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Medication use during preconception, pregnancy and lactation: towards safe and rational use enhanced by community pharmacists' counseling

Medication use during preconception, pregnancy and lactation: towards safe and rational use enhanced by community pharmacists' counseling - Michael Ceulemans

International research has shown that pregnant and lactating women commonly use medicines. Besides medication use, women can also be exposed to other health products, such as folic acid, multivitamins and herbal remedies, as well as to substances. To reduce the risk for neural tube defects, all women trying to get pregnant are advised to start folic acid intake prior to conception. In contrast, the use of substances such as alcohol and tobacco is strongly discouraged during pregnancy and lactation due to negative obstetric, fetal and neonatal outcomes.

Pregnancy and lactation are unique situations where the benefits of pharmacological treatment have to be weighed against potential risks for the unborn or nursing infant. The available evidence suggests that pregnant women might overestimate the teratogenic risk of medicines and that their beliefs about medicines are important predictors of medication avoidance. To make informed decisions, women need reliable information about medicines. However, inaccurate information and inconsistencies between different sources have been observed, which can lead to anxiety, discontinuation of medicines or early cessation of breastfeeding. Hence, understanding of women’s beliefs about medicines and their information needs is important for healthcare professionals (HCPs) to appropriately counsel these women.

As medication experts, community pharmacists do have the potential to optimize the safe and rational use of medicines in the community setting. A specific high-risk population that would benefit from appropriate counseling on the use of medicines and health products are women trying to get pregnant, pregnant and breastfeeding women. Although the current evidence on the role of pharmacists during preconception, pregnancy and lactation is scarce, the available literature points towards lack of knowledge and inadequate counseling. To collect reliable evidence-based information regarding this topic, HCPs employed in many countries can appeal to Teratology Information Services (TIS). However, a TIS does not exist in Belgium yet.

The general objective of this PhD project was to contribute to the safe and rational use of medicines during preconception, pregnancy and lactation, including the investigation of the role of community pharmacists in this regard. The PhD project further served as needs assessment for the establishment of a TIS in Belgium.

The research project was divided into two parts. The first part aimed to collect epidemiological data in Belgium regarding the use of medicines and health products during pregnancy and, to a lesser extent, during lactation. The second part aimed 1) to explore community pharmacists’ attitudes, barriers, knowledge and counseling practice, and 2) to assess the impact of a blended learning program on pharmacists’ barriers, knowledge and counseling practice with regard to pharmaceutical care during preconception, pregnancy and lactation.

This PhD manuscript starts with a general introduction on the topic which is partially based on a narrative review that has been published as part of the doctoral research project (Chapter 1). The overall and study-specific objectives are explained in Chapter 2.

The first part of the results’ section describes the findings of the epidemiological research on medication and health products’ use during pregnancy and lactation, and consists of four chapters (Chapters 3-6). The results obtained during the PREVIM-study and described in Chapter 3 show that pregnant women living in Belgium frequently use medicines, pregnancy vitamins, and other health products. In line with this observation, the PREVIM-study pointed towards counseling opportunities as to avoid a potential risk for drug-drug interactions, exposure to inappropriate health products, purchasing health products without any medical counseling and initiation of the use of health products on own initiative. In addition, the PREVIM-study showed that preconception lifestyle changes such as folic acid intake and alcohol and smoking cessation are still poorly implemented, corroborating the need for nationwide strategies to improve preconception care in Belgium.

In Chapter 4, pregnant women’s beliefs about medicines and information needs measured as part of the PREVIM-study are reported, along with patient characteristics associated with beliefs. To collect research data, women were asked to complete the general and pregnancy-specific statements of the beliefs about medicines questionnaire. Pregnant women reported to have a higher threshold to use medicines during pregnancy compared to non-pregnant situations. About 40% of women preferred natural remedies during pregnancy. Education in healthcare and education level were the main determinants associated with beliefs, with highly educated women showing a higher threshold to use medicines during pregnancy. Furthermore, pregnant women showed high information needs, including for information about medicines during pregnancy. However, less than one third discussed online retrieved information with HCPs. This paper showed that HCPs should consider women’s individual beliefs, guide women towards reliable websites, and discuss online retrieved information and perceived risks and benefits of medicines during counseling.

