LW is a 32 year old female patient who comes to your medical clinic for primary care. ?She has been on hormonal contraceptives for years, although

Topic III: Men's and Women's Health

Introduction

pregnancy and related

Each medication prescribed during pregnancy and lactation should be scrutinized via drug information resources for adverse effects during pregnancy / lactation, with particular attention paid to the timing of the drug's administration (early, mid, or late pregnancy, or timing of doses in relation to expression of milk/infant feeding). Pre-pregnancy planning is strongly encouraged for patients with chronic conditions and on medications. There is a need to ascertain if there are safer alternative medications available as well as examining the overall necessity of continued therapy during pregnancy.

All practitioners should be familiar with drugs that are absolutely contraindicated in pregnancy (drugs which have proven teratogenic effects – Category X drugs) and have understaning of how medications are classified (i.e. fetal risk) based on the former Category Ratings and the Pregnancy and Lactation Labeling Rule (PLLR)

Many common medications include classes such as statins, ACE inhibitors/ARBs, many anticonvulsants, isotretinoin, lithium, NSAIDS, and warfarin (See Table 48-3 in PPP).  Women of childbearing age should be counseled on possible pregnancy consequences if they take these drugs.

Medication use during pregnancy and lactation is challenging – patients with chronic conditions must be managed and acute issues requiring medication must be addressed as well.  Patients must also be counseled with regard to over the counter medication use during pregnancy and lactation.  Although many of these patients are also managed by specialists in obstetrics / gynecology, primary care practitioners should be familiar with the chronic and acute medications which pose risks in pregnancy and lactation.

There are many options available for medical contraception.  Women may require a trial of several hormonal contraceptives before they find an option that is ideal for them.  Clinicians may streamline medications by choosing OCs that are approved for additional indications (acne control, etc.).  Choice of combined OC may be based on regimen that patient prefers (cyclic versus continuous).

Many drugs may interact with hormonal contraceptives and alter efficacy.  Common interactions include antibiotics, steroids, and anticonvulsants.  Hormonal contraceptives may also affect other medications as well. Patients should be counseled and interactions should be checked whenever a new medication is added to a patient on hormonal contraceptives (particularly oral formulations)

menopause

For older women, long term use of hormone replacement therapy for  menopause is associated with more overall risk than benefit and should not be used.  Short term hormonal therapy can be useful for patients with bothersome vasomotor symptoms, although should be prescribed at the lowest possible dose and for the shortest possible duration.  Hormone replacement therapy should not be continued for any other purpose (eg. prevention of osteoporosis). Topical estrogen products (not transdermal systemic) with limited systemic absorption may be useful for women experiencing vulvovaginal atrophy.

Nonhormonal therapies can also be considered in those women for whom estrogens can not be used. Nonhormonal therapies for alleviation of vasomotor symptoms include selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), clonidine, and gabapentin

American College of Obstetricians and Gynecologists (ACOG), American Association of Clinical Endocrinologists (AACE), North American Menopause Society (NAMS), and the Endocrine Society conclude insufficient evidence to support the use of herbal remedies for vasomotor symptoms associated with menopause due to inconsistent results in trials

Mens health 

Erectile dysfunction (ED) is defined as the persistent inability to achieve or maintain an erection sufficient for sexual intercourse

Patients with erectile dysfunction (ED) should be carefully assessed for cardiac function  prior to beginning medical therapy with PDE5 inhibitors (sildenafil, etc.).  (See PPP Table 51-3)

For men, erectile dysfunction may be worsened by a variety of diseases and drugs.  Treatment should always look to remove or modify potential contributing factors (including offending medications) before drugs are prescribed.  First line treatment with PDE5 inhibitors is usually preferable for most patients due to ease of oral dosing and convenience.  Second line therapies including injections and intraurethral pellets should probably be managed by a specialist. (See PPP Table 51-1, 51-2 ).

· All PDE5 inhibitors appear to have similar efficacy for treatment of ED.

· Up to a third of patients will not respond to therapy with PDE5 inhibitors. To achieve the greatest effect, patients must be fully informed of the onset and duration of effect, impact of high-fat meals, the need for sexual stimulation, and explanation that a single trial is not adequate. It is estimated that six to eight attempts with a medication and specific dose may be needed before successful intercourse

Testosterone replacement has limited role in treatment of ED, and should not be offered routinely to older men in without other clinically significant symptoms and low testosterone levels.  

BPH can be managed conservatively in the mild to moderate stages, and drug therapy can be started and escalated as the patient's symptoms worsen. Keep in mind that 5a reductase inhibitors will not provide immediate benefits for the patient. Patients on drug treatment for BPH should be monitored for adverse effects including hypotension and sexual dysfunction.

Medical management should be utilized for patients with moderate to severe BPH with bothersome symptoms, and should initially consist of alpha 1 blockers (alfuzosin 10 mg, doxazosin 2-8 mg, tamsulosin 0.4-0.8 mg, terazosin 2-10 mg, or silodosin 8 mg orally once daily).  5a-reductase inhibitors should be utilized for patients with larger prostate sizes and/or elevated PSA values.  These two medication classes can be combined for patients with severe voiding issues. 

Alpha 1-blockers are similar in efficacy within the medication class, as are 5a-reductase inhibitors. Older alpha blockers require titration to avoid orthostasis, an adverse event avoided with the use of uro-selective agents.

Objectives

At the completion of this module the student will be able to:

· See "Learning Objectives" outlined in chapters 48-52 of Pharmacotherapy: Principles and Practices

· Recognize common drugs that are absolutely contraindicated in pregnancy (category X).

· State the appropriate course of action for checking the appropriateness of medications prior to prescribing medication to women who are pregnant or nursing.

· Recognize the drugs commonly causing interactions with hormonal contraception which may affect efficacy.

· State the appropriate uses of hormonal replacement therapy and topical hormonal therapy for menopausal/post-menopausal women.

· Recognize medications which may contribute to ED.

· Suggest a first line treatment plan for ED and BPH.

Readings 

Pharmacotherapy Principles and Practice

· Chapter 48: Pregnancy and Lactation: Therapeutic Considerations

· Chapter 49: Contraception

· Chapter 50: Menopause and Menstruation Related Disorders

· Focus on Menopause only for this course

· Chapter 51: Erectile Dysfunction

· Chapter 52: Benign Prostatic Hyperplasia

Other Resources

· Dynamed Summary for Oral Contraceptives:  https://www-dynamed-com.wilkes.idm.oclc.org/drug-review/oral-contraceptives

· Dynamed Summary for Hormone Replacement Therapy (HRT):  https://www-dynamed-com.wilkes.idm.oclc.org/management/hormonal-replacement-therapy-hrt-for-menopause-and-perimenopause

· Dynamed Summary for Erectile Dysfunction (ED):  https://www-dynamed-com.wilkes.idm.oclc.org/condition/erectile-dysfunction

· Dynamed Summary for Benign Prostatic Hyperplasia (BPH):  https://www-dynamed-com.wilkes.idm.oclc.org/condition/benign-prostatic-hyperplasia-bph

Videos

· Impact of pregnancy on pharmacokinetics of medications (Mary F. Hébert, Pharm.D., FCCP): 

· Erectile Dysfunction (osmosis):

Module III	Discussions & Assignments