Notice to Staff Using a Paper Copy of This Guidance

Plymouth Teaching Primary Care Trust

Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle® 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists Patient Group Direction (PGD)

Version No 1:2

Notice to staff using a paper copy of this guidance

The policies and procedures page of Healthnet holds the most recent and approved version of this guidance. Staff must ensure they are using the most recent guidance.

Authors/Editor Anne Jones: Prescribing Adviser

Access ID Number 388 1 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 Reader Information

Type of Formal Paper Patient Group Direction Category Clinical Title Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle® 1500) by Appropriately Trained Pharmacists Patient Group Direction (PGD) v1:2 Document Purpose To authorise appropriately trained Community and Description Pharmacists to supply levonorgestrel emergency hormonal contraception to women 13 to 19 years, under a Local Enhanced Service (LES) as defined in the Community Pharmacy Contractual Framework. Author(s)/Editor(s) Anne Jones Ratification Date and July 2006 Plymouth tPCT Clinical Practice Council Group September 2006 Clinical & Corporate (Service) Governance Group Publication Date September 2006 Review Date September 2008 Disposal Date See Retention and Disposal Schedule Job Title of Person Prescribing Adviser Responsible for Prescribing and Medicines Management Team Review Plymouth tPCT Target Audience Specified Healthcare Professionals who have been assessed as competent to supply medication as contained in this document. Circulation List Electronic: Via Healthnet Via PCT website (subject to Freedom of information exemptions) Written: Upon request to the Public Information Service on  01752 272511

Please note this document can be made available in other formats if required please contact the Public Information Service on  (01752) 272511

Patient and Public Consultation with youth groups and young parent group Involvement Circulated to all members of the Clinical Practice Council References CPPE Emergency Hormonal Contraception Information Booklet (DLP095) HMSO 2005

Patient Group Direction (PGD) for the supply of oral progesterone-only emergency contraception (POEC) Levonelle-2 by appropriately trained nurses working in the South Hams and West Devon PCT. 2 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 Levonelle 1500 microgram tablet Marketing Authorisation (Summary of Product Characteristics)

Confidentiality and people under 16: Guidance issued jointly by the BMA, GMSC, Brook Advisory Centres, FPAfpa and RCGP, January 1994

House of Lords in the case of Gillick vs. West Norfolk and Wisbech AHA & DHSS in 1985 Supersedes New document Document Contact Details Anne Jones Prescribing Adviser Building 1 Derriford Business Park 01752 434870 [email protected]

3 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 Document Version Control

Version Details Date Author of Description of Number e.g. Change Changes and Reason for Updated or Change full review 1 First full April 2006 Anne Jones: New Document review Prescribing Adviser 1:1 Updated April 2006 Jade Brelsford: Minor changes to comply Deputy with corporate standards Manager, Public Information Service 1:2 Update September Anne Jones: Amendments to draft 2006 Prescribing document for ratification Adviser

4 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 Contents

Section Content Page No 1 Introduction 6 2 Characteristics of Staff 7 3 Consent 8 4 Patient Confidentiality 8 5 Patient Group Direction: 9 1. Clinical Condition 9 2. Description of Treatment 13 6 References 17 7 Bibliography 17 8 Authorisation 19 App 1 Clients Under 16 Years of Age: Competency 20 App 2 EHC PGD Overview Flowchart 21 App 3 EHC PGD Consultation Prompts 22 App 4 EHC PGD Consultation Record Sheet 23

App 5 List of Abbreviations Reference Signpost 24 Information for Community Pharmacists App 6 Reference Signpost Information for 25 Community Pharmacists List of Abbreviations

5 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 1. Introduction

1.1 Definition

A Patient Group Direction (PGD) is a written instruction for the supply and/or administration of medicines by specified healthcare professionals to groups of patients who may not be individually identified before presentation and is signed by a doctor or dentist and by a pharmacist.

1.2 Rationale

To enable a registered pharmacist who has received specific training, who declares themselves competent to supply medication in accordance with the patient group direction. For patients they offer protection and ease of access to treatment. For pharmacists they offer uniformity, best practice and protection.

