listwmee University-Level Study Guide: Hormonal Contraception - Patch, Ring, and Progestin-Only Methods

Combination Hormonal Contraceptive Patch: Products and Labeling

  • Transdermal Patch Products:     * Xulane™ and Zafemy: These contain ethinyl estradiol (35 mcg/day35\,\text{mcg/day}) and norelgestromin (150 mcg/day150\,\text{mcg/day}).     * Twirla: This contains ethinyl estradiol (30 mcg/day30\,\text{mcg/day}) and levonorgestrel (120 mcg/day120\,\text{mcg/day}).

  • Xulane™ Detailed Specifications:     * Each 14 cm214\,\text{cm}^2 transdermal system contains 4.86 mg4.86\,\text{mg} norelgestromin and 0.53 mg0.53\,\text{mg} ethinyl estradiol, USP.     * Inactive Components: Polyisobutene adhesive, crospovidone, mineral oil, non-woven polyester fabric, oleyl alcohol, dipropylene glycol, polyester backing film laminate, and polyester release liner.     * NDC Number: 0378-3340-53.

  • Effectiveness and Safety Considerations:     * Weight Limitation: The patch may be less effective in women weighing more than 198 lb198\,\text{lb}.     * BMI Contraindications: Per the FDA label, the patch is contraindicated in women with a \text{BMI} > 30\,\text{kg/m}^2 due to an elevated risk of Venous Thromboembolism (VTE). However, the CDC Medical Eligibility Criteria (MEC) does NOT list this as a contraindication.     * Protection: The product is intended to prevent pregnancy; it does not protect against HIV infection (AIDS) or other STDs.

  • General Precautions: The patch carries the same cautions, contraindications, risks, and drug interactions as combination Combined Oral Contraceptives (COCs).

Patch Directions for Use and Adverse Effects

  • Administration Guidelines:     * Application Sites: The patch should be applied to the abdomen, upper outer arm, torso, or buttocks.     * Schedule: Each patch is worn for one week. It must be replaced every week for 3 weeks on the same "patch change day."     * Hormone-Free Interval: No patch is worn during the 4th week (there is no placebo patch).     * Change Timing: The patch can be changed at any time on the designated "patch change day."     * Adherence: The patch should remain attached during all daily activities.

  • Adverse Effects:     * Adverse effects are similar to COCs but include localized skin irritation.

  • Pharmacokinetics and Risk Profile:     * Per the Xulane label, the patch results in 60%60\% higher steady-state (SS) concentrations of estrogen compared to 35 mcg35\,\text{mcg} EE COCs.     * The patch has 25%25\% lower peak concentrations compared to these COCs.     * The increased total estrogen exposure could potentially increase the risk of VTE.

Combination Hormonal Vaginal Contraceptive Rings

  • Product Overview: These are flexible, transparent vaginal rings that the patient inserts themselves; no clinical placement is necessary.

  • NuvaRing (including EluRyng, EnilloRing, Haloette):     * Hormones Released: Ethinyl estradiol (EE) and etonorgestrel.     * Dosage: Releases 0.120 mg/day0.120\,\text{mg/day} etonorgestrel and 0.015 mg/day0.015\,\text{mg/day} EE.     * Usage: 1 ring is used for 3 weeks.

  • Annovera:     * Hormones Released: Segesterone acetate (SA) and ethinyl estradiol (EE).     * Dosage: Average of 0.15 mg/day0.15\,\text{mg/day} segesterone acetate and 0.013 mg/day0.013\,\text{mg/day} ethinyl estradiol.     * Usage: 1 reusable ring is used for a total of 13 to 28-day cycles (1 year1\,\text{year}).     * Limitation: This product was not studied in women with a \text{BMI} > 29\,\text{kg/m}^2.

  • Safety and General Directions:     * Contraindications, risks, and drug interactions are similar to combination COCs.     * The ring is inserted into the vagina and removed 3 weeks later on the same day and approximately the same time.     * Single-use rings (NuvaRing): After removal, wait 1 week, then insert a new ring on the same day/time.     * Reusable ring (Annovera): After removal, clean the ring with mild soap and water, then reinsert after the 1-week break.

Vaginal Ring Adverse Effects and Patient Education

  • Most Common Adverse Effects: Vaginitis, vaginal secretion, headache, nausea, weight gain, Upper Respiratory Infection (URI), and sinusitis.

  • Reasons for Discontinuation in Trials:     * Foreign body sensation, coital problems, and expulsion.     * Vaginal discomfort or secretion.     * Emotional lability, headache, and weight gain.

  • Education on Use:     * Removal during Intercourse: Allowed for a maximum of 3 hours3\,\text{hours} (NuvaRing/EnilloRing) or 2 hours2\,\text{hours} (Annovera).     * Concomitant Products: For NuvaRing, spermicides, yeast infection treatments, and tampons are acceptable. For Annovera, water-based vaginal creams are OK, but oil-based treatments should be avoided.     * Accidental Expulsion: Rinse the ring in lukewarm water (not hot) and reinsert as soon as possible.

