HEALTH TECHNOLOGY Medicines, Vaccines, Laboratory, Devices, Equipment

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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

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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.
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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.

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This Presentation

• PART 1 Health Technologies and Health
• Systems
• PART 2 Essential Medicines Pharmaceutical
  Polices Zafar Mirza
• PART 3 Vaccine Regulation and Production Houda
  Langer
• PART 4 Other Health
• Technologies Nabila
  Metwalli Adham Ismail
  
• 
  
  

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PART 1 Health Technologies Health Systems
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Health Technologies in WHO Health System
Framework
MEDICINES, VACCINES OTHER HEALTH TECHNOLOGIES
National Regulatory Authority
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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.
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Cosmetics
Biotechnology Products
Medical Devices
Blood Products
Vaccines
Homeopathic Medicines
MEDICAL PRODUCTS HEALTH PRODUCTS
Water
Pharmaceuticals
Laboratory facilities
Food
Herbal Medicines
PESTICIDES
Medical Equipment
NEUTRACEUTICALS
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NATIONAL REGULATORY AUTHOIRTY
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
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PART 2 Essential Medicines Pharmaceutical
Policies
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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

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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.

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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

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National Medicine Policiescommitment to goals
and guide to action

• Legislation, Regulation and Guidelines
• Selection of Drugs
• Supply (incl. procurement production issues)
• Quality Assurance
• Rational Drug Use
• Economic Strategies for Drugs
• Monitoring Evaluation of NDPs
• Research
• Human Resources Development
• Technical Cooperation among Countries

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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

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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
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Essential Medicines List

• WHO Model List of Essential Medicines
• first list in 1977
• Latest is14th revised version, March 2005
• 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

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The WHO Essential Medicines Library, status 2005
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
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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

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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

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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

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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.

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10 national strategies to promote RUMneeds
sufficient govt. investment for medicines staff
!

• Evidence-based standard treatment guidelines
• Essential Drug Lists based on treatments of
  choice
• Drug Therapeutic Committees in hospitals
• Problem-based training in pharmacotherapy in UG
  training
• Continuing medical education as a licensure
  requirement
• Independent drug information e.g bulletins,
  formularies
• Supervision, audit and feedback
• Public education about drugs
• Avoidance of perverse financial incentives
• Appropriate and enforced drug regulation

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Part 2Vaccine Regulation and Production
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WHO 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 from
  manufacturer,
• National Regulatory Authority fully functional,
• Non unresolved reported problem with manufactured
  vaccine

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Why an efficient National Regulatory Authority
for vaccines?

• Biologicals and complex products
• Vaccines used for prophylactic purposes on
  healthy population
• Ensure the quality, efficacy and safety of
  vaccines
• Know all vaccines circulating in the country
• Know the specifications of vaccines
• Be aware about the vaccine lots marketed
• AEFI causality assessment

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Role of NRA for vaccines

• NRA independent regulatory agency
• Ensure that vaccines released for use are
  evaluated properly and meet international
  standards safety, efficacy and quality
• Role of the NRA 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

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Role of NRA for vaccines (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

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Key elements for an efficient vaccine NRA

• Legal basis
• Policy/strategy for regulation and control
• Independence, competency, objectivity integrity
  
• Quality Management System organization,
  responsibilities, communication, long term vision
  and strategic plan, human and financial
  resources, documentary system (quality manual,
  Procedures, records), methodology, monitoring and
  evaluation (audits)

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WHO Process to strengthen NRAs
NRA Network of regulatory experts
Benchmarking
NRA assessment using tools
5 day assessment
Institutional Development Plan
Planning to address gaps
GTN placement within 1-3 months
Training Technical assistance
15-24 months (6-8 months in needs much
improvement)
Follow - up visit
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National Regulatory Functions vaccine supply
source
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Situation in EMR

• Vaccine producing countries 3, 4 ? or 5?
• Egy, Ira, Pak, (Tun), (KSA)
• GAVI eligible countries (6) (through UNICEF, WHO
  PQ)
• Afg, Dji, Pak, Som, Sud, Yem
• Self-procuring countries KSA, Bah, Kuw, UAE,
  Qat, Oma, Syria, Jordan, Libya, Tun, Egy
• 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

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Why is it recommended to use WHO prequalified
vaccines ?