1.3 Process

The pharmacist must operate within all the legal requirements of the Patient Group Direction as well as the professional requirements of the Royal Pharmaceutical Society of Great Britain (RPSGB) code of ethics.

Details in all sections are legally required for a valid Patient Group Direction and the document should be used in its entirety.

6 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 2. Characteristics of Staff

Professional Qualification Registered Pharmacist and Member of The Royal Pharmaceutical Society of Great Britain Additional Training and Requirements  Attendance at and participation in briefing meeting run by Plymouth tPCT, including Fraser guidelines.  Supply is in accordance with current scope of professional practice.  Successful completion of Centre for Pharmacy Postgraduate Education (CPPE) Open Learning “Emergency Hormonal Contraception”.  Pharmacist must be familiar with the Patient Group Direction.  Pharmacists should be familiar with the Summary of Product Characteristics.  The Pharmacist will train pharmacy staff on handling of requests for EHC by clients 19 years of age and younger.

Facilities required  Quiet area in the Pharmacy  Access to Levonelle 1500  Access to PGD and associated paperwork and telephone  Access to the manufacturer’s Summary of Product Characteristics  Access to current edition British National Formulary (BNF) Continuing Training Requirements Following training, the pharmacist must feel competent and confident to undertake the procedure. It is the responsibility of the professional to keep up to date with continuing professional development.

of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 3. Consent

All patients for whom treatment is proposed should give their consent.

Written consent is not needed; however consent should be specifically sought and not implied.

If the client is believed to be less than 16 years of age, the pharmacist will assess the client’s competence under the Fraser Guidelines. Discussion with the young person should explore the following issues at each consultation:

 The young person’s ability to understand the advice given.  The young person should be encouraged to involve parents  The effect on the physical or mental health of the young person if advice/treatment is withheld.  The action is in the best interest of the young person

This should be fully documented and should include an assessment of the young person’s maturity.

4. Patient Confidentiality

The duty of confidentiality owed to a person under 16 is as great as the duty owed to any other person. The statutory body, the General Medical Council states that:

"Patients are entitled to expect that the information about themselves or others which a doctor learns during the course of a medical consultation, investigation or treatment, will remain confidential.

An explicit request by a patient that information should not be disclosed to particular people, or indeed to any third party, must be respected save in the most exceptional circumstances, for example where the health, safety or welfare of someone other than the patient would otherwise be at serious risk".

8 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 5. Patient Group Direction

Patient Group Direction for the supply of Oral Levonorgestrel Emergency Hormonal Contraception (EHC) Levonelle 1500 (by appropriately trained pharmacists)

To  All clients, 13 to 19 years of age, who present requesting emergency contraceptive advice, may be considered for treatment under this direction. You must be authorised, by name, under the current revision of this PGD before you can attempt to work under it.

1. Clinical Condition

Indication Emergency contraception within 72 hours of unprotected sexual intercourse (UPSI) or failure of a contraceptive method. All clients, 13 to 19 years of age, who present requesting emergency contraceptive advice, may be considered for treatment under this direction. If for medical reasons the client is excluded from treatment within the criteria of this protocol they will be provided with information to enable them to access other family planning services, (e.g. General Practitioner, Contraceptive or Family Planning Clinic, or local youth providers).

Criteria for inclusion  All clients, 13 to 19 years of age, presenting within 72 hours of UPSI, including no contraception, barrier method failure and “missed-pill”  Fraser Guidelines If the client is believed to be less than 16 years of age, the appropriately trained registered community pharmacist will assess the client’s competence under the Fraser Guidelines. Discussion with the young person should explore the following issues at each consultation. 1. Understanding of advice given 2. Encouraged to involve parent(s) or guardian(s) 3. The effect on the physical or mental health of the young person if advice / treatment is withheld 4. Action in the best interest of the young person This should be fully documented on the record sheet and should include an assessment of the young person’s maturity. There is no evidence of any listed conditions as laid down in the exclusion criteria, below.

