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

FIRST REVIEW OF LITERATURE

In the year 2016, a cross-sectional survey was conducted by Abduelmula R. Abduelkarem¹ and Hafsa Mustafa² to assess the level of awareness and knowledge of pregnant women (of varying trimesters) concerning OTC drugs. The study took place in the Emirate of Sharjah, UAE at four different clinics/hospitals , over a period of three months (October to December 2016). 140 questionnaires were distributed to 140 pregnant patients visiting the clinic. The only inclusion criteria for this study was the patient’s ability to understand either English or Arabic. The survey was divided into six sections :Personal information (Q1–Q6),  level of knowledge (Q7–Q10), past and current medication use (Q11-Q12), past and current medication use (Q11-Q12), current health status of the pregnant women (Q13-Q14), information on previous children (Q15) born & assessment of over-the-counter drug use (Q16–Q19). At the completion of the study, 31 participants who consented and agreed were provided with information about OTC drugs in the form of short paragraphs via the mobile application WhatsApp. This information was available in both English and Arabic and was provided to the consenting patients in accordance with their preferred language. Test-retest reliability was calculated using Spearman’s correlation coefficient (r). The rho value was found to be 0.87, which implies an acceptable level of test-retest reliability. The participants’ responses were encoded and the data were analyzed using Statistical Package for the Social Sciences (IBM SPSS Statistics for Windows, version 20.0, IBM Corp., Armonk, NY, USA). Descriptive analysis was used to calculate the response proportion of each group of respondents for each item in the questionnaire. Public responses options to the survey questions related to education level, use of over-the-counter drugs, medical history, and over-the-counter drug and vitamin use were reduced to three categories: yes, no, and sometimes. This enabled more reader comprehensible confidence intervals for the relative proportions to be calculated. The level P< 0.05 was considered as the cut-off value for statistical significance. The reported 40% usage of OTC medications among pregnant women in this study is high and not healthy. The perception of the safety of herbal drugs among the pregnant women is worrisome. There is a need to educate, counsel, and increase awareness among pregnant women regarding safe OTC drug and herbal medicine use while pregnant in Sharjah,

SECOND REVIEW OF LITERATURE

In the year 2018 January, a formative research study was conducted on Making Decisions About Medication Use During Pregnancy: Implications for Communication Strategies by Molly M. Lynch, Linda B. Squiers & Katherine M. Kosa et al. This study was conducted with a purposive sample of women who took medication during pregnancy or who were planning a pregnancy in the upcoming year and were taking prescription medication.The main objective of this study was to explore women’s perceptions of the risks and benefits associated with medication use during pregnancy and to better understand how women make decisions related to medication use in pregnancy. A total of 48 women from across the United States participated in six virtual focus groups, and 12 of these women participated in follow-up telephone interviews. Our analysis indicated that participants had gaps in their knowledge about their medication use during pregnancy and that they were concerned about the health of their child, their own health, and the unknown risks of medications. In addition, results identified participants’ needs and preferred sources of information about medication use during pregnancy and determined how participants would use this information to make decisions

THIRD REVIEW OF LITERATURE

Am Fam Physician, conducted a study on Over the counter medications in Pregnancy, in the year 2014, and found that many pregnant women take over-the-counter (OTC) medications despite the absence of randomized controlled trials to guide their use during pregnancy. Most data come from case-control and cohort studies. In 1979, the U.S. Food and Drug Administration began reviewing all prescription and OTC medications to develop risk categories for use in pregnancy. Most OTC medications taken during pregnancy are for allergy, respiratory, gastrointestinal, or skin conditions, as well as for general analgesia. Acetaminophen, which is used by about 65% of pregnant women, 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. Many gastrointestinal medications are now available OTC. Histamine H2 blockers and proton pump inhibitors have not demonstrated significant fetal effects. Nonsteroidal anti-inflammatory drugs are generally not recommended in pregnancy, especially during organogenesis and in the third trimester. There are even fewer data regarding use of individual herbal supplements. Ginger is considered safe and effective for treating nausea in pregnancy. Topical creams are considered safe based on small studies and previous practice. All OTC medication use should be discussed with patients, and the effects of the symptoms should be balanced with the risks and benefits of each medication. 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.