1
NR 568 Final Exam Study Guide
Week 5-8
● Prevention of osteoporosis with hormone replacement therapy
○ HT reduces postmenopausal bone loss and thereby decreases the risk for osteoporosis
and related fractures.
○ When HT is stopped, bone mass rapidly decreases by approximately 12%.
○ Hence to maintain bone health, HT must continue lifelong.
○ The risk for harm is increased.
○ Alternative treatments are preferred.
○ The labeling of HT products currently must carry the following advice: When this
product is prescribed solely to prevent postmenopausal osteoporosis, approved
nonestrogen treatments should be carefully considered. Furthermore, HT should be
considered only for women with significant risk for osteoporosis, and only when that risk
outweighs the risks of HT.
○ Effective alternatives to HT include raloxifene (Evista), bisphosphonates (e.g., alendronate
[Fosamax]), calcitonin (Miacalcin), and teriparatide (Forteo).
○ All women (not to mention men) should practice primary prevention of bone loss by
ensuring adequate intake of calcium and vitamin D, performing regular weight-bearing
exercise, and avoiding smoking and excessive alcohol use.
● When and when not to use progestin for hormone replacement therapy and why ○
Therapeutic Goal:
■ Goals for non-contraceptive uses are to counteract endometrial hyperplasia
caused by unopposed estrogen during hormone therapy; management of
dysfunctional uterine bleeding, amenorrhea, and endometriosis; and support of
pregnancy in women with corpus luteum deficiency. Progestins are also used in
in vitro fertilization cycles and to prevent prematurity in women at high risk for
preterm birth.
■ Baseline Data: Heart rate, blood pressure, and weight. Pregnancy test. Screening
for breast and cardiovascular disease. Pelvic exam as indicated for age.
■ Monitoring: Blood pressure. Assessment for fluid retention, including weight.
Consider referral for transvaginal ultrasound or hysteroscopy for occurrence of
undiagnosed bleeding that continues for 6 months.
■ Identifying High-Risk Patients: Progestins are contraindicated in the presence of
undiagnosed abnormal vaginal bleeding. Relative contraindications include
active thrombophlebitis or a history of thromboembolic disorders, active liver
disease, and carcinoma of the breast.
■ Minimizing Adverse Effects: Progestins can cause breakthrough bleeding,
spotting, and amenorrhea. Warn patients that this may occur and instruct them
to report any abnormal or prolonged vaginal bleeding.
, 2
● Local vs. systemic estrogen options and why one would be chosen over the other?
○ Because systemic estrogen carries significant risks, the FDA recommends that, if HT is
being used solely to manage vulvar and vaginal symptoms, a topical estrogen
formulation should be considered. Options include vaginal creams, vaginal inserts, and
vaginal rings
○ Although long-term data are lacking, it seems likely that topical estrogen is safer than
oral estrogen because, with nearly all topical formulations, blood levels of estrogen
remain low.
○ The notable exception is the Femring, which releases enough estrogen to cause significant
systemic effects.
○ Local – treat vulva/vaginal atrophy.
○ Systemic – Vaginal ring Femring (treat hot flashes and night sweats) as well as local
effects like tx of vuvla/vaginal atrophy.
○ Parental is rarelyy used. Limited to acute/emergent control of heavy uterine bleeding
■ Peri-menopausal estrogen therapy (ET)
● ET: The most effective means to suppress menopausal symptoms. ET replaces Estrogen that was
lost to menopause. It can prevent Osteoporosis but carries risks of Breast Ca and Stroke
● Transdermal estrogen therapy has fewer adverse effects.
○ The total dose of estrogen is greatly reduced (because the liver is bypassed).
○ There is less nausea and vomiting.
○ Blood levels of estrogen fluctuate less.
○ There is a lower risk for DVT, pulmonary embolism, and stroke.
● Osteoporosis, osteopenia, and hormone replacement therapy (HRT)
■ Selective estrogen receptor modulator (SERM) - SERM are drugs that activate
estrogen receptors in some tissues and blocks them in others. Created to
provide the benefits of estrogen such as protection against osteoporosis and
reduction of
LDL.
■ Bazedoxifene (Duavee)- was approved by the FDA for prevention of vasomotor
symptoms and osteoporosis in postmenopausal women with a uterus. First
drug to combine estrogen with an estrogen agonist/antagonist (bazedoxifene).
The bazedoxifene component of Duavee reduces the risk of excessive growth to
the lining of the uterus.
● Management of oral contraceptives (OCs)
○ How to change patients from one combination oral contraceptive to another?