9 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 Criteria for exclusion  Clients must be present, supply to a 3rd party is not permitted under this direction  Any person under 16yrs who is not considered sufficiently mature (Fraser Guidelines)  Absolute contra-indication: Any person identified as having a hypersensitivity to the active substance Levonorgestrel or any of the excipients  Any person presenting more than 72hrs after any unprotected sexual intercourse, missed pill, condom breakage / leakage etc. (Please see note below)  NOTE Insertion of an intra-uterine device is more effective than hormonal methods of emergency contraception. A copper IUD can be inserted up to 5 days after unprotected intercourse. If unprotected intercourse has occurred more than 5 days previously, the device can still be inserted up to 5 days after the earliest likely calculated ovulation (this may be up to day 19 of a 28 day cycle).  Known or suspected pregnancy  Any person who has had previous episode(s) of UPSI more than 72 hours ago within the current cycle.  Any person who has already had emergency hormonal contraception since her last menstrual period.  Any person identified as having other medical contra-indications  Any other situation where the pharmacist has reservations about prescribing

Cautions  Actual or possible pregnancy, i.e. previous risk in cycle  Having established Previous supply of emergency contraception within the cycle in that the interval question. (If Levonelle 1500 has been taken and vomited refer between the first to guidance notes). episode of  Severe liver disease e.g. Porphyria unprotected sexual  Severe mal-absorption syndromes such as Crohn's disease intercourse and  Has experienced any severe clinical problems, (including having been seen is hypersensitivity reactions) with hormonal contraception less than 72 hours, if it previously, apart from nausea. is then identified that  Hypersensitivity to the active substance levonorgestrel or any of the client has a history the excipients. of any of the following  Levonelle® 1500 contains lactose. This should be taken into then the client must account in women with rare hereditary problems of galactose be referred to a intolerance, the Lapp lactase deficiency or glucose-galactose doctor. mal-absorption.  N.B. for multiple acts of unprotected sexual intercourse since the last menstrual period the calculation must start from the time of the first episode of unprotected sexual intercourse.  Interacting drugs – listed below – also refer to BNF

10 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 Interactions  POSSIBLE DRUG INTERACTIONS (PLEASE ALSO REFER TO CURRENT BNF)  Metabolism of levonorgestrel is enhanced by concomitant use of liver enzyme enhancing drugs, including CARBAMAZEPINE GRISEOFULVIN* MODAFINIL NELFINAVIR NEVIRAPINE OXCARBAZEPINE RIFAMPICIN* RIFABUTIN* PHENYTOIN BARBITURATES (including PRIMIDONE) RITONAVIR TOPIRAMATE ST. JOHN’S WORT  Medicines containing levonorgestrel may increase the risk of ciclosporin toxicity due to possible inhibition of ciclosporin metabolism. NB – Antibiotics – no alteration of dose is required when antibiotics are taken concurrently except for the previously mentioned enzyme inducing antibiotics, viz. marked*

Criteria for postponement Not appropriate for postponement

Action if excluded or If a client falls with the exclusion criteria the pharmacist must not patient declines supply EHC and action should be taken accordingly – i.e. an explanation as to why the pharmacist is unable to supply should be given. If the patient is excluded or declines treatment, they should be advised to attend an appointment with their GP or Contraceptive Clinic and given details of services available. A record should be kept of consultations resulting in exclusion (for reasons other than age 20 years or older), or where the client declines treatment.

11 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 Additional After Consultation: The Intended Outcome information o The client is able to make an informed choice about whether to use emergency contraception and which method might be most suitable. o The client is safely supplied with emergency contraception o The client is made aware of the need to consider a longer- term method of contraception and the support and follow-up available to them through Community Family Planning Services or their GP. o The patient is aware of the risk of sexually acquired infection o If pregnancy occurs after treatment with Levonelle 1500 then ectopic pregnancy should be considered. o If the Pharmacist is concerned about child protection issues then local child protection procedures should be followed.

Note: The risks of undergoing an unintended pregnancy and/or termination generally outweigh those of using hormonal emergency contraception.

12 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 2. Description of Treatment

Name of Medicine Levonelle 1500 (One tablet containing 1500 micrograms levonorgestrel)

POM/P/GSL POM

Dose One tablet should be taken as soon as possible, preferably within 12 hours, and no later than 72 hours after unprotected intercourse. The earlier in the 72-hour period the dose is given the greater the efficacy. Route Method Oral

Frequency As above.

