PRESCRIBING SUPPORT TEAM AUDIT: Hormone Replacement Therapy DATE OF AUTHORISATION: AUTHORISING GP: PRESCRIBING SUPPORT TECHNICIAN:

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1 PRESCRIBING SUPPORT TEAM AUDIT: Hormone Replacement Therapy DATE OF AUTHORISATION: AUTHORISING GP: PRESCRIBING SUPPORT TECHNICIAN: SUMMARY This audit aims to ensure that patients on HRT are reviewed annually and offered the opportunity to reduce or stop treatment where appropriate or be supported to continue treatment if they choose. OBJECTIVES To identify those patients eligible for review and document the criteria. To identify a GP(s) who will implement the pharmaceutical care issues AIM All women should be offered menopause management advice of the highest order Menopause management advice will be evidence-based wherever possible. All practice members will offer consistent advice, aided by practice protocols All protocols should be reviewed, and updated when necessary, annually RATIONALE The number of women who will live half their adult life after the menopause increases every year. 1 Since the publication of the Women s Health Initiative (WHI) study in 2002, prescribing of HRT has declined substantially. 2 These women now face a complex decision regarding whether to use postmenopausal HRT. This audit has been designed to ensure that patients currently prescribed Hormone Replacement Therapy (HRT) are assessed for continued need annually and monitored in line with current evidence. BACKGROUND As female life expectancy increases to greater than 75 years, many women will now spend up to 40% of their lives in the postmenopausal state. As a result of this increased longevity, postmenopausal women now comprise approximately 17% of the UK population and this proportion is rising. The menopause is associated with symptoms of estrogen deficiency which may be extremely debilitating and seriously reduce the quality of life. Additionally, the increased risk of cardiovascular disease and 1

2 osteoporosis, which occur with loss of ovarian function, has important implications for an ageing population. Symptoms: Vasomotor Flushing Sweats Headaches/migraine Sleep disturbance Urogenital Urgency Dysuria Vaginal dryness Psychological Labile Mood Poor concentration/memory Reduced libido Tiredness Skin/Connective tissue Dry skin, pruritis Male pattern baldness, hirsutism Joint aches, stiffness Data from observational studies, and randomised controlled trials (RCTs) that used surrogate endpoints, suggested protective effects of HRT on chronic diseases such as coronary heart disease (CHD), osteoporosis, colorectal cancer and dementia. There was also evidence of harm associated with HRT such as increased risk of breast cancer, and venous thromboembolism. There is no doubt that HRT is the most effective treatment for menopausal symptoms currently available. Recent analysis of both observational and randomized controlled trials such as the Women s Health Initiative trial has shown that when HRT is used within 10 years of the menopause the benefits far outweigh the minimal risks. Women should be helped to make an informed choice and be able to take HRT for as long or as little a time as they feel the benefits outweigh the risks for them. Management summary incorporating Committee on Safety of Medicines (CSM) advice: Short term use HRT, benefits outweigh the risks Longer term usage: Counsel regarding the incidence of breast cancer and other adverse effects but let women choose how long to stay on treatment; since duration of symptoms cannot be predicted, neither can duration that HRT is required A joint decision to commence HRT is made with the patient. Treatment is monitored at 3 monthly intervals until the patient is stable, then annually All women are encouraged to be breast aware and to attend for regular breast screening after the age of 50 years When the patient wishes to discontinue HRT, further counselling is offered regarding stopping from a low dose Women who have a premature or early menopause should generally be advised to take HRT at least until the normal age of menopause When stopping HRT, it is generally recommended that a high or medium estrogen dose preparation (e.g. 2mg tablet oestradiol, mg or 1.25mg conjugated equine estrogen tablet or 50, 75 or 100mcg patch) should be reduced for 2-3 months before stopping to minimise the chance of estrogen deficiency symptoms returning. If already on a low dose preparation (e.g. 1mg tablet oestradiol, 0.3mg conjugated equine estrogen tablet or 25mcg patch) this reduction is unnecessary. On initial cessation of therapy, symptoms may return fairly soon but then resolve. Ideally, staying off treatment for 2-3 months should be considered before deciding whether or not to recommence. METHOD 1: Conduct a search to identify those women who are taking hormone replacement therapy (drugs listed in Appendix A). 2: For all those women identified, complete the audit form. (Appendix B) 2

