Binny Thomas

Medication used in Nausea and Vomiting of Pregnancy - A Review of Safety and Efficacy

Nausea and vomiting are common symptoms experienced by 50– 90% of women’s in early pregnancy. ‘Morning sickness’ is a misnomer frequently used to describe nausea and vomiting in pregnancy (NVP), although the symptoms may persist the whole day and/or night. Pregnant women experience these symptoms mainly in the first trimester between 6 and 12 weeks of gestation, few of them continue till 20 weeks of gestation while in few others it continues throughout the pregnancy. The problem peaks at 9-week gestation, and approximately 60% of NVPs resolve by the end of first trimester. In a very small minority of these patients, the symptoms become severe leading to dehydration, weight loss, excessive vomiting, and mandate hospital admission; this condition is known as Hyperemesis Gravidarum. Fairweather D.V proposed the most widely used definition of Hyperemesis Gravidarum (HG). He defined HG based on the symptoms, vomiting exceeding three times a day with significant ketonurea or weight loss more than or equal to 5% of pre pregnancy weight, electrolytic imbalance or fluid depletion, and onset occurs at 4 to 8 weeks of pregnancy till 14 to 16 weeks. Nausea and vomiting in pregnancy is of multifarious etiology (fluctuating levels of progesterone, estrogens, Thyroid Stimulating Hormone (TSH), slow peristaltic movement of Gastrointestinal (GI) tract); however, the exact mechanism remains still unclear. Given the uncertainty in treatment of NVPs, both patients and healthcare practitioners often fear the use of antiemetic medications in pregnancy due to the potential risk to fetus and mother. The manifestation of nausea and vomiting in pregnancy is different among each woman, so its management should be tailored similarly. An early treatment of nausea and vomiting is important and beneficial since it prevents a more severe form of occurring, or a possible hospitalization, and prevents both emotional and psychological problems. It is very important for the women and the healthcare providers to understand that a safe and effective NVP treatment benefits both fetus and mother, thus all the treatment options should be open and considered. Nonetheless, given the widespread prevalence of nausea and vomiting, its adverse effects and effects on psychological conditions of pregnant women, it is necessary to be treated effectively and safely during embryonic and fetal developmental stages. First trimester exposure is important to be assessed to monitor the teratogenic potential of the drug; however, randomized control trials are rarely conducted for pregnant women for ethical reasons. Whereas the epidemiological studies done are observational and lack population strength to establish safety and risk involved. This review will mainly focus on pharmacological drugs used in treatment of NVP, and explore their safety and efficacy and evidence based practice. There have been many studies examining the safety of drugs used in NVPs and few of them are covered in this review. The dietary, lifestyle modifications, and nonpharmacological approaches are not covered in this section.

Overview of pharmacovigilance practices at the largest academic healthcare system in the State of Qatar

Adverse Drug Reactions (ADRs) are major global concern, adversely impacting patient safety and health outcomes. ADRs cause significant morbidity and mortality among hospitalised patients, causing greater length of hospital stay, increased healthcare costs and patient dissatisfaction to the treatments. Pharmacovigilance (PV), a process of detecting, monitoring and preventing drug-related harm, plays a vital role to ensure patient safety. ADR reporting is the cornerstone of PV. PV practices in Qatar are relatively new and are evolving rapidly. The purpose of this article is to explore the medication safety practices (notably ADR reporting) at the largest academic healthcare center in Qatar. The article further provides evidence on how information related to ADRs are generated and interpreted. Furthermore, it describes how a designated center for monitoring medication safety activities was established at the largest healthcare provider in Qatar.

Misoprostol for miscarriage management in a woman with previous five cesarean deliveries: a case report and literature review

Background Misoprostol is an effective medical method for the management of pregnancy loss. However, data on its efficacy and safety in women with previous cesarean deliveries are limited. Case presentation We report a 36-year-old patient, gravida 11 para 6, with a diagnosis of missed miscarriage at 15 weeks of gestation. The patient had a significant obstetric history of previous five cesarean deliveries and uterine rupture. Following patient counseling about the medical and surgical options of managing her miscarriage, the patient opted for medical method. Low-dose misoprostol of 100 µg was inserted vaginally and repeated again after 6 hours. The patient had an uneventful complete miscarriage following the second dose of misoprostol. No uterine rupture, no extra vaginal bleeding, and no blood transfusion were observed. Conclusion We conclude that adopting a low-dose misoprostol protocol could be potentially safe and effective in managing second trimester missed miscarriage in women with repeated cesarean deliveries and/or uterine rupture history. Further studies are needed to confirm these results.

