Question

Topic: Safety of OTC Medications in Pregnant Women".

Select at least 5 key references to complete the Literature Review .

i. Two of these five references must be from the primary literature.

1. References selected from the primary literature must be current (e.g. published within the past 5 years).

ii. For each of the references, provide a summary of the key information that was learned and will be used from this reference in the poster.  The summary should include content consisting of calculations, study design and statistical terminology when applicable for citations. This summary should be written in your own words. If direct quotations are used, they must be included within quotation marks and correctly cited within the literature review worksheet.

Answer 1

REVIEW OF LITERATURE

Sr no	Title of the study	Author and population	Keywords and Study design	Findings and conclusions
1.	Over-the-Counter Medications in Pregnancy	Am Fam Physician. 2014 Oct 15;90(8):548-55. Servey J, Chang J	OTC medications, allergies, analgesia, NSAIDS Design: Systemic review	A lot of pregnant women take OTC medications despite the absence of RCTs to guide their use during pregnancy. In 1979, the U.S. Food and Drug Administration reviewed all prescription and OTC medications to develop risk categories for use in pregnancy. Most common indications for these medications are allergies, respiratory, gastrointestinal, or skin conditions and for general analgesia. 65% of pregnant women commonly used acetaminophen which is generally considered safe during any trimester. Cold medications are also commonly used and are considered safe for short-term use outside of the first trimester. Nonsteroidal anti-inflammatory drugs are not recommended during organogenesis and in the third trimester. Topical creams are considered safe based on small studies and previous practice. Use of all OTC medications should be first discussed with patients, risks and benefits should be balanced. Because of the expanding OTC market, formalized studies are warranted for patients to make a safe and informed decision about OTC medication use during pregnancy.
2.	Improving Safe and Effective Use of Drugs in Pregnancy and Lactation	Laura E, Alison G. Cahill, Richard Beigi, Renate Savich and George Saade Am J Perinatol 2017 Jul; 34(8): 826–832. Published online 2017 Jan 31. doi: 10.1055/s-0037-1598070	Drug safety, pregnancy, lactation, pharmacokinetics, drug surveillance Workshop Summary	In February 2015, given high rates of use of medications by pregnant women and the relative lack of data on safety and efficacy of many drugs utilized in pregnancy, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the Society for Maternal-Fetal Medicine (SMFM), the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Pediatrics (AAP) convened a group of experts to review the “current” state of the clinical care and science regarding medication use during the perinatal period. The expert panel chose selected medications to demonstrate what existing safety and efficacy data may be available for clinicians and patients when making decisions about use in pregnancy or lactation. Furthermore, these example medications also provided opportunities to highlight where data are lacking, thus forming a list of research gaps. Last, after reviewing the existing vaccine safety surveillance system as well as the legislative history surrounding the use of drugs for pediatric diseases, the expert panel made specific recommendations concerning policy efforts to stimulate more research and regulatory attention on drugs for pregnant and lactating women.Go to:In February 2015, given high rates of use of medications by pregnant women and the relative lack of data on safety and efficacy of many drugs utilized in pregnancy, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the Society for Maternal-Fetal Medicine (SMFM), the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Pediatrics (AAP) convened a group of experts to review the “current” state of the clinical care and science regarding medication use during the perinatal period. The expert panel chose select medications to demonstrate what existing safety and efficacy data may be available for clinicians and patients when making decisions about use in pregnancy or lactation. Furthermore, these example medications also provided opportunities to highlight where data are lacking, thus forming a list of research gaps. Last, after reviewing the existing vaccine safety surveillance system as well as the legislative history surrounding the use of drugs for pediatric diseases, the expert panel made specific recommendations concerning policy efforts to stimulate more research and regulatory attention on drugs for pregnant and lactating women. Keywords: drug safety, pregnancy, lactation, pharmacokinetics, drug surveillance
3.	Maternal bodies and medicines: a commentary on risk and decision-making of pregnant and breastfeeding women and health professionals.	McDonald K, Amir LH, Davey BMC Public Health. 2011 Nov 25;11 Suppl 5:S5. doi: 10.1186/1471-2458-11-S5-S5.	Health care professionals, biomedical information, cultural and societal norms. Review paper	Mostly women rely not only on biomedical information and the expert knowledge of their health care professionals but on their own experiences and cultural understandings as well. Pregnant and breastfeeding women are most of the times influenced by their families, partners and their cultural societal norms and expectations. There is a huge inherent conflict in medicine use for maternal bodies. ("Good" mothers should manage and avoid any risks, thereby protecting their babies from harm and put their children's needs before their own - they should not allow toxins to enter the body. On the other hand, "responsible" women take and act on medical advice - they should take the medicine as directed by their health professional.). The increased complexity involved when one body's actions impact the body of another - as in the pregnant and lactating body - has received little acknowledgment. For pregnant or breastfeeding women, weighing risks and benefits becomes immensely complex because the effect on two bodies rather than one, should be considered. The aim of this paper is to generate a discussion that focuses on the complexity around risk, responsibility and decision-making of medicine use by pregnant and breastfeeding women.
4.	Delphi survey of international pharmacology experts: an attempt to derive international recommendations for use of medicine in breastfeeding women.	Amir LH, Ryan K, Barnett C Breastfeed Med. 2015 Apr;10(3):168-74. doi: 10.1089/bfm.2014.0144. Epub 2015 Mar 16.	A three-round Web-based Delphi qualitative research design was used. Saftey hierarchy, classification, decision making.	There are currently no common and standard guidelines used by health professionals to aid decision-making around the use of medicines during breastfeeding and pregnancy. Several specialized books, Web sites, and drug information services exist; however, all use slightly different criteria to derive their "safety hierarchy." 17 experts (pharmacy/pharmacology and breastfeeding) identified 15 key parameters most commonly used to inform decisions about medicines and breastfeeding. Parameters about the infant were age and health of the child, and safety profile of medicine and experience of use in infants. Experts had a clear understanding of the complexity of decision-making when prescribing for breastfeeding women. Although the current number or letter classification systems do not incorporate important considerations such as infant age, a longer "descriptive text" incorporating all considerations may be impractical in busy clinical practice. Although clinicians and lay people would appreciate a simple classification scheme, in practice, decision-making about the safety of medicines for breastfeeding women is complex.
5.	Use of Over-the-Counter Medication among Pregnant Women in Sharjah, United Arab Emirates.	Abduelmula R. Abduelkarem and Hafsa Mustafa Journal of Pregnancy Volume 2017, Article ID 4503793, 8 pages https://doi.org/10.1155/2017/4503793	A cross-sectional survey	OTC medications are widely available in pharmacies and their safety profile does not extend to pregnant women. Educational programs should be developed for pregnant women. Aim. This study was planned to create awareness and assessing OTC medication usage among pregnant women in Sharjah, UAE. A self-administered questionnaire was distributed. 75.7% reported that they are familiar with the term “over-the-counter drugs.” And 40% of the respondents replied that they took OTC drugs during pregnancy, and the majority (94.2%) agreed with the survey statement “not all OTC medications are safe to be taken during pregnancy.” Most frequent side effect reported was constipation. Folic acid (36%), calcium (28.6%), and iron (35.1%) were the most common supplements used by the pregnant women. 40% usage of OTC medications among pregnant women in this study is worrisome and calls for the need to educate, counsel, and increase awareness among pregnant women regarding the dangers of OTC drugs usage while pregnant in Sharjah, UAE.