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Making A Difference Reporting of Adverse Reactions

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					    Making A Difference:
Reporting of Adverse Reactions

                                           PTSA
                        Lisa Walzak, Coordinator
               Canada Vigilance Regional Office -
                                        AB/NWT
• Disclaimer
• As per the definition regarding bias or conflict of
  interest put forth in the Guidelines and Criteria for
  CCCEP Accreditation and as per Section 10.3, I am
  declaring that I have no real or potential conflict to
  disclose.
June 30 – July
10, 2008
Learning Objectives (or questions I hope
you can answer by the end)
• What are adverse reactions (ARs)?
• What is the Canada Vigilance Program?
• Why is it important to report an adverse
  reaction?
• Which adverse reactions do I report?
• How do I report an adverse reaction?
• What happens with the reports?
Definitions

Adverse Drug Reaction (ADR)
Food and Drug Regulations definition:

• A noxious and unintended response to
  a drug which occurs at doses normally
  used or tested for the diagnosis,
  treatment or prevention of a disease or
  the modification of an organic function.



                                             5
Definitions
Adverse Event
World Health Organization (WHO) definition ¹ :
   Any untoward medical occurrence that may
   appear during treatment with a
   pharmaceutical product but which does not
   necessarily have a causal relationship with
   the treatment.

¹World Health Organization, The Importance of Pharmacovigilance, 2002
Definitions:
Serious Adverse Reaction
 • Requires or prolongs hospitalization
 • Causes a congenital malformation
 • Results in significant disability or
   incapacity
 • Is life - threatening
 • Results in death
 • Requires intervention to prevent one of the
   outcomes listed above

                                                 7
Definitions

Unexpected Adverse Reaction:
World Health Organization (WHO) definition¹ :


   An adverse reaction, the nature or severity
   of which is not consistent with domestic
   labelling or market authorization, or
   expected from characteristics of the drug.

                ¹World Health Organization, The Importance of Pharmacovigilance, 2002
Definitions

 Pharmacovigilance:
 World Health Organization (WHO) definition¹ :


    The science and activities relating to the
    detection, assessment, understanding and
    prevention of adverse drug effects or any
    other drug related problems.


          ¹World Health Organization, The Importance of Pharmacovigilance, 2002
Canada Vigilance Program


• Canada Vigilance is part of Health Canada’s post-
  market surveillance program

• A mechanism to report suspected adverse
  reactions to pharmaceuticals (both prescription
  & non-prescription), biologics, natural health
  products & radiopharmaceuticals.


                                                 10
                           Health Canada

                    Health Products and Food Branch


                  Marketed Health Products Directorate


Marketed Health Product Safety and Effectiveness Information Bureau (MHPSEIB)



             Canada Vigilance - National Office (Ottawa)


BC / Yukon     AB / NWT    SK       MB     ON / Nunavut    QC      Atlantic



                                                                              11
         Canada Vigilance … Sources of
          Adverse Reaction Information

Health Care Professionals       Canada Vigilance
                                  Health Canada
& Patients
                                   Voluntary

      Voluntary

Market Authorization Holder     Canada Vigilance
                                  Health Canada
(Manufacturer)
                                   Mandatory
    Canada Vigilance … Sources of
    Adverse Reaction Information
• Post-marketing studies
• Active surveillance activities
• Publication in scientific journals
• Collaboration with patient groups, academic
  institutions, professional associations in Canada and
  internationally
• AR information and risk-communication materials
  exchanged with HC by foreign regulatory agencies
The Importance of Reporting ...




           McBride, W.G. 1961. Thalidomide and congenital abnormalities. Lancet. 2: 1358.
WHO. Pharmacovigilance: ensuring the safe use of medications. 2004
 The Importance of Reporting …
     clinical trial limitations
• Small sample sizes and short duration

• Highly selected patients via exclusion criteria

• Rare/serious adverse reactions may not be
  detected
   The Importance of Reporting …
       clinical trial limitations

• FDA study between 1976 – 1985 found
  51.5 % of products had serious post-
  approval risks

• Evidenced by labeling changes or
  market withdrawals


          United States General Accounting Office. FDA drug review: post-approval risks
          1976-85
          (GAO/PEMD-90-15).Washington: GAO; 1990
  The Importance of Reporting ...
            Impact
• Recent study of hospital admissions in UK found 6.5%
  had experienced ADR¹
  - 80% - ADR directly responsible
  - 2.3% (28) had fatal outcomes related to the adverse
       reaction.

