Does not apply to this measure

This measure is used to assess the percentage of pregnant patients for whom methotrexate and leflunomide are not used.

Methotrexate and leflunomide have known fetal risks that outweigh the benefits of drug therapy in the patient (pregnant mother). However, pregnant women with rheumatoid arthritis (RA) should continue treatment, ensuring avoidance of teratogenic agents.

The American College of Rheumatology (ACR) Guidelines for Monitoring Drug Therapy in Rheumatoid Arthritis (RA), in concordance with the U.S. Food and Drug Administration (FDA) acknowledges the maternal and fetal risks associated with disease-modifying antirheumatic drug (DMARD), non-steroidal anti-inflammatory drug (NSAID), and aspirin use during pregnancy. The ACR's recommendations include the FDA's Use-in-Pregnancy rating and emphasize the importance of weighing the risk-benefit ratio when deciding whether or not to prescribe these medications during pregnancy.

Rheumatoid arthritis; pregnancy; methotrexate; leflunomide

Pregnant patients with a diagnosis of rheumatoid arthritis

Patients for whom methotrexate or leflunomide are not used

• A clinical practice guideline or other peer-reviewed synthesis of the clinical evidence
• A formal consensus procedure involving experts in relevant clinical, methodological, and organizational sciences
• One or more research studies published in a National Library of Medicine (NLM) indexed, peer-reviewed journal

Unspecified

Current routine use

Internal quality improvement

Ambulatory Care
Physician Group Practices/Clinics

Physicians

Individual Clinicians

Women of childbearing age

Female (only)

Unspecified

Rheumatoid arthritis (RA) affects one percent of the adult population. RA affects approximately 2.5 million Americans, disproportionately women.

Methotrexate (MTX) and leflunomide are designated as risk category X, and there use is contraindicated during pregnancy. The congenital defects most often associated with MTX use include craniofacial and limb defects and central nervous system abnormalities (i.e., neural tube defects, such as anencephaly, hydrocephaly, and meningomyelocele). See also the "Burden of Illness" and "Incidence/Prevalence" fields.

Forty percent of patients with early rheumatoid arthritis (RA) (less than six months of symptoms) have erosive disease at presentation and remission is rare (less than 5%).

The U.S. Food and Drug Administration (FDA) and the Australian Drug Evaluation Council (ADEC) have rated the safety of drugs in pregnancy. Table 11 in the original measure documentation summarizes the FDA and ADEC ratings of disease-modifying antirheumatic drugs (DMARDs) as well as the known adverse effects to the fetus.

Over nine million physician visits and greater than 250,000 hospitalizations are attributed to rheumatoid arthritis (RA) per year.

Rheumatoid arthritis (RA) has significant economic implications for the individual patient, as well as for society. Individuals with RA have 3 times the direct medical costs, twice the hospitalization rate and 10 times the work disability rate on an age- and sex-matched population. A recent study has shown annual medical costs for a patient with RA to be approximately $8,500. Annual costs rise as the duration of the disease increases and as function declines. Indirect costs related to disability and work loss have been estimated to be 3 times higher than the direct costs associated with the disease.

Living with Illness

Effectiveness
Safety

Users of care only

Pregnant patients with a diagnosis of rheumatoid arthritis

Patients associated with provider

Inclusions
Pregnant patients with a diagnosis of rheumatoid arthritis

Exclusions
Unspecified

All cases in the denominator are equally eligible to appear in the numerator

Clinical Condition

Time window follows index event

Inclusions
Patients for whom methotrexate or leflunomide are not used

Exclusions
Unspecified

The measure results are somewhat or substantially under the control of the health care professionals, organizations and/or policymakers to whom the measure applies.

Episode of care

Administrative data
Medical record
Pharmacy data

Individual Case

Unspecified

Rate

Better quality is associated with a higher score

Unspecified

Internal time comparison

Using a modification of the RAND Corporation/University of California Los Angeles (RAND/UCLA) Appropriateness Method, a multi-disciplinary expert panel comprised of nationally recognized experts in arthritis, primary care, and pain management discussed and rated the validity of each of the proposed measures based on 1) a summary of the evidence to support or refute each proposed measure and 2) their expert opinion.

Quality indicator 24. Reproductive issues.

Arthritis Foundation

Arthritis Foundation
RAND Health

Unspecified

Unspecified

Unspecified

Measure was not adapted from another source.

2005 Jan

This is the current release of the measure.

This NQMC summary was completed by ECRI on October 25, 2006. The information was verified by the measure developer on February 1, 2007.

No copyright restrictions apply.