Patient Group Direction for the supply/administration of by Community Pharmacists Valid from 1st August 2015 to 31st July 2017* This patient group direction must be agreed to and signed by all pharmacists involved in its use. The PGD must be easily accessible in the pharmacy. This PGD is authorised only for use in providing services commissioned by the PHA/HSCB and may not be used for any other purpose. (*valid dates for PGD only; service contract dates will vary from this. The PGD may be reviewed/ withdrawn before this date in event of changes to SPC of drug or related guidance) Purpose of this Patient Group Direction To enable PSNI registered pharmacists to supply levonogesterol as a form of emergency contraception to women aged 16 to 19 years inclusive in accordance with the requirements outlined
Staff Characteristics Qualifications Specialist competencies or qualifications Continuing training & education Pharmaceutical Society of Northern Ireland (PSNI) registration You must be authorised by name, under the current version of this PGD before you attempt to work according to it The pharmacist should have completed the NICPLD online learning courses Emergency Hormonal Contraception and Safeguarding children: a guide for the pharmacy team All pharmacists are personably accountable for their practice and in the exercise of professional accountability there is a requirement to maintain and improve their professional knowledge and competence. The pharmacist should keep up to date with the relevant Summary of Product Characteristics (SPC) and be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-todate with continued professional development and to work within the limitations of individual scope of practice. Clinical Condition Indication Inclusion criteria Prevention of pregnancy from unprotected sexual intercourse (UPSI) (e.g. no contraception, missed pills, failed condom/barrier method) in patients presenting in pharmacy requesting emergency contraception. Women who present in pharmacy and who: are aged 16 years to 19 years inclusive present within 72 hours of exposure to the risk of pregnancy following UPSI prefer to be treated with levonorgestrel having been made aware of the other emergency contraception options available and their effectiveness (Copper coil and ullipristal) Women who meet the above criteria and who have vomited previous EHC dose taken within last 3 hours are also eligible for treatment Exclusion criteria Patients who are not able to attend the pharmacy (supply is not permissible to a third party) Patient does not consent to treatment Outside inclusion age limits More than 72 hours after UPSI Suspected, possible or established pregnancy A previous supply of EHC within this cycle (unless dose vomited and still within 72 hours) Severe liver disease or history of jaundice within last 6 months Active acute porphyria Known hypersensitivity to levonorgestrel or any ingredient contained in the product Severe malabsorption syndromes such as Crohn s disease or ulcerative Exp date: 31/07/2017 Authorised only for services commissioned by the PHA/HSCB 2 of 11 pages
Cautions/Need for further advice Action if patient is excluded Action if patient declines treatment Additional information colitis Patients who are at risk of ectopic pregnancy (previous history of salpingitis or of ectopic pregnancy Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption due to presence of lactose monohydrate Currently taking any clinically significant interacting drug as identified with a black dot in the current BNF, Appendix 1: Interactions. Has taken any clinically significant interacting drug (as identified with a black dot in the current BNF, Appendix 1: Interactions and also including ciclosporin) within a time period where there could be a residual effect on levonorgestrel efficacy If the patient is taking a medication listed in the current BNF Appendix 1: Interactions which does not carry a black dot and is therefore unlikely to be clinically significant then professional knowledge should be used to ascertain: 1) effect on levonorgestrel and 2) effect on concurrent treatment Appropriate advice should be provided to patient and shared with other healthcare professionals involved in patient s concurrent treatment if deemed necessary (with appropriate consent from patient). In the case of missed pills the most recent version of the Faculty of Sexual and Reproductive Healthcare Missed Pill Recommendations should be consulted to clarify if EHC is required i.e. if UPSI took place (available at www.fsrh.org/pages/clinical_guidance.asp ). In the case of problems with other forms of long-term contraception e.g. Evra patch or Depo-provera consult the respective SPC of