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HEALTH TECHNOLOGY Medicines, Vaccines, Laboratory, Devices, Equipment

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Title: HEALTH TECHNOLOGY Medicines, Vaccines, Laboratory, Devices, Equipment


1
HEALTH TECHNOLOGYMedicines, Vaccines,
Laboratory, Devices, Equipment
from policy to practice
  • Zafar Mirza, Houda Langar, Nabila Metwalli, Adham
    Ismail
  • H T P Team
  • Department of Health Systems Services
    Development
  • Capacity Development Workshop on Health System
    Development
  • EMRO, Cairo, June 8-12, 2008

2
What is a Health Technology ?
  • WHO defines Health Technologies as
  • The application of organized knowledge and
    skills in the form of devices, medicines,
    vaccines, procedures and systems developed to
    solve a health problem and improve quality of
    lives.
  • This broad definition also encompasses
    traditional medicine, health promotion and
    prevention activities, and includes information
    systems (such as electronic medical records and
    telemedicine applications).

WHA Resolution 60.29, May 2007.
3
Our Aim is
  • To assist member states in establishing and
    optimizing the use of technologies with multiple
    applications for health services in the fields
    of
  • Medicines
  • Vaccines
  • Other Health Technologies including
  • Blood products and related biologicals, as well
    as blood transfusion and injection safety.
  • Diagnostic Imaging and Medical Devices.
  • Diagnostics and Laboratory technology.
  • Emerging and essential surgical care and
    Transplantation
  • e-Health for Healthcare Delivery.

4
This Presentation
  • PART 1 Health Technologies and Health Systems
  • PART 2 Essential Medicines Pharmaceutical
    Polices Zafar Mirza
  • PART 3 Essential Vaccines and
  • Biologicals Policy Houda
    Langar
  • PART 4 Other Health Technologies Adham Ismail

5
PART 1 Health Technologies Health Systems
6
Health Technologies in WHO Health System
Framework
MEDICINES, VACCINES OTHER HEALTH TECHNOLOGIES
National Regulatory Authority
7
Medicines, Vaccines other Health Technologies
consume approximately 50 of recurrent health
budget.
Well over 50 of expenditure on Medicines,
Vaccines other Health Technologies is wasted
due to one reason or the other.
8
Cosmetics
Biotechnology Products
Medical Devices
Blood Products
Vaccines
Homeopathic Medicines
HEALTH PRODUCTS MEDICAL PRODUCTS
Water
Pharmaceuticals
Laboratory facilities
Food
Herbal Medicines
PESTICIDES
Medical Equipment
NEUTRACEUTICALS
9
Scope of National Regulatory Authorities
Food . Bottled Water . Medicines . Medical
Devices . Medical Equipment . Pesticidies
. Cosmetics
Medicines for Human Use ? Pharmaceuticals ?
Biologicals - Vaccines - Sera - Blood products ?
Pharmaceutical raw materials Herbal Medicines
? Homeopathic Medicines
Medicines for Veterinary Use
10
PART 2 Essential Medicines Pharmaceutical
Policies
11
Expenditure on medicinesfrom 9 NHA studies in
the Region
  • 40 of total health expenditure is on medicines
  • Up to 30 of the budget of ministries of health
    is spent on medicines
  • Out-of-pocket expenditure is high
  • Egypt 53 of all medicines are purchased
    directly by households
  • Morocco 74

12
WHO Medicines Strategy 2004 2007Our goal in
medicines
  • WHOs goal in medicines is to help save
    lives and improve health by ensuring the
    quality, efficacy, safety and rational use
    of medicines, including traditional medicines,
    particularly for the poor and disadvantaged.

13
WHO Medicines Strategy 2004 2007 4
objectives, 7 components, 44 expected outcomes
  • Objectives
  • Policy
  • Access
  • Quality safety
  • Rational use
  • Components
  • Implementation and monitoring of medicines
    policies
  • Traditional and complementary medicine
  • Fair financing and affordability
  • Medicines supply systems
  • Norms and standards
  • Regulations and quality assurance systems
  • Rational use by health professionals and consumers

14
National Medicine Policiescommitment to goals
and guide to action
  1. Legislation, Regulation and Guidelines
  2. Selection of Drugs
  3. Supply (incl. procurement production issues)
  4. Quality Assurance
  5. Rational Drug Use
  6. Economic Strategies for Drugs
  7. Monitoring Evaluation of NDPs
  8. Research
  9. Human Resources Development
  10. Technical Cooperation among Countries