A retrospective drug use evaluation of cabergoline for lactation inhibition at a tertiary care teaching hospital in Qatar.

BACKGROUND Breastfeeding is considered as gold standard for infant nutrition and should be interrupted only when a compelling indication exists. Certain medical conditions such as abortion, stillbirth, HIV infection, or infant galactosemia and certain medications such as chemotherapy necessitate lactation inhibition to protect the health of mother and infant. Drug use evaluation (DUE) studies are done to explore the current practice in a setting and help to identify areas in which further information and education may be needed by clinicians. OBJECTIVE The aim of this study was to conduct a DUE of cabergoline to assess indications for lactation inhibition, dosage regimen, and its safety. METHOD A retrospective cross-sectional DUE study was conducted over a period of 4 months from September 1, 2013, till December 31, 2013, at the Womens Hospital, Qatar. All cabergoline prescriptions written for lactation inhibition within 10 days of delivery or abortion were included in the study. A descriptive data analysis was undertaken. RESULTS Of the 85 patients included, stillbirth (50.6%) was considered as the main reason for lactation inhibition, followed by abortion (27.1%) and neonatal death (12.9%). The remaining 9.4% of the patients had live baby, and the majority of them were prescribed cabergoline for lactation inhibition because their maternal medical conditions required the use of drugs with insufficient safety data (n=6). Seventy-four percent of patients received cabergoline at accurate time and dose. However, 14% of the patients had preexisting hypertensive disorder and 58.3% of them were diagnosed as uncontrolled hypertension. CONCLUSION The current DUE study found that cabergoline was mainly used to inhibit lactation for patients with stillbirth, abortion, and neonatal death. In mothers who use medications for other medical conditions, benefits and risks of breastfeeding should be carefully balanced before prescribing cabergoline. Current prescribing pattern can be further enhanced through informing health care providers regarding appropriate cabergoline dosage regimen and its safety in patients with uncontrolled hypertension.

Exploring facilitators and barriers to medication error reporting among healthcare professionals in Qatar using the theoretical domains framework: A mixed-methods approach

Background There is a need for theory informed interventions to optimise medication reporting. This study aimed to quantify and explain behavioural determinants relating to error reporting of healthcare professionals in Qatar as a basis of developing interventions to optimise the effectiveness and efficiency of error reporting. Methods A sequential explanatory mixed methods design comprising a cross-sectional survey followed by focus groups in Hamad Medical Corporation, Qatar. All doctors, nurses and pharmacists were invited to complete a questionnaire that included items of behavioural determinants derived from the Theoretical Domains Framework (TDF), an integrative framework of 33 theories of behaviour change. Principal component analysis (PCA) was used to identify components, with total component scores computed. Differences in total scores among demographic groupings were tested using Mann-Whitney U test (2 groups) or Kruskal-Wallis (>2 groups). Respondents expressing interest in focus group participation were sampled purposively, and discussions based on survey findings using the TDF to provide further insight to survey findings. Ethical approval was received from Hamad Medical Corporation, Robert Gordon University, and Qatar University. Results One thousand, six hundred and four questionnaires were received (67.9% nurses, 13.3% doctors, 12.9% pharmacists). Questionnaire items clustered into six components of: knowledge and skills related to error reporting; feedback and support; action and impact; motivation; effort; and emotions. There were statistically significant higher scores in relation to age (older more positive, p<0.001), experience as a healthcare professional (more experienced most positive apart from those with the highest level of experience, p<0.001), and profession (pharmacists most positive, p<0.05). Fifty-four healthcare professionals from different disciplines participated in the focus groups. Themes mapped to nine of fourteen TDF domains. In terms of emotions, the themes that emerged as barriers to error reporting were: fear and worry on submitting a report; that submitting was likely to lead to further investigation that could impact performance evaluation and career progression; concerns over the impact on working relationships; and the potential lack of confidentiality. Conclusions This study has quantified and explained key facilitators and barriers of medication error reporting. Barriers appeared to be largely centred on issues relating to emotions and related beliefs of consequences. Quantitative results demonstrated that while these were issues for all healthcare professionals, those younger and less experienced were most concerned. Qualitative findings highlighted particular concerns relating to these emotional aspects. These results can be used to develop theoretically informed interventions with the aims of improving the effectiveness and efficiency of the medication reporting systems impacting patient safety.