  • Storage Requirements:     * NuvaRing: Must be refrigerated at the pharmacy before dispensing. Once dispensed, it can be stored at room temperature but expires 4 months4\,\text{months} after being moved to room temperature. The expiration date must be placed on the label by the pharmacist.     * Annovera: Should be kept at room temperature in its provided compact case. Avoid direct sunlight and temperatures above 86∘F86^\circ F (30∘C30^\circ C).

Progestin-Only Pills (POPs)

  • Terminology: Often referred to as the "Mini Pill."

  • Available Products:     * Norethindrone 0.35 mg0.35\,\text{mg} tablets: Brand names include Micronor and Nor-QD.     * Drospirenone 4 mg4\,\text{mg} tablets: Brand name Slynd.     * Norgestrel 0.075 mg0.075\,\text{mg}: Brand name Opill, which is available Over-the-Counter (OTC) without a prescription.

  • Norethindrone & Norgestrel Specifics:     * Dosing: 28 days of active pills with no placebo/hormone-free interval.     * Bleeding Patterns: Breakthrough bleeding (BTB), spotting, and intermittent amenorrhea are common.     * Efficacy: These have higher failure rates than combination hormonal contraceptives (CHCs).     * Primary Population: Most common use is in breastfeeding women.     * Start-up Requirement: If started within the first 5 days of menses, no backup is needed. If started later, 2 days of backup contraception are required.

  • Missed Dose Protocol for Norethindrone/Norgestrel:     * If a pill is $> 3\,\text{hours}$ late, or if vomiting/diarrhea occurs within $3\,\text{hours}$ of taking the pill:         1. Take 1 pill as soon as possible.         2. Continue once daily at the same time (this may require taking 2 pills on the same day).         3. Use backup contraception until 2 pills have been taken on time for 2 consecutive days.         4. Consider Emergency Contraception (EC) if unprotected intercourse occurred.

  • Drospirenone (Slynd) Specifics:     * Dosing: 24 days active pills, 4 days placebo.     * Unique Risks: Risk of hyperkalemia.     * Start-up: No backup needed if started on the first day of menses; otherwise, use 7 days of backup.     * Missed Doses: If 1 dose is missed, take ASAP. If 2 or more are missed, take ASAP and use backup for 7 days.     * Pros: Features antiandrogenic activity and offers more flexibility with adherence.

Access to Opill (OTC Progestin-Only Pill)

  • Reasons for Patient Interest:     * Privacy: Patients on parents' insurance may want oral contraceptives without a claim appearing on the insurance statement.     * Convenience: Difficult access to a primary care provider.     * MN Specific Regulation: Patients may not realize MN pharmacists can prescribe contraceptives or they may be under 18 and ineligible for pharmacist-prescribed pills if they haven't been on them before.     * Distrust: General distrust of the medical system or concerns regarding data privacy.     * Non-Contraceptive Indications: Use for conditions like PCOS or dysmenorrhea.

General Patient Education for Contraceptives

  • Reasonably Certain Criteria (Starting without Pregnancy Test): A provider is reasonably certain a woman is not pregnant if she has no signs/symptoms of pregnancy AND meets one of these:     * ≤7 days\le 7\,\text{days} after start of normal menses.     * No sexual intercourse since start of last normal menses.     * Consistent and correct use of a reliable contraceptive.     * ≤7 days\le 7\,\text{days} after spontaneous or induced abortion.     * Within 4 weeks postpartum.     * Fully/nearly fully (≥85%\ge 85\%) breastfeeding, amenorrheic, and $< 6\,\text{months}$ postpartum.

  • When to Start and Backup Requirements:     * CHCs: Anytime. If started $> 5\,\text{days}$ after menses started, use backup for 7 days.     * POPs: Anytime. If started $> 5\,\text{days}$ after menses started, use backup for 2 days.     * Injectable/Implant: Anytime. If started $> 7\,\text{days}$ after menses started, use backup for 7 days.     * Copper IUD: Anytime. No backup needed.     * Levonorgestrel IUD: Anytime. If $> 7\,\text{days}$ after menses, use backup for 7 days.

  • Educational Components: Should always include how/when to start, backup rules, adverse effects (emphasizing those that improve like nausea/BTB), drug interactions, risks, and non-contraceptive benefits.

Missed Pill Rules: COCs

  • General Rules: Need 7 days of active treatment to prevent conception. If off for $> 48\,\text{hours}$, backup is required until 7 consecutive days of active pills are taken.

  • One Pill Missed: Take missed pill ASAP, continue pack as usual. No backup needed.

  • Two Pills Missed (24\,\text{to} < 48\,\text{hours} since last dose): Take last missed pill ASAP. May take 2 pills on the same day. No backup needed.