■ The change is best made at the beginning of a new cycle.
○ How to initiate treatment (when in the cycle is it best to start- may vary based on the
type of contraceptive)
, 3
■ The sequence is begun on either the first day of the menstrual cycle or the first
Sunday after the onset of menses. With the first option, protection is conferred
immediately; hence no backup contraception is needed.
■ With a Sunday start, which is done to have menses occur on weekdays rather
than the weekend, protection may not be immediate; hence an alternate form
of birth control should be used during the first 7 days of the pill pack.
■ With both options, each dose should be taken at the same time every day (e.g.,
with a meal or at bedtime).
■ Successive dosing cycles should commence every 28 days even if there is
breakthrough bleeding or spotting.
■ OC users can achieve an extended-cycle schedule by discarding the inert pills
and beginning a new pack for up to four [4] cycles. In other words, purchase
four
[4] packets of a 28-day product [each contains 21 active pills] and then take the
active pills for 84 days straight. Recommendation from HCP regarding the use of
combination OC for an extended time rather than following traditional 28-day
cycle because doing so decreases episodes of withdrawal bleeding with the a/s
menstrual pain, premenstrual symptoms, headaches, and other problems.
○ What teaching needs to be
done ■ Risks associated:
● Thrombosis or Thromboembolism
○ (e.g., leg tenderness or pain, sudden chest pain, shortness of
breath, severe headache, sudden visual disturbance) and
instructed to consult the prescriber if these occur.
■ If one or more pills are missed in the first week, take one pill as soon as possible
and then continue with the pack. Use an additional form of contraception for 7
days.
■ If one or two pills are missed during the second or third week, take one pill as
soon as possible and then continue with the active pills in the pack but skip the
placebo pills and go straight to a new pack once all the active pills have been
taken.
■ If three or more pills are missed during the second or third week, follow the
same instructions given for missing one or two pills but use an additional form
of contraception for 7 days.
○ What baseline data is needed?
■ Baseline Data: Assess history of hypertension, diabetes, thromboembolism,
cerebrovascular or cardiovascular disease, breast cancer. Urine pregnancy test.
○ Contraindications for OCs:
■ Absolute contraindication
● Thrombophlebitis
● thromboembolic disorders
● cerebral vascular disease ● coronary occlusion
, 4
● a history of or a condition that predisposes to these disorders:
○ Abnormal liver function
○ Known or suspected breast cancer
○ Undiagnosed abnormal vaginal
bleeding ○ Known or suspected pregnancy
○ Smokers older than 35 years.
■ Relative
contraindication: ●
Hypertension
● Cardiac disease
● Diabetes
● History of cholestatic jaundice of pregnancy
● Gallbladder disease
● Uterine leiomyoma
● Epilepsy
● Migraine
● How to achieve an extended cycle with oral contraceptives
○ For most products, each cycle is 28 days long. However, with a few newer products, the
cycle is either extended (to 91 days) or continuous (Amethyst). To achieve an extended
schedule, the user would simply purchase four packets of a 28-day product (each of
which contains 21 active pills) and then take the active pills for 84 days straight.
● What behaviors would make one birth control method more effective over another?
○ Be able to evaluate a patient scenario and suggest an appropriate birth control method
(type of prescribed contraception: OC, long-term methods, IUD, long-acting reversible
contraceptives (LARCs), etc.
● What effect do CYP450 inhibitors or inducers have on OCs?
○ Recall examples of CYP450 inhibitors and inducers from NR565 (Chapter 4 in textbook).
How does this impact prescribing OCs?
■ Inducers increase the metabolism of OCs and reduce their effectiveness. May
need an OC with increased estrogen. INDUCERS: “BS CRAP GPS: barbiturates,
St. John’s Wort, carbamazepine, rifampin, alcohol (chronic), phenytoin,
griseofulvin, phenobarbital, sulfonylureas
■ Inhibitors decrease the metabolism of OCs and increase their effects–risk of
toxicity or increased side effects/adverse drug effects. INHIBITORS: “VISA
CK GQ” Valproate, isoniazid, sulfonamides, amiodarone, chloramphenicol
(which btw is no longer used in the US), ketoconazole, grapefruit juice, quinidine. Also,
Fluoroquinolone antibiotics, erythromycin, omeprazole, metronidazole, cimetidine, protease
inhibitors, verapamil ● Benefits and drawbacks of progestin-only contraception:
○ Benefits: can be used in early breastfeeding when combination OCPs would reduce milk
production. Can be used by women who have had thrombotic events in the past.