the product (www.medicines.org.uk) to identify if UPSI has occurred. Explain reason for exclusion to patient Document the reason along with advice given Refer patient to a GP, GP out of hours service, Family Planning Service or as per local arrangement if patient will still require EHC on leaving pharmacy or if any other reason for follow up applies If patient is excluded as UPSI was more than 72 hours ago but less than 120 hours the patient may be suitable for ulipristal or insertion of the copper IUD. Patient should be advised of this timeframe and referred to an appropriate alternative service as listed above to allow this to happen. If the reason for exclusion is an identified contraindication to the drug this should be communicated to the onward referral service wherever possible to avoid subsequent prescribing (with appropriate consent from patient). Advise on the consequences of not receiving treatment Provide information on alternative services (if receptive to this) Document advice given Supply is not permisible under this PGD to a third party- the patient must present in pharmacy in person. Exp date: 31/07/2017 Authorised only for services commissioned by the PHA/HSCB 3 of 11 pages
Drug Details Name, form & strength of medicine Legal status Route/Method Dosage, frequency and duration of treatment Maximum treatment period Quantity to supply/administer Side effects Advice to patient/carer Levonorgestrel 1500 microgram tablet (current brand name Levonelle 1500) Oral One tablet as a single dose to be taken as soon as possible, preferably within 12 hours, and not later than 72 hours after UPSI A second tablet may be supplied if a patient returns having vomited within 3 hours of taking the tablet; the tablet should be taken immediately as long as the dose remains within 72 hours of UPSI The tablet should be taken by the patient within the pharmacy One tablet may be supplied per cycle, or two tablets if vomiting occurs as above One tablet at first presentation. One further tablet may be supplied if patient returns having vomited as above. In both cases the tablet must be taken in the pharmacy. Side effects are uncommon but may include: Nausea (in 25% women) Vomiting (in 5% women) Temporary disturbance of menstrual cycle (bleeding, spotting, next period early or late) Breast tenderness, headache, dizziness, fatigue For full details of side-effects, the product literature should always be consulted Supply patient with the manufacturer s Patient Information Leaflet from the packet and advise patient to read it Advise the patient that levonorgestrel can sometimes cause nausea but that vomiting is very unlikely to occur. However, if she does vomit within 3 hours of taking the medication advise to return to the pharmacy or seek alternative medical advice as another dose will be required immediately (providing the repeat dose is still within 72 hours of UPSI). Explain to the patient that she may experience disruption to the timing of her next period, and that she may have some intermenstrual bleeding before her next period. Advise patient if she is more than 5 days late she must have a pregnancy test, as there is a risk of pregnancy even if levonorgestrel has been taken (it has been estimated that levonorgestrel prevents 95% of pregnancies if taken within 24 hours, 85% within 48 hours and 58% within 72 hours). Advise on future contraception. Explain that the tablets are for emergency use only and not a regular method of contraception because it is not effective as regular contraception. Provide written information on other methods of contraception. Advise a follow-up at a local contraception clinic or patient s GP surgery. If the patient is taking a regular oral contraceptive pill or using a contraceptive patch and EHC is required, advise the patient to use a barrier method in addition to her usual method until she has taken the pill Exp date: 31/07/2017 Authorised only for services commissioned by the PHA/HSCB 4 of 11 pages
or applied the patch correctly for 7 consecutive days Advise if she is not using any other form of contraception she will not be protected from pregnancy for the rest of the cycle without additional contraception (barrier methods) Use of emergency contraception does not replace the necessary precautions against sexually transmitted infections (STIs). Advise the patient on their exposure to STIs and give them details of local GUM services. Ensure all patient counselling points on the protocol form are covered by advice and information given. Follow up If patient returns to pharmacy having vomited within 3 hours then resupply should take place as described above For self-referral arrangements following treatment see Referral arrangements below