Patient Group Direction for the Supply Of

PGD NRT –Pharmacist and Nurse Supply

Patient Group Direction for the supply of

NICOTINE REPLACEMENT

THERAPY PRODUCTS (NRT)

Developed in partnership with Gloucestershire

NHS Stop Smoking Service (GSAS)

Authorisation of Supply or Administration

Sanger House
5220 Valiant Court
Gloucester Business Park
Brockworth
Gloucester

GL3 4FE

This document has been written and authorised on the understanding that it remains in its entirety with no additions, omissions or alterations.

Prepared By: The Countywide Patient Group Directions Working Group

Date Direction Comes Into Force: 1.5.2014

Date Direction Expires: 30.04.2016

Chief executives should ensure that any current or new PGDs comply with new legal requirements and the guidance set out in circular HSC 2000/026

Purpose of the Patient Group Directions (PGDs)

To enable a nurse or pharmacist (or other specified healthcare professional) who has received specific, appropriate training and has been assessed as competent to administer drugs in accordance with the following patient group direction and recommendations issued by the Department of Health 1998, the NMC Code of Professional Conduct: standards for conduct, performance and ethics (2007) and the NMC Standards for Medicines Management (2008) and the NMC Guidelines for Record Keeping (2007) or GPhC Standards of Conduct, Ethics and Performance Sept 2010 for Pharmacists and Pharmacy Technicians.

The PGDs may be adopted for use by General Practice Surgeries, for practice nurses to use.

This PGD must be signed off by the Pharmacy Clinical Governance Lead to authorise its use within the pharmacy

All information contained within this document was correct at the time of going to press. It is acknowledged that systems and processes change over time and that new drugs may be introduced. As licences vary, if a new brand is introduced it will not necessarily be covered within its corresponding PGD. If there are changes to practice, or the need for more PGDs to be developed, please contact the Head of Medicine Management at NHS Gloucestershire Clinical Commissioning Group (CCG).

For full product information please refer to the appropriate Summary of Product Characteristics (SPC) or visit the website at: www.emc.medicines.org.uk

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Clinic manager/clinical governance lead agreement:

(For all premises other than community pharmacies)

Medical approval for the supply/administration of Nicotine Replacement Therapy (NRT) under PGD within the following setting:

I, ………………………………………………., (Print name of clinic manager/clinical governance lead for clinic/surgery), give authorisation on behalf of: ……………………………………………………………………………………………………………………………………………………………………………………….(Clinic site/location)

All Surgeries/Departments should retain a ‘fully signed’ copy (both signatures as above i.e. completed pages 2 and 11) of the PGD for their files and/or this should be sent on to the head of service for their reference.

Signature ……………………………………………. Date…………………….

AUTHORISATION PAGE FOR PHARMACISTS

By signing this Patient Group Direction (PGD) you are indicating that you agree to its contents and that you will work within it.

PGDs do not remove inherent professional obligation or accountability

It is the responsibility of each professional to practice only within the bounds of their own competence. You cannot delegate tasks under this PGD to anyone else.

If this is an update or replacement PGD please ensure that all older versions are withdrawn from use with immediate effect.

It is your responsibility to make sure you are using the current version.

·  I have read and understood this Patient Group Direction, and agree to

issue NRT within ……………………………………………….(location).

·  By agreeing to act as an authorised practitioner under this PGD I am extending my role but this extension has not been a compulsory requirement.

NAME OF PHARMACIST

/ SIGNATURE / DATE / LOCATION

Please note: All practitioners using the PGD should retain a ‘fully signed’ copy for their personal use/files.

The signatures required to comply with a ‘fully signed copy’ are:

1.  The signature of the practitioner themselves (above)

2.  The signature of the Clinical Governance Pharmacist for the Pharmacy (page 11). This demonstrates the PGD has been approved for use at each location.

All Pharmacy Contractors should retain a ‘fully signed’ copy (both signatures as above) of the PGD for their files and/or this should be sent on to the head of service for their reference.

All Pharmacy Contractors should:

·  Retain a ‘fully signed’ copy (both signatures as above) of the PGD for their files,

·  Ensure that ONE copy of completed pages 11 and 15 of the PGD are sent to the Service Manager of GSAS (Address below)

Page 11 - requires signature of the Clinical Governance Pharmacist for the premises Page 15 - requires the name, registration number, date of training and signature of pharmacist(s) employed by you who have also signed a copy of the PGD and are accredited to work under it.

