TABLE 3.
Top 5 challenges and potential solutions identified by workshop participants in aligning FA intake among women with recommendations for primary prevention of NTDs1
| Themes | Challenges | Solutions and potential implementation strategies |
|---|---|---|
| Need for additional evidence on the effective dose and duration to prevent NTDs | Different groups have developed different guidelines, in part due to gaps in the knowledge about the minimally effective dose and duration of supplemental FA for NTD prevention. Gaps are due to the following:- Evidence used for setting initial recommendations was derived from RCTs and observational studies that used the dose of FA in supplements commercially available at the time.- Because FA was traditionally given in a prenatal supplement combined with iron to prevent pregnancy-related anemia, FA was consumed for the entire pregnancy, which has influenced guidelines in regards to the duration of supplement use. | - Commitment from professional groups to have harmonized guidelines based on the best available evidence.- Harmonization of definitions of women at low, moderate, and high risk of an NTD-affected pregnancy.- Recommendations that do not fully align with the available evidence should be acknowledged in guidelines to ensure that recommendations based on judgment are differentiated from those based on a high(er) level of evidence. For example, it is recommended that prenatal supplements containing FA be consumed throughout pregnancy even though FA is required for the neural tube closure in the first trimester. |
| - The foundational RCT studies included women not consuming FA-fortified foods, so baseline folate status was likely different than that of the current Canadian and US populations. | ||
| - The foundational RCT studies supplemented with FA up to 12 wk only, so there is lack of evidence for additional health benefits of FA supplement intake beyond the first trimester. | ||
| - National surveys show that ∼20% of Canadian women of childbearing age do not have RBC folate values that provide maximal reduction of NTD risk (e.g., <906 nmol/L). It is known that the majority of these women are likely not supplement users and may benefit from supplement use, not necessarily a higher FA dose. These women need to be identified and characterized. | ||
| - Aboriginal and immigrant pregnant women are underrepresented in Canadian studies. | ||
| - Pregnant women living in remote areas (North or rural) have poor access to fresh fruit and vegetables (i.e., high cost, low availability) and FA-containing supplements. | ||
| - Women at moderate risk of an NTD-affected pregnancy are ill-defined. | ||
| - Because of the use of different study designs, each with its own limitations, and the lack of harmonization among analytic folate methods used to assess status across studies, it has proven difficult to consistently integrate and interpret data. | ||
| Supplement content inconsistent with recommendations | Despite the 2015 SOGC and Health Canada/Public Health Agency of Canada aligning their FA recommendations,it can be difficult for women to purchase supplements with the recommended doses due to the following:- Lack of availability of prenatal supplements containing the recommended 400 μg FA.- Health care providers prescribe a 1000-μg prenatal supplement because that is what is generally available in the marketplace, and they are hesitant to recommend something that is not available.- Insurance companies reimburse for prescribed supplements only, so women consume what their health care provider prescribes.- Individual supplement companies are reluctant to reduce the FA dose in their prenatal supplements because it may put them at a competitive disadvantage if they are not comparable with other products.- The 2015 SOGC guidelines maintain a dose range (400–1000 µg) for moderate-risk women so supplement companies are producing products that, in part, still meet the current guidelines.- Reformulation of a supplement is a significant undertaking for industry with associated costs; Canada is a smaller market. | - Education of both health care professionals and consumers on harmonized recommendations of FA to increase demand for products with the recommended dose. These efforts could benefit from the inclusion of women of childbearing age in the development of knowledge translation initiatives.- Reformulation should be encouraged industry-wide to mitigate risk to companies who are the first to align dose with recommendations.- Industry could take a stepwise approach to reformulation to allow sufficient time to transition prenatal vitamins to contain 400 μg FA.- Develop a multivitamin/mineral monograph specific for prenatal supplements that aligns the allowable FA content with the recommended dose of FA. Other nutrients of concern regarding pregnancy would also be included.- Change the maximum allowable over-the-counter dose of FA in supplements to 400 μg, resulting in doses ≥400 μg being available by prescription only. - Allow a label content claim on prenatal supplements indicating that the product contains the recommended dose of FA for NTD risk reduction. |
