CONTRACEPTIVE IMPLANTS

Transcription

1 CONTRACEPTIVE IMPLANTS The contraceptive implant Nexplanon is a flexible rod containing 68mg of etonogestrel in a plastic, ethylene vinylacetate copolymer matrix. Nexplanon contains 5mg of barium sulphate (3%) dispersed throughout the implant, rendering it radio-opaque Nexplanon is suitable for women who wish reversible contraception. The primary mode of action is to prevent ovulation; it also alters the cervical mucus and inhibits normal endometrial development. The implant is usually inserted into the non-dominant upper arm and should be removed or replaced after three years, or sooner if indicated or requested. Efficacy Extremely low failure rate. Some pregnancies have occurred when the client was already pregnant prior to insertion of the implant or has not observed appropriate contraceptive cover after initial fitting. Current experience suggests a method failure rate of around < in 0000 over 3 years of use. Contraindications Absolute (please also see table in appendix) Pregnancy Undiagnosed abnormal vaginal bleeding Progestogen dependent tumours Sensitivity to any components of Nexplanon Porphyria Breast cancer within the past 5 years Side Effects High possibility of irregular vaginal bleeding particularly in first 3-6 months. Breast pain or tenderness Acne Discomfort over insertion site Alopecia/hirsutism has rarely been reported No causal association has been found with the following side effects: Headache Weight changes Abdominal pain Changes in libido Mood swings CONTRACEPTIVE IMPLANTS CEG: MARCH 05 Page of 9

2 Drug Interaction Liver enzyme inducers such as Rifampicin, Rifabutin and St John s Wort reduce contraceptive effect Ciclosporin: plasma levels of cyclosporin are possibly increased Antiretrovirals: liver enzyme inducing ARTs reduce efficacy of contraceptive implants (FSRH Drug Interactions with Hormonal Contraception 0 or Broad spectrum antibiotics do not affect contraceptive implants Assessment Efficacy and failure rate discussed. Procedure fully explained and demonstration implant shown. Decision to proceed taken by client and clinician. Written method information including contact telephone number is given to client. Insertion should be offered at drop-in services if clinically appropriate, or client can be triaged into a LARC appointment Documentation The visit history should be completed or updated as required, Written method information including contact number is given to client. Prescription should be completed on NaSH. Site of implant, batch number and expiry date of medication recorded. Confirm that the implant is palpable after insertion and document this. Record of implant site and date due for removal given to client. A standard letter will automatically be generated by Sandyford IT dept and sent to the client s GP informing them of the procedure, provided GP permission is given on NaSH Timing of insertion of subdermal implant First use Can be inserted up to and including day 5 of cycle without additional methods. Can be inserted after day 5 if reasonably certain the woman is not pregnant- additional precautions should then be used for 7 days after insertion. A careful history should be taken to ensure that the women has not had unprotected intercourse since last menses and has been correctly and consistently using a reliable method of contraception., Pregnancy testing adds weight to the diagnosis, but cannot reliably exclude a pregnancy if intercourse has occurred within the past 3 weeks. Following abortion or miscarriage Start on day of surgical or second part of a medical abortion - no additional precautions required. If started more than 5 days after abortion or miscarriage then 7 days of additional contraceptive precautions required. Insertion Post Natally If inserted up to day, no additional contraceptive cover is required. If started after day will need 7 days of additional contraceptive precautions required, unless client is fully breast-feeding Breast feeding Nexplanon is safe and licensed to for use in breast feeding mothers CONTRACEPTIVE IMPLANTS CEG: MARCH 05 Page of 9

