File Name: drugs used in obstetrics and gynecology .zip
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- Marijuana Use During Pregnancy and Lactation
- Drug Treatment in Obstetrics
- Postpartum Pain Management
Marijuana Use During Pregnancy and Lactation
Metrics details. Estimating the true risk of fetal malformations attributable to the use of medications is difficult and perception of risk by health professionals will impact their counseling and treatment of patients who need medication during pregnancy.
Medians and interpercentile ranges of the perceived background risk and perceived risks for each of the drugs were included in the questionnaire. Estimates provided by the participants were generally in accordance with current knowledge of drugs with established safety during pregnancy. Perceptions of risks associated with warfarin and retinoid exposure were severely underestimated.
Understanding of teratogenic background risk and specific risks associated with in utero exposure to 12 different drugs generally approached the established knowledge. The risk associated with warfarin and retinoid exposure was severely underestimated by both groups of health care professionals, while general practitioners specifically overestimated the risk of sertraline and citalopram to some extent. In Denmark, general practitioners can prescribe antidepressants, and even minor misconceptions of the teratogenic potential of citalopram and sertraline may be of clinical relevance.
In Denmark, systemic retinoids can only be prescribed by a dermatologist, and warfarin treatment is only rarely initiated in women of the fertile age without involvement of specialists in internal medicine. Peer Review reports. Knowledge about the risk of medications being teratogenic became apparent after the thalidomide disaster [ 1 , 2 ] some 50 years ago. The tragedy gave rise to concerns on the safety of drugs during pregnancy and prompted international agencies to develop systematic preclinical reproductive testing protocols [ 2 ].
Estimating the true risk of fetal malformations attributable to the use of medications is difficult and controversial. While randomized controlled trials are seen as the gold standard for assessing safety and efficacy of medications, pregnant women are routinely excluded from such trials [ 3 ].
This places a heavy reliance on observational studies and pharmacoepidemiological data to provide evidence in support of informed decision making on medication use during pregnancy [ 3 ]. Perception of risk by health professionals will impact their level of counseling and treatment of patients who need medication during pregnancy.
Overestimating this risk can lead to insufficient treatment of patients, whereas underestimating may lead to hazardous practice. Legal medical issues may additionally complicate matters, and in case of Bendectin such issue led to the market withdrawal of a documented safe and effective product [ 4 ]. Perceptions of risk by patients impact their decision on whether or not to use medicine during pregnancy, and the risk perceived by patients has been shown to be heavily dependent on the information received from their physician [ 5 — 7 ].
The demographic characteristics, patterns of health care utilization and medication use are very homogenous in Denmark, and the Region of Southern Denmark compares well to other regions [ 16 ]. Information was gathered by anonymous self-completed questionnaires. An invitation to the study, including a link and a code to the questionnaire, were sent to the study participants by mail.
Email addresses could not be obtained as the respective organizations declined to release email addresses for the purpose of this study. The online questionnaire was accessible from November 19, to February 28, Translations of the cover letter to participating physicians and the questionnaire are provided in Additional file 2.
The participants were asked to estimate the overall risk of malformations in the background population. To evaluate the perception of the teratogenic risk of specific medications during pregnancy, the participants were asked to give their best estimate based on their active knowledge. The survey comprised drugs with documented no or minor increased risks of teratogenicity phenoxymethylpenicillin, metoclopramide, citalopram and sertraline representing selective serotonin reuptake inhibitors SSRIs , benzodiazepines, inhalation glucocorticoids, fluconazole, and lamotrigine [ 17 — 19 ], one drug with insufficient data for risk estimation quetiapine [ 20 ] and drugs with documented increased risk retinoids, warfarin and thalidomide [ 17 — 19 ].
No more than a 1. For all drugs, the most common trade names were stated in the questionnaire together with the generic names. The questionnaires were analyzed by standard non-parametric descriptive statistics, using STATA release Among the remaining GP, 28 had answered less than half the questions, 24 had answered more than half but not all questions and 91 had answered all questions.
Sensitivity analysis with respect to numbers of questions answered did not alter the results data not shown. A substantial proportion of responders had entered values for risks associated with specific drug exposure as excess risk relative to background risk rather than absolute risks. In these cases, values entered for teratogenic risks associated with specific drug exposures were lower than the values entered for the overall background risk. In such cases, we added the risk value entered for risk associated with the specific drug exposure to the value entered for the overall background risk.
Generally, the median values of risk perception indicate a realistic perception of drugs with established safety. Distribution of perceived background risk. Perception of background risk and for drugs with no or minor excess risk.
Statistically significant p - values are indicated. Perceptions of risk for known teratogenic drugs. Statistically significant p -values are indicated. This is one of the largest systematic surveys on risk perception following in utero exposure to drugs among health care professionals reported in the literature, and the only study reporting on a nation-wide basis. Generally, our results demonstrate a better understanding of teratogenic potential that otherwise reported in the literature.
Damase-Michel et al. Contrary to these rather substantial overestimations, 74 Norwegian GP, assigned low values below 1. The overall reasonable risk estimates from the responders in our study may to some extent be attributed to selection bias see study limitations below , but dissemination of relevant information in a systematic and useable form is likely a contributing factor [ 23 — 25 ].
The by far most commonly used Danish drug information resource by health care professionals was completely restructured in with respect to pregnancy and lactation recommendations [ 19 ].
Numerous data are available and a recent comprehensive meta-analysis documented more than 56, exposed pregnancies [ 21 ]. This analysis found no overall increased risk of major congenital malformations OR 1. A complete analysis from register data in all Nordic countries comprising almost exposed pregnancies found largely comparable estimates. The overall major malformation risk was slightly increased OR 1. Interestingly, the latter signal disappeared completely in a subsequent sibling-controlled analysis.