NR 568 Final Exam Study Guide
Week 5-8
● Prevention of osteoporosis with hormone replacement therapy
○ HT reduces postmenopausal bone loss and thereby decreases the risk for osteoporosis
and related fractures.
○ When HT is stopped, bone mass rapidly decreases by approximately 12%.
○ Hence to maintain bone health, HT must continue lifelong.
○ The risk for harm is increased.
○ Alternative treatments are preferred.
○ The labeling of HT products currently must carry the following advice: When this
product is prescribed solely to prevent postmenopausal osteoporosis, approved
nonestrogen treatments should be carefully considered. Furthermore, HT should be
considered only for women with significant risk for osteoporosis, and only when that risk
outweighs the risks of HT.
○ Effective alternatives to HT include raloxifene (Evista), bisphosphonates (e.g., alendronate
[Fosamax]), calcitonin (Miacalcin), and teriparatide (Forteo).
○ All women (not to mention men) should practice primary prevention of bone loss by
ensuring adequate intake of calcium and vitamin D, performing regular weight-bearing
exercise, and avoiding smoking and excessive alcohol use.
● When and when not to use progestin for hormone replacement therapy and why ○
Therapeutic Goal:
■ Goals for non-contraceptive uses are to counteract endometrial hyperplasia
caused by unopposed estrogen during hormone therapy; management of
dysfunctional uterine bleeding, amenorrhea, and endometriosis; and support of
pregnancy in women with corpus luteum deficiency. Progestins are also used in
in vitro fertilization cycles and to prevent prematurity in women at high risk for
preterm birth.
■ Baseline Data: Heart rate, blood pressure, and weight. Pregnancy test. Screening
for breast and cardiovascular disease. Pelvic exam as indicated for age.
■ Monitoring: Blood pressure. Assessment for fluid retention, including weight.
Consider referral for transvaginal ultrasound or hysteroscopy for occurrence of
undiagnosed bleeding that continues for 6 months.
■ Identifying High-Risk Patients: Progestins are contraindicated in the presence of
undiagnosed abnormal vaginal bleeding. Relative contraindications include
active thrombophlebitis or a history of thromboembolic disorders, active liver
disease, and carcinoma of the breast.
■ Minimizing Adverse Effects: Progestins can cause breakthrough bleeding,
spotting, and amenorrhea. Warn patients that this may occur and instruct them
to report any abnormal or prolonged vaginal bleeding.
, 2
● Local vs. systemic estrogen options and why one would be chosen over the other?
○ Because systemic estrogen carries significant risks, the FDA recommends that, if HT is
being used solely to manage vulvar and vaginal symptoms, a topical estrogen
formulation should be considered. Options include vaginal creams, vaginal inserts, and
vaginal rings
○ Although long-term data are lacking, it seems likely that topical estrogen is safer than
oral estrogen because, with nearly all topical formulations, blood levels of estrogen
remain low.
○ The notable exception is the Femring, which releases enough estrogen to cause significant
systemic effects.
○ Local – treat vulva/vaginal atrophy.
○ Systemic – Vaginal ring Femring (treat hot flashes and night sweats) as well as local
effects like tx of vuvla/vaginal atrophy.
○ Parental is rarelyy used. Limited to acute/emergent control of heavy uterine bleeding
■ Peri-menopausal estrogen therapy (ET)
● ET: The most effective means to suppress menopausal symptoms. ET replaces Estrogen that was
lost to menopause. It can prevent Osteoporosis but carries risks of Breast Ca and Stroke
● Transdermal estrogen therapy has fewer adverse effects.
○ The total dose of estrogen is greatly reduced (because the liver is bypassed).
○ There is less nausea and vomiting.
○ Blood levels of estrogen fluctuate less.
○ There is a lower risk for DVT, pulmonary embolism, and stroke.
● Osteoporosis, osteopenia, and hormone replacement therapy (HRT)
■ Selective estrogen receptor modulator (SERM) - SERM are drugs that activate
estrogen receptors in some tissues and blocks them in others. Created to
provide the benefits of estrogen such as protection against osteoporosis and
reduction of
LDL.
■ Bazedoxifene (Duavee)- was approved by the FDA for prevention of vasomotor
symptoms and osteoporosis in postmenopausal women with a uterus. First
drug to combine estrogen with an estrogen agonist/antagonist (bazedoxifene).
The bazedoxifene component of Duavee reduces the risk of excessive growth to
the lining of the uterus.
● Management of oral contraceptives (OCs)
○ How to change patients from one combination oral contraceptive to another?
