Certified Women’s Health Pharmacist (CWHP) Review

A-C

• ACOG: American College of Obstetricians and Gynecologists.
• ART: Assisted Reproductive Technology.
• ASCVD: Atherosclerotic Cardiovascular Disease.
• AUB: Abnormal Uterine Bleeding.
• BHRT: Bioidentical Hormone Replacement Therapy.
• BMD: Bone Mineral Density.
• BV: Bacterial Vaginosis.
• CDC: Centers for Disease Control and Prevention.
• CHC: Combined Hormonal Contraceptive.
• COC: Combined Oral Contraceptive.

D-H

• DMPA: Depot Medroxyprogesterone Acetate.
• DVT: Deep Vein Thrombosis.
• E2: Estradiol.
• EC: Emergency Contraception.
• ERT: Estrogen Replacement Therapy.
• ET: Estrogen Therapy.
• FDA: Food and Drug Administration.
• FSH: Follicle-Stimulating Hormone.
• GnRH: Gonadotropin-Releasing Hormone.
• HPV: Human Papillomavirus.

I-P

• IUD: Intrauterine Device.
• IUI: Intrauterine Insemination.
• IVF: In Vitro Fertilization.
• LARC: Long-Acting Reversible Contraceptive.
• LH: Luteinizing Hormone.
• MEC: Medical Eligibility Criteria for Contraceptive Use.
• MHT: Menopausal Hormone Therapy.
• NAMS: North American Menopause Society.
• PCOS: Polycystic Ovary Syndrome.
• PID: Pelvic Inflammatory Disease.

P-S

• PMDD: Premenstrual Dysphoric Disorder.
• PMS: Premenstrual Syndrome.
• POP: Progestin-Only Pill.
• PPD: Postpartum Depression.
• SERM: Selective Estrogen Receptor Modulator.
• SHBG: Sex Hormone-Binding Globulin.
• STI: Sexually Transmitted Infection.
• SUI: Stress Urinary Incontinence.
• T-score: A measure of bone density.
• TSH: Thyroid-Stimulating Hormone.

U-Z

• UI: Urinary Incontinence.
• USP: United States Pharmacopeia.
• UTI: Urinary Tract Infection.
• VMS: Vasomotor Symptoms.
• VTE: Venous Thromboembolism.
• VVC: Vulvovaginal Candidiasis.
• WHI: Women's Health Initiative.
• GDM: Gestational Diabetes Mellitus.
• GSM: Genitourinary Syndrome of Menopause.
• HRT: Hormone Replacement Therapy (older term for MHT).

A Lifespan Approach

• Women's health encompasses a wide range of conditions and needs that evolve throughout a woman's life.
• This includes stages from adolescence (menarche) through the reproductive years, perimenopause, menopause, and postmenopause.
• A CWHP must be knowledgeable about the unique health concerns and therapeutic considerations at each stage.
• This lifespan perspective is essential for providing comprehensive, patient-centered care.
• It recognizes that a woman's health needs are dynamic, not static.

The Pharmacist's Role

• Pharmacists are highly accessible healthcare providers who can play a vital role in women's health.
• This includes providing evidence-based recommendations for contraception and menopausal hormone therapy.
• They are key educators on the proper use of medications and devices.
• They screen for health conditions, provide immunizations, and counsel on preventive care.
• A CWHP has advanced, specialized knowledge that allows them to be a leader and a key resource on the women's health team.
• They often work under collaborative practice agreements to manage complex medication regimens.

Evidence-Based Practice

• All recommendations must be grounded in the best available scientific evidence.
• This requires the ability to critically appraise the medical literature, including clinical trials and systematic reviews.
• Key sources of evidence are the clinical practice guidelines published by major professional societies, such as ACOG and NAMS.
• The practice of women's health is constantly evolving as new evidence emerges (e.g., the WHI trial).
• A commitment to lifelong learning is a core professional responsibility.
• The CWHP must be able to distinguish high-quality evidence from misinformation.

Shared Decision-Making (SDM)

• Many decisions in women's health are preference-sensitive.
• This includes choices about contraception and menopausal hormone therapy.
• SDM is the ideal model of care in these situations.
• It is a collaborative process where the clinician shares the evidence on the risks and benefits of all options.
• The patient then shares her personal values and preferences.
• Together, they arrive at a decision that is both evidence-based and aligned with what matters most to the patient.
• A CWHP is a key facilitator of this process.

Cultural Competency and Inclusivity

• A CWHP must provide care that is respectful of and responsive to a diverse patient population.
• This requires cultural competency and an understanding of how cultural beliefs can influence health decisions.
• It also requires providing care that is inclusive of all individuals, including transgender women who may have specific health needs.
• Creating a welcoming and non-judgmental environment is essential for building trust.
• This is a cornerstone of patient-centered care.

The Hypothalamic-Pituitary-Gonadal (HPG) Axis

• The HPG axis is the hormonal feedback loop that governs the menstrual cycle.
• The hypothalamus releases Gonadotropin-Releasing Hormone (GnRH).
• GnRH stimulates the anterior pituitary to release Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH).
• LH and FSH act on the ovaries to stimulate the production of estrogen and progesterone.
• Estrogen and progesterone then provide negative feedback to the hypothalamus and pituitary.
• Hormonal contraceptives work by manipulating this axis.

The Menstrual Cycle

• The menstrual cycle has two main phases: the follicular phase and the luteal phase.
• The cycle begins with the start of menses (Day 1).
• During the follicular phase, FSH stimulates the growth of an ovarian follicle, which produces estrogen.
• A surge in LH in the middle of the cycle triggers ovulation (the release of the egg).
• After ovulation, the luteal phase begins, and the corpus luteum produces progesterone.
• If pregnancy does not occur, hormone levels fall, and the cycle begins again.

Estrogens (Estradiol, Estrone, Estriol)

• Estrogens are the primary female sex hormones.
• Estradiol (E2): The most potent and predominant estrogen in premenopausal women, produced by the ovaries.
• Estrone (E1): The primary estrogen after menopause, produced in peripheral tissues.
• Estriol (E3): The primary estrogen during pregnancy.
• Estrogens are responsible for the development of female secondary sexual characteristics and have effects on many organ systems, including bone, the cardiovascular system, and the brain.

Progestogens (Progesterone and Progestins)

• Progesterone: The main natural progestogen, produced by the corpus luteum. Its primary role is to prepare the uterus for pregnancy and to maintain pregnancy.
• Progestins: Synthetic versions of progesterone.
• Progestins are a key component of hormonal contraceptives and menopausal hormone therapy.
• Different progestins have different properties and side effect profiles (e.g., androgenic activity).
• A CWHP must be an expert on the differences between progestins.

Androgens in Females

• Androgens like testosterone and DHEA are also produced in women by the ovaries and the adrenal glands.
• They are important for libido, energy, and bone and muscle mass.
• Excess androgen production can lead to conditions like Polycystic Ovary Syndrome (PCOS), causing symptoms like hirsutism and acne.
• The role of testosterone therapy in women is a controversial and evolving area of practice.

The Comprehensive Medication History

• The assessment begins with a Best Possible Medication History (BPMH).
• This includes all prescription, OTC, and herbal/supplemental medications.
• It is crucial to ask about all forms of contraception and hormone therapy.
• The history should include questions about adherence and any side effects.
• This is the foundation for identifying medication-related problems.

The Reproductive and Sexual Health History

• Taking a reproductive and sexual health history requires sensitivity and a non-judgmental approach.
• Key components include menstrual history (age at menarche, cycle length, regularity).
• It also includes obstetric history (number of pregnancies and their outcomes).
• The "5 P's" is a useful framework for a sexual health history: Partners, Practices, Protection from STIs, Past history of STIs, and Prevention of pregnancy.
• This information is essential for contraceptive counseling and STI prevention.

Screening for Common Conditions

• A CWHP should be skilled at screening for common health conditions in women.
• This includes screening for cardiovascular risk factors like hypertension and dyslipidemia.
• It includes screening for mental health conditions like depression and anxiety, which are more prevalent in women.
• Screening for intimate partner violence should also be done in a safe and confidential manner.
• The use of validated screening tools (e.g., PHQ-9) is a best practice.

Preventive Health Screenings

• A CWHP must be an expert on the current preventive health guidelines for women.
• Cervical Cancer: Pap tests and/or HPV testing.
• Breast Cancer: Mammograms.
• Osteoporosis: Bone mineral density (BMD) testing.
• STIs: Screening for chlamydia, gonorrhea, and HIV in at-risk populations.
• The pharmacist plays a key role in educating patients about these screenings and providing referrals.

Cultural Competency and Health Literacy

• A CWHP must provide care that is respectful of a diverse patient population.
• This requires being aware of how cultural beliefs can influence health decisions.
• It is also essential to assess and adapt to the patient's level of health literacy.
• All communication should be in plain, simple language.
• The "teach-back" method should be used to confirm understanding.
• This patient-centered approach is key to building trust and improving outcomes.

