Substance abuse services for pregnant women: the Buffalo experience

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Reproductive Toxicology

In 229,000 1985-1992 hnks, the following maternal cholesterol-towering agent outcomes were obtained (number with birth defect diagnoses m parentheses)

Niacin Probucol Gemfibrozd Cholestyramme Lovastatln

First trimester 25 (2) 11 9 4 3 (1)

Any t~me m pregnancy 87 (2) 13 15 (1) 37 II (1)

Of the 51 first trimester recipients, 3 offspnng had birth defect diagnoses The 2 defects with niacin have not been defined as they were not "sentinel" defects A cardiovascular defect was among the 3 lovastatm rec~pients One of the 15 maternal gemfibrozll linked to a pediatric structural brain defect, but first trimester history was unavailable It would be Important to know about weight-for-dates relative to exposures any time in pregnancy, but this information is unavailable m Med~cmd There were no recipients anytime in pregnancy for colestlpol, clofibrate, fluvastatln, slmvastatln, or pravastatln

Volume 8, Number 5. 1994

Probucol, trade name Lorelco, is a hpophdlc cholesterol-lowering agent, unrelated to the other agents It has been avadable since 1977 It does not have ammal teratogenlclty and ts labeled pregnancy category B Despite this category, the labeling does not recommend use during pregnancy, unless clearly needed REFERENCES 1 Wysowskl DK, Kennedy DL, Gross T Prescribed use of cholesterol-lowenng drugs in the Umted States, 1978 through 1988 JAMA 1990,263 2185-8 2 Bresow J Hypercholesterolemta In Buyse ML, ed Birth defects encyclopedm Cambridge, Massachusetts Blackwell SctentlfiC Pubhcatlons, 1990 898-9 3 Committee on Nutrmon, American Academy of Pedmtncs Indications for cholesterol testing in children Pediatrics 1989,83 141-2 4 Goldstem JL, Brown JS Familial hypercholesterolemm In Scnver C et al, eds The metabohc basis of inherited disease New York McGraw Hill, 1989 1215-50 5 Center for Environmental Health and Injury Control Predicting future cholesterol levels for coronary heart d~sease risk assessment MMWR 1989,38 364-6 6 Rosa F. Baum C Computerized on-hne pharmaceutical survedlance system (COMPASS) teratology Reprod Toxlcol 1993,7 639-40

FDA drug experience case reports FDA has four retrospective reports of birth defects suspected to be associated with first trimester exposures to these agents

Dlsclatmer This is not an official FDA statement or a posmon on the safety of these agents

1 Lovastatm

Aortic hypoplasm, cerebral ventrlcular septal defect with cerebral dysfunction, fatal 2 Lovastatm Anal atresla and renal dysplasm 3. Lovastatm Short forearm, absent thumb, thoracic scohosls 4 Gemfibrozd Pierre Robin syndrome Cholesterol agent pregnancy labeling and usage

Lovastatm, trade name Mevacor, an HMG CoA reductase inhtbltor, available since 1987, is currently the most widely used agent It is labeled pregnancy category X, although animal teratogenicity is negative The pregnancy labehng of human experience is limited to a mention of "rare reports of congemtal anomalies following intrauterine exposure " Stmvastattn, trade name Zocor, fluvastatm, trade name Lescol, and pravastatm, trade name Pravachol, are more recently marketed HMG CoA reductase agents, carrying a pregnancy category X label like lovastatm Gemfibrozd, trade name Lopld, a fibnc acid derivative available since 1982, IS less effective against hypercholesterolemla and IS not recommended for managing the congenital condmon It is labeled pregnancy category C because ofammal teratogeniclty Clofibrate, trade name Atrom~d-S, is another fibrlc acid derivative, but its use has been largely superceded by gemfibrozd Cholestyramlne, trade name Questran, IS a bile acid sequestrant available since 1973 It is widely used currently but is not absorbed systemically and is not expected to cause fetal harm Colesttpol, trade name Colestld, is another bile acid sequestrant, less widely used than cholestyramme

Substance abuse services for pregnant women: the Buffalo experience. S Gangell, L K Robinson Teratology Information Service of Western New York, Wllhamsvllle, NY

Objectme Despite the recognition of the teratogenlc and fetopath~c effects of alcohol and cocaine, prenatal exposures to these agents continue m hlgh-nsk populattons A review of our telephone inquiries for the calendar year 1993 showed that only l 5% of our calls arose from individuals or health care providers m the communities defined as high risk Moreover, none of these involved inqmnes concerning alcohol or cocaine As a commumtybased TIS, we sought to organize a communlty-w~de effort to impact effectively on this problem With support from the Center for Substance Abuse Prevention, we orgamzed a group of community professionals representing such disciplines as social services, taw enforcement, education, and substance abuse services to come together and contribute to an lnterd~sclphnary project that would focus on three high-risk populations m Buffalo, New York This group is formally known as the Commumty Actmn Team on Maternal Addictions (aka Catbirds) Method The Catbirds developed a survey geared toward identifying existing services and gaps In services for pregnant women who use alcohol or other drugs in the three high-risk areas defined by New York State as the Neighborhood Based Alhance (NBA) The survey was mailed to providers that serve the NBA, using a voluntary mailing

