Talk to your doctor or pharmacist to see if Class X is right for you

If you’re a women of childbearing age, a recently published study offered news you can use. Its results offered such an important message — possibly saving babies born to 17% of women taking prescription medications from risks of birth defects. But it also illustrated for the rest of us the problems of a health insurance company evaluating physicians’ practices and members’ behaviors and health using electronic databases of claims data.

Pregnant women are continually frightened by sensationalized news of ill-founded scares about dangerous things in the environment that could harm their unborn babies. Understanding the truth and myths of birth defects can help women take steps to keep their babies safe, while lessening their worries abut things where there’s nothing remotely plausible to worry about. This story actually has a valuable take-home message of a doable way women can help to protect their unborn babies.

The Associated Press provided the story about this study that found its way to some of our papers, but the issue is more complicated. It reported:

MDs don't issue pregnancy, drugs warning

Doctors aren't doing a very good job of warning young women to avoid getting pregnant when they're taking prescription drugs that can cause birth defects, a new study suggests. Nearly half of the women taking the medicines didn't get counseling from their doctor about using contraceptives or other birth control measures, University of Pittsburgh Medical Center researchers found in a study of nearly 500,000 women.

“The message is not that women should avoid taking prescription medications that they need and that their doctors recommend," said Dr. Eleanor Bimla Schwarz, lead author of the study in Tuesday's Annals of Internal Medicine. But women should discuss the potential pregnancy risks with their doctors before taking the drugs, she said.

The researchers noted that the study might overestimate the problem because the data is from health plan billing codes, which don't have the same detailed medical histories as patient medical charts. Some doctors may have provided counseling but didn't bother to mark it with a billing code. Even with its limitations, they say, it's clear that lots of women aren't getting the message about avoiding pregnancy while taking certain drugs. Medicines that may cause birth defects include some antibiotics, acne medications, cholesterol reducers, anti-seizure drugs, sleep aids and blood thinners.... The Food and Drug Administration classifies drugs into categories of whether they're safe or potentially harmful to developing fetuses. But the reality for busy doctors often means they don't consult the FDA listings, Schwarz said....

To start off, this study didn’t actually know if doctors were warning young women about risks of getting pregnant when taking meds or not, as it didn’t examine any medical records.

Rather than automatically blame doctors or feel afraid to trust your doctor, this study did indicate why it’s important for women, and all patients, to be their own advocates. Prescription and over-the-counter meds, as well as dietary supplements, aren’t things to take lightly. It’s important for us to educate ourselves about what we put into our bodies and to remember that while we may take a pill for a possibly beneficial effect, all medicines also come with (side) effects we might not want. The risks and benefits need to be weighed with every medicine.

The FDA classifies drugs into five categories. Two were examined in this study: classes D and X, which identify potentially teratogenic medications. A class D medication is a drug for which there is evidence of fetal risk but “the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.” Class X medications are “contraindicated in women who are or may become pregnant.” More than 11.7 million prescriptions for these two possibly teratogenic classes of medications are written every year just for women of reproductive age in the United States, said the researchers.

This study was a retrospective (looking back) through Kaiser Permanente’s electronic databases on women of childbearing ages in northern California who had continuous membership during 2001. They compared prescriptions filled through Kaiser’s pharmacy benefit program, clinical billing claim records to see if the ICD code for contraceptive counseling had been checked, and pregnancy tests done through the Kaiser Permanente Northern California laboratories. This is an example of how electronic databases can be used by insurers to track the behaviors and compliance of doctors and patients. One can only imagine how things like this will impact doctors’ performance-based compensations and ratings.

The researchers wanted to see how many of these women had received documented counseling about the need for contraceptives, or who had become pregnant, while taking class D or X prescription medications. A few caveats about this study are important to help keep it in perspective.

· It bears repeating that this study may have overestimated the problem of not counseling about contraceptives, because not every doctor may have checked it off on their claim form filed with Kaiser to have been considered “documentation.” A claim form is not the same as a medical record.

· There is also controversy among professionals as to the teratogenic risks of some medications; the fact that most meds haven’t been tested on pregnant women making decision-making difficult; the reliability of the classification system and whether a single letter can adequately summarize the clinical issues and scientific data; and especially, what medications necessitate preventing pregnancy, the authors noted.

· The researchers also had no way of knowing how many women had done home pregnancy tests, which may have led to them underestimate the number of pregnancies. Nor did they have any way of knowing how many women wanted to get pregnant, even knowing the risks.

· And most of the prescription medications filled by these women of childbearing age had no evidence of being possibly harmful to their babies. A total of 801,354 filled prescriptions fell into these classes (A and B).

