Patient Group Direction

Transcription

1 Patient Group Direction The Supply of levonorgestrel 1500mcg (Levonelle -1500) for Version: EHC by Community pharmacists/ CLINICAL CONTENT page 1 of 4 Protocol Details Date comes into effect 1 st April 2011 Date of expiry + review 31 st March 2013 or in the light of significant changes in best practice Staff characteristics HAG Accredited community pharmacists registered with the General Pharmaceutical Council supplying as part of a NHS Cumbria or NHS North Lancashire EHC enhanced service. Pharmacists must complete: CPPE EHC learning pack CPPE Contraception learning pack CPPE Child protection learning pack A local workshop including role play and training on the use of PGDs >>YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING UNDER IT- SEE MANAGERIAL CONTENT SECTION<< Clinical Details Indication Inclusion criteria Prevention of pregnancy within 72 hours of unprotected sexual intercourse (UPSI) or failure of a contraceptive method Women requesting emergency hormonal contraception within 72 hours of unprotected intercourse. The Fraser guidelines for under 16 years must be followed. Missed or incorrectly used combined or progestogen only contraceptive pill / patch No contraception used or failed barrier method of contraception Contraceptive pill vomited or affected by diarrhoea or medicines Late depo injection, over 14 weeks since the last injection was given Removal or loss of intrauterine device and UPSI in the previous 7 days Loss of protection following change in contraceptive method Women who have irregular periods who have not had unprotected intercourse in the last three weeks apart from within the last seventy two hours and have a negative pregnancy test done at the time of consultation as appropriate. (See exclusion criteria) Women who cannot be reassured that they are not at risk that contraception was not used correctly. >>See BNF, Summary of Product Characteristics and FSRH for details of contraceptive failure<< Exclusion criteria UPSI > 72hours Women who could already be pregnant, i.e. other episode of unprotected sexual intercourse in this cycle or women who have irregular periods, where pregnancy cannot be excluded at the time of consultation. Pregnancy >21 days can be ruled out with a negative pregnancy test; ideally with first morning urine. Less than 21 days post partum Prior use of 2 or more Levonelle-1500 since last menstrual period Prior use of ullipristal acetate (EllaOne ) in the previous 7 days Unexplained or unusual vaginal bleeding Acute porphyria Severe intestinal malabsorption conditions e.g. active Crohn s disease. Hypersensitivity to any of the ingredients in the preparation (see product insert) contains lactose refer patients with galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Previous experience of any severe clinical problems with hormonal contraception, apart from nausea. Management of Excluded Patients Action for patients not wishing to receive care under this PGD Discuss reasons for exclusion with patient If > 72 hours since UPSI, a post-coital copper Intra-uterine contraceptive device (IUCD) or Ulipristal acetate (EllaOne ) may be a possible recommended option for up to 5 days after the expected date of ovulation in a regular cycle. Refer urgently to GP or to the next Contraceptive clinic or other suitable facility If < 72hrs refer client to a doctor (pharmacist may wish to contact doctor by phone) Make patient aware of alternative sources of treatment. (GP or Community Contraceptive Clinics) Document refusal and actions taking in the patient assessment form

