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NURSE PROTOCOLS FOR WOMEN’S HEALTH THIS PAGE INTENTIONALLY LEFT BLANK Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 TABLE OF CONTENTS WOMEN’S HEALTH World Health Organization Medical Eligibility Criteria for Contraceptive Use Combined Oral Contraceptives Abnormal Lipid Tests While Taking Oral Contraceptives Hypertension While Taking Oral Contraceptives Spotting or Breakthrough Bleeding While Taking Oral Contraceptives Progestin-Only Pill Emergency Contraceptive Pills Implanon: Insertion Implanon: Removal IUD Insertion: Copper T380A IUD Insertion: Mirena LNG IUD IUD-Related Dysmenorrhea Lost IUD Strings IUD-Related Menorrhagia Pregnancy With IUD In Place IUD Removal IUD Complications and Actions Medroxyprogesterone Acetate Injectable Contraceptive Ortho Evra Patch NuvaRing Diaphragm Norplant Removal Amenorrhea (Primary and Secondary) Bacterial Cystitis Dysmenorrhea Ectopic Pregnancy Nurse Protocol for Prophylactic Therapy with Folic Acid for Reproductive-Age Women Iron Deficiency Anemia In Non-Pregnant and Non-Lactating Women 18 and Over Osteoporosis in Women Sexual Abstinence Counseling Local Estrogen Therapy 11 11.1 11.11 11.16 11.19 11.22 11.25 11.30 11.35 11.39 11.42 11.47 11.52 11.55 11.57 11.60 11.62 11.65 11.67 11.74 11.79 11.84 11.87 11.90 11.94 11.99 11.102 11.104 11.108 11.112 11.118 11.121 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 THIS PAGE INTENTIONALLY LEFT BLANK Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 World Health Organization (WHO) Medical Eligibility Criteria for Contraceptive Use Third Edition, 2004 CONDITION TYPE OF CONTRACEPTIVE CATEGORY CLARIFICATIONS/ I=Initiation EVIDENCE C=Continuation Condition Clarifications and Condition classified from evidence regarding the 1 to 4 classification The categories for fertility awarenessbased methods and surgical sterilization are described at the beginning of the relevant section. NA denotes a condition for which a ranking was not given by the Working Group but for which clarifications have been provided. Classification of categories Each condition was defined as representing either an individual's characteristics (e.g., age, history of pregnancy) or a known pre-existing medical/pathological condition (e.g., diabetes, hypertension). It is expected that national and institutional health and service delivery environments will decide the most suitable means for screening for conditions according to their public health importance. Client history will often be the most appropriate approach. The conditions affecting eligibility for the use of each contraceptive method were classified under one of the following four categories: 1. 2. 3. 4. 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. Women’s Health 11.1 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Using the categories in practice Categories 1 and 4 are self-explanatory. Classification of a method/condition as category 2 indicates the method can generally be used, but careful follow-up may be required. However, provision of a method to a woman with a condition classified as category 3 requires careful clinical judgment and access to clinical services; for such a woman, the severity of the condition and the availability, practicality, and acceptability of alternative methods should be taken into account. For a method/condition classified as category 3, use of that method is not usually recommended unless other more appropriate methods are not available or acceptable. Careful follow-up will be required. Where resources for clinical judgment are limited, such as in community-based services, the four-category classification framework can be simplified into two categories. With this simplification, a classification of Category 3 indicates that a woman is not medically eligible to use the method. CATEGORY 1 2 3 4 WITH CLINICAL JUDGMENT WITH LIMITED CLINICAL JUDGMENT Use method in any circumstances Yes (Use the method) Generally use the method Use of method not usually recommended unless other more appropriate methods are not available or not acceptable No (Do not use the method) Method not to be used ABBREVIATIONS: COC – Combined oral contraceptive CIC – Combined injectable contraceptive P/R – Patch/Ring POP – Progestin-only pill DMPA – Depot medroxyprogesterone acetate NET-EN – Norethinsterone enantate LNG/ETG – Levonorgestrel/Etonorgestrel (Norplant & Jadell/Implanon Cu IUD – Copper IUD (ParaGard) LNG IUD – Levonorgestrel IUD (Mirena) Women’s Health 11.2 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Women’s Health 11.3 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Women’s Health 11.4 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Women’s Health 11.5 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Women’s Health 11.6 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Women’s Health 11.7 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Women’s Health 11.8 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Women’s Health 11.9 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Women’s Health 11.10 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR COMBINED ORAL CONTRACEPTIVES (OCs) DEFINITION Combined oral contraceptives work primarily before fertilization. The progestins in all combined hormonal contraceptives provide most of the birth control activity by: Thickening cervical mucus to prevent sperm penetration into the upper genital tract. Blocking the lutenizing hormone (LH) surge prohibiting ovulation. Inhibiting capacitation of the sperm which may delay sperm transport. Some progestin effects additionally alter the environment that would be required for embryogenesis to proceed by: Disrupting transport of the fertilized ovum. Inducing endometrial atrophy, changing underlying vascular function and structure and altering the metalloproteinase in the endometrium which may inhibit implantation. SUBJECTIVE OBJECTIVE 1. Desires OCs as choice of contraception. 2. Has detailed health history (includes menstrual, sexual, contraception, personal health and family history) that does not reveal a condition representing an unacceptable health risk according to the product prescribing information and the World Health Organization (WHO) Medical Eligibility Criteria for Contraceptive Use. 3. If breastfeeding, has been breastfeeding at least 6 weeks, but, preferably six months or more after childbirth, to ensure that breastfeeding has been well established. 4. If age 35 or older, client does not smoke. Physical examination and laboratory tests according to programmatic guidelines. OR Physical exam deferred up to 3 months. Document reason for deferral on chart. Document on Request for and Consent to Family Planning Services (form 3700) that client agreed to have physical exam delayed. Women’s Health 11.11 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 ASSESSMENT Patient has no condition representing an unacceptable risk for taking OCs. PLAN DIAGNOSTIC STUDIES 1. Lipid profile beginning by age 45. Consider screening women age 20-44 in the presence of high-risk factors for CVD. Rescreen every 5 years or more often depending on test results and high-risk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 2. Blood glucose beginning by age 45. Consider screening women at an earlier age in the presence of high-risk factors for diabetes. Rescreen every 3 years or more often depending on test results and high risk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 3. Screen women for colorectal cancer according to district policy/procedure for colorectal cancer screening. THERAPEUTIC PHARMACOLOGIC 1. If the patient can take a pill with estrogen, give one tablet daily PO of any FDA approved <35 mcg oral contraceptive. 2. If the patient has been successfully taking OCs that are not available in the clinic, select pill with comparable composition or phone order to pharmacy. 3. Start patient on lowest acceptable dose with acceptable level of side effects. 4. For patients not receiving physical exam prior to first 3month supply, a physical exam must be performed to dispense additional OCs. 5. If patient is currently taking OCs or took previously without problems, may dispense appropriate number of cycles until next exam is to be performed. Women’s Health 11.12 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 PATIENT EDUCATION/COUNSELING 1. Counsel patient according to the seven basic elements of informed consent (BRAIDED). 2. Benefits of the method. Risks of the method (both major risks and all common minor ones), including consequences of method failure. Alternatives to the method (including abstinence and no method). Inquiries about the method are the patient’s right and responsibility. Decision to withdraw from using the method without penalty is the patient’s right at any time. Explanation of the method is owed the patient, in a format that is understandable to the patient. Documentation that the care-giver has ensured understanding of each of the preceding six points, usually by use of a consent form. Instructions in OC use: a. b. c. d. e. f. Take pills at the same time every day. Use back-up birth control for the first 7 days of OCs. Sunday-start, first day of menses start or quick start (refer to Contraceptive Technology, p. 420). Taking a pill more than a few hours late increases the risk of pregnancy; missing more than 2 pills in a row greatly increases the risk. When finishing one pack, take the first pill in the next packet on the very next day. Discuss medications that may reduce effectiveness. 3. Side effects and danger signs (ACHES). 4. Effectiveness and back-up methods. 5. Advise patient if she misses a pill(s) to refer to her pill package insert for missed pills instructions. 6. Counsel on the use of condoms to reduce the risk of STD/HIV. 7. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). 8. Emphasize importance of keeping immunizations current; assess client’s immunization status and administer vaccines Women’s Health 11.13 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed online at http://www.health.state.ga.us/programs/immunization/publications. asp. FOLLOW-UP 1. Return as scheduled for evaluation or contact clinic if side effects or danger signs develop. Outside of clinic hours, seek physician or emergency care if danger signs develop. 2. If patient did not receive a physical exam, have her return within 3 months for an exam and reassessment. 3. Established patients should return for evaluation at the end of the current supply of pills, or sooner if side effects or danger signs develop. CONSULTATION/REFERRAL 1. Development of any danger signs: a. b. c. d. e. f. g. Abdominal pain (severe). Eye problems (vision loss or blurring). Speech problems. Chest pain (severe), coughs, shortness of breath. Severe leg pain (calf or thigh). Severe headaches that start or become worse after beginning to take OCs. Dizziness, weakness, numbness or depression. 2. Any serious health concern expressed by patient. 3. If patient is under the supervision of medical doctor(s) for a health problem (e.g., hypertension). 4. Abnormal initial laboratory values or development of abnormal laboratory values or physical findings that indicate oral contraceptives should not be continued. Women’s Health 11.14 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 5. To nutritionist if patient has poor dietary intake, is overweight or underweight, is anemic or has any chronic disease related to poor nutrition. REFERENCES 1. 2. 3. 4. 5. 6. American Society of Health-Systems Pharmacists. American Hospital Formulary Service, Bethesda, MD, 2007, pp. 3072-3086. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co., New York, 2004. (Current) World Health Organization, Medical Eligibility Criteria for Contraceptive Use, Third Edition, 2004, <http:www.who.int/reproductive-health/publications/mec/> (March 15, 2005). Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters Kluwer Health, Inc., 2007 <http://online.factsandcomparisons.com>. "Preventive Screenings and Immunizations," U. S. Department of Health and Human Services, Office of Women's Health, <http://www.womenshealth.gov/screeningcharts/highrisk/>. Women’s Health 11.15 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR ABNORMAL LIPID TESTS WHILE TAKING ORAL CONTRACEPTIVES (OCs) DEFINITION Increased blood cholesterol levels are causally related to an increased risk of coronary heart disease. Coronary risk rises progressively with cholesterol levels, particularly when total cholesterol levels rise above 200 mg/dL. Borderline total cholesterol levels are 200-239 mg/dL and high levels are >240 mg/dL. Desirable levels of low-density lipoprotein cholesterol (LDL) are <130 mg/dL. Desirable levels of high-density lipoprotein cholesterol (HDL) are >40 mg/dL and are as significant as total cholesterol levels. Ethinyl estradiol increases HDL cholesterol and reduces LDL cholesterol. Progestins diminish the magnitude of the favorable impact; the more androgenic formulations have a more pronounced negative effect. Although triglyceride levels increase somewhat with estrogen-containing contraception, there is little concern because those remnants are not atherogenic. However, estrogen-containing contraceptives should be avoided if their use will be anticipated to raise triglycerides levels to >350 mg/dL and place the woman at risk for pancreatitis. SUBJECTIVE OBJECTIVE Patient may have: 1. Family history of cardiovascular disease prior to age 50. 2. History of hypertension. 3. History of smoking cigarettes. 4. Diabetes or gestational diabetes. 1. BMI of 27 or greater. 1. Total cholesterol 200 mg/dL or greater. AND/OR High-density lipoprotein cholesterol (HDL) <40 mg/dL. AND/OR Low-density lipoprotein cholesterol (LDL) >130 mg/dL. AND/OR Triglycerides >150mg/dL. 2. 3. 4. ASSESSMENT Elevated Cholesterol and/or Triglycerides (hypertriglyceridemia). Women’s Health 11.16 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 PLAN DIAGNOSTIC STUDIES Fasting total cholesterol and lipid profile (to include HDL, LDL) and triglycerides. Assessment cannot not be made on screening total cholesterol only. THERAPEUTIC PHARMACOLOGIC Change to OC containing either desogestrol (Desogen, OrthoCept), norgestimate (Ortho-Cyclen, Ortho-Tricyclen), lowest dose norethindrone (Ovcon-35, Brevicon, Modicon) or drospirenone (Yasmin) or progestin-only OC. PATIENT EDUCATION/COUNSELING 1. Discuss risk factors associated with smoking, hypertension, diabetes and obesity. 2. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). 3. Discuss lifestyle changes such as diet modifications to lower blood cholesterol, diet low in fat, high in fiber (plenty of whole grains, vegetables and fruits). 4. Advise patient to increase exercise and/or physical activity. 5. Lower dose OCs probably do not adversely affect lipid levels in most women. FOLLOW-UP Recheck lipid profile in 3–6 months. CONSULTATION/REFERRAL Refer to physician: 1. If total cholesterol is 240 mg/dL or greater, HDL <40 mg/dL, LDL>160 mg/dL, and/or Triglycerides >200 mg/dL. Must have MD approval to continue OCs. 2. To nutritionist for dietary counseling as needed. Women’s Health 11.17 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 REFERENCES 1. 2. 3. 4. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co., New York, 2004. (Current) Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III), Executive Summary, NIH, Publication No. 01-3670 National Heart, Lung, and Blood Institute, US Department of Health and Human Services, Bethesda, MD, May, 2001. (Current) Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters Kluwer Health, Inc., 2007 <http://online.factsandcomparisons.com>. Women’s Health 11.18 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR HYPERTENSION WHILE TAKING ORAL CONTRACEPTIVES DEFINITION Women who use oral contraceptives (OCs) rarely develop hypertension. However, the probability of developing hypertension increases with age. Hypertension may appear at any time and is not limited to the first months of use. OC-related hypertension is usually mild to moderate (a rise over baseline of 10-20 mmHg diastolic and/or 20 to 40 mmHg systolic). The hypertension is usually reversible within one to three months after discontinuing OCs. Only a few cases progressing to malignant hypertension have been reported. ETIOLOGY Variables such as previous toxemia of pregnancy or previous renal disease do not predict whether a woman will develop hypertension while using OCs. The mechanism for an effect of OCs on blood pressure is thought to involve the renin angiotensin system. SUBJECTIVE 1. May or may not have past history of hypertension. 2. Is currently taking OCs and hypertension has developed since starting pills. OBJECTIVE Blood pressure, measured according to Nurse Protocol for Primary Hypertension in Adults, shows: 1. 2. Systolic blood pressure ≥ 140 mmHg on three or more separate occasions. OR Diastolic blood pressure ≥ 90 mmHg on three or more separate occasions. NOTE: See Nurse Protocol for Primary Hypertension in Adults ASSESSMENT Hypertension, possibly related to oral contraceptives. PLAN THERAPEUTIC PHARMACOLOGIC Change to another contraceptive method that is not combined hormonal. NON-PHARMACOLOGIC MEASURES Review the following lifestyle modifications with all clients, as applicable: Women’s Health 11.19 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 1. Counsel regarding the Dietary Approaches to Stop Hypertension (DASH), Reduced Sodium Diet. 2. Achieve/maintain desirable body weight or Body Mass Index of 18.5-24.9 kg/m2. 3. Reduction of dietary sodium (1500 mg to no more than 2400 mg/day). 4. Reduction of dietary fats and cholesterol. 5. Moderation of alcohol intake (less than one ounce [30mL] ethanol/day for men and less than 0.5 oz [15mL] for women). One ounce of ethanol equals 24 oz Beer, 10 oz wine, or 3 oz 80-proof whiskey. 6. Adequate dietary potassium intake (if renal function is normal and not taking drugs known to raise potassium, such as angiotensin-converting enzyme Inhibitors) of 3500 mg/day. 7. Regular aerobic physical activity at least 30 minutes per day, most days of the week. 8. If smoker or tobacco user, refer to local cessation program and/or Georgia Quit Line 1-877-270-STOP (7867). 9. Adequate intake of calcium, 1000-1500 mg/day. PATIENT EDUCATION/COUNSELING 1. Educate patient on lifestyle changes that may help lower blood pressure. a. b. c. d. e. g. h. i. Limit sodium intake to no more than 1500-2000 mg/day. Eat a diet rich in vegetables, fruits and low-fat dairy products such as low-fat milk and yogurt. Exercise and/or increase physical activity. Quit smoking Decrease intake of caffeine and alcohol. Avoid over-the-counter-oral decongestants and diet pills. Attain and maintain optimal weight Attain and maintain adequate calcium. Women’s Health 11.20 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 2. Discuss possible risks and complications of hypertension. FOLLOW-UP Monitor blood pressure monthly, for 3 months. REFERRAL/CONSULTATION 1. For uncontrolled blood pressure consistently >140 mmHg systolic, or >90 mmHg diastolic. 2. To nutritionist for diet counseling about optimal food intake to attain/maintain normal blood pressure, Na intake and weight. 3. Systolic pressure ≥210 mmHg or diastolic pressure ≥120 mmHg on any occasion. REFERENCES 1. 2. 3. 4. 5. American Society of Health-Systems Pharmacists, American Hospital Formulary Service, Bethesda, MD, 2007, pp. 3072-3091. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co., New York, 2004. (Current) Leon Speroff and Marc Fritz, Clinical Gynecologic Endocrinology and Infertility, Seventh Edition, Lipincott Williams & Wilkins, Philadelphia, 2005. Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters Kluwer Health, Inc., 2007 <http://online.factsandcomparisons.com>. Women’s Health 11.21 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR SPOTTING OR BREAKTHROUGH BLEEDING WHILE TAKING ORAL CONTRACEPTIVES DEFINITION Breakthrough bleeding (BTB) is bleeding that requires use of a pad or tampon during the cycle of oral contraceptives (OCs). A lesser amount of bleeding while taking OCs is called spotting. Light bleeding between menses for the first few months on OCs is generally not a sign of any serious problems and is common (30-50% of women) in the first few months of OC use. BTB generally resolves by the third or fourth month of OC use. There is no evidence that the onset of bleeding is associated with decreased efficacy, no matter what oral contraceptive formulation is used, even the lowest dose products. SUBJECTIVE 1. May have a recent history of missed OCs or incorrect usage. 