Introduction to National Medicines Policy in Relation to Pharmaceutical Services
Session 13: Introduction to National Medicines Policy in Relation to Pharmaceutical Services
Total Session Time: 120 minutes
Prerequisites
None
Learning Tasks
By the end of this session students are expected to be able to:
Define the terms
Policy
National medicine/drug Policy
List Steps in formulating National medicine policy.
List Elements of National Medicine Policy.
Mention Common Components of National Medicine Policy.
Explain Tasks of National Medicine Policy.
Strategies to implement National Medicine Policy.
Explain challenges to implementation of National Medicine Policy.
Resources Needed:
Flip charts, marker pens, and masking tape
Black/white board and chalk/whiteboard markers
SESSION OVERVIEW
Step
Time
Activity/
Method
Content
1
5 minutes
Presentation
Introduction, Learning Tasks
2
10 minutes
Presentation Buzzing
Definition of the Terms Policy and National Medicine/Drug Policy.
3
10 minutes
Presentation
Elements of National Medicine Policy.
4
15 minutes
Presentation
Common Components of National Medicine Policy.
5
15 minutes
Presentation
Tasks of National Medicine Policy.
6
30 minutes
Presentation
Strategies to Implement National Medicine Policy.
7
25 minutes
Presentation
Challenges to Implementation of National Medicine Policy.
8
5 minutes
Presentation
Key Points
9
5 minutes
Presentation
Evaluation
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: Definition of the Terms Policy and National medicine/drug Policy. (10 minutes)
Activity: Buzzing (5 minutes)
PROVIDE students with the Pharmacy Act 2011 and Pharmacy Practice Regulations 2012
ASK students to pair up and buzz on the following question for 5 minutes
Define the following terms;
Policy
National medicine policy
ALLOW few pairs to respond
WRITE their responses on the flip chart/ board
CLARIFY and SUMMERIZE by using the content bellow
Policy: Defined as a system of laws, regulatory measures, courses of action, and funding priorities concerning a given topic promulgated by a governmental entity or its representatives.
National medicine/drug Policy: Is the policy, usually of a government, regarding the control and regulation (access, quality and rational use) of drugs considered dangerous, particularly those which are addictive.
STEP 3: Elements of National Medicine Policy. (5 minutes)
The following are steps in formulating National medicine policy
Organizing the process.
Identifying and analysing problems.
Setting goals and Tasks.
Drafting the policy.
Seeking wide agreement on the policy.
Obtaining formal endorsement of the policy.
Launching the policy.
STEP 4: Common Components of National Medicine Policy. (10 minutes)
Those five elements has the common components of national medicine policy which are;
Legislative and regulatory framework e.g. Drug regulatory authority.
Selection of essential medicine.
Supply.
Rational use of medicine.
Affordability.
Financial strategies for medicines.
Human resources development.
Monitoring and evaluation.
Research.
STEP 5: Common Components of National Medicine Policy. (15 minutes)
A national drug policy is a comprehensive framework in which each component plays an important role in achieving one or more of the general Tasks of the policy (access, quality, and rational use).
The following are explanation of key components of a National Medicine Policy;
Selection of essential medicines: Drug selection, preferably linked to national clinical guidelines, is a crucial step in ensuring access to essential drugs and in promoting rational drug use.
Affordability: Affordable prices are an important prerequisite for ensuring access to essential drugs in the public and private sectors. Eg government commitment to ensuring access through increased affordability
Drug financing: Drug financing is another essential component of policies to improve access to essential drugs, eg increased government funding for priority diseases, and the poor and disadvantaged, guidelines for drug donations, and commitment to measures to improve efficiency and reduce waste.
Supply systems: The fourth essential component of strategies to increase access to essential drugs is a reliable supply system, through: public–private mix in drug supply and distribution systems, inventory control, prevention of theft and waste, disposal of unwanted or expired drugs, publication of price information on raw materials and finished products, drug supply systems in acute emergencies and commitment to good pharmaceutical procurement practices in the public sector.