2 Description of Treatment Page 2 of 4 Name, form and strength Levonorgestrel 1500 microgram (1.5mg) tablet (Levonelle -1500) Route Oral Dosage One tablet (1.5mg) to be taken in the pharmacy as a single dose. Repeated course and Supplying professionals can issue a maximum of 2 courses in any single menstrual cycle dose instructions (unlicensed use). Where a patient returns having vomited the first dose within 2 hours of taking it, a replacement dose should be administered, as long as the replacement dose is also taken within 72 hours of the episode of unprotected sexual intercourse. For women taking liver enzyme-inducing drugs or within 28 days of stopping them (Appendix 1 BNF) a single 3mg dose (two tablets) should be given (unlicensed use) following FSRH Drug interactions with hormonal contraception guidance January Quantity to supply Single dose or double as above. Dose is to be taken at the consultation; supplies are not to be given to take away. Legal status Prescription Only Medicine (POM) Special Precautions Efficacy appears to decline with time after intercourse (95% within 24 hours, 85% hours, 58% if taken between 48 and 72 hours). If pregnancy occurs after treatment with Levonelle 1500, the possibility of an ectopic pregnancy should be considered. Patients taking liver-enzyme inducing drugs must be advised that an IUD is more effective than taking two tablets. Patients taking ciclosporin should be advised that Levonelle 1500 may increase the risk of ciclosporin toxicity. Aprepitant can reduce the efficacy of hormonal contraception for the time of administration and the following 28 days Bosentan can reduce the efficacy of hormonal contraception. Adverse effects Levonelle-1500 is generally well tolerated. Very common side-effects (>1/10): bleeding not related to menses, nausea, low abdominal pain and fatigue. Common side-effects (>1/100): vomiting, diarrhoea, breast tenderness, headache, dizziness and temporary disturbance of bleeding patterns. Refer to BNF and SPC for complete list. Adverse effects should be reported using the Yellow Card system if appropriate. Patient Advice Follow patient counselling guidelines on patient assessment form. Refer to patient assessment forms while the patient is present Give the patient the information leaflet from the packet Discuss efficacy rates and in particular that it is not 100% effective. Discuss increased efficacy of IUCD especially if mid-cycle. Advise that menstrual cycle timing may be disrupted. Supply of a second course in the same menstrual cycle is more likely to disrupt the normal menstrual pattern. Advise to seek medical advice if there is any lower abdominal pain Discuss STI risk, offer Chlamydia testing kit < 25yrs old, and refer to GUM where appropriate Discuss use of and give patient a supply of condoms Discuss need for reliable contraception for the remainder of cycle Supply Family Planning Association leaflets if available Women who become pregnant after EHC use should seek medical follow up to exclude this ectopic pregnancy. Records and Follow Up Referral arrangements The Pharmacist administering must have up to date contact details for a medical officer, Contraceptive clinics and Child Protection Nurse. Where there are immediate child protection concerns, discuss with named nurse for child protection. All contacts with <13 year olds must be discussed with child protection but this should not prevent EHC being given. Records to be kept Fully completed Patient Assessment form (2 Pages) including signatures of Pharmacist and patient. Records should be kept for 8 years. In the case of children and young people, until their 25 th birthday or in the case of a 17 year old until their 26 th birthday Unlicensed use Items or leaflets supplied to the patient Document any adverse reaction as above Fraser guidelines completed for all patients under 16 or where competence is in doubt. Follow up Advise patient attends an appropriate service with an Early Morning Urine (EMU) sample for a pregnancy test if no normal bleed within the next three weeks or if the next bleed is light Ensure patient aware of local arrangements, e.g. community contraception clinics Advise to seek medical attention if they have any problems esp. abdominal pain

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4 Patient Group Direction The Supply of levonorgestrel 1500mcg (Levonelle -1500) for Version: EHC by Community Pharmacists/ MANAGERIAL CONTENT page 4 of 4 Individual Authorisation BY SIGNING THIS PATIENT GROUP DIRECTION YOU ARE INDICATING THAT YOU AGREE TO ITS CONTENTS AND THAT YOU WILL WORK WITHIN IT PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY IT IS THE RESPONSIBILITY OF EACH PROFESSIONAL TO PRACTICE ONLY WITHIN THE BOUNDS OF THEIR OWN COMPETENCE IF THIS IS AN UPDATED OR REPLACEMENT PGD ENSURE THAT ALL OLDER VERSIONS ARE WITHDRAWN FROM USE WITH IMMEDIATE EFFECT IT IS YOUR REPONSIBILITY TO MAKE SURE YOU ARE USING THE CURRENT VERSION NOTE TO AUTHORISING MANAGERS: AUTHORISED STAFF SHOULD BE PROVIDED WITH AN INDIVIDUAL COPY OF THE CLINICAL CONTENT OF THE PGD AND A PHOTOCOPY OF THE AUTHORISATION SHEET SHOWING THEIR AUTHORISATION Name of Professional Signature Authorising Manager Date

