This article will be focused on notable provisions of the National Agency For Food and Drug Administration and Control (NAFDAC) on Good Practices of Pharmacovigilance, which the World Health Organization(WHO) has defined Pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
The ultimate goal of pharmacovigilance is to improve the safe and rational use of medicines, thereby improving patient care and public health. The National Agency for Food and Drug Administration and Control (NAFDAC) ACT Cap N1, LFN 2004 empowers the Agency to control and regulate the manufacture, importation, exportation, distribution, advertisement, sale and use of its regulated products.
This mandate requires the Agency to ensure the quality, safety and efficacy of all regulated products. The Agency therefore has developed NAFDAC Good Pharmacovigilance Practice Regulations to ensure safety of medicinal products that it regulates.
The NAFDAC regulations describe the obligations of the Certificate of Registration Holder to set up a system for pharmacovigilance in order to collect, collate and evaluate information about suspected adverse reactions of products it puts into the Nigerian market. The ultimate goal is to ensure that medicinal products put into the Nigerian market are safe and effective, and continue to provide a satisfactory balance between their benefits and risks.
The obligations concerned with the monitoring of adverse reactions occurring in clinical trials do not fall within the scope of pharmacovigilance activities, as described in these guidelines. The relevant obligations in safety reporting for clinical trials are as prescribed in NAFDAC Good Clinical Practice Regulations.
What are the objectives of the guidelines?
These guidelines are intended to help all stakeholders comply with the provisions of the GVP regulations. They provide detailed guidance for Certificate of Registration holders on establishing and maintaining a pharmacovigilance system including its quality management, pharmacovigilance system master file, adverse reaction/event reporting, risk management, post authorization safety/efficacy studies, risk communication and pharmacovigilance audit. The first edition of these guidelines published in 2016 was adapted from the European Medicines Agency’s guidelines for Good Pharmacovigilance Practices (GVP), that provides the most comprehensive description of best practices in safety monitoring and reporting for Certificate of Registration holders.
This first review is in compliance to the NAFDAC Quality Management System requirement for continuous improvement. This document is to be used in conjunction with other existing relevant medicinal product statutes in the country. The good practices outlined below are to be considered general guides, and they may be adapted to meet individual needs as long as the Certificate of Registration holder achieves compliance with regulatory objectives.
What is the scope of the guidelines?
These guidelines apply to all entities that have authorisation to put medicinal products into the Nigerian market.
Who is an eligible certificate of registration holder under the guidelines?
The Certificate of Registration holders include but are not limited to :-
– NAFDAC license holders;
– Individuals,
-Public and private institutions,
– Manufacturers, importers and donors of medicinal products.
These guidelines apply to products whose authorisation to market or distribute include requirements for active safety monitoring.
What are the product categories covered by the GVP regulations?
The products covered by the GVP regulations include but are not limited to:
- Products developed wholly or to a greater extent in other regions.
- Products with less than ten (10) years post marketing experience elsewhere or five (5) years in Nigeria.
- Advanced therapeutic products such as tissue, cell or gene based products .
- Products that are subject to risk management plans in any other country .
- Orphan medicinal products
- Products that received accelerated or conditional marketing approval in any country .
- Products for use solely in special populations such as children and the elderly.
- Products that act via the immune system such as cytokines and monoclonal antibodies.
- CNS therapeutic products such as medicines for epilepsy, neurodegenerative diseases, antipsychotics, antidepressants
- Any other product based on benefit risk assessment of the Agency .The Agency may also require a Certificate of Registration holder to adhere to these guidelines where the Agency identifies safety concerns in the course of post marketing surveillance. This does not discharge the Certificate of Registration holder of the responsibility of monitoring the safety of all its medicinal products through the established pharmacovigilance systems required by the Agency.
What exactly is a Pharmacovigilance system as mentioned under the guidelines?
-A pharmacovigilance system is defined as a quality system used by the Certificate of Registration Holder to fulfill its regulatory responsibilities in relation to pharmacovigilance. It is designed to monitor the safety of authorized medical products and detect any change to their benefit-risk balance.
– A pharmacovigilance system is characterized by its structures, processes and outcomes. It covers organizational structure, responsibilities, procedures, processes and resources of the pharmacovigilance system as well as appropriate resource management, compliance management and record management.
What are the quality objectives of a pharmacovigilance system?
The overall quality objectives of a pharmacovigilance system are:
- Complying with the legal requirements for pharmacovigilance tasks and responsibilities;
- Preventing harm from adverse reactions in humans arising from of authorized medicinal medicinal products within or outside the terms of Certificate of Registration such as off label use, misuse, abuse or medication errors which result in ADR or from occupational exposure;
- Promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public; and
- Contributing to the protection of patients and public health.
What are the general principles guiding the execution of quality objectives under the guidelines?
With the aim of fulfilling the overall quality objectives, the following principles should guide the design of all structures and processes as well as the conduct of all tasks and responsibilities:
- The needs of patients, healthcare professionals and the public in relation to the safety of medicines should be met.
- Top management should provide leadership in the implementation of the quality system and motivation for all staff members in relation to the quality objectives. All persons within the organization should be involved in and support the pharmacovigilance system on the basis of task ownership and responsibility to a degree according to their tasks and assigned responsibilities.
- All persons involved with the entire organization should engage in continuous quality improvement.