Nature of supply Wherever possible the client should be encouraged to take the tablet in front of the pharmacist. If the client declines to do so, a time when the client will take the tablet it will be taken should be agreed. If the medication is to be taken away from the pharmacy for consumption, to take, the packet must be labelled appropriately: (Cclient details, date of issue, directions for use, Pharmacy name and addressdetails and “Keep out of the reach of children”).

Total dose number One pack of 1 tablet per client. 2nd pack of 1 tablet may be supplied in the event of vomiting (in line with guidance below).

Verbal Advice  Explain treatment and administration including advice that if vomiting or severe diarrhoea occurs within 3 hours of taking the tablet, the client should seek immediate advice from a pharmacist or doctor or Family Planning Clinic  Advise of possible adverse drug reactions (ADRs), including nausea and vomiting, breast tenderness, headaches, dizziness and fatigue.  Advise that bleeding pattern may be temporarily disturbed.  Advise that it is still possible to become pregnant after taking emergency hormonal contraception. If menstrual period is delayed by more than 5 days or are abnormal in any way (light, heavy or painful), client should see their GP or Family Planning Clinic, so that pregnancy may be excluded. If pregnancy should occur following failure of EHC, the client should contact GP /Family Planning Clinic for follow-up to ensure that it is not ectopic.

13 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2  Advise client that EHC provides no contraceptive effect for the remainder of the cycle, so abstinence, or a barrier method of contraception must be used.  Emphasize that emergency contraceptives are not suitable for repeated use as they have a higher failure rate then regular oral contraception. It may be advisable for the client to seek advice about ongoing contraception. EHC does not reduce the risk of sexually transmitted diseases.  Discuss condom use

Guidance Notes: Vomited Tablets

If vomiting occurs within three hours of taking the tablet, another tablet should be taken immediately 3. Anti-emetics may be advised. (If the new dose would be later than 72 hours after the first unprotected intercourse that cycle, referral for an IUD may be indicated.)

Written Advice All clients should be given the following before they leave the community pharmacy  Product information leaflet (PIL)  Information about on-going contraception, if desired  Information about Contraceptive Services in the area.  A leaflet about sexually acquired infections and Genito-urinary medicine services (GUM) in the area.

Follow up Progestogen only emergency contraception should be supplied only after adequate counselling and advice has been given. Arrangements for follow up and support should be detailed to the client. Client may require follow-up by GP or Contraceptive Clinic for ongoing contraceptive advice or for missed or abnormal period. If a sexually acquired infection is suspected, the client should be referred to their GP or Genito-urinary medicine clinic (GUM). In the event of “missed-pill”, please see current BNF for full guidance.

14 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 Additional Latest CSM Advice (January 2003) counselling  Women should be encouraged to seek treatment as early as possible after unprotected sex and advised that treatment failure may occur.

 Women who do not experience a normal period after using Levonelle® 1500 should be followed up so that pregnancy can be excluded.

 The possibility of an ectopic pregnancy should be considered, particularly in women with a previous ectopic pregnancy, fallopian tube surgery or pelvic inflammatory disease.

15 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 Additional Failure rate – A 1500 microgram single dose of levonorgestrel Information (taken within 72 hours of unprotected sexual intercourse) prevented 84% of expected pregnancies (compared with 79% when two 750 microgram tablets are taken 12 hours apart). Efficacy of treatment appears to decline with time of start of treatment after intercourse:

Time taken after Proportion of pregnancies intercourse prevented 24 hours or less 95% 25-48 hours 85% 49-72 hours 58% Taken from Levonelle® 1500 Summary of Product Characteristics Foetal effects - No evidence that this method of contraception has any teratogenic effects but every pregnancy has a 1/50 overall chance of foetal abnormality.

Record In discussion with the client, complete the protocol pro-forma. The completed pro-forma for the supply of Progestogen-Only Emergency Contraception Levonelle® 1500 must be signed by the appropriately trained pharmacist. Record batch number and expiry date of product supplied. All records to be retained within the pharmacy for 12 years.