2. Intermenstrual spotting/bleeding for several months. 3. May have recent history of GI problems such as vomiting or diarrhea. 4. May have history of taking antiseizure medications (phenobarbital, phenytoin, carbamazepine, or promidone), rifampin, topiramate or griseofulvin. Herbal substances such as St. John’s Wort may increase metabolism of estrogen and cause side effects and/or decreased effectiveness. 5. May have history of abnormal vaginal discharge. 6. May have history of dyspareunia or pelvic pain. OBJECTIVE Pelvic exam is negative for other causes of bleeding. ASSESSMENT Spotting or breakthrough bleeding while on OCs. PLAN DIAGNOSTIC STUDIES 1. Urine dip stick if indicated. 2. Gonorrhea and chlamydia tests, if indicated. 3. Pregnancy test if indicated. 4. Hemoglobin/hematocrit if indicated. 5. Wet prep if indicated. Women’s Health 11.22 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 THERAPEUTIC 1. For women with persistent irregular bleeding after 2-3 months, consider changing to other formulations, although no research indicates any specific OC is best at eliminating spotting or bleeding. 2. If spotting or bleeding before completion of active OCs, increase the progestin content of OC either by changing to a different monophasic formulation or by switching to a triphasic formulation that increases the progestin level of active OCs. OR 3. If spotting continues after withdrawal bleed, increase the estrogen in each tablet or decrease the progestin in the early pills (especially with triphasic formulation). OR 4. For mid-cycle spotting/bleeding, increase both estrogen/progestin mid-cycle with OCs such as Triphasil and Tri-Levlen. PATIENT EDUCATION/COUNSELING 1. Reassure new OC users that breakthrough bleeding decreases dramatically over the first 3-4 months of pill use. 2. Reinforce proper usage of OCs, especially taking pills at the same time each day. 3. Counsel on use of alternate method if OCs are discontinued. 4. Counsel on use of condoms to reduce the risk of STDs/HIV. 5. Breakthrough bleeding occurs at a higher rate in women who smoke. 6. If smoker, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). FOLLOW-UP Reassess in 3 months depending on the acuity of the problem. Women’s Health 11.23 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 REFERRAL/CONSULTATION 1. If problem continues. 2. Pelvic pathology. 3. Abnormal diagnostic tests. REFERENCES 1. 2. 3. 4. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co., New York, 2004. (Current) Leon Speroff and Marc Fritz, Clinical Gynecologic Endocrinology and Infertility, Seventh Edition, Lippincott Williams & Wilkins, Philadelphia, 2005. Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters Kluwer Health, Inc., 2007 <http://online.factsandcomparisons.com>. Women’s Health 11.24 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR PROGESTIN-ONLY PILL (MINIPILL) DEFINITION The minipill is an oral contraceptive (OC) pill that contains only progestin. The amount of progestin in the minipill is less than what is found in the lowest-dose combination oral contraceptives. Progestin-only pills prevent pregnancy by: inhibiting ovulation, thickening and decreasing cervical mucus preventing sperm penetration, suppressing mid-cycle peaks of LH and FSH, inhibiting progesteronereceptor synthesis, reducing number/size of endometrial glands associated with a thin atrophic endometrium, reducing activity of the cilia in the fallopian tubes, arresting movement of the blastocyst, and premature luteolysis (diminished function of the corpus luteum). Minipills do not suppress the milk supply once breastfeeding is well established and studies have found no adverse effects on infant health. The minipill is often used after a woman has experienced one of the estrogen-excess side effects with use of combination pills. Because minipills often cause irregular bleeding, undiagnosed abnormal vaginal bleeding is one of the more important contraindications to their use. Also, minipills do not protect against ectopic pregnancy as effectively as they protect against intrauterine pregnancy. SUBJECTIVE OBJECTIVE 1. May complain of estrogen-excess side effects while taking combined oral contraceptives, such as headaches, leg pain, weight gain, nausea. 2. Breastfeeding patients must give a history of no unprotected intercourse within the prior two weeks. 3. May want lowest-dose oral contraceptive available. 4. Has detailed health history (includes menstrual, sexual, contraception, personal health and family health) that does not reveal a condition representing an unacceptable health risk according to the product prescribing information and the World Health Organization (WHO) Medical Eligibility for Contraceptive Use. 1. Physical examination and laboratory tests according to programmatic guidelines. OR 2. Physical exam deferred up to 3 months. Women’s Health 11.25 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Document on Request for and Consent to Family Planning Services (form 3700) that client agreed to have physical exam delayed. 3. Pregnancy test, if indicated, is negative. ASSESSMENT Patient has no condition representing an unacceptable risk if taking minipills. PLAN DIAGNOSTIC STUDIES 1. Lipid profile beginning by age 45. Consider screening women age 20-44 in the presence of high-risk factors for CVD. Rescreen every 5 years or more often depending on test results and high-risk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 2. Blood glucose beginning by age 45. Consider screening women at an earlier age in the presence of high-risk factors for diabetes. Rescreen every 3 years or more often depending on test results and high risk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 3. Screen women for colorectal cancer according to district policy/procedure for colorectal cancer screening. THERAPEUTIC PHARMACOLOGIC 1. Order any FDA approved progestin-only OC. 2. If breastfeeding, wait until breastfeeding well established (usually at six weeks postpartum) before starting mini pills. May begin on first day of menses or on any day that pregnancy has been ruled out. 3. Always take one pill every day at the same time. Taking a pill more than a few hours late increases the risk of pregnancy, and missing two or more pills in a row greatly increases the risk. When one packet is finished, take the first pill from the next packet on the very next day. All pills are active, hormonal pills. There is no wait between packets. Women’s Health 11.26 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 4. With missed pills or more than three hours late taking the pills, use a barrier method or avoid sex for two days. Take the last missed pill as soon as possible and continue taking one pill each day as usual. 5. If pills were not taken on schedule and patient has had unprotected sex in the past 72 hours, may want to use emergency contraceptive pills (ECP) to reduce the risk of pregnancy (See Nurse Protocol for Emergency Contraceptive Pills). 6. For patients not receiving physical exam prior to first supply, a physical should be performed prior to dispensing additional OCs. 7. If patient currently taking OCs or took previously without problems, may dispense appropriate number of cycles until next exam is to be performed. PATIENT EDUCATION/COUNSELING 1. Counsel patient according to seven basic elements of informed consent (BRAIDED – Benefits Risks Alternatives Inquiries Decision Explanation Documentation). 2. The minipill may cause irregular bleeding or amenorrhea. 3. Danger signs: a. Abdominal pain may be due to an ovarian cyst or ectopic pregnancy. b. A delayed period after several months of regular cycles may be a sign of pregnancy. c. Repeated, very severe headaches. 4. The minipills must be taken at about the same time every day. The margin for error is less with minipills than with combined OCs. 5. There appear to be no significant metabolic effects and there is an immediate return to fertility upon discontinuation of the minipill. 6. Counsel patient on use of condoms to reduce the risk of STDs/HIV. 7. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). Women’s Health 11.27 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 9. Emphasize importance of keeping immunizations current; assess client’s immunization status and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed online at http://www.health.state.ga.us/programs/immunization/publicatio ns.asp. FOLLOW- UP 1. Return as scheduled for evaluation, or contact clinic if side effects, danger signs or symptoms of possible pregnancy. Outside of clinic hours, seek physician or emergency care if danger signs develop. 2. If patient did not receive a physical exam, have her return within 3 months for an exam and reassessment. 3. Established patients should return for an evaluation at the end of the current supply of pills, or sooner if side effects or danger signs develop. CONSULTATION/REFERRAL 1. Development of danger signs. 2. To nutritionist if patient has poor dietary intake, is overweight or underweight, is anemic or has any chronic disease related to poor nutrition. 3. Extremely heavy bleeding. 4. Suspected pregnancy (e.g., missed menses after several regular cycles), especially if she has signs of ectopic pregnancy such as abdominal pain or tenderness, or fainting. Women’s Health 11.28 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 REFERENCES 1. 2. 3. 4. 5. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York. 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co. New York, 2004. (Current) American Society of Health-Systems Pharmacists, American Hospital Formulary Service, Bethesda, MD, 2007, pp. 3086 - 3091. Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters Kluwer Health, Inc., 2007 <http://online.factsandcomparisons.com>. "Preventive Screenings and Immunizations," U. S. Department of Health and Human Services, Office of Women's Health, <http://www.womenshealth.gov/screeningcharts/highrisk/>. Women’s Health 11.29 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR EMERGENCY CONTRACEPTIVE PILLS (ECPs) DEFINITION For the average fertile couple, the probability of conception is about 20% each cycle, which means there is an 80% probability that conception will not occur. There are many steps in the process of reproduction that potentially could be affected by emergency contraception: Follicle maturation, egg maturation and the ovulatory process. Sperm migration and function. Fertilization. Zygote, morula, and blastocyst development, and transport in the fallopian tube and uterine cavity. Development of receptive uterine lining. Maintenance of necessary hormone levels by the corpus luteum. The effect of treatment depends on when in the woman’s cycle emergency contraception is used. SUBJECTIVE 1. Patient requests postcoital contraception as an emergency measure only (not as ongoing routine contraception). Patient has had unprotected intercourse within the last 120 hours. NOTE: Emergency Contraceptive is most effective if given within 72 hours of unprotected intercourse. The sooner ECPs are initiated, the more effective treatment is. 2. Precautions: When dispensing Plan B®: a. History of hypersensitivity to any component of progestin only pills. b. Undiagnosed vaginal bleeding. c. Known or suspected pregnancy. Contraindications when dispensing combined OCs: a. Known or suspected pregnancy. b. Hypersensitivity to any component of combined OCs. c. Acute migraine headaches at the time patient plans to take the OCs. d. History of thromboembolic disease or pulmonary embolus (Use Plan B®). Women’s Health 11.30 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 OBJECTIVE 1. 2. Negative pregnancy test. Pelvic exam, if indicated. ASSESSMENT Patient requests emergency contraception: no contraindications. PLAN THERAPEUTIC PHARMACOLOGIC 1. Brand Manufacturer Plan B® (dedicated WCC product) Alesse® Wyeth-Ayerst Emergency contraceptive pills, one dose as soon as possible within 120 hours after unprotected intercourse, and another dose 12 hours later. Number of Pills per Dose Ethinyl Estradiol per Dose (µg) Levonorgestrel per Dose (mg) Antinausea Rx Recommended 1 white pill 0 0.75 No 5 pink pills 100 0.50 Yes Aviane™ Duramed 5 orange pills 100 0.50 Yes Levlen® Burlex 4 light orange pills 120 0.60 Yes Levlite™ Burlex 5 pink pills 100 0.50 Yes Levora® Watson 4 white pills 120 0.60 Yes Low-Ogestrel® Watson 4 white pills 120 0.60 Yes Lo/Ovral® Wyeth-Ayerst 4 white pills 120 0.60 Yes Nordette® Wyeth-Ayerst 4 light orange pills 120 0.60 Yes Ogestrel® Watson 2 white pills 100 0.50 Yes Ovral® Wyeth-Ayerst 2 white pills 100 0.50 Yes Seasonale Barr 4 pink pills 120 0.60 Yes Tri-Levlen® Berlex 4 yellow pills 120 0.50 Yes Triphasil® Wyeth-Ayerst 4 yellow pills 120 0.50 Yes 2. For preventing or treating nausea: NOTE: Antiemetics not needed with Plan B.® Women’s Health 11.31 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Non-prescription (Adult Dose) a. b. c. Meclizine HCl 25mg (OTC available as Dramamine II® or Bonine® , by prescription Antivert® 25mg and 50mg), 25-50mg PO taken one hour prior to dose. Meclizine HCl has a 24 hour duration. OR Cyclizine hydrochloride (Marezine®) 50 mg tablets, one tablet PO a half hour before taking ECPs; repeat every 4 to 6 hours prn, up to 200 mg/day. OR Diphenhydramine hydrochloride (e.g., Benadryl®) 25 mg tablets, 1-2 tablets PO 1 hour before taking ECPs; repeat every 4-6 hours prn. Maximum dose 300 mg/day. OR To order and/or dispense (Adult Dose) d. e. f. g. Trimethobenzamide hydrochloride (Tigan®) 300 mg capsule, one capsule PO one hour before taking ECPs; repeat every 6 to 8 hours prn. OR Tigan 200 mg rectal suppository, insert one suppository one hour before taking ECPs; repeat every 6 to 8 hours prn. OR Promethazine hydrochloride (Phenergan®) 25 mg tablets, one tablet PO a half hour before taking ECPs; repeat every 4 hours prn. OR Promethazine hydrochloride (Phenergan®) 25 mg rectal suppository inserted a half hour before taking ECPs; repeat every 4 hours prn. NOTE: Medication used to prevent or treat nausea may cause drowsiness. Therefore, caution the patient who is driving or operating dangerous equipment. Caution on alcohol use. (Medication is not as likely to be effective if already nauseated.) 3. If patient wants to use OCs, as an ongoing method, initiate a new pack of OCs according to manufacturers directions at the next menstrual cycle, or begin taking OCs one tablet daily the day after ECP treatment is complete. If taking Levlen, Lo/Ovral, Low-Ogestrel, Nordette or Portia for Women’s Health 11.32 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 ECPs, continue taking one pill per day from the same pack. If using other OC brands, begin a new pack the day after ECP treatment is complete. Use condoms as back-up for 7 days if OCs started immediately. PATIENT EDUCATION/COUNSELING 1. Exact directions for taking medication. 2. Risks of nausea and emesis. a. b. c. d. The nausea is usually mild and should stop within a day or so after treatment. If severe gastrointestinal side effects occur after the first dose of combined ECPs, patient may need additional medication. If patient vomits within one hour after either dose, take an additional dose. If patient vomits more than two hours after taking the pills, additional pills are not recommended. 3. The next menstrual period should begin sometime within next 2 or 3 weeks. If no menses in 3 weeks advise patient to return to clinic for pregnancy test. 4. Strongly encourage patient to choose an acceptable, ongoing method of birth control. 5. Counsel on the use of condoms to reduce the risk of STDs/HIV. 6. Extensive information about emergency contraception is available in English/Spanish by calling 1-888-NOT-2-LATE. 7. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). FOLLOW-UP 1. If period has not started in 3 weeks, or if next menses is unusually light or unusually painful, return to clinic. 2. Return to clinic for long-term birth control method if not provided at visit. Women’s Health 11.33 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 CONSULTATION/REFERRAL 1. Immediately, if nausea/vomiting cannot be controlled. 2. Development of any serious side effects of combined OCs. REFERENCES 1. 2. 3. 4. 5. American Society of Health-Systems Pharmacists, American Hospital Formulary Service, Bethesda, MD, 2007, pp. 2935-2939, 2557-2559. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co. New York, 2004. (Current) Leon Speroff et al., Clinical Gynecologic Endocrinology and Infertility, Seventh Edition, Lipincott Williams and Wilkins, Baltimore 2005. Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters Kluwer Health, Inc., 2007 <http://online.factsandcomparisons.com>. Women’s Health 11.34 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PRACTITIONER PROTOCOL FOR CONTRACEPTIVE IMPLANT INSERTION: IMPLANON DEFINITION The subdermal contraceptive implant (Implanon®) is an etonogestrelimpregnated 4 cm plastic rod. It is placed under the skin of the upper arm. Implanon does not contain estrogen. It prevents pregnancy primarily by inhibiting ovulation. Other contraceptive effects include thickening cervical mucus and thinning the endometrial lining. The implant must be removed at the end of the third year of use and may be replaced with a new implant if continued contraception is desired. SUBJECTIVE 1. Desires an implant as method and long-term contraception. 2. Has detailed health history (includes menstrual, sexual, contraception, personal health and family history) that does not reveal a condition representing an unacceptable health risk according to the product prescribing information and to the World Health Organization (WHO) Medical Eligibility Criteria for Contraceptive Use. 1. Physical exam and laboratory tests according to programmatic guidelines. OBJECTIVE OR 2. ASSESSMENT Physical exam deferred up to 3 months. Document reason for deferral on chart. Document on Request for and Consent to Family Planning Services (form 3700) that client agreed to have physical exam delayed. Patient has no condition representing an unacceptable risk if using Implanon. PLAN DIAGNOSTIC STUDIES 1. Pregnancy test if indicated to rule out pregnancy before inserting Implanon. 2. Lipid profile beginning by age 45. Consider screening women age 20-44 in the presence of high-risk factors for CVD. Rescreen every 5 years or more often depending on test results and highrisk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 3. Blood glucose beginning by age 45. Consider screening women at an earlier age in the presence of high-risk factors for diabetes. Women’s Health 11.35 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Rescreen every 3 years or more often depending on test results and high-risk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 4. Screen women for colorectal cancer according to district policy/procedure for colorectal cancer screening. PHARMACOLOGIC 1. Local anesthesia with 1% lidocaine should be injected under the skin and along the insertion track. 2. Insert Implanon per manufacturer’s directions. May be inserted any time in the cycle as long as pregnancy has been ruled out and manufacturer’s instructions regarding backup contraception are followed. NOTE: Before insertion, the patient must read and sign the consent form provided by the manufacturer in addition to the program’s method specific consent form. 3. IMPORTANT: Organon, the manufacturer of Implanon, requires practitioners to attend an Implanon-specific clinical training program before insertion privileges are granted. For information, call 1-877-467-5266. NON-PHARMACOLOGIC MEASURES 1. Take precautions to avert a vasovagal reaction (syncope/fainting). Allow the patient to lie still several minutes after insertion. Ask about pain or feeling faint. If the patient says she feels like she can sit up, have her sit up slowly while being supported. If no problems in 1-2 minutes, allow her to stand. 2. Treat signs of vasovagal reaction (pallor/cyanosis, pinchedface look, dilated pupils, weak and rapid pulse, rapid shallow breathing, hypotension) according to the Emergency Protocols and Procedures section of this manual. 3. Ice to insertion area for discomfort. Women’s Health 11.36 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 PATIENT EDUCATION/COUNSELING 1. Counsel patient according to seven basic elements of informed consent (BRAIDED – Benefits Risks Alternatives Inquiries Decision Explanation Documentation). 