Referral Arrangements and Audit Trail Referral arrangements If patient has been excluded from receiving levonorgestrel under PGD but still will require emergency contraception on leaving pharmacy advise patient to self-refer to local contraception clinic, GP surgery or GP out of hours service. Patient should be advised to self-refer to GP if a pregnancy test carried out in pharmacy is positive Advise patient to seek medical advice promptly if any abdominal pain develops, if the menstrual period is delayed by more than 5 days, if abnormal bleeding occurs at the expected date of the next menstrual period, or if pregnancy is suspected for any other reason. Advise a follow up appointment with the local contraception clinic or Records/audit trail patient s GP surgery in 3 to 4 weeks to ensure that the method has worked A protocol form must be completed for each client. The pharmacist should sign the form and ask the client to sign as an indication of consent. The medication should be labelled as per normal practice before supply. As part of this process a Patient Medication Record (PMR) should be generated on the pharmacy computer system which includes details of the supply having been made under PGD. Report all serious suspected adverse reactions to the MHRA using a Yellow Card (even if they are listed in the SPC, the BNF or above). Serious reactions are those that are fatal, life-threatening, disabling, incapacitating or which result in or prolong hospitalisation and/or are medically significant. Records should be retained in line with DHSSPSNI Good Management Good Records. Record keeping should comply with the requirements outlined in Human Medicines Regulations 2012 in particular regulation 253 (Pharmacy records) and Schedule 23 (Particulars in pharmacy records). Exp date: 31/07/2017 Authorised only for services commissioned by the PHA/HSCB 5 of 11 pages
PGD Development Lead authors: Matthew Dolan (Public Health Pharmacist, HSCB) Dr Louise Herron (Consultant in Public Health, PHA) This Patient Group Direction has been reviewed by the Regional PGD Group which is a multidisciplinary team from the Health and Social Care Board, Public Health Agency and Health and Social Care Trusts (with exception of NIAS). A full list of members is available on request from the Dept of Integrated Care, HSCB (Belfast office). Exp date: 31/07/2017 Authorised only for services commissioned by the PHA/HSCB 6 of 11 pages
Authorisation Page- HSCB/PHA This Patient Group Direction has been reviewed and updated by a multidisciplinary team from the Health and Social Care Board, Public Health Agency and Health and Social Care Trusts This Patient Group Direction has been approved for use in services provided on behalf of the Health and Social Care Board and Public Health Agency by: Joe Brogan Assistant Director Integrated Care Pharmacy and Medicines Management HSC Board Dr Louise Herron Consultant in Public Health Public Health Agency Exp date: 31/07/2017 Authorised only for services commissioned by the PHA/HSCB 7 of 11 pages
Authorisation Page- Community Pharmacies Organisations using PGDs must designate an appropriate person within the organisation to ensure that only fully competent, qualified and trained healthcare professionals operate within a PGD. Superintendent pharmacists and owner pharmacists who take on this role may still operate under the terms of the PGD providing they meet the training and competencies described previously. They should sign the individual signature sheet as well as this page. One PGD should be used per premises*. Locum and floating pharmacists should ensure they sign a PGD at every location they work. Pharmacy:...... The Healthcare Manager/Employer on behalf of the organisation/independent contractor has accepted the responsibility to ensure that: 1. Their named staff (listed on the signature sheet) have received the appropriate training as detailed in the PGD 2. Only fully competent, qualified and trained healthcare professionals operate within these directions on behalf of the organisation. 3. The content of the Patient Group Direction is agreed on behalf of the pharmacy 4. Authorised staff should be provided with an individual copy of the PGD and a photocopy of the document showing their authorisation. Signature... Date Name (please print)... *Technically one PGD could be used to cover a group of pharmacies however for the logistical process of obtaining signatures (particularly from locums) this PGD should be used on a one per pharmacy basis Exp date: 31/07/2017 Authorised only for services commissioned by the PHA/HSCB 8 of 11 pages