Mechanisms of Hormonal Contraception

• Hormonal contraceptives primarily work by suppressing ovulation.
• They do this by providing negative feedback to the HPG axis, which suppresses the release of FSH and LH.
• Secondary mechanisms include thickening of the cervical mucus, which makes it harder for sperm to penetrate.
• They also cause thinning of the endometrium, which makes it less suitable for implantation.
• A CWHP must be able to explain these mechanisms to patients.

Contraceptive Effectiveness

• It is crucial to understand the difference between "perfect use" and "typical use" effectiveness.
• Perfect Use: The effectiveness when the method is used exactly as directed.
• Typical Use: The effectiveness in the real world, which accounts for human error (e.g., missed pills).
• The gap between perfect and typical use is largest for user-dependent methods like the pill, patch, and ring.
• Long-acting reversible contraceptives (LARCs) have typical use effectiveness rates that are nearly identical to their perfect use rates.

The U.S. Medical Eligibility Criteria (MEC)

• The CDC's MEC is the evidence-based guideline for contraceptive safety.
• It is the most important tool for patient assessment.
• It categorizes medical conditions based on the level of risk for each contraceptive method.
• Category 1: No restriction.
• Category 2: Advantages generally outweigh the risks.
• Category 3: Risks generally outweigh the advantages.
• Category 4: Unacceptable health risk (contraindication).
• A CWHP must be an expert at using the MEC to screen patients for contraindications.

The Patient-Centered Counseling Process

• The choice of a contraceptive method is a highly personal one.
• The best method is the one that the patient will use correctly and consistently.
• The counseling process should be patient-centered and based on shared decision-making.
• It starts with understanding the patient's goals, preferences, and lifestyle.
• The pharmacist then provides information on all of the available options that are medically appropriate for that patient.
• This allows the patient to make an informed choice.

Non-Contraceptive Benefits

• Hormonal contraceptives have many important non-contraceptive benefits.
• They can make periods lighter, more regular, and less painful.
• They are an effective treatment for conditions like PMS/PMDD and endometriosis.
• They can improve acne and hirsutism.
• Long-term use of combined hormonal contraceptives significantly reduces the risk of ovarian and endometrial cancer.
• These benefits should be a key part of the counseling conversation.

Formulations

• CHCs contain both an estrogen (usually ethinyl estradiol) and a progestin.
• Oral Contraceptives (COCs): The most common form. Available as monophasic, biphasic, or triphasic pills.
• Transdermal Patch: Applied weekly.
• Vaginal Ring: Inserted monthly.
• The patch and ring provide more stable hormone levels than the pill and bypass first-pass metabolism.
• This may be associated with a lower risk of certain side effects.
• A CWHP must be an expert on the different delivery systems.

The Role of the Progestin

• There are multiple generations of progestins used in CHCs.
• The specific progestin determines the side effect profile of the pill.
• Older progestins (e.g., levonorgestrel) have more androgenic activity (can worsen acne).
• Newer progestins (e.g., drospirenone) are anti-androgenic, which can be helpful for acne.
• Drospirenone also has anti-mineralocorticoid activity and carries a slightly higher risk of VTE.
• A CWHP uses their knowledge of these differences to help select the best product for a patient.

Initiation and Dosing Regimens

• A "Quick Start" method (starting the day of the appointment) is now preferred over the traditional Sunday start.
• Traditional regimens involve 21 days of active pills followed by a 7-day placebo week, which induces a withdrawal bleed.
• Extended-cycle regimens (e.g., 84 days of active pills) reduce the number of withdrawal bleeds to four times a year.
• Continuous-use regimens eliminate the placebo pills altogether, stopping withdrawal bleeds entirely.
• A CWHP can counsel patients on these different regimen options.

Contraindications and The MEC

• The CDC MEC is the key tool for assessing safety.
• Absolute contraindications to CHCs (Category 4) include a history of VTE, stroke, or heart attack.
• They are also contraindicated in women over 35 who smoke, those with uncontrolled hypertension, and those with certain types of migraine headaches (migraine with aura).
• A personal history of breast cancer is also an absolute contraindication.
• A CWHP must be an expert at using the MEC to screen patients for contraindications.

Managing Side Effects

• Common side effects include nausea, breast tenderness, and breakthrough bleeding.
• These often improve after the first three months.
• The side effect profile can be managed by switching to a pill with a different progestin or a different estrogen dose.
• For example, if a patient is experiencing androgenic side effects like acne, switching to a pill with a less androgenic progestin can help.
• If a patient has persistent breakthrough bleeding, a pill with a higher estrogen dose may be needed.
• A CWHP is skilled at troubleshooting and managing these common side effects.

Progestin-Only Pills (POPs)

• POPs (or "minipills") contain only a progestin and no estrogen.
• They are a key option for women who have contraindications to estrogen (e.g., smokers over 35, history of VTE).
• They are also a safe option for postpartum and breastfeeding women.
• Their primary mechanism is thickening of the cervical mucus.
• They must be taken at the same time every day to be effective; there is only a 3-hour window for the traditional POP.
• A newer POP containing drospirenone has a 24-hour missed pill window.
• The main side effect is irregular bleeding.

Injectable Contraception (DMPA)

• Depot medroxyprogesterone acetate (DMPA or "the shot") is a progestin-only injection given every 3 months.
• It is a highly effective contraceptive because it reliably suppresses ovulation.
• A key side effect is irregular bleeding, which often improves over time, with many women becoming amenorrheic after one year.
• There is a Black Box Warning about a potential loss of bone mineral density with long-term use. This is generally reversible after stopping.
• There can be a delayed return to fertility after stopping the injection.

Contraceptive Implant

• The etonogestrel implant (Nexplanon) is a type of Long-Acting Reversible Contraceptive (LARC).
• It is a small, flexible rod inserted under the skin of the upper arm.
• It releases a progestin and is effective for 3 years.
• It is one of the most effective forms of contraception available ("forgettable contraception").
• The main reason for discontinuation is irregular bleeding patterns.
• A CWHP should be able to provide detailed counseling on this highly effective method.

Hormonal Intrauterine Devices (IUDs)

• Hormonal IUDs (e.g., Mirena, Kyleena) are another type of LARC.
• They are T-shaped devices inserted into the uterus that release a small amount of levonorgestrel.
• They are effective for 5-8 years, depending on the device.
• They primarily work locally by thickening cervical mucus and thinning the endometrium.
• They are highly effective and often lead to much lighter periods or no periods at all, making them a good option for women with heavy menstrual bleeding.
• The copper IUD is a non-hormonal LARC that is effective for 10 years.

The Importance of LARCs

• LARCs (implants and IUDs) are considered first-line contraceptive options for most women by major medical organizations.
• This is because their effectiveness is not dependent on user adherence.
• They have "perfect use" and "typical use" effectiveness rates that are nearly identical and greater than 99%.
• They are highly effective, safe, and cost-effective over the long term.
• A CWHP should be a strong advocate for increasing access to and education about LARCs.
• They are a key strategy for reducing unintended pregnancies.

Indications for Use

• EC is used to prevent pregnancy after unprotected or inadequately protected sexual intercourse.
• This includes instances of condom breakage, missed oral contraceptive pills, or sexual assault.
• It is a backup method, not a regular form of contraception.
• A CWHP must be able to provide non-judgmental counseling and access to EC.
• It is important to provide information about ongoing, more effective contraceptive methods at the same time.

Mechanism of Action

• The primary mechanism of action for all forms of EC is to inhibit or delay ovulation.
• They work by preventing the LH surge that triggers the release of an egg.
• They are not effective if ovulation has already occurred.
• It is critical to understand that EC is not an abortifacient; it does not interrupt an established pregnancy.
• A CWHP must be able to clearly explain this mechanism to patients.

Oral Levonorgestrel (Plan B)

• This is the most common form of EC, available over-the-counter without age restriction.
• It is a single, high-dose progestin pill (1.5 mg of levonorgestrel).
• It is most effective when taken as soon as possible after unprotected intercourse, but can be used up to 72 hours (3 days).
• Its effectiveness decreases with time and may be reduced in women with a higher BMI.
• The main side effect is nausea.

Ulipristal Acetate (ella)

• Ulipristal is a selective progesterone receptor modulator, available by prescription only.
• It is more effective than levonorgestrel, especially closer to the time of ovulation.
• It can be used up to 120 hours (5 days) after unprotected intercourse.
• Its effectiveness is also less affected by a higher BMI compared to levonorgestrel.
• A patient should not use a progestin-containing contraceptive for 5 days after taking ulipristal, as it can reduce its effectiveness.