Abstracts

Results. Of 140 surveys sent, 32 (22%) have been returned to date (2/28/94) Prehmlnary results indicate 38% of agencies queried provide services to pregnant women who use alcohol or other drugs Twenty-five percent of agencies that do not provide services to this population asserted that there IS an inadequate number of resources to which referrals could be made The remaining 75% of the agencies that do not provide services referred the target population to the same three agencies, which identify themselves as being filled to capacity None of the agencies responding to this survey provides support services for the male partners or other family members of these women Although referral centers exist for children prenatally exposed to cocaine, identification and followup of chddren with fetal alcohol syndrome were considered by respondants to be inadequate Prenatal screening for alcohol and other drug abuse was found to be inconsistent, with self-report bemg the most common indication for screening Concluslons The deficiency of resources, particularly with respect to service provision in high-risk areas, may contribute to the overrepresentatlon of FAS and other teratogen-lnduced disabilities among the poor, often minority populations. Our team has documented specific service needs In the high-risk population and has committed to work together using a common language, minimizing institutional boundaries that interfere with critically focuslng on the problem For the TIS, our involvement in this group has broadened our focus to better appreciate the breadth of the problem of drug use m pregnancy and the role our program serves in this effort

Substance abuse campaigns: what are the risks? L Martlnez Utah Pregnancy RtskLlne, Salt Lake City, UT. During the 10 years the Pregnancy RaskLlne has been providing teratology information, a recurring theme among clients has emerged Every week, at least one pregnant woman or family member contacts our program with significant concern generated by educational materials aimed at reducing the fetal risks of maternal behaviors, most usually regarding the use of alcohol, tobacco, or illicit substances The typical call is from a woman who is pregnant, has read, seen, or heard something about the need to avoid a particular drug, chemical, or infectious agent, and has already been exposed, usually before she realized she was pregnant. Many of these women are referred to the RlskLme by one of the two abortion providers in the state, when they call to make appointments for pregnancy terminations based on fears generated by these materials. Others are referred to us by prenatal diagnostic centers in the state when there are demands for procedures to determine if harm has befallen the fetus because of maternal exposure to something discussed in a prevention campaign. The vast majority (at least 90%) of these callers are not at increased risk based on the exposure of concern The materials to which these women are reacting are often seen or obtained in clinical settings. Many of the pamphlets, brochures, and counselling facihtles and other medical sites are aimed at women who are either not pregnant or assume the pregnant woman has not yet used

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or been exposed to any of the agents discussed by the materials. Phrases such as, "There is no known safe level of alcohol consumption dunng pregnancy Even small amounts, especially at the beginning of a pregnancy, can harm the developing child"; "Illicit drug use by pregnant women, particularly in the first trimester, can cause permanent brain damage in her child", or " W h e n a mother smokes cigarettes while she's pregnant, she puts her baby at risk for Sudden Infant Death Syndrome" are Intended to alert the pubhc to the possible problems of drug abuse during pregnancy These retentions often go awry when the message is received by a woman who has had a few drinks in the first couple of weeks of her pregnancy or who has been smoking marijuana occasionally or tobacco on a regular basis Since the messages are so general, it is very possible, even likely, for these women to personahze them and to assume that the statements apply to their pregnancies and babies Most of these educational resources are based upon assumptions that have been shown to be erroneous, first, that women do not know that alcohol, tobacco, and other drugs of abuse can cause problems for a fetus, second, that if the woman knows about the risks, all she needs to change her risky behavior is a reminder, and, third, that based upon this information, she will simply change. The substance abuse literature, as well as literature related to FAS, has indicated repeatedly that the keys to prevention are far more complicated than lack of information. Information, however emotional and inaccurate, is available in abundance A discussion of these issues is intended to provoke those of us providing teratology information to evaluate the materials we use and the messages we promote

OTIS and the communication industry: risks and benefits. A K Stem, E Pergament Illinois Teratogen Information Service, Chicago The November 1993 issue of Baby Talk magazine contained an article entitled, "Hothne, Some of the Biggest Questions Pregnant Women Have About Exposures That Could Harm the F e t u s - - A n d the World of Hothnes Designed to H e l p . " The telephone numbers of TISs located throughout the United States were listed at the end As a direct consequence, inquiries to the Illinois TIS increased 50%, with a corresponding 63% increase in the number of different exposures about which people expressed concerns This experience was likely to be similar to that of other TISs Based on the number of inquiries, the article certainly generated many questions but, how many of these exposures were of any biologic significance 9 In our experience, virtually none TOne immediate consideration is whether or not the " m e d i a " generate unnecessary fear in pregnant women And, ff so, does the benefit of increasing a pregnant woman's knowledge regarding teratogens and TISs outweigh the potential risks, for example, unnecessary anxiety culminating in elective termination of an unaffected pregnancy ~ Specific case reports will be cited During the 1990s, it is to be expected that the Influence and impact of the communication Industry will markedly expand and that the public's interest concernlng potential teratogens will parallel this expansion The question then IS, " W h a t should be the role of OTIS