15
Essential Medicines in a therapeutic jungle
  • Safe
  • Efficacious
  • Proven quality
  • Time tested
  • Affordable, although price is no more a strict
    criteria
  • Cover needs of the majority of population

16
The Essential Medicines Target
National list of essential medicines
Registered medicines
All the drugs in the world
Levels of use
CHW
S
S
dispensary
Health centre
Supplementary specialist medicines
Hospital
Referral hospital
Private sector
17
Essential Medicines List
  • WHO Model List of Essential Medicines
  • first list in 1977
  • Latest is15th revised version
  • 315 active ingredients
  • around 15 fixed-dose combinations
  • almost 99 are patent free
  • One of the 8 pillars of PHC
  • Equitable access to essential drugs is integral
    part of right to health
  • In poor countries almost half of the population
    do not have regular access to needed medicines
  • 156 countries have national EMLs

18
The WHO Essential Medicines Library
WHO clusters
WHO/EDM
Summary of clinical guideline
Clinical guideline
WHO/BNF
WHO Model Formulary
WHO/EC, Cochrane, BMJ
Reasons for inclusion Systematic reviews Key
references
WHO EM List
WHO Model List
WHO/PSM
MSH UNICEF MSF
Quality information - Basic quality tests -
Intern. Pharmacopoeia - Reference standards
Statistics - ATC - DDD
Link to price information
WCCs Oslo/Uppsala
19
The challenge of meeting essential medicine needs
  • 1. Unaffordable medicine prices
  • 2. Irrational Use of medicines
  • 3. Unfair health financing mechanisms
  • 4. Unreliable medicines supply
  • 5. The quality of medicines
  • 6. New medicines are needed

20
Survey FindingsAvailability of medicines in
public sector health facilities
  • Yemen
  • 16/35 medicines were not found in any facility
  • 29/35 medicines were available only in 4
    facilities
  • Pakistan
  • 23/29 medicines were not found in more than 15
    facilities
  • Lebanon
  • only 15 of the 32 surveyed medicines were found
    at 20 public dispensaries
  • Morocco
  • 20/34 medicines were not available in more than
    half the health facilities

21
Survey FindingsAffordability
Number of days income a lowest paid government
servant has to spend to buy pre-selected
treatment regimes for 9 common diseases
  • Respiratory infection 2.4 days income to buy a
    weeks supply of branded amoxicillin in Jordan
  • Depressive illness 7.7 days income to buy a
    months supply of generic fluoxetine in Pakistan
    and 36.4 days income to buy branded fluoxetine
  • Ulcer One months treatment with generic
    omeprazole 2.9 days income in Sudan and 19.3
    days income in Jordan with originator brand
    10.6 days income in Morocco and 23.7 days
    income in Pakistan

22
Irrational Use of Medicines
  • We estimate that more than half of all medicines
    are prescribed, dispensed or sold
    inappropriately, and that half of all patients
    fail to take them correctly.
  • Irrational use is a complex problem.
  • Solution requires collaborative efforts and
    different types of interventions (Educational,
    Managerial, Economic Regulatory).
  • Experience shows that attention to one aspect of
    the problem does not work.

23
10 national strategies to promote RUMneeds
sufficient govt. investment for medicines staff
!
  1. Evidence-based standard treatment guidelines
  2. Essential Drug Lists based on treatments of
    choice
  3. Drug Therapeutic Committees in hospitals
  4. Problem-based training in pharmacotherapy in UG
    training
  5. Continuing medical education as a licensure
    requirement
  6. Independent drug information e.g bulletins,
    formularies
  7. Supervision, audit and feedback
  8. Public education about drugs
  9. Avoidance of perverse financial incentives
  10. Appropriate and enforced drug regulation

24
Part 2Essential Vaccines and Biologicals Policy
25
WHOs Goal
  • Assured quality for 100 of vaccines used in all
    national immunization program
  • Definition of assured quality ECBS and
    recommendations on safety, efficacy and quality
    in WHO TRS)
  • National Regulatory Authority independent
  • National Regulatory Authority fully functional,
  • Non unresolved reported problem with vaccine

26
Why an efficient National Regulatory Authority?
  • Biologicals and complex products
  • Vaccines used for prophylactic purposes on
    healthy population
  • Ensure the quality, efficacy and safety of
    vaccines
  • Knowing all kind of vaccines circulating in the
    country and all lots marketed
  • Knowing the specifications of vaccines
  • AEFI causality assessment

