#Kingston, March 15, 2019 – Jamaica – It is the right of all Caribbean people to have access to healthcare services, including essential quality medicines and pharmaceutical products they can trust. Poor quality and falsified medicines if left unchecked, can reverse progress the Region has made in its fight against diseases.
“We live in a world where medicines are being developed and
consumed at an increasingly higher rate; and there are increased findings of
substandard and falsified medicines reported to global monitoring systems. We
cannot have that proliferated in the Caribbean. Manufacturers are seizing the
opportunity to import and flood markets in countries where medicines are of
short supply or where the regulatory systems for medicines are weak.
Thanks to CARPHA Medicines Quality Control and Surveillance Department (MQCSD) and its efforts to implement a “proactive, risk-based,
planned sampling programme” for the post market surveillance of medicines, we
are in a position to guard against this,” stated Dr the Honourable Christopher
Tufton, Minister of Health, Jamaica.
Minister Tufton was speaking at the opening of the CARPHA Meeting
on Post Market Surveillance and the Caribbean Pharmaceutical Policy which is
taking place from 12 – 13 March at the conference room of the MQCSD in Kingston, Jamaica.
He went on to say “The importance of the CARPHA MQCSD, as the only
accredited medicines quality control laboratory in the English-speaking
Caribbean, cannot be over stated. It is to the MQCSD that we now look to
implement a Post Marketing Surveillance (PMS) strategy, that is, among other
things, to provide test results that confirm the good quality of medicines or
otherwise identify problems with them; and provide test results that give the
opportunity for national medicines regulatory authorities to evaluate and make
decisions on the actual quality of products used in country.”
In closing, Minister Tufton stated “The systematic and emergency
monitoring of medicines by CARPHA MQCSD through its PMS strategy, has the
support of the Ministry of Health – recognising that its success is dependent
on nurtured collaboration among Member States and key stakeholders, and on it
being adequately resourced.” Other speakers at the opening ceremony were
Dr Virginia Asin-Oostburg, Director, Surveillance, Disease Prevention and Control,
CARPHA; Mrs. Jesse Schutt-Aine, Sub-regional
Program Coordinator, Caribbean, PAHO/ WHO; and Dr Rudolph Cummings, Programme
Manager, Health Sector Development, CARICOM Secretariat.
In her welcome and opening remarks, Dr Virginia Asin-Oostburg,
Director, Surveillance, Disease Prevention and Control stated “This is the
first meeting CARPHA is hosting with key regional partners of the Post Market
Surveillance (PMS) programme that is organised by CARPHA’s Medicines Quality
Control and Surveillance Department. We see this as an important
milestone for CARPHA and its Member States. Since Jamaica is host country
to CARPHA MQCSD, it is more than fitting to experience this milestone with our
host. We consider this meeting, a milestone in repositioning what
used to be the Drug Testing Laboratory and rebranding the laboratory as the
Medicine Quality Control and Surveillance Department that also offers a
surveillance programme to our Member States to actively monitor the safety of
registered drugs. PMS is a programme developed by MQCSD that will further
shape and form in collaboration with our partners and colleagues from Member
States.”
The importance of the CARPHA MQCSD as the only ISO/ IEC 17025
accredited medicines quality control laboratory in the English-speaking
Caribbean, cannot be over-emphasized. The department has embarked on a
post market surveillance programme for medicines, which seeks to monitor the
quality of selected medicines circulating in the pharmaceutical markets of
participating CARPHA Member States. This will ensure that Member States
have access to information which can be utilized to develop evidence-based
approaches such as issuing of alerts, implementing risk reduction strategies
and overall management of national public health risks.
Given the limited resources and other challenges facing small
island developing states such as CARICOM countries, the responsibilities
related to regulatory systems are difficult to carry out single-handedly or
individually. In collaboration with other partners such as
PAHO/WHO, CARPHA MQCSD will function as a critical part of a robust mechanism
for regulating medicines in CARICOM.
Mrs. Jesse Schutt-Aine, Sub-regional
Program Coordinator, Caribbean, PAHO/ WHO stated “PAHO is happy to be working with CARICOM
and CARPHA and Member States on this initiative. Strong regulatory
systems are the foundation for strong health systems. A strong health
system is what’s needed for universal health, and universal health is essential
for the attainment of the sustainable development goals. PAHO has been
working on these issues for many years supporting the development of the
Caribbean Pharmaceutical Policy, as well as a roadmap for a regional regulatory
platform. More recently PAHO has been working closely with CARICOM and
CARPHA and Member States to advance the Caribbean Regulatory Systems – the
regional regulatory system that is managed by CARPHA. Ms. Schutt-Aine acknowledged “CARPHA as a regional
public health platform that is transforming its drug testing laboratory into
something that can enhance post market surveillance in the Region through risk
based sampling of products in Caribbean markets.”
The introduction of the new surveillance programme will allow
CARPHA MQCSD laboratory to monitor medicines such as those used for the control
of non-communicable diseases and other medicines. This programme is aligned
with CARICOM’s strategy of advancing initiatives for health and wellness by
ensuring access to safe, reliable medicines thereby improving the quality of
life of the Region. The Caribbean region will have access to information to
undertake evidence-based approaches to enable warning, risk reduction and
management of national public health risks.
Speaking at the opening, Dr Rudolph
Cummings, Programme Manager, Health Sector Development, CARICOM
Secretariat said,
“The Medicines Quality Control
and Surveillance Department needs to be complemented for the tremendous work
that it has done to prepare for this meeting and in positioning itself to
support the efforts require for a successful regional pharmacovigilance program.”
Access to healthcare and essential quality medicines and
pharmaceutical products is critical for the Caribbean population’s well-being
and optimal health. Through dossier evaluation and pre-marketing quality
control of generic medicines for the purpose of registration, some countries
are ensuring that quality medicines are on the market.
At the closing of the opening ceremony, Ms. Sonia Thomas-Gordon,
Acting Head/Senior Chemist, CARPHA MQCSD, in her vote of thanks, acknowledged
the commitment and endorsement by partners and participants to the MQCSD post
surveillance programme. She said “Post market is a small component
of pharmacovigilance, and the laboratory component is important. What we
are trying to do is be proactive and monitor those medicines that are on the
market. Most Member States do not have capacity to monitor and we are hoping to
bridge the gap to have one central area, where medicines come to us for testing
and we issue the results.”
The 2-day meeting will seek to sensitize CARICOM’s Technical
Advisory Committee on Pharmaceutical Policy (TECHPHARM) and Caribbean
Regulatory Systems (CRS) focal points on MQCSD’s post market surveillance
program with a view to strengthen regional integration and partnerships for
sustainable development of the programme. The meeting will also aim to
reaffirm the role of TECHPHARM in regional PMS and as a Technical Advisory
Committee (TAC) to MQCSD. Also, down for discussion are the acknowledgement
and endorsement of MQCSD’s PMS Strategy and Field Guide.
More
information about the CARPHA MQCSD can found http://carpha.org/MQCSD.