3 Switching from another contraceptive method Always check the current method has been consistently and correctly used. COC and POP: immediate with no break, no additional contraception required. If any break, 7 days additional contraception will be required DEPO: if inserted up to 4 weeks after previous injection, no additional contraception required. If beyond 4 weeks, additional contraception for 7 days. Timing Of Removal Implants cause anovulation. Contraceptive cover is present until the device is removed, irrespective of when last sexual intercourse occurred. Any sexual intercourse after removal must be covered by an alternative method of contraception if pregnancy is to be avoided. If an implant is removed and another implant reinserted, there is no need for additional contraceptive precautions, as long as the original implant was within licence IInsertion and Removal procedures Fitting and removal techniques as per training for LoC SDI. Skin should be cleaned with 0.5% Chlorhexidine Palpate arm after insertion and check implant loading device to ensure implant has been inserted. Document that implant was palpated after insertion Dosage Recommendations for % lidocaine: Recommended dosage for insertion of sub dermal implant is.5ml 3ml. Recommended dosage for removal and insertion of sub dermal implant is.5-3ml Recommended dosage for removal of sub dermal implant is between 0.5ml to ml. Amount must be adequate to provide anaesthesia for procedure. If the person experiences pain during the procedure further doses of lidocaine may be given up to the recommended maximum of 5ml. Post- Insertion Instructions Advised to use additional contraception for seven days if necessary. Wound care instructions given at time of insertion. Advised to take simple analgesia if required. CONTRACEPTIVE IMPLANTS CEG: MARCH 05 Page 3 of 9

4 Routine post-insertion follow up is not necessary. Deep or Impalpable Implant If the implant is deep or impalpable, or if you are not confident that you can safely remove the implant, the client should be referred to Dr Audrey Brown at Sandyford Central, or can be booked directly into the SC SRH A Brown clinic. Linear array ultrasound is the imaging technique of choice for locating contraceptive implants. Dr Brown will arrange an x-ray =/- etonogestrel assay if the implant is not visible on ultrasound scan. CLIENTS WITH OTHER IMPLANTS Implanon is no longer manufactured in the UK, although some clients may still have an expired Implanon in situ. The removal technique is identical to Nexplanon and staff who are trained to remove Nexplanon can remove Implanon Occasionally clients may present with different implants which have been inserted overseas. These may be Norplant (6 capsules, 5 years use) or Jadelle or Norplant II ( capsules, 5 years use). Members of staff who have been trained to fit and remove single rod devices should not attempt to remove these devices, but should refer the client to Drs Audrey Brown, Julie Cumming, Kay McAllister or Angela Ford. Reference: Faculty of Sexual & Reproductive Health Care Clinical Guidance. Progestogen-only Implants. February 04 Faculty of Sexual and Reproductive Healthcare Clinical Guidance. Drug Interactions with Hormonal Contraception January 0 (Accessed March 05) Appendix CATEGORY CATEGORY CATEGORY 3 CATEGORY 4 DEFINITION OF CATEGORY A condition for which there is no restriction for the use of the contraceptive method. A condition where the advantages of using the method generally outweigh the theoretical or proven risks. A condition where the theoretical or proven risks usually outweigh the advantages of using the method. A condition which represents an unacceptable health risk if the contraceptive method is used. TABLE IMPLANON COMMON REVERSIBLE METHODS CONTRACEPTIVE IMPLANTS CEG: MARCH 05 Page 4 of 9

5 I = Initiation, C = Continuation Condition CATEGORY Personal characteristics & reproductive history PREGNANCY AGE PARITY BREASTFEEDING POSTPARTUM (non breastfeeding women) a) < days b) > days POST ABORTION a) First trimester b) Second trimester c) Immediate post septic abortion PAST ECTOPIC PREGNANCY HISTORY OF PELVIC SURGERY (including caesarean section) (see also postpartum section) SMOKING a) Age < 35 years b) Age 35 years OBESITY Cardiovascular disease MULTIPLE RISK FACTORS FOR ARTERIAL CARDIOVASCULAR DISEASE (such as older age, smoking, diabetes and hypertension) HYPERTENSION a) Adequately controlled hypertension b) Consistently elevated blood pressure levels (properly taken measurements) i. systolic 40 to 59mmHg or diastolic 90 to 94 mmhg ii. systolic 60 or diastolic 95mmHg c) Vascular disease HISTORY OF HIGH BLOOD PRESSURE DURING PREGNANCY (where current BP is normal) VENOUS THROMBO-EMBOLISM (VTE) (including deep vein thrombosis and pulmonary embolism) a) History of VTE b) Current VTE (on anticoagulants c) Family history of VTE d) Major surgery i. With prolonged immobilisation ii. Without prolonged immobilisation e) Minor surgery without immobilisation f) Immobility (unrelated to surgery) eg: wheelchair use, debilitating illness) KNOWN THROMBOGENIC MUTATIONS (eg: Factor V Leiden; Prothrombin mutation; Protein S, n/a CONTRACEPTIVE IMPLANTS CEG: MARCH 05 Page 5 of 9