27
Role of NRA
  • Ensure that vaccines released for use are
    evaluated properly and meet international
    standards safety, efficacy and quality
  • Covering a cycle starting from vaccine
    development until the administration of the
    vaccine as well as after immunization
  • Define scientific documentation and criteria for
    licensing
  • Issue, vary, suspend or withdraw licenses for
    vaccines on the basis of quality, safety and
    efficacy of vaccines

28
Role of NRA (Contd)
  • Continually oversee the quality of vaccines by
    releasing each lot intended for use in the
    country
  • Monitor the impact of vaccines in use through a
    well functioning surveillance system for safety
    and quality
  • Active role in vaccine procurement, management
    and best practices of use
  • Regular review of standardization and control of
    vaccines according to the current state of
    science and technology

29
Key elements for an efficient NRA
  • Government commitment
  • Legal basis
  • National Policy/strategy for regulation and
    control
  • Independence, competency, objectivity,
    impartiality, transparency integrity
  • Effective Quality Management System
    organization, responsibilities, communication,
    long term vision and strategic plan, skilled
    qualified human resources and sustainable
    financial resources, documentary system (quality
    manual, procedures, records), tools, monitoring
    and evaluation

30
National Regulatory Functions vaccine supply
source
Source of vaccines Source of vaccines Source of vaccines Regulatory functions
Produce Procure UN agency Regulatory functions
? ? ? Regulatory system
? ? ? Marketing Authorization/Licensing
? ? ? Post marketing surveillance/AEFI
? ? Functions undertaken in producing countries Lot release
? ? Functions undertaken in producing countries Laboratory access
? Regulatory inspections
In countries that conduct clinical trials In countries that conduct clinical trials In countries that conduct clinical trials Authorization/Approval of CT
31
WHO Process to evaluate performance of regulatory
system
NRA Network of regulatory experts
Benchmarking
NRA assessment using tools
5 day assessment
Planning to address gaps
Institutional Development Plan
GTN placement within 1-3 months
Training Technical assistance
15-24 months (6-8 months in needs much
improvement)
Follow - up visit
32
Situation in EMR
  • Vaccine producing countries 3, 4 ? or 5?
  • Egy, Ira, Pak, (Tun), (KSA)
  • GAVI eligible countries (6) (through UNICEF, WHO
    PQ vaccines)
  • Afg, Dji, Pak, Som, Sud, Yem
  • Self-procuring countries KSA, Bah, Kuw, UAE,
    Qat, Oma, Syr, Jor, Lib, Tun, Egy, Ira
  • Countries procuring through UN agencies Pal,
    Iraq, Leb, Mor
  • Private sector and non EPI vaccines
    self-procurement
  • No NRA fully functional No pre-qualified
    vaccines

33
Why is it recommended to use WHO prequalified
vaccines ?
  • ASSURED QUALITY Effective and reliable NRA
  • Evaluated by WHO
  • Initial evaluation of vaccines Review of
    Product Summary file, testing of final product
    characteristics and consistency lots, evaluation
    of clinical data, Verification of GMP compliance
  • Regular reassessment
  • Continuous monitoring by WHO

34
WHO Challenges
  • Weak NRA status
  • Few vaccine producers, traditional vaccines only
  • Vaccine insecurity and no vaccine
    self-sufficiency vaccine supply, affordability
    of price, assured quality
  • New vaccines, new formulation (combination), high
    cost
  • Emerging pandemic situation (pandemic flu)
  • Quality and access of sera/immunoglobulins
    public health issue

35
Way Forward
  • Mapping vaccine regulatory system in EMR
    countries
  • WHO technical support for strengthening the NRAs
  • Regional network for control of vaccines sharing
    information and experiences
  • Global network for Post-marketing surveillance
  • Improving the vaccine procurement system
  • Vaccine self-sufficiency (strengthening vaccine
    production, pooled vaccine procurement)
  • New guidelines

36
Part 3Other Health Technologies
37
Targeted Technologies
  • Blood Transfusion Safety
  • Blood Safety.
  • Injection Safety.
  • Infection Prevention and Control.
  • Clinical Procedures
  • Emergency Surgical Care.
  • Essential Clinical Procedures
  • Transplantation
  • Diagnostic Imaging and Medical Devices
  • Diagnostic Imaging.
  • Medical Supplies and Instrumentations.
  • Medical Equipment.
  • Diagnostics and Laboratory Technology
  • Diagnostics and Lab Supplies.
  • Laboratory Services

38
Main Thrust
  • The main thrust is to assist MS in establishing
    and optimizing the selection, procurement and use
    of health technologies with multiple applications
    for service delivery.
  • To achieve this, we need adequate Assessment and
    proper Management

39
What is HT Assessment (HTA)?
  • HTA is a multi-disciplinary activity that
    examines the effect of technologies on
  • Available Resources,
  • Cost Cost-effectiveness,
  • Technical Aspects (ex. safety efficacy)
  • Other Aspects (ex. legal ethical issues)
  • HTA goal is to
  • Provide input to decision-making in policy and
    practice.
  • Ensure value for money.
  • Develop a department within NRAs to deal with
    Medical Devices, as well as other technologies.

