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					     Implementing
 Pharmacovigilance in
Public Health Programs
Public Health Programs (PHP)
• Objective – promote, protect, and restore
  health
• Components – education, environment,
  nutrition, lifestyle/behavior, prevention
  (immunization), pharmacotherapy
• Priority in developing countries – reducing
  morbidity and mortality of major common
  diseases
PHP Functions
• Prevent, treatment, and control of infectious
  diseases: malaria, TB, HIV/AIDS
• Direct administration of medicines and
  vaccines
• Mass distribution of free medicines
   – national MOH
  – donors: WHO, UNICEF, GF, USAID, etc.
Objectives of Pharmacovigilance

• improve patient care and safety
• improve public health and safety
• encourage safe, rational and appropriate
  use of drugs
• promote understanding, education and
  clinical training in pharmacovigilance
  Importance of pharmacovigilance

• Complete safety data (especially for unexpected
  and serious adverse events) can only be captured
  through pharmacovigilance
• It cannot be captured through clinical trials which
  are conducted in an ―artificial environment.‖
   – In clinical trials
     • patients are not taking any other medications
     • do not have concomitant diseases
     • are taking the drug short-term (during the duration of the trials only)
       and
     • are not part of vulnerable groups (e.g., children, pregnant women,
       elderly, etc.)
 Importance of pharmacovigilance

Cannot extrapolate data from developed countries:

• Type of drug use is different
   – Do not use the co-formulated ARVs
   – Minimally use anti-TB, anti-malarial and anti-diarrhoeal drugs

• Patient genotype, phenotype, social and economic
  conditions are markedly distinct
   – Large number of malnourished patients
   – Patients with concomitant diseases
   – High rates of illiteracy and poverty, increases likelihood of
     inappropriate use by pregnant women, breast feeding mothers,
     young children, elderly
   – Large number of patients using herbal and other traditional
     medicines
   Importance of pharmacovigilance

We are accelerating the use of new drugs in new environments,
  which are mostly devoid of pharmacovigilance activities

• Faster scale up of public health programs due to
  availability of new funding from major donors such as the
  Global Fund, World Bank, PEPFAR, PMI, etc

• New drugs are reaching developing countries in greater
  numbers and more quickly because of new funding from
  several donors, including the Bill and Melinda Gates
  Foundation
Impact of ADRs in USA

• 1.2 million hospitalized patients in 20041

• Cost of drug-related morbidity and mortality
  >$177.4 billion2

• ADRs are the 4th - 6th leading cause of death3



1 Exilhauser, Owen AHRQ 2007
2 Ref. Ernst & Grizzle J Am Pharm Assoc. 41: 192(2001)
3 Lazarou et al JAMA 1998;279: 1200 - 1205
  Examples of Product Recalls due to Poor Safety
Even in developed countries, which have, relatively speaking, stringent
regulatory authorities, several drugs have been withdrawn from the market in
the past few years—experience shows 4% to 5% of drugs on the market are
withdrawn.
GLOBAL FUND QUALITY ASSURANCE POLICY FOR
PHARMACEUTICAL PRODUCTS
Adherence, Drug Resistance and Monitoring Adverse Effects
 It is strongly recommended that PRs implement mechanisms to encourage
  adherence to treatment regimens (including but not limited to providing medicines in FDCs,
  once-a-day formulations and/or blister packs, and providing peer education and support), to
  monitor and contain resistance, and to monitor adverse drug reactions according to
  existing international guidelines[1]. The cost of implementing such mechanisms may
  be included in the budget for the relevant Global Fund grant. To help contain resistance to
  second-line TB medicines and consistent with the policies of other international funding
  sources, all procurement of FPPs to treat Multi Drug Resistant Tuberculosis (MDR-TB) must
  be conducted through the Green Light Committee of the Stop TB Partnership hosted by the
  WHO (GLC).[2]

  [1]    E.g. WHO, The Uppsala Monitoring Centre. The Importance of
  Pharmacovigilance. Safety Monitoring of medicinal products. Geneva: World Health
  Organization, 2002, available at http://www.who.int/medicinedocs/en/d/Js4893e/. Safety
  of Medicines. A guide to detecting and reporting adverse drug reactions. Geneva: World
  Health Organization, WHO/EDM/QSM/2002.2, available at
  http://www.who.int/medicinedocs/en/d/Jh2992e/
 [2]    http://www.who.int/gtb/policyrd/DOTSplus.htm
Organization of PHP

  International    Donors
                             Vaccines
                              TB
  National MOH
               PHP             HIV-AIDS
                  Managers      Malaria

Local Coordinator
                  Health
                   Workers
Medicine Safety Concerns
 Rapid scale-up of PHP to treat large
 populations
  Pregnant women, young children, and
   elderly
 Emphasis of donors on pharmacovigilance as
 part of health system strengthening
  key component of PSM plan (GF)
  subsidized ACTs (PMI)
Flow of Medicines in PHP
                                      PSM unit
    NEML                              PHP
    NDA                               NDA
    DTC
           1                     2
           Selection   Procurement




 PV/NDA        Use     Distribution      PSM unit
 PHP                                     PHP
 NGOs      4                     3       NDA
 HWs                                     NGOs
 “Some remedies are worse than the disease”
         Publilius Syrus, Roman writer, 1st century BC.