Copper IUD

• The copper IUD is the most effective form of emergency contraception (>99% effective).
• It can be inserted up to 5 days after unprotected intercourse.
• Its primary mechanism is to prevent fertilization by creating an inflammatory reaction that is toxic to sperm.
• A major advantage is that it can then be left in place to provide highly effective, long-term contraception for up to 10 years.
• A CWHP should always include the copper IUD as an option when counseling on EC.

Dysmenorrhea

• Dysmenorrhea is the medical term for painful menstruation.
• Primary Dysmenorrhea: Caused by an excess of prostaglandins, which cause uterine contractions.
• Secondary Dysmenorrhea: Caused by an underlying medical condition, such as endometriosis or fibroids.
• First-line treatment for primary dysmenorrhea is NSAIDs, which block prostaglandin production.
• Combined hormonal contraceptives are also highly effective, as they prevent ovulation and thin the endometrium.

Abnormal Uterine Bleeding (AUB)

• AUB is a broad term for bleeding that is abnormal in its regularity, volume, frequency, or duration.
• The causes are categorized by the PALM-COEIN acronym.
• PALM (Structural): Polyp, Adenomyosis, Leiomyoma (fibroid), Malignancy.
• COEIN (Non-structural): Coagulopathy, Ovulatory dysfunction, Endometrial, Iatrogenic, Not yet classified.
• Hormonal therapies, such as CHCs and the levonorgestrel IUD, are often used to manage AUB caused by ovulatory dysfunction.

Heavy Menstrual Bleeding (HMB)

• HMB is a subtype of AUB characterized by excessive menstrual blood loss.
• It can lead to anemia and a significant reduction in quality of life.
• First-line treatment is often the levonorgestrel-releasing IUD, which is highly effective at reducing blood loss.
• Combined hormonal contraceptives are another effective option.
• Tranexamic acid, an antifibrinolytic agent, can be taken just during the period to reduce bleeding.

Premenstrual Syndrome (PMS) and PMDD

• PMS is a collection of physical and emotional symptoms that occur in the luteal phase of the menstrual cycle and resolve with the onset of menses.
• Premenstrual Dysphoric Disorder (PMDD) is a severe form of PMS with symptoms that cause significant functional impairment.
• First-line treatment for PMDD is an SSRI antidepressant. This can be taken continuously or just during the luteal phase.
• Combined hormonal contraceptives that suppress ovulation, especially those containing drospirenone, are also effective.

Amenorrhea

• Amenorrhea is the absence of menstruation.
• Primary Amenorrhea: The failure of menses to occur by age 15.
• Secondary Amenorrhea: The cessation of menses for 3 or more months after they have begun.
• The most common cause of secondary amenorrhea is pregnancy, which must always be ruled out first.
• Other causes include hypothalamic dysfunction (e.g., from excessive exercise or low body weight), PCOS, and premature ovarian failure.
• The treatment is directed at the underlying cause.

Pathophysiology

• PCOS is the most common endocrine disorder in reproductive-age women.
• It is a complex condition characterized by insulin resistance, elevated androgen levels, and ovulatory dysfunction.
• Insulin resistance leads to high levels of insulin, which stimulates the ovaries to produce more androgens.
• The high androgen levels interfere with normal follicle development, leading to irregular or absent ovulation.
• It is a major cause of infertility.

Diagnosis (Rotterdam Criteria)

• The diagnosis of PCOS is made using the Rotterdam criteria.
• A diagnosis requires the presence of at least two of the following three features:
• 1. Oligo- or anovulation (irregular or absent ovulation), which presents as irregular menstrual cycles.
• 2. Clinical and/or biochemical signs of hyperandrogenism (high androgen levels).
• 3. Polycystic ovaries on ultrasound.
• Other conditions that can mimic PCOS must be ruled out.

Clinical Features

• Menstrual Irregularity: The most common feature.
• Hyperandrogenism: Can manifest as hirsutism (excess male-pattern hair growth), acne, and androgenic alopecia.
• Metabolic Syndrome: PCOS is strongly associated with obesity, insulin resistance, and dyslipidemia.
• Patients with PCOS are at a significantly increased risk for type 2 diabetes and cardiovascular disease.

Non-Pharmacologic Management

• Lifestyle modification is the cornerstone of PCOS management.
• Weight loss, even a modest 5-10%, can restore ovulation and improve metabolic parameters.
• A healthy diet and regular exercise are essential.
• This is the most important first-line intervention.
• A CWHP plays a key role in counseling and motivating patients to make these lifestyle changes.

Pharmacotherapy

• The choice of medication depends on the patient's primary goal.
• For Menstrual Regulation and Hirsutism: Combined hormonal contraceptives are the first-line treatment. They regulate the cycle, suppress ovarian androgen production, and increase SHBG.
• For Insulin Resistance: Metformin is often used, especially in patients with diabetes or prediabetes.
• For Infertility: Ovulation induction agents, such as letrozole or clomiphene, are used to stimulate ovulation.
• A CWHP must be an expert in tailoring the pharmacotherapy to the individual patient's needs.

Pathophysiology of Endometriosis

• Endometriosis is a chronic, estrogen-dependent inflammatory disease.
• It is defined by the presence of endometrial-like tissue outside of the uterine cavity.
• These implants are most commonly found in the pelvic cavity.
• The tissue responds to hormonal changes of the menstrual cycle, leading to inflammation, pain, and scarring.
• It is a major cause of chronic pelvic pain and infertility.
• A CWHP must understand the hormonal basis of this condition.

Clinical Presentation

• The classic symptom is cyclical pelvic pain that is worse during menstruation (dysmenorrhea).
• Other symptoms include painful intercourse (dyspareunia) and chronic non-cyclical pelvic pain.
• Infertility is also a common presenting complaint.
• The severity of symptoms does not always correlate with the extent of the disease.
• A definitive diagnosis requires a surgical laparoscopy.

First-Line Pharmacotherapy

• The goal of pharmacotherapy is to suppress the growth of the endometrial implants and to manage pain.
• First-line treatment is typically a combined hormonal contraceptive (CHC).
• Using a CHC in a continuous or extended-cycle fashion is often preferred to suppress menstruation.
• Progestin-only therapies (e.g., norethindrone acetate, DMPA, levonorgestrel IUD) are also highly effective first-line options.
• These agents induce atrophy of the endometrial tissue.

Second-Line and Advanced Therapies

• If first-line therapies fail, more advanced options are used.
• GnRH Agonists (e.g., leuprolide): These drugs suppress the HPG axis and induce a temporary, reversible "medical menopause."
• They are very effective but cause significant menopausal side effects. "Add-back" therapy with low-dose estrogen/progestin is used to manage these side effects.
• GnRH Antagonists (e.g., elagolix): A newer class of oral medications that also suppress the HPG axis.
• A CWHP must be an expert in the complex management of these agents.

Adenomyosis

• Adenomyosis is a related condition where endometrial tissue exists within the muscular wall of the uterus (the myometrium).
• It typically causes heavy menstrual bleeding and painful periods.
• It is often considered a "cousin" of endometriosis.
• The hormonal treatments are similar to those for endometriosis.
• The levonorgestrel-releasing IUD is a particularly effective treatment.
• The definitive treatment is a hysterectomy.

Causes of Female Infertility

• Infertility is defined as the inability to conceive after one year of regular, unprotected intercourse.
• Female factor is a contributing cause in about half of all cases.
• The most common causes of female infertility are ovulatory disorders (e.g., PCOS).
• Other causes include tubal disease (e.g., from prior PID), endometriosis, and uterine abnormalities.
• Age is the single most important factor affecting female fertility, as egg quality declines with age.

Initial Assessment

• The initial workup for infertility is a couple's issue.
• It includes a semen analysis for the male partner.
• For the female partner, the initial assessment is focused on confirming ovulation.
• This can be done with basal body temperature charting, ovulation predictor kits (which measure the LH surge), or a mid-luteal phase progesterone level.
• The anatomy of the uterus and fallopian tubes is also assessed.

Ovulation Induction Agents

• For women with anovulatory infertility (like in PCOS), the goal is to induce ovulation.
• Clomiphene Citrate: An oral SERM that blocks estrogen's negative feedback, increasing FSH and LH release.
• Letrozole: An oral aromatase inhibitor that also increases FSH release. It is now considered first-line for PCOS-related infertility.
• Injectable Gonadotropins (FSH/LH): Used for women who do not respond to oral agents. This requires intensive monitoring due to the risk of multiple births and ovarian hyperstimulation syndrome (OHSS).
• A CWHP must be an expert in these medications.

Assisted Reproductive Technology (ART)

• ART refers to procedures that involve handling both eggs and sperm.
• Intrauterine Insemination (IUI): Prepared sperm is placed directly into the uterus at the time of ovulation.
• In Vitro Fertilization (IVF): The most common form of ART. Ovarian stimulation is used to produce multiple eggs, which are then retrieved and fertilized with sperm in a lab. The resulting embryos are then transferred back into the uterus.
• A CWHP is often part of the team that manages the complex medication protocols for IVF.

