REPORT OF NAFDAC/WHO REVIEW MEETING/TRAINING
WORKSHOP ON COHORT EVENT MONITORING (CEM) OF ACTs IN NIGERIA
MAY 10 - MAY 14 2010
The National Pharmacovigilance Center Abuja in collaboration with the Yakubu Gowon Center (YGC), National Malarial Control Programme (NMP) and the Society for Family Health (SFH) under WHO sponsorship organised a 3 day workshop aimed at building capacity of site personnel for scale up of the Cohort Event Monitoring Programme from a cohort of 3,000 patients to 10,000 patients. This is a follow up to the Pilot CEM which was concluded in 2009. The workshop attracted over 80 healthcare providers (doctors, pharmacists and nurses) from 18 health care facilities across the six geo political zones of the country. The healthcare facilities to be engaged for the scale up range from tertiary hospitals to general hospitals for the public sector and community pharmacies for the private sector.
The CEM is an active pharmacovigilance programme whose broad objective is to evaluate safety in the use of ACTs among populations in Nigeria and develop the safety profile of ACTs used in Nigeria specifically Artemeter-Lumefantrine (AL) and Artesunate+Amodiaquine (AA) combinations, through active follow-up of patients treated with the monitored medicines and recording of any adverse event they may experience.
REVIEW MEETING
Activities for the scale-up started with a two-day review meeting at which all the tools (CEM field manual, CEM Prototcol, Standard Operating Procedure (SOP), Pre and Post treatment questionnaires and patient tracking cards) and processes employed for the pilot phase of the programme were reviewed with a view to improving on them for more successful outcome in the scale-up. The review meeting was attended by all the site coordinators in addition to members of the National Drug Safety Advisory Committee who served as facilitators at the meeting. Participants were informed that specific objectives of the meeting were to;
- Review the tools and activities of the pilot study with a view to identifying ways to improve on the outcome of the CEM programme
- Come up with perfect or ‘near-perfect’ tools to be used for scale-up of the CEM programme
- Identify those activities and issues that will positively impact the conduct and outcome of the CEM
- Identify and eliminate activities and processes that may hinder successful completion of the CEM
The site co-ordinators in each of the six sites used for the pilot CEM made presentations on lessons learnt from implementation of the pilot programme so as to foster learning from their individual and collective experiences. It was noted that the most common problems encountered during the pilot CEM were the late arrival of CEM materials (ACTS and Long Lasting Insecticidal Nets), poor turn out of patients for follow-up visit and insufficient funds for patient follow-up, logistic and administrative issues.
At the end of the review meeting, the CEM tools (field guide, protocol, pre and post treatment questionnaires and SOP) were successfully reviewed and ready to be used to train the CEM site personel. Also, participants advised the NPC to ensure that all materials necessary for the scale-up were available before actual patient recruitment begins otherwise it could affect the integrity of the CEM team at each site.
TRAINING WORKSHOP
Activities for the 3 – day training workshop began with an opening ceremony attended by the representatives of the Director General of NAFDAC, Coordinator of the National Malaria Control Programme, Executive Director of the Society for Family Health (SFH), and Director of the Yakubu Gowon Centre. Also present were the Chairman of the National Drug Safety Advisory Committee, the Principal Investigator for the CEM programme and the coordinator of the National Pharmacovigilance Centre.
The training was attended by 5 healthcare providers per site for each of the 12 hospital sites to be engaged for the CEM as well as 2 persons per site for each of the 6 community pharmacies. Each hospital team was made up of at least 1 doctor, 1 pharmacist and 1 nurse while each community pharmacy team was made up of at least 1 pharmacist. The names and contact details of participants at the training can be found here.
EXPECTATIONS OF PARTICIPANTS AT THE WORKSHOP
Participants introduced themselves and expressed some of their expectations as follows:
- To learn about Pharmacovigilance so as to be able to educate others about it.
- To learn more about malaria management including the effects of ACTs in our population.
- To be better informed on ACTs.
- To get feedback on the findings from the pilot CEM programme and use this as evidence on the need to monitor ACTs and other medicines.