16 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 6. References

1. CPPE Emergency Hormonal Contraception Information Booklet (DLP095) HMSO 2005

2. Patient Group Direction (PGD) for the supply of oral progesterone-only emergency contraception (POEC) Levonelle-2 by appropriately trained nurses working in the South Hams and West Devon PCT.

3. Levonelle 1500 microgram tablet Marketing Authorisation (Summary of Product Characteristics)

4. Confidentiality and people under 16: Guidance issued jointly by the BMA, GMSC, Brook Advisory Centres, FPAfpa and RCGP, January 1994

5. House of Lords in the case of Gillick vs. West Norfolk and Wisbech AHA & DHSS in 1985

7. Bibliography

British National Formulary (BNF) 51 March 2006

FFPRHC Guidance Emergency Contraception (April 2003) (updated June 2003) Journal of Family Planning and Reproductive Healthcare 2003: 29(2)

Faculty statement from the CEU on Levonelle 1500 and the use of liver enzyme inducing drugs. Faculty of Family Planning and Reproductive Healthcare

Patient Group Directions: A practical Guide and framework of competencies for all professionals using patient group directions. National Prescribing Centre March 2004.

Fitness to Practice and Legal Affairs Directorate Fact Sheet: Ten: Patient Group Directions RPSGB November 2004

Plymouth Community Services NHS Trust. Protocol for the supply of oral post-coital contraception by nurses working in family planning clinics in the absence of a family planning doctor.

Best Practice Guidance for Doctors and other Health Professionals on the provision of advice and treatment to young people under 16 on contraception, sexual and reproductive health. 29 July 2004. Department of Health Gateway Reference Number 3382

17 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 Adapted from Patient Group Direction (PGD) for the supply of oral progesterone-only emergency contraception (POEC) Levonelle-2 by appropriately trained nurses working in the South Hams and West Devon PCT.

Initial Draft Reviewed by: Dr Kim Storrow Mags Davies Alison Cruse Diana Vegh Jane Michie Oksana Riley Anne Jones Christine Beer

18 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 19 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 Appendix 1 Clients Under 16 Years of Age: Competency

The Fraser Ruling

“But there may well be cases, and I think there will be some cases, where the girl refuses

either to tell the parents herself or to permit the doctor to do so and in such cases the doctor

will, in my opinion, be justified in proceeding without the parents’ consent or even knowledge

provided he is satisfied on the following matters: (1) that the girl (although under 16 years of

age) will understand his advice; (2) that he cannot persuade her to inform her parents or to

allow him to inform the parents that she is seeking contraceptive advice; (3) that she is very

likely to begin or to continue having sexual intercourse with or without contraceptive

treatment; (4) that unless she receives contraceptive advice or treatment her physical or

mental health or both are likely to suffer; (5) that her best interest require him to give her

contraceptive advice, treatment or both without the parental consent.”

Gillick v West Norfolk and Wisbech Area Health authority and another [1985] 3 A11 ER 402 per Fraser LJ at 423

For clients who are believed to be under 16 years of age: Discussion with the young person should explore the following issues at each consultation. This should be fully documented and should include an assessment of the young person’s maturity.

20 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 +Appendix 2 EHC PGD Overview Flowchart

EHC REQUESTED

20 years or older: Under 13 years OUTSIDE PGD Refer to Family Offer private Ask age Planning Service, GP, consultation and/or GP out-of-hours or A&E signposting information (Pharmacist to phone ahead whenever possible) make records 19 YEARS OR YOUNGER

Take history Signpost as appropriate

Discuss alternatives Signpost as (IUD) appropriate

Discuss long term Signpost as contraception appropriate

Discuss infection Signpost as risk appropriate

16 YEARS OR OVER or 13 to 15 YEARS: “Fraser-competent” Consider FRASER GUIDELINES Make assessment and RECORD Consider Child Protection issues Counsel on use of EHC

Not “Fraser-competent” Refer as for under-13s above Make supply and record.

21 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 Appendix 3 EHC PGD Consultation Prompts

20 or older P sale or refer Under 13 years Refer AGE OF CLIENT 13 to 19 years PGD Under-16 think: “Fraser” 1. Mature enough to understand 2. Encouraged to discuss with parents 3. In best interests to have EHC 4. Possibility of non-consensual intercourse considered 5. Child protection issues addressed

Is Levonelle for own use?

