Introduction
Pharmacoepidemiology is the “study of the use of and the effects of
drugs in large numbers of people”. It borrows heavily from methods used
in general epidemiology. Areas of focus in pharmoepidemiology are:
costs of medicines; patterns and determinant s of consumption; quality
of drug use and dispensing; effectiveness of drugs; drug related
policies; formulation of treatment guidelines; and drug supply
problems.
Pharmacovigilance is also known as Drug Safety and is a pharmacological
science. Its main focus is the collection, detection, assessment,
monitoring, and prevention of adverse effects and medication errors
caused by pharmaceuticals and medical deveices. The word
Pharmacovigilance is derived from the Greek and Latin words pharmakon and vigilare
which mean “drug” and “to watch out respectively”. The prevalent of
drug induced adverse effects is very high. Medication errors such as
overdose, misuse and abuse are common. Pharmacovigilance is considered
to be a branch of Pharmacoepidemiology.
In Kenya, pharmacovigilance activities were initiated and co-ordinated
by the Pharmacy and Poisons Board which is a World Health
Organisation/Uppsala Monitoring regional center for pharmacovigilance.
Online reporting of mediation errors and adverse drug reactions can be
done at www.pv.pharmacyboardkenya.org.
History of the Thematic Unit
The development of a postgraduate training curriculum in
Pharmacoepidemiology and Pharmacovigilance began in 2005 in response to a
need for specialists in this area. Development of the curriculum was
supported by Management Sciences for Health.
The Department of Pharmacology and Pharmacognosy received senate
approval in December, 2011 to offer the program. The first lot of 11
students was received in September, 2012.
Programs/courses offered
The thematic unit offers training at post-graduate level to students pursuing Master of Pharmacy in Pharmacoepidemiology and Pharmacovigilance. Under the unit/module Pharmacovigilance learners on trained on:
- How to code adverse drug events
- Methods and tools for reporting
- Seriousness and causality assessment
- Reporting methods
- Regulations on reporting
- Managing an adverse event
Pre-requisites for training in Pharmacoepidemiology and
Pharmacovigilance are: undergraduate training in pharmacology.
Foundation courses in the post-graduate program are: epidemiological
methods, biostatistics and research methodology. Other modules/units
offered include pharmacoeconomics, regulatory pharmacovigilance, drug
utilization review/studies; evidence based health care and an
introductory course on pharmacogenetics.
In addition, the thematic unit offers post-graduate training in
Epidemiology to students pursuing a Master of Pharmacy in Clinical
Pharmacy. It also offers post-graduate training in Research Methods to
all post-graduate students registered in the School of Pharmacy.
Research and Projects / Impact of the Thematic Unit
Though the program is still in its infancy, Kenyatta National Hospital
has benefitted from the services provided by the learners. Five drug
utilization studies have already been carried out and problems
identified in drug use were presented to the Medicines and Therapeutics
Committee of the Hospital. It is hope that these studies will be used
to modify current practice.
In this year, the learners submitted 33 reports on adverse drug
reactions to the Pharmacy and Poisons Board Pharmacovigilance unit.
Members of unit have supervised about 15 students pursuing post
graduate studies in Master of Pharmacy (Clinical Pharmacy). About 5
papers have resulted from the supervised research activities.
One comparative study on the renotoxicity of stavudine and tenofovir
was presented at the International Society of Pharmacoepidemiology
annual conference in Barcelona, 2012. A second study that examined
patterns of antibiotic use in patients with renal failure will be
presented in an ISPE conference in Canada in 2013.
Future plans
The unit hopes to work with the Pharmacovigilance Unit of the Board and
other stakeholders to strengthen drug regulation in Kenya. It also
hopes to work together with the Department of Quality Assurance of the
Ministry of Health in treatment guideline development and monitoring
quality of care.
Career opportunities
All alumni of the Pharmacology and Therapeutics thematic unit can
pursue careers in academia, clinical trials, health programs (e.g.
BASCOP), regulatory institutions (e.g. Pharmacy and Poisons Board),
hospitals and health facilitites and institutions involved in drug
research.