The EUROCAT data were not subject to any covariate control analysis, and may be subject to reporting and observer bias as these data are typically only reported from certain regions in participating countries. This is quite different from the Nordic dataset, which represents a complete cohort of all exposed pregnancies in the Nordic countries [ 22 ].
It should be noted that there is some overlap of data among these studies, as data from the Nordic countries to a varying degree contribute to all three analyses. While overall no clinically important risk of major congenital malformations following first-trimester in utero exposure to SSRIs has materialized from the best meta-analyses available, a slightly increased relative risk of cardiovascular malformations appears consistently reproduced.
One study suggests that confounding by indication be an issue as identical signals were found for pregnant women pausing SSRI treatment during pregnancy [ 30 ]. Ascertainment bias may contribute to these observations as well [ 31 ]. The clinical significance of this increase in absolute risk of cardiovascular malformations is subject to much controversy, though most do not believe it to preclude medical treatment [ 32 — 34 ].
Treating physicians are sometimes poorly helped by regulatory information that often leads to confusion: At the time this survey was performed, different pregnancy labeling existed for generic variations of citalopram in Denmark.
None of these adhered to the guideline on pregnancy labeling given the data at hand [ 37 ]. This discrepancy has later been corrected by the Danish Health and Medicines Authority. The perception of teratogenic potential has a direct influence on patient compliance, and misconceptions may lead to unwarranted discontinuation of antidepressant treatment [ 38 , 39 ]. Thus, even minor misconceptions of the teratogenic potential of citalopram and sertraline may be of clinical relevance.
This is in contrast to other studies in which these same risks were grossly overestimated [ 10 , 11 ]. In Denmark, systemic retinoids can only be prescribed by a dermatologist, and warfarin treatment is rarely initiated in women of the fertile age without involvement of specialists in internal medicine deep venous thrombosis or cardiologists heart valve replacement [ 40 ].
Lamotrigine is considered safe during pregnancy, except at very high doses, as substantial amounts of data do not suggest an increased risk of unwanted fetal effects [ 41 ]. Lamotrigine treatment is primarily initiated by specialists within psychiatry or neurology, and the active knowledge on lamotrigine's teratogenic potential among other healthcare professionals may not be adequate.
Anticonvulsants have generally been associated with teratogenic potential, especially carbamazepine, valproate and phenytoin [ 41 , 42 ]. This study comes with a number of limitations. While the absolute number of responders is high compared to most other relevant studies, the response rates in our questionnaire are unimpressive but comparable to those of another recent study [ 15 ].
We also have no way of determining whether in fact responders only used actual knowledge or made use of reference sources while filling out the questionnaire.
Bias in both cases would likely be conservative as invitees may be more inclined to respond if they feel that their actual knowledge on the subject would be clinically sufficient. We were unable to analyze results from responders and non-responders according to demographic characteristics of interest such as age, sex, or length of medical experience. Accordingly, generalization of our results should be made with caution.
In conclusion, responders to this survey demonstrated an understanding of teratogenic background risk and specific risks associated with in utero exposure to 12 different drugs that generally approached established knowledge. The risks associated with warfarin and retinoid exposure were severely underestimated by both groups of health care professionals, while GP specifically overestimated the risk of sertraline and citalopram. McBride WG. Thalidomide and congenital abnormalities.
Letter to the editor. Thalidomide: the tragedy of birth defects and the effective treatment of disease. Toxicol Sci. Erratum in: Toxicol Sci. Investigating outcomes associated with medication use during pregnancy: A review of methodological challenges and observational study designs. Reprod Toxicol. Brent RL. Bendectin and birth defects: hopefully, the final chapter. Birth Defects Res Part A.
Use of antidepressants by pregnant women: evaluation of perception of risk, efficacy of evidence based counseling and determinants of decision making. Arch Womens Ment Health. Medicines information needs during pregnancy: a multinational comparison.
BMJ Open. Impact of physician counseling and perception of teratogenic risks: a survey of 96 nonpregnant women with anxiety. Perception of risk regarding the use of medications and other exposures during pregnancy. Eur J Clin Pharmacol. Pregnant women's beliefs about medications-a study among Norwegian women. Ann Pharmacother. Perception of teratogenic risk of common medicines.
Drug Treatment in Obstetrics
A more recent article on this topic is available. Related Editorial. Pregnant women commonly use over-the-counter medications. Although most over-the-counter drugs have an excellent safety profile, some have unproven safety or are known to adversely affect the fetus. The safety profile of some medications may change according to the gestational age of the fetus. Because an estimated 10 percent or more of birth defects result from maternal drug exposure, the U. Food and Drug Administration has assigned a risk category to each drug.
Ergometrine, known as 'Ergot' is an ergot alkaloid medication. It became routine to use it to treat postpartum haemorrhage (PPH). It is an uterotonic drug that.
Postpartum Pain Management
Drugs are used in over half of all pregnancies, and prevalence of use is increasing. The most commonly used drugs include antiemetics, antacids, antihistamines, analgesics, antimicrobials, diuretics, hypnotics, tranquilizers, and social and illicit drugs. Despite this trend, firm evidence-based guidelines for drug use during pregnancy are still lacking. However, few well-controlled studies of therapeutic drugs have been done in pregnant women.
Read terms. El-Sayed, MD. Pain can interfere with a woman's ability to care for herself and her infant. Untreated pain is associated with a risk of greater opioid use, postpartum depression, and development of persistent pain. Nonpharmacologic and pharmacologic therapies are important components of postpartum pain management.
A Handbook of Prescribing
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