| - There is a perception among stakeholders that responsibility for supplement formulation belongs to another stakeholder, resulting in inaction regarding reformulation (e.g., industry is reluctant to initiate reformulation in the absence of regulatory requirement changes; health care professionals are unlikely to prescribe a dose that is not already available on the market). | ||
| - There is some concern that women who have low supplement-use compliance will not benefit from supplement formulations with lower doses. | ||
| Facilitating access to FA-containing supplement during periconception | Despite recommendations to consume an FA-containing supplement in the periconceptional period, many women do not consume the recommended dose (or supplements at all) because they have limited access to them. This can be due to the following:- Cost and access of prenatal supplements for women are variable across municipalities, regions, and provinces, especially for those living in poverty, who are food insecure, or living in remote locations.- Access to health care and family planning is uneven in Canada.- About half of pregnancies in Canada are estimated to be unplanned. | - FA-containing prenatal supplements (recommended dose) and contraception should be made available to all women (e.g., free of charge to those unable to purchase).- Clinicians and policymakers should develop an increased awareness of the social determinants of health that may influence the risk of an unplanned pregnancy, the ability to access FA-containing supplements, and the ability to adhere to FA recommendations. |
| Knowledge transfer | Whereas many health care professionals are aware of the FA recommendations, many others remain unaware, resulting in lost opportunities for ensuring that women consume the recommended amount of FA. Also, many women themselves are not aware of the recommendations.- The SOGC guidelines are the preferred source of information regarding FA for most health care professionals, but the guidelines are not accessible to everyone (e.g., need to pay for access to guidelines if not a member of SOGC).- There is a lower level of awareness of the new 2015 SOGC guidelines among medical subspecialists (e.g., family physicians, reproductive endocrinologists).- Many women of childbearing age are not aware of the recommendations for FA supplement use during pregnancy.- Vulnerable women such as those who are younger, are of certain ethnicities, or who have lower levels of education/socioeconomic status may be at the highest risk of lower folate status, due in part to food insecurity and low prevalence of supplement intake, and are also the least likely to be aware of FA recommendations. | - More education of the public and health care professionals regarding the recommended FA intake is needed. This could be facilitated by making guidelines more widely available and engaging stakeholders, including consumers, in the development of knowledge transfer activities.- A refreshed public health campaign on FA recommendations should adopt innovative marketing strategies (e.g., front-of-package messaging or coupons on sanitary products; shelf information at the point of purchase) and online social media that target all women of childbearing age, not just those planning a pregnancy.- FA recommendations could be packaged within an overall strategy targeting women about a healthy lifestyle and family planning.- Anticipatory guidance on FA and NTD, family planning, etc., should be routinely provided to all women of childbearing age at “well woman” visits (e.g., preventive care visits; pap exams).- More education of the public and health care professionals regarding the recommended FA intake is needed. This could be facilitated by making the guidelines more widely available and including them in sex education classes in public school and in the curriculum of health care professionals. |
| - Engage with health care professional bodies to promote the recommendations, including those for alternative and complementary medicine providers. | ||
| - Engage with the Canadian Prenatal Nutrition Program and those on the front lines delivering prenatal support to vulnerable women. Revisit preconception care guidelines to ensure they are aligned and up to date. | ||
| - Harmonization of definitions of women at low, moderate, and high risk of an NTD-affected pregnancy to facilitate health care professionals in recommending appropriate FA doses to women. | ||
| “More is better” attitude | Decades ago, micronutrient deficiencies were common in Canada, and the emphasis had been on ensuring nutrient adequacy in the population. However, this “more is better” attitude persists.- There is a low level of awareness that supplemental vitamin and mineral intake in high amounts may not provide additional benefit and might even cause harm. | - Messaging that “more is not always better” in terms of use of vitamin and mineral supplements could be incorporated into knowledge transfer solutions identified above.- It is important that messages should be positive without scaring women; the concept that 400 μg is sufficient should be emphasized. |
| - Take the opportunity to have pharmacists serve as “gatekeepers” regarding the appropriate FA dose for low-risk women. |
1FA, folic acid; NTD, neural tube defect; RBC, red blood cell; RCT, randomized controlled trial; SOGC, Society of Obstetricians and Gynaecologists of Canada.