2. In addition to the manufacturer’s consent form, the packaging also includes a User Card. The User Card should be filled out and given to the patient after Implanon insertion so she will have a record of the location of Implanon and when Implanon should be removed. 3. Teach patient how to check for Implanon. a. The implant should be palpated by both the clinician and patient before patient goes home to ensure proper placement. b. The patient may confirm placement at any time by palpating her inner upper arm. c. If patient cannot feel the implant, she should use another method of contraception (e.g., condoms or abstinence) and return to the clinic. 4. Review warning signs and symptoms of possible insertion site problems: redness, swelling, or purulent discharge at insertion site. 5. Menstrual irregularities (spotting, light bleeding, prolonged bleeding, no bleeding) are common. 6. Take over-the-counter ibuprofen or acetaminophen and/or apply ice to insertion area for discomfort. 7. Use condoms to reduce the risk of STDs, including HIV. 8. Outside of clinic hours, seek physician or emergency care if warning signs develop. 9. Implanon is approved for use for 3 years. 10. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). 11. Emphasize importance of keeping immunizations current; assess client’s immunization status and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Women’s Health 11.37 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed online at http://health.state.ga.us/publications/manuals.asp. FOLLOW-UP 1. Return as scheduled for evaluation or contact clinic if side effects or danger signs develop. 2. If patient did not receive a physical exam, have her return within 3 months for an exam and reassessment. 3. After an Implanon has been in place for 3 years, check with manufacturer regarding possible approval for a longer time. CONSULTATION/REFERRAL 1. Difficult Implanon insertion or removal. 2. Suspected ectopic pregnancy. 3. Other complications related to implant use. REFERENCES 1. Robert Hatcher et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) 2. Implanon Etonogestrel Subdermal Contraceptive Implant, Physician Prescribing Information, Organon, July 2006. 3. World Health Organization, Medical Eligibility Criteria for Contraceptive Use, Third Edition, 2004, <http:www.who.int/reproductive-health/publications/mec/>(May 31, 2007). 4. U. S. Department of Health and Human Services, Office of Women's Health, http://www.womenshealth.gov/screeningcharts/highrisk/. 5. American Society of Health-Systems Pharmacists. American Hospital Formulary Service, Bethesda, MD, 2007, pp 3086-3091. Women’s Health 11.38 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PRACTITIONER PROTOCOL FOR IMPLANON® REMOVAL DEFINITION Removal of Implanon® at the patient's request, due to clinical findings such as pregnancy or side effects, or per guidelines that Implanon® must be removed after 3 years. SUBJECTIVE 1. Patient desires Implanon® removal. 2. May be pregnant. 3. Complains of severe side effects. 4. Three years may have elapsed since insertion. 1. Positive pregnancy test. 2. Clinical findings of severe side effects or a contraindication for continuing with Implanon®. OBJECTIVE ASSESSMENT Removal of Implanon® is desired or recommended. PLAN DIAGNOSTIC STUDIES Implant palpable under skin and exact position localized. If implant is not palpable, do not attempt to begin removal process. Implant must be localized with ultrasound using a high frequency linear array transducer (≥10 mHz) or MRI. Only remove a non-palpable implant once the location of the implant has been established. If imaging methods fail, call the manufacturer, Organon, at 1-877-467-5266 for further instructions. THERAPEUTIC Per manufacturer’s instructions, remove the Implanon® capsule through a very small incision over the tip that is closest to the elbow. 1. Per manufacturer’s removal instructions: a. Inject local anesthetic under the distal tip of the implant. b. Make a 2-3 mm incision just above the tip of the rod. c. Gently push the tip of the implant through the incision and grasp with a hemostat or forceps for removal. d. Place bandage over incision. 2. If implant is not palpable but has been localized by ultrasound and is found to be deeply inserted, referral to a specialist with expertise in deep removals is highly recommended. This specialist should have a good understanding of the vessels and Women’s Health 11.39 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 nerves of the arm. Any adverse events associated with removal should be reported to Organon at 1-877-467-5266. PATIENT EDUCATION/COUNSELING 1. Provide patient with instructions for care. Take over-the-counter ibuprofen or acetaminophen for discomfort if needed. 2. Discuss alternative contraceptive method, if desired. 3. Menses may be delayed or irregular for a month or more after removal. 4. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). 6. Emphasize importance of keeping immunizations current; assess client’s immunization status and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed online at http://health.state.ga.us/publications/manuals.asp. FOLLOW-UP Return, as needed, for contraception or yearly exam. CONSULTATION/REFERRAL 1. Difficult/failed removal. 2. Successful removal, patient pregnant. 3. Persistent side effects. REFERENCES 1. Robert Hatcher et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) 2. Implanon Etonogestrel Subdermal Contraceptive Implant, Physician Prescribing Information, Organon, July 2006. Women’s Health 11.40 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 3. World Health Organization, Medical Eligibility Criteria for Contraceptive Use, Third Edition, 2004, <http:www.who.int/reproductive-health/publications/mec/>(May 31, 2007). 4. U. S. Department of Health and Human Services, Office of Women's Health, http://www.womenshealth.gov/screeningcharts/highrisk/. 5. American Society of Health-Systems Pharmacists. American Hospital Formulary Service, Bethesda, MD, 2007, pp 3086-3091. Women’s Health 11.41 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PRACTITIONER PROTOCOL FOR IUD INSERTION: COPPER T380A DEFINITION The Copper T380A (ParaGard®) intrauterine device, is a copper-bearing contraceptive device. It prevents pregnancy by immobilizing sperm, inhibiting fertilization and preventing implantation due to local inflammatory responses and endometrial effects. SUBJECTIVE 1. Desires an IUD as method and long-term contraception. 3. Not at high risk for sexually transmitted infections. 4. Has detailed health history (includes menstrual, sexual, contraception, personal health and family history) that does not reveal a condition representing an unacceptable health risk according to the product prescribing information and to the World Health Organization (WHO) Medical Eligibility Criteria for Contraceptive Use. 1. Normal pelvic exam at the time of insertion. 2. Negative pregnancy test at the time of insertion. 3. Laboratory tests: OBJECTIVE a. b. c. d. Pap smear in last 12-15 months which rules out cervical malignancy. Negative gonorrhea and chlamydia tests within last 60 days. Wet mount if indicated. Normal hemoglobin or hematocrit within last 60 days. ASSESSMENT Patient has no condition representing an unacceptable risk if using a Copper T380A. PLAN DIAGNOSTIC STUDIES 1. Blood glucose beginning by age 45. Consider screening women at an earlier age in the presence of high-risk factors for diabetes. Rescreen every 3 years or more often depending on test results and high risk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 2. Screen women for colorectal cancer according to district policy/procedure for colorectal cancer screening. Women’s Health 11.42 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 PHARMACOLOGIC 1. May give an over-the-counter (OTC) nonsteroidal antiinflammatory agent 30-60 minutes before the procedure to reduce discomfort. 2. Insert Copper T380A per manufacturer’s directions. May be inserted any time in the cycle as long as pregnancy has been ruled out. NOTE: Before insertion, the patient must read and sign the consent form if provided by the manufacturer in addition to the program’s method specific consent form. 3. If hemoglobin below 12.0 g/dL for non-smoker or below 12.3 g/dL for smoker or hematocrit below 35.7% for nonsmoker or below 36% for smoker, treat according to appropriate nurse protocol for age for iron deficiency anemia. NON-PHARMACOLOGIC MEASURES 1. Take precautions to avert a vasovagal reaction (syncope/fainting) caused by uterine manipulation and sounding. After IUD insertion, allow the patient to lie still for at least 30 seconds (while explaining how to check for strings). Ask about pain or cramping. If the patient says she feels okay, have her sit up slowly while being supported. If no problems in 30 seconds, allow her to stand. 2. Treat signs of vasovagal reaction (pallor/cyanosis, pinchedface look, dilated pupils, weak and rapid pulse, rapid shallow breathing, hypotension) according to the Emergency Protocols and Procedures section of this manual. 3. Heat to pelvic area for discomfort. PATIENT EDUCATION/COUNSELING 1. Counsel patient according to seven basic elements of informed consent (BRAIDED – Benefits Risks Alternatives Inquiries Decision Explanation Documentation). 2. Teach patient how to check for IUD strings. Women’s Health 11.43 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 a. b. c. d. e. The IUD can be expelled without being noticed. Check for the strings frequently during the first months, then after each menses and any time there is abnormal cramping while menstruating. Inspect tampons on removal for IUD. If patient cannot feel the strings, or if the plastic part is felt, use another method of contraception and return to the clinic. Most likely cause of IUD failure is expulsion with risk highest during the first year, particularly within the first 3 months after insertion. 3. Review warning signs and symptoms of possible problem: abdominal pain, discharge, or missing string. 4. There is a small increased risk of PID, which is most likely to occur within the first 2-3 weeks after insertion. 5. Menstrual irregularities (spotting, light bleeding) are common in the first 3-6 months after insertion. 6. Take over-the-counter ibuprofen or naproxen sodium and/or apply heat to pelvic area for discomfort. 7. Should strongly consider changing to another contraceptive method if behavior puts client at risk for PID (multiple partners, partner with multiple partners). 8. Use condoms to reduce the risk of STDs, including HIV. 9. Outside of clinic hours, seek physician or emergency care if warning signs develop. 10. The T380A is approved for use for 10 years. 11. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). 12. Emphasize importance of keeping immunizations current; assess client’s immunization status and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and Women’s Health 11.44 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed online at http://www.health.state.ga.us/programs/immunization/publications. asp. FOLLOW-UP 1. Re-examine and evaluate the patient shortly after the first postinsertion menses, but no later than three months afterwards. 2. If patient had a low hemoglobin or hematocrit, recheck after completion of at least 4–6 weeks of iron therapy: a. b. If hemoglobin drops >2 g/dL or hematocrit drops >6%, strongly consider removal and treat according to appropriate nurse protocol for age for iron deficiency anemia. If hemoglobin <9 g/dL or hematocrit <27%, strongly consider removal and treat according to protocol. If IUD removed for the above reasons: 1) Repeat hemoglobin/hematocrit in 1-2 months. 2) Provide an alternate method of contraception. 3. If evidence of pelvic inflammatory disease, see Nurse Protocol for Pelvic Inflammatory Disease (PID). IUD removal is not necessary unless no improvement after 2-3 days of antibiotic treatment. 4. If pregnancy occurs, counsel patient that IUD should be removed at time of diagnosis whether pregnancy is continued or terminated. 5. After a T380A has been in place for 10 years, check with manufacturer regarding possible approval for a longer time. CONSULTATION/REFERRAL 1. Difficult IUD insertion or removal. 2. Suspected ectopic pregnancy. 3. To NP or MD for IUD removal if pregnant. 4. Other complications related to IUD use. 5. Presence of actinomyces on Pap smear report and evidence of pelvic infection. Women’s Health 11.45 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 REFERENCES 1. 2. 3. 4. 5. 6. Robert Hatcher et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co., New York, 2004. (Current) ParaGard T380A Intrauterine Copper Contraceptive, Physician Prescribing Information, Duramed Pharmaceuticals, Inc., May 2006. World Health Organization, Medical Eligibility Criteria for Contraceptive Use, Third Edition, 2004, <http:www.who.int/reproductive-health/publications/mec/> (March 15, 2005). Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters Kluwer Health, Inc., 2007 <http://online.factsandcomparisons.com>. "Preventive Screenings and Immunizations," U. S. Department of Health and Human Services, Office of Women's Health, <http://www.womenshealth.gov/screeningcharts/highrisk/>. Women’s Health 11.46 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PRACTITIONER PROTOCOL FOR IUD INSERTION: MIRENA® LNG IUS (levonorgestrel-releasing intra-uterine system) DEFINITION The levonorgestrel intrauterine system (LNG IUS, brand name Mirena®) system consists of a small T-shaped frame with a steroid reservoir that contains LNG, a potent progestin found in many combination oral contraceptives, progestin-only pills, and implants. The IUS releases a low dose of LNG (20 mcg per day) into the uterine cavity for at least five years, a system similar to that of LNG implants or LNG-containing mini-pills. As with these methods, thickening the cervical mucus and inhibition of ovulation, sperm motility and function are considered the primary means of preventing pregnancy. A weak foreignbody effect is also noted which could decrease implantation. SUBJECTIVE OBJECTIVE ASSESSMENT 1. Desires an IUD as method and long-term contraception. 2. Is in a stable, mutually monogamous relationship. 3. Has at least one child. 4. History is negative for pelvic inflammatory disease unless there has been a subsequent intrauterine pregnancy. 5. Has detailed health history (includes menstrual, sexual, contraception, personal health and family history) that does not reveal a condition representing an unacceptable health risk according to the product prescribing information and to the World Health Organization (WHO) Medical Eligibility Criteria for Contraceptive Use. 1. Normal pelvic exam at the time of insertion. 2. Negative pregnancy test at the time of insertion. 4. Negative laboratory tests at the time of insertion: a. Pap smear in last 12-15 months which rules out cervical malignancy. b. Negative gonorrhea and chlamydia tests within the last 60 days. c. Wet mount if indicated. d. Hemoglobin or hematocrit within the last 60 days. Patient has no condition representing an unacceptable risk if using the Mirena. Women’s Health 11.47 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 PLAN DIAGNOSTIC STUDIES 1. Lipid profile beginning by age 45. Consider screening women age 20-44 in the presence of high-risk factors for CVD. Rescreen every 5 years or more often depending on test results and high-risk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 2. Blood glucose beginning by age 45. Consider screening women at an earlier age in the presence of high-risk factors for diabetes. Rescreen every 3 years or more often depending on test results and high risk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 3. Screen women for colorectal cancer according to district policy/procedure for colorectal cancer screening. THERAPEUTIC PHARMACOLOGIC 1. May give an over-the-counter (OTC) nonsteroidal antiinflammatory agent 30-60 minutes before the procedure to reduce discomfort. 2. Insert Mirena per manufacturer’s directions. May be inserted any time in the cycle as long as pregnancy has been ruled out. NON-PHARMACOLOGIC MEASURES 1. Take precautions to avert a vasovagal reaction (syncope/fainting) caused by uterine manipulation and sounding. After IUD insertion, allow the patient to lie still for at least 30 seconds (while explaining how to check for strings). Ask about pain or cramping. If the patient says she feels okay, have her sit up slowly while being supported. If no problems in 30 seconds, allow her to stand. 2. Treat signs of vasovagal reaction (pallor/cyanosis, pinchedface look, dilated pupils, weak and rapid pulse, rapid shallow breathing, hypotension) according to the Women’s Health 11.48 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Emergency Protocols and Procedures section of this manual. 3. Heat to pelvic area for discomfort. PATIENT EDUCATION/COUNSELING 1. Counsel patient according to seven basic elements of informed consent (BRAIDED – Benefits Risks Alternatives Inquiries Decision Explanation Documentation). 2. Teach patient to check for IUD strings. a. b. c. d. The IUD can be expelled without being noticed. Check for the strings frequently during the first months, then after each menses and any time there is abnormal cramping while menstruating. Inspect tampons on removal for IUD removal. If patient cannot feel the strings, or if the plastic part is felt, use another method of contraception and return to the clinic. 3. Review warning signs and symptoms of possible problem: pain, discharge, abdominal pain or missing string. 4. Take over-the-counter ibuprofen or naproxen sodium and/or apply heat to the pelvic area for discomfort. 5. Should consider changing to another contraceptive method if behavior puts client at risk for PID (i.e., multiple partners, partners with multiple partners). 6. Use condoms to reduce the risk of STDs/HIV. 7. Discuss altered menstrual bleeding patterns: a. 1 to 4 months: may have frequent spotting. b. 1 to 6 months: reduced duration and amount of bleeding. c. Overall 90% reduction in menstrual bleeding. d. After 12 months, about 20% of women have no bleeding. e. The patient should keep a menstrual record and report a sudden change in menses or suspected pregnancy immediately. f. Give patient copy of Mirena post-insertion instructions. 8. The Mirena system reduces dysmenorrhea and leads to a significant reduction in the amount and length of bleeding. 9. After the system is removed, menstruation returns within 30 days. Fertility rapidly returns to normal. Women’s Health 11.49 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 10. Outside of clinic hours, seek physician or emergency care if warning signs develop. 11. As with other progestin-only methods, persistent ovarian follicles can occur. They do not require treatment or removal of the Mirena, and they usually resolve spontaneously. However, regular follow-up by ultrasound is recommended until cysts disappear. 12. The Mirena is effective for five years. 13. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). 14. Emphasize importance of keeping immunizations current; assess client’s immunization status and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed online at http://www.health.state.ga.us/programs/immunization/publicatio ns.asp. FOLLOW-UP 1. Re-examine and evaluate the patient shortly after the first postinsertion menses, but no later than three months afterwards. 2. If evidence of pelvic inflammatory disease, see Nurse Protocol for Pelvic Inflammatory Disease. IUD removal not necessary unless no improvement after 2-3 days of antibiotic treatment. 3. If pregnancy occurs, advise patient IUD should be removed at time of diagnosis whether pregnancy is continued or terminated. CONSULTATION/REFERRAL 1. Difficult IUD insertion or removal. 2. Suspected ectopic pregnancy. 3. To NP or MD for IUD removal if pregnant. Women’s Health 11.50 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 4. Other complications related to IUD use. 5. Presence of actinomyces on Pap smear report and evidence of pelvic infection. REFERENCES 1. 2. 3. 4. 5. 6. Robert Hatcher et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co. New York, 2004. (Current) Mirena (levonorgestrel intrauterine system) Physician Prescribing Information, Berlex, April 2006. World Health Organization, Medical Eligibility Criteria for Contraceptive Use, Third Edition, 2004, <http:www.who.int/reproductive-health/publications/mec/> (March 15, 2005). Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters Kluwer Health, Inc., 2007 <http://online.factsandcomparisons.com>. "Preventive Screenings and Immunizations," U. S. Department of Health and Human Services, Office of Women's Health, <http://www.womenshealth.gov/screeningcharts/highrisk/>. Women’s Health 11.51 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR IUD-RELATED DYSMENORRHEA DEFINITION Painful menses during intrauterine device (IUD) use. ETIOLOGY Presence of the IUD. Differential diagnosis includes mechanical pressure of IUD against wall of uterus, partial expulsion, pelvic inflammatory disease (PID), endometriosis, cancer, leiomyomata and ectopic pregnancy. Since cramping and abdominal pain may be signs of pregnancy or infection, those two problems must always be ruled out. SUBJECTIVE 1. Patient says she has an IUD, and complains of painful menses. 2. May have history of heavy or late menses. 3. Patient reports IUD type and date inserted, when last checked and when the strings were last felt. 4. May have history of: a. PID/STDs; vaginal infection/discharge. b. Recent partner change or multiple partners. c. Pain with IUD in past. 5. May have symptoms of vaginal or pelvic infection. 1. External exam usually within normal limits. 2. Speculum exam usually within normal limits; may note vaginal discharge or partially-expelled IUD. Note length of IUD strings. 3. Bimanual exam usually within normal limits; may note tenderness on examination; may feel partially-expelled IUD. OBJECTIVE ASSESSMENT IUD-related dysmenorrhea. PLAN DIAGNOSTIC STUDIES 1. Sensitive urine pregnancy test. 2. Hemoglobin/hematocrit, if indicated. 3. Gonorrhea and chlamydia tests; vaginal wet mount, if indicated. 4. Pap smear, if indicated. Women’s Health 11.52 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 THERAPEUTIC PHARMACOLOGIC Prostaglandin inhibitors/nonsteroidal anti-inflammatory drugs such as: 1. 2. 3. Ibuprofen 400 mg PO 4 hours as needed for pain. (Maximum dose 1.2g/day) OR Naproxen 500 mg every 12 hours as needed for pain. (Maximum dose 1gm/day) OR Over-the-counter-strength products (e.g., Advil, Nuprin, Aleve, Motrin IB, coated aspirin, or acetaminophen) per package directions prn. NON-PHARMACOLOGIC MEASURES 1. Heating pad or hot-water bottle to pelvic region; hot baths or showers; warm liquids taken orally. 2. For moderate to severe dysmenorrhea not relieved by any of the above, the IUD may be removed if the patient desires and replaced with progestin-releasing IUD. PATIENT EDUCATION/COUNSELING 1. Discuss findings, treatment rationale. 2. Discuss correct use and side effects of medications. FOLLOW-UP Return to the clinic if symptoms are not relieved or if foul discharge begins. CONSULTATION/REFERRAL Symptoms not relieved by the above measures. Women’s Health 11.53 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 REFERENCES 1. 2. 3. American Society of Health-Systems Pharmacists, American Hospital Formulary Service, Bethesda, MD, 2007, pp. 2061-2067, 2102-2108. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co., New York, 2004. (Current) Women’s Health 11.54 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR LOST IUD STRINGS DEFINITION Disappearance of the IUD (intrauterine device) strings. ETIOLOGY Expulsion of the IUD, retraction of the strings into the uterine cavity, or perforation of the IUD through the cervix or uterine wall. Use of an IUD (from another country) that never had a string attached. In some rare instances, clinicians have intentionally cut strings off or cut the strings short. SUBJECTIVE Patient may report that she cannot feel IUD strings on self-exam. OBJECTIVE No IUD strings visible upon careful examination of the vagina and cervical opening, and inability to feel the strings. ASSESSMENT IUD strings not visible. PLAN DIAGNOSTIC STUDIES Sensitive urine pregnancy test (HCG) THERAPEUTIC If pregnancy is ruled out by HCG and exam: 1. Prepare cervix as with insertion. 2. Gently rotate cytobrush inside cervical canal to snag IUD string. If unsuccessful, attempt to retrieve the IUD string using curved forceps, alligator forceps, or IUD retriever. Use tenaculum if necessary to steady the cervix. a. b. c. 3. If strings located and patient wants removal, remove the IUD with gentle, steady traction. Provide another method of contraception if appropriate. If dislodgement or abnormal placement suspected, remove IUD. Provide alternative contraceptive methods. Consider giving doxycycline 100 mg BID for 7-10 days if aggressive probing for string retrieval or IUD removal difficult. If unsuccessful in locating strings: a. Refer for pelvic ultrasound or if necessary, abdominal xrays. Women’s Health 11.55 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 b. c. If the IUD is identified as properly positioned in the uterus, no action is necessary; reassure the patient. If ultrasound identifies the IUD, but unable to identify in uterus, refer to MD. Advise alternative method of contraception. PATIENT EDUCATION/COUNSELING 1. If the IUD is removed advise the patient to use another method of contraception. 2. Check for IUD strings after each menstrual period. 3. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). FOLLOW-UP Return to clinic as needed for contraception or yearly exam. CONSULTATION/REFERRAL Consult with a physician for any questions regarding management (see Nurse Practitioner Protocol for IUD Removal). REFERENCES 1. 2. 3. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co. New York, 2004. (Current) Leon Speroff and Phillip Darney, A Clinical Guide for Contraception, Lippincott Williams and Wilkins, Baltimore, 2001. (Current) Women’s Health 11.56 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR IUD-RELATED MENORRHAGIA DEFINITION Abnormal heavy menstrual bleeding with an IUD in place, defined as heavy, prolonged periods lasting more than seven days with large clots. The use of eight (8) or more pads/day may also constitute heavy bleeding. ETIOLOGY Presence of IUD in utero. Other causes to consider may be: pelvic inflammatory disease (PID), partial expulsion of the IUD, dysfunctional uterine bleeding as a result of an endocrine imbalance, cancer of the cervix or endometrium, cervical or uterine polyps, abnormal perimenopausal bleeding, fibroids, and pregnancy. SUBJECTIVE OBJECTIVE 1. Patient describes prolonged (7+ days) bleeding, heavy menses with or without clotting, cramping pain, and/or needing frequent pad change. 2. May have decrease in appetite. May have dizziness, weakness or tiredness. 1. Patient's skin may appear pale. 2. External exam usually within normal limits. 3. Internal exam may be within normal limits, or may note partiallyexpelled IUD or feel device in the cervical canal, and/or may elicit pain upon cervical motion. 4. Bimanual exam may be within normal limits, or may elicit tenderness or pain in uterus and adnexal areas characteristic of PID. ASSESSMENT IUD-related menorrhagia. PLAN DIAGNOSTIC STUDIES 1. Hematocrit or hemoglobin. 2. Sensitive urine pregnancy test. 3. Gonorrhea and chlamydia tests, vaginal wet mounts, if indicated. 4. Pap smear, if indicated. Women’s Health 11.57 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 THERAPEUTIC PHARMACOLOGIC 1. If hemoglobin below normal, treat according to Nurse Protocol for Iron Deficiency Anemia. 2. Ibuprofen 400 mg PO every 4 hours as needed for relief of pain. Begin at the onset of menses and continue at least 3 days. (Maximum dose 1.2 g/day.) NON-PHARMACOLOGIC MEASURES 1. Remove the IUD for the following: a. b. c. 2. Partial expulsion. Patient is using/soaking 1 pad per hour. Patient desires removal for any reason. Strongly consider IUD removal if hemoglobin has dropped >2 g/dL from previous reading or is <9 g/dL or hematocrit has dropped >6% over 4-6 weeks, or is <27%. PATIENT EDUCATION/COUNSELING 1. Iron-rich foods. 2. Signs of possible pelvic infection and excessive bleeding. 3. Check for IUD string after each period. 4. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). FOLLOW-UP Return in 4-6 weeks for evaluation of bleeding and hematocrit/hemoglobin. CONSULTATION/REFERRAL 1. Refer immediately if suspect ectopic pregnancy. 2. If no relief with therapy after 1-2 menstrual periods. 3. If no improvement in anemia after 4 weeks of therapy. Women’s Health 11.58 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 REFERENCES 1. 2. 3. 4. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co. New York, 2004. (Current) Leon Speroff et al., Clinical Gynecologic Endocrinology and Infertility, Seventh Edition, Lippincott Williams and Wilkins, Baltimore, 2004. (Current) American Society of Health-Systems Pharmacists, American Hospital Formulary Service, Bethesda, MD, 2007, pp. 2061–2067. Women’s Health 11.59 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR PREGNANCY WITH IUD IN PLACE DEFINITION Intrauterine pregnancy while an IUD is in place. There is a 50% chance that a spontaneous abortion will occur if the IUD is left in place. An increased risk of septic abortion is noted in the second trimester if an IUD is left in a pregnant uterus. If the IUD is removed early in pregnancy, the abortion rate will be approximately 25%. Approximately 5% of the spontaneous pregnancies occurring in women who have an IUD in place will be ectopic. Rule out ectopic pregnancy in any woman with a positive pregnancy test while using an IUD. ETIOLOGY Failure of the IUD to prevent implantation of a blastocyst. SUBJECTIVE 1. Patient reports possible symptoms of pregnancy (e.g., nausea, breast tenderness, missed menses, spotting and/or change in appetite). 2. IUD history: IUD type, when inserted, expulsions, last checked and last felt strings. Patient may report that strings have become shorter or cannot be felt at all. 3. Patient may report repeated late, heavy, painful periods. 4. May have pelvic pain, vaginal discharge, fever, chills, myalgias and headaches. 1. External exam is usually within normal limits, although tenderness may be noted. 2. Cervix may have bluish discoloration (Chadwick's/Goodall's sign); strings of IUD may or may not be seen at os. 3. Cervical softening, softening of the uterine-cervical junction (Hegar's sign) detected on bimanual exam; may feel strings at cervical os; uterus may be enlarged and soft; adnexae usually within normal limits. 4. Sensitive urine pregnancy test is positive. OBJECTIVE ASSESSMENT Pregnancy with IUD in place. PLAN DIAGNOSTIC STUDIES Serum pregnancy test and/or ultrasound if indicated. Women’s Health 11.60 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 PATIENT EDUCATION/COUNSELING 1. Discuss findings, implications, treatment rationale and possible complications. 2. Discuss risk of ectopic pregnancy and infection which are indications to go to the ER. 3. Advise patient she is at increased risk for preterm labor and spontaneous abortion if IUD left in place. However, reassure her that fetus is not at increased risk for birth defects with IUD in place. Advise patient that at time of removal she is also at risk for spontaneous abortion, although spontaneous abortion risk is less with removal than if IUD were left if place. 4. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). CONSULTATION/REFERRAL To nurse practitioner or physician, for possible IUD removal and pregnancy management (See Nurse Practitioner Protocol for IUD Removal). REFERENCES 1. 2. 3. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co., New York, 2004. (Current) Robert Hatcher et al., The Essentials of Contraceptive Technology, Johns Hopkins School of Public Health, Population Information Program, Baltimore, 2001. (Current) Women’s Health 11.61 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PRACTIONER PROTOCOL FOR IUD REMOVAL DEFINITION Removal of an IUD by the clinician at the patient's request, due to clinical findings such as pregnancy, infection or partial expulsion, or per recommended time frame for the device. It is important to comply with a woman’s wishes if she wants to have her IUD removed. SUBJECTIVE 1. Patient may request IUD removal for any reason. 2. Patient may report a condition that precludes IUD use, such as suspected or confirmed pregnancy, or no longer in a stable, mutually monogamous relationship. 3. Patient may complain of dysmenorrhea, dyspareunia, menorrhagia, aching, abdominal pains, tenderness on ambulation, malaise, chills/fever. 4. History of use of the Copper T380A for 10 years or Mirena for 5 years. OBJECTIVE May have findings on pelvic exam or laboratory tests that require IUD removal such as: partial expulsion, enlargement of uterus, positive pregnancy test, other pelvic infection/disease. ASSESSMENT Indications for removal of IUD. PLAN DIAGNOSTIC STUDIES If indicated: 1. Sensitive urine pregnancy test. 2. Wet mount of vaginal secretions. 3. Gonorrhea and chlamydia tests. THERAPEUTIC (by APRN or MD) NOTE: Easier removal may be possible at the time of menses or at midcycle. 1. If indicated, paracervical block. 2. If patient not pregnant, remove IUD slowly, applying gentle, steady traction to string with sponge forceps. Women’s Health 11.62 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 3. If patient is not pregnant and the IUD cannot be removed with gentle traction, use a tenaculum to steady the cervix and straighten the anteversion or retroversion. 4. If the patient is not pregnant and the strings are not visible, probe for them in the cervical canal with a cytobrush or cotton tipped applicator, narrow (e.g., alligator-type) forceps or IUD retriever. See Nurse Protocol for Lost IUD Strings. 5. If patient is pregnant and in first trimester with strings visible, after counseling and with patient’s consent, attempt to remove IUD using gentle traction on IUD strings. PATIENT EDUCATION/COUNSELING 1. Choose a non-hormonal method of contraception for two menstrual cycles if the patient desires pregnancy or any method if the patient does not desire pregnancy. 2. Delay pregnancy for 2-3 months, to allow uterus to regain normal endometrium. 3. There are no known major long-term side effects after removal of an IUD. 4. In pregnant patient, advise her that she is at increased risk of preterm labor and spontaneous abortion if IUD is left in place. However, reassure her that the fetus is not at increased risk for birth defects with IUD in place. Advise patient that at time of removal she is also at risk for spontaneous abortion, although spontaneous abortion risk is less with removal than if IUD were left in place. 5. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). 6. Emphasize importance of keeping immunizations current; assess client’s immunization status and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed online at Women’s Health 11.63 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 http://www.health.state.ga.us/programs/immunization/publicatio ns.asp. FOLLOW-UP Return to clinic as needed, for contraception or yearly exam. CONSULTATION/REFERRAL Refer or consult with physician if: 1. Difficult/failed removal. 2. Successful removal, patient pregnant. 3. Unable to visualize and/or probe for strings. REFERENCES 1. 2. 3. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Leon Speroff and Phillip Darney, A Clinical Guide for Contraception, Lippincott Williams and Wilkins, Baltimore, 2001. (Current) Robert Hatcher et al., The Essentials of Contraceptive Technology, Johns Hopkins School of Public Health, Population Information Program, Baltimore, 2001. (Current) Women’s Health 11.64 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 TABLE OF IUD COMPLICATIONS AND ACTIONS CONDITION ACTION 1. Pain from tenaculum application to cervix. May consider application of topical anesthesia such as Lidocaine gel, Xylocaine gel, etc. 2. Pain with sounding of the uterus during insertion. Sound slowly and gently consider smaller sound. If severe, check alignment of uterine cavity. 3. Cramping/pain immediately after insertion, for a day or so thereafter, or with each menses: a. if severe b. if mild 4. Pain at time of insertion, persistent and increasing, and signs of abdominal tenderness: a. if strings are present b. if strings are absent Consider IUD removal. See Nurse Protocol IUD Related Dysmenorrhea. Presume partial perforation has occurred; remove IUD and treat for pelvic infection. Consider possibility of perforation. Refer client to physician. 5. Partial expulsion of an IUD Remove IUD. Pregnancy test as indicated. 6. Pelvic inflammatory disease See Nurse Protocol for Pelvic Inflammatory Disease. 7. Spontaneous abortion Refer to physician 8. Ectopic pregnancy Refer to physician Women’s Health 11.65 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 REFERENCES 1. 2. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co. New York, 2004. (Current) Women’s Health 11.66 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR MEDROXYPROGESTERONE ACETATE (Injectable Contraceptive) DEFINITION Medroxyprogesterone acetate inhibits ovulation presumably by suppressing levels of follicular-stimulating hormone (FSH) and luteinizing hormone (LH) and by eliminating the LH surge. The pituitary gland remains responsive to gonadatropin-releasing hormone, which suggests that the site of action of medroxyprogesterone acetate is the hypothalamus. SUBJECTIVE 1. Patient desires medroxyprogesterone acetate as choice of contraception. 2. Has detailed health history (includes menstrual, sexual, contraception, personal health and family history) that does not reveal a condition representing an unacceptable health risk according to the product prescribing information and to the World Health Organization (WHO) Medical Eligibility Criteria for Contraceptive Use. 3. May have known risk factor(s), medical condition(s) or medication use that can increase the risk of developing osteoporosis (see Nurse Protocol for Osteoporosis in Women: Assessment and Prevention). 1. Physical examination and laboratory tests according to programmatic guidelines. OBJECTIVE OR ASSESSMENT 2. Physical exam deferred up to 3 months. Document reason for deferral on chart. Document on Request for and Consent to Family Planning Services (Form 3700) that client agreed to have physical exam delayed. 3. Pregnancy test, if indicated, is negative. If necessary, (amenorrhea or irregular menses) repeat pregnancy test after a two-week interval of abstinence or consistent use of a reliable method of contraception. Patient has no condition representing an unacceptable risk if using medroxyprogesterone acetate. Women’s Health 11.67 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 PLAN DIAGNOSTIC STUDIES 1. Lipid profile beginning by age 45. Consider screening women age 20-44 in the presence of high-risk factors for CVD. Rescreen every 5 years or more often depending on test results and high-risk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 2. Blood glucose beginning by age 45. Consider screening women at an earlier age in the presence of high-risk factors for diabetes. Rescreen every 3 years or more often depending on test results and high risk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 3. Screen women for colorectal cancer according to district policy/procedure for colorectal cancer screening. THERAPEUTIC PHARMACOLOGIC NOTE: Allergic reactions may occur. Encourage client to remain in the clinic at least 20 minutes after each injection. Refer to the Allergic Reaction Nurse Protocol as needed. 1. Give injections to non-pregnant clients: preferred start time is within the first five days after onset of menstruation, immediately post-abortion, or within five days postpartum if not breastfeeding, and at the sixth week postpartum if breastfeeding. Inject anytime in the cycle if not pregnant; use back-up method for 7 days. 2. Medroxyprogesterone acetate 150 mg IM, injected deep into the deltoid or gluteal muscle. Depending on the size of the client, may need to use a 1.5 inch needle. Do not massage the injection site, and also instruct client not to massage site. Depo-subQ provera 104 must be given subcutaneously into the anterior thigh or abdomen. Avoid bony areas and the umbilicus. Gently grasp and squeeze a large area of skin in the chosen injection area between the thumb and forefinger, pulling it away from the body. Insert the needle at a 45 degree angle so most of needle is in the fatty tissue. Women’s Health 11.68 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 The plastic hub should be nearly or almost touching the skin. Inject slowly – taking about 5-7 seconds. NOTE: Medroxyprogesterone acetate is to be stored at room temperature 20o to 25oC (68o to 77o F). Both the vial and the prefilled syringe should be vigorously shaken at least one minute just before use to ensure the dose is uniformly suspended. 