Perspectives of healthcare professionals in Qatar on causes of medication errors: A mixed methods study of safety culture

Background There is a lack of robust, rigorous mixed methods studies of patient safety culture generally and notably those which incorporate behavioural theories of change. The study aimed to quantify and explain key aspects of patient safety culture which were of most concern to healthcare professionals in Qatar. Methods A sequential explanatory mixed methods design of a cross-sectional survey followed by focus groups in Hamad Medical Corporation, Qatar. All doctors, nurses and pharmacists were invited to complete the Hospital Survey on Patient Safety Culture (HSOPS). Respondents expressing interest in focus group participation were sampled purposively, and discussions based on survey findings using the Theoretical Domains Framework (TDF) to explain behavioural determinants. Results One thousand, six hundred and four questionnaires were received (67.9% nurses, 13.3% doctors, 12.9% pharmacists). HSOPS composites with the lowest levels of positive responses were non-punitive response to errors (24.0% positive) and staffing (36.2%). Specific TDF determinants potentially associated with these composites were social/professional role and identity, emotions, and environmental context and resources. Thematic analysis identified issues of doctors relying on pharmacists to correct their errors and being reluctant to alter the prescribing of fellow doctors. There was a lack of recognition of nurses’ roles and frequent policy non-adherence. Stress, workload and lack of staff at key times were perceived to be major contributors to errors. Conclusions This study has quantified areas of concern relating to patient safety culture in Qatar and suggested important behavioural determinants. Rather than focusing on changing behaviour at the individual practitioner level, action may be required at the organisational strategic level to review policies, structures (including resource allocation and distribution) and processes which aim to promote patient safety culture.

Incidence, nature and causes of medication errors in hospitalised patients in Middle Eastern countries: A systematic review

Background and aim: Medication errors (MEs) are a major global issue, adversely impacting patient safety and health outcomes. Promoting patient safety through minimising MEs is therefore a key global healthcare objective. This study aims to systematically review the incidence, nature and causes of MEs in hospitalised patients in Middle Eastern countries. Method: A systematic search of studies related to MEs originated from Middle Eastern countries was performed using the following databases: MEDLINE, EMBASE, International Pharmaceutical Abstracts, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Cochrane Database of Systematic Reviews (CDSR), Centre for Review and Dissemination (CRD) database, Joanna Briggs Institute Library. A systematic review protocol was developed and registered with the Centre for Reviews and Dissemination (CRD). The title, abstract and full article were screened for inclusion. Each paper was assessed by two reviewers for methodological quality prior to inclusion in the review. Studies were critically appraised prior to data extraction and findings synthesised using a narrative approach. Results: Database searching identified 2611 studies; 51 met the inclusion criteria and originated from nine of fifteen Middle Eastern countries, largely Iran, Saudi Arabia and Israel. Preliminary review results indicate error incidence rates of between 11 and 90% of patients (depending on the method of data collection), with the categories of errors reported being mostly prescribing errors followed by administration, dispensing and transcribing. Deficiencies in staff knowledge, lack of experience, insufficient training, poor adherence with protocols and policies, miscommunication and excessive workload were identified as major causative factors. Conclusion: MEs occur at high rates of incidence in the Middle East. Causes of errors are multifactorial and should be targeted in future interventions, which are likely to be complex interventions at varying levels within the healthcare systems. This project is funded by QNRF (NPRP project NPRP–388-3-095).

Is pyridoxine effective and safe for post-partum lactation inhibition? A systematic review

It has been suggested that pyridoxine has an antilactogenic effect. Studies of the efficacy of pyridoxine in suppressing lactation have reported conflicting results. The aim of this review was to evaluate the effectiveness and safety of high‐dose pyridoxine in post‐partum lactation inhibition.

A case of probable esomeprazole-induced transient liver injury in a pregnant woman with hyperemesis.

We report a case of 22-year-old primigravida presented to Women’s Hospital – Hamad Medical Corporation emergency with severe epigastric pain, nausea, and vomiting. On admission, she was dehydrated with remarkably worsening symptoms. Laboratory findings revealed significantly elevated liver enzymes with unknown etiology. Her past medical history showed an admission for nausea and vomiting 3 weeks previously and she was discharged on antiemetics, and esomeprazole for the first time. Due to the predominantly elevated liver enzymes, the clinical pharmacist discussed the possibility of esomeprazole-induced adverse effects and suggested to suspend esomeprazole based on the evidence from literature review. The liver enzymes showed a substantial improvement within days after the discontinuation of the drug; however, a rechallenge was not done since it could have adversely affected the mother or the fetus. Using the Naranjo Adverse Drug Reaction Probability scales, the adverse reaction due to esomeprazole was classified as “probably”.