Medications Used in IVF

• IVF involves a complex, multi-drug protocol.
• Ovarian Stimulation: High doses of injectable gonadotropins (FSH) are used to stimulate the growth of multiple follicles.
• Ovulation Prevention: A GnRH agonist or antagonist is used to prevent a premature LH surge.
• Triggering Ovulation: An injection of hCG is used to trigger the final maturation of the eggs before retrieval.
• Luteal Phase Support: Progesterone supplementation is given to support the uterine lining.
• A CWHP must be an expert in the use and administration of these specialty medications.

The Importance of Preconception Care

• Preconception care is the healthcare a woman receives before she becomes pregnant.
• The goal is to identify and modify any risks to a woman's health or pregnancy outcome.
• This is a critical time for intervention, as many pregnancies are unplanned, and the most critical period of fetal development occurs in the first few weeks.
• The pharmacist plays a key role in preconception care.

Folic Acid Supplementation

• This is the most important component of preconception care.
• All women of childbearing potential should take a daily supplement containing 400-800 mcg of folic acid.
• This supplementation significantly reduces the risk of neural tube defects (like spina bifida).
• The neural tube closes very early in pregnancy, often before a woman knows she is pregnant.
• Women at high risk (e.g., those on certain anti-seizure medications) require a higher dose (4 mg/day).
• A CWHP must be a strong advocate for this public health measure.

Preconception Medication Review

• A key role for the pharmacist is to conduct a preconception medication review.
• This involves assessing all of a woman's medications for their potential risks during pregnancy.
• Any medications that are known teratogens should be identified.
• The pharmacist then works with the prescriber to switch the patient to a safer alternative before she tries to conceive.
• This proactive management is much safer than making changes after a pregnancy has already occurred.

Prenatal Vitamins

• Once a woman is pregnant, she should switch from a folic acid supplement to a full prenatal vitamin.
• Prenatal vitamins contain a range of vitamins and minerals needed to support a healthy pregnancy.
• In addition to folic acid, a key ingredient is iron, which is needed to prevent anemia.
• Calcium and Vitamin D are also important for the baby's bone development.
• A CWHP can help patients select an appropriate prenatal vitamin.

Lifestyle Modifications

• Preconception care is also a crucial time to counsel on lifestyle modifications.
• This includes achieving a healthy weight before pregnancy.
• It involves counseling on smoking cessation and the avoidance of alcohol and illicit drugs.
• It is also important to ensure that all of the woman's immunizations are up-to-date.
• A CWHP provides this important counseling as part of a comprehensive preconception plan.

Principles of Teratology

• A teratogen is an agent that can cause a birth defect.
• The risk of a drug causing a birth defect depends on several factors.
• Timing of Exposure: The first trimester, especially weeks 3-8, is the period of organogenesis and the time of greatest risk for major malformations.
• Dose of the Drug: Most drugs have a threshold dose below which the risk is negligible.
• Genetic Susceptibility: The genetic makeup of the mother and fetus can influence the risk.
• A CWHP must understand these basic principles.

The Old FDA Pregnancy Categories (A, B, C, D, X)

• For decades, the FDA used a letter-based system to categorize the risk of drugs in pregnancy.
• This system was overly simplistic and often misinterpreted.
• For example, there was often little difference in the actual risk between a Category B and a Category C drug.
• The Category X was often interpreted as an absolute contraindication, even when the risk was not applicable to a pregnant woman.
• This system was phased out starting in 2015.
• A CWHP must know that this system is obsolete.

The New Pregnancy and Lactation Labeling Rule (PLLR)

• The PLLR, or "Final Rule," replaced the old letter categories.
• It requires the drug label (package insert) to have a new, detailed section on "Pregnancy, Lactation, and Females and Males of Reproductive Potential."
• The Pregnancy subsection includes a risk summary based on both human and animal data.
• It also includes clinical considerations and data.
• The new format provides a narrative summary of the available evidence, rather than a simplistic letter grade.
• This is intended to help clinicians and patients make a more informed, individualized benefit-risk decision.

Key Teratogenic Drugs

• A CWHP must have a working knowledge of the most well-known teratogens.
• ACE Inhibitors/ARBs: Cause fetal renal damage.
• Warfarin: Causes fetal bone abnormalities.
• Valproic Acid and other Antiepileptics: Increase the risk of neural tube defects.
• Isotretinoin: A potent teratogen that causes severe, multi-organ birth defects. Subject to a strict REMS program (iPLEDGE).
• Methotrexate: A folic acid antagonist that can cause a range of malformations.

Resources for Information

• There are several key resources for obtaining evidence-based information on medication use in pregnancy.
• Briggs' Drugs in Pregnancy and Lactation: A comprehensive reference textbook.
• MotherToBaby / OTIS: Provides evidence-based information to patients and providers and conducts observational studies.
• Reprotox: A subscription-based database.
• The drug's package insert, with the new PLLR format, is also a key resource.
• A CWHP must be skilled at using these resources to answer complex questions.

Principles of Drug Transfer into Breast Milk

• Most drugs transfer into breast milk to some extent.
• However, the amount is usually very small.
• Factors that favor drug transfer include: low molecular weight, low protein binding, and high lipid solubility.
• The amount of drug the infant receives is described by the Relative Infant Dose (RID).
• An RID of less than 10% is generally considered safe.
• A CWHP must understand these pharmacokinetic principles.

The PLLR Lactation Subsection

• The new FDA labeling rule also includes a detailed section on Lactation.
• This section provides a risk summary, including what is known about the presence of the drug in human milk.
• It also discusses the potential effects on the breastfed infant.
• It includes clinical considerations, such as ways to minimize infant exposure.
• This narrative format provides a much more useful summary of the data than the old system.

Assessing Risk to the Infant

• The majority of medications are safe to take while breastfeeding.
• The decision is a benefit-risk assessment that considers the importance of the medication to the mother's health and the potential risk to the infant.
• The risk is highest for premature infants and newborns, as their ability to metabolize and clear drugs is immature.
• Drugs that are known to be unsafe include chemotherapy agents, lithium, and some illicit drugs.
• Opioids should be used with extreme caution due to the risk of sedation and respiratory depression in the infant.

Minimizing Infant Exposure

• There are several strategies to minimize infant exposure to a medication.
• Choose drugs with a short half-life and low protein binding.
• Advise the mother to take the medication immediately after breastfeeding.
• This allows for the maximum amount of time for the drug level to decrease before the next feeding.
• For some drugs, it may be possible to "pump and dump" for one half-life after a dose.
• A CWHP can provide this practical counseling.

Key Resources (Hale's)

• There are several key resources for information on medications in lactation.
• Hale's Medications & Mothers' Milk: The definitive reference textbook in this field.
• It provides detailed information and a Lactation Risk Category for thousands of drugs.
• LactMed: A free online database from the National Institutes of Health.
• Briggs' Drugs in Pregnancy and Lactation.
• A CWHP must be an expert at using these resources to provide evidence-based recommendations.

Nausea and Vomiting of Pregnancy (NVP)

• NVP, or "morning sickness," is very common in the first trimester.
• First-line treatment involves dietary changes and ginger.
• The first-line pharmacotherapy is a combination of pyridoxine (Vitamin B6) and doxylamine.
• A prescription combination product is available, but the components can also be purchased OTC.
• For more severe cases, other antiemetics like metoclopramide or ondansetron may be used.
• Hyperemesis gravidarum is a severe form of NVP that can require hospitalization.

Gestational Diabetes Mellitus (GDM)

• GDM is diabetes that is first diagnosed during pregnancy.
• It is caused by hormonal changes that lead to insulin resistance.
• All pregnant women are screened for GDM between 24 and 28 weeks of gestation.
• The cornerstone of management is medical nutrition therapy (MNT) and regular exercise.
• If blood glucose targets are not met with lifestyle changes, medication is needed.
• Insulin is the traditional first-line medication, as it does not cross the placenta.
• Metformin and glyburide are sometimes used, but there is more long-term safety data with insulin.

Hypertensive Disorders of Pregnancy

• This includes chronic hypertension, gestational hypertension, and preeclampsia.
• Preeclampsia is a serious condition characterized by new-onset hypertension and proteinuria after 20 weeks.
• First-line medications for hypertension in pregnancy include labetalol, nifedipine, and methyldopa.
• ACE inhibitors and ARBs are contraindicated due to the risk of fetal harm.
• Low-dose aspirin is recommended for the prevention of preeclampsia in high-risk women.

Infections (UTIs, GBS)

• Asymptomatic bacteriuria must be treated in pregnancy to prevent the progression to pyelonephritis.
• Commonly used antibiotics include penicillins and cephalosporins.
• Tetracyclines and fluoroquinolones should be avoided.
• All pregnant women are screened for Group B Streptococcus (GBS) at 36-37 weeks.
• If positive, they receive IV antibiotics during labor to prevent transmission to the newborn.
• Penicillin is the drug of choice.

