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Ministry of Health and Quality of Life

Pharmacovigilance

What is Pharmacovigilance? Drug Safety Monitoring
 
To build and update the safety profile of a medicinal product, it is necessary to collect and evaluate reports from healthcare providers, patients and the scientific literature on all adverse events that occur in connection with the use of the medicine.
 
As a result of the monitoring of adverse events, over the course of time, new information about the hazards associated with a particular medicine can come to light. Any changes to the safety profile need to be reflected in the Summary of Product Characteristics and Patient Information Leaflet, the updated information ultimately helps to prevent harm to patients.
 
The WHO definition is: Pharmacovigilance is concerned with the detection, assessment, understanding and prevention of adverse reactions to drugs. It is also concerned with drug related problems.
 
Why do we need Pharmacovigilance ?
 
No medicinal product is entirely or absolutely safe for all people, in all places, at all times. We must always live with some measure of uncertainty when taking medicines.
 
In the 1960’s, the thalidomide disaster led to limb deformities in the newborns of those mothers who took the drug while pregnant. This implies that pre marketing evaluation of drug safety, in animal experiments and in phase 1-3 clinical trials, provides insufficient evidence of safety.
 
 There are four main reasons of why we need Pharmacovigilance :
 
1.        Clinical trials concern a very small group of persons and they give insufficient evidence of safety.
 
2.        Adverse Drug Reactions may lead to serious health issues and even death in some cases.
 
3.        We have to  protect patients  from unnecessary  harm as many ADRs are preventable
 
4.        To promote the Rational use of medicines and adherence to treatment
 
And  there are two specific reasons why we need Pharmacovigilance in Mauritius :
 
1.      The prevalence of chronic diseases which implies lifelong drug treatment
 
2.      The wide use of generics
 
3.      Mauritius is a land of immigrants and the genetic pool results from different regions of the world
 
The WHO international drug monitoring program started in 1968; it is located in Uppsala, Sweden.
 
The National Pharmacovigilance Committee in Mauritius  was established in December 2011 and Mauritius became a full member of the the WHO Programme for International Drug Monitoring in 2014. It functions to manage and address any potential safety and quality issues that could arise from the use of health products marketed in Mauritius.
 
The National Pharmacovigilance Centre is the executive arm of the Committee
 
 Composition of The National Pharmacovigilance Committee:
 
1.      Dr.Yee  Hoy - Specialist /Senior Specialist, Internal Medicine, Victoria Hospital Chairperson
 
2.      Mrs S. Boolell  Principal Pharmacist i/c of the Pharmacovigilance Centre
 
3.      Dr. Bhoma : Gynecologist
 
4.      Dr. Doarika : Dermatologist
 
5.      Dr. P.How: General Practitioner
 
6.      Dr. F Khodabacus : Community Physician
 
7.      The Director Pharmaceutical Services
 
8.      the Registrar of the Pharmacy Board
 
9.      Mrs S. Rajanah  : Nursing Officer
 
10.  Mr. M.Teeluck : Epidemiologist
 
11.  Mr. A. Chooroomooney : Community Pharmacist
 
12.  Dr (Mrs) A.Jheelan-Ramxchandur Lecturer, Department Health Science, University of Mauritius
 
13.  Mrs D. Chui Wan Cheong  Pharmacist (Private Hospital )
 
14.  Ms. A. Mangatha Pharmacist (Public Hospital)
 
15.  The Registrar of the Pharmacy Council as and when required
 
 
 
How to report?
 
Reporting Guidelines For Mauritius:
 
A. Health Care Professional
 
Reports concern all medicines including vaccines, blood factors and immunoglobulins, herbal medicines ,Ayurvedic and  homeopathic remedies, available on the Mauritian market and/or in Private Institutions and/or in Government Health Institutions
 
 Health Care professionals may report by using any one of these three methods :
 
1.      By sending a mail to  pharmacovigilancemauritius @gmail.com
 
2.      Online :
 
 i. For adverse drug reactions at:  https://form.myjotform.com/80387732894571 ii. For quality issues at: https://form.myjotform.com/80393242855561
 
3.      Or on the Yellow Card available on request from points of contact in hospitals or download here  and sending the form to the National Pharmacovigilance Centre , 10th Floor, Emmanuel Anquetil Building, Port-Louis
 
Points of Contact:
 
1.  SSRN Hospital: Mr. A. Seeneevassen, Pharmacist/Sr Pharmacist
2.  Dr. A. G. Jeetoo Hospital: Mrs. K. Capery, Pharmacist/Sr Pharmacist
3.  Victoria Hospital: Mrs. B. Nuckchady-Hurry, Pharmacist/Sr Pharmacist
4.  Flacq Hospital: Ms. N. Eathally, Pharmacist/Sr Pharmacist
5.  J. Nehru Hospital: Mrs. S. Hurbissoon, Pharmacist/Sr Pharmacist
6.  S. Bharati Eye Hospital: Ms. S. Lalloo, Pharmacist/Sr Pharmacist
7.  Brown Sequard Mental Health: Mrs. H. B. Uteene, Pharmacist/Sr Pharmacist
8.  Central Supplies Division: Mr. V. Mooneeramsing, Pharmacist/Sr Pharmacist
 
 
B. Pharmaceutical Companies, Pharmaceutical Manufacturers and Pharmacy Wholesalers
 
The National Pharmacovigilance Committee of Mauritius has adopted the ICH guidelines for the reporting of ADRs.
 
 Serious Adverse Drug Reactions that  occurred in Mauritius should be reported to the National Pharmacovigilance Committee within 7 days. We stress on the reporting of reactions where:
1.          Patient died due to reaction
2.          the reaction was life-threatening
3.          the reaction caused congenital abnormality
 
PV reports must be done on CIOMS form and can be sent by mail on:
 
 pharmacovigilancemauritius @gmail.com  and/ or
 to the National Pharmacovigilance Centre , 10th Floor, Emmanuel Anquetil Building, Port-Louis
 
All non-serious ADRs  occurring inside the Mauritian territory must be reported within 30 days. The Committee examine reports from both Health Care Professionals and consumers for ADR occurring within Mauritius.
 
Evaluation or revaluation reports or marketing suspension by other pharmacovigilance centres or drug agency should reach us within 15 calendar days
 
 
C. Members of the Public
 
You may report  by using one of these two methods
 
1.    By sending a mail to  pharmacovigilancemauritius @gmail.com
 
2.    Online:
 
 i. For adverse drug reactions at:  https://form.myjotform.com/80387732894571 ii. For quality issues at: https://form.myjotform.com/80393242855561

 

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