• ASSURED QUALITY
• Effective and reliable NRA
• 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
• WHO Reassessment evaluation at regular intervals
• Continuous monitoring by WHO

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WHO Challenges

• NRA status.
• Vaccine production status.
• Vaccine security and vaccine self-sufficiency
  vaccine supply, affordable price, assured
  quality.
• New vaccines.

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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)

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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

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Main Thrust

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

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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.

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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.

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HTA Utilization of resources Medical Equipment
Study
Source Swiss Center for International Health,
Basel, 2005
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HTA of Technical Aspects Procurement of MRI
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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

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Health Technology Management (HTM) Components
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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

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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.

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Part 3Other Health Technologies
47

• Dr. Nabila E. Metwalli
• metwallin_at_emro.who.int

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WHO Essential HT

• Blood and Blood Transfusion Safety
• Support Member States to Develop NRAs for BTSs
• Biennial Meetings for Blood Transfusion Focal
  Points and their NRA counterparts
• Developments of norms, standards, guidelines,
  information, training material fostering
  research.
• Training on Voluntary Non-Remunerated Blood
  Donation Practices.
• Collaboration with IFRC, Arab Division of ISBT/
  ATMC courses Arab Organization for Transfusion
  Medicine in their yearly activities.

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WHO Essential HT (Cont.)

• Blood and Blood Transfusion Safety (Cont.)
• Training on detection elimination of
  Transfusion Transmissible Infections.
• Training on GMP in Blood Blood Products
• Training Clinicians on Appropriate Clinical Use
  of Blood Blood Products
• Developing publications of particular interest to
  the EMR member states
• contribute with concerned units in relation to
  Blood Transfusion Safety of clinical procedures

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WHO Essential HT (Cont.)

• Diagnostics and Lab Technology
• Providing NRAs for all biologicals including
  Laboratories
• Biennial meetings of Laboratory Directors
• Regional LAB EQAS in collaboration, with Lyon/HQ
• PulseNet project for Microbiologic identification
  of foodborne diseases, in collaboration with
  CDC/Atlanta, NAMRU-3/Cairo and WHO/HQ/Lyon
• AMRS Containment.

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WHO Essential HT (Cont.)

• Diagnostics and Lab Technology (Cont..)
• Establishment of lab diagnostic reference
  intervals for regional populations, as well as
  Biosafety Biosecurity standards.
• Implementing Biosecurity practices in Lab
  environments with establishment of regulations
  (especially with threats such as H5N1 virus)
• Assisting MS in disease control programs,
  emerging diseases, outbreaks, epidemics under the
  IHRs
• Developing publications for MS.
• Contributing with other units in relation to the
  lab aspects of clinical procedures

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WHO Essential HT (Cont.)

• Diagnostic Imaging and Medical Devices
• Support MSs to develop NRAs for Medical Devices
• Development Interpretation of Imaging Techniques,
  etc
• Hands on workshops on QA in Radiology
  Radioprotection
• Contribute with other units in relation to
  imaging technology of clinical procedures
• Accessible, safe and reliable diagnostic imaging.
  
• Increased patient safety by ensuring access to
  safe and effective medical devices.

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WHO Essential HT (Cont.)

• Surgical/Clinical Procedures and Transplantation
• Include Cell, Tissue Organ Transplantation
  technology, within ethically accepted programs in
  order to reduce gaps in Service Delivery
• Improved access to ethical, safe and suitable
  transplantations.
• Strengthened capacity at PHC facilities to
  provide emergency/essential surgical care.

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QMP Activities

• Implementation of QMP at country level.
• National QMP courses in SUD, SOM, DJI, PAK, YEM,
  IRQ, PAL, LEB, AFG, SYR, and IRA.
• Workshop on QA for HIV, HBV and HCV testing, and
  for blood group serology.
• Translation of Curriculum and facilitators
  toolkit into Arabic.
• Printing and creation of a CD-ROM for use.

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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.

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• Thank You