Send one copy of completed pages 11 and 15 to:

Service Manager

Gloucestershire NHS Stop Smoking Service (GSAS)

Edward Jenner Court

Brockworth GL1 4AW

Patient Group Direction for:

Nicotine Replacement Therapy (NRT)

For smoking cessation

1. Medicine details

Medicine name / Nicotine Replacement Therapy (NRT)
Form (e.g. tabs, inj etc) / NRT may be supplied in one or more of the following forms:
w  transdermal patches
w  chewing gum
w  lozenges
w  inhalator
w  nasal spray
w  micro tabs/sublingual tablets
w  oromucosal spray
Below is a table, which lists current products and strengths available.
Strength / Strengths vary depending on dosage form.
Dose including frequency / Dosage to be determined by the smoking cessation adviser in line with the recommendations of the product supplied.
The supply of product given to the person at each consultation will be in line with his/her requirement, until the next consultation.
The total number of week’s supply of NRT product given to anyone will be based on the individual’s need.
Compliance should be confirmed through the use of Carbon Monoxide (CO) readings.
Legal Category (POM,GSL or P) / General Sale List (GSL)
Route of administration / Oral, transdermal, nasal or inhaled, according to the product.
Storage instructions / w  Products should be stored below 25OC.
Potential adverse reactions
See BNF for full list and for a full list, the manufacturers Specification of Product Characteristics (SPC) available at www.emc.medicines.org.uk / Usually transient and may be due to either the NRT or the cessation of smoking.
Side effects may include:
Gastro-intestinal disturbances (including nausea, vomiting and dyspepsia); headache, dizziness, cold/flu-like illness, dry mouth, rash.
Less frequently: palpitations,
Rarely: atrial fibrillation,
With nasal spray: sneezing, epistaxis, watering eyes, ear sensations.
With lozenge: thirst, paraesthesia of mouth, taste disturbance.
Continued
Potential adverse reactions
See BNF for full list and for a full list, the manufacturers Specification of Product Characteristics (SPC) available at www.emc.medicines.org.uk
(continued) / With patches: skin reactions –discontinue if severe, vasculitis reported and changes in blood pressure
With patches or lozenge: sleep disturbances, nightmares, chest pain.
With gum or lozenge: mouth ulceration, increased salivation.
With gum, lozenge, sublingual tablet or inhalator: hiccups, throat irritation
With oromucosal spray: hiccups, oral symptoms such as burning lips or taste disturbance and gastric upset,
See Summary of Product Characteristics (SPC) for full list for each product.
Management of adverse reactions / If an adverse reaction occurs:
w  Stop treatment
w  Inform person’s GP as soon as possible
w  Document details
w  Discuss with GP the need to report the reaction to the MHRA (Medicines & Healthcare Products Regulatory Agency), using the yellow card system via the following link: http://yellowcard.mhra.gov.uk/
Note: specific adverse reactions may be listed for each individual drug, see summary of product characteristics for full list for each product.