Authorisation Page - Individual Signature Sheet The following registered healthcare professionals employed by the trust/ independent contractor named previously are allowed to operate under this PGD. I have read and understood the Patient Group Direction and agree to supply/administer this medicine only in accordance with this PGD. I understand that PGDs do not remove inherent professional obligations or accountability and it is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct. Locums and pharmacists working on more than one site must sign a PGD for each site Name of Professional (PRINT) Signature Date ` Print extra copies of this page as need be. Page of Exp date: 31/07/2017 Authorised only for services commissioned by the PHA/HSCB 9 of 11 pages
Appendix 1: Protocol Form (Aide memoir only; consult main body of PGD for full details) PATIENT DETAILS Patient Name: Date of Birth: Address: Normal cycle lasts days and is regular / irregular* (delete as applicable) Date of Last Menstrual Period (LMP): Approx Time UPSI: INCLUSION CRITERIA- all must apply otherwise refer to appropriate provider (e.g. GP, OOH, HYPE, Brooke or per other local arrangement) Aged 16,17, 18 or 19 years of age and present in pharmacy Has had unprotected sexual intercourse (UPSI) within the last 72 hours (e.g. no contraception, missed pills, failed condom/barrier method). All emergency contraceptive options discussed with the patient and hormonal method preferred? EXCLUSION CRITERIA If any apply patient may not receive EHC under PGD (advise and refer as per body of PGD) More than 72 hours after UPSI? Suspected or possible pregnancy? (i.e. last menstrual period (LMP) more than four weeks ago or previous UPSI since LMP, unless proved otherwise by a pregnancy test) A previous supply of EHC within this cycle? (unless dose vomited and still within 72 hours) Previous allergic reaction to levonorgestrel or any other ingredient within the product? Takes a clinically significant interacting drug? (See main body of PGD for definition) LMP abnormal in any way (e.g. different length or flow), or any unexplained vaginal bleeding in the current cycle? A medical condition which could change the efficacy of EHC or which could be affected by EHC (see main body of PGD for details of medical conditions) History of ectopic pregnancy or salpingitis Patient does not consent to treatment PATIENT COUNSELLING Discuss all the following with the patient before supply. The failure rate with levonorgestrel and other methods Possible adverse effects including nausea and effects on menstrual cycle Action to take if vomiting occurs Recommend pregnancy test after four weeks or if next period is more than 5 days late/abnormal Advise EHC does not provide future contraception? If applicable: Advise on need to use barrier methods if EHC requested due to failure of a regular mode of contraception Long-term contraceptive needs (signpost to appropriate services) STI risk of UPSI (signpost to services) PGD for EHC by Community Pharmacy Appendix 1 10 of 11 pages
Appendix 1: Protocol Form (Aide memoir only; consult main body of PGD for full details) ACTION TAKEN Supplied: Levonorgestrel 1500mcg x1 Condoms Levonelle PIL Health promotion leaflets Additional Levonorgestrel 1500mcg x1 due to vomiting If any of the above not supplied indicate reason: Age > 72 hours since UPSI Clinically excluded Refused Other: Referred/ Signposted to: GP OOH GUM Brook HYPE Other: Any further notes: CLIENT SIGNATURE AND CONSENT I agree that the information obtained during the service can be shared, where in the opinion of my pharmacist it is appropriate to do so, with: the Regional Board or PHA as part of a clinical audit or project evaluation Regional Board, the Business Services Organisation (BSO), the Department of Health, Social Services and Public Safety (DHSSPS), healthcare practitioners and other health and social care bodies for the purposes of administering and managing health and social care services and to verify that the service has been delivered by the pharmacy as part of post-payment verification This service has been explained to me by the pharmacist including other treatment options. I am happy to be treated in this way and to be supplied with Emergency Contraception if appropriate. I agree that this information may be shared with my own doctor (GP) if required: YES / NO (circle) Client initials: Age: Postcode:.. Date:.. All the information you have provided will be treated in strictest confidence. It will not be shared with any person or agency except for those identified in this box Pharmacy Voucher Reference Number: Data Collection Pharmacy Stamp: Pharmacist Signature: Prescription Book Reference: FAX THIS SIDE OF FORM ONLY TO 02895 363947 (FAO Dr L Herron) (IN ADDITION TO SUBMITTING PV VOUCHER) PGD for EHC by Community Pharmacy Appendix 1 11 of 11 pages