Introduction to Pharmaceutical Assessment and Monitoring – PST06211 Monitoring and Evaluation of Medicine Use

NTA Level 6 • Semester 2 • PST06211

Introduction to Pharmaceutical Assessment and Monitoring

Monitoring and Evaluation of Medicine Use • Source Session/Topic 2
Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability.

Session 2: Introduction to Pharmaceutical Assessment and

Monitoring

Total Session Time: 60 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• List the aims of pharmaceutical assessment and monitoring
• Give reasons for monitoring and assessment of pharmaceutical services
• Explain the use of assessment and monitoring results
• List importance of using indicators in monitoring and evaluation of pharmaceuticals

Resources Needed:

• Flip charts, marker pens, and masking tape
• Black/white board and chalk/whiteboard markers
• Computer and LCD Projector
• Handout 2.1:Pharmaceutical assessment and monitoring

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

10 minutes Presentation Aims of Pharmaceutical Assessment and

2

Buzzing Monitoring

10 minutes Presentation Reasons for Monitoring and Assessment of

3

Brainstorming PharmaceuticalServices

15 minutes Presentation

4 Usage of Assessment and Monitoring Results

Buzzing

10 minutes Presentation Importance of Indicators in Monitoring and

5

Evaluation of Pharmaceuticals services

6 05 minutes Presentation Key Points

7 05 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

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SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Aims of Pharmaceutical assessment and Monitoring

(10 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

• What are aims of pharmaceutical assessment and monitoring?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• The following are aims of pharmaceutical assessment and monitoring;

o Monitoring and assessing the pharmaceutical sector are vital to determine if the key

pharmaceutical objectives are met.

o Evaluate accessibility of essential medicines to people.

o Help to assess the safety, efficacy and quality of medicines

o Monitoring of rational use of medicines.

STEP 3: Reasons for Monitoring and Assessment of Pharmaceuticals

Services (10 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• What Reasons for Monitoring and Assessment of Pharmaceuticals Services?

ALLOW few students to respond?

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

12

• There are various reasons why we monitor and assess pharmaceutical situations these

includes;

o To assess country capacity in infrastructures, resources and human

resources to support the pharmaceutical sector and implement NMPs;

o To review implementation strategies so adjustments can be made. Such as

implementation of national medicine policy

o To measure outcome of pharmaceutical objectives in terms of access and rational use of

quality medicines.

o To evaluate progress towards identified objectives

STEP 4: Usage of Assessment and Monitoring Results (15 minutes)

Activity: Buzzing (5minutes)

ASK students to pair up and buzz on the following question for 5 minutes

• What are usage of assessment and monitoring pharmaceuticals results?

ALLOW few pairs to respond and let other pairs add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• Various results from monitoring and assessment of pharmaceuticals situations can be used

by different stakeholders ;

• Countries

o To focus action, prioritize, measure achievement

• National policy-makers

o To synchronize health and economic policies

o To get a clear picture of national problems and identify and prioritize strategies

o To present the performance of the pharmaceutical sector to donors and other

governmental agencies

• Health facilities

to be aware of the institutional problems and identify strategies to improve the situation

• International agencies

o To assess the structure and capability of countries when developing new projects

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

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o To assess the progress and accomplishment of current projects

o To assess the impact of aid

• Professional groups, NGOs and academia

o To focus their activities on advocacy activities and information campaigns

Refer students to Handout 2.1: Usage of Assessment and Monitoring Results

STEP 5:Importance of Indicators in Monitoring and Evaluation of

Pharmaceuticals Services (10 minutes)

• The following are importance‘s of using indicators in monitoring and evaluation of

pharmaceutical services

o It helps in comparing the performance of facilities, districts, regions and the overall

situation in the country. By using indicators we can compare situations such the

availability and accessibility of essential medicines between one country and another,

one region and another and districts as well.

o It helps in seeing trends over time. Helps to identify the rise and fall in availability of

essential medicine in particular time and specifically the demands of the health facilities

o It helps in setting targets. It helps set goals and guiding policy-makers in developing and

planning national strategy, including budget planning, reallocation of funding and

human resource management. Which are key cross-cutting factors that can influence

access to medicines

STEP 6: Key Points (5 minutes)

• Various results from monitoring and assessment of pharmaceuticals situations can be use

by; countries, international agencies,national policy makers, health facilities, Professional

groups, NGOs and academia

• Monitoring and evaluation of pharmaceuticals by using indicators facilitates; seeing trends

overtime, setting targets and comparing performance of facilities.