• Recent Canadian prospective study found ADRs
  accounted for 39.3% for drug -related visits to ER³

                             ¹Pirmohamed et al. BMJ, 2004; 329: 15-19
                             2
                               Zed et al. CMAJ, 2008; 178(12): 1563-1569
The Importance of Reporting ...
           Impact

Most importantly … what is the
impact on your patient?
   The Importance of Reporting …
             And Yet ?
• 2006 systematic review of 37 studies to
  estimate the extent of under-reporting
  (using variety of surveillance methods)
  found ……
 that the overall median under-reporting
 rate was 94%


                        Hazel, L., Shakir, A. W. 2006. Under-Reporting of
                        Adverse Drug Reactions. Drug Safety. 29: 385-396.
   The Importance of Reporting ...
             And Yet?
• Canadian Burn Treatment centres -
  retrospective review of Toxic Epidermal
  Necrolysis (TEN) cases from January 1995
  – December 2000.


- Only 25/674 (4%) of TEN cases reported to
  Health Canada.

  Mittman, N. et al. 2004. Evaluation of the Extent of Under-Reporting of Serious Adverse Drug Reactions.
  Drug Safety. 27: 477-487.
Current State of AR Reporting - Canada
National                          Other
Reporting                        2% (238)

Statistics   Consumers/                         Physicians
              patients                          32% (3903)
2007         29% (3592)



Number of
Domestic
Cases
              Other health
Received:     professionals
              12% (1488)                    Pharmacists
12,294                         Nurses       18% (2201)
                              7% (872)
  Who Can Report ???

• Anyone … students,
  too!!



• Your information is
  extremely valuable
Who Can Report?
• In one US teaching hospital – ADR
  reporting increased significantly with
  Pharmacy student participation.¹

- 2005, ADRs documented: 42

- 2006, ADRs documented: 310



             Sullivan KM, Spooner.LM. 2008. Adverse-drug-reaction reporting by pharmacy
                 students in a teaching hospital. Am. J. Health Syst. Pharm. 65: 1177-1179.
Reporting to Canada Vigilance …

Which ARs to Report?
Suspected adverse reactions that are:
(If in doubt, fill it out)
• Serious

• Unexpected

• Related to recently marketed (< 5 years)
  health products.

                                             25
Reporting to Canada Vigilance …
Which products to report?

•   Prescription drugs
•   Non-prescription drugs
•   Natural health products
•   Radiopharmaceuticals
•   Biologics
Reporting to Canada Vigilance …
What else can be reported?

• Any unintended effect
• Health product abuse
• Overdose
• Interaction e.g. drug-drug , drug-food
• Unusual lack of therapeutic efficacy
Reporting to Canada Vigilance …
Products not reported to Canada Vigilance
  • Vaccines (prevention of infectious disease)
    - local public health department
    - Adverse Events following Immunization Reporting form
    - http://www.phac-aspc.gc.ca//im/aefi_e.html


  • Medical Devices
    - Health Canada’s Health Products and Food Branch
    Inspectorate
    - Medical Device Problem Report
Reporting
… How       A. Patient Information
                  Identifier, age, sex, height, weight

            B. Adverse Reaction
                  Outcome, date, reaction description
                  Relevant tests / Lab data
                  Relevant medical history/Pre-existing
                   medical conditions

            C. Suspected Health Product
                  Name of drug/health product
                  Dose, frequency, route, Indication, lot #,
                   expiry
                  Concomitant health products
                  Treatment of adverse reaction

            D. Reporter Information
                  Name, address, phone number
                  Health professional or consumer?
                  Also reported to manufacturer?
What about Confidentiality?

                Information related to the identity of
                 the patient and/or reporter will be
                 protected as per the Privacy Act

                Please do NOT provide names,
                 initials, DOB, SIN, chart numbers,
                 health card numbers etc… that
                 could identify patient
Reporting …
How?
               • Download form at
                 www.healthcanada.gc.ca/medeffect
               • Form also found in back of the
                 Compendium of Pharmaceuticals and
                 Specialties (CPS)

               • A suspected ADR report can be
                 provided to Canada Vigilance:
               • Phone 1-866-234-2345
 Report form   • Fax 1-866-678-6789
               • Mail to regional offices (postage paid
                 envelopes available)

                                                      31
Reporting … How?      Report online at:
   www.healthcanada.gc.ca/medeffect




                                          32
Reporting to Canada Vigilance …
What happens to the reports received?
                                           Health Santé



   • Acknowledgement letter
                                           Canada Canada
                                                                                           Canada Vigilance

                                                                                                                                        Canada Vigilance Atlantic Office
                                                                                                                                      1505 Barrington Street, Maritime Centre
                                                                                                                                                         Suite 1625, 16th Floor
                                                                                                                                                        Halifax, NS B3J 3Y6
                                                                                                                                               Tel: Toll-free 1-866-234-2345
                                                                                                                                              Fax: Toll-free 1-866-678-6789
                                                                                                                                       Canadavigilance_atlantic@hc-sc.gc.ca




   • Initial screening
                                                                                                                                                                      DATE
                              Address

                              Dear NAME:
                                                                      Re: Adverse Reaction Tracking Number #####

                                Thank you for the case report recently submitted to Canada Vigilance. Suspected health product adverse reaction
                              reports are submitted on a voluntary basis, and maintained in a computerized database. Adverse reaction
                              information is used for the monitoring of marketed health products, and may contribute to the detection of potential
                              product-related safety issues as well as to the benefit-risk assessments of these products.