3. For clients who have received an initial physical examination showing no contraindications, and have not developed side effects or danger signs. Give routine re-injections for medroxyprogesterone acetate 150 mg IM between 11 weeks and 13 weeks from the previous injections. Give routine reinjections for depo-subQ provera 104 between 12 and 14 weeks from the previous injection. If client returns after 13 weeks for medroxyprogesterone acetate 150 mg IM or 14 weeks for depo-subQ provera 104 and has been sexually active, perform a pregnancy test. Offer emergency contraception if client has had unprotected intercourse in the last 120 hours. May give injection after negative pregnancy tests two weeks apart and either abstinent or consistent use of a reliable contraceptive method or give during the next menses. 4. Assure that patients, who did not receive an initial physical examination prior to the first injection, have received an examination showing no contraindications, and have not developed side effects or danger signs, before giving re-injections. 5. Assess the patient’s for risk factors for osteoporosis. (See Nurse Protocol for Osteoporosis in Women: Assessment and Prevention.) Medroxyprogesterone acetate use plus risk factors for osteoporosis may pose an increased risk of osteoporosis. Discuss potential risk for bone loss and consider alternative contraceptives in patients with significant risk factors for osteoporosis. 6. With regard to bone metabolism, there should not be restriction on the use of medroxyprogesterone acetate, including no restriction on duration of use, among women aged 18-45 who are otherwise eligible to use the method. Women’s Health 11.69 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 7. Among adolescents (menarche to <18) and women over 45, the advantages of using medroxyprogesterone acetate generally outweigh the theoretical safety concerns regarding fracture risk. Since date are insufficient to determine if this is the case with long-term use among these age groups, the overall risks and benefits for continuing use of the method should be reconsidered over time with the individual user. 8. It is up to the clinician along with the patient to consider bone density monitoring if medroxyprogesterone acetate is the desired method and there are concerns about particular risk factors for osteoporosis. However, dual x-ray absorptiometry (DXA) is not routinely indicated at initiation or follow- up of healthy adolescents who choose medroxyprogesterone acetate. There is a lack of established criteria in this age group regarding the degree of loss that would provoke clinician concern and action. 9. Recommend calcium/vitamin D supplement(s) daily if patient’s diet is calcium deficient. 10. Treatment of side-effects: a. b. Heavy bleeding – Consult/referral. For bleeding irregularities: Rule out infection or cervical lesions. May give: 1) A combined low-dose oral contraceptive for 1-3 cycles. 2) Ibuprofen 400mg PO every 4 to 6 hours as necessary. (Maximum dose 1.2 g/day.) PATIENT EDUCATION/COUNSELING 1. Counsel client according to seven basic elements of informed consent (BRAIDED – Benefits Risks Alternatives Inquiries Decision Explanation Documentation) with emphasis on schedule associated with use of this method of contraception. Instruct client to use back-up contraception during the first week after the initial injection or if injections are late or missed. 2. Medroxyprogesterone acetate may decrease the amount of calcium in the bones. It is not known if use during the reproductive years affects the risk of fracture in later postmenopausal years. Women’s Health 11.70 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 3. The critical years for building bone mass are from prior to adolescence to about age 30. A decrease of calcium in the bones is of most concern for teenagers and those women who have the following risk factors: low body weight, bone disease, anorexia nervosa, strong family history of osteoporosis, drugs that can lower the amount of calcium in the bones (drugs for epilepsy or steroids), high intake of alcohol, sodas, caffeine and smoking (see Nurse Protocol for Osteoporosis in Women: Assessment and Prevention). 4. Counsel patients on adequate calcium intake from foods like milk, cheese, yogurt or ice cream or a calcium/vitamin D supplement daily; regular exercise; and avoiding alcohol, smoking and excessive intake of sodas and caffeine. 5. The average delay to ovulation is about 9 months (range of 4-31 months) after the last injection and does not increase with longer duration of use. 6. Common side effects may include: bleeding/menstrual irregularities, weight changes, headache, nervousness, abdominal pain, dizziness, and weakness or fatigue. Less common side effects include: decreased libido, backache, leg cramps, depression, nausea, acne, vaginitis, breast pain, hair loss, bloating, rash, and hot flashes. WARNING SIGNALS: a. Repeated painful headaches. b. Heavy bleeding. c. Jaundice. d. Severe lower abdominal pain (may be sign of pregnancy). e. Pus, prolonged pain, or bleeding at the injection site. 7. Bleeding irregularities are very common (30% in the first year and 10% thereafter). If necessary, bleeding can be treated with medication. 8. Amenorrhea usually occurs in one year or less. Counsel women in their 40s not to think they are going through menopause when amenorrhea occurs. 9. Common side effects may not be relieved until the drug clears the body 6-8 months after the last injection. 10. There is minimal to no apparent increased risk for breast cancer. Women’s Health 11.71 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 11. No adverse effects have been noted in infants of mothers using medroxyprogesterone acetate during lactation. Quality and quantity of breast milk is not adversely affected. 12. Decreases in high-density lipoproteins (HDL) and increase in total and LDL cholesterol levels have been reported in some studies of women using medroxyprogesterone acetate. 13. Medroxyprogesterone acetate offers no protection from STDs/HIV. Counsel on condom use to reduce the risks of STDs/HIV. 14. Call or return if there are questions about possible side effects or development of reasons to avoid use, such as weight gain, heavy bleeding, headaches or depression. 15. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). 16. Emphasize importance of keeping immunizations current; assess client’s immunization status and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed online at http://www.health.state.ga.us/programs/immunization/publicatio ns.asp. FOLLOW-UP 1. Return for the next injection in 11-13 weeks for medroxyprogesterone acetate 150mg IM. Return for next injection in 12-14 weeks for depo-subQ provera 104. If client returns after 13 weeks for medroxyprogesterone acetate 150 mg IM or after 14 weeks for depo-subQ provera 104 and has been sexually active, perform a pregnancy test. Offer emergency contraception if client has had unprotected intercourse in last 120 hours. May give injection after negative pregnancy tests two weeks apart and either abstinent or consistent use of a reliable method of contraception OR give during next menses. 2. Outside of clinic hours, seek physician or emergency care if warning signs develop. Women’s Health 11.72 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 CONSULTATION/REFERRAL 1. Development of prolonged side effects (e.g., irregular bleeding). 5. Development of contraindicating conditions. 6. Management of chronic coexisting medical problems. 7. Call Pfizer Medical Information at 1-800-438-1985 for product information. REFERENCES 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. American Society of Health-Systems Pharmacists. American Hospital Formulary Service, 2007, p. 3103. “Black Box Warning Added Concerning Long-Term Use of Depo-Provera Contraceptive Injection,” FDA Talk Paper, T04-50, Food and Drug Administration, November 17, 2004. (Current) Depo-Provera Contraceptive Injection Physician Prescribing Information, Pharmacia & Upjohn Company, November 2004. (Current) Depo-subQ provera 104TM Physician Prescribing Information, Pharmacia & Upjohn Company, March 2005. Robert Hatcher et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Robert Hatcher et al., The Essentials of Contraceptive Technology, Johns Hopkins School of Public Health, Population Information Program, Baltimore, 2001. (Current) World Health Organization, Medical Eligibility Criteria for Contraceptive Use, Third Edition, 2004, <http:www.who.int/reproductive-health/publications/mec/> (March 15, 2005). Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters KluwerHealth, Inc., 2007 <http://online.factsandcomparisons.com>. Barbara Cromer, Delia Scholes, Abbey Berenson, “Depot medroxyprogesterone acetate and Bone Mineral Density in Adolescents-The Black Box Warning: A Position Paper for the Society of Adolescent Medicine,” Journal of Adolescent Health, 2006, 39: 296-301. WHO, Hormonal Contraception and Bone Health, July 2005, <http://www.who.int/reproductive-health/family_planning/bone_health.html> (March 12, 2007). "Preventive Screenings and Immunizations," U. S. Department of Health and Human Services, Office of Women's Health, <http://www.womenshealth.gov/screeningcharts/highrisk/>. Women’s Health 11.73 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR ORTHO EVRA™ TRANSDERMAL SYSTEM (CONTRACEPTIVE PATCH) DEFINITION ORTHO EVRA™ is a transdermal patch applied to the skin that releases synthetic estrogen and progestin hormones to prevent pregnancy. ORTHO EVRA™ acts by suppressing gonadotropins, similar to combination oral contraceptives. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus which increase the difficulty of sperm entry into the uterus, and changes in the endometrium which reduce the likelihood of implantation. SUBJECTIVE 1. Patient desires to use contraceptive patches. 2. Has detailed health history (includes menstrual, sexual, contraception, personal health and family history) that does not reveal a condition representing an unacceptable health risk according to the product prescribing information and the World Health Organization (WHO) Medical Eligibility Criteria for Contraceptive Use. 3. If breastfeeding, has been breastfeeding at least 6 weeks, but preferably six months or more, after childbirth, to ensure that breastfeeding has been well established. 4. If age 35 or older, and does not smoke. 1. Physical exam and laboratory tests according to programmatic Guidelines. OBJECTIVE OR 2. Physical exam deferred up to 3 months. Document reason for deferral on chart. Document on Request for and Consent to Family Planning Services (form 3700) that client agreed to have physical exam delayed. ASSESSMENT Patient has no condition representing an unacceptable risk if using the patch. PLAN DIAGNOSTIC STUDIES 1. Lipid profile beginning by age 45. Consider screening women age 20-44 in the presence of high-risk factors for CVD. Rescreen every 5 years or more often depending on test results and high-risk factors. For Recommended Tests Women’s Health 11.74 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 2. Blood glucose beginning by age 45. Consider screening women at an earlier age in the presence of high-risk factors for diabetes. Rescreen every 3 years or more often depending on test results and high risk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 3. Screen women for colorectal cancer according to district policy/procedure for colorectal cancer screening. THERAPEUTIC PHARMACOLOGIC 1. ORTHO EVRA™ Patch, box of three patches. a. b. c. d. e. 2. Apply the first patch on the first day of menses, on the Sunday following menses or same day as clinic visit (quick start). The first day is designated as “Patch Change Day.” Remove liner and apply the sticky surface of the patch on clean, dry skin of the lower abdomen, buttocks, upper outer arm, or upper torso (not on the breasts). Press down firmly on the patch with the palm of the hand for 10 seconds. Make sure that the edges stick well. Remove the patch and apply a new patch on "patch change day" on weeks 2 and 3. Apply the new patch to a different area of skin to reduce skin irritation. No patch is applied on week 4. For patients not receiving physical exam prior to first 3 months supply, a physical exam must be performed to dispense additional patches. PATIENT EDUCATION/COUNSELING 1. Counsel patient according to the seven basic elements of informed consent (BRAIDED – Benefits Risks Alternatives Inquiries Decision Explanation Documentation). 2. The absorption of medication is identical when applied on any of the four suggested areas of the body. Women’s Health 11.75 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 3. Women who use Ortho Evra are exposed to about 60% more estrogen than if they were taking a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen exposure may increase the risk of developing serious blood clots (for instance, in the legs or lungs) that can block blood vessels and cause death or serious disability. However, it is not known whether women using Ortho Evra are at a greater risk of having these serious problems. One study found a doubling of this risk and another study found no increased risks. The manufacturer of Ortho Evra is doing studies on this. 4. The transdermal contraceptive patch may be less effective in women with body weight of 198 lbs. or higher. May consider back up method such as condoms if weight is 198 lbs. or higher. 5. Check the patch every day to make sure it is sticking. Avoid touching the sticky surface. 6. Do not apply creams, oils, or cosmetics near the patch site. 7. If the patch becomes loose and is still sticky, try to reattach it. If it is not sticky, replace it with a new patch, and then change the new patch on the usual change day. 8. If the patch was off for more than 24 hours, immediately begin a new cycle of patches and use a back-up method of birth control during the first week. May want emergency contraception. 9. If forget to change a patch, change it as soon as it is remembered. Use a back-up method of birth control for one week. May want emergency contraception. 10. Counsel on the use of condoms to reduce the risk of STDs/HIV. 11. The primary side effects of the patch are headache, nausea, application site reactions, and breast discomfort. Women using the patch are more likely to experience breakthrough bleeding and/or spotting during the first 2 months compared with users of a triphasic levonorgestrel-containing OC. Discuss danger signs (ACHES). 12. Do not attempt to tape down a patch that has become loosened. 13. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). Women’s Health 11.76 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 14. Emphasize importance of keeping immunizations current; assess client’s immunization status and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed online at http://www.health.state.ga.us/programs/immunization/publicatio ns.asp. FOLLOW-UP 1. Return as scheduled for evaluation or contact clinic if side effects or danger signs develop. 2. If patient did not receive a physical exam, have her return within 3 months for an exam and reassessment. 3. Established patients should return for evaluation at the end of the current supply of patches, or sooner if side effects or danger signs develop. Outside of clinic hours, seek physician or emergency care if danger signs develop. CONSULTATION/REFERRAL 1. Development of any danger signs. 2. Any other serious health concerns expressed by the patient. 3. If patient is under the supervision of private doctor(s) for health problem (e.g. hypertension). 4. Abnormal initial laboratory values or development of abnormal values or physical findings that indicate patch should not be continued. 5. To nutritionist as indicated. Women’s Health 11.77 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 REFERENCES 1. 2. 3. 4. 5. 6. American Society of Health-Systems Pharmacists, American Hospital Formulary Service, Bethesda, MD, 2007, pp. 3076. Ortho Evra Transdermal System Physician Prescribing Information, Ortho-McNeil Pharmaceutical, Inc., revised September 2006. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) World Health Organization, Medical Eligibility Criteria for Contraceptive Use, Third Edition, 2004,<http:www.who.int/reproductive-health/publications/mec/> (March 15, 2004). (Current) Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters Kluwer Health, Inc., 2007 <http://online.factsandcomparisons.com>. "Preventive Screenings and Immunizations," U. S. Department of Health and Human Services, Office of Women's Health, <http://www.womenshealth.gov/screeningcharts/highrisk/>. Women’s Health 11.78 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR NuvaRing® DEFINTION SUBJECTIVE OBJECTIVE All combination hormonal contraceptives suppress gonadotropins. Although the primary effect of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). The NuvaRing is a vaginal contraceptive loop made with a flexible polymer, which contains estrogen and progestin. 1. Patient desires to use the NuvaRing® as choice of contraception. 2. Has detailed health history (includes menstrual, sexual, contraception, personal health and family history) that does not reveal a condition representing an unacceptable health risk according to the product prescribing information and the World Health Organization (WHO) Medical Eligibility Criteria for Contraceptive Use. 3. If breastfeeding, has been breastfeeding at least 6 weeks, but preferably six months or more, after childbirth. 4. If age 35 or older and does not smoke. 1. Physical examination and laboratory tests according to programmatic guidelines. OR 2. Physical exam deferred up to 3 months. Document reason for deferral on chart. Document on Request for and Consent to Family Planning Services (form 3700) that client agreed to have physical exam delayed. ASSESSMENT Patient has no conditions representing an unacceptable health risk if using the NuvaRing. PLAN DIAGNOSTIC STUDIES 1. Lipid profile beginning by age 45. Consider screening women age 20-44 in the presence of high-risk factors for CVD. Rescreen every 5 years or more often depending on test results and high-risk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. Women’s Health 11.79 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 2. Blood glucose beginning by age 45. Consider screening women at an earlier age in the presence of high-risk factors for diabetes. Rescreen every 3 years or more often depending on test results and high risk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 3. Screen women for colorectal cancer according to district policy/procedure for colorectal cancer screening. THERAPEUTIC PHARMACOLOGIC 1. Box of 3 NuvaRing ® sachets. Store out of direct sunlight. NOTE: Prior to dispensing to the user, refrigerate at 2-8C (36-46 F). After dispensing to the user, NuvaRing can be stored for up to 4 months at room temperature out of direct sunlight. When dispensed to the user, place an expiration date on the label not to exceed either 4 months from the date of dispensing or the expiration date, whichever comes first. a. b. c. 2. Place one folded NuvaRing® high in the vagina within five days of starting a menstrual period, even if still bleeding. May also be started days 2-5 of cycle, but in this case use barrier method for first seven days of NuvaRing use in the first cycle. Wear ring for three weeks in a row and remove ring. After 7 ring-free days, insert a new ring. Use a back-up non-hormonal method of birth control for one week when initiating NuvaRing for the first time. Do not use a diaphragm with the NuvaRing. Women switching from estrogen-progestin oral contraceptives to the vaginal ring should insert the ring within 7 days of the last hormonally-active tablet and no later than the day that a new oral contraceptive cycle would have been started; a back-up method of contraception is not needed. PATIENT EDUCATION/COUNSELING 1. Counsel the patient according to the seven elements of informed consent (BRAIDED – Benefits Risks Alternatives Inquiries Decision Explanation Documentation). Women’s Health 11.80 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 2. If starting to use NuvaRing® within the first five days following a complete first trimester abortion, do not need to use an additional method of contraception. 