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Equitable Access to Controlled Medicines in Nigeria: Assessment of access barriers.

Author(s) Ogori Taylor1, Olubukola Oyetunde2, Maureen Ebigbeyi3, Egbuta Okibe 4, Rui Vaz 5, Hashim Yusuf6, Iyabo Okpeseyi7, 8
Affiliation(s) 1Essential Drugs and Medicine Policy, Health Systems, World Health Organisation, Nigeria, Abuja, Nigeria, 2Clinical Pharmacy, Faculty of Pharmacy, University of Lagos, Lagos, Nigeria, 3Narcotics and Controlled Substances , National Agency for Food and Drug Administration and Control, Lagos, Nigeria, 4Food and Drugs Services Department, Federal Ministry of Health, Abuja, Nigeria, 5African Regional Office , World Health Organization, Abuja, Nigeria, 6Narcotics and Controlled Substances , National Agency for Food and Drug Administration and Control, Lagos, Nigeria, 7Food and Drug Services Department, Federal Ministry of Health, Abuja, Nigeria.
Country - ies of focus Nigeria
Relevant to the conference tracks Health Systems
Summary Nigeria is currently undergoing a critical shortage of controlled medicines especially in the management of moderate and acute pain. National policies and regulations on controlled medicines focus mainly on preventing the diversion of the products to illicit channels without corresponding efforts to promote availability for medical use. Several strategies for control have been instituted which serve as barriers to access. Demand for narcotic analgesics was shown to be low, leading to an expiry of procured products. National policies should be reviewed to facilitate availability, accessibility and rational use of controlled substances for medical purposes while promoting adequate control.
Background WHO (2011) estimates that 83% of the world’s population who live in low and medium income countries have low to non-existent access to narcotic medicines especially for the treatment of moderate to severe pain. Thus, millions of people suffer moderate to severe pain and death due to not having access to narcotic medicines. Patients in this group include HIV/AIDS, cancer, accident/violence victims, chronic illnesses, surgery, women in labour, paediatric patients, and women in childbirth.Access to controlled medicines especially in the management of moderate and acute pain is currently acute in Nigeria. The Global Access to Pain Relief Initiative (2012) reported that Nigeria consumed only 0.1% of the minimum amount of narcotic analgesics required to manage pain in patients who died of HIV/AIDS and cancer in 2009. Consequently patients with end stage HIV/AIDS, terminal cancer, those suffering from injuries caused by accidents and violence, some chronic illnesses and those recovering from surgery undergo untold suffering due to lack of opioid analgesics which can easily control pain.
Objectives In order to provide sustainable solutions to the problem of access to narcotic analgesics and other controlled medicines, an assessment was carried out which studied the access to controlled medicines in Nigeria. Particular attention was paid to narcotic analgesics as psychotropic substances available in health facilities in public and private sector. The objective of the assessment was to locate the factors that affect access to controlled medicines in Nigeria. These factors were examined in the context of national policies and legislation, the country procurement and supply management systems, and regulatory control instituted as well as the rational use in facilities. The results will help with the formulation of adequate interventions that will ensure universal access to all patients who require them in a sustainable manner.
Methodology The relevant laws, policies, regulatory control practices, procurement and supply management relating to narcotics and controlled medicines were examined to determine their appropriateness in promoting or hindering access to controlled medicines. The procurement and supply at the Federal Central Medical Stores (FMS) and samples of secondary and tertiary health facilities throughout the country were examined. The WHO Country Assessment tool was used to analyse national policies, legislation and practices established in the country. The procurement history, quantification, pricing, storage facilities, distribution, expiry and documentation were evaluated using a tool developed at the WHO Country office.Interviews with the medicine regulatory authority were categorized and summarized. Procurement and supply management indicators from the FMS were calculated and presented as tables and graphical representations. Facility responses were summarized, categorized and presented as frequencies in tables and graphs. Prices of medicines were analysed using the WHO/HAI price and availability workbook. The median price ratios were compared with international prices.
Results Policies and Legislation.
The laws and policies on controlled medicines focus their provisions on control without any definite statement on the necessity to make them available for medical use. In addition, there is no specific national policy on controlled medicines to promote equitable access and rational use. Nigerian laws and regulations on controlled medicines are outdated and have stigmatizing words such as “dangerous drugs”, “addiction” which tend to confuse prescribers and limit their use.Procurement and Distribution.
Procurement of narcotic medicines is infrequent due to inadequate and irregular release of funds and lack of quantification of needs. The cost of procurement is high in relation to international reference prices probably due to the low quantity usually procured.There is poor geographical coverage. Distribution is centralized to Federal Medical Stores in Lagos requiring approval from several officers located at different locations. Currently, controlled medicines are limited to hospital pharmacies in the public sector. Private pharmacies and primary health care facilities are not permitted to stock controlled medicines. In addition, the heads of department of pharmacy or authorized pharmacists of institutions are required to appear in person at the FMS to collect their stocks. Most of these require travel between two to several days to collect stock thereby incurring very high costs. Sometimes controlled medicines expire at the FMS because facilities are unaware of their availability.

Although, Nigeria does not require further licensing to prescribe controlled medicines, most facilities limit prescribing to senior medical officers rather than to all trained, qualified and licensed officers. Prescriptions for narcotics in almost all facilities are limited to a duration of less than one week . Most facilities claimed not to stock narcotic medicines due to lack of prescriptions as physicians prefer combinations with analgesics for moderate and severe pain. Some combinations may cause adverse drug reactions and promote drug dependence. Inadequate capacity to prescribe may constitute a key barrier to use.

While pharmacists are not required to obtain additional licences in order to dispense narcotics, most facilities in the study permit only senior pharmacists to dispense controlled substances. The capacity to compound individual patient need is lacking in most facilities.

Conclusion Policies and legislation.
Develop/review and disseminate policies, legislation, guidelines and corresponding procedures for narcotics and controlled medicines that will promote availability and accessibility as well as adequate control of the products. Policies on the management of HIV, Family and Reproductive Health, Cancer, Mental Health, Surgery etc. need to incorporate adequate statements to require constant availability of relevant controlled products in health facilities at all times.Procurement and supply management.
Institute a Narcotics Medicines Revolving Fund in order to ensure adequate and sustainable financing for the procurement of narcotic medicines. Procure and distribute narcotics only on the basis of quantification of expressed needs by facilities. Procure annual needs in bulk to ensure affordable pricing. Evolve a decentralized distribution system based on the state structure in order to ensure equitable geographical distribution throughout the country and reduced cost of procurement by facilities.Rational use of narcotic medicines.
Build the capacity of health care professionals in prescribing and dispensing in order to ensure that patients receive narcotics appropriate to their medical needs. This can be achieved through the provision of pre and in-service training, clinical guidelines, dispensing and compounding guidelines as well as standard operating procedures.

Regulatory control.
Build adequate regulatory capacity of sufficient number of inspectors who are equipped with relevant guidelines, procedures and training and are evenly spread to ensure coverage of all facilities that procure, distribute and manufacture narcotics and controlled substances. Ensure coordination of all control agencies to improve effectiveness and promote communication.

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