Thromboembolism

• Pregnancy is a hypercoagulable state, which increases the risk of VTE.
• For the treatment of VTE in pregnancy, low-molecular-weight heparin (LMWH) is the drug of choice.
• It does not cross the placenta and is safe for the fetus.
• Warfarin is a teratogen and is contraindicated.
• The use of DOACs is not recommended due to a lack of safety data.
• A CWHP must be an expert on the management of these common conditions.

Definitions

• Menopause: The final menstrual period, confirmed after 12 consecutive months of amenorrhea. The average age in the U.S. is 51.
• Perimenopause: The transitional period before menopause, characterized by hormonal fluctuations and irregular cycles. Can last for several years.
• Postmenopause: The years following the final menstrual period.
• Premature Menopause: Menopause that occurs before age 40.
• A CWHP must be an expert in the terminology and staging of menopause.

Pathophysiology

• Menopause is caused by the natural depletion of ovarian follicles with age.
• As the number of follicles declines, the ovaries become less responsive to FSH and LH.
• This leads to a dramatic decrease in the production of estrogen and progesterone.
• The loss of negative feedback from estrogen causes the pituitary to release much higher levels of FSH.
• This hormonal shift is the underlying cause of all the symptoms of menopause.

Vasomotor Symptoms (VMS)

• VMS, also known as hot flashes and night sweats, are the hallmark symptom of menopause.
• They are caused by the effect of estrogen withdrawal on the thermoregulatory center in the hypothalamus.
• They can range from mild to severe and can have a major impact on quality of life and sleep.
• The presence of moderate to severe VMS is the primary indication for menopausal hormone therapy.
• A CWHP must be skilled at assessing the severity and impact of VMS.

Genitourinary Syndrome of Menopause (GSM)

• GSM is a collection of symptoms associated with the decline in estrogen in the vulvovaginal tissues.
• Symptoms include vaginal dryness, burning, and irritation.
• It can also lead to painful intercourse (dyspareunia) and an increased risk of urinary tract infections.
• Unlike VMS, which usually improves over time, GSM is a chronic and progressive condition.
• It is another major indication for hormone therapy, particularly low-dose local vaginal estrogen.

Diagnosis

• In a healthy woman over age 45, the diagnosis of perimenopause or menopause is made based on symptoms and menstrual cycle changes.
• Routine measurement of hormone levels (like FSH) is not necessary or recommended to diagnose menopause in this age group.
• However, an FSH level may be useful in younger women (<45) with suspected premature menopause.
• The primary role of the clinician is to rule out other medical causes for the symptoms.
• A CWHP understands that menopause is a clinical diagnosis.

Indications for MHT

• The primary indication for systemic MHT is the treatment of moderate to severe vasomotor symptoms (VMS).
• Another key indication is the treatment of moderate to severe symptoms of vulvar and vaginal atrophy (Genitourinary Syndrome of Menopause - GSM).
• MHT is also approved for the prevention of postmenopausal osteoporosis.
• However, it is generally not recommended as a first-line therapy for osteoporosis alone due to the risks.
• The decision to use MHT should be individualized based on the patient's symptoms and benefit-risk profile.

The Women's Health Initiative (WHI) and the "Timing Hypothesis"

• The WHI trial found that MHT was associated with an increased risk of stroke, VTE, and breast cancer in older women.
• This led to a dramatic decrease in its use.
• Subsequent analyses have led to the "timing hypothesis," which suggests that the risks are lower and the benefits may be greater for women who start MHT within 10 years of menopause or before age 60.
• A CWHP must be an expert on the nuances of the WHI data.

Estrogen Formulations

• Oral Estrogens: The most studied, but associated with a higher risk of VTE.
• Transdermal Estrogens (Patches, Gels): Avoid the first-pass effect in the liver and are not associated with an increased risk of VTE. They are the preferred route for most women.
• Vaginal Estrogens: Low-dose products for the local treatment of GSM with minimal systemic absorption.
• A CWHP is an expert on the pros and cons of each formulation.

The Role and Types of Progestogens

• In a woman with an intact uterus, a progestogen must always be added to systemic estrogen to protect the endometrium from cancer.
• Micronized Progesterone: A bioidentical option that may have a better safety profile than synthetic progestins.
• Medroxyprogesterone Acetate (MPA): The synthetic progestin used in the WHI.
• Levonorgestrel-releasing IUD: An effective off-label option for endometrial protection.

Contraindications and Risk Assessment

• Absolute contraindications to MHT include a history of breast cancer, coronary heart disease, a previous VTE or stroke, and unexplained vaginal bleeding.
• Before starting MHT, a thorough benefit-risk assessment must be conducted.
• This includes an assessment of the patient's cardiovascular and breast cancer risk.
• The principle is to use the lowest effective dose for the shortest duration necessary, but the duration should be individualized.

SSRIs and SNRIs

• Low-dose selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) are the most effective non-hormonal treatments for vasomotor symptoms.
• Paroxetine salt (Brisdelle) is the only non-hormonal drug that is FDA-approved for this indication.
• However, other agents like venlafaxine, citalopram, and escitalopram are commonly used off-label.
• They are a good option for women who cannot or do not want to take MHT.

Gabapentinoids

• Gabapentin and pregabalin have also been shown to be effective for treating vasomotor symptoms.
• They are particularly useful for women who have troublesome night sweats, as they can be dosed at bedtime.
• The main side effects are dizziness and somnolence.
• The dose should be started low and titrated up slowly.

Clonidine

• Clonidine is an older antihypertensive agent that has a modest effect on hot flashes.
• It is not as effective as SSRIs or gabapentin.
• Its use is limited by side effects like dry mouth and sedation.
• A transdermal patch formulation is available.

Therapies for GSM

• For women who only have genitourinary symptoms, non-hormonal options are the first line.
• This includes regular use of vaginal moisturizers and lubricants.
• Ospemifene is an oral SERM that is FDA-approved for the treatment of dyspareunia due to GSM.
• Prasterone is a vaginal DHEA insert that is also FDA-approved for this indication.
• A CWHP can help patients navigate these different options.

Lifestyle and Complementary Therapies

• Lifestyle modifications can help to manage VMS.
• This includes dressing in layers, avoiding triggers like spicy food and alcohol, and maintaining a healthy weight.
• Some evidence suggests that cognitive behavioral therapy and clinical hypnosis can be effective.
• The evidence for most herbal supplements, such as black cohosh and soy isoflavones, is weak and inconsistent.
• A CWHP must be able to provide evidence-based counseling on these complementary approaches.

Pathophysiology and Risk Factors

• Osteoporosis is a skeletal disorder characterized by low bone mass and microarchitectural deterioration, leading to an increased risk of fracture.
• The rapid decline in estrogen at menopause is the primary cause of osteoporosis in women.
• Other risk factors include advanced age, low body weight, a history of a prior fracture, and long-term glucocorticoid use.
• A CWHP must be an expert at identifying women at high risk for osteoporosis.

Screening and Diagnosis

• Bone mineral density (BMD) testing with a DXA scan is the gold standard for diagnosis.
• Screening is recommended for all women age 65 and older, and for younger postmenopausal women with risk factors.
• A T-score of -2.5 or lower at the hip or spine indicates osteoporosis.
• The FRAX tool is used to calculate a patient's 10-year fracture risk, which helps to guide treatment decisions.

Non-Pharmacologic Management

• Lifestyle modifications are the foundation of osteoporosis management.
• Adequate intake of calcium (1200 mg/day) and vitamin D (800-1000 IU/day).
• Weight-bearing and muscle-strengthening exercise.
• Smoking cessation and moderation of alcohol intake.
• Fall prevention is also a critical component of the management plan.
• A CWHP provides counseling on all of these measures.

First-Line Pharmacotherapy (Bisphosphonates)

• Oral bisphosphonates (alendronate, risedronate) are the first-line treatment for most women.
• They work by inhibiting osteoclast activity, which reduces bone resorption.
• They have been shown to significantly reduce the risk of vertebral and hip fractures.
• A key counseling point is the complex administration requirements (e.g., must be taken with a full glass of water on an empty stomach, and the patient must remain upright for 30 minutes).
• IV bisphosphonates (zoledronic acid) are an option for women who cannot tolerate oral therapy.

Other Pharmacologic Agents

• Denosumab: A biologic agent (monoclonal antibody) that is a powerful inhibitor of bone resorption. Given as a subcutaneous injection every 6 months.
• Teriparatide: An anabolic agent (a recombinant form of parathyroid hormone) that stimulates new bone formation. Reserved for severe osteoporosis.
• Raloxifene: A SERM that is approved for the prevention and treatment of osteoporosis. It reduces the risk of vertebral fractures but not hip fractures.
• A CWHP must be an expert on the use of all of these agents.