3. If client is switching from progestin-only pills, she should place the first ring on the same day she takes the last pill. 4. The NuvaRing® does not require fitting or placement in a specific position, nor the use of spermicidal jelly. It does not need to surround the cervix. If discomfort is felt, the device is probably not placed high enough in the vagina. 5. Keep the foil pouch. After removal of the system in 3 weeks, dispose of the NuvaRing® in the pouch. Do not flush it down the toilet. Keep it out of reach of children and animals. 6. The primary side effects of the NuvaRing® are similar to those of combined OC pills. Some women may experience vaginal irritation or infection. Discuss danger signs (ACHES). 7. NuvaRing® can be accidentally expelled when it has not been inserted properly, while removing a tampon, or when straining to move the bowels. If expelled, rinse ring with cool/lukewarm water and re-insert promptly (within 3 hours from the time it was expelled). If lost, insert a new one. Remove new ring on the original replacement date. 8. The NuvaRing® does not need to be removed for intercourse. If removed for longer than 3 hours, use a back-up method for 7 days. If device is out >3 hours and patient has unprotected sex, use emergency contraception. 9. Check for possible pregnancy if: a. Miss a period and the device was out of the vagina for longer than 3 hours. b. Miss a period and waited longer than a week to insert a new device. c. Miss a period and the NuvaRing® was in place more than 4 weeks. d. Followed instructions, but miss 2 periods in a row. 9. Cigarette smoking increases the risk of serious cardiovascular side effects from combination oral contraceptive use and NuvaRing®. Women’s Health 11.81 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 10. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). 11. NuvaRing® does not protect against HIV infection and other sexually transmitted diseases. Counsel on use of condoms to reduce the risk of STDs including HIV. 12. If scheduled for laboratory tests or major surgery, tell the health care provider that you are using the NuvaRing®. 13. Ovulation resumes during the first recovery cycle after discontinuation, suggesting rapid return of fertility. 14. Emphasize importance of keeping immunizations current; assess client’s immunization status and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed online at http://www.health.state.ga.us/programs/immunization/publications. asp. FOLLOW- UP 1. Return to clinic in three months for another box of three (3) NuvaRing® sachets. After that, return as needed for re-ordering NuvaRing® or for yearly exams. 2. If patient did not receive a physical exam, have her return within 3 months for an exam and reassessment. 3. Return for evaluation or contact clinic if side effects or danger signs develop. Outside of clinic hours, seek physician or emergency care if danger signs develop. CONSULTATION/REFERRAL 1. 2. 3. 4. Development of danger signs. Any serious health concerns expressed by the patient. Abnormal initial laboratory values or development of abnormal values or physical findings that indicate the ring should not be continued. To nutritionist as indicated. Women’s Health 11.82 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 5. If patient is under the supervision of medical provider for a health problem (e.g., hypertension). REFERENCES 1. 2. 3. 4. 5. 6. 7. American Society of Health-Systems Pharmacists. American Hospital Formulary Service, Bethesda, MD, 2007 pp. 3075-3085. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co. New York, 2004. (Current) NuvaRing Physician Prescribing Information, Organon USA Inc., 2005 World Health Organization, Medical Eligibility Criteria for Contraceptive Use, Third Edition, 2004, <http:www.who.int/reproductive-health/publications/mec/> (March 15, 2005). Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters Kluwer Health, Inc., 2007 <http://online.factsandcomparisons.com>. "Preventive Screenings and Immunizations," U. S. Department of Health and Human Services, Office of Women's Health, <http://www.womenshealth.gov/screeningcharts/highrisk/>. Women’s Health 11.83 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR VAGINAL CONTRACEPTIVE DIAPHRAGM DEFINITION The diaphragm is a dome-shaped rubber cup that is inserted into the vagina before intercourse. The posterior rim rests in the posterior fornix and the anterior rim fits snugly behind the pubic bone. The dome of the diaphragm covers the cervix and prevents sperm from entering. Spermicidal cream or jelly placed in the dome prior to insertion adds to its effectiveness. SUBJECTIVE 1. Desires vaginal diaphragm for contraception. 2. No history of: a. b. OBJECTIVE Known hypersensitivity to latex or natural rubber. Toxic shock syndrome (TSS). 3. Has not had a full-term delivery within the past 6-12 weeks. 1. Pelvic exam shows: a. b. c. d. 2. Adequate vaginal tone to hold the diaphragm in place. Absence of uterine prolapse, severe cystocele or rectocele. Uterus is not fixed in retroflexed or retroverted position. Notch behind the symphysis pubis is adequate to support the rim of the diaphragm. Patient is physically able to insert a diaphragm. ASSESSMENT Patient has no condition representing an unacceptable risk if using the diaphragm. PLAN DIAGNOSTIC STUDIES 1. Blood glucose beginning by age 45. Consider screening women at an earlier age in the presence of high-risk factors for diabetes. Rescreen every 3 years or more often depending on test results and high risk factors. For Recommended Tests and Immunizations for Women with High-Risk Factors refer to www.womenshealth.gov. 2. Screen women for colorectal cancer according to district policy/procedure for colorectal cancer screening. Women’s Health 11.84 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 THERAPEUTIC PHARMACOLOGIC Contraceptive jelly/cream containing spermicide. NON-PHARMACOLOGIC MEASURES Fit patient for appropriate size and type diaphragm. PATIENT EDUCATION/COUNSELING 1. Counsel patient according to the seven basic elements of informed consent (BRAIDED – Benefits Risks Alternatives Inquiries Decision Explanation Documentation). 2. Insertion, removal and care of diaphragm, with return demonstration. 3. Once in position, the diaphragm provides effective contraceptive protection for 6 hours. 4. After intercourse, the diaphragm must be left in place for at least 6 hours, but it should be removed as soon as possible thereafter. Continuous wearing of a contraceptive diaphragm for more than 24 hours is not recommended. 5. If more than one act of intercourse in 6 hours, do not remove diaphragm. Add additional spermicide before each act of intercourse. 6. Prevention of toxic shock syndrome a. b. c. 7. Do not use diaphragm during menses. Do not leave diaphragm in place for more than 24 hours. Seek care for danger signs of toxic shock: 1) Temperature of 101° F or higher. 2) Diarrhea. 3) Vomiting. 4) Muscle aches. 5) Rash appearing like a sunburn. Diaphragm will need to be refitted and replaced with new diaphragm at least every 2 years or: a. After vaginal delivery. Women’s Health 11.85 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 b. c. d. After gynecologic or lower abdominal surgery. After weight loss or gain of over 10 pounds. After second trimester abortion. 8. Counsel on use of condoms to reduce the risk of STDs/HIV. 9. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). 10. Emphasize importance of keeping immunizations current, assess client’s immunization status and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed online at http://www.health.state.ga.us/programs/immunization/publications. asp. FOLLOW-UP Return to clinic in one month, with diaphragm in place, to assess for proper fit. REFERRAL/CONSULTATION 1. Signs/symptoms of toxic shock syndrome. 2. Signs/symptoms of urinary tract infection as appropriate. 3. Signs/symptoms of cystocele or rectocele. REFERENCES 1. 2. 3. 4. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co. New York, 2004. (Current) Ortho-McNeil, Ortho Diaphragm, Physician Prescribing Information, Ortho-McNeil Pharmaceutical Inc., August 2006. "Preventive Screenings and Immunizations," U. S. Department of Health and Human Services, Office of Women's Health, <http://www.womenshealth.gov/screeningcharts/highrisk/>. Women’s Health 11.86 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PRACTITIONER PROTOCOL FOR NORPLANT® REMOVAL DEFINITION Removal of Norplant® at the patient's request, due to clinical findings such as pregnancy or side effects, or per guidelines that Norplant® must be removed after 5 years. SUBJECTIVE 1. Patient desires Norplant® removal. 2. May be pregnant. 3. May complain of severe side effects. 4. Five years may have elapsed since insertion. 1. May have a positive pregnancy test. 2. May have clinical findings of side effects or a contraindication for continuing with Norplant®. OBJECTIVE ASSESSMENT Removal of Norplant® is desired or recommended. PLAN DIAGNOSTIC STUDIES Pregnancy test, if indicated. THERAPEUTIC Remove the Norplant® capsules through a very small incision 1-2 mm above the insertion site (over the tips of Norplant®) with one of the following methods, which may take two visits: 1. 2. Wyeth Instructions/Population Council (standard) at the incision made to insert implants; use small 3 cubic centimeter syringe of 1% lidocaine; make a 5 mm incision just above the previous incision and use curved hemostat to disrupt and remove the implants. OR Emory Technique Use 6-8 cubic centimeter of 1% lidocaine; make an 8 mm to 1 cm incision at the same location as the incision made to insert implants, using small hemostat to disrupt adhesions; use Adson forceps or scalpel to strip the tissue off the implants. OR Women’s Health 11.87 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 3. 4. Pop Out Technique 2-4 cubic centimeter of 1% lidocaine; 2-3 mm incision at the base of the fan slightly above previous incision, (just large enough to push implant through opening); push implants to opening; use scalpel to remove the adhesions; all tips of implants must be fairly close together to use this technique. OR "U" Technique Make 4-6 mm vertical incision between the lower ends of implants #3 and # 4; remove implants using a modified vasectomy clamp (available through Wyeth Laboratories). PHARMACOLOGIC Prostaglandin inhibitors/nonsteroidal anti-inflammatory drugs such as: 1. 2. 3. Ibuprofen 400 mg PO 4 hours as needed for pain. (Maximum dose 1.2g/day) OR Naproxen 500 mg every 12 hours as needed for pain. (Maximum dose 1gm/day) OR Over-the-counter-strength products (e.g., Advil, Nuprin, Aleve, Motrin IB, coated aspirin, or acetaminophen) per package directions prn. PATIENT EDUCATION/COUNSELING 1. Dark pigmentation is frequently seen over the implants. It will eventually go away after removal of implants. 2. Provide patient with instructions for care and advise to return in one week for recheck. 3. Discuss alternative contraceptive method, if desired. Remind client that she may become pregnant immediately following Norplant removal if not using alternative contraceptive method. 4. Menses may be delayed or irregular for a month or more after removal. 5. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). Women’s Health 11.88 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 6. Emphasize importance of keeping immunizations current; assess client’s immunization status and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed online at http://www.health.state.ga.us/programs/immunization/publications. asp. FOLLOW-UP 1. Return in one week for recheck. Appointment for second removal visit, if necessary. 2. Return, as needed, for contraception or yearly exam. CONSULTATION/REFERRAL 1. Difficult/failed removal. 2. Successful removal, patient pregnant. 3. Persistent side effects. REFERENCES 1. 2. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Robert Hatcher et al., The Essentials of Contraceptive Technology, Johns Hopkins School of Public Health, Population Information Program, Baltimore, 2001. (Current) Women’s Health 11.89 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR AMENORRHEA (PRIMARY AND SECONDARY) DEFINITION Primary amenorrhea is defined as no menstrual period by age 14, in the absence of growth or development of secondary sexual characteristics, or no menstrual period by age 16, regardless of the presence of normal growth and development with the appearance of secondary sexual characteristics. Secondary amenorrhea is defined as absence of menstrual periods for a length of time equivalent to a total of at least three of the previous cycle intervals or six-twelve months of amenorrhea in a woman who normally experiences irregular menses. ETIOLOGY Primary: 1. 2. 3. Gonadal failure. Congenital absence of uterus & vagina. Constitutional delay. Secondary: 1. 2. 13. 14. 15. 16. 17. Pregnancy; breastfeeding. Pituitary disease or tumor; disruption of hypothalamicpituitary axis. Menopause. Too little body fat (about 22% required for menses). Excessive exercise (e.g., long-distance running, ballet dancing, gymnastics, figure skating, etc.). Rapid weight loss. Cessation of menstruation following use of OCs or medroxyprogesterone acetate. Recent change in lifestyle (e.g., increased stress). Thyroid disease. Polycystic ovary disease. Anorexia nervosa or other eating disorders. Premature ovarian failure, ovarian dysgenesis, infection, hemorrhage, necrosis, neoplasm. Asherman’s Syndrome. Cervical stenosis. Medications including psychotropics. Chronic illness. Tuberculosis. 1. Patient reports absence of menses (as defined above). 2. History may include: 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. SUBJECTIVE Women’s Health 11.90 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 a. b. c. d. e. f. g. h. i. OBJECTIVE Changes in skin/hair, vision/hearing or voice. Palpitations. Breast size changes or galactorrhea. Vasomotor Symptoms. Changes in weight, dietary habits. Cold or heat intolerance. Known medical problems. Stress. Exercise patterns (changes or rigorous). 1. May be obese or underweight for height. 2. May note on physical examination: a. b. c. d. e. f. Skin/hair changes -- dry skin or warm, moist skin, excessive sweating, palmar erythema, acne, hirsutism, purple abdominal striae, absence of pubic or axillary hair. Facial plethora, moon facies, exophthalmos, ocular signs, visual fields defect, impaired auditory acuity, abnormal thyroid size and consistency, fine silky scalp hair or alopecia pattern. Tachycardia. Breast tissue atrophy, galactorrhea. "Buffalo" hump of back. On pelvic exam: 1) External – Vulvar atrophy, clitoromegaly. 2) Internal – Atrophic vaginal mucosa, change in cervical mucous, or imperforate hymen. 3) Bimanual – Softening of cervix or cervical uterine junction, cervical stenosis, uterine or ovarian atrophy or enlargement. ASSESSMENT Primary amenorrhea. OR Secondary amenorrhea with or without galactorrhea. PLAN DIAGNOSTIC STUDIES 1. Pregnancy test. 2. For secondary amenorrhea only: a. Amenorrhea with galactorrhea, and not breastfeeding: Draw prolactin level(s) prior to breast exam or 1 week after exam and no nipple stimulation for 1 week. Women’s Health 11.91 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 b. Thyroid-stimulating hormone (TSH) test (for underlying hypothyroidism). THERAPEUTIC PHARMACOLOGIC Amenorrhea without galactorrhea and negative pregnancy test – Progestin challenge. Medroxyprogesterone 5-10 mg 1 tab PO daily for 5-10 days. If bleeding occurs with progestin challenge test (usually within 2-7 days) and 1. Patient desires contraception and OCs do not pose an unacceptable health risk, begin any FDA approved < 35 mcg OC. OR 2. Patient does not desire contraception, give medroxyprogesterone acetate, 10 mg PO daily, for the first 10 days of every month, for three (3) consecutive months. If no bleeding occurs with progestin challenge test, repeat pregnancy test. PATIENT EDUCATION/COUNSELING 1. Give menstrual calendar and counsel on its use. 2. Inform that bleeding usually occurs within 2 weeks after treatment (frequently 2-7 days). 3. Discuss what can be expected during future evaluation. Explain that accurate diagnosis may take time. 4. Review female anatomy and menstrual cycle to help her understand the testing being done. 5. Discuss contraception, as indicated. 6. Explain that post-pill amenorrhea or resumption of normal menses may take up to 6 months. Women’s Health 11.92 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 FOLLOW-UP Return in two weeks if no withdrawal bleeding has occurred after medroxyprogesterone acetate or no withdrawal bleeding with OCs. CONSULTATION/REFERRAL 1. If patient has primary amenorrhea. 2. Positive pregnancy test. 3. Amenorrhea with galactorrhea and abnormal test results. 4. If patient does not have a withdrawal bleed after progestin challenge. 5. Patient fails to have spontaneous menses within 3 months after treatment. 6. Suspected eating disorders, or polycystic ovarian syndrome. 7. If patient has abnormal laboratory test(s). REFERENCES 1. 2. 3. 4. American Society of Health-System Pharmacists, American Hospital Formulary Service, Bethesda, MD, p. 3232, 2007. R. Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co., New York, 2004. (Current) Leon Speroff and Marc Fritz, Gynecologic Endocrinology and Infertility, Seventh Edition, Lippincott, Williams & Wilkins, Philadelphia, 2005. Women’s Health 11.93 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR BACTERIAL CYSTITIS NOTE: Females under age 18 must be established Women's Health patients. DEFINITION Cystitis is a bladder inflammation that may be characterized by dysuria, frequency and urgency. Bacteria and viruses are often the cause. Rarely, fungi, chemical agents, and radiation exposure may cause cystitis. SUBJECTIVE 1. Frequency, burning on urination. 2. Urgency, with or without incontinence. 3. Suprapubic pain and/or tenderness. 4. No symptoms of vaginal infection. If indicated, do work-up for possible vaginal infection, chlamydia and gonorrhea. 5. No recent history of fever, shaking chills, unilateral flank pain, inability to urinate or a sudden decrease in urine volume. No history of kidney disease. 1. Lower abdominal tenderness on palpation. 2. Temperature greater than or equal to 100ºF. 3. Diagnostic criterion: Dipstick urinalysis positive for either white blood cells (WBCs) and/or nitrites. OBJECTIVE ASSESSMENT Bacterial cystitis PLAN DIAGNOSTIC STUDIES 1. Urine pregnancy test, if any possibility of pregnancy. 2. If diagnosis is in question, obtain clean-catch urine for urinalysis and culture and sensitivity. 3. If abnormal vaginal discharge or discharge from the urethra, perform wet prep and perform tests for gonorrhea and chlamydia. Women’s Health 11.94 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 THERAPEUTIC PHARMACOLOGIC 1. Trimethoprim 160 mg / sulfamethoxazole 800 mg (Bactrim DS, Cotrim DS, Septra DS, Sulfatrim DS). 1 tablet PO, with food, every 12 hours for 3 days. NOTE: Do not give if patient: has a history of allergy to the drug components; asthma, kidney or liver disease, folic acid deficiency states, G6PD-deficiency, or any other blood dyscrasia; is taking thiazide diuretics, warfarin (Coumadin), phenytoin (Dilantin), or methotrexate; is pregnant; or, is breastfeeding an infant <2 months old, or with or an elevated bilirubin. OR 2. Nitrofurantoin (Macrobid®)100 mg, 1 capsule PO with food, every 12 hours for 7 days or Macrodantin 50 mg. 1 tab PO four times a day for 7 days. NOTE: Do not give if patient: has a history of nitrofurantoin allergy, kidney or liver disease, optic neuritis, G6PDdeficiency or anemia; is taking sulfinpyrazone/Anturane, probenecid, or magnesium-containing antacids; or is breastfeeding an infant less than one month old or with G6PD-deficiency. OR 3. If allergic or otherwise intolerant of treatments above, is at least 18 years old and not pregnant or breast-feeding, a. b. Norfloxacin (Noroxin®) 400 mg, 1 tablet PO every 12 hours for 3 days if uncomplicated and due to E. coli, K. pneumoniae, or P. mirabilis. All other organisms, Norfloxacin 400 mg., 1 tablet PO 2 times a day for 7 – 10 days. Take at least 2 hours before or 2 hours after food, milk products, iron or zinc supplements, antacids and/or other medications. NOTE: Do not give if: patient has a history of quinolone antibiotic allergy, tendon rupture, atherosclerotic cardiovascular disease, kidney or liver disease, neurologic Women’s Health 11.95 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 disorder or blood dyscrasia; or is taking theophylline, caffeine (e.g., in pain and fever-relieving medications), cyclosporine, warfarin (Coumadin®), probenecid, nitrofurantoin or sucralfate (Carafate®). 