■ The change is best made at the beginning of a new cycle.
○ How to initiate treatment (when in the cycle is it best to start- may vary based on the
type of contraceptive)
, 3
■ The sequence is begun on either the first day of the menstrual cycle or the first
Sunday after the onset of menses. With the first option, protection is conferred
immediately; hence no backup contraception is needed.
■ With a Sunday start, which is done to have menses occur on weekdays rather
than the weekend, protection may not be immediate; hence an alternate form
of birth control should be used during the first 7 days of the pill pack.
■ With both options, each dose should be taken at the same time every day (e.g.,
with a meal or at bedtime).
■ Successive dosing cycles should commence every 28 days even if there is
breakthrough bleeding or spotting.
■ OC users can achieve an extended-cycle schedule by discarding the inert pills
and beginning a new pack for up to four [4] cycles. In other words, purchase
four
[4] packets of a 28-day product [each contains 21 active pills] and then take the
active pills for 84 days straight. Recommendation from HCP regarding the use of
combination OC for an extended time rather than following traditional 28-day
cycle because doing so decreases episodes of withdrawal bleeding with the a/s
menstrual pain, premenstrual symptoms, headaches, and other problems.
○ What teaching needs to be
done ■ Risks associated:
● Thrombosis or Thromboembolism
○ (e.g., leg tenderness or pain, sudden chest pain, shortness of
breath, severe headache, sudden visual disturbance) and
instructed to consult the prescriber if these occur.
■ If one or more pills are missed in the first week, take one pill as soon as possible
and then continue with the pack. Use an additional form of contraception for 7
days.
■ If one or two pills are missed during the second or third week, take one pill as
soon as possible and then continue with the active pills in the pack but skip the
placebo pills and go straight to a new pack once all the active pills have been
taken.
■ If three or more pills are missed during the second or third week, follow the
same instructions given for missing one or two pills but use an additional form
of contraception for 7 days.
○ What baseline data is needed?
■ Baseline Data: Assess history of hypertension, diabetes, thromboembolism,
cerebrovascular or cardiovascular disease, breast cancer. Urine pregnancy test.
○ Contraindications for OCs:
■ Absolute contraindication
● Thrombophlebitis
● thromboembolic disorders
● cerebral vascular disease ● coronary occlusion
, 4
● a history of or a condition that predisposes to these disorders:
○ Abnormal liver function
○ Known or suspected breast cancer
○ Undiagnosed abnormal vaginal
bleeding ○ Known or suspected pregnancy
○ Smokers older than 35 years.
■ Relative
contraindication: ●
Hypertension
● Cardiac disease
● Diabetes
● History of cholestatic jaundice of pregnancy
● Gallbladder disease
● Uterine leiomyoma
● Epilepsy
● Migraine
● How to achieve an extended cycle with oral contraceptives
○ For most products, each cycle is 28 days long. However, with a few newer products, the
cycle is either extended (to 91 days) or continuous (Amethyst). To achieve an extended
schedule, the user would simply purchase four packets of a 28-day product (each of
which contains 21 active pills) and then take the active pills for 84 days straight.
● What behaviors would make one birth control method more effective over another?
○ Be able to evaluate a patient scenario and suggest an appropriate birth control method
(type of prescribed contraception: OC, long-term methods, IUD, long-acting reversible
contraceptives (LARCs), etc.
● What effect do CYP450 inhibitors or inducers have on OCs?
○ Recall examples of CYP450 inhibitors and inducers from NR565 (Chapter 4 in textbook).
How does this impact prescribing OCs?
■ Inducers increase the metabolism of OCs and reduce their effectiveness. May
need an OC with increased estrogen. INDUCERS: “BS CRAP GPS: barbiturates,
St. John’s Wort, carbamazepine, rifampin, alcohol (chronic), phenytoin,
griseofulvin, phenobarbital, sulfonylureas
■ Inhibitors decrease the metabolism of OCs and increase their effects–risk of
toxicity or increased side effects/adverse drug effects. INHIBITORS: “VISA
CK GQ” Valproate, isoniazid, sulfonamides, amiodarone, chloramphenicol
(which btw is no longer used in the US), ketoconazole, grapefruit juice, quinidine. Also,
Fluoroquinolone antibiotics, erythromycin, omeprazole, metronidazole, cimetidine, protease
inhibitors, verapamil ● Benefits and drawbacks of progestin-only contraception:
○ Benefits: can be used in early breastfeeding when combination OCPs would reduce milk
production. Can be used by women who have had thrombotic events in the past.
