CALDERDALE PRIMARY CARE TRUST PATIENT GROUP DIRECTION FOR THE SUPPLY AND ADMINISTRATION OF MEDICINES BY NON- MEDICAL PERSONNEL Progestogen-only emergency contraception for use in Community Pharmacies APPROVED FOR USE BY: Medical Director Director of Quality and Engagement Senior Pharmacist (Patient Safety) Dr M Walsh...Signature on file... Sue Cannon...Signature on file... Helen Foster...Signature on file... OBJECTIVES OF CARE/RATIONALE a. To provide ease of access to Emergency Contraception b) To prevent unwanted conception c) To make best use of available professional skills d) To make best use of resources Date of PGD: 1 st August 2011 Valid Until: 1 st August 2013 PGD Expiry extended to 1 st August 2014 by Cabinet Calderdale MBC on 8.7.13 PSGPGD3211v1 1
CALDERDALE PRIMARY CARE TRUST Patient Group Direction Definition of patient condition this is intended to address Provision of emergency contraception to females in Calderdale aged 13 and over, for the prevention of unwanted pregnancy from unprotected sexual intercourse presenting at a community pharmacy. (e.g. no contraception, missed pills, failed condom/barrier method) References British National Formulary 61 (March 2011) London: BMA & RPSGB Bayer Healthcare: Levonelle -1500 Summary of product Characteristics. Updated 11/11/2010 Accessed from www.medicines.org.uk Faculty of Family Planning and Reproductive Health Care (FFPRHC) Clinical Effectiveness Unit. Emergency Contraception (April 2006). www.ffprhc.org.uk General Pharmaceutical Council Standards of Conduct, Ethics and Performance 2010. www.pharmacyregulation.org Community Pharmacy Emergency Hormonal Contraception Service Specification Jan 10 (and any subsequent update) Agreement for the provision of Community Pharmacy Enhanced Services (LES Agreement) 2011-12 (see annual update) PSGPGD3211v1 2
CLINICAL CONDITION OF PATIENT GROUP Description of patients included in treatment Females who are 13 years or over who are at risk of pregnancy due to: Unprotected sexual intercourse Failure of barrier method of contraception Missed contraceptive pill Vomiting within 3 hours of taking levonorgestrel emergency contraceptive pill (this may have been provided to the patient by another sexual health provider). And who present within 72 hours of intercourse. The pharmacist may supply only if the client is present in person. Description of patients excluded from treatment under the terms of this PGD Age less than 13 years Pregnancy Presentation more than 72 hours from unprotected intercourse Last period more than 4 weeks ago. Hypersensitivity to levonorgestrel or any components of the tablet Severe hepatic dysfunction Severe malabsorption syndromes (such as Crohn s disease or severe diarrhoea) Porphyria Unexplained or unusual vaginal bleeding Lack of valid consent Lack of competence Patients who are not able to attend the pharmacy Action if excluded Immediate referral to provider of full range of sexual health services. Inform patient of importance of attending as soon as possible, preferably within 72 hours. Consider IUCD refer to local service providing this method of contraception e.g. Calderdale Contraception and Sexual Health, some GPs and other commissioned sexual health services. Document refusal/reasons/action taken in computerised patient medication record or proforma. Refer to child safeguarding if excluded because under 13 years old PSGPGD3211v1 3
Patients self exclusion action Immediate referral to provider of sexual health services. Inform patient of importance of attending as soon as possible, preferably within 72 hours. Document action taken in computerised patient medication record or proforma. TREATMENT Names of drugs/dose Levonorgestrel 1500 micrograms tablets Legal status of drugs POM P = Pharmacy POM = Prescription only medicine GSL = General sales list Frequency of drugs One tablet to be taken orally as a single dose, preferably within 12 hours, and no later than 72 hours after unprotected intercourse. The patient should be advised that if they vomit within three hours of taking the tablet, that another tablet is required and they should return to the pharmacy, family planning clinic or GP to receive another dose of emergency hormonal contraceptive (EHC). Method and Route of Administration Total dosage and number of times Oral The pharmacist will normally supervise the administration of the Levonorgesterel (unless a valid reason is given not to administer the tablet at that time, in which case the Levonorgesterel will be dispensed and the service user informed to administer as soon as it is possible). One tablet as a single dose as soon as possible preferably within 12 hours and no later than 72 hours of unprotected sexual intercourse. 1500 micrograms (1.5 mg= 1 tablet) per course. Where the patient is taking enzyme inducing drugs the dose may be doubled to two tablets (3mg) taken as a single dose in line with BNF and FFPRHC Clinical Effectiveness Unit guidance. See BNF, SPC and FFPRHC guidance for full details of these drugs. Where the patient has vomited within 3 hours of taking levonorgestrel emergency hormonal contraception a second dose may be given. Use outside terms of Marketing Authorisation/Product Licence The following uses are outside the terms of the Product Licence: In females under 16 years PSGPGD3211v1 4