3 3: If the patient has not received counselling in the last 12 months they should be referred. (A leaflet is acceptable as alternative to face to face counselling) The Prescribing Support Technician will record on the data collection form, the following information regarding each patient identified by the search; Patient name (and ID): Drug name: (practices will be able to identify from this their level of non-formulary prescribing)* Indication: With or without a uterus Date initiated: Where information is not available in the patient s electronic records, the notes will be checked by the Prescribing Support Technician and missing information recorded on the data collection form. This information will be verified by the GP and added to the electronic notes by administrative staff. Review of women on HRT should include Initial review: When commenced on HRT, or when HRT changed, consultation with doctor or nurse after 3 months to: assess effect of therapy discuss any side effects and bleeding pattern have check of blood pressure and weight When settled on therapy consultation should be at least once per year to: Check effectiveness of therapy & presence of side effects. Update on best type of therapy for the patient. Discuss pros and cons of continuing HRT, in particular, discussing increased risk of breast cancer with long-term HRT Have blood pressure checked. Breast and pelvic examination need only be performed if there is a clinical indication, and cervical smears as indicated by the screening programme in your area. EXCLUSION CRITERIA As specified by practice. REFERENCES 1. Barrett-Connor E. Hormone replacement therapy. BMJ 1998; 317: MeRec Bulletin. Hormone replacement therapy: an update. Volume 15, Number Accessed June Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principle results from the Women's Health Initiative randomized controlled trial. JAMA 2002;288: Million Women Study Collaborators. Breast cancer and hormone replacement therapy in the Million Women Study. Lancet 2003;362: BNF March MIMs June NHS Dumfries & Galloway Joint Formulary 8. Menopause Matters. Benefits of HRT. Accessed 15/06/08 9. PRODIGY. Menopause ( accessed 15/06/08 3

4 IDENTIFYING PATIENTS REQUIRING REVIEW OF HRT 1. The audit must be checked and agreed with a GP in the practice prior to work being undertaken by the Prescribing Support Technician 2. Agreement is made between the Practice and the Prescribing Support Technician on a suitable date for implementation. 3. The Prescribing Support Technician conducts a search of the Practice Clinical System to identify patients currently prescribed HRT as authorised on the Prescribing Review form. 4. The patient list is checked to ensure that all patients are still undergoing treatment (recently deceased or recent discontinuation of HRT) 5. Patients are assessed, with respect to potential referral to GP or who require documentation of clinical information held on paper notes only. 6. No patient may be changed beyond the scope of the SPC unless authorised by the prescriber. 7. All changes to prescribing must be recorded within the prescribing field and, wherever possible, an indication recorded for the medication added. 8. Each patient should be informed of any changes made in accordance with the Practice s preferred mode of communication. The Prescribing Support Team recommends personalised written communication sent from the Practice. Additional information e.g. patient leaflets may be included wherever possible. 9. If the patient is in residential care or has their medication otherwise supervised, e.g. Dosette dispensing, information regarding any changes should also be communicated to the relevant service providers and community pharmacy. (For nursing homes sister in charge) 10. The Prescribing Support technician will communicate information about the review to relevant personnel within the practice e.g. receptionists, nurses and will, if appropriate, create on-screen reminders on the Clinical System. 11. A project file is retained by the Practice containing a list of patients involved, patient letter templates and any individual information sent, a copy of the protocol and prescribing review form and contact details for the Prescribing Support Team. 12. The Prescribing Support Technician may record statistics of the review for report purposes and analysis of the review. No information regarding individual patients leaves the practice. 4

5 Appendix A Hormone Replacement Therapy Brand Oestrogen Progestogen Formulation Bleed RX* Cost Sequential combined therapy Climagest Estradiol (1mg, 2mg) Norethisterone (1mg) Tabs M Clinorette Estradiol (2mg, 2mg) Norethisterone (1mg) Tabs M Cyclo-progynova Estradiol (2mg) Norgestrel (0.5mg) Tabs M Elleste Duet * Estradiol (1mg, 2mg) Norethisterone (1mg) Tabs M Estracombi Estradiol (50mcg) Norethisterone (0.25mg) Patches M Evorel Sequi * Estradiol (50mcg) Norethisterone (170mcg) Patches M Femapak Estradiol (40mcg, 80mcg) Dydrogesterone (10mg) Patches + Tabs M , 8.06 Femoston * Estradiol (1mg, 2mg) Dydrogesterone (10mg) Tabs M FemSeven Sequi * Estradiol (50mcg) Levonorgestrel (10mcg) Patches M Novofem Estradiol (1mg) Norethisterone (1mg) Tabs M Nuvelle Estradiol (2mg) Levonorgestrel (75mcg) Tabs M Premique Cycle Conj oestr (0.625mg) Medroxyprogesterone (10mg) Tabs M Prempak-C * Conj. Oestr (0.625mg, 1.25mg) Norgestrel (0.15mg) Tabs M Tridestra Estradiol (2mg) Medroxyprogesterone (20mg) Tabs Q Trisequens Continuous combined therapy Estradiol (2mg, 2mg, 1mg) Norethisterone (1mg) Tabs M Angeliq Estradiol (1mg) Drospirenone (2mg) Tabs X Climesse Estradiol (2mg) Norethisterone (0.7mg) Tabs X Elleste Duet Conti Estradiol (2mg) Norethisterone (1mg) Tabs X Evorel Conti * Estradiol (50mcg) Norethisterone (170mcg) Patches X Femoston Conti Estradiol (1mg) Dydrogesterone (5mg) Tabs X FemSeven Conti * Estradiol (50mcg) Levonorgestrel (7mcg) Patches X Indivina Estradiol (1mg, 2mg) Medroxyprogesterone (2.5mg, 5mg) Tabs X Kliofem Estradiol (2mg) Norethisterone (1mg) Tabs X Kliovance * Estradiol (1mg) Norethisterone (0.5mg) Tabs X Nuvelle Continuous Estradiol (2mg) Norethisterone (1mg) Tabs X Premique Low Dose Conj. Oestr (0.3mg) Medroxyprogesterone (1.5mg) Tabs X Premique * Conj. Oestr (0.625mg) Medroxyprogesterone (5mg) Tabs X

