Download Chlamydia_treatment_PGD_for_Community_Pharmacy_2_2

Patient Group Directions for Community
Pharmacists signed up to the Pharmacy
Integrated Sexual Health LES 2010/11
Patient Group Direction
For the treatment of 16-24 year olds diagnosed with uncomplicated
Chlamydia trachomatis
Date of Issue: July 2010
Date of review: June 2012
PATIENT GROUP DIRECTIONS
What are Patient Group Directions (PGD)?
“A Patient Group Direction is a specific written instruction for the supply or the
administration of named medicines in an identified clinical situation. It is drawn
up locally by doctors, pharmacists and other appropriate professionals. It applies
to groups of customers or other service users who may not be individually
identified before presentation for treatment”.
The PGD will define:
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Specifics of person authorised to supply under the PGD
Minimum training requirements
Individual assessment prior to supply
Inclusion criteria
Exclusion criteria
Referral criteria
Further Information:
HSC 2000/026 Patient Group Directions (England)
RPSGB Professional Standards Directorate: Patient Group Directions a resource
pack for pharmacists
RPSGB Professional Standards Directorate: Fact Sheet: Ten: Patient Group
Directions
1. PCT Authorisation Form
Patient Group Directions for Community Pharmacists signed
up to the Pharmacy Integrated Sexual Health LES 2010/11
PGD for treatment of 16-24 year olds diagnosed with
uncomplicated Chlamydia trachomatis
The Patient Group Directions contained in this document have been
approved and authorised for use by Berkshire West PCT.
Position of
Name
Signature
signatory
Chief Executive
Charles Waddicor
Chair of Berkshire
West PCT
Integrated
Governance
Wendy Bower
Clinical Director
Dr David Buckle
PCT Prescribing
Lead
Dr Martin Smith
Strategic Head of
Medicines
Management
Maha Yassaie
Director of Public
Health
Helen Mackenzie
Date of implementation: July 2010
Date of review: June 2012
Date
TRAINING & PROFESSIONAL REQUIREMENTS
All Pharmacists proving treatment of 16-24 year olds diagnosed with uncomplicated Chlamydia
trachomatis.
Patient Group Direction are required to meet the following criteria: Be registered as member of the Royal Pharmaceutical Society of Great Britain.
 To have signed the Service Level Agreement to provide services according to the patient
group direction for which they are competent.
 Ensure that they continue to update their skills and knowledge by attending training as
necessary.
 To be aware of local referral options.
 To be able to designate specific window space for a poster or sticker relating to the
scheme
 To train their Pharmacies staff to confidentially and discreetly direct any referrals from
GPs or nurses to the pharmacist.
 To complete all necessary paperwork and collect agreed data to enable monitoring and
evaluation of the project.
 Have a suitable area for consultation with customers, not necessarily a room.
 To attend reaccredidation training updates as required.
 Maintain their competency and have a commitment to continuing professional
development
Intended outcomes
 The customer is able to make an informed choice about treatment options and who they
wish to receive treatment from.
 The supply of Azithromycin 250mg Capsules or Azithromycin 250mg Tablets in
accordance with the PGD.
 The customer is managed in a way that meets their need, and GP referral is encouraged
where appropriate.
 Improve access to a wider range of treatments from Community Pharmacists.
Labelling
The pack should be labelled with the following information:
 Product name
 Pharmacy address
 Keep out of the reach of children
 Directions for use
 Name of customer
 Date of supply
Patient information leaflet
Customers should be given a copy of the manufacturers 'patient information leaflet' and any
Berkshire West PCT patient information leaflet.
Record keeping
A standard record form should be completed for each customer, including those which are
excluded from the protocol or declined treatment. It is expected that these clients will be given
additional advice in accordance with the intended outcomes of the scheme.
The Pharmacist may also want to keep a record in the PMR.
Adverse drug monitoring
All ADRs should be reported to the MHRA using the yellow card system.
Serious event monitoring
If a Pharmacist makes a supply and becomes aware the supply was outside the authority of this
PGD, a record should be made and appropriate action taken.
Pharmacists should consider reporting any issue relating to the scheme to the PCT using the
adverse event report form.