  • Two or More Consecutive Pills Missed (> 48\,\text{hours}):     * Take the last missed pill ASAP.     * Use backup until active pills have been taken for 7 consecutive days.     * If missed in the 3rd week of active pills: Skip the placebo week and start a new pack immediately.     * EC Consideration: Consider if pills were missed in the 1st week and unprotected intercourse occurred in the previous 5 days.

  • Extended Cycle CHCs: Up to 7 days can be missed as long as the hormone-free interval (HFI) does not exceed 7 days. This only applies after 21 consecutive days of use.

Vomiting and Diarrhea Protocols for CHCs

  • Symptoms lasting < 48\,\text{hours}: Continue pills at usual time. Re-dosing is unnecessary. No backup needed.

  • Symptoms lasting ≥48 hours\ge 48\,\text{hours}:     * Continue pills at usual time.     * Use backup until 7 consecutive active pills are taken after symptoms resolve.     * If symptoms occur in the last week of active pills: Skip placebo pills and start new pack.     * Consider EC if symptoms were in the 1st week and intercourse occurred in the last 5 days.

Delayed Patch or Ring Application/Insertion

  • Patch Detachment/Delay (< 48\,\text{hours}): Apply new patch ASAP. If detached $< 24\,\text{hours}$, can try to reattach the same one. No backup needed.

  • Patch Detachment/Delay (≥48 hours\ge 48\,\text{hours}): Apply new patch ASAP. Use backup for 7 days. If in week 3, skip the patch-free week.

  • Ring Delay (< 48\,\text{hours}): Insert ring ASAP. No backup needed.

  • Ring Delay (≥48 hours\ge 48\,\text{hours}): Insert ring ASAP. Use backup for 7 days. If in week 3, skip the ring-free week.

  • Ring Left in Too Long:     * If in for $> 3\,\text{weeks}$ but $< 4\,\text{weeks}$: Remove, insert new ring after 1-week break. No backup needed.     * If in for $> 4\,\text{weeks}$: Insert new ring; use backup for 7 days.

Questions & Discussion

  • Question 1: Using CDC recommendations, which of the following patients should NOT take CHCs?     * Options: A. 18 y/o with gonorrhea; B. 35 y/o with tension headaches; C. 28 y/o breastfeeding 6-month-old; D. 45 y/o with uncontrolled hypertension.     * Context: Uncontrolled hypertension is a contraindication (BP≥160/100\text{BP} \ge 160/100).

  • Question 2: A woman on norethindrone 1 mg1\,\text{mg}/EE 35 mcg35\,\text{mcg} for 3 weeks complains of GI upset and nausea. Recommendation?     * Recommendation: Continue therapy; GI symptoms often improve with time.

  • Question 3: Patient on EE 20 mcg20\,\text{mcg}/levonorgestrel 0.1 mg0.1\,\text{mg} for 8 months with consistent early cycle spotting/BTB for 3 months. Recommendation?     * Recommendation: Change to a product with higher estrogenic activity (estrogen stabilizes the endometrium).

  • Question 4: Patient on norethindrone 0.5 mg0.5\,\text{mg}/EE 35 mcg35\,\text{mcg} continuous cycle c/o breast tenderness, cramping, and bloating. Recommendation?     * Recommendation: Change to a product with lower estrogenic activity.

  • Question 5: Patient on norethindrone acetate 1 mg1\,\text{mg}/EE 20/30/35 mcg20/30/35\,\text{mcg} for 7 months has gained 8 lb8\,\text{lb} despite exercise and diet. Recommendation?     * Recommendation: Change to a product with lower progestational activity.

  • Question 6: Patient started desogestrel 0.15 mg0.15\,\text{mg}/EE 30 mcg30\,\text{mcg} 4 weeks ago and reports daily bleeding. Recommendation?     * Recommendation: Make no change yet; educate that this usually improves within the first 3 months.

  • Question 7: 23 y/o on drospirenone 3 mg3\,\text{mg}/EE 30 mcg30\,\text{mcg} reporting severe headaches (no aura) during placebo week. Recommendation?     * Recommendation: Change to an extended cycle regimen to avoid the drop in estrogen that triggers withdrawal headaches.

  • Question 8: 39 y/o on drospirenone 3 mg3\,\text{mg}/EE 30 mcg30\,\text{mcg} for 1 year reporting decreased libido. Recommendation?     * Recommendation: Switch to a product with more androgenic activity.

  • Question 9: 35 y/o patch user realizes in week 3 that her patch fell off at an unknown time. Action?     * Recommendation: Apply new patch immediately, use backup for 7 days, skip the placebo week, and continue with active patches (Option B).

  • Question 10: 32 y/o with history of DVT 3 years ago (while on the pill) wants contraception. Which is safe?     * Options: A. Patch; B. Ring; C. DMPA; D. Paragard IUD.     * Answer: Paragard IUD (non-hormonal) is the safest choice given the history of VTE.