In Chapter 5, the experiences of Arabic-speaking pregnant women with a migration background and living in Belgium were explored. We focused on their communication with HCPs as well as their perceptions towards HCPs and the use of healthcare products during pregnancy. The results of the 17 semi-structured interviews showed that most women were suffering from the language barrier, which hindered their communication with HCPs and had undesirable consequences on their treatment and medication use. Obviously, the communication was largely affected by the presence of interpreters. In addition, a high threshold to use medicines during pregnancy and a preference for natural remedies was observed. Overall, it was concluded that this subgroup of pregnant women is a vulnerable target group for prenatal counseling on medicines. The paper showed that, besides early dectection and willingness to help these women, HCPs should refer these women to appropriate and understandable websites and provide evidence-based information on the use of healthcare products during pregnancy. To facilitate the patient-HCP communication, strategies are highly needed to encourage these women to learn a national language and to increase their social integration.

In the absence of a TIS in Belgium, the National Poison Center might act as a substitute center for answering pregnancy and lactation related questions regarding medication use. To investigate the current role of the National Poison Center, a retrospective analysis of pregnancy and lactation related calls involving health products and received by the Belgian Poison Center between 2012-2017 was performed. The results, as described in Chapter 6, showed that the Poison Center received almost daily calls from patients and HCPs on medication exposure during pregnancy and lactation. Many questions involved over-the-counter medicines such as paracetamol and ibuprofen. However, given the safety issues related to other involved products, seeking for advice was justified. In conclusion, the study findings underlined the importance of evidence-based counseling of pregnant and lactating women, and encourage HCPs to engage more actively when counseling on the safe and rational use of medicines during pregnancy and lactation. On top of that, the findings contribute to the ongoing discussion to establish a TIS in Belgium.

The first part of the PhD project showed counseling opportunities for HCPs to optimize the safe and rational use of medicines and health products during preconception, pregnancy and lactation. In the second part of the PhD project, the counseling role of community pharmacists during preconception, pregnancy and lactation was investigated in the ECTOPIC-study. The results of the ECTOPIC-study are described in Chapter 7 and 8.

In Chapter 7, pharmacists’ attitudes, barriers, knowledge and counseling practice with regard to pharmaceutical care during preconception, pregnancy and lactation was explored. Overall, pharmacists acknowledged to have an important role in providing pharmaceutical care during preconception, pregnancy and lactation, but reported to currently not provide the presented services to most patients, which was confirmed during the mystery shopping showing inadequate information gathering, dosing errors and lack of provided information. Several barriers were identified hindering the implementation of pharmaceutical care, such as difficulties to identify the woman’s status and lack of knowledge. Likewise, challenges regarding adequate staffing of pharmacies and the role and educational background of pharmacy technicians were observed. In any case, the findings underscored the urgent need for educational programs to improve pharmacists’ knowledge and counseling on this topic.

In Chapter 8, the impact of an educational intervention (i.e. a blended learning program) on pharmacists’ barriers, knowledge and counseling practice with regard to pharmaceutical care during preconception, pregnancy and lactation was evaluated. In general, the blended learning improved pharmacists’ barriers and short- and long-term knowledge. However, pharmacists’ counseling practice only partially improved after the training, as poor information gathering, dosing errors and incomplete information was still observed. Hence, the blended learning program did not result in the full implementation of pharmaceutical care during preconception, pregnancy and lactation. The increased prevalence of barriers such as lack of privacy and lack of time after the training showed that the implementation of pharmaceutical care services is associated with other challenges besides lack of education. As pharmacists’ knowledge declined again over time, regularly repeating the content of the training is needed to maintain the newly acquired knowledge. 

In the closing chapter of the PhD manuscript (Chapter 9), the general discussion of the findings, methodological considerations, recommendations for pharmacy practice and healthcare policy, as well as future research perspectives are provided.

To conclude, the results obtained as part of this PhD project and described in this manuscript show that pregnant women in Belgium commonly use medicines and health products, despite a higher threshold to use medicines during pregnancy and high information needs about medicines. Furthermore, pregnant women may also use health products without informing their HCPs and purchase some of these products even without any medical counseling. As medication experts, community pharmacists are committed to provide pharmaceutical care during preconception, pregnancy and lactation, but admitted not to provide pharmaceutical care to most women yet, mainly due to a lack of education. A blended learning program to tackle pharmacists’ challenges did improve their knowledge and, to a certain extent, the counseling practice, although counseling opportunities still exist. From a public health perspective, the uncertainty and high prevalence of questions among patients and HCPs as well as the paucity of evidence regarding the safe and rational use of medicines during preconception, pregnancy and lactation explicitly underscore the urgent need to establish a TIS in Belgium. 

Date:21 Sep 2015 →  5 Nov 2019
Keywords:Pharmacoepidemiology, Drug safety, Pharmavigilance, Teratology, Primary health care, Drug information
Disciplines:Pharmacotherapy
Project type:PhD project