Women of childbearing age in this cohort filled 177,663 prescriptions for class D medications and 32,641 prescriptions for class X medications, just at the Kaiser Permanente Northern California pharmacies. That made up 14.2% and 2.8%, respectively, of the prescriptions these young women filled through Kaiser. The researchers reported that just over half of these women had filled class D or X medications without any contraceptive method dispensed through Kaiser, with no record in their database of having been sterilized, and with no documentation of contraceptive counseling in the previous 2 years on claim records.

While hearing that 2.8% of prescriptions filled by women of childbearing age were for medications contraindicated during pregnancy is concerning, we don’t know the full story. How many were medically essential? How many of these women were sexually active heterosexually, and they or their partners were taking measures to prevent pregnancy? Only the women know for sure. How many women had discussed the risks with their doctors and wanted to get pregnant anyway? Based on claim records, it appears about half of those taking class D and X drugs hadn’t been counseled by their doctors about taking measures to avoid becoming pregnant. That doesn’t mean they hadn’t been. But what supports that this number may be closer to reality, is that prescriptions for contraceptives (devices, implants, injections and pills) and previous sterilizations were equally likely among the women filling prescriptions for class A and B drugs — drugs without any teratogenic risks.

On the other hand, the percentages of prescriptions filled for certain class D or X meds where there was no documentation about contraceptive usage were oddly high. For example, a stunning 72% of cancer agents, 70% of statins, 69% of immunologic agents and 68% of anticonvulsants filled had no contraceptive use on billing or pharmacy records. It’s difficult to imagine that doctors wouldn’t have taken special care with such high-risk medications and noted it on the actual medical records. This may most point out the dangers and inaccuracies of using insurer electronic databases and claims records as measures of clinical practice or patient health.

Regardless of the level of counseling, however, the most troubling finding was the number of women who actually became pregnant within 3 months of filling a prescription for a class D or X drug, even just based on Kaiser laboratory positive pregnancy tests: 1.64%. This pregnancy rate was almost no different from women taking class A or B prescriptions. But this figure also needs to be viewed carefully.

Regrettably, the authors didn’t break down these 3,449 pregnancies as to class D or X prescriptions, or follow the women to see how many continued taking the prescriptions after filling their prescriptions or becoming pregnant, how many might have had abortions fearing birth defects, and how many babies were born with birth defects. Meaningful information on the real life impact for these young women. More importantly, they had no way of knowing if the women had wanted to get pregnant knowing the risks, and the medical decision had been made that they needed those medications and they were working with their doctors to minimize risks to their unborn baby. Every situation is unique. The healthplan billing records and database was being used to second guess the doctors’ practice of medicine and their members’ decisions.

The take-home message isn’t that doctors are necessarily incompetent or that insurers know best. It’s that women do become pregnant while taking prescription meds, meds that are generally not recommended, or are contradicted, for use during pregnancy. The most-prescribed class D and X medications among these young women (used by 12%) were antidepressants. And about half of all pregnancies in the United States are unintended. If you’re a women who could possibly become pregnant, you don’t want to wait until you know you’re pregnant to look out for yourself and your unborn baby.

Talking and working with your doctor, ideally before becoming pregnant, and maintaining good communication throughout pregnancy, can enable your doctor to modify the use of medications to help ensure a safe pregnancy. He/she can also provide another source for more information to make informed choices about medication use. You and your doctor, working with a dysmorphologist, if need be, can also help weigh the risks and make the soundest decisions. Gather all the information you can. It is your body and you have the final decision.

A review published last fall in the Maternal Child Health Journal, led by Dr. Janet D. Cragan with the National Center on Birth Defects and Developmental Disabilities at the CDC, noted that it’s not always possible to avoid taking medications during pregnancy. Pregnant women get sick and need medications and “in many other cases, proper treatment of a chronic condition during pregnancy may be safer for both the woman and her baby than stopping this treatment.”

It’s not recommended to just stop taking all medications when you become pregnant, because that can have “profound, long-term implications both for [your] health and that of [your] baby,” Dr. Cragan and colleagues cautioned. Effective management of conditions prior to pregnancy, and close medical supervision during pregnancy can help assure the best possible outcome for a woman and her baby, they advise. Nonessential medications can and should be avoided; necessary medications known to be harmful to the embryo or fetus can be adjusted to minimize exposure; and the dose, route of administration and timing can be adjusted at each stage of pregnancy to help keep you healthy while safeguarding your unborn baby.

With so many prescriptions, and new safety information continually being released, if you have questions about the teratogenic risks of a medication you’re taking or are considering taking, you can also talk to the professionals who have the most readily available and up-to-date information: your local pharmacists. Few consumers realize that they are another available resource about medications.

And don’t forget to take equal care with herbals and dietary supplements, which can also impose risks to unborn babies and pregnant women. Pharmacists will be able to help with those, too. While supplements aren’t regulated, multiple resources are at their fingertips. One of the top herbal references, Herbal Medicines, has just released its third edition for health professionals.

Acting on fear alone can lead us to make unwise choices to take or not take medications. Information is power.

© 2007 Sandy Szwarc