Have they had Client Under 13 years of age unprotected sex and Refer to: Family Planning Service Plymouth 31436608451 558015 Last period – when 9.30 to 4.00 Mon-Fri and usual/ unusual in Answer-phone message out of hours

UPSI – first incident Client’s own GP practice since LMP Out-of-Hours GP service 01392 824600 EHC since LMP? Accident and Emergency Derriford Hospital 0845 155 8160 Other medication? (Pharmacist to phone ahead whenever possible)

Other medical conditions Allergies to Levonelle or especially liver/small bowel other hormonal disease contraceptives?

22 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 Appendix 4

EHC PGD Consultation Record Sheet Clients 13 to 19 Years of Age Service User Name (please see note below)_ DOB (please Postcode

Date: Start time of Day of the week: M T W Th F S Sun (Please circle) consultation Note: Whilst service users are to be encouraged to share their name and DOB with the pharmacist, an unwillingness to do so does not preclude a person from accessing this service.

All Clients

Counselling/advise/discussion prompts and record Yes /No Effectiveness

Effect on cycle – “What if…?” late/unusual/absent next menstrual period Side effects – “What if…?” vomiting/diarrhoea within 3 hours of dose Continuing contraception – this cycle and longer term Sexually acquired infection Written information offered

Clients under 16 years of age

See appendix 1 for further detail Yes / No Do you consider she is sufficiently mature and able to understand the advice you have given? Have you advised and encouraged her to discuss the situation with her parents/guardian? Do you consider it in her best interests to have EHC? Have you considered the possibility that sexual intercourse may have been non-consensual? Have any child protection issues been addressed?

Patient outcome

Levonelle® 1500 supplied YES/NO If no NO state reason: Batch Number Expiry Date

23 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2 Pharmacist’s Name Signature

To be retained in the pharmacy for 12 years

Reference Signpost Information for Community Pharmacists

Emergency Contraceptive contacts Family Planning Services 31463308451 558015 Devon Doctors on Call (Out of Hours GP) 01392 824600 Derriford A&E 08451 558160

Long-term contraceptive Family Planning Leaflet 31463308451 558015 Client’s General Practitioner The ZONE at YES 206626

Sexual Health contacts www.ruthinking.co.uk A web site for young people, which has the entire, local Plymouth services on its database.

GUM clinic, Derriford 76391008451 558189

Other Support Child Protection, Lead Nurse, Sue Baldwin 272480

Police Child Protection Team 284522

Social services advice and referral service 308600

Devon and Cornwall Police 08452 777444

Youth services 306596

School nurses 272414

Alison Cruse:Nurse Manager Family Planning and Sexual Health Advisory Service 314632

Shift training at Eddystone 257077

Health promotion resources 437177

Pregnancy advisory service, Derriford Hospital 76362608451 558189

Public Health development unit 515470

Children’s information service 0800 7834259

Teenage Pregnancy team 254444434868

List of Abbreviations Used Throughout Patient Group Direction (PGD)

ADR Adverse Drug Reaction

BMA British Medical Association

BNF British National Formulary

CEU Clinical Effectiveness Unit

CPPE Centre for Pharmacy Postgraduate Education

EHC Emergency Hormonal Contraception

FFPRHC Faculty of Family Planning & Reproductive Healthcare

GUM Genito-Urinary Medicine fpa Family Planning Association

GP General Practitioner

IUD Intrauterine Device

LES Local Enhanced Service

PIL Product information leaflet

POEC Progesterone Only Emergency hormonal Contraception

POM Prescription only medicine

PGD Patient Group Direction

(t)PCT (teaching) Primary Care Trust

RPSGB Royal Pharmaceutical Society of Great Britain

UPSI Unprotected Sexual Intercourse

YES Youth Enquiry Service

26 of 26 Supply of Levonorgestrel Emergency Hormonal Contraception (EHC) (Levonelle 1500) to 13 to 19 year olds by Appropriately Trained Pharmacists PGD v1: 2