ACOG Opposes Switching Contraceptives Without Woman's Assent

WASHINGTON, July 31 -- It should be a woman's right to know what oral contraceptive she is taking, according to the American College of Obstetricians and Gynecologists.

If a physician or pharmacist switches a woman's oral contraceptive prescription for cost, insurance coverage, compliance, or any other reason, the patient should always be notified about the substitution to avoid confusion and poor compliance, said an opinion issued by ACOG's Committee on Gynecologic Practice, published n the August issue of Obstetrics and Gynecology.

Generic oral contraceptives approved by the FDA have been shown to be bioequivalent and pharmaceutically equivalent to the branded product and are interchangeable, according to the ACOG statement. There are no evidence-based data to challenge this.

However, because of possible effects on patient compliance, the ACOG committee said it supports patients' requests or clinicians' as-written prescriptions. This includes branded contraceptives or continuation of the same generic or branded drug, if the request is based on clinical experience, concerns about packaging or compliance, or if the branded product is considered a better choice for that individual patient.

Although considered clinically equivalent by the FDA, branded and generic contraceptives may differ in shape, packaging, color, flavor, and shelf life, and, of course, cost. In addition, nonactive ingredients such as preservatives, labeling, and storage requirements also may differ.

To avoid confusion and poor compliance, patients should be informed if a physician or pharmacist changes the prescription, the ACOG statement said.

A physician may prescribe a brand-name contraceptive because of the potential benefits for a specific woman who is more comfortable with the branded product, or prescribe a generic when cost or compliance is an issue, said the ACOG committee.

However, pharmacists will sometimes substitute a generic equivalent because the generic is less expensive or because a woman's insurance covers generics only, without informing the patient. The difference in price can be as much as 70% less for a generic, especially when multiple generic choices are available.

In addition, some women are skeptical about using generic medications, and changes in prescriptions can be confusing if a woman expects to use a contraceptive she is familiar with or has requested, said Steven J. Sondheimer, M.D., vice chair of ACOG's Committee on Gynecologic Practice.

According to the ACOG opinion, patients and clinicians have questioned whether generic and brand-name oral contraceptives are clinically equivalent and interchangeable, as effective in preventing pregnancy, and have similar occurrences of side effects, such as breakthrough bleeding.

Although the FDA considers generic and brand name oral contraceptives clinically equivalent and interchangeable, the statistical methods used by the FDA to determine bioequivalence have been challenged, the ACOG committee wrote.

Nevertheless, the FDA Center for Drug Evaluation and Research has taken a firm stand upholding the therapeutic equivalence and interchangeability of generic and branded products, according to ACOG.

Products are considered bioequivalent if they fall within required parameters, namely that the mean bioequivalence cannot be more than 20% lower or 25% higher, with 95% certainty. In practice, the reported ranges of generics are much narrower, the ob-gyns wrote,

Given the range of acceptable generic bioequivalence, switching between generic contraceptives or from branded to generic drugs might be associated with increased side effects or other problems, but similar problems theoretically might occur when switching between two batches made by the same manufacturer, according to the statement.

Although there are no clinical data on any difference in compliance between different branded drugs or between generic and branded drugs, patients and clinicians anecdotally report problems when switching occurs.

It is possible that side effects or pregnancy occur as a result of poor compliance because patients are confused by new packaging, fear they have received the wrong pill, or lack confidence in generics, Dr. Sondheimer's group said.

However, there are no evidence-based data addressing these issues. The FDA has pointed out that patients may be more likely to be aware of symptoms when substitutions occur or if they are told they are taking a generic drug.

"It is important that a woman be involved in the process of deciding which pill is right for her and informed if any changes are made to her prescription. Additionally, whether cost, preference, or compliance is the main factor in choosing a woman's oral contraceptive, ob-gyns should be able to prescribe the pill that is most appropriate for their patients," Dr. Sondheimer said.