Human Papillomavirus (HPV)

• HPV is the most common STI in the United States.
• Most infections are asymptomatic and clear on their own.
• However, persistent infection with high-risk HPV types is the cause of almost all cases of cervical cancer.
• It can also cause genital warts.
• The most important prevention strategy is the HPV vaccine.
• The vaccine is recommended for all adolescents and for adults up to age 26.
• A CWHP is a key advocate for and provider of the HPV vaccine.

Chlamydia and Gonorrhea

• These are the two most common bacterial STIs.
• They are often asymptomatic in women, which is why screening is so important.
• If left untreated, they can lead to Pelvic Inflammatory Disease (PID), a serious infection of the reproductive organs.
• PID can cause chronic pelvic pain and infertility.
• The CDC recommends annual screening for all sexually active women under 25.
• A CWHP must be up-to-date on the latest CDC treatment guidelines, which change due to antibiotic resistance.

Genital Herpes (HSV)

• Genital herpes is a chronic viral infection caused by Herpes Simplex Virus type 1 or 2.
• There is no cure for herpes.
• Antiviral medications (acyclovir, valacyclovir, famciclovir) can be used to treat outbreaks (episodic therapy).
• They can also be taken daily to suppress the virus and reduce the risk of transmission to a partner (suppressive therapy).
• Special considerations are needed during pregnancy to prevent transmission to the newborn.
• A CWHP is an expert in counseling patients on these different treatment strategies.

Trichomoniasis

• Trichomoniasis is a common STI caused by a protozoan parasite.
• It often causes a frothy, yellow-green vaginal discharge with a strong odor.
• However, many women are asymptomatic.
• The treatment of choice is a single, 2-gram oral dose of metronidazole or tinidazole.
• It is essential to treat the patient's sexual partner(s) as well to prevent reinfection.
• Expedited Partner Therapy (EPT), where a prescription is provided for the partner without an exam, is a key public health strategy.

HIV Pre-Exposure Prophylaxis (PrEP)

• PrEP is the use of antiretroviral drugs by HIV-negative individuals to prevent HIV infection.
• It is a highly effective prevention tool for women at high risk for HIV.
• The most common regimen is a once-daily oral pill containing tenofovir and emtricitabine.
• A long-acting injectable formulation is also now available.
• A CWHP is a key provider of PrEP services.
• This includes identifying candidates, providing education, and performing the necessary safety monitoring.

Bacterial Vaginosis (BV)

• BV is the most common cause of vaginal discharge in reproductive-age women.
• It is not an STI but is associated with sexual activity.
• It is caused by a disruption of the normal vaginal flora, leading to an overgrowth of anaerobic bacteria.
• The classic symptom is a thin, gray discharge with a "fishy" odor.
• The first-line treatment is oral or vaginal metronidazole, or vaginal clindamycin.

Vulvovaginal Candidiasis (VVC)

• VVC, or a "yeast infection," is another very common condition.
• It is caused by an overgrowth of Candida, usually Candida albicans.
• The classic symptoms are intense itching and a thick, white, "cottage cheese-like" discharge.
• Treatment for uncomplicated VVC includes a wide variety of OTC and prescription topical azole antifungals, or a single oral dose of fluconazole.
• Recurrent or complicated VVC requires a longer course of therapy.

Atrophic Vaginitis (Part of GSM)

• This condition is a component of the Genitourinary Syndrome of Menopause (GSM).
• It is caused by the decline in estrogen after menopause.
• This leads to thinning and inflammation of the vaginal tissues.
• Symptoms include vaginal dryness, itching, and painful intercourse.
• First-line treatment is non-hormonal moisturizers and lubricants.
• The most effective treatment is low-dose, local vaginal estrogen therapy (creams, tablets, or rings).

Contact Dermatitis

• The vulvar skin is very sensitive and can be irritated by a wide range of products.
• This can include soaps, detergents, douches, and scented pads or tampons.
• This can cause an irritant or allergic contact dermatitis, leading to itching and inflammation.
• A key part of the CWHP's role is to counsel patients on proper vulvar hygiene.
• This includes avoiding all irritating and scented products.
• A low-potency topical steroid may be used for a short time to treat the inflammation.

The Pharmacist's Role in Triage

• Many women self-treat vaginal symptoms with OTC products.
• Pharmacists are in a key position to help women determine if self-care is appropriate or if they need to see a clinician.
• This is known as triage.
• For example, a woman with her first yeast infection should be referred for a diagnosis.
• A woman with recurrent infections should also be referred.
• A CWHP is an expert at performing this triage and providing appropriate counseling.

Types of Urinary Incontinence

• UI is the involuntary leakage of urine. It is very common in women, especially after menopause.
• Stress UI (SUI): Leakage that occurs with effort or exertion (e.g., coughing, sneezing, laughing). Caused by weakness of the pelvic floor muscles.
• Urgency UI (UUI): Leakage that is accompanied by a sudden, intense urge to urinate. This is the main symptom of Overactive Bladder (OAB). Caused by involuntary contractions of the bladder muscle.
• Mixed UI: A combination of both stress and urgency symptoms.

Non-Pharmacologic Management

• Lifestyle modifications are the first-line treatment for all types of UI.
• For SUI: Pelvic floor muscle exercises (Kegel exercises) are the cornerstone of therapy.
• For UUI: Bladder training, which involves scheduled voiding and urge suppression techniques.
• Other general measures include weight loss, caffeine reduction, and fluid management.
• A CWHP should be able to provide counseling on all of these non-pharmacologic strategies.

Pharmacotherapy for Urgency UI / OAB

• The main drug classes for UUI work by relaxing the bladder muscle.
• Anticholinergics (e.g., oxybutynin, solifenacin): These are effective but have significant anticholinergic side effects, which are a major concern in older women. Extended-release and transdermal formulations have fewer side effects.
• Beta-3 Adrenergic Agonists (e.g., mirabegron): A newer class that is equally effective and does not have anticholinergic side effects. It can increase blood pressure.
• These are the two main classes of drugs used.

Other Treatments for UUI / OAB

• For refractory UUI, more advanced therapies are available.
• OnabotulinumtoxinA (Botox) injections: Injected directly into the bladder muscle to relax it.
• Peripheral Tibial Nerve Stimulation (PTNS): A form of "bladder acupuncture."
• Sacral Neuromodulation: An implantable device that stimulates the sacral nerves ("bladder pacemaker").
• A CWHP should be aware of these third-line options.

Pharmacotherapy for Stress UI

• There are no FDA-approved drugs for the treatment of SUI in the United States.
• Duloxetine, an SNRI, has been shown to have some efficacy but is used off-label due to side effects.
• Vaginal estrogen can help with symptoms in postmenopausal women if there is underlying atrophy.
• The mainstay of treatment for moderate to severe SUI is surgical (e.g., a mid-urethral sling).
• The CWHP's role is primarily to provide counseling on non-pharmacologic options and to identify medications that could be worsening the condition.

CVD as the Leading Cause of Death

• Cardiovascular disease is the number one killer of women in the United States.
• There is a common misperception that CVD is a "man's disease."
• A key role for a CWHP is to raise awareness and promote cardiovascular risk reduction.
• Women often have different symptoms of a heart attack than men (e.g., fatigue, nausea instead of classic chest pain).

The Role of Menopause

• Before menopause, women have a lower risk of CVD than men.
• After menopause, this protective effect is lost, and a woman's risk of CVD increases dramatically.
• This is due to the loss of estrogen's beneficial effects on cholesterol and blood vessels.
• The menopausal transition is a critical window for focusing on cardiovascular risk reduction.

Unique Risk Factors in Women

• In addition to the traditional risk factors, women have several unique, sex-specific risk factors.
• These include a history of adverse pregnancy outcomes, such as preeclampsia or gestational diabetes.
• Polycystic Ovary Syndrome (PCOS) is another major risk factor.
• Autoimmune diseases like lupus and rheumatoid arthritis, which are more common in women, also increase CVD risk.
• A CWHP must be aware of these unique risk factors when assessing a patient.

Hypertension and Dyslipidemia Management

• The management of hypertension and dyslipidemia is the cornerstone of primary prevention.
• The ACC/AHA guidelines for these conditions apply to both men and women.
• A key role for the CWHP is to ensure that women are being screened for and treated to goal for these conditions.
• There is evidence that women are less likely than men to receive guideline-directed therapy.
• The pharmacist can help to close this care gap.

The Pharmacist's Role in Prevention

• The CWHP is a leader in women's cardiovascular health.
• They use tools like the ASCVD risk calculator to assess a woman's risk.
• They provide counseling on lifestyle modifications.
• They are experts in the pharmacotherapy for risk reduction, including the special considerations during pregnancy.
• They play a critical role in improving medication adherence for these chronic, asymptomatic conditions.

