Transcript The Role of Healthcare Professionals in ADR reporting

The Role of
Healthcare Professionals
in ADR reporting
Michael Bonett
Post-Licensing Section
Medicines Authority
“There are no safe drugs,
there are only safe doctors”
B Berde, 1997
Are there any safe drugs?
10,000
Perhaps the greatest
of all drug disasters
was the thalidomide
tragedy of 1961-1962
when thalidomide
caused major birth
defects in an
estimated 10 000
children in the
countries in which it
was widely used for
the treatment of
nausea and vomiting
in early pregnancy.
Are licensed drugs safe?
• The thalidomide disaster led to the establishment of the
drug regulatory mechanisms of today, however
• Tests in animals are insufficiently predictive of human
safety
• In clinical trials patients are selected and limited in
number, the conditions of use differ from those in
clinical practice and the duration of trials is limited
• Information about rare but serious adverse drug
reactions (ADR’s), chronic toxicity, use in special
groups or drug interactions is often incomplete or not
available
Are healthcare professionals safe?
• Healthcare professionals may have expectations
that licensed drugs are “safe” and are surprised
when a very small proportion of licensed drugs
have to be withdrawn due to unexpected drug
toxicity
• Not all ADRs are detected before licensing
Are healthcare professionals safe?
• A potential reporter may have an exaggerated
confidence in the safety of a drug
• Based on the incorrect belief that the phase III
development of a drug reveals its entire safety
profile
• A form of scientific naiveté, assuming that “only
safe drugs are marketed.”
• Promotion of the drug may stress efficacy at the
expense of safety issues
Pharmaco - vigilance
Greek
Latin
Pharmakon
Vigilare
Drug
To keep awake or
alert, to keep watch
To keep watch on drugs, in particular their safety
Medicina – The first healthcare professional
Cockrel
Wreath of
laurels
Snake
Medicina
Aesculapius’
staff
A symbolic representation of what pharmacovigilance entails, (van Goothest, 2003)
The Essential Role of HCPs
•
The signals of adverse drug reactions derived from experiences with
patients using drugs as reported by doctors and pharmacists lie at the
heart of pharmacovigilance.
•
In all countries, where pharmacovigilance systems operate the role of
HCPs is vital in recording and reporting suspected ADRs observed in
their practice.
•
The advantages of an ADR reporting system include that it operates for
all drugs throughout their lifetime and that it is the only affordable
method of detecting really rare ADRs.
•
The participation of HCPs is therefore considered essential for the
functioning of the pharmacovigilance system.
HCPs & ADR reporting
• ADR reporting is now an accepted and understood
routine in many countries
• ADR reporting is integral to the healthcare
professionals’ duties
• Healthcare professionals are motivated by their
professional conscience to comply with reporting
requirements established by law
Causality
• Causality is the probability that an ADR is due to a
drug and refers to individual cases and the
assessment of what a healthcare professional
would call clinical likelihood that the ADR was
due to the drug. (Biron et al., 2002)
• The healthcare professional may be uncertain that
the drug caused the ADR
• Uncertainty about the causality between a suspected ADR and the
drug used is mentioned by both physicians and pharmacists as a
barrier to the submission of reports. This is perhaps unsurprising,
and signifies a scientific way of thinking that requires certainty for
action. However, it is unfortunate that this mind-set prevents some
from reporting. After all, pharmacovigilance concerns the
gathering of data on suspected ADRs.
• It is the task of the national reporting centres to establish the
causality between reported suspected ADRs and the drugs used by
elimination of as many uncertainties as possible by means of
causality assessment and statistical methods (Meyboom, 1997)
• Healthcare professionals should not refrain from
publishing a first case report until they have a
second or third case in their practice
The Answer:
“When there is a suspicion, report’
• This phenomenon is an important source of delay
in the publication or reporting of important
signals, particularly when the second case occurs a
year or two after the first
• Although the desire for scientific validation with a
second case is very understandable, the healthcare
professional is requiring that the second case
occur in his or her own practice, although it could,
in fact, be seen and thus validated by a different
observer. The failure to report to the health
agencies or the manufacturer can delay the
appropriate analysis and actions (e.g. a call for
additional cases) of a serious signal. (Barton et al,
2002)
• The decision to use a particular treatment is
based on the analysis of the benefit/risk
ratio
• There also exists the entirely
understandably impression in the prescriber
that he or she has given a patient a
medication that has produced harm. In a
study of Irish physicians, 7.6% expressed
this idea (Feely, 1990). This factor might
also impede ADR reporting.
• The fear of being ridiculed for having sent
to a pharmacovigilance unit “an ADR that
everybody is already aware of” and is “of
little or no signaling value” was cited by
Irish physicians in a study as a reason to
hesitate about reporting a suspected ADR.
(McGettigan, 1995)
• If the drug was used for an unapproved
indication (off-label prescribing) the
prescriber may not wish to call attention to
this. (Biron et al, 2002) The reporter may
not want to supply privileged details even if
anonymised, along with his or her name and
address to government and manufacturers.
(Biron et al, 2002)
• In Great Britain and Australia, healthcare
professionals are proud of their publications
Current Problems in Pharmacovigilance and
the Austrialian Drug Adverse Reactions
Bulletin, respectively.
• In countries where no such bulletin exists,
awareness to ADR reporting is lower.
(Biron et al, 2002)
• You can be reassured that the Medicines
Authority will value your reports
• Factors dissuading hospital pharmacists
from participation included lack of clinical
knowledge, pressure of work and a lack of
time
Relationship between GP & Pharmacist
• Discussed reports with GPs and other
pharmacists
• relationship between the pharmacist and
doctor
• Where pharmacists lack confidence about
their knowledge level or skills
Reporting Form
• The Reporting form is easy to fill in
• Not too time-consuming
Feedback
• Feedback is the prime motivator for ADR
reporting
• Publications on ADR are the most important
stimulus in reporting
Benefits of Reporting
• Reporting is an indication of taking your
patient’s complaints seriously
Thank you for your attention
You can visit our website at:
http://www.health.gov.mt/mru