CLINPHARM
D M C C F I - P H A R M A C Y D E PA RT M E N T
M I D T E R M TO P I C 2 n d S e m
OBJECTIVES
• Learn the Professional frameworks for
prescribing
• Practice the Calgary Cambridge
consultation framework
• Build interpersonal skills and reasoning
skills
• Understand the importance of
communicating risks and benefits of
treatment
PRESCRIBING
Professional frameworks for prescribing
Professional standards for pharmacists
defined within ‘Medicines, Ethics and Practice’ and contain
additional requirements for pharmacists who are qualified as
non-medical prescribers and also good practice guidance.
PRESCRIBING
Off-label and unlicensed prescribing
For a medicine to be licensed for use in a specific country,
the manufacturer must obtain a marketing authorization,
formerly called the product license.
PRESCRIBING
Off-label and unlicensed prescribing
Unlicensed Medicines
Any medicine which does not have a marketing authorization
for the specific country where it is prescribed.
Ex: -Medicines undergoing clinical trial
-Licensed and imported from another country but not
licensed in the country where they are to be used
PRESCRIBING
Off-label and unlicensed prescribing
Off-label
If a licensed medicine is prescribed outside that specified in
the marketing authorization.
Ex: -Many medicines are not licensed for use in children but
are prescribed for conditions outside their marketing
authorization.
PRESCRIBING
Off-label and unlicensed prescribing
What happens if a patient is harmed from the medicine even
though it is used within marketing authorization?
The company which holds the marketing authorization has
the responsibility to compensate patients who are proven to
have suffered unexpected harm caused by the medicine
when prescribed and used in accordance with the marketing
authorization.
PRESCRIBING
Off-label and unlicensed prescribing
Advice for prescribing unlicensed and off-label medicines (from
Drug Safety Update, 2009)
CONSIDER
• Before prescribing an unlicensed medicine be satisfied
that an alternative licensed medicine would not meet the
patient’s needs.
PRESCRIBING
Off-label and unlicensed prescribing
CONSIDER
• Before prescribing an off-label medicine be satisfied that
such use would better serve the patient’s needs than an
appropriately licensed alternative.
• Before prescribing an unlicensed medicine or using an
off-label medicine:
￭ be satisfied that there is a sufficient evidence
base and/or experience of using he medicine to
show its safety and efficacy;
PRESCRIBING
Off-label and unlicensed prescribing
CONSIDER
￭ take responsibility for prescribing the medicine and
for overseeing the patient’s care, including
monitoring and follow up;
￭ record the medicine prescribed and, where common
practice is not being followed, the reason for
prescribing the medicine; you may wish to record
that you have discussed this with the patient.
PRESCRIBING
Off-label and unlicensed prescribing
COMMUNICATE
• You give patients, or those authorizing treatment on their
behalf, sufficient information about the proposed
treatment, including known serious or common adverse
drug reactions, to enable them to make informed
decision.
PRESCRIBING
Off-label and unlicensed prescribing
COMMUNICATE
• Where current practice supports the use of a medicine
outside the terms of its license, it may not be necessary
to draw attention to the license when seeking consent.
However, it is a good practice to give as much
information as patients or carers require or which they
see as relevant.
PRESCRIBING
Off-label and unlicensed prescribing
COMMUNICATE
• You explain the reasons for prescribing an off-label
medicine or prescribing an unlicensed medicine where
there little evidence to support its use, or where the use
of the medicine is innovative.
PRESCRIBING
Clinical governance
the system through which NHS organizations are
accountable for continuously improving the quality of their
services and safeguarding high standards of care, by
creating an environment in which clinical excellence will
flourish
PRESCRIBING
Clinical governance
parallels Corporate Governance within commercial
organizations and as such provides a systematic set of
mechanisms such as duties, accountabilities and rules of
conduct to deliver quality health care.
PRESCRIBING
Clinical governance
Corporate Governance is the system of rules, practices and
processes by which a company is directed and controlled.
PRESCRIBING
Clinical governance
7 pillars of clinical governance
• Patient, service user, carer and public involvement
• Risk management
• Clinical audit
• Staffing and management
• Education, training and Continuing Professional
Development (CPD)
• Research and clinical effectiveness
• Use of information
PRESCRIBING
Clinical governance
Overview of clinical governance practice recommendations
for prescribers
• Ensure effective communication with patients and carers
to meet the patient’s needs, so that the patient can make
informed choices about their treatment.