“the science and activities relating to the
  detection, assessment, understanding and
  prevention of adverse effects or any other
  possible drug-related problems”

                                   [WHO 2002]
Pharmacovigilance

Or more simply…

Safety Monitoring System
 Medicines
 Other pharmaceutical products
Key PV Issues
 Adverse drug reactions (ADR)
   harm caused by the use of a drug at normal
   doses
 Medication errors (ME)
  faulty systems/processes/use
 Poor quality medicines
  counterfeits/sub-standards
ADE-ADR-ME Relationship
                                                 About 25% of ADEs
                                                 due to medication
                                                 errors
                                  ADEs
  Medication
   Errors                         ADRs

                                             About 7% of medication
                                             errors potentially harmful
                                             but preventable ADRs

   Barker et al. Arch. Int. Med. 162: 1897-1903 (2002)
Safety concerns with anti-TB drugs
Product                   Potential ADRs and Risks
Isoniazid                 Liver toxicity 10 – 20%, neurotoxicity, Lupus syndrome
Ethambutol                Ocular toxicity (up to 5%); Not to be used in children

Rifampicin/ nevirapine    Liver toxicity occurs frequently
interaction

 Safety concerns with Anti-Retrovirals
 Product                 Potential ADRs and Risks
 Abacavir                Hypersensitivity, potentially fatal, up to 5%
 Didanosine              Pancreatitis – often fatal, very difficult to manage;
                         neuropathy
 Indinavir               Disfiguring change of fat distribution identifies HIV+
 Ritonavir               patients on ARV treatment, leading to drop-out;
                         severe skin reactions – potentially fatal
 Saquinavir
Safety Concerns with ACTs used in Malaria
Product                   Potential ADRs and Risks
Artemisinin derivatives   In animal studies, exposure may cause foetal
                          death during early pregnancy; risks in humans
                          unknown
                          Significant concerns when product moves to
                          OTC and for home-based treatment
Artesunate/               Neuromuscular conditions such as dystonia and
amodiaquine               dykinesia, etc
Impact of ADRs on PHP
 Significant cause of morbidity and
  mortality
 Affect treatment adherence
 Increase risk of drug resistance
 Public confidence in PHP
 Wasted financial resources
     Current Status of Pharmacovigilance

 Less than 2% of          Country Distribution in VigiBase
  all Adverse                                   October 2008
  Drug Reaction                            Sweden
                                            2% Thailand
  (ADR) data are                   Spain
                                                    2%
                                    2%                    Netherlands
  captured in                                                 2%
                              Australia
  Africa and Asia               4%
                            Canada
 Many                       5%

  developing              France
                           5%
  countries              Germany
                                                                        United States
                                                                            50%
                           6%
  collect less than
  100 ADRs per
                      United Kingdom
  year <1% of              11%
  their target
                                       Other Countries
                                            11%
Current Status of PV in Africa
 ANIMATE                                     Strong
                                        Pharmacovigilance
                                            Capacity
   Data is Gathered, Analyzed, Shared and        South Africa, Algeria, Ghana, Morocco,
   Processed into Policy                         Nigeria, Tunisia


   Data is Gathered, Analyzed, Shared            Namibia, Tanzania, Zimbabwe,


   Data is Gathered                              Mozambique, Uganda, Madagascar, Sierra
                                                 Leone,Togo


   May have an office or a person, a reporting    Cameroon, DRC, Eritrea, Ethiopia, Kenya,
   form, but minimal or no activity              Senegal, Sudan, Zambia + all other African
                                                 countries

                                             Weak
                                        Pharmacovigilance
Source: UMC Analysis
                                            Capacity
ADR Reporting



    Analysis          Response




               Data
Data  Multi-level Action


                    •Prescriber
                    training
 Response           • Revising
                    formulary
                    • Drug recall
PV Impact
 Meaningful PV can be done at any level of
 health care system
  hospital drug and therapeutics committee
 Drug safety data/information should always
 benefit country first
  data feedback loop
  data reported to decision makers
  results in action
      Benefit of Pharmacovigilance—beyond Safety

 Benefit       Safety            Quality              Resistance
  of PV




 Impact       Improves         Improves             Reduces Drop
  on PV
            Quality of Care   Compliance              Out Rates


   Impact          More volume         More variety of drugs
on Supply                               (alternative first line,
    Chain
                     of drugs                second line)
    How Pharmacovigilance works


   1           2           3           4
  ADR         ADR        ADR         Sharing
Suspicion   Reporting   Analysis   of Findings
In-Country ADR Supply Chain

  Private
                  Patient-HW             PV Unit/MoH
     +
  Public                    fax - mail
• drug outlets                 courier
• pharmacies
• clinics
• hospitals                              Analysis
                 Suspect ADR             Policy Action
                 Reporting ADR
                                                                            Botswana
  ADR Supply Chain

                          PV Unit/
Patient-HW                                           PV Unit/MoH
                          Coordinator

                                                                   Web
               hand                     fax - mail
                                                                   upload
               delivery                 courier

                                                        HQ
Suspicion of               Reporting                 Analyze ADR            Analyze global
ADR                          ADR                     & submit to            ADRs
                                                     WHO/UMC
                                                     database
ADR Supply Chain--bottlenecks         Botswana




Suspicion   Reporting   Analyze ADR
of ADR        ADR       & submit to
                        WHO/UMC
                        database
Other ADR Supporting Roles
 Patient education
 Prevent programmatic errors
 Promote rational drug use
 Follow treatment guidelines
 Communicate with patients and public
                                        PHP

Take-home Messages                 HW

                                              PV


 PV is about patient safety and treatment
  effectiveness
 PHP is an effective means for building PV
 HW is the vital link in ADR supply chain

				
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