ABSTRACT
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Objective
Food for special medical purpose (FSMP) has become essential in clinical nutrition care. However, comprehensive data on FSMP utilization practices among healthcare professionals in South Korea are limited. This study aimed to investigate perceptions, current practices, and needs regarding FSMP among healthcare professionals.
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Methods
A mixed-methods approach was employed, combining a cross-sectional survey of 417 healthcare professionals (47 physicians, 219 nurses, and 151 dietitians) from 90 institutions with focus group interviews of 24 Nutrition Support Team members from six institutions. Data were collected from May to October 2025.
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Results
Substantial interphysician variability was observed in documentation for enteral formula prescriptions. Infusion rates were documented in 9.2% of the physician orders; feeding method was recorded in 14.1%. Across all professional groups, diarrhea was the most common reason for changing enteral formulas (36%–39%). In education related enteral formulas, 59.6% of the physicians expected dietitians to educate patients; however, this role was most commonly performed by nurses (59.8%). Dietitians prioritized hygiene (66.9%) and safety (64.2%) when selecting products, and 84.1% of the institutions were providing oral nutritional supplements.
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Conclusion
These findings highlight the need for standardized prescription documentation, evidence-based feeding protocols, and clearly defined professional roles in multidisciplinary frameworks, to optimize FSMP utilization.
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Keywords: Enteral nutrition; Health care surveys; Focus groups; Surveys and questionnaires
INTRODUCTION
In the evolving landscape of clinical medicine, the paradigm of patient care has been profoundly transformed. Although diagnostic accuracy and pharmacological treatment have advanced remarkably, the nutritional status of patients continues to determine recovery and clinical outcome. Food for special medical purpose (FSMP) or enteral nutrition (EN) is not merely considered a supportive adjunct to medical therapy, rather it has emerged as a core therapeutic modality that modulates disease pathophysiology and metabolic responses; ultimately improving prognosis [
1]. The transition from passive “nutrition support” to active “nutrition therapy” represents a critical recognition that targeted nutrition is essential to mitigate the detrimental effects of disease-related malnutrition (DRM). DRM results from inadequate intake or impaired absorption of nutrients, leading to alterations in body composition, specifically reduction in fat-free mass and body cell mass, ultimately decreasing physical and cognitive function and worsening clinical outcomes [
2].
The clinical efficacy of FSMP is most pronounced in patients with severe catabolic stress, such as those admitted to the intensive care unit (ICU) or undergoing major surgical procedures. In clinical situations where oral intake is either impossible or inadequate, disease-specific or high-protein formulations serve as crucial immunometabolic support, functioning as both an immune defense and a metabolic stabilizer [
3]. Early EN, initiated within 24 to 48 hours of injury or surgery, attenuated the catabolic response, preserved intestinal mucosal integrity to prevent bacterial translocation, and reduced mortality significantly [
4]. Meta-analytic evidence indicates that critically ill pediatric patients who received early EN had an up to 64% lower risk of mortality than those who received delayed nutritional intervention [
5]. Collectively, these findings underscore the role of FSMP not merely as a nutritional option but as an essential therapeutic component integral to survival and recovery.
FSMP plays a vital role in managing chronic conditions such as cancer, diabetes, and chronic obstructive pulmonary disease. These diseases induce chronic inflammation that dramatically alters patients’ nutritional requirements in addition to what a normal diet can provide [
6]. Specialized formulations of FSMP designed for specific disease states help minimize metabolic stress while optimizing nutrient utilization, leading to shorter hospital stays and lower readmission rates. From a health economics perspective, the systematic management of DRM through targeted FSMP interventions represents a key strategy for achieving healthcare sustainability. In Europe, DRM imposes an annual economic burden of more than €10 billion, primarily due to extended hospitalization and associated complications. Conversely, proactive nutritional therapy reduced acute care costs by approximately $2,818 per patient within the model timeframe of 6 months ($63,228 in the intervention group vs. $66,045 in the control group) through reduced infection rate and shorter length of stay, which decreased resource utilization [
7].