6 Protein C and Antithrombin deficiencies) Condition SUPERFICIAL VENOUS THROMBOSIS a) Varicose veins b) Superficial thrombophlebitis CURRENT AND HISTORY OF ISCHAEMIC HEART DISEASE STROKE (history of cerebrovascular accident) CATEGORY I C 3 I C 3 KNOWN HYPERLIPIDAEMIAS (screening is NOT necessary for safe use of contraceptive methods) VALVULAR AND CONGENITAL HEART DISEASE a) Uncomplicated b) Complicated (e.g. with pulmonary hypertension, trial fibrillation, or a history of subacute bacterial endocarditis) Neurological conditions HEADACHES a) Non migrainous (mild or severe) b) Migraine without aura at any age c) Migraine with aura at any age d) Past history (> 5 years ago) of migraine with aura at any age EPILEPSY be aware of potential drug interactions Depressive disorders DEPRESSIVE DISORDERS Reproductive tract infections and disorders VAGINAL BLEEDING PATTERNS a) Irregular pattern without heavy bleeding b) Heavy or prolonged bleeding (includes regular and irregular patterns) UNEXPLAINED VAGINAL BLEEDING (suspicious for serious condition) before evaluation 3 ENDOMETRIOSIS BENIGN OVARIAN TUMOURS (including cysts) SEVERE DYSMENORRHOEA GESTATIONAL TROPHOBLASTIC NEOPLASIA (GTN) (includes hydatidiform mole, invasive mole, placental site trophoblastic tumour) a) Decreasing or undetectable β-hcg levels b) Persistently elevated β-hcg levels CERVICAL ECTROPION CERVICAL INTRAEPITHELIAL NEOPLASIA (CIN) CERVICAL CANCER (awaiting treatment) Condition BREAST DISEASE CATEGORY CONTRACEPTIVE IMPLANTS CEG: MARCH 05 Page 6 of 9

7 a) Undiagnosed mass b) Benign breast disease c) Family history of cancer d) Carriers of known gene mutations associated with breast cancer (eg: BRCA) e) Breast cancer i. Current ii. Past and no evidence of current disease for 5 years ENDOMETRIAL CANCER OVARIAN CANCER UTERINE FIBROIDS PELVIC INFLAMMATORY DISEASE (past or current) STIs HIV/AIDS HIGH RISK OF HIV HIV INFECTED a) Not using anti-retroviral therapy b) Using anti-retroviral therapy be aware of potential drug interactions - AIDS AND USING HAART Condition 4 3 CATEGORY Other infections SCHISTOSOMIASIS TUBERCULOSIS MALARIA Endocrine conditions DIABETES a) History of gestational diabetes b) Non vascular disease i. non insulin dependent ii. insulin dependent c) Nephropathy/retinopathy/neuropathy d) Other vascular disease or diabetes of >0 years duration THYROID DISORDERS Gastrointestinal conditions GALL BLADDER DISEASE a) Symptomatic b) Asymptomatic HISTORY OF CHOLESTASIS a) Pregnancy related b) Past COC related VIRAL HEPATITIS a) Acute or flare CONTRACEPTIVE IMPLANTS CEG: MARCH 05 Page 7 of 9

