Regulatory curriculum, Rational use of medicines,
Pharmaceutical services based on PHC and the Pharmacy curricula
IX Pan American Conference of Pharmaceutical Education 2‐4 June , 2014 Baltimore., USA José Luis Castro
PAHO/WHO
Regulatory curriculum Strengthening Regulatory Authorities in
Medicines and Biologicals (CD50.R9), 2010
To request Member States:
 Strengthen and evaluate their regulatory capacity with respect to the
functions characteristic of a regulatory agency for medicines and
biologicals, through an examination of the performance of their
essential functions;
 Use the results of the qualification activity and the designation of the
regulatory authorities of regional reference to strengthen their
performance in terms of the steering role of the health authority; …
To Request the Director:
 Support initiatives for the strengthening and qualification of national
regulatory authorities to guarantee the quality, safety, and efficacy of
medicines, biologicals and other health technologies; …
 Promote technical cooperation among country regulatory authorities as
well as recognition of the existing capacity in the Region; …
Ottawa, Canada; 2013
Regulatory curriculum for the Americas
2014-2016
•Core competencies for Regulators
•Diagnostic of capacities and actors.
•Development plan
•Pilot implementation
5
Pharmaceutical services based on PHC
Pharmaceutical Services based on PHC:
Mission, Vision, Values
Right to the highest
attainable standard of
health
Respect
Equity
Vision
Social
Ethics
Pharmaceutical services with social relevance,
Integrated to the healthcare system (PHC),
Meet the needs of the individual, family and
community,
Well-defined roles and functions
That promote healthy lifestyles, access and
rational use of medicines.
Solidarity
Mission
Transparency
Contribute to the individual and collective healthcare of the population, through the active involvement of the pharmaceutical staff with the healthcare team and the community. Comprehensive, integrated and continuous pharmaceutical services..
Humanism
Excellence
PAHO/WHO. Position paper for strengthening Pharmaceutical Services based in Primary Health Care (PHC) (under revision)
Pharmaceutical services: Core Pha
functions
Rational use of medicines
WHA 60.16: RUM
• URGES Member States:
• (1) to invest sufficiently in human resources
• (2)National drug regulatory authority and a full national
programme and/or multidisciplinary body
• (3) The application of an essential medicines list into
• the benefit package of the existing or new insurance funds;
• (4) to develop and strengthen existing training programmes
on rational use of medicines…..
• Promote programmes of public education in rational use of
medicines;
• (5) to enact new, or enforce existing, legislation to ban
inaccurate, misleading or unethical promotion of medicines,
• (6) to develop and implement programmes that will provide
independent, non promotional information about medicines;
Rational use of medicines
(and other HT)
National Health -> Pharmaceutical policies,
economic factors, etc
-Selection-Incorporation to HSBasic curricula,
-Prescription–
training
standards
-Dispensing –
EML, NDF,
STG, etc
Independent
Information
-Utilization (patients)-
Medicines
promotion
Pharmaceutical
Industry
Regulatory
system
cultural
Factors
Rational use of medicines
DTC, EML, NF
•ECUADOR
•BARBADOS, OECS.
•DOMINICAN REP.
•PED.
•GUYANA
•CHILE
•……ongoing
•Medicines selection
manual
•On line training.
More than 200 participants from DTC from 16 countries
13
Regional proposal to develop a national
strategy for the Rational use of
medicines.
•Sustainable and integrated strategy
•Main axes:
• Policy- Regulation-EducationInvestigation-Management
•Cross cutting axes.
(2010:NIC, BOL, 2013-2014: CHI, GUT)
.
Rational use of medicines
(and other HT)
National Health -> Pharmaceutical policies,
economic factors, etc
-Selection-Incorporation to HSBasic curricula,
training
-Prescription–
standards
-Dispensing –
Independent
EML, NDF,
STG, etc
Information
-Utilization (patients)-
Medicines
promotion
Pharmaceutical
Industry
Regulatory
system
cultural
Factors
Pharmacy competencies related to
• Information: critical appraisal, selection, evaluation.
• Medicines and patient safety.
• Pharmacotherapy.
• Clinical practice, patient follow‐up.
• Supply management.
• Regulatory functions
• Pharmaceutical policies.
• Perspective of PHC and UHC
Thank you!.