- Resources and tasks should be organized as structures and processes in a manner that will support the proactive, risk proportionate, continuous and integrated conduct of pharmacovigilance.
- All available evidence on the benefit-risk balance of medicinal products should be sought and all relevant aspects, which could impact on the benefit-risk balance and the use of a product, should be considered for decision-making.
- Good cooperation should be fostered between Certificate of Registration Certificate of Registration holders , the Agency, public health organizations, patients, healthcare professionals, learned societies and other relevant bodies in accordance with the applicable legal provisions.
What are the provisions of the guidelines on Personnel ?
-A sufficient number of competent and appropriately qualified and trained personnel should be available for the performance of pharmacovigilance activities. Their responsibilities should include adherence to the principles defined in the guidelines.
– Managerial staff should be responsible for:
- Ensuring that the organization documents the quality system as described under the guidelines.
- Ensuring that the documents describing the quality system are subject to document control in relation to their creation, revision, approval and implementation;
- Ensuring that adequate resources are available and that training is provided ;
- Ensuring that suitable and sufficient premises, facilities and equipment are available ;
- Ensuring adequate compliance management ;
f.Ensuring adequate record management ;
- Reviewing the pharmacovigilance system including its quality system at regular intervals in a risk- based manner to verify its effectiveness and introducing corrective and preventive measures where necessary;
- Ensuring that mechanisms exist for timely and effective communication of safety concerns relating to medicinal products within the organization;
- Identifying and investigating concerns arising within the organization regarding suspected non-adherence to the requirements of the quality and pharmacovigilance systems and taking corrective and preventive action as necessary;
- Ensuring that audits are performed .
-In relation to the management responsibilities described above, top management within the organization should provide leadership through:
- Motivating all staff members’ based on shared values, trust and freedom to speak and act with responsibility and through recognition of staff members contributions within the organization;
- Assigning roles, responsibilities and authorities to staff members according to their competencies and communicating and implementing these throughout the organization.
Training of personnel for pharmacovigilance
– Achieving the required quality for the conduct of pharmacovigilance processes and their outcomes by an organization is intrinsically linked with the availability of a sufficient number of competent and appropriately qualified and trained personnel.
-All personnel involved in the performance of pharmacovigilance activities should receive initial and continued training. This training should relate to the roles and responsibilities of the personnel.
– The organization should keep training plans and records for documenting, maintaining and developing the competences of personnel. Training plans should be based on training needs assessment and should be subject to monitoring.
– The training should support continuous improvement of relevant skills, the application of scientific progress and professional development and ensure that staff members have the appropriate qualifications, understanding of relevant pharmacovigilance requirements as well as experience for the assigned tasks and responsibilities.
– All staff members of the organization should receive and be able to seek information about what to do if they become aware of a safety concern.
– There should be a process in place within the organization to check that training results in the appropriate levels of understanding and conduct of pharmacovigilance activities for the assigned tasks and responsibilities.
– The system should also be able to identify unmet training needs, in line with professional development plans agreed for the organization as well as the individual staff members.
– Adequate training should also be considered by the organization for those staff members to whom no specific pharmacovigilance tasks and responsibilities have been assigned but whose activities may have an impact on the pharmacovigilance system or the conduct of pharmacovigilance.
– Such activities include but are not limited to those related to clinical trials, technical product complaints, medicinal information, terminologies, sales and marketing, regulatory affairs, legal affairs and audits.
Facilities and equipment for pharmacovigilance
-Achieving the required quality for the conduct of pharmacovigilance processes and their outcomes is also intrinsically linked with appropriate facilities and equipment used to support the processes.
-Facilities and equipment should include office space, information technology (IT) systems and (electronic) storage space.
– Facilities and equipment should be located, designed, constructed, adapted and maintained to suit their intended purpose in line with the quality objectives for pharmacovigilance and also be available for business continuity.
– Facilities and equipment which are critical for the conduct of pharmacovigilance should be subject to appropriate checks, qualification and/or validation activities to prove their suitability for the intended purpose.
– There should be processes in place to keep awareness of the valid terminologies in their valid versions and to keep the IT systems up-to-date accordingly.
Specific quality system procedures and processes by Certificate of Registration holders For the purpose of compliance management
-Certificate of Registration holders should have specific quality system procedures and processes in place in order to ensure the following:
- The continuous monitoring of pharmacovigilance data, the examination of options for risk minimisation and prevention and that appropriate measures are taken by the Certificate of Registration holder;
- The scientific evaluation of all information on the risks of medicinal products as regards patients or public health, in particular as regards adverse reactions in human beings arising from use of the product within or outside the terms of its Certificate of Registration or associated with occupational exposure ;
- The submission of accurate and verifiable data on serious and non-serious adverse reactions to the Agency within the legally required time-limits ;
- The quality, integrity and completeness of the information submitted on the risks of medicinal products, including processes to avoid duplicate submissions and to validate signals ;
- Effective communication by the Certificate of Registration holder with the Agency, including:
- Communication on new or changed risks ,
- The pharmacovigilance system master file ,
iii. Risk management systems ,
- Risk minimization measures ,
- Periodic safety update reports ,
- Corrective and preventive actions,
vii. Post-authorisation safety studies .
- The update of product information by the Certificate of Registration holder in the light of scientific knowledge;
- Appropriate communication of relevant safety information to healthcare professionals and patients.
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