Breast Cancer Screening

• Breast cancer is the most common cancer in women (besides skin cancer).
• Screening with mammography is the key to early detection.
• Guidelines on the exact age to start and the frequency of screening vary slightly between organizations.
• The USPSTF recommends biennial screening mammography for women aged 50 to 74 years.
• A CWHP should be able to counsel women on the importance of regular screening.

Hormone Receptor-Positive Breast Cancer

• The majority of breast cancers are hormone receptor-positive.
• This means their growth is fueled by estrogen.
• The mainstay of treatment for these cancers is endocrine therapy, which blocks the effects of estrogen.
• This therapy is given for 5-10 years after initial treatment to prevent recurrence.
• A CWHP must be an expert in the management of these hormonal therapies.

Selective Estrogen Receptor Modulators (SERMs)

• SERMs are drugs that have mixed estrogenic and anti-estrogenic effects in different tissues.
• Tamoxifen: The most well-known SERM. It blocks estrogen's effects in the breast tissue but acts like an estrogen in the bone and uterus. It is the standard endocrine therapy for premenopausal women.
• Raloxifene: Also approved for the prevention and treatment of osteoporosis.
• A key side effect of these drugs is an increased risk of VTE and hot flashes.

Aromatase Inhibitors (AIs)

• AIs (e.g., anastrozole, letrozole) are the standard endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer.
• They work by blocking the aromatase enzyme, which prevents the production of estrogen in peripheral tissues.
• They are more effective than tamoxifen in postmenopausal women.
• A major side effect is bone loss and an increased risk of fractures.
• They also cause significant musculoskeletal pain and vaginal dryness.
• A CWHP is key in managing these challenging side effects.

Gynecologic Cancers

• This includes cancers of the uterus (endometrial), ovaries, and cervix.
• Endometrial cancer is the most common gynecologic cancer. The primary risk factor is unopposed estrogen exposure.
• Ovarian cancer often presents at a late stage and has a poor prognosis.
• Cervical cancer is almost always caused by HPV and is largely preventable with the HPV vaccine.
• The CWHP's role in promoting the HPV vaccine is a key cancer prevention strategy.

Epidemiology

• Women are twice as likely as men to be diagnosed with depression and anxiety disorders.
• This is due to a complex interplay of biological, psychological, and social factors.
• Hormonal fluctuations throughout a woman's life play a significant role.
• A CWHP must be skilled at recognizing and managing these common conditions.

Premenstrual Dysphoric Disorder (PMDD)

• PMDD is a severe form of PMS with symptoms of depression, anxiety, and irritability that occur in the week before menstruation and resolve with the onset of the period.
• The symptoms must cause significant functional impairment.
• First-line treatment is an SSRI antidepressant. This can be taken continuously or just during the luteal phase.
• Combined hormonal contraceptives that suppress ovulation are also an effective treatment.

Perinatal and Postpartum Depression (PPD)

• Depression during pregnancy (perinatal) and after delivery (postpartum) is very common.
• All pregnant and postpartum women should be screened for depression.

Certified Pharmacy Operations Manager (CPOM)

1. Foundations of Pharmacy Operations Management

   • Core Management Principles: The foundational roles of a manager, including planning, organizing, leading, and controlling (POLC) within a pharmacy setting.
   • Pharmacy as a Business Unit: Understanding the pharmacy as a micro-business with revenues, expenses (COGS, labor), and the need for financial sustainability.
   • Key Performance Indicators (KPIs): Identifying and tracking critical metrics for success, such as prescription volume, inventory turnover, wait times, and patient satisfaction.
   • Strategic Planning: Developing a vision, mission, and strategic goals for the pharmacy department that align with the broader organization's objectives.
   • Healthcare Environment: Awareness of the external factors impacting pharmacy operations, including regulatory changes, market competition, and new technologies.

2. Financial Management

   • Budgeting and Forecasting: Creating and managing operational and capital budgets, including forecasting drug and labor expenses.
   • Profit and Loss (P&L) Analysis: Reading and interpreting financial statements to assess profitability and manage expenses.
   • Inventory Financials: Calculating and interpreting key inventory metrics like Inventory Turnover Rate and Gross Margin Return on Investment (GMROI).
   • Revenue Cycle Management: Overseeing the entire process from prescription intake to final payment, including billing, adjudication, and denial management.
   • Cost of Dispensing (COD): Calculating the total cost to dispense a prescription to inform contract negotiations and assess operational efficiency.

3. Inventory and Supply Chain Management

   • Procurement and Purchasing: Managing relationships with wholesalers and GPOs, and understanding different purchasing models (e.g., JIT, perpetual).
   • Inventory Control Systems: Implementing and managing systems to optimize inventory levels, minimize carrying costs, and prevent stock-outs (e.g., PAR levels, automated replenishment).
   • Drug Shortage Management: Developing and executing a strategy for managing drug shortages to ensure continuity of patient care.
   • Controlled Substance Management: Ensuring strict compliance with all DEA regulations for ordering, storing, dispensing, and record-keeping of controlled substances.
   • Reverse Logistics and Returns: Managing the process for returning expired or overstocked medications to the manufacturer or reverse distributor for credit.

4. Human Resources and Staff Management

   • Staffing and Scheduling: Developing data-driven staffing models and creating efficient schedules that match workload demands.
   • Recruitment and Onboarding: Leading the process of hiring qualified staff and ensuring a comprehensive onboarding and training program.
   • Performance Management: Setting clear expectations, providing regular coaching and feedback, and conducting formal performance reviews.
   • Employee Engagement and Retention: Creating a positive work culture that fosters engagement, professional development, and reduces staff turnover.
   • Labor Laws and Compliance: Ensuring adherence to all relevant labor laws, including FLSA (exempt/non-exempt status), FMLA, and EEO regulations.

5. Quality, Safety, and Regulatory Compliance

   • Quality Improvement (QI) Methodologies: Applying principles of QI, such as PDCA, Lean, and Six Sigma, to improve pharmacy processes.
   • Medication Safety Programs: Developing and overseeing programs to prevent medication errors, including managing high-alert medications and analyzing error data.
   • Regulatory and Accreditation Standards: Ensuring continuous compliance with standards from the Board of Pharmacy, DEA, The Joint Commission, and USP (e.g., <797>, <800>).
   • Policies and Procedures (P&Ps): Overseeing the development, review, and implementation of a comprehensive and up-to-date P&P manual.
   • Risk Management: Proactively identifying and mitigating operational, financial, and clinical risks within the pharmacy.

6. Technology and Automation

   • Pharmacy Information Systems (PIS): Managing and optimizing the core pharmacy computer system for efficiency and safety.
   • Automation and Robotics: Evaluating, implementing, and managing automated systems like dispensing robots, packagers, and IV compounders.
   • Data Analytics and Business Intelligence: Using data to make informed decisions about staffing, inventory, and clinical programs.
   • Telepharmacy and Remote Services: Understanding the operational and regulatory aspects of providing pharmacy services remotely.
   • System Integration: Ensuring seamless integration between the PIS, EHR, ADCs, and other clinical information systems.

Certified Pharmacy Billing & Reimbursement Specialist (CPBRS)

1. Foundations of Pharmacy Reimbursement

   • The Pharmacy Revenue Cycle: Understanding the complete lifecycle of a claim, from patient registration and insurance verification to payment posting and denial management.
   • Payer Landscape: Differentiating between major payer types, including commercial/private insurance, government payers (Medicare, Medicaid), and Pharmacy Benefit Managers (PBMs).
   • Key Terminology and Acronyms: Mastery of the essential language of billing, including terms like AWP, MAC, U&C, copay, deductible, and coinsurance.
   • The Adjudication Process: Understanding the real-time electronic processing of a pharmacy claim, including the roles of the switch vendor and PBM.
   • Coordination of Benefits (COB): Managing claims for patients with multiple insurance plans by determining primary and secondary payers.

2. Government Payer Programs

   • Medicare Overview (Parts A, B, C, D): Understanding the structure of the Medicare program and which part covers specific drugs and services.
   • Medicare Part D: Deep knowledge of the outpatient prescription drug benefit, including its structure (deductible, gap, catastrophic), formularies, and billing processes through private PDPs.
   • Medicare Part B: Understanding the billing process for drugs covered under the medical benefit, such as certain injectables and DME supplies, which requires using medical claim forms (CMS-1500) and HCPCS codes.
   • Medicaid: Knowledge of the federal-state health program for low-income individuals, including rules around Fee-for-Service vs. Managed Care, and the Medicaid Drug Rebate Program.
   • Other Government Programs: Familiarity with other programs like TRICARE (for military) and State Pharmaceutical Assistance Programs (SPAPs).

