TITLE from VIEW and SLIDE MASTER | 26 October 2016 1 |
Evolving role of DTC
including prescribing guidance
Interface Management of Pharmacotherapy Barcelona – 17th October 2016
NICOLA MAGRINI
SECRETARY OF ESSENTIAL MEDICINES LIST ESSENTIAL MEDICINES AND HEALTH PRODUCTS DEPARTMENT
Essential Medicines List: Concept and Procedures 2 |
Essential Medicines
Guiding principle: A limited range of carefully selected medicines leads to better health care, better medicines management, and lower costs
Definition: Essential medicines are those that satisfy the priority health care needs of the population
Selection: Selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness
Essential Medicines List: Concept and Procedures 3 |
A more transparent and evidence-based process (EB109/8 2001)
Essential Medicines List: Concept and Procedures 4 |
EML and DTC
Role of evidence – value of drugs
Link between essential medicines and guidelines
High cost of many new and effective medicines
Essential Medicines List: Concept and Procedures 5 |
EML, DU and guidelines
Important role of evidence in the development of the recommendations
– strong vs weak recommendations (listing/sub-listing, restrictions … – Indicators of and level of use
Guidelines and conflicts of interests
DTC and comprehensive pharmaceutical policy – Strong link/coordination with GLs groups – Tender management groups – One approach and common methodologies
Essential Medicines List: Concept and Procedures 6 |
Essential medicines and guidelines
Important role of evidence in the development of the recommendations
– strong vs weak recommendations (listing/sublisting, restrictions … – Indicators and level of use
Guidelines and conflicts of interests
DTC and comprehensive pharmaceutical policy – Strong link/coordination with GLs groups – Tender management groups
Essential Medicines List: Concept and Procedures 7 |
Tender competencies: a complex task
Tenders need
Technical guidance (from DTC) and feedbacks from prescribers and patients
Administrative and legal support (ad hoc from HS)
Management and policy capacity (ad hoc from HS)
Essential Medicines List: Concept and Procedures 8 |
EML/DTC, GL and … financing
1. Evaluation, evidence synthesis and value
2. Recommendation and planning of expected use
3. Indicators: for monitoring and budget
4. Review it at different level and share all the information with all different stakeholders
financing / affordability / sustainability
Essential Medicines List: Concept and Procedures 9 |
Essential medicines and guidelines
Important role of evidence in the development of the recommendations
– strong vs weak recommendations (listing/sublisting, restrictions … – Indicators and level of use
Guidelines and conflicts of interests
DTC and comprehensive pharmaceutical policy
Pharmaceutical policies • By pharmaceutical policy we mean the conscious efforts of
national governments to influence the pharmaceutical system
Marc J. Roberts and Michael R. Reich. Pharmaceutical Reform.
A Guide to Improving Performance and Equity. World Bank, 2011
Functions of pharmaceutical sector • Registration of medicines • Licensing of pharmaceutical business • Inspection of establishment • Medicine promotion • Clinical trials and independent confirmatory research • Indipendent drug information • National (NHS) guidelines program • Selection of essential medicines • Procurement of medicines • Distribution of medicines • Drug utilization
National level Local level
Access to Essential Medicines| 26 October 2016 12 |
The pharmaceutical market: a highly regulated one
Promotion
Patent
R&D and clinical trials
Manufacturing
Inspection
Distribution
Registration
Selection
Procurement & import
Pricing
Prescription
Dispensing
Pharmacovigilance
Access to Essential Medicines| 26 October 2016 13 |
The pharmaceutical market: inefficiencies and unethical practices can occur
Promotion
Conflict of interest
Pressure
Falsification safety/
efficacy data Bribery
Patent
R&D and clinical trials
Manufacturing
Inspection
Distribution
Registration
Selection
Procurement & import
Pricing
Prescription
Dispensing
Pharmacovigilance
Thefts Over- invoicing
Counterfeit/ substandard
Collusion Unethical donations
Unethical promotion
High prices
Inappropriate forecasting
Inappropriate use
Losses
Access to Essential Medicines| 26 October 2016 14 |
The pharmaceutical market: a highly regulated one
Promotion
Patent
R&D and clinical trials
Manufacturing
Inspection
Distribution
Registration
Selection
Procurement & import
Pricing
Prescription
Dispensing
Pharmacovigilance
Falsification safety/
efficacy data
Collusion Unethical donations
Conflict of interest
Inappropriate forecasting
Inappropriate use
Losses Bribery
Thefts Over- invoicing
Counterfeit/ substandard
Pressure
Unethical promotion
Jama, 11 October 2016
Rawlins - Jama Sept 2016 • Richer countries spend more on health care than poorer ones; and there is a
remarkably close correlation between a country’s gross domestic product and its expenditure on health care, even when public and private resources for health care are combined.
• Cost easy to define – • whereas effectiveness much more complex and disease specific • Even though these techniques provide evidence of effectiveness in specific
conditions, they are of virtually no use to organizations seeking to compare the costs and benefits of treating one condition compared with another. For example, how are payers expected to compare the value of a new treatment for breast cancer with a new treatment for schizophrenia if the benefits are expressed in totally different ways?
• … (QALYs) gained so the clinical benefits of interventions can be compared across disease states.
HIS/EMP | Communications Planning HIS | EMP
Questions? All questions are welcome
As all questions are useful to understand EML role and what I just presented