Consistent with global trends, South Korea faces a similar urgency due to its rapidly aging population and the increasing burden of chronic disease. This escalating clinical demand has catalyzed a significant expansion in the domestic FSMP sector. According to the Food and Drug R&D Issue Report published by the National Institute of Food and Drug Safety Evaluation, the production value of FSMP in South Korea reached 98.2 billion Korean won in 2021, demonstrating a compound annual growth rate of 30.4% from 2019 to 2021 [
8]. This market expansion was further accelerated by a strategic decision made by the Ministry of Food and Drug Safety in 2020 to reclassify FSMP as an independent food category and establish disease-specific standards. Such growth indicates a rising dependency on specialized nutritional management in hospitals and long-term care facilities.
Providing optimal nutrition to patients unable to meet their nutritional needs represents a practical application of the ethical principles of beneficence and non-maleficence [
9]. As utilization patterns of FSMP continue to evolve among healthcare professionals and patients, it has become increasingly important to understand how FSMPs are utilized in clinical practice. Therefore, this study conducted a field survey to investigate the actual use of FSMP products in hospitals and long-term care facilities, followed by in-depth interviews with three key professional groups—physicians, nurses, and dietitians—to examine their perceptions and needs regarding patient-tailored nutritional formulas. The findings are expected to provide foundational evidence for developing strategies that enhance the clinical application of FSMP and inform the design of products that meet clinical demands better.
METHODS
Ethics statement
This study was approved by the Institutional Review Board of Hanyang Women’s University (No. AN01-202505-HR-001-01). Data collection was conducted from May to October 2025. All participants were provided with a written study information sheet containing the research purpose, procedures, voluntary participation, confidentiality measures, and research team contact information. Written informed consent was obtained from all participants before they completed the questionnaires and participated in focus group interview (FGI). Participants were informed that they could withdraw from the study at any time without penalty. For the survey, consent was confirmed through signed consent forms; for FGI, written consent was obtained before each interview session.
Study design
This study employed a mixed-methods approach, combining a cross-sectional survey with FGI, to investigate healthcare professionals’ perceptions, utilization practices, and needs regarding FSMP in South Korea. The quantitative survey was conducted to assess the perceptions of healthcare professionals who prescribe or administer FSMP in clinical settings. Qualitative FGI was to evaluate factors influencing FSMP utilization in clinical practice. This study was conducted by the Korean Society of Clinical Nutrition from February to November 2025. Funding support was provided by the Ministry of Food and Drug Safety.
Study participants
Survey participants were recruited using convenience sampling. The target was to collect 520 questionnaires from ≥130 healthcare institutions nationwide, including at least 20 tertiary hospitals, 30 general hospitals, 50 long-term care hospitals, and 30 long-term care facilities. Hospital lists categorized by grade were obtained from the Ministry of Health and Welfare and Health Insurance Review and Assessment Service. Cooperation was requested through the research team’s network from professional associations (e.g., Korean Dietetic Association). Long-term care hospitals and facilities were recruited through contact with regional public health centers and welfare organizations. The survey targeted healthcare professionals including physicians who prescribe FSMP and nurses and dietitians who directly provide prescribed FSMP to patients. To enable comparison of perceptions across all professional groups, recruitment efforts ensured that all professional groups responded from each participating institution.
For FGI, participants were recruited using purposive sampling to ensure diversity and maximize representativeness. Following the distribution of cooperation request letters, institutions that voluntarily agreed to participate were prioritized for selection. To ensure institutional quality and standardization of nutrition care practices, selection criteria required either Nutrition Support Team (NST) certification from the Korean Society for Parenteral and Enteral Nutrition or healthcare accreditation from Korea Institute for Healthcare Accreditation. A total of six institutions were selected based on hospital type and geographic region as follows: one tertiary hospital, one general hospital, and one long-term care hospital from the capital region and one each from noncapital regions. One physician, nurse, and dietitian each most closely involved in FSMP prescription and administration was selected to participate in the interviews. To prevent conflicts of interest, the researchers’ affiliated institutions were excluded from the selection. The FGI participants consisted of NST members from multidisciplinary teams directly involved in FSMP prescription and administration. A total of 24 participants were selected from six institutions, with one expert from each of the four professional groups (physician, nurse, dietitian, and pharmacist) per institution.