4. For non-curative symptomatic relief, if patient is >12 years old, is not pregnant or breast-feeding, and has no history of liver disease: a. b. c. Phenazopyridine HCL (Pyridium®) 200 mg, 1 tablet PO 3 times a day after meals as needed for 3-15 days. OR Nonprescription phenazopyridine HCl 95 mg (AzoStandard, Azo-Gesic, Prodium) for <2 days. Follow package directions. Discontinue medication immediately if any yellowish or orange discoloration of skin or eyes is noted. This medication may stain contact lenses. NON-PHARMACOLOGIC MEASURES 1. Increase fluid intake (cranberry juice might be suggested) and empty bladder frequently. 2. Warm sitz baths. PATIENT EDUCATION/COUNSELING 1. The importance of taking the full course of treatment, unless serious side-effects occur. 2. Drug-specific instructions and cautions: a. b. c. For trimethoprim/sulfamethoxazole: avoid sun exposure, discontinue drug immediately if develop a rash or signs of liver problems. Drink a full glass of water with each dose. For nitrofurantoin: discontinue drug if develop peripheral neuropathy, visual problems, diarrhea, or symptoms of liver or lung problems. For norfloxacin: avoid sun exposure, discontinue drug if develop diarrhea, tendon symptoms, rash or other allergic symptoms. Drink a full glass of water. May cause dizziness/drowsiness. Women’s Health 11.96 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 d. Phenazopyridine may cause discoloration of urine and may stain panties. Recommend pantyliners. 3. Potential risk factors for cystitis and prevention strategies. 4. Eating or consuming cultured milk products (yogurt, buttermilk) may help prevent vaginal yeast infection while antibiotics are being taken. 5. Seek medical care immediately if medication side-effects or systemic symptoms develop. 6. Post-menopausal women may have increased susceptibility for cystitis because of a decrease in vaginal lactobacilli and an increased pH. Cultured milk products (yogurt, buttermilk) which contain live active cultures are good dietary sources of lactobacilli. Look for product containers labeled "LAC”. FOLLOW-UP 1. Patient should call the clinic if cystitis symptoms are not improved within 48 hours of starting therapy. 2. If no improvement in 48 hours after starting therapy or if symptoms persist after therapy is complete, either perform complete UA, culture and sensitivity and treat or refer for testing. REFERRAL/CONSULTATION 1. If patient is pregnant. 2. Gross hematuria in a specimen uncontaminated by menses. 3. Systemic complaints such as temperature >100°F, fast pulse, shaking chills or unilateral flank pain. 4. Recurrent cystitis within one month, or more than 3 episodes in one year. 5. If follow-up urinalysis reveals unexplained (non-menstrual) microhematuria without WBCs or nitrite. Women’s Health 11.97 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 REFERENCES 1. 2. 3. 4. American Society of Health-Systems Pharmacist, American Hospital Formulary Service, Bethesda, MD, 2007, pp. 387-393, 410-418, 890-892, 3538-3539. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Constance Uphold and Virginia Graham, Clinical Guidelines in Family Practice, Fourth Edition, Barmarrae Books, Inc., Gainesville, FL, 2003. (Current) Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters Kluwer Health, Inc., 2007 <http://online.factsandcomparisons.com>. Women’s Health 11.98 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR DYSMENORRHEA (PRIMARY) DEFINITION Primary dysmenorrhea is painful menstruation without identifiable causes; it is also known as spasmodic dysmenorrhea. Elevated levels of prostagladins E2 and F in the endometrium cause uterine contractions. This increases intrauterine pressure, creating uterine ischemia and spasmodic pain. Differential diagnosis includes: pelvic inflammatory disease, endometriosis, adenomyosis, endometrial hyperplasia, endometrial cancer, leiomyomata, ectopic pregnancy, IUD with partial expulsion. SUBJECTIVE 1. Note history of: parity, menarche, method of contraception, pelvic inflammatory disease/sexually transmitted diseases, onset of symptoms/changes over time, family history of dysmenorrhea, nutritional status. 2. May report symptoms of congestive (secondary) dysmenorrhea: irritability, depression, nervousness, exhaustion, backache, constipation, bloating, weight gain, breast tenderness, dull ache, and/or onset of symptoms prior to menses. 3. May report symptoms of spasmodic dysmenorrhea: nausea, vomiting, diarrhea, weakness, dizziness, pelvic cramping, abdominal/back/thigh cramping, sweating, pallor, and/or headache. OBJECTIVE Physical examination usually within normal limits, unless secondary factors are present. ASSESSMENT Primary dysmenorrhea PLAN DIAGNOSTIC STUDIES As indicated: Pap smear, gonorrhea/chlamydia tests, vaginal wet mount, pregnancy test. Women’s Health 11.99 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 THERAPEUTIC PHARMACOLOGIC 1. Over the counter analgesics – Coated aspirin, Aleve®, Motrin IB®, Nuprin®, acetaminophen (e.g., Tylenol®), per package directions prn. OR 2. Ibuprofen 400 mg PO every 4 hours as needed for pain. (Maximum dose 1.2g/day) or Naproxen 500 mg 2 times a day prn for pain. (Maximum dose 1g/day) NOTE: Do not order if patient has a history of allergic reaction to aspirin. 3. If patient wants contraception and method poses no unacceptable health risk: OCs, medroxyprogesterone acetate, Ortho Evra Patch, NuvaRing may decrease symptoms. NON-PHARMACOLOGIC 1. Topical heat. 2. Regular exercise may be helpful. PATIENT EDUCATION/COUNSELING 1. Primary dysmenorrhea probably does not affect fertility. 2. Assess patient’s knowledge of activities that may provide relief. 3. Caution patient if taking prostaglandin inhibitors (Aleve®, Motrin IB®, Nuprin®, aspirin) a. b. Prolonged chronic use may cause kidney problems and GI upset. Stop medication and report severe persistent headaches, fever and muscle aches, which may be signs of aseptic meningitis. Women’s Health 11.100 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 FOLLOW-UP Return to clinic if no relief from therapy. CONSULTATION/REFERRAL 1. For differential diagnosis, as indicated. 2. Refer to physician if no relief from therapy, or severe side effects of medication. REFERENCES 1. 2. 3. 4. 5. 6. American Society of Health-Systems Pharmacists, American Hospital Formulary Service, Bethesda, MD, 2007, pp. 2061-2067, 2102-2108. Linda French, “Dysmenorrhea,” American Family Physician, Vol. 71, No. 2, January 2005. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co., New York, 2004. (Current) Constance Uphold and Mary Graham, Clinical Guidelines in Family Practice, Fourth Edition, Barmarrae Books, Inc., Gainesville, FL, 2003. (Current) Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters Kluwer Health, Inc., 2007 <http://online.factsandcomparisons.com>. Women’s Health 11.101 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR ECTOPIC PREGNANCY DEFINITION Implantation of a blastocyst in a location other than the corpus of the uterus. This may be intrauterine (cervix, interstitial portion of the tube) or extrauterine (ovary, tube, abdomen, or ligaments). Rupture of the fallopian tube occurs at 6-12 weeks or up to 3-4 months, after the menstrual cycle, depending on location of the pregnancy. Predisposing factors are: previous ectopic pregnancy, history of salpingitis or pelvic inflammatory disease, adhesions from previous surgery (e.g., appendicitis), previous tubal ligation and/or tubal re-anastamosis, or situations where tubal structure is distorted (developmental, uterine, or adnexal tumors). While an IUD (e.g., Copper T-380A) may decrease a woman's risk for an ectopic pregnancy, when a woman using an IUD becomes pregnant, the percentage of pregnancies which are ectopic is increased. SUBJECTIVE 1. History of last normal menstrual period and contraception. 2. May report: a. b. c. d. OBJECTIVE 1. Associated signs/symptoms of pregnancy such as nausea, vomiting, dizziness, breast tenderness and/or discharge. Spotting, cramping prior to expected menses, or missed menses followed by spotting to profuse bleeding, amenorrhea (75%). Mild to severe pain in the pelvic region, often unilateral, increasing in intensity, particularly on one side, with radiation to left shoulder. History of predisposing factors, such as previous ectopic pregnancy, pelvic infections, use of the IUD and previous pelvic surgery. May find on physical examination: a. b. c. d. Decreased bowel sounds and/or rebound tenderness. Soft, bluish cervix; blood at os or in vaginal vault. Cervical motion tenderness with softening of the cervicaluterine junction; uterus normal to slightly increased in size (may not correspond to dates), tender, and soft; adnexal mass or thickness with tenderness. Signs of hypovolemia or shock (BP lowered, pulse increased) if tube is ruptured and bleeding profusely. Women’s Health 11.102 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 2. Laboratory tests: a. b. Sensitive urine pregnancy test will usually be positive. Hematocrit/Hemoglobin - within normal limits or below normal. ASSESSMENT Possible ectopic pregnancy. PLAN Immediate referral to hospital emergency room. PATIENT EDUCATION/COUNSELING 1. Stress urgency of life-threatening situation. 2. Provide emotional support. 3. Discuss need to know Rh status and be given RhoGAM, if indicated. FOLLOW-UP At first follow-up visit, discuss: 1. Possibility of further fertility problems and/or repeat ectopic pregnancy. 2. How to decrease the chance of future infection and preserve remaining fertility. 3. Options for contraception. REFERENCES 1. 2. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins, et al., Protocols for Nurse Practitioners in Gynecological Settings, Eighth Edition, Springer Publishing Co., New York, 2004. (Current) Women’s Health 11.103 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR PROPHYLACTIC THERAPY WITH FOLIC ACID FOR REPRODUCTIVE-AGE WOMEN DEFINITION Folic acid is a B-vitamin that is necessary for proper cell growth. All women of reproductive age should consume 400 mcg (0.4 mg) of folic acid daily to meet 100% of the Recommended Daily Allowance (RDA). If folic acid is consumed before and during early pregnancy from a multi-vitamin or fortified food, it can prevent from 50% up to 70% of some forms of birth defects called neural tube defects (NTD), such as spina bifida and anencephaly. Foods naturally rich in folate include dark green leafy vegetables, orange juice, dried peas, beans, and lentils. Since 1998, some enriched flour, cereal, grain products, bread, rice and pasta have been fortified with folic acid. It is possible, that women that consume fortified products still may not consume enough folic acid. Taking a daily multivitamin or pill containing folic acid is another easy and effective way to assure meeting the recommended. All women of reproductive-age who have had a pregnancy affected by a NTD have an increased need for folic acid. The CDC guideline published in August 1991 and the PHS guideline published in September 1992 recommends that, women who have had a previous NTD-affected pregnancy: Consume 400 micrograms (0.4 milligram) of folic acid daily if they are not planning a pregnancy. Consume 4,000 micrograms (4 milligrams) of folic acid daily under the direction of their health care provider if they are planning a pregnancy. More studies of the prevention of NTDs among other higher risk women need to be done. Nevertheless, these women should follow the PHS recommendation of 400 micrograms (0.4 milligram) of folic acid daily throughout their childbearing years. If they are planning a pregnancy, it is advisable for them to discuss their potential risk for having an affected child with their physician. They should talk about the advantages and disadvantages of using 4,000 micrograms (4 milligrams) periconceptionally (that is, one month before conceiving a baby through the first three months of pregnancy). Other high-risk women include: Women with a close relative (e.g., sibling, niece, nephew) who has an NTD. Women or their partners who themselves have an NTD. Women with insulin-dependent diabetes mellitus. Women’s Health 11.104 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Women with seizure disorders being treated with valproic acid or carbamazepine. Women with medically diagnosed obesity. ETIOLOGY Neural tube defects occur in the first few weeks after conception. This is near the time a woman misses her menses. Therefore, neural tube defects may occur in an unborn baby before a woman realizes she is pregnant. The spinal cord forms and closes within the first 28 days of a pregnancy. The chance of having a child with a neural tube defect for those without a family history are approximately 1/500 - 1/1000. SUBJECTIVE Patient is not currently taking multivitamins with folic acid or 400 mcg folic acid daily. 1. 2. Patient has no history of neural tube defect either in pregnancy or personal history. Patient has a history of a NTD with a previous pregnancy. OBJECTIVE There are usually no obvious signs of folic acid deficiency. ASSESSMENT Reproductive age woman with inadequate folic acid intake. 1. 2. PLAN No history of previous neural tube defect-affected pregnancy. Has a history of previous neural tube defect-affected pregnancy. THERAPEUTIC PHARMACOLOGIC 1. Patient has no history of neural tube defect either in pregnancy or personal history. a. b. 2. Folic acid 400 mcg (0.4mg), one tablet PO daily. OR Multivitamin with folic acid 400 mcg (0.4mg), one tablet PO daily. Patient has history of a neural tube defect with a previous pregnancy. a. If the patient plans to become pregnant: Refer to a physician for planning how to obtain 4 mg of folic acid (one month before conceiving a baby through the first three months of pregnancy). Women’s Health 11.105 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 b. If the patient is not planning a pregnancy: Multivitamin with folic acid 400 mcg (0.4 mg), one tablet PO daily or folic acid 400 mcg, one tablet PO daily. PATIENT EDUCATION/COUNSELING 1. All women of reproductive age a. Assess patient’s knowledge about health benefits of folic acid and neural tube defects b. Provide examples of good sources of folate which include: 1) Green leafy vegetables (broccoli, romaine lettuce, spinach, turnip greens, asparagus) 2) Lentils, black-eyed peas, split peas 3) Liver 4) Orange juice 5) Many fortified breakfast cereals. Some cereals with 400 mcg (0.4 mg) of folic acid per serving include: Total®, Product 19®, Grape Nuts®, Wheat Total®, Multigrain Cheerios Plus®, Smart Start®. 6) Since 1998, folic acid has been added to cereals, breads, pastas, and other foods labeled "enriched.” c. The human body absorbs folic acid more efficiently from vitamin supplements than from food. d. Cooking and storage destroy some of the folate in foods. e. Explain proper use of folic acid supplements. Taking large doses of multivitamins can be harmful to a pregnancy; too much of certain other vitamins can actually cause birth defects. f. Review present form of birth control in detail and assure adherence if not planning a pregnancy. Women’s Health 11.106 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 g. 2. Extra amounts of folic acid may make it more difficult to detect a rare condition called vitamin B12 deficiency, or pernicious anemia. Women of reproductive age with a previous history of pregnancy affected by an NTD a. Give handouts about folic acid that are specifically designed for these women. Emphasize that folic acid will not prevent all reoccurrence of neural tube defects. b. Stress the benefit of planning pregnancies to lessen the chances of having a baby with a neural tube defect. These women should return to the clinic if they are even “thinking” about becoming pregnant. FOLLOW-UP 1. Discuss folic acid at each gynecologic visit. Stress the importance of birth control and planned pregnancies. 2. Schedule return appointment as appropriate for patient’s family planning needs. CONSULTATION/REFERRAL Refer to physician if history of previous neural tube defect-affected pregnancy. REFERENCES 1. 2. 3. 4. 5. American Academy of Pediatrics, “Folic Acid for the Prevention of Neural Tube Defects,” Pediatrics, Vol. 104, No. 2, August 1999, pp.325-327. (Current) American Society of Health-System Pharmacists, American Hospital Formulary Service, Bethesda, MD, 2007, pp. 3620-3622. CDC, “Spina Bifida and Anencephaly Before and After Folic Acid Mandate---United States, 1995-1996 and 1999-2000”, MMWR, Vol. 53, No. 17, 2004. (Current) Robert Hatcher, et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) CDC, Folic Acid Educational Materials For Health Care Professionals, “Appendices to Preventing Neural Tube Birth Defects: A Prevention Model and Resource Guide,” http://www.cdc.gov/ncbddd/folicacid/health_materials.htm. Women’s Health 11.107 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR IRON-DEFICIENCY ANEMIA IN NON-PREGNANT AND NON-LACTATING WOMEN 18 AND OVER DEFINITION Anemia is a decrease in the number of red blood cells or quantity of hemoglobin or hematocrit. This reduced blood cell count reduces the amount of oxygen the blood can carry in the body. Iron-deficiency anemia, the most common type of anemia, is present in 20% of all premenopausal women in the United States. ETIOLOGY The primary cause of iron-deficiency anemia in premenopausal women is loss of blood through menstruation. In men and postmenopausal women, bleeding is usually from the GI tract (chronically bleeding lesions, reflux esophagitis, peptic ulcers, gastric or colorectal adenocarcinomas). Iron-deficiency anemia also commonly occurs during pregnancy. SUBJECTIVE 1. Usually no symptoms. 2. Patient may have: a. b. c. d. e. f. g. 3. Pallor, malaise, and/or anorexia. History of GI bleeding. Changes in stool color or bleeding from hemorrhoids. Excessive blood loss during menses or history of fibroid tumors. Poor dietary intake of iron rich foods, and pica. History of drug/medication use, especially aspirin and other NSAIDs. Nonspecific complaints of headache, poor concentration, and/or palpitations. With severe anemia, the patient may also present with: Weakness and faintness Shortness of breath Increased heart rate Headaches Sore tongue 4. Nausea and loss of appetite Dizziness Bleeding gums Confusion and dementia Symptoms of heart failure No history of major hemoglobinopathies (e.g., sickle cell anemia, sickle C disease, sickle beta thalassemia, Hemoglobin CC disease). Women’s Health 11.108 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 OBJECTIVE 1. Patient may have a. b. c. d. e. 2. Pallor, best seen in conjunctivae. Atrophy of the surface or edges of the tongue. Inflammation/cracking of the lips. Spoon nails (thin and concave from side to side). Tachycardia, flow murmur. Hemoglobin below 12 g/dL for a non-smoker and below 12.3 g/dL for smoker or hematocrit below 35.9% for non-smoker and below 36.9% for smoker. ASSESSMENT Iron-deficiency anemia. PLAN DIAGNOSTIC STUDIES 1. Order hemoglobin electrophoresis, sickle cell test, if not previously done or if client’s status unknown. 2. Stool occult blood x 3, if clinically indicated or patient is age 35 years or older. THERAPEUTIC PHARMACOLOGIC Give 60-120 mg elemental iron PO daily. If patient is taking a multi-vitamin and mineral supplement with iron, the multi-vitamin and mineral supplement plus the iron should equal a total of 60120 mg of elemental iron/day. Do not give if client has sickle cell or hemoglobin variants. PATIENT EDUCATION/COUNSELING 1. If the iron upsets the stomach, take iron with a small amount of food, but not with dairy products. 2. Introduce iron gradually to minimize stomach upset. Take one tablet once a day x 1 week, then increase to twice daily if needed. 3. Beverages consumed with meals have a dramatic effect on iron absorption from blood. a. Orange juice doubles the absorption of iron. b. Tea or milk can reduce absorption to less than one half and should be consumed in moderation between meals. 4. Antacids, tetracycline, cimetidine and pancrelipase interfere with iron absorption. Do not take iron within 3 hours of taking these Women’s Health 11.109 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 medications. Iron affects other medications and a pharmacist or health care provider should be consulted before starting another medication. 5. Iron supplements may cause black or dark green bowel movements, diarrhea, or constipation. 