8 b) Carrier c) Chronic CIRRHOSIS a) Mild (compensated without complications) b) Severe (decompensated) 3 LIVER TUMOURS a) Benign i) Focular nodular hyperplasia ii) Hepatocellular (adenoma) 3 b) Malignant (hepatoma) 3 INFLAMMATORY BOWEL DISEASE (includes Crohn s disease, Ulcerative colitis) Anaemias THALASSAEMIA SICKLE CELL DISEASE IRON DEFICIENCY ANAEMIA RAYNAUD S DISEASE a) Primary b) Secondary i. without lupus anticoagulant ii. with lupus anticoagulant RHEUMATIC DISEASES SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) People with SLE are at an increased risk of ischaemic heart disease, stroke and venous thromboembolism and this is reflected in the categories given. a) Positive (or unknown) antiphospholipid antibodies 3 b) Severe thrombocytopenia c) Immunosuppressive d) None of the above DRUG INTERACTIONS ANTIRETROVIRAL THERAPY This section relates to the SAFETY of contraceptive use in women using these antiretroviral. EFFECTIVENESS may be reduced and pregnancy itself may have a negative impact on health for some women with certain medical conditions Antiretroviral therapy and hormonal contraception: Antiretroviral drugs have the potential to either decrease or increase the bioavailability of steroid hormones in hormonal contraceptives. Limited data suggest potential drug interactions between many antiretroviral drugs (particularly some non-nucleoside reverse transcriptase inhibitors and ritonavir-boosted protease inhibitors) and hormonal contraceptives. These interactions may alter the safety and effectiveness of both the hormonal contraceptive and the antiretroviral drug. Thus, if a woman on antiretroviral treatment decides to initiate or continue hormonal contraceptive use,the CONSISTENT USE OF CONDOMS IS RECOMMENDED.This is for both preventing HIV transmission and to compensate for any possible reduction in the effectiveness of the hormonal contraceptive.when a COC is chosen, a preparation containing a minimum of 30mcgs EE should be used. CONTRACEPTIVE IMPLANTS CEG: MARCH 05 Page 8 of 9

9 Antiretroviral therapy and IUDs: There is no known interaction between antiretroviral therapy and IUD use. However, AIDS as a condition is classified as Category 3 for insertion and Category for continuation unless the woman is clinically well on antiretroviral therapy, in which case both insertion and continuation are classified as Category. (See AIDS condition). a) Nucleoside reverse transcriptase inhibitors b) Non-nucleoside reverse transcriptase inhibitors c) Ritonavir-boosted protease inhibitors Certain anticonvulsants and combined oral contraception: When a COC is chosen, a preparation containing a minimum of 30mcgs EE should be used. THE CONSISTENT USE OF CONDOMS IS RECOMMENDED*. Certain anticonvulsants and progestogen-only contraception: Although the interaction of certain anticonvulsants with POPs, NET-EN and implants is not harmful to women, it is likely to reduce the effectiveness of POPs, NET-EN and implants.whether increasing the hormone dose of POPs alleviates this concern remains unclear. If a woman on certain anticonvulsants decides to use CHC, POP or implant THE CONSISTENT USE OF CONDOMS IS RECOMMENDED*. Use of other contraceptives should be encouraged for women who are long-term users of any of these anticonvulsant drugs. Use of DMPA is a Category because its effectiveness is NOT decreased by the use of certain anticonvulsants. Lamotrigine: When a COC is chosen, a preparation containing a minimum of 30mcgs EE should be used. Anticonvulsant treatment regimens that combine lamotrigine and non-enzyme inducing antiepileptic drugs (such as sodium valproate) do not interact with COCs a) Certain anticonvulstants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine) b) Lamotrigine * Rifampicin or rifabutin therapy and combined oral contraception: When a COC is chosen, a preparation containing a minimum of 30mcgs EE should be used. THE CONSISTENT USE OF CONDOMS IS RECOMMENDED*. Rifampicin or rifabutin therapy and progestogen-only contraception: Although the interaction of rifampicin or rifabutin with POPs, NET-EN and implants is not harmful to women, it is likely to reduce the effectiveness of POPs, NET-EN and implants. Whether increasing the hormone dose of POPs alleviates this concern remains unclear. If a woman on rifampicin or rifabutin decides to use POP or implant THE CONSISTENT USE OF CONDOMS IS RECOMMENDED*. Use of other contraceptives should be encouraged for women who are long-term users of rifampicin or rifabutin. Use of DMPA is a Category because its effectiveness is unlikely to be decreased by the use of rifampicin or rifabutin. a) Broad spectrum antibiotics b) Antifungals c) Antiparasitics d) Rifampicin or rifabutin therapy * CONTRACEPTIVE IMPLANTS CEG: MARCH 05 Page 9 of 9