What screening is necessary before prescribing the Evra (ethinyl estradiol and norelgestromin) patch to a female patient of reproductive age with a potential history of thromboembolic events, hypertension, liver disease, or smoking?

Screening Before Prescribing the Evra Patch

Before prescribing the Evra patch, you must assess pregnancy status and measure blood pressure—these are the only two essential screening requirements. 1, 2

Essential Baseline Assessments

Mandatory Screening

• Pregnancy testing: Confirm the patient is not pregnant before initiation 1, 2
• Blood pressure measurement: Document baseline blood pressure to identify uncontrolled hypertension 1, 2

No Routine Examinations Required

• Pelvic examination is NOT necessary before prescribing the Evra patch 1
• Breast examination is NOT required for asymptomatic women of reproductive age 1
• Laboratory tests are NOT needed in healthy women, including lipid panels, liver enzymes, or coagulation studies 1

Critical Contraindications to Screen For (History Only)

Absolute Contraindications

Screen for these conditions through history alone—no testing required: 1, 2

Thromboembolic History:

• Active or history of deep vein thrombosis or pulmonary embolism 1
• History of stroke or myocardial infarction 1
• Known thrombogenic mutations or hypercoagulopathies 1

Cardiovascular Risk:

• Cerebrovascular or coronary artery disease 1
• Uncontrolled hypertension (systolic ≥160 or diastolic ≥100 mmHg) 1
• Smoking in women ≥35 years of age 1
• Migraine headaches with focal neurologic symptoms or aura if ≥35 years 1

Hepatic Disease:

• Active liver disease or hepatic tumors (benign or malignant) 1
• History of cholestatic jaundice with prior hormonal contraceptive use 1

Malignancy:

• Current or history of breast cancer 1
• Estrogen- or progestin-sensitive cancers 1

Other:

• Undiagnosed abnormal vaginal bleeding 1
• Pregnancy 1

Important Clinical Considerations

VTE Risk with the Evra Patch

The patch delivers 1.6 times higher estrogen exposure than low-dose combined oral contraceptives, raising concerns about venous thromboembolism risk 1. The 2012 FDA package insert contains a black box warning citing studies with odds ratios of 1.2 to 2.2 for VTE compared to 20-35 μg combined oral contraceptives, though only one study showed statistically significant findings 1. However, more recent research found no increased VTE risk compared to norgestimate-containing oral contraceptives (OR 0.9,95% CI 0.5-1.6) 3.

Weight Considerations

The patch may be less effective in women weighing >198 pounds (90 kg), with perfect use failure rates of 0.9% versus 0.3% in lighter women 2, 4. Consider alternative methods for patients above this weight threshold.

Smoking Assessment

Smoking status is critical: The patch is absolutely contraindicated in women ≥35 years who smoke 1. For women <35 years who smoke, carefully weigh risks versus benefits, particularly if smoking >10 cigarettes daily 1.

Common Pitfalls to Avoid

• Do not require pelvic examination as a barrier to same-day initiation—this is unnecessary and delays contraceptive access 1, 2
• Do not order routine laboratory tests in healthy women—history and blood pressure are sufficient 1
• Do not overlook weight: Specifically ask about current weight and document if >198 pounds 2, 4
• Do not forget to assess multiple cardiovascular risk factors: The combination of older age, smoking, diabetes, and hypertension together increases risk beyond individual factors 1

Ongoing Monitoring

After initiation, routine follow-up should include: 1, 2

• Blood pressure monitoring
• Assessment of satisfaction with the method
• Evaluation for any health status changes that would affect continued safe use