6. Counsel patient on other common side effects of iron therapy. 7. Too much iron is dangerous. Iron tablets may look like candy and a package of iron tablets can poison a child. Keep iron supplements out of the reach of children. FOLLOW-UP Recheck hemoglobin/hematocrit at the end of 4 weeks of initial treatment. 1. If the hemoglobin has increased 1 g/dL or hematocrit by 3%, continue treatment for 2-3 months to replenish iron stores. 2. If the hemoglobin is not increased 1 g/dL or hematocrit by 3%: a. b. Assess for compliance with therapy, diet, enteric parasites and other possible anemia-causing conditions. Refer to a physician for further evaluation. CONSULTATION/REFERRAL 1. Hemoglobin <9 g/dL or hematocrit <27%. 2. If after 4 weeks the hemoglobin does not increase by 1 g/dL or hematocrit by 3%, despite compliance with iron supplementation regimen and the absence of acute illness. 3. A patient with sickle cell anemia or hemoglobin variants. 4. If there is evidence of other medical problems. Women’s Health 11.110 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 REFERENCES 1. 2. 3. 4. American Society of Health-System Pharmacists, American Hospital Formulary Service, Bethesda, MD, 2007, pp. 1410-1417. Constance Uphold and Virginia Graham, Clinical Guidelines in Family Practice, Fourth Edition, Barmarre Books, Inc., Gainesville, FL, 2003. (Current) Phyllis Leppert and Jeffery Peipert, Primary Care of Women, Second Edition, Lippincott, Williams & Wilkins, Philadelphia, 2004. (Current) Centers for Disease Control and Prevention, "Recommendations to Prevent and Control Iron Deficiency in the United States," MMWR, Vol. 47, No. RR-3, April 3, 1998. Women’s Health 11.111 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR OSTEOPOROSIS IN WOMEN: ASSESSMENT AND PREVENTION DEFINITION Osteoporosis means "porous bone.” This condition decreases the amount of bone in the skeleton, causing the bones to become so weak that the slightest injury can cause a fracture. Often there are no visible symptoms or warning signs. Osteoporosis can affect any bone in the body, but most commonly involves the spine, wrist and hip. In the spine, individual vertebrae fracture and collapse, causing the client to become shorter and stooped. Chronic pain and the appearance of a "dowager's hump" are signals that the spine is fracturing. Fractures of the wrist or arm can lead to permanent loss of the use of the arm due to slow healing. Osteoporosis is the most common cause of hip fracture, which can result in permanent disability, loss of independence or death. One out of two women and one in four men over age 50 will have osteoporosis-related fractures. ETIOLOGY 1. 2. 3. 4. SUBJECTIVE 1. Peak bone mass may not be attained because of poor calcium intake from childhood through the early 30s. After the early 30s, a gradual loss of bone occurs naturally with aging, though calcium in the diet will help minimize this. At about age 35, people begin to lose bone at a rate of 1% to 2% per year. Bone loss increases significantly at menopause when the ovaries stop producing estrogen, or at any time if the ovaries are removed. In the first 3-5 years after the reduction of estrogen in a woman's body, bone loss can increase as much as 3% to 10% per year. Osteoporosis is eight times more common in women than in men, partly due to menopause, but also because women usually have smaller bones and generally live longer. Women also typically consume less calcium. May have a known risk factor: a. b. c. d. e. f. Sex—Women are twice as likely as men to fracture a bone as a result of osteoporosis. Age—Older women, especially age 65 and over. Family history of fractures or osteoporosis. Personal history of fractures as an adult. Race—Caucasian and Asian women are at higher risk. However, African American and Hispanic women are also at significant risk. Bone structure and body weight—Small-boned and thin women have higher risk for osteoporosis. Women’s Health 11.112 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 g. h. i. j. k. OBJECTIVE Menopause History—Early menopause brought about naturally or surgically. Women who stop menstruating because of conditions such as anorexia, bulimia or excessive exercise are at increased risk. Menstrual History—Women who stop menstruating because of conditions such as anorexia, bulimia or excessive exercise. Lifestyle—Cigarette smoking, drinking excessive alcohol, inadequate calcium, little or no weight-bearing exercise. Medications—Some medications used to treat disorders such as rheumatoid arthritis, endocrine disorders (e.g., hypothyroidism), seizure disorders and gastrointestinal diseases are risks for osteoporosis. For example, long term use of parenteral progesterone (medroxyprogesterone acetate), GnRH (used to treat endometriosis), long term heparin use, lithium, cholestyramine (used to treat high cholesterol). Chronic Diseases/Medical Conditions—AIDS, Cushing’s syndrome, gastrectomy, hyperthyroidism, inflammatory bowel disease, rheumatoid arthritis, eating disorders, severe liver disease, insulin-dependent diabetes mellitus, chronic obstructive pulmonary disease and cancer are risk factors. 2. May have history of chronic back pain. 3. May have history of fracture of vertebrae, wrist, hip or other bones. 1. Note findings on evaluation of skin, thyroid, breast, lungs, weight, height, abdomen, pelvis and extremities. 2. May have small bones or thin and petite frame. 3. Decrease in height. ASSESSMENT History, physical exam or age (>65 years old) indicates patient at risk for osteoporosis AND/OR patient needs education and counseling to prevent osteoporosis. PLAN Refer if indicated for further evaluation. Women’s Health 11.113 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 THERAPEUTIC NON-PHARMACOLOGIC 1. Vitamin D, 400 international units daily (women over age 60, 800 international units daily as a supplement). Vitamin D can also be obtained from fortified dairy products, egg yolks, saltwater fish, liver and fortified cereals. 2. If client does not consume milk and dairy products, or has a milk allergy or is lactose intolerant: Calcium supplement, 500 mg or less, 2-3 times a day, between meals and at bedtime. (See the following Calcium Recommendations.) Tums can be taken (two twice a day) for calcium supplementation, but should not be taken within two hours prior to taking other medication(s). Calcium Recommendations AGE DIETARY REFERENCE INTAKE 9-18 years 1300 mg 19-50 years 1000 mg 51 and older 1200 mg Pregnant/Lactation < 18 years 1300 mg Pregnant/Lactation > 18 years 1000 mg NOTE: Certain drugs, such as tetracycline, corticosteroid or aluminum-containing antacids interfere with calcium absorption. NON-PHARMACOLOGIC MEASURES 1. Adequate dietary intake of calcium (e.g., broccoli, turnip greens, milk, cheese, yogurt, fortified foods and juices). See Calcium Recommendations. Women’s Health 11.114 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 2. Exercise for 30-60 minutes 3-5 days per week. Maximize weight-bearing exercise during daily routines (walking, carrying, moving, playing). PATIENT EDUCATION/COUNSELING 1. If in bone-building years (up to age 35), develop good habits: a. b. c. d. e. f. g. h. 2. Get adequate calcium each day. See Calcium Recommendations. Get enough Vitamin D through sunshine (15 minutes a day) and fortified foods, such as milk. If worried about the fat and cholesterol content of dairy products, low-fat milks, cheeses and yogurts are available and are rich in calcium. If lactose intolerant, or have problems digesting dairy products, consider other foods that are high in calcium and additives that provide the lactase enzyme so that dairy foods can be digested. Some lactose-intolerant individuals can tolerate up to one cup of milk a day. Consume smaller servings and consume with meals. Choose naturally-aged cheeses such as Swiss and cheddar; try yogurt with active cultures. Include weight-bearing exercises, such as walking, aerobics, jogging. Do not smoke. Limit consumption of alcohol (i.e. no more than 2 drinks/day), limit caffeine (i.e. no more than 2-3 cups of coffee/day or the equivalent), avoid excessive sodium, phosphate and protein. Emphasize importance of keeping immunizations current; assess client’s immunization status and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Immunization Program Manual “Recommended Schedule and Guidelines” for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed online at http://www.health.state.ga.us/programs/immunization/publi cations.asp. If near or in menopause, take steps to slow the progress of osteoporosis and prevent injury: a. Get at least 1000 mg of calcium a day. Women’s Health 11.115 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 b. c. Get regular weight-bearing exercise 30-60 minutes 3-5 days per week, such as walking, dancing, hiking. To reduce the chance of falling: 1) Wear low-heeled shoes. 2) Keep stairs free from loose rugs or objects. 3) Place non-skid tape in the shower/bathtub. 4) Keep floors uncluttered, free from wires and throwrugs. 5) Install a night light in the bathroom. 6) Turn on a light if you get up during the night. 7) Limit alcohol consumption. 8) Be aware of medication or medical conditions that might impair coordination. 3. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). 4. If alcohol abuser, refer to local addiction program. FOLLOW-UP As indicated. CONSULTATION/REFERRAL 1. For nutrition counseling. 2. For assessment and possible pharmacologic treatment of osteoporosis. The decision to test for bone mineral density should be based on an individual’s risk profile, and testing is not indicated unless the results could influence a treatment decision. Recommendations by the National Osteoporosis Foundation for bone mineral density screening in women include the following: a. b. c. All postmenopausal women under age 65 who have one or more additional risk factors for osteoporosis (in addition to being postmenopausal and female). All women age 65 and over regardless of additional risk factors. Postmenopausal women who present with fractures (to confirm diagnosis and determine disease severity). Women’s Health 11.116 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 REFERENCES 1. 2. 3. 4. 5. American Society of Health-Systems Pharmacists, American Hospital Formulary Service, Bethesda, MD, 2007, pp. 2655-2663. Robert Hatcher et al., Contraceptive Technology, Eighteenth Revised Edition, Arden Media, Inc., New York, 2004. (Current) Constance Uphold and Virginia Graham, Clinical Guidelines in Family Practice, Fourth Edition, Barmare Books, inc., Gainesville, Fl., 2003. (Current) National Osteoporosis Foundation, Physician’s Guide to Prevention and Treatment of Osteoporosis, Washington, DC, 2003. (Current) Mayo Clinic, <http://www.mayoclinic.com/health/osteoporosis/DS00128, February 28, 2007. Women’s Health 11.117 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR SEXUAL ABSTINENCE COUNSELING DEFINITION Sexual abstinence is defined as refraining from sexual activity. People of all ages choose to abstain from sex, for a variety of reasons. Abstinence is the most effective way to avoid both pregnancy and the spread of sexually transmitted diseases (STDs). It is important for everyone, including healthcare professionals, to accept abstinence as a normal and common choice. Sexual abstinence can be either primary or secondary. Primary abstainers have never engaged in sexual activity with another person. Secondary abstainers are sexually-experienced persons who have currently chosen to avoid some or all sexual activity. SUBJECTIVE Client desires to be sexually abstinent. This may be for personal, family, religious or medical reasons. 1. Client may express feelings of not being physically, emotionally or spiritually ready for sexual activity. 2. Client may verbalize feelings of pressure from peers, community and media to begin, or resume, sexual activity. OBJECTIVE Physical exam not required. ASSESSMENT Sexual abstinence is client’s current lifestyle choice. PLAN EDUCATION/COUNSELING 1. Abstinence education guided by the 1997 General Assembly House Resolution 457 gave guidelines for expenditure of funds appropriated for teen pregnancy prevention. 2. Discuss the following ways to achieve the goal of sexual abstinence: a. b. c. Decide what to do about sex when feeling clear-headed, sober and good about one's self. Decide, in advance, what sexual activities to say “yes” to; discuss this with partner and a supportive family member. Tell a potential sex partner, very clearly in advance, not at the last minute, what activities you will not do. If possible, talk at a time when feeling close to each other, but not sexual (e.g., taking a walk and holding hands). Women’s Health 11.118 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 d. Avoid high-pressure sexual situations. Stay sober and drug-free and avoid being in an empty house or the back seat of a car with someone who may try to pressure you. e. Say “no” clearly, and mean it! Practice the following: Techniques Simple “no” Emphatic “no” Repetitive “no” Turn the tables Examples “No, thanks,” or “ No.” “No. I don' t want to do that.” “No. No. No.” "You say that if I love you I would. But if you really loved me, you wouldn’t insist.” Give a reason "I’m not ready.” “We can’t be too careful in this age of AIDS.” “I have decided to wait until marriage.” Leave the scene Walk out of there. Steer clear If you suspect you will be pressured, do not go with that person. Safety in numbers Double date; keep trusted friends nearby. f. g. h. i. 3. Learn more about your body and how to keep it healthy. Learn more about birth control and safe sex for when a conscious decision is made about being ready to accept the responsibility that sexual activity brings. Talk with a parent or guardian, religious leader or other adult about this important life decision. Discuss sexual coercion. Emphasize importance of keeping immunization’s current; assess client’s immunization status and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed on line at http://www.health.state.ga.us/programs/immunization/p ublications.asp. When appropriate, inform client of the current Georgia laws about statutory rape: a. b. Having sexual intercourse with any person under the age of 16 is considered statutory rape; It does not matter if the person is a male or female; Women’s Health 11.119 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 c. 4. It does not matter if the sex is consensual. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). FOLLOW-UP Invite client to come back for another discussion, as needed. CONSULTATION/REFERRAL 1. Talk with teenage clients about adolescent health, youth development and/or other community programs that can support sexual abstinence as a choice, provide a safe environment, and can assist in building skills for remaining abstinent. 2. For adults who have difficulty with abstinence issues, suggest that they talk with a religious or other counseling professional who deals with relationship issues. REFERENCES 1. 2. Robert Hatcher et al., Contraceptive Technology, Eighteenth Revised Edition, Ardent Media, Inc., New York, 2004. (Current) State of Georgia, Statutory Rape Law, O.C.G.A. § 16-6-3. Women’s Health 11.120 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR LOCAL ESTROGEN THERAPY FOR TREATMENT OF VULVAR/VAGINAL ATROPHY DEFINITION Symptoms of urogenital atrophy are seen in almost half of untreated menopausal women as well as in 10-25% of women receiving conventional doses of systemic hormone therapy (HT). The vagina as well as the urethra and trigone of the bladder are estrogen-dependent tissues. When circulating estrogen levels drop because of transient or permanent ovarian failure (including menopause) or because of antiestrogenic medications, these tissues atrophy. SUBJECTIVE Patient may complain of vaginal irritation, pruritis, vaginal dryness, dyspareunia, dysuria, urge incontinence as well as hot flushes/flashes, insomnia, and night sweats. OBJECTIVE Physical exam findings of urogenital atrophy including the following: Pale, thin friable vaginal epithelium. Loss of vaginal rugae and elasticity. Sparse pubic hair. Dryness of labial skin and loss of turgor. Introital petechiae or fissure. Erythematous urethral meatus. Eversion of urethral mucosa, urethral caruncle. ASSESSMENT Vulvovaginal atrophy associated with menopause. According to product package insert, no contraindications to using vaginal estrogen. NOTE: contraindications for vaginal estrogen products are the same as for systemically administered estrogen. PLAN DIAGNOSTIC STUDIES 1. Consider FSH and/or thyroid studies if menopause is in question. 2. Wet prep, urine dip stick, STD tests as indicated to rule out vaginitis and cystitis. 3. Pap smear and mammogram according to Georgia Breast and Cervical Cancer Screening Program guidelines. 4. Fasting lipid profile and glucose. 5. Additional screening tests for age as indicated. Women’s Health 11.121 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 THERAPEUTIC PHARMACOLOGIC 1. For relief of atrophic vaginitis: Premarin vaginal cream (or equivalent), 0.5 - 2 g daily intravaginally for 3 weeks and one week off. Lower doses may be effective. Medication should be discontinued as promptly as possible. a. b. c. 2. Patient should use lowest dose possible to relieve symptoms. Treatment with vaginal cream longer than 6-12 months requires ultrasonic monitoring of endometrial thickness with biopsy when indicated as estrogen cream is absorbed systemically. Latex condom, diaphragm and cervical cap may be weakened by vaginal cream. For ASCUS Pap smear with evidence of atrophy: Premarin vaginal cream (or equivalent), 0.5 - 2 g daily intravaginally for 3 weeks. Lower doses may be effective. Medication should be discontinued as promptly as possible. PATIENT EDUCATION/COUNSELING 1. Counsel patient according to seven basic elements of informed consent (BRAIDED – Benefits Risks Alternatives Inquiries Decision Explanation Documentation). 2. Vaginal estrogen cream provides the quickest response and subsequent relief of symptoms of atrophic vaginitis. 3. Vaginal moisturizers such as Replens, applied on a regular basis, have been shown to be beneficial for local vaginal symptoms. 4. Vaginal estrogen cream may weaken latex condoms, diaphragms and cervical caps, therefore reducing their effectiveness. 5. Regular sexual activity has been shown to help maintain vaginal health. Women’s Health 11.122 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 6. Counsel on good health practices, including: diet, intake of calcium and vitamin D, weight-bearing exercises and increase in physical activity, breast and cervical cancer screening, safer sex and STD/HIV risk reduction and testing. 7. If smoker or tobacco user, refer to local cessation program and/or Georgia Tobacco Quit Line, 1-877-270-STOP (7867). FOLLOW UP 1. As needed for specific problems. 2. Evaluate response to therapy in 3 months or sooner. 3. Annual physical exam, Pap smears and mammograms according to Breast and Cervical Cancer Program guidelines. REFERRAL/CONSULTATION 1. For any questions regarding management. 2. For ultrasound of endometrium and biopsy and if indicated if treatment with vaginal cream is longer than 6-12 months. 3. Emphasize importance of keeping immunizations current; assess client’s immunization status and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule. If client declines vaccination, document refusal. See the Georgia Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed online at http://www.health.state.ga.us/programs/immunization/publications. asp. Women’s Health 11.123 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 REFERENCES 1. 2. 3. 4. 5. 6. American Society of a Health System Pharmacists, American Hospital Formulary Service, Bethesda, MD, 2007, pp. 3103-3107. Robert Hatcher, et al., Contraceptive Technology, Eighteenth Edition, Ardent Media, Inc., New York, 2004. (Current) Joellen Hawkins et al., Protocols for Nurse Practitioners in Gynecologic Settings. Eighth Edition, Springer Publishing Co., New York, 2004. (Current) Leon Speroff and Marc Fritz, Clinical Gynecologic Endocrinology and Infertility, Seventh Edition, Lippincott, Williams & Wilkins, Philadelphia, 2005. Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters Kluwer Health, Inc., 2007 <http://online.factsandcomparisons.com>. Premarin Vaginal Cream, Physician Prescribing Information, Wyeth Pharmaceuticals, Inc., July 2006. Women’s Health 11.124