Increased dose of levonorgestrel in patients taking enzyme inducing medicines. Use more than once in a cycle (provided emergency hormonal contraception administered within 72 hours of previous unprotected sexual intercourse) The use in these circumstances is in line with the FFPRHC and BNF guidance. This is intended to reduce the frequency of unwanted pregnancies in Calderdale. Advice for Clients before and after treatment Advise of effectiveness of the treatment (i.e. it is not 100% effective). Advise what to do if vomits within 3 hours of taking the medicine. Advise re risk of adverse effects (as below). A pregnancy test is advised if their expected menstruation is more than 7 days late, or lighter than usual. Levonorgestrel does not provide contraceptive cover for the remainder of the cycle and effective contraception or abstinence must be advised Refer to Calderdale PCT Emergency Hormonal Contraception Guidelines for further information and EHC service specification. Potential Reactions Managing and reporting adverse events Concurrent Medication Refer to individual Manufacturers Summary of Product Characteristics. Report all serious suspected adverse reactions using Yellow Card system. Record on the PCT consultation proforma Check current medication and refer to BNF & SPC for information If necessary refer to information source e.g. Newcastle Regional Drug and Therapeutics Centre. 0191 260 6198 Supporting Facilities required All premises on which this PGD is operated must have a confidential consultation area. PSGPGD3211v1 5
Treatment Record Records should include An assessment of patient need in relation to the intervention including patient history, inclusion criteria, and criteria for referral as per guidelines Product batch number and expiry date Date of supply / administration Advice given to the patient Records completed in line with service specification Record details as per service specification. STAFF Professional qualifications required Pharmacist registered with the General Pharmaceutical Council of Great Britain. Any exceptions to above None Extra training and qualifications experience or competence required Has appropriate underpinning knowledge to competently undertake the clinical assessment of patient leading to treatment according to the indications listed in this PGD (including completion of the Centre for Postgraduate Pharmacy Education (CPPE) training on emergency contraception or equivalent). Has undertaken specific training covering o Appropriate supply of Emergency Hormonal Contraception under the Patient Group Direction. o Child Protection Awareness o Fraser Guidelines o Local referral pathways and signposting Completed the CPPE distance learning emergency hormonal contraception and attended a PCT event on EHC to include sexual health and child protection Pharmacists must be accredited to provide the service. Accreditation is proven by possession of a current, expiry dated certificate provided by the accrediting PCT which, if relevant, bears the HAG standard mark. Pharmacists are expected to re-validate their accreditation at least every three years. This should be in the form of a self-declaration of competency or other method of assessment as considered appropriate by Calderdale PCT. Continuing education and training The practitioner should be aware of any change to the recommendations for the medicine listed. PSGPGD3211v1 6
It is the responsibility of the individual to keep up-to-date with Continuing Professional Development. MANAGEMENT AND MONITORING Authors of PGD Helen Foster - Senior Pharmacist (Patient Safety) Dr Jane Keighley, General Practitioner Reviewed by: David Green Immunisation Co-ordinator Peter Bullock - Patient Safety Manager Diane Catlow - Deputy Head of Children s and Young People s Services Anne Brier - Professional Lead District Nurses Sarah Beeden Practice Nurse Pat Perry Professional Lead Health Visitors Robbie Turner Chief Executive Officer, Leeds, Bradford and Calderdale & Kirklees LPCs Records to be kept for audit purposes PCT consultation proforma Date of writing 10 th November 2009 Updated 7 July 2011 Record of names of those authorised to work under this Patient Group Direction is held by: Senior Pharmacist Community Pharmacy PSGPGD3211v1 7
AUTHORISATION OF NAMED HEALTH PROFESSIONAL TO SUPPLY OR ADMINISTER MEDICINES UNDER PATIENT GROUP DIRECTIONS Progestogen-only emergency contraception for use in Community Pharmacies I have read and understood the Patient Group Direction and agree to work within its confines. Named Pharmacist Signature of Pharmacist Date Date of EHC training