                                The case report for health product(s):
                              PRODUCT NAME




   • Data Entry
                              with identifier XX has been assigned tracking number #####. If further information becomes available for this case,
                              please forward it to our centre citing this tracking number. For your convenience, please find enclosed an adverse
                              reaction reporting form for your future use.

                                Any information related to the identity of the patient and/or the reporter of the adverse reaction is kept strictly
                              confidential. For more details with regards to personal information collected under this program, visit the Personal
                              Information Bank; Health Canada; Health Products and Food Branch; Branch Incident Reporting System; PIB #
                              PPU 088 at: http://infosource.gc.ca/inst/shc/fed07_e.asp .

                                We would also like to take this opportunity to invite you to join Health Canada’s MedEffect e-Notice mailing list to
                              receive the Canadian Adverse Reaction Newsletter and health product advisories by e-mail. To subscribe, please
                              visit: http://www.hc-sc.gc.ca/dhp-mps/medeff/subscribe-abonnement/index_e.html .

                                 Your contribution and commitment to health product safety monitoring are appreciated.




   • Report Assessment                                                                   Yours sincerely,

                                                                                         Canada Vigilance Atlantic Office




                              Health Professionals and consumers may use the following toll-free numbers to report adverse reactions, or request further information about the
                              Canada Vigilance program. Calls will automatically be routed to the appropriate Canada Vigilance regional office based on the area code from




   • Detection of signals
                              which the call originates.

                                                                   Toll-free telephone: 1-866-234-2345     Toll-free fax: 1-866-678-6789




                                                                                                                                                                                  33
Definitions
  Signal
  • Preliminary indication of a product-related safety issue

  • Not in itself proof of the association of an AR to a health
    product, but triggers the need for further investigation

  • Identified through a systemic review of AR reports and other
    information on product safety

  • Preliminary evaluation determines the likelihood of an
    association between the AR and the health product


                                                                  34
Possible actions
  • Post-marketing studies
  • Comprehensive re-assessment of the risk
    and benefit profile of the health product
  • Product labelling changes
  • Altered packaging to clearly identify risks
  • Addition of “warnings” in patient information
    leaflets
  • Issuing public alerts
  • Conducting market withdrawals

                                                    35
Communication …   www.healthcanada.gc.ca/medeffect




                                                     36
Communication:   www.healthcanada.gc.ca/carn
Communication:
Future Direction: Moving from Passive to Proactive




    Current Point-in-Time Process
 Making a difference …. Wisdom for
 the day.


“ Knowing is not enough; we must
  apply,
  Willing is not enough; we must do.”
  - Goethe
Making a difference …. Questions ?
Contact information:

Mail
  Health Canada
  Canada Vigilance Regional Office -
  Ste 730 9700 Jasper Avenue
  Edmonton AB
  T5J 4C3
Phone: Toll Free 1-866-234-2345
Fax: Toll Free 1-866-234-6789
Email: CanadaVigilance_AB@hc-sc.gc.ca

                                        42
References:
  •   Hazel, L., Shakir, A. W. 2006. Under-Reporting of Adverse Drug Reactions. Drug
      Safety. 29: 385-396.
  •   Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in
      hospitalized patients: a meta-analysis of prospective studies. JAMA 1998; 279(15):
      1200-1205.
  •   McBride VG. Thalidomide and congenital abnormalities (Correspondence). The Lancet.
      1961; 278(7216): 1358
  •   Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of
      admission to hospital: prospective analysis of 18 820 patients. Br Med J 2004;
      329(7456): 15-19
  •   Karyn M. Sullivan, and Linda M. Spooner. 2008. Adverse-drug-reaction reporting by
      pharmacy students in a teaching hospital. Am. J. Health Syst. Pharm. 65: 1177-1179.
  •   Mittman, N. et al. 2004. Evaluation of the Extent of Under-Reporting of Serious Adverse
      Drug Reactions. Drug Safety. 27: 477-487.
  •   The Importance of Pharmacovigilance, World Health Organization 2002
  •   United States General Accounting Office. FDA drug review: post-approval risks
      1976-85 (GAO/PEMD-90-15). Washington: GAO; 1990
  •   WHO. Pharmacovigilance: ensuring the safe use of medications. 2004
  •   Zed et al. 2008. Incidence, severity and preventability of medication-related visits to the
      emergency department: a prospective study. CMAJ. 178(12): 1563-1569

				
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