Transcript No Slide Title

Medicines Act: Pharmacovigilance
and the Medical Profession
Medicines Regulatory Unit - Malta
 Set-up more than one year ago
 Currently employs 12 pharmacists
 Headed by Ms. L. Wismayer, Director, MRU
 Will establish the Medicines Authority (MA) in Malta
 Preparation of Medicines Act
MRU - Legislation & Structure
 Future Structure of Medicines Authority:
• Inspectorate
(incl. Pharmacies, Distribution, Manufacturing)
• Pre-licensing
(incl. Launch of Marketing Authorisation Project)
• Post-licensing
(incl. Pharmacovigilance & Advertising)
 Legislation:
• Main legislation: Role of Medicines Authority to deal with all
pharmacovigilance issues
• Subsidiary legislation i.e. regulations which transpose
relevant parts of EU directives/regulations
Relationships between MA and others
LICENSING
AUTHORITY
EXPERTS
MEDICINES
REVIEW BOARD
(Appeals)
MEDICINES
ADVISORY BOARD
(to be consulted
on various issues
as required)
(Mainly dealing with safety issues but
also any other issues which require
expert consultation)
MEDICINES
AUTHORITY
(a scientific body carrying out its functions
in accordance with scientific evidence)
Some Functions of Licensing Authority
 To establish standards to ensure the quality, safety
and efficacy of medicinal products
 To establish standards for the reporting of adverse
reactions, serious adverse reactions or suspected
unexpected adverse reactions and make provisions
for the collection or submission of related
information from any person or activity by or under
this act
 To withdraw or recall medicinal products from the
market in the interest of public health or as a
measure of precaution
PHARMACOVIGILANCE
 DISASTER!
 1961
 Thalidomide
 WHO Project
 1968
 International
Drug Monitoring
PHARMACOVIGILANCE
UK - Yellow Card Scheme
 Since more than 30 years (1964)
 Also recently as electronic reporting
CIOMS - 1990
 Council International Organisation of Medical
Science
 Common format for reporting of ADR’s
European Union
 Directive2001/83/EC
 TITLE IX, Articles 101 - 108
Some Definitions from 2001/83/EC

Adverse reaction:
A response to a medicinal product which is noxious and unintended and which
occurs at doses normally used in man for the prophylaxis, diagnosis or
therapy of disease or for the restoration, correction or modification of
physiological function.

Serious adverse reaction:
An adverse reaction which results in death, is life-threatening, requires
inpatient hospitalisation or prolongation of existing hospitalisation, results in
persistent or significant disability or incapacity, or is a congenital
anomaly/birth defect.

Unexpected adverse reaction:
An adverse reaction, the nature, severity or outcome of which is not consistent
with the summary of product characteristics.
Legislation & Pharmacovigilance
Draft Regulations:
“The Medicines Authority shall establish a pharmacovigilance
system. This system shall be used to collect information useful
in the surveillance of medicinal products, with particular
reference to adverse reactions in human beings, and to
evaluate such information scientifically.”
MRU Projects:
 Design of ADR report form
 Launching of form during Seminar for HCP
 Setting up of Medicines Advisory Board
Legislation & Pharmacovigilance
Draft Regulation:
“This system shall also take into account any available
information on misuse and abuse of medicinal products which
may have an impact on the evaluation of their benefits and
risks.”
Definition:
Abuse of medicinal products:
“Persistent or sporadic, intentional excessive use of Medicinal
products which is accompanied by harmful physical or
psychological effects.”
Legislation & Pharmacovigilance
Draft Regulation:
“The Medicines Authority shall take all appropriate measures
to encourage doctors and other health care professionals to
report suspected adverse reactions to the Medicines
Authority.”
MRU projects:
 Seminar/Workshops to reinforce use of ADR reporting system
 Newsletter published at regular intervals throughout the year
 Education in Pharmacy Curriculum for Undergraduates
Effects of Adverse Drug Reactions
ADR’s cause admissions to:
 Hospitals (2% - 6% of all admissions)
 Attendance to Primary Care
Complicate hospital in-patient stay
 10% - 20% cases
Responsible for deaths
 Possibly as high as the 4th common cause
Effects of Adverse Drug Reactions
 Increase the length of hospital stay
 Increase the cost of patient care
 Adversely affect patient quality of life
 Cause patients to lose confidence in doctors
 Occurrence of toxicity in a minority of patients will
preclude use of the drug in the majority of patients
 Mimic disease and result in unnecessary
investigations and/or delay in treatment
 Major economic burden on the
pharmaceutical industry
Design of ADR Report Form
 In Confidence
ADVERSE DRUG REACTION (ADR) REPORT FORM
IN
CONFIDENCE
Do not be put off reporting if some details are not known. Please complete as much information as possible.
PATIENT DETAILS
INITIALS _________ SEX  MALE  FEMALE
 Patient Details
 Suspected Drugs
SUSPECTED DRUG (S) / VACCINE (S)
Brand name of drug and batch no. (if known)
AGE (at time of reaction) ________ WEIGHT (in kg, if known) _________
Dosage
Date started
Date started
SUSPECTED REACTION(S) (Description of Toxic/Side Effects/Interaction)
OTHER DRUGS (including self-medication & herbal remedies)
Brand name of drug and batch no. (if known)
Dosage
Date stopped
Date started
Date stopped
Prescribed for:
Date stopped
Prescribed for:
 Suspected Reactions
 Other Drugs
How serious do you consider this ADR?
 Fatal
 Life threatening
 Caused or prolonged hospitalisation
 Congenital abnormality
 Caused disability or incapacity
 Not serious
 Other: (please state) ___________________
Outcome from ADR:
 Recovered
 Recovering
 Continuing
 Long-term effects
 Death related to the ADR
 Death not related to ADR
 Not known
For this ADR was:
YES NO
Drug discontinued
 