5 The Supply of levonorgestrel 1500mcg (Levonelle -1500) for Version: EHC by Community pharmacists/ PATIENT ASSESSMENT FORM FOR PGD Patient Competence and Confidentiality (Fraser Guidelines apply) This section must be completed for all patients less than 16 years of age or where competence is in doubt. Whilst is it permissible to offer young people confidential contraceptive advice they must be made aware that there can be rare occasions when this confidentiality may be broken and other agencies involved. This is usually if the professional suspects that someone is hurting or harming the patient. In some situations, such as where there is a discrepancy in age between a very young patient and their partner, concerns may be raised. If you are unsure, discuss the situation with a colleague or contact the designated Child Protection Nurse. It is probably not in the patient s best interests to withhold emergency contraception but record keeping should reflect details of the consultation. Does the patient understand the advice given, the potential risks and benefits of treatment, and has sufficient maturity to understand what is involved in terms of moral, social and emotional implications? Has the patient been encouraged to involve her parents or to allow the healthcare professional to? Has the possible effect on the physical or mental health of the patient, if treatment were withheld, been considered? Is providing contraceptive advice and treatment in the best interest of the patient? All the above areas must be fully discussed during the consultation which should be documented and include an assessment of the patients maturity. If any question is answered no, the patient must be referred. Patient History: Date of consultation: ID Number / Name: Date of Birth Patient s usual General Practitioner Date of, or time since, start of Last Menstrual Period (LMP): Details of when UPSI occurred: Age of Partner First Four Digits of the Patients Postcode Day of cycle:. Hours elapsed since:. How many days is each normal cycle?: and is regular / irregular * (* Delete as applicable) Reason for seeking emergency contraception: 1. No contraception used 2. Failed barrier method of contraception 3. Missed or incorrectly used combined or progestogen only contraceptive pill / patch 4. Contraceptive pill vomited or affected by diarrhoea or medicines 5. Late depot injection 6. Removal or loss of intrauterine device 7. Vomited supplied course of EHC 8. Loss of protection following change in contraceptive method 9. Other appropriate reason (please state): See BNF or SPC for detail of contraceptive failure (Ring appropriate number) Inclusion Criteria A Has the patient had unprotected sexual intercourse (UPSI) in this menstrual cycle? (See possible reasons above and notes within PGD clinical pages) Yes B Did this episode of UPSI occur within the last 72 hours? C All emergency contraceptive options (including mode of action and failure rates) discussed with the patient and hormonal method preferred? To be eligible for supply of Levonelle-1500 under this protocol, the answers to sections A, B and C must be yes. If any of these do not apply, the patient should be referred to a GP or a Contraceptive Session. No

6 The Supply of levonorgestrel 1500mcg (Levonelle -1500) for Version: EHC by Community pharmacists/ PATIENT ASSESSMENT FORM FOR PGD Exclusion Criteria D Did the UPSI occur more than 72hrs ago? E Has the patient ever had an allergic reaction / severe adverse effect to Levonelle or any ingredient? F Have there been any other episodes of UPSI in the last three weeks for which the patient has not had emergency contraception? G Is the patient pregnant or likely to be pregnant? H Was the LMP abnormal in any way (eg different length or flow), or any unexplained or unusual vaginal bleeding in the current cycle? I Has the patient used any form of emergency contraception more than once within the current menstrual cycle, or in last three weeks if amenorrhaic or has an irregular cycle? J Are there any child protection issues or serious concerns? (SEE ADVICE BELOW) K Does the patient have acute porphyria? L Does the patient have any severe intestinal malabsorption syndromes eg Crohn s Disease? * Is the client on any other medication? Refer to PGD If the answer to H is yes, exclude pregnancy before proceeding. If pregnant refer to GP. If the answer to J is yes, proceed if it is in the patient s best interests, whether proceeding or not refer as appropriate and involve child protection team If the answer is yes to any other question refer as above. Patient Counselling Guidelines All the following subjects must be discussed with the patient before supply. Possible adverse effects, including possible ectopic pregnancy, and actions to take if they occur Advise that Levonelle-1500 is not 100% effective and that pregnancy can still occur Possible effects on the foetus if pregnancy occurred How to take Levonelle-1500 and action to take if vomiting occurs within 2 hours The need to abstain from intercourse or to consistently and correctly use a reliable barrier method of contraception at least until the next menstrual period. Other hormonal contraception may be continued Future contraceptive needs, including supply of family planning leaflets, if available and condoms That Levonelle-1500 does not protect against sexually transmitted diseases, offer a Chlamydia testing kit to patients < 25 yrs old. Refer to GUM as appropriate Recommend pregnancy test if next period is late or abnormal in any way. In the case of pre-existing amenorrhea carry out pregnancy test 3 weeks after unprotected intercourse. Action Taken Was the patient supplied Levonelle-1500? Confirm that the dose was taken and supervised at the consultation: Batch number and expiry date of issued packet(s):.. Was the patient referred to another agency? (if yes state which agency below): Any further notes e.g. unlicensed use: Confirmation and consent Fraser Competence has been assessed The patient is to be referred. Emergency Hormonal Contraception has not been supplied I confirm that the information detailed above has been discussed and that I understand it. This supply is for a free of charge contraceptive and no prescription charges are due. (Delete as Appropriate) Name of pharmacist making supply:. Pharmacy address stamp Signature of pharmacist:. Signature of patient::.