- To understand the importance of Pharmacovigilance and be equipped with the tools to spread the importance of PVG.
- To have better understanding of Pharmacovigilance in the community pharmacy to enable active participation at the community level.
- To be better informed to serve the community better.
- To increase knowledge in order to decrease mortality and resistance rate.
- To be able to make clear bold statements to patients and fellow physicians after the workshop about the use and effects of ACTs in Nigerians.
A pre-workshop evaluation of participants’ knowledge of pharmacovigilance showed an average score of about 63% with the highest and lowest scores being 95% and 15% respectively. Unfortunately, participants’ post workshop knowledge was not assessed immediately after the workshop. However, the Centre plans to use the upcoming on-site training for CEM site personnel to evaluate participants’ ‘short term’ retention of knowledge impacted during the training. The on-site training is planned to take place not later than two months after the initial training and just before commencement of patient enrolment.
The training was facilitated by a number of in-country experts on pharmacovigilance and malaria. The presentations listed below which can be accessed from here were made to acquaint participants with the objectives of the training, concept of pharmacovigilance (PV) and how to conduct CEM. The presentations were followed by a question and answer session where concerns regarding PV, CEM and other relevant issues were addressed.
- Workshop Objectives: Pharm. C. Suku
- Overview of Pharmacovigilance: Dr I. Oreagba
- Pharmacovigilance in Nigeria: Pharm. (Mrs.) A. I. Osakwe
- Clinical aspects of PVG: Prof A. Isah
- Epidemiology and current treatment of Malaria: Dr B.M. Afolabi
- Overview of CEM (the 4W & H of CEM: Pharm. C. K. Suku
- Introduction to field guide: Dr P.U. Bassi
- Pilot CEM implementation, lesson learnt and the way forward: Dr P.U. Bassi
- Data Requirements: Dr S. Nwaosu
- Risk Factors: Dr. P. U. Bassi
- Presentation of reviewed tools (protocol, SOP, pre and post treatment questionnaires) Pharm. (Mrs) A. I. Osakwe
- SOP for obtaining verbal consent: Prof. E.O. Okoro
- Ethical issues: Prof. A. Isah
- Pharmacology of ACTs: Dr I. Oreagba
- Statistical analytical techniques: Dr S. Nwaosu
- Presentation of CEM flow: Pharm. K. Musa
Participants were taken through a practical session on how to properly fill out the questionnaires. They were also taken through the SOP which gives site personnel step by step details of what to do if they are presented with different scenarios during the programme. At the end of the session, participants were grouped into their zones and asked to come up with a plan on how they propose to implement the CEM at the various zonal and site levels. Participants then presented their site zonal and site implementation plans.
Following the proceedings from the meeting, the below suggestions and recommendations were made in order to ensure successful implementation of the scale up.
RECOMMENDATIONS FOR SCALE UP
- All materials needed for CEM scale-up should be made available before commencement.
- Appropriate funding for logistics, administrative cost and other things such as follow up visits by home visit or call should be put in place to achieve better results.
- Everyone should work as a team to ensure achievement of optimal results
- There is need for NAFDAC to pay advocacy visit to the Heads of Institutions to be engaged for the CEM before commencement of the exercise.
- There should be adequate community mobilization/sensitization which may include community stakeholders’ meetings.
- There is need to obtain ethical clearance for the CEM scale –up at both the National and Institutional levels before commencement.
- The CEM programme should also obtain a waiver from the National Health Research Ethics Committee (NHREC) on the need to obtain written informed consent from patients who wish to participate in the programme.
- Site co-ordinators within each zone should meet at regular intervals during the course of implementing the programme to review their progress, share experiences and ideas on how to improve implementation.
PROPOSED NEXT STEPS BASED ON THE ADJUSTED TIMELINE
The next steps are as follows;
- Obtain ethical clearance for scale up including waiver for written consent from NHREC
- Conduct advocacy visit to the heads of all healthcare institutions participating in the CEM scale up
- Undertake on-site training for other site personnel not present at the training/refresher for the personnel that attended.
- Distribute all materials needed to commence patient enrolment to all sites
- Commence patient enrolment