Improvement on discontinuation  
Patient rechallanged
 
Manufacturer notified
 
Treatment required
 
If yes, which? ____________________
If pregnant, state age: ________ weeks
ADDITIONAL RELEVANT INFORMATION (medical history, test results, known allergies, suspected drug interactions)
 Seriousness
REPORTER DETAILS (name, speciality, address, telephone number)
 Outcome
Signature _____________________
 Reporter Details
Date___________________
MEDICINES REGULATORY UNIT Tel: 34939000 Fax: 34939161
http://www.health.gov.mt/mru EMAIL: [email protected]
E-MAIL ______________________________
SUPPLY OF ADR REPORT CARDS IS REQUIRED 
FURTHER INFORMATION ABOUT OTHER ADR’s 
What to report
 Reports on all suspected adverse reactions known
or not, serious or not, are welcome and useful
 Established drugs - Serious or unusual reactions are
of particular importance
 Known and minor reactions are of less interest
 If an increased frequency of a given reaction is
suspected this is also a reason for reporting
Causality Categories
 Category A: ‘Good reasons and sufficient documentation to
assume a causal relationship, in the sense of plausible,
conceivable, likely, but not necessarily highly probable’
 Category B: ‘Reports containing sufficient information to
accept the possibility of a causal relationship, in the sense
of not impossible and not unlikely, although the connection
is uncertain and may even be doubtful, e.g. because of
missing data, insufficient evidence or the possibility of
another explanation’
 Category 0: ‘Reports where causality is, for one or another
reason, not assessable, e.g. because of missing or
conflicting data’
“Reporting Culture”
Raising HCP’s awareness


All medicines can cause adverse drug reactions
Responsibility to participate in national pharmacovigilance system
Advantages of Spontaneous ADR Reporting:


Operates for all drugs throughout the whole of their lifetime
Only affordable method of detecting really rare ADR’s
Main weaknesses


Under-reporting (not more than 10%)
“numerator” data (the number of reports of each suspected reaction)
Under-reporting
Reporting of ADR’s needs continuous stimulation:
 To achieve a positive attitude towards reporting
 To make reporting an accepted and understood routine
The following may stimulate reporting:






Easy access to pre-paid ADR reporting forms
Acknowledgement of receipt of ADR forms
Feedback in the form of bulletin/newsletter
Participation in education and scientific meetings
Collaboration with professional associations and committees
Pharmacovigilance in clinical pharmacy
Pharmacovigilance & Market Authorisation
Draft Regulations:
“The marketing authorization holder shall be required to record
and report all other suspected serious adverse reactions which
are brought to his attention by a health care professional
immediately to the competent authority ... and in no case later
than 15 calendar days following the receipt of the information.”
“Where, as a result of the evaluation of pharmacovigilance
data, the Medicines Authority considers that a marketing
authorisation should be suspended, withdrawn or varied…”
“In case of urgency, the Medicines Authority may suspend the
marketing authorisation of a medicinal product….”
Medicines Advisory Board and Experts
MAB:
Physician, Pharmacologist,Toxicologist
Experts: All specialist areas






Anatomy, Physiology, Pharmaceutics etc…
Medicine, Surgery, Cardiology, Dermatology etc...
Paediatrics, Geriatrics, Diabetes, Vaccines etc..
Intensive care, Anaesthesiology, Dentistry etc...
Biotechnology, Genetics, Medical Devices etc…
Nutrition, Pharmacognosy, Herbals, Homeopathics
etc...
Work to be carried out by MAB
 Review of data and advice given leading to Variations,
Suspension or Withdrawals of Marketing Authorisations of
Medicinal Products
Example: Aspirin - association with Reye’s Syndrome - UK
 1986 - CSM advised that children less than 12 years should not
receive aspirin except on medical advice
 1999- 2001 Relevant data for children aged 12 and over
reviewed
 New proposed warning: “Do not give to children aged under 16
years, unless on the advice of a doctor”
In Conclusion the Aims of PhVG are to:
 Improve patient care and safety
 Improve public health and safety
 Contribute to the assessment of benefit, harm,
effectiveness and risk of medicines
 Promote understanding, education and clinical
training in pharmacovigilance and its effective
communication to the public
Summary of Pharmacovigilance Plan
 Design of ADR reporting card
 Launching of new ADR reporting system (Seminar, Workshops)
 Launching of market authorisation project
 Seminar (NtMAHs, obligations of MAHs, HCPs and regulatory
authority, as well as reinforcing use of ADR reporting card)
 Launch of newsletter on drug safety issues
• targeting HCPs, scientific institutions & patient groups
 Academia – regulatory affairs education
Thank you for your attention
You can visit our website at:
http://www.health.gov.mt/mru