Direction for the
administration of:
Azithromycin 250mg Capsules or Azithromycin 250mg Tablets
Purpose of the treatment:
To treat individuals testing positive for uncomplicated Chlamydia
trachomatis genital infection
Specialism to which the
PGD applies:
Community Pharmacy
Clinical condition
Clinical condition /
situation:
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For the treatment of confirmed uncomplicated genital infection
due to Chlamydia trachomatis.
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Asymptomatic male and female patients with a laboratory
confirmed Chlamydia positive diagnosis who are aged 16 to 24
years.
Patients must weigh over 45kg body weight.
Inclusion Criteria:
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Exclusion Criteria:
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Individuals falling outside of the Inclusion Criteria
Individuals under 16 years old
Individuals under 45kg body weight
Known hypersensitivity to azithromycin or any of the macrolide
or ketolide antibiotics, such as erythromycin or to any of the
excipients
Patients taking drugs that could potentially interact with
Azithromycin such as the anti-depressant drug reboxetine or
taking concomitant terfenadine, ciclosporin, coumarins, digoxin,
rifabutin, theophylline, drugs that prolong the QT interval or any
ergot derivatives. Patients taking these drugs need to be
referred to a Doctor. See BNF Appendix 1 for full list of
Interacting Drugs.
Pregnancy, risk of pregnancy or breast-feeding mothers.
Known hepatic or renal impairment.
Symptomatic patients-Refer to the Florey Unit Or GP
Avoid in patients with congenital or documented acquired QT
prolongation and patients with clinically relevant bradycardia,
cardiac arrhythmia or severe cardiac insufficiency.
Avoid in patients with electrolyte disturbance (particularly in
hypokalaemia and hypomagnesemia).
Use with caution in patients with neurological or psychiatric
diseases.
Patients with rare hereditary problems of galactose intolerance,
the Lapp lactase deficiency or glucose-galactose malabsorption
should not take this medicinal product- Azithromycin tablets
(TEVA brand). Zithromax capsules contain lactose.
Invalid consent.
Action if patient
excluded:
Refer to the sexual health service / doctor as appropriate.
Document reason for exclusion, advice given and any action taken.
Action if patient declines
treatment
Document advice given. Advise referral to a doctor / sexual health
service. Advice to be given of the risks and complications of untreated
Chlamydia trachomatis and advice given to use condoms in future.
Treatment
Name, strength and
formulation of medicine:
Azithromycin 250mg Capsules
Azithromycin 250mg Tablets
Route:
Oral
Oral
Legal status of medicine:
Prescription only medicine
(POM)
Prescription only medicine (POM)
1g (as 4 x 250mg capsules) as a
stat dose, swallowed whole either
on an empty stomach or at least
1 hour before or 2 hours after
food and ideally taken as directly
observed therapy (DOT).
1g (as 4 x 250mg tablets) as a stat
dose. Can be taken either with or
without food ideally as directly
observed therapy (DOT).
The product must be labelled in
line with regulations.
The product must be labelled in line
with regulations.
Minimum and maximum
total doses:
1g (as 4 x 250mg capsules)
1g (as 4 x 250mg tablets)
Frequency of
administration:
Single dose only
Single dose only
Maximum and minimum
treatment periods:
Not Applicable
Details of
administration/special
instructions:
Storage
Follow up actions
required:
Store in the original packaging according to the individual manufacturers
instructions.
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Written and verbal advice
given to patients
Pre or post treatment:
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Relevant warnings,
including potential
adverse reactions/contraindications:
None, if drug taken in accordance to instructions.
If vomiting occurs after treatment the patient should be referred
to a doctor.
If intolerance, non-compliance or re-exposure is suspected or
occurs, refer for retreatment as per protocol.
Advise to avoid taking any food with the supply of Azithromycin
capsules
Azithromycin Tablets can be taken with food.
If using antacids, Azithromycin should be taken at least one
hour before or two hours after taking the antacid.
Advise of possible side effects of nausea and diarrhoea.
Give information about the condition and on safer sexual
practices.
Advise that at least one week must elapse following treatment of
both patient and partners before resuming sexual activity.
Partner notification is essential for Chlamydia infections. Ensure
all Chlamydia cases are referred to the appropriate health care
professional.
Supply product patient information leaflet (PIL) and give patient
the opportunity to read it before taking the medication.
