This week, we have been looking 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 concluding part i.e prescribing and dispensing
Regulations for Prescribing and Dispensing Drugs
A prerequisite for effective drug control is that prescribing, dispensing and the sale of drugs be undertaken by duly authorised persons. Regulations for prescribing, dispensing and sale of drugs shall take into consideration the policy goal of rational drug use and the supply of safe and efficacious essential drugs at affordable cost.
In view of the fact that drugs will be prescribed and dispensed at all levels of health care, including the most peripheral health stations manned by village health workers, regulations for prescribing and dispensing of drugs shall be sufficiently flexible to cover the activities of such health workers.
In view of the fact that research in many countries has shown that dispensing doctors or prescribing pharmacists use more drugs than others, it has become necessary to separate prescribing and dispensing functions, therefore, the laws and regulations regarding those who are allowed to prescribe, supply, sell and dispense drugs to the public at the different levels of the health care system shall be periodically updated, with the following minimum provision
i. In tertiary and secondary health care institutions, only duly qualified and licensed medical practitioners shall have the authority to prescribe drugs.
At the primary health care level, government shall designate appropriate health care personnel to prescribe drugs;
ii. Only qualified and licensed medical practitioners shall have the authority to prescribe drugs in the private sector; and
iii. Prescriptions shall be made, using the International Non-Proprietary or Generic Names. It shall be made in a manner to ensure that proper records are kept at the records and pharmacy departments of health care institutions in both private and public sectors.
i. Only duly licensed pharmacists shall have the authority to supply, sell and dispense drugs to the public. Such sales shall take place in premises licensed for the purpose, which shall be subject to regular inspection. Continuing registration of a licensed premise shall depend on a satisfactory report by
inspectors of the Pharmacists’ Council of Nigeria (PCN) and the payment of prescribed fees;
ii. In view of the need for every Nigerian to have access to appropriate drugs, it shall be permissible for certain OTC drugs to be sold in patent medicine stores operated by Patent and Proprietary Medicine Vendor’s Licensees (PPMVL), particularly in areas where there are no licensed pharmacists in practice. The premises for the sale of such drugs shall be approved and licensed and shall be subject to periodic inspection by pharmaceutical inspectors of the PCN. The list of drugs to be sold in such premises shall be those approved by government;
iii. In every health care facility where there is a qualified and licensed medical
practitioner, there shall be a qualified and licensed pharmacist to manage drugs; and
iv. In order to enhance total patient care, particularly as regards in-patients, government shall promote the practice of clinical pharmacy in secondary and tertiary health care institutions.
Since no active drug is entirely free from adverse reactions, the introduction of an adverse drug reaction reporting system is an essential component of a national healthcare delivery system, government shall, therefore, encourage the establishment of adequately equipped pharmacovigilance units nation-wide, to collect, evaluate and disseminate relevant information on adverse drug reactions and poisoning. All drugs shall be regularly monitored with respect to their efficacy, safety, quality as well as adverse reactions to evaluate the need to change the conditions of their continuing registration or withdrawal from the market. Any drug withdrawn or banned in many countries, due to unacceptable health risks, shall be automatically withdrawn from distribution in Nigeria.
Drug Information and Promotion
Information about drugs is usually provided by manufacturers in the form of package inserts and labels, as well as promotional literature and advertisements. These shall be in keeping with the national health policy and in compliance with national regulations. They shall be reliable, accurate, informative, balanced, upto-date, capable of substantiation, not misleading and in good taste. In this regard
government shall continue to:
i. Sustain ethical, professional and scientific standards regarding the content of package inserts, labels, advertisements and other drug promotional materials to ensure that health care providers, practitioners, and patients have accurate and relevant information about drugs;
ii. Prevent all forms of direct advertising of prescription and controlled drugs to consumers;
iii. Prevent media advertisements of drugs and drug products, whether orthodox or traditional medicines, used in the treatment of certain ailments and diseases, as contained in the drug laws of the country;
iv. Vet and approve advertisement scripts and formats in respect of the advertisement of OTC drugs; and
v. Undertake post-marketing surveillance of drugs in order to make appropriate changes in approved information in light of new relevant data.
drop by tomorrow as we will take out some critical points of the the NDP as regards the role of pharmacist, and we expect your questions and if you need a full copy of the national drug policy, subscribe to our news letter and we will mail a copy to you