• Prescribe within competence (scope of practice).
• Obtain patient consent for investigations and
management.
PRESCRIBING
Clinical governance
Overview of clinical governance practice recommendations
for prescribers
• Document in the patient’s medical record, a
comprehensive record of the consultation and the agreed
treatment plan.
• Undertake full assessment of patients competently and
with consent.
• Prescribe safely, legally, appropriately, clinically and cost-
effectively with reference to national local guidelines.
PRESCRIBING
Clinical governance
Overview of clinical governance practice recommendations
for prescribers
• Assess and manage risk of treatment and associated
investigations.
• Prescribe and refer in accordance with the clinical
management plan if relevant,
• Ensure the secure storage of prescriptions and follow the
relevant organizational procedures if they are lost or
stolen.
PRESCRIBING
Clinical governance
Overview of clinical governance practice recommendations
for prescribers
• Ensure wherever possible separation of prescribing and
dispensing; prescribing and administration.
• Audit prescribing practice.
• Identify and report incidents and adverse drug reactions.
PRESCRIBING
Clinical governance
Overview of clinical governance practice recommendations
for prescribers
• Participate in and record continuing professional
development relating to prescribing.
• Follow organizational procedures for dealing the the
pharmaceutical industry regarding gifts and hospitality.
PRESCRIBING
Competence and competency frameworks
Competence can be described as the knowledge, skills and
attributes required to undertake an activity to a specific
minimum standard within a defined environment.
PRESCRIBING
Competence and competency frameworks
Competency framework is a group of competencies identified
as essential to effectively perform a specific task. It can be
used by an individual or an organization to assess
performance in this defined area.
PRESCRIBING
Competence and competency frameworks
Overview of the National Prescribing Center competency
framework for pharmacists (Granby and Picton, 2006)
Competency area
• Consultation
• Prescribing effectively
• Prescribing in context
PRESCRIBING
Competence and competency frameworks
Competency area
• Consultation
Competency
• Clinical pharmaceutical knowledge
Behavior indicator
• 10 statements
• Ex, understands the conditions being treated, their
natural progress and how to assess their severity
PRESCRIBING
Competence and competency frameworks
Competency area
• Consultation
Competency
• Establishing options
Behavior indicator
• 14 statements
• Ex, assesses the clinical condition using appropriate
techniques and equipment
PRESCRIBING
Competence and competency frameworks
Competency area
• Consultation
Competency
• Communicating with patients
Behavior indicator
• 11 statements
• Ex, explains the nature of the patient’s condition, the
rationale behind and potential risks and benefits of
management options
PRESCRIBING
Competence and competency frameworks
Competency area
• Consultation
Competency
• Communicating with patients
Behavior indicator
• 11 statements
• Ex, explains the nature of the patient’s condition, the
rationale behind and potential risks and benefits of
management options
PRESCRIBING
Competence and competency frameworks
Competency area
• Prescribing effectively
Competency
• Prescribing safely
Behavior indicator
• 9 statements
• Ex, only prescribes a medicine with adequate, up-to-date
knowledge of its actions, indications, contraindications,
interactions, cautions, dose and side effects
PRESCRIBING
Competence and competency frameworks
Competency area
• Prescribing effectively
Competency
• Prescribing professionally
Behavior indicator
• 8 statements
• Ex, accepts personal responsibility for own prescribing
and understand the legal and ethical applications of
doing so
PRESCRIBING
Competence and competency frameworks
Competency area
• Prescribing effectively
Competency
• Improving prescribing practice
Behavior indicator
• 7 statements
• Ex, reports prescribing errors and near misses, reviews
practice to prevent recurrences
PRESCRIBING
Competence and competency frameworks
Competency area
• Prescribing context
Competency
• Information in context
Behavior indicator
• 6 statements
• Ex, critically appraises the validity of information sources
(e.g. promotional literature, research)
PRESCRIBING
Competence and competency frameworks
Competency area
• Prescribing context
Competency
• The NHS in context
Behavior indicator
• 5 statements
• Ex, follows relevant local and national guidance for
medicines use (e.g. local formularies, care pathways,
NICE guidance)
PRESCRIBING
Competence and competency frameworks
Competency area
• Prescribing context
Competency
• The team and individual context
Behavior indicator
• 7 statements
• Ex, establishes relationships with colleagues based on
understanding, trust and respect for each other’s roles