• Key objectives in monitoring and assessment of pharmaceuticals are to ensure people have

access to essential medicines, quality medicines, and use of medicines rationally.

STEP 7: Evaluation (5 minutes)

• Who can use the results from assessment and monitoring of pharmaceuticals?
• What are the aims of monitoring and assessment of pharmaceuticals?
• What are the importance of using indicators in monitoring and assessment of

pharmaceuticals?

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

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References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

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Handout 2.1:Usage of Assessment and Monitoring Results

• Monitoring and assessing the pharmaceutical sector are vital to determine if the key

pharmaceutical objectives are met: people have access to essential medicines, these

medicines are safe, effective and of good quality, and they are used correctly.

A systematic method to assess and monitor the impact of strategies and activities will

provide information on issues and gaps, all-important input in the development of

health policies.

The WHO process for pharmaceutical monitoring and assessment uses a hierarchical

approach with three groups of indicators: Level I, Level II and Level III. This provides a

standard methodology to follow progress over time and to compare situations in

different facilities, districts and countries.

• Given the complexity of the pharmaceutical sector, a systematic method of gathering

data is very important for assessing access, quality and rational use of medicines. There

are multiple, cross-cutting factors that can influence access and rational use of quality

medicines, and a variety of strategies that countries can adopt and implement to

improve their pharmaceutical situations.

Indicators have been developed for monitoring national medicines policies (NMPs)

that enable systematic assessment, evaluation and monitoring of the formulation and

implementation of pharmaceutical policies and programmes.

• These can be used to:

o Assess country capacity, such as available infrastructure, logistics and human

resources to support the pharmaceutical sector and implement NMPs;

o monitor the implementation of NMPs;

o measure the impact of implementation strategies; and

o Evaluate progress towards identified objectives.

• Who can use the results?

All stakeholders in the pharmaceutical sector can use indicator-based assessment of the

pharmaceutical situation to inform priorities and set targets.

• They can also use regular monitoring of the sector through indicator-based studies to assess

strengths and weaknesses of strategies to improve the provision of pharmaceuticals.

o Indicators provide policy-makers and managers with a clear picture of national and

institutional problems.

• Policy-makers and managers can refer to study results when developing strategies to

strengthen the pharmaceutical sector.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

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• Results can also be used to synchronize policies. For instance:

o Low access, as measured by availability and affordability of essential medicines, could

indicate that policies on health and medicines financingshould be reviewed.

o Economic policies may be focused on joining the global economy without adequate

consideration of the implications on pricing, affordability and availability of important

medicines.

• The presence on the market of a large number of substandard medicine

products could indicate the need to assess various policies and systems,

including licensing and inspection of manufacturers, quality assurance or

product registration.

International agencies and donors can use the results of indicator-based studies to

identify where their activities will achieve the greatest impact. Professional groups and

nongovernmental organizations (NGOs) can use the results to focus their advocacy and

information campaigns.

Standard indicators allow informative comparisons among countries. For example an

indicator-based assessment in 12 countries revealed:

• Most of the countries surveyed have relevant structures in place, however, ―it is

easier to create a structure than to make it work‖.

• Most of the countries have medicines regulatory authority with a mandate to

register medicines and inspect manufacturer and retail outlets, however, the

enforcement of regulations is often weak.

• In most of the countries, public financing for medicines is limited.

Countries may use the information as follows:

• Advocacy to disseminate and to share the results with national stakeholders,

politicians, civil society, academia and key partners (awareness issue).

Comparison with other countries at a similar level of economic development,

within the region or globally can also be made.

• Sharing the information through national workshops, by posting the

information on website links and through national brochures. These are also

good ways to elicit feedback from stakeholders.

• Analysing the country situation allows gaps, probable causes of problems and

unmet objectives to be identified. This in turn facilitates the identification of

appropriate strategies.

• Reporting by topic (access, quality, safety and rational use of medicines), and

doing the analysis by type of indicator (structure, process and output) will also

guide countries to share sub-regional experiences, through informative

comparisons.

• Guiding policy-makers in developing and planning national strategy, including

budget planning, reallocation of funding and human resource management.

Which are key cross-cutting factors that can influence access to medicines.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

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• Providing the national medicines regulatory authorities with adequate

information for the enforcement of regulations and to assess the level of

regulatory authority capability.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

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