Azithromycin is generally well tolerated with a low incidence of side
effects and causes fewer GI side effects than other macrolide antibiotics
such as erythromycin. Common potential side effects include nausea,
Identification and
management of adverse
reactions:
vomiting, loose stools and diarrhoea and abdominal discomfort.
Uncommon: Dizziness and vertigo, somnolence, headache,
convulsions, taste and smell disturbance, syncope, loose stools,
flatulence, digestive problems, anorexia, dyspepsia, pruritis and rash,
arthralgia, vaginitis
Rare: Thrombocytopenia, haemolytic anaemia, aggressiveness,
agitation, anxiety, nervousness, paraesthesia and asthenia, insomnia,
hyperactivity, impaired hearing, deafness, ringing in the ears,
palpitations, arrhythmias including ventricular tachycardia, QT
prolongation and torsades de pointes, hypotension, constipation, tongue
and teeth discolouration, pancreatitis, pseudomembranous colitis,
hepatitis and cholestatic jaundice, abnormal LFT’s, hepatic necrosis and
dysfunction, angioneurotic oedema, urticaria, photosensitivity, erythema
multiforme, Stevens_Johnson syndrome, toxic epidermal necrolysis,
interstitial nephritis, acute renal failure, anaphylaxis, candidiasis, fatigue,
malaise and delirium (especially in the elderly).
Azithromycin may reduce the effectiveness of combined oral
contraceptives or contraceptive patches. It is recommended to use
additional contraceptive precautions during concomitant use and for 7
days after completing the course. If these 7 days run beyond the end of
the current packet of contraceptive pills or beyond the 3 weeks of patch
treatment, a new contraceptive cycle should be started without a
treatment- free break. In the case of ED tablets, the inactive tablets
should be omitted.
The patient should consult a doctor if any side effects experienced are
severe or troublesome.
Circumstances in which
further advice should be
sought from a Doctor
and arrangements for
referral:
Reporting procedure of
adverse
reactions/incidents:
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Patient is taking any drugs that potentially could interact with
Azithromycin – see exclusion criteria.
Pharmacist is unsatisfied that all criteria are met.
Referral to Doctor as per local protocols.
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Document on PMR.
Any serious adverse reaction to the product should be reported
to the Medicines Health Regulatory Agency (MHRA) through the
yellow card scheme and to the patient’s GP with the patient’s
consent.
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In rare circumstances, azithromycin has been reported to have
caused serious allergic reactions including angioneurotic
oedema and anaphylaxis (rarely fatal). Some of these reactions
have caused recurrent symptoms and have required longer
observation and treatment.
Prolonged cardiac repolarisation and QT interval have been
seen in treatment with other macrolide antibiotics. A similar
effect with azithromycin can’t be ruled out in patients at
increased risk of cardiac effects - see Exclusion Criteria.
Special warnings/
precautions for use.
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Records:
Robust procedures must be in place to protect confidentiality of
information received, stored, sent and destroyed.
Chlamydia Screening records are required to be completed in all
cases. Consultation record should include:
Full history, results of sexual health screen, advice given and
any product information supplied including leaflets
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Details of product and quantity issued
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Date and signature of pharmacist issuing the drug
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Follow up referral arrangements as appropriate
Additional Information:
All drugs supplied must be labelled in accordance with the legal
requirements for dispensed medicines and a manufacturer’s patient
information leaflet provided.
Reference to national/local policies or guidelines:
 2006 UK National Guidelines for the Management of
Chlamydia Trachomatis. Ref BASHH http://www.bashh.org
 British National Formulary
 SPC for Zithromax capsules revised March 2008 Pfizer Ltd
 SPC for Azithromycin Tablets 250mg
 Medicines, Ethics and Practice: A guide for pharmacists and
pharmacy technicians, July 2007, available at
http://www.rpsgb.org/informationresources/
downloadsocietypublications/#m
* Key POM Prescription only
P Pharmacy only
GSL
General Sales List
Staff criteria
Professional
qualifications required:
Pharmacist registered with the Royal Pharmaceutical Society of Great
Britain
Specialist/additional
qualifications,
experience or training
required:
Accepts professional accountability for working within the PGD,
understands the legal implications of doing so and works within the
scope of the PDG.
Requirements for
continuing training and
education:
Maintains own level of updating with evidence of continued professional
development.