, observation and interview with staff at the centre and the periphery.

Monitoring and supervision of prescribing/dispensing by supervisors
Please remember to cover the following points: 

National Formulary
Please remember to cover the following points:

 Is there a national formulary? and if so, which government body developed it?  Does the national formulary include only EML drugs or also non-EML drugs also?  What information provided in the formulary:
o Drug indications, contra-indications, side effects, drug interactions, drug costs, generic names, branded names, drug schedules?  What is the availability of national formulary in health facilities and on the web?  Is the national formulary used in pre-service and in-service training?  Is the national formulary used by prescribers and dispensers? Did any of the health staff met during the situational analysis have a copy of the national formulary?

Drug information Centre
Please remember to cover the following points:  Is there a national drug information centre? If so, which government or non-governmental body runs it?  What services and information are supplied?  What sources of information are used?  What is the frequency of use by end-users according to the centre?  Have any health workers met during the situational analysis used it?  How is the drug information centre funded?

Independent drug information
Please remember to cover the following points:  National clinical guidelines;  Prescriber access to internet;  Visits by medical representatives.

Drug and Therapeutics Committees (DTCs)
Please remember to cover the following points:  What is the role of health professional bodies and accreditation in continuing medical education?  Has any CME covered topics on traditional medicine? Antimicrobial resistance and use? 6.5.9. Public Education on the safe and prudent use of medicines Please remember to cover the following points:  Have any national public education campaigns on prudent use of medicines (including antibiotics) been undertaken in the last 10 years?  What messages on prudent and safe use of medicines (including antibiotics) were spread?  Which government department or other organization was responsible?  What were the channels used (media, community health workers, etc.) and what proportion of the population was covered?  How easy is it for patients to buy prescription-only drugs over-the-counter without prescription (Very easy / easy / possible / impossible)?

Generic Policies
Please remember to cover the following points: Banning of unsafe medicines 1 Medicines (medicinal products) regulation issues may be covered in more than one law and may have multiple associated regulations, so ensure that all relevant documentation is identified & obtained for review. 2 Includes provisions for the Drug Regulatory Authority to define and publish its policies and procedures, publicly account for its decisions, conduct and actions, and follow a regulatory code of conduct.   composition of the committee;  roles and responsibilities of the drug regulatory authority versus the committee;  procedures for managing conflict of interest.

Quality management system
Please describe any quality management system used by the drug regulatory authority

Regulation of Traditional Medicine
Please describe how traditional medicine products and outlets are regulated and whether it is the national drug regulatory authority that is responsible or another agency.

Drug Schedules
Please remember to cover the following points: 

Drug Registration
Please remember to cover the following points:

 Is there a designated unit? If yes, what is the staffing and budget of the designated unit?  Written Standing Operating Procedures for dossier evaluation and registration process?
 Number of products approved in the last 5 years -new active pharmaceutical ingredients (APIs) and APIs already existing in the market;  Description of the process of approval for molecules already on the market with regard to (1) imported drugs (2) locally manufactured drugs;  Description of the process of approval for new molecules;  Number of products de-registered (licence revoked) in the last 5 years -due to expiry of the existing licence or due to safety and/or quality reasons  Membership of the Technical Advisory Committee (that approves registration).  Registration of traditional medicine products.  How many waivers or "No objection letters" to product registration have been issued in the last one year?

Pharmacovigilance
Please remember to cover the following points:

Introduction
Please meet the person in charge of the health facility to explain your purpose in visiting the facility. Choose one person from the team to explain that you wish to learn about how medicines are managed in the health facility and that you are not here to make any judgments and that what staff members tell you will be treated in confidence.
Please explain that you will be holding a national stakeholder workshop and that 1-2 persons from that facility are invited to participate. At the workshop the findings overall (not for individual facilities) from the situational analysis will be discussed & recommendations made for future action.
Please then fill in section 13.2.

Health Facility Identification
Health