2. Administration/supply criteria

Clinical condition or situation / Adults and children over 12 years of age, who are seeking support to quit smoking.
Inclusion criteria / w  Adults and children over 12 years of age who have presented at, or been referred to/ by GSAS and who agree to enter the support programme.
w  Adults and children over 12 years of age who have presented at a Community Pharmacy, and who are deemed sufficiently motivated to quit.
NOTE – see cautions if woman is pregnant
NOTE – see cautions if aged 12-18yrs
NOTE – see cautions if history of gastritis oesophagitis or peptic ulcers
Exclusion criteria / w  No valid consent
w  Person’s lack of commitment to the support programme
w  Current use of Buproprion (Zyban)
w  Current use of Varenicline (Champix)
w  Previous allergic reaction to an NRT product
w  Unstable Cardiovascular disease (unless approved by hospital consultant – see referral arrangements)
w  Stroke in the previous 2 weeks (unless approved by GP – see referral arrangements)
w  Uncontrolled hyperthyroidism or phaeochromocytoma (unless approved by GP – see referral arrangements)
Continued
Exclusion criteria (continued) / w  Chronic generalised skin disease (patches only)
w  Chronic nasal disorder (nasal spray only)
w  Phenylketonuria (lozenges only)
w  People who have been unsuccessful with the service in the last six months, unless deemed ready for another attempt by the Smoking Cessation Adviser
w  Hypersensitivity to any of the ingredients contained within the product
w  Under 12 years of age.
General action for patients excluded from, declining or not adhering to the treatment or if patient/parent/guardian declines treatment on behalf of a child / If person is excluded, refer to his or her own GP.
If person refuses to participate in programme:
w  Ensure they understand the benefits of the programme
w  Make them aware of the statistics for success rates of those following the programme compared with those who do not
w  Tell them NRT is available to buy if they wish to attempt to quit without involvement in the programme
w  Make sure they keep a note of contact telephone numbers if they decide to participate in the programme in the future.
Cautions/Need for further advice. / General
w  Diabetes – Diabetics will need to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.
w  Gastrointestinal problems may be exacerbated if using oral NRT preparations.
w  Caution in people with severe renal impairment.
w  Caution in people with moderate or severe hepatic impairment.
w  Caution in people with uncontrolled hyperthyroidism or phaeochromocytoma
w  If aged 12-16 years it is important that they are encouraged to involve parents/guardians for consent to NRT and further support. If young person refuses to involve parents use “Fraser ruling competence”, and make a record of this assessment. (See appendix). It is not necessary to contact his/her GP.
w  People who have suffered from any gastritis, oesophagitis or peptic ulcers should be encouraged to stop smoking without the use of NRT. (See side-effects). If they still feel they need NRT then use patches. If using oral products ensure correct use, as swallowing nicotine could cause increased gastric problems.
Continued
General cautions/further advice. (continued) / Pregnancy and breastfeeding:
w  In order to issue NRT to pregnant or breastfeeding women, advisers must have undertaken the additional specific training and assessment in NRT and pregnancy provided by GSAS.
w  In the event that this training has not been undertaken, the pregnant or breastfeeding woman must be referred to her GP or GSAS
If the NRT Adviser has been assessed as competent to treat pregnant women (see above) NRT may be supplied in pregnancy and breastfeeding as long as:
w  The woman understands the risks and benefits
w  All pregnant and breastfeeding women should be advised to give up smoking without any NRT
w  In the event that the woman feels unable to stop smoking without NRT, a risk benefit analysis form must be completed. Following this assessment the adviser can issue the NRT without GP consent
w  Pregnant women should firstly be offered an oral product unless they are suffering from nausea or vomiting. If a patch is issued then it must be removed at night (16 hour patch is recommended).
w  Pregnant women can be offered ‘Combination NRT’ (i.e.16 hr patch in combination with an oral product such as lozenge, gum, inhalator, sub lingual tablet or mouth spray)
w  For lactating mothers an oral product is recommended. It is important to discuss the timing of NRT use during the day (i.e. after a breast feed and two hours prior to a feed).
Drug interactions:
Smoking cessation may cause alteration to drug levels in the patients taking the following drugs. This would not normally be sufficient to cause therapeutic problems but clients should ensure their GP is aware that they are attempting to quit.
w  Insulin
w  Beta agonists
w  Beta blockers
w  Alpha blockers
w  Oxazepam
w  Furosemide
w  H2 receptor antagonists
w  Warfarin
w  Fluvoxamine
Continued
General cautions/further advice (continued) / Drug Interactions: (continued)
w  Clomipramine
w  Imipramine
w  Olanzapine
w  Flecainide
w  Tacrine
w  Pentazocine
w  Theophylline
w  Cinacalcet,
w  Ropinirole
w  Some antipsychotics ( including clozapine, olanzapine, chlorpromazine and haloperidol
Written / verbal advice to be given to patient or carer
Provide patient information leaflet where available / People should be given advice on:
w  Withdrawal symptoms
w  Possible weight gain
w  Effects of caffeine may be enhanced
w  Effects of smoking while using NRT
w  Self-help groups
w  Information leaflets
w  Support-line telephone numbers
w  Follow-up information
Referral arrangements / w  People for whom buproprion (Zyban) is more appropriate should be referred to their GP.
w  People for whom Varenicline▼ (Champix) is more appropriate should be referred to their GP, unless the pharmacist working under this PGD can also provide Varenicline▼ under PGD.
People who would normally be excluded due to unstable Cardiovascular disease, Recent Stroke (within the previous two week) may receive treatment under this PGD as long as:
w  They have been referred to their GP for the initial prescription, using the standard letter, and the GP has consented to the adviser continuing the treatment under the PGD.
w  The person has consented to the GP being approached by the adviser.
Consent / w  All people for whom treatment is proposed should give their consent - written, verbal or implied. In adults consent is implied by request /attendance. In children the consent of the parent or legal guardian must be obtained, after a child’s fitness and suitability have been established.
w  If a young person refuses to involve parents use “Fraser ruling competence” to ensure patient understands implications of quitting and treatment. It is not necessary to contact his/her GP. Should discussion with his/her GP be thought to be necessary, the young person must give consent for this.
w  Written consent provides a permanent record. All people must agree to the terms of the supply of NRT products, including the participation in the support programme, sharing information with their GP, and inclusion in NHS Gloucestershire data. Consent may be written, verbal or implied.
w  Those under 12 years old should be referred to his/her GP.
For consent to be valid, the patient must
w  be competent to take the particular decision
w  have received sufficient information to take it
w  not be acting under duress
For further guidance please refer to Department of Health document consent for examination or treatment (second edition) DH 2009. Gateway reference 11911
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/138296/dh_103653__1_.pdf
or
GPhC guidance on consent Feb 12
http://www.pharmacyregulation.org/sites/default/files/GPHC%20Guidance%20on%20consent.pdf
Records / A record of supply should be made on patient medication record. This should include:
w  Start date and quit date
w  Date of supply
w  Name and address and date of birth
w  Product supplied
w  Quantity supplied
w  Dose
w  Frequency
w  Batch number and expiry date
w  Advice given, oral or written
w  Contra-indications and medical advice
w  Signature of supplier, or record on computer using individual-protected password
Continued
Records (continued) / w  Date of next consultation
w  Monitoring form – to be returned to GSAS on a monthly basis
In addition, for those supplied through Community Pharmacy:
w  Invoices
w  Prescription charges collected
w  Claim for payment – to be made by 5th of each month
w  Record of attempts to contact those lost to follow-up. At least two attempts must be made by the Smoking Cessation Adviser.
Audit forms should be completed and returned as requested by GSAS.
Patients who refuse to participate should have the refusal recorded.
A computer or manual record of all individuals receiving NRT under this Direction should also be kept for audit purposes within each organisation using it.

3. Characteristics of staff