3. Commercial and Private Insurance

   • Benefit Design: Understanding common features of commercial plans, including tiered formularies, prior authorization requirements, and quantity limits.
   • PBM Role and Function: In-depth knowledge of how PBMs manage formularies, negotiate rebates with manufacturers, and process claims on behalf of health plans.
   • Claim Submission Standards: Proficiency in the NCPDP Telecommunication Standard used for submitting electronic pharmacy claims.
   • High-Deductible Health Plans (HDHPs): Understanding the impact of HDHPs and Health Savings Accounts (HSAs) on patient costs and pharmacy collections.
   • Specialty Pharmacy and Limited Distribution: Navigating the complex billing and fulfillment processes for high-cost specialty medications.

4. Coding and Billing

   • National Drug Code (NDC): Understanding the 11-digit NDC format and its critical role in identifying the specific drug, strength, and package size for billing.
   • HCPCS and CPT Codes: Knowledge of the Healthcare Common Procedure Coding System (HCPCS, including J-codes for injectables) and Current Procedural Terminology (CPT) codes used for billing clinical services and drugs under the medical benefit.
   • ICD-10-CM Diagnosis Codes: Understanding the importance of linking a diagnosis code to a drug claim to establish medical necessity, particularly for medical benefit billing.
   • Claim Forms (NCPDP, CMS-1500, UB-04): Differentiating between and knowing when to use the standard electronic pharmacy claim, the professional medical claim form, and the institutional claim form.
   • DAW and Submission Clarification Codes: Correctly using Dispense as Written (DAW) codes and other NCPDP codes to accurately communicate dispensing information to the payer.

5. Denial Management and Revenue Integrity

   • Denial vs. Rejection: Differentiating between a real-time claim rejection and a post-payment denial.
   • Analyzing Denials and EOBs: Interpreting rejection codes, Claim Adjustment Reason Codes (CARCs), and Remittance Advice Remark Codes (RARCs) to understand why a claim was denied.
   * SSRIs are the first-line treatment. The safety of SSRIs in pregnancy and lactation is a key counseling topic.
   • A new oral agent, zuranolone, has been specifically approved for PPD.
   • A CWHP is a key part of the care team for these women.

   Perimenopausal Depression

   • The hormonal fluctuations of the perimenopausal transition can increase the risk of depression.
   • For women with both depression and vasomotor symptoms, an antidepressant with efficacy for both (like venlafaxine or escitalopram) is a good choice.
   • Menopausal hormone therapy can also improve mood in perimenopausal women.
   • It is important to screen for depression in women going through this life stage.

   Pharmacotherapy Considerations in Women

   • Women may experience different side effects from antidepressants than men.
   • They may be more prone to weight gain or sexual side effects.
   • A key role for the CWHP is to counsel on these potential side effects and to help manage them.
   • This can involve switching to an agent with a more favorable side effect profile (e.g., bupropion for sexual side effects).

Epidemiology

• Migraine headaches are three times more common in women than in men.
• This difference emerges after puberty and is driven by hormonal fluctuations.
• Many women experience a clear link between their migraines and their menstrual cycle.
• A CWHP must be knowledgeable about the management of this common and debilitating condition.

Menstrual Migraine

• Menstrual migraine refers to migraine attacks that occur exclusively or more frequently in the days just before or during the menstrual period.
• It is caused by the drop in estrogen levels that occurs at this time.
• These attacks are often more severe and less responsive to treatment than non-menstrual migraines.
• The treatment strategy is specifically aimed at preventing or treating these hormonally-driven attacks.

Acute Treatment

• First-line treatment for acute migraine attacks includes NSAIDs and triptans.
• Triptans (e.g., sumatriptan) are serotonin agonists that are highly effective.
• Newer classes of acute treatments include the CGRP antagonists ("gepants") and the ditans.
• It is important to treat the attack as early as possible.
• Overuse of acute medications can lead to medication-overuse headache.

Hormonal Prophylaxis for Menstrual Migraine

• For women with predictable menstrual migraines, hormonal therapy can be used for prevention.
• Mini-prophylaxis: This involves taking an NSAID or a triptan for a few days before and during the expected time of the migraine.
• Hormonal Contraceptives: Using a CHC in a continuous or extended-cycle fashion can prevent the drop in estrogen that triggers the migraine. This is a very effective strategy.

Migraine with Aura and CHCs

• This is a critical safety issue.
• Migraine with aura is associated with an increased risk of ischemic stroke.
• Combined hormonal contraceptives also increase the risk of stroke.
• Therefore, the use of CHCs is an unacceptable health risk (MEC Category 4) in women who have migraine with aura.
• A CWHP must always screen for a history of aura before recommending a CHC.
• Progestin-only methods are safe to use in women with migraine with aura.

U.S. Medical Eligibility Criteria for Contraceptive Use (MEC)

• The CDC's evidence-based guideline for contraceptive safety.
• It is the most important assessment tool for selecting a safe contraceptive method.
• It categorizes medical conditions based on the level of risk for each contraceptive method (Category 1-4).
• A CWHP must be an expert at using the MEC wheel or app.

FRAX® (Fracture Risk Assessment Tool)

• A computer-based algorithm that calculates a patient's 10-year probability of a major osteoporotic fracture.
• It is a key tool for assessing a patient's baseline fracture risk.
• A CWHP uses this to help guide decisions about osteoporosis treatment and the use of MHT for prevention.

Menopause Rating Scale (MRS)

• An assessment tool used to measure the severity of menopausal symptoms and their impact on quality of life.
• It is a patient-completed questionnaire with subscales for somatic, psychological, and urogenital symptoms.
• A CWHP can use this tool to get a baseline assessment and to track response to therapy.

ASCVD Pooled Cohort Equations Risk Calculator

• An assessment tool that calculates a patient's 10-year risk of having a first atherosclerotic cardiovascular disease (ASCVD) event.
• It is used to guide decisions about primary prevention therapies like statins.
• In the context of hormone therapy, it is used to assess a patient's baseline cardiovascular risk before starting MHT.

Female Sexual Function Index (FSFI)

• A 19-item, patient-reported questionnaire for assessing female sexual function.
• It includes domains for desire, arousal, lubrication, orgasm, satisfaction, and pain.
• It can be a useful tool for a structured assessment of female sexual dysfunction.
• A CWHP can use this to identify issues and monitor response to therapy.

Creatinine Clearance (CrCl) - Cockcroft-Gault

• Essential for assessing renal function to guide the dosing of numerous medications used in women's health (e.g., bisphosphonates for osteoporosis, certain antibiotics for UTIs).

Body Mass Index (BMI)

• BMI is a critical factor in women's health. Obesity is a risk factor for infertility, GDM, and VTE. BMI is a key criterion for the CDC MEC for contraception.

Corrected Calcium for Albumin

• Since calcium levels are affected by albumin, which can change during pregnancy or with malnutrition, this calculation is important when assessing bone health or preeclampsia risk.

Ideal Body Weight (IBW)

• IBW is used in some dosing calculations. It is a foundational clinical pharmacy calculation that a CWHP should know.

Absolute Risk vs. Relative Risk

• This is a conceptual calculation essential for counseling on the risks of MHT or CHCs. A CWHP must be able to calculate and explain the difference to help a patient make an informed decision. For example, if a risk goes from 1 in 10,000 to 2 in 10,000, the relative risk has doubled (100% increase), but the absolute risk increase is only 0.01%.

Individualization is Everything

• There is no "one-size-fits-all" approach in women's health.
• Every decision, from contraception to MHT, must be individualized based on the patient's specific medical history, risk factors, goals, and preferences.
• Guidelines provide the framework, but the art of women's health is in the application of these guidelines to the individual.
• A CWHP is an expert in this patient-centered, individualized approach.

The Benefit-Risk Profile is Dynamic

• The benefit-risk balance of a medication is not static; it changes throughout a woman's lifespan.
• The risks of a CHC are different for a 20-year-old than for a 40-year-old.
• The benefits of MHT are different for a 52-year-old than for a 68-year-old.
• This requires an ongoing, periodic reassessment of all long-term medications.
• A CWHP is a leader in this process of continuous re-evaluation.

Shared Decision-Making is the Standard of Care

• Most of the key decisions in women's health are preference-sensitive.
• The role of the clinician is to provide the evidence and then to help the woman make a choice that aligns with her own values.
• This requires excellent communication skills and a commitment to patient partnership.
• A CWHP is an expert facilitator of these shared decision-making conversations.

Prevention is a Core Focus

• A huge part of women's health is focused on prevention.
• This includes preventing unintended pregnancies with effective contraception.
• It includes preventing cervical cancer with the HPV vaccine.
• It includes preventing osteoporosis and cardiovascular disease.
• A CWHP must be a proactive champion for all of these preventive health services.

A Lifespan Approach

• A CWHP must be able to care for women across their entire lifespan.
• This requires expertise on a wide range of topics, from the first menstrual period to the postmenopausal years.
• It requires an understanding of how a woman's physiology and health needs change over time.
• This holistic, lifespan perspective is the hallmark of a true expert in women's health.
• This certification represents a commitment to this comprehensive and specialized area of practice.