Rational use: The rational use of drugs means that patients receive medicines appropriate for their clinical needs, in doses that meet their individual requirements, for an adequate
period of time, and at the lowest cost to them and their community, this can be done through;
Promotion of the concepts of essential drugs, rational drug use and generic
Prescribing in basic and in-service training of health professionals;
The need and potential for training informal drug sellers;
Continuing education of health care providers and independent, unbiased drug information;
Consumer education, and ways to deliver it;
Financial incentives to promote rational drug use
Research: Operational research facilitates the implementation, monitoring and evaluation of different aspects of drug policy, so is an important tool that apart from other issues it assesses the drug policy’s impact on national health service systems and delivery, in studying the economics of drug supply, in identifying problems related to prescribing and dispensing, and in understanding the sociocultural aspects of drug use.
Human resource development: Human resources development includes the policies and strategies chosen to ensure that there are enough trained and motivated personnel available to implement the components of the national drug policy, eg definition of minimum education and training requirements for each category of staff.
Monitoring and evaluation: Monitoring and evaluation are essential components of a national drug policy, and the necessary provisions need to be included in the policy.
Key policy issues are:
Explicit government commitment to the principles of monitoring and evaluation.
Monitoring of the pharmaceutical sector through regular indicator-based surveys.
Independent external evaluation of the impact of the national drug policy on all sectors of the community and the economy.
STEP 6: Tasks of National Medicine Policy. (30 minutes)
The common specific Tasks of a national medicine policy are;
To make essential medicine available and affordable to those who need them.
To ensure the safety, efficacy and quality of all medicines provided to the public and private sectors.
To improve prescribing and dispensing practice.
To promote ethical practice among health professions and correct medicine use among health workers and consumers.
To ensure efficient and effective drug management in the public and private sectors.
To ensure access to safe, effective, affordable and good quality drugs at all levels of health care on the basis of health needs.
To promote the rational use of drugs by prescribers, dispensers and consumers.
To increase local drug manufacture/production and promote export;
To ensure that all drugs in the national drug distribution system are safe, efficacious, effective and of good quality.
STEP 7: Strategies to implement National Medicine Policy. (25 minutes)
In order to implement national medicine policy we must;
Use appropriate timing and combination of approach
Adopt a flexible policy
Use experts to vouch for policy’s technical soundness
Mobilize consumer, the media or other key groups
Create constituencies that support the policy outside and inside the country.
STEP 8: Challenges to Implementation of National Medicine Policy. (30 minutes)
Sometimes implementation of national medicine policy becomes is difficult due to the following reasons;
Lack of political will
Lack of resources
Opposition from those who benefit from laisse’s fair approach
Corruption
Support of domestic and international interest group
Macroeconomic situation
Technical expertise
STEP 9: Key Points (5 minutes)
Policy: Defined as a system of laws, regulatory measures, courses of action, and funding priorities concerning a given topic promulgated by a governmental entity or its representatives National medicine/drug Policy: Is the policy, usually of a government, regarding the control and regulation (access, quality and rational use) of drugs considered dangerous, particularly those which are addictive
STEP 10: Evaluation (5 minutes)
What is National Medicine Policy?
What are the goals of National Medicine Policy?
What is Drug Policy?
References
MSH and WHO (2012). Managing Access to Medicines and Health Technology, (3rd Edition). Kumarian Press
MoHSW (2003). Tanzania, Food, Drugs and Cosmetics Act, Government Printers Dar es Salaam
MoHSW (2011). Pharmacy Act, Government Printers Dar es Salaam
United Republic of Tanzania (1971). the drugs and prevention of illicit traffic in drugs act, Government Printers Dar es Salaam
United Republic of Tanzania (2011). Public Procurement Act, Dar es Salaam
MoHSW (2003). The National Health Policy, Government Printers Dar es Salaam
MoHSW (1991). The National Drug Policy, Government Printers Dar es Salaam
United Republic of Tanzania (1993).Medical Stores Department Act, Government Printers Dar es Salaam
Figure 2f from: Irimia R, Gottschling M (2016) Taxonomic revision of Rochefortia Sw. (Ehretiaceae, Boraginales). Biodiversity Data Journal 4: E7720. https://doi.org/10.3897/BDJ.4.e7720. (n.d.). doi:10.3897/bdj.4.e7720.figure2f
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