40
How to assess HT Needs?
  • A tool (e.g. a questionnaire) is needed for
    proper assessment of needs.
  • The questionnaire provides Structural, Process
    and Management indicators of all HT aspects in
    each country.
  • Using this common approach allow comparisons
    between MS, and suggest regional strategies.

41
HTA Utilization of resources Medical Equipment
Study
Source Swiss Center for International Health,
Basel, 2005
42
HTA of Technical Aspects Procurement of MRI
43
Why do we need Health Technology Management (HTM)?
  • Health technologies provide an opportunity for a
    better service
  • Lack of national systems for standardizing their
    selection and use may lead to a disproportionate
    escalation in delivery costs
  • To reap the maximum benefits, proper health
    technology management plans should be developed
  • To conserve resources, countries need clear
    evidence-based plans on how to
  • Conduct proper needs assessment
  • Assess cost-effectiveness of technologies
  • Develop policies on rational selection and use
  • Regulate public-private purchasing decisions

44
HTM Components
45
HTM Proper Selection and Adequate Procurement
  • Many interacting factors determine the type of
    technology to be used.
  • For example, in medical devices, the factors
    could be
  • Type of disease under consideration and
    associated level of healthcare delivery (primary,
    secondary, tertiary)
  • Type and structure of the health facility
    (hospital, centre, etc.)
  • Public health conditions and/or situations
    (normal, disasters, emergencies, etc.)
  • In medicines, selecting and procuring medicines
    to meet the needs of the population are affected
    by
  • Medicine quality, prices and supply.
  • Health financing mechanisms
  • New medicines

46
Priority Medical Devices and Clinical
Procedures
  • As with WHO model list of Essential Medicines,
    a similar list for Priority devices and
    procedures can be useful in developing national
    policies.
  • The aim is to introduce simple technologies that
    address health problems, especially in
    under-resourced areas.
  • WHO should provide guidance on minimum set of
    devices procedures critical for HS to be
    functional and efficient.
  • This set should be dynamic and country-specific.
  • This requires
  • Using a single uniform nomenclature system (GMDN
    or UMDNS).
  • Preparation of integrated interrelated data
    sets on devices, procedures, resources, etc.
  • A methodology for assessment of needs, selection,
    acquisition and management of HT.
  • Prioritization schemes that rely on BOD, existing
    resources, etc.

47
WHO Essential HT
  • Blood and Blood Transfusion Safety
  • Gaps in availability of blood .
  • Promotion of voluntary donation.
  • Focus is on blood safety through capacity
    development and technical expertise.
  • Use of WHO collaborating centers.
  • Rational use of blood products
  • Safe injections infection prevention/control
  • Rehabilitation of blood transfusion services

48
WHO Essential HT (Cont.)
  • Diagnostics and Lab Technology
  • Rehabilitation of lab networks to support service
    delivery at different levels.
  • Focus is on capacity development.
  • Improvement of quality using external/internal
    assurance schemes and SOPs.
  • Reducing antimicrobial resistance containment
    and control of hospital infections.
  • Improving bio-safety and bio-security
  • Improving access through linkages with
    surveillance and epidemiology departments.

49
WHO Essential HT (Cont.)
  • Diagnostic Imaging, Medical Devices and Clinical
    Procedures
  • Accessible, safe and reliable diagnostic imaging.
  • Increased patient safety by ensuring access to
    safe and effective medical devices.
  • Strengthened capacity at PHC facilities to
    provide emergency/essential surgical care.
  • Improved access to ethical, safe and suitable
    transplantations.
  • Strengthened services through e-Health.

50
Conclusions
  • HT are important building blocks and resources of
    HS.
  • To avoid huge wastage of resources and ensure
    adequate access, investments need to be made in
    developing appropriate polices, strategies and
    management systems (selection, procurement,
    storage, supply maintenance).
  • Safety and quality of HT require institutional
    development of resourceful NRA with appropriate
    independence in technical, administrative and
    financial decision making.
  • Appropriate use of HT needs urgent attention.
  • HT must be regulated for its affordability.
  • Unimpeded transfer of technology between
    countries needs to be controlled.

51
  • Thank You
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