National Drug Policy and Essential Drugs Concept Flashcards
Dr. Ogbo
What is a National Drug Policy (NDP)?
National Drug Policy (NDP) is a comprehensive framework adopted by a government to ensure the availability, affordability, safety, efficacy and rational use of medicines within a country.
When was The Maiden NDP adopted and launched in NIgeria?
In 1990
What were the factors that contributed to the inadequacies of drug availability and distribution, necessitating the adoption of The Maiden NDP?
i. An ineffective system of drug administration and control
ii. Inadequate funding of drug supply and control activities
iii. Poor selection and procurement practices
iv. The involvement of unqualities persons in the procurement, distribution and sale of drugs.
v. High dependence on foreign sources for finished drug products, raw materials and equipment.
vi. Inadequate facilities for storage, production and distribution of drugs.
vii. Poor performance of drug suppliers to public health care institutions
viii. Lack of political will to provide adequate qualiry drugs to meet the health needs of NIgerians.
What are the goals of the Nigerian NDP?
- To make available, at all times, to the Nigerian populace adequate supplies of drugs that are effective, affordable, safe and of good quality.
- To ensure the rational use of such drugs
- To stimulate increased production of essential drugs
Mention 7 objectives of the Nigerian NDP.
- To ensure efficient and effective drug management in the public and private sectors
- To ensure access to safe, effective, affordable and quality drugs at al levels of healthcare basedon health needs
- To promote the rational use of drugs by prescribers, dispensers and consumers.
- To increase local drug production and exportation
- To promote research on herbal remedies and integrate the safe and efficacious ones into the health care system
- To promote research and development of raw materials for the production, compounding and formulation of pharmaeutical products.
- To strengthen administrative, legislative and regulatory contol of the importation, manufacture, procurement, storage, distribution, sale and use of drugs.
Mention 7 targets of the NDP.
- Establishment of NDP Monitoring and Evaluation Division in the Food and Drug Services Department of the Federal MInistry of Health by 2005
- 90% of targeted publication of prices of essential drugs by 2005
- Establishment of appropriate storage and quality control laboratories at designated ports of entry and export of drugs by 2005
- Establishment of three new, fully equipped and adequately staffed labs in strategic locations of the country for more effective quality assurance of drugs and pharmaceutical products in Nigeria by 2005
- Production of National Standard Treatment Guidelines (STGs) for all levels of the health care system by 2006 and 80% adherence by 2008
- 80% adherence to good drug procurement practices in the public sector by 2008
- Availability of adequate drug storage conditions in 80% of the public and private health care sectors by 2008
Mention 15 strategies for implementing the NDP.
- Selection of drugs
- Procurement of drugs
- Inspection of drugs
- Importation and exportation of drugs
- Registration of drugs
- Drug storage
- Drug distribution
- Regulation for prescribing and dispensing drugs
- Rational drug use
- Drug revolving fund scheme
- Price policy
- Legislation
- Research and development
- Herbal remedies
- Local drug production
- Quality assurance
- Patents
- Pharmacovigilance
What are essential drugs?
Essential drugs are drugs that satisfy the needs of the majority of the population and therefore should be available at all times.
What is the rational for using a limited number of drugs?
It leads to:
i. improved drug supply
ii. more rational prescribing
iii. lower costs
What are the WHO criteria for selection of essential drugs?
- Pattern of prevalent disease, treatment facilities, training and experience of available personnel, the financial resources; and genetic, demographic and environmental factors.
- Only drugs with evidence of clinical efficacy and safety based on high-quality data, and proven performance in a variety of medical settings should be selected
- Selected drugs must be available in a form in which adequate quality can be ensured and its stablity under anticipated storage and use conditions must be established
- When two or more drugs are similar in the above respect, the choice between them should be made based on their relative efficacy, safety, quality price and availability
- In cost comparisons, the cost of the treatment and cost-benefit ratio, not only the cost of the drug must be considered.
- Most essential drugs should be formulated.
- Fixed-ratio combinations are acceptable only when dosage requirements of each component meets the requirements of a defined population group and when the combination has a proven advantage over single compounds admininstered separately in terms of efficacy, safety and patient adherence.
In a nutshell, the selection criteria are:
i. relevance to disease pattern
ii. Proven efficacy and safety
iii. evidence of performance in a variety of settings
iv. adequate quality including bioavailability and stability
v. favourable cost-benefit ratio on terms of total treatment cost
vi. preference for well-known drugs with good pharmacokinetic profile and suitablity for local manufacture
What is a National Formulary?
National Formulary is an official, government-approved document that serves as a reference guide for the selection, use, and standardisation of medicines within a country.
Define the following terms:
i. Formulary list
ii. Formulary manual
iii. Formulary system
i. Formulary list: a document that provides a comprehensive list of medicines approved for use in a specific healthcare setting e.g hospital-specific formulary list, provincial list, or list reimbursed by a health insurance program. In many places, a formulary list is synonymous with essential drug list
ii. Formulary manual: a detailed document that contains relevant drug information, such as generic name, dosing, indication and contraindications, interactions, side effects etc., that serves a reference to the prescriber, dispenser or health worker.
A national formulary manual is based on the national list of essential drugs.
iii. Formulary system: the framework or process used to develop, implement, and manage the formulary list and manual within a healthcare system or institution.
A fully developed formulary system usually includes in addition to the formulary list and manual, regular newsletters, bulletins, guidelines for use of nonformulary drugs, and methods for evaluating the need for changes in the formulary list or manual.
What are standard treatment guidleines (STG)?
Standard treatment guidelines are systematically developed statements that assist prescribers in deciding on appropriate treatments for specific clinical problems.
What are the features of STGs?
i. The guidelines usually reflect the consensus on the optimal treatment options within a health
facility or health system.
ii. The information is disease-centered, emphasising the common diseases and complaints, and the various treatment alternatives
iii. Information on drugs is usually limited to strength, dosage and duration
iv. Most guidelines indicate a treatment of first choice
v. Some guidelines include diagnostic criteria for starting the treatment or for choosing among
treatment alternatives.
What is the key-difference between a formulary manual and a treatment guideline?
A formulary manual is drug-centered, concentrating on drug information and usually not providing comparisons between different drugs
while
a treatment guideline is disease-centered, listing treatment alternatives and indicating a treatment of choice.
