An introduction to PGDs and
Varenicline
Sarah Hudson, Acting Chief Pharmacist
Objectives for this afternoon
• PGDs in practice
• Varenicline
What is a PGD?
• A written instruction for the supply or
administration of a medicine to a group of
patients who may not be individually identified
before presentation for treatment.
• Replace standing orders, group protocols,
unit/department procedures, etc.
• These are now unlawful.
• Supply of a POM or P other than on
prescription or PGD is a criminal offence.
Background
• Before PGDs, law was unclear.
• Practitioners administering POMs not on
individual prescription were probably breaking
the law (Medicines Act 1968).
• Crown 1 recommended clarification.
• Law changes came into effect August 2000.
What do PGDs permit?
• Authorise named professionals from specified
groups to supply or administer POMs other
than on individual prescription from a doctor in
specific circumstances.
• Supply/administration, not prescribing.
• Empowering for non-prescribers.
• Opportunity to ensure best practice.
What does this mean
in practice?
PGDs specify
• What registered professional group can use the
PGD e.g. Pharmacists.
• In what situations.
• Inclusion and exclusion criteria (how would you
check).
• Product to be used.
• Follow up.
When to use a PGD
• Most patients should be treated on an individual,
patient-specific basis.
• “Use PGDs in limited situations where there is
an advantage for patient care”.
• Patient safety must not be compromised.
• Must be consistent with appropriate professional
relationships & accountability.
How to use a PGD
• Pharmacists must work in line with GPhc
Professional Standards.
• PGD must be authorised for your organisation.
• You must sign the PGD.
How to use a PGD
• No scope for interpretation, discretion or
adjustment.
– This is not prescribing, it is
supply/administration.
• A patient excluded from treatment under a
PGD might still be treated, but only on
prescription from a doctor or non-medical
prescriber if applicable.
How are PGDs produced?
• Specific requirements in legislation.
• Must be produced by a doctor, pharmacist and
member of profession to which applies.
• Must be authorised for use by specified senior
staff.
Labelling of medicines
• Must use original packs (eg Levonelle) or use
pre-packs from a pharmacist unless giving for
immediate administration or be labelled as
per labelling legislation.
• All patients should be given the
manufacturer’s patient information leaflet.
Other responsibilities
• Signing up mechanism required.
• Named person to be responsible for maintaining
the file.
• System for review and updating.
• Distribution.
• Questions?
Completing the voucher
• The Stop Smoking Advisor (Specialist Service or
LES) will complete the first 3 sections of the
voucher – client details, advisor details &
request titration or maintenance pack
• The dispensing pharmacist must complete the
date of supply, inclusion/exclusion criteria, client
consent and sign the voucher at the bottom of
the form.
Inclusion/exclusion criteria
1. Aged 18 or above
2. Tobacco dependant & sufficiently motivated to stop smoking
3. Agreed to behavioural support during course of Varenicline
Is the client currently:
4. Pregnant or breastfeeding?
Does the client have a history of:
5. Renal disease?
6. Epilepsy?
7. Sensitivity to Varenicline or any of its excipients?
8. Psychiatric illness?
All clients must answer YES to Questions 1-3 to be eligible.
If clients answer YES to any of Questions 4 -8, not eligible for Varenicline via
the PGD.
Quick Questions??
1) According to the PGD what would you supply on
the 1st Supply?
2) What would you do if the person arrives for the
second supply 4 weeks after receiving supply 1?
3) Can you issue varenicline under a PGD you
haven’t signed?
4) Can you supply to a pregnant woman under this
PGD?
5) Can you supply if the person indicates they wont
access behavioral support?
Useful resources
www.medicines.org.uk
www.bnf.org
Varenicline (Champix) ▼
• CHAMPIX is indicated for smoking cessation in
adults.
• Black triangle status and MHRA advice.
• http://www.mhra.gov.uk/Safetyinformation/DrugS
afetyUpdate/CON087901
Dose
• The recommended dose is 1 mg varenicline
twice daily following a 1-week titration as follows:
Days 1 – 3:
0.5 mg once daily
Days 4 – 7:
0.5 mg twice daily
Day 8 – End of treatment 1 mg twice daily
Treatment
• The patient should set a date to stop smoking.
CHAMPIX dosing should usually start at 1-2
weeks before this date.
• Patients who cannot tolerate adverse reactions
of CHAMPIX may have the dose lowered
temporarily or permanently to 0.5 mg twice daily.
• Patients should be treated with CHAMPIX for 12
weeks.
Effect of smoking cessation
Physiological changes resulting from smoking
cessation, with or without treatment with
CHAMPIX, may alter the pharmacokinetics or
pharmacodynamics of some medicinal products,
for which dosage adjustment may be necessary
(examples include theophylline, warfarin and
insulin).
Neuropsychiatric symptoms
• Changes in behaviour or thinking, anxiety,
psychosis, mood swings, aggressive behaviour,
depression, suicidal ideation and behaviour and
suicide attempts have been reported in patients
attempting to quit smoking with CHAMPIX.
• Depressed mood, rarely including suicidal
ideation and suicide attempt, may be a symptom
of nicotine withdrawal.
Cardiovascular events
• Certain cardiovascular events were reported
more frequently in patients treated with
CHAMPIX.
• Patients taking CHAMPIX should be instructed
to notify their doctor of new or worsening
cardiovascular symptoms and to seek immediate
medical attention if they experience signs and
symptoms of myocardial infarction or stroke.
Reporting adverse reactions
• Compliance and adverse reactions will be monitored at
the bi-weekly follow-up.
• Staff will report all adverse reactions in accordance with
the UK Adverse Drug Reaction Reporting Guidelines
(Yellow card system available at;
http://www.yellowcard.gov.uk/).
• Clients who report agitation/ depression/ suicide ideation
/change of mood or new or worsening cardiovascular
symptoms must stop treatment immediately and seek
prompt medical advice.
Any Questions or Comments?