This week, we have been lookingn into the national drug policy, it is my sincere hope that at the end of the week, we will have a better understanding of the place of the pharmacist as regards drugs in Nigeria, from manufacture till it is administered to the patient. Today, we will look at the following
Drugs and Therapeutics Committees
Local Drug Production
Inspection of Drugs
Drugs and Therapeutics Committees
Drugs and Therapeutics Committees are institutionalised mechanisms for promoting, implementing and monitoring the concept of rational drug use in health care institutions. Therefore, the following measures shall be taken:
i Drugs and Therapeutics Committees (DTCs) shall be established in all tertiary and secondary health care institutions;
ii Membership of such committees shall comprise representatives of the pharmaceutical, nursing, medical, and administrative services of the institution; and
iii A DTC shall, among other duties, be responsible for:
• the selection of drugs for use in the institution, based on the National Essential Drug List,
• the accurate estimation of pharmaceutical requirements for the hospital,
• monitoring of the use of therapeutic guidelines and overall drug utilisation, and
• monitoring of the rational use of drugs in the institution.
Self-medication is especially useful in any situation where access to health care facilities is limited. It can offer the advantage of providing quick and effective relief that does not require medical attention, thereby relieving pressure on medical personnel and freeing them to devote more time to serious problems. However,it could lead to inappropriate use of drugs, delay of proper diagnosis and the
delivery of effective treatment. It could also lead to drug misuse and abuse. In order to obtain the benefits of self-medication while avoiding its risks, the following steps shall be taken:
i A list of drugs that can be sold without prescription and used for the short-term relief of symptoms, without prior medical consultation and precise diagnosis, shall be drawn up and published by government;
ii Such listed drugs shall satisfy the criteria for the selection of essential drugs, be effective for their condition of use, and have a wide margin of safety;
iii The list shall be reviewed from time to time in the light of experience and available new information;
iv Information on, and the labelling and promotion of drugs, meant for self-medication, shall conform to laws and regulations set out for such categories of drugs;
v Health education to the public on appropriate self-medication shall be provided through the use of print and electronic media, and other communication methods.
Experience has shown that some donated drugs have often not been relevant to the emergency situation for which they were donated or for the disease pattern, or for the level of care that was available. They may sometimes be unknown to local health professionals and patients and may not comply with locally agreed policies and standard treatment guidelines; they may even be harmful. In the
light of this experience, the following measures shall be taken;
i All drug donations for use in the country shall be processed through the Federal Ministry of Health as a clearing house to ensure compliance with the guidelines for drug donations.
ii Donated drugs shall among other things be required to:
• be registered for use, both by the Drug Regulatory Authority of the donor country and in Nigeria,
• have at least twelve months remaining shelf life after arrival in the country, and
• be labelled in English to include its international non proprietary or generic name; and
iii. The Federal Ministry of Health shall put in place an adequate machinery for monitoring the distribution of donated drugs. In an emergency, the Federal Ministry of Health, in collaboration with National Emergency Management Agency (NEMA), shall immediately establish a co-ordinating body to assess and inform donors about national needs, approve donations, and co-ordinate their receipt and distribution.
Local Drug Production
The need for increased capacity in local drug production has been well recognised. Such capacity should cover the production of raw materials and intermediate products, not just formulation and packaging.
facilities in the country are presently operating under severe constraints, including
• poor infrastructural facilities such as water and electricity supply,
• poor transportation and communication,
• poor waste disposal management,
• inadequate incentives such as tax relief, capital allowance, and government patronage
• limited access to funds for capital development,
• unfair competition by imported drugs, and
• reliance on imported raw materials, machinery and spare parts.
In order to achieve the target of greater reliance on local drug production, steps shall be taken by government to:
i. Encourage the development of a stable economic and political environment;
ii. Intensify efforts to improve basic infrastructure and facilities;
iii. Provide an efficient regulatory environment;
iv. Provide favourable tax, interest rate regime and duty structures for locally manufactured products and imported raw materials, as well as for drug packaging materials;
v. Intensify efforts to ensure that the petrochemical and other essential industries for the proper development of the pharmaceutical manufacturing industry come on stream;
vi. Encourage research on pharmaceutical raw materials;
vii. Promote the development of associated industries for the production of materials, such as plastics, glass, paper, aluminium foil, etc., which are essential for drug packaging;
viii. Encourage patronage of local drug manufacturers by public and private health care institutions;
ix. Provide grants for the establishment of plants for the production of basic raw materials.
x. Encourage small-scale pharmaceutical production.
Legislation is the instrument by which the implementation of a drug policy is given a legal basis by statutorily defining the various strategies for achieving the objectives of the policy. It also defines the qualifications, duties, privileges, and obligations of individuals, organisations, institutions, and other bodies concerned with the implementation of the various strategies of the policy, and provides for sanctions in the event of violations.
For the effective implementation of legislation, there is need to review and update the relevant laws regularly, in consultation with relevant stakeholders, in order to achieve the desired objectives. Some of the existing drug laws are in dire need of review and harmonisation.
Accordingly the following measures shall be taken:
i. Government shall strengthen legislation relating to:
• The essential drugs policy,
• Definition of drugs,
• Registration of drugs,
• Control of the supply, importation, exportation, production, manufacture, storage, distribution, and sale of drugs;
• Prescribing and dispensing of drugs;
• Quality control of drugs and pharmaceutical substances;
• Licensing of manufacturing, wholesale and retail premises and their inspections;
• Regulation of the labelling and promotion of medicines (including traditional medicines);
• Establishment of different control regimens for drugs and especially scheduling of controlled substances;
• Imposition of fees for services;
• Administration and control of drugs including the procedure for appealing against regulatory decisions;
• Licensing of qualified persons;
• Types of packaging materials of medicines and other pharmaceutical products;
• National Health Insurance as it relates to drug supply to patients
• Disposal of unwanted or expired drugs;
• Delineation of prescribing/dispensing functions;
• Clinical trials;
• Offences and sanctions;
ii. Government shall also enact appropriate legislation in respect of the following:
• generic prescription and substitution,
• removal of import taxes on pharmaceutical raw materials,;
• parallel importation in accordance with Trade-Related Intellectual Property Rights (TRIPS),
• compulsory licensing in accordance with Trade-Related Intellectual Property Rights (TRIPS),
• drug donations,
• Good Manufacturing Practice,
• traditional and herbal medicines (advertisement and sales), and
• use of antibiotics and hormones in agriculture and livestock products;
iii. Government shall provide the necessary material and financial resources to strengthen enforcement of the provisions of the laws and regulations.
iv. Government shall designate special courts for drug-related offences in each of the geo-political zones of Nigeria for the speedy trial of persons or corporate bodies apprehended for such offences.
Inspection of Drugs
Effective inspection of drug products and manufacturing facilities is critical to ensuring the quality, safety and efficacy of drugs. It is also necessary in order to ensure compliance with the statutory requirements relating to the storage, supply, distribution and sale of drugs, etc. Therefore, national regulatory authorities shall establish effective mechanisms for inspection in all drug manufacturing
establishments, public and private health institutions, as well as, in drug sales and distribution outlets.
Government shall also establish suitable mechanisms for inspecting the import/ export of drug products, in line with the various regulations, and apply appropriate sanctions where violations are committed
If you missed the 3rd edition, see it here http://futurerxdream.com.ng/wp-admin/post.php?post=1074&action=edit