6 Brand Oestrogen Progestoge n Formulation Blee d RX* Cost Gonadomimetic Livial * Tibolone (2.5mg) Tabs X Unopposed oestrogen (if uterus is intact an adjunctive progestogen must be used) Bedol Estradiol (2mg) Tabs Climaval Estradiol (1mg, 2mg) Tabs Elleste Solo * Estradiol (1mg, 2mg) Tabs Elleste Solo MX Estradiol (40mcg, 80mcg) Patches , 5.99 Estraderm MX Estradiol (25mcg, 50mcg, 75mcg, 100mcg) Patches , 5.74, 6.69, 6.94 Estraderm TTS Estradot * Evorel * Estradiol (25mcg, 50mcg, 100mcg) Estradiol (25mcg, 37.5mcg, 50mcg, 75mcg, 100mcg) Estradiol (25mcg, 50mcg, 75mcg, 100mcg) Patches , 7.48, 9.02 Patches , 5.21, 5.22, 6.08, 6.31 Patches , 3.24, 3.44, 3.57 Fematrix Estradiol (40mcg, 80mcg) Patches , 5.40 FemSeven * Estradiol (50mcg, 75mcg, 100mcg) Patches , 6.98, 7.28 Harmogen Oestrone (0.93mg) Tabs Hormonin Estriol/Estradiol/Oestrone (1 strength) Tabs Oestrogel Estradiol (0.06%) Gel Premarin * Conj. oestr (0.3, 0.625mg, 1.25mg) Tabs , 3.24, 4.39 Progynova Estradiol (1mg, 2mg) Tabs Progynova TS Estradiol (50mcg, 100mcg) Patches , 6.13 Sandrena Estradiol (0.5mg, 1mg) Gel , 6.08 Zumenon Estradiol (1mg, 2mg) Tabs Adjunctive progestogen Climanor Medroxyprogesterone (5mg) Tabs Mirena Levonorgestrel (20mcg/24hrs) IUS Utrogestan Progesterone (100mg, 200mg) Caps ,

7 Brand Oestrogen Progestogen Formulation Bleed RX* Cost Oestrogen only Estring Estradiol (7.5mcg) Vaginal ring 1 Ortho-Gynest Pessary Ortho-Gynest Cream Estriol (0.5mg) Pessary 1 Estriol (0.01%) Vaginal cream 1 Ovestin cream Estriol (0.1%) Vaginal cream 1 Premarin Conj. oestr (0.0625%) Vaginal cream 1 Vagifem Estradiol (25mcg) Vaginal tabs 1 Red drug names are in D&G formulary Bleed: M=Monthly; Q=Quarterly; X=No bleed *Combination packs incur multiple prescription charges Cost=28 days Table from MIMS June

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9 HORMONE REPLACEMENT THERAPY AUDIT PRACTICE. DATE. Patient ID E.g. Has the woman received counselling Y if N in the previous 12 months? refer Menopause initial assessment Menopause follow-up assessment Hormone Replacement Therapy review Current HRT therapy CC Indication intact uterus (IU) / without uterus(wu) Date initiated 12/05/07 Next review date 01/04/08 Were any changes in the woman s health/risk factors discussed? Advice about the menopause O/E Weight Y O/E BP reading Y (Cervical smear result) (Mammography screening) Alcohol consumption Tobacco consumption Health Education Hormone Replacement Therapy Were the following risks discussed? Either face to face counselling (F) or patient leaflet given (L) Y IU Breast Cancer Y(F) Heart disease Y(F) Stroke Y(F) Venous thromboembolism Endometrial cancer Y(F) Ovarian cancer Y(F) 9