Survey and interview instruments
A structured questionnaire was developed to assess healthcare professionals’ perceptions and needs regarding FSMP. Three versions of the questionnaire were developed to reflect the roles and work characteristics of the three professional groups. Survey items were derived through literature review and expert consultation. Physician and nurse questionnaires comprised the following four domains: institutional characteristics and respondent demographics, perceptions, current FSMP utilization practices, and needs assessments. The dietitian questionnaire included an additional domain on oral nutrition supplements (ONS) utilization practices, totaling five domains.
The physician questionnaire consisted of 27 items covering institutional characteristics (5 items), FSMP classification and labeling (7 items), enteral formula utilization practices (13 items), and FSMP needs (2 items). The dietitian questionnaire consisted of 30 items covering institutional characteristics (8 items), FSMP classification and labeling (4 items), enteral formula utilization practices (11 items), ONS utilization practices (1 item), and FSMP needs (6 items). The nurse questionnaire consisted of 23 items covering institutional characteristics (6 items), FSMP classification and labeling (7 items), and enteral formula utilization practices (10 items).
Survey items were constructed using multiple-choice, 5-point Likert scale, and open-ended questions. Content validity was verified through consultation meetings with clinical nutrition experts and literature analysis. The final survey showed <5% nonresponse and inappropriate responses, indicating sufficient reliability of the survey responses. The FGI interview guide was designed with reference to the Consolidated Criteria for Reporting Qualitative Research checklist [
10]. The final FGI questionnaire was developed through three internal research team meetings, three review meetings, and expert consultation. Interview items were structured to include FSMP prescription, utilization practices, problems, and development needs.
Survey data were collected in May–September 2025 using both online and offline methods. Information letters and questionnaires were sent to each healthcare institution by mail, and respondents could choose to submit surveys either online or offline. For offline submissions, completed questionnaires and consent forms were photographed and submitted. For online submissions, respondents completed a Google forms questionnaire and consent form using QR code. Questionnaires were requested to be submitted within 2 weeks of receipt when possible.
FGI sessions covered roles and experiences in NST, current status of FSMP prescription and utilization, FSMP needs, and utilization and management practices. Interviews were conducted for 60 to 90 minutes per institution with NST healthcare professionals. All interviews were audio-recorded with participant consent. The recordings were transcribed verbatim without omissions. Meaningful statements that aligned with the research objectives were extracted from the transcripts and categorized based on similar or common content.
Statistical analysis
Survey data were analyzed using IBM SPSS ver. 29.0 (IBM Corp.). Descriptive statistics were used to summarize participant characteristics, perception levels, utilization practices, and needs. Categorical variables were presented as frequencies and percentages.
RESULTS
Participant characteristics
A total of 417 questionnaires were collected from 210 healthcare institutions nationwide, including 26 tertiary hospitals, 56 general hospitals, 85 long-term care hospitals, and 43 long-term care facilities. The institutional response rate was 161.5% of the target 130 institutions (210 institutions), and the questionnaire response rate was 80.2% of the target 520 questionnaires (417 questionnaires).
Characteristics of study participants are presented in
Table 1. A total of 417 healthcare professionals participated in the survey, comprising 47 physicians (11.3%), 219 nurses (52.5%), and 151 dietitians (36.2%). The most common age group was 40–49 years (35.2%), followed by 30–39 years (32.6%). The majority had 10–20 years of clinical experience (36.7%), with 18.9% having ≥20 years of experience. Notably, physicians had a higher proportion of those with ≥20 years of experience (27.7%) than nurses (21.0%) and dietitians (13.2%).
By hospital type, respondents were distributed as follows: general hospitals (37.6%), long-term care hospitals (30.7%), tertiary hospitals (21.6%), and long-term care facilities (10.1%). Distribution patterns varied by professional group. In tertiary hospitals, 36.2% physicians, 18.3% nurses, and 21.8% dietitians responded. In general hospitals, 51.1% physicians, 33.8% nurses, and 39.1% dietitians responded. In long-term care hospitals, 12.7% physicians, 39.7% nurses, and 23.2% dietitians responded. In long-term care facilities, 8.2% nurses and 15.9% dietitians responded. No physician responded from long-term care facilities.
To ensure nationwide representativeness, respondents were recruited from healthcare institutions located across all administrative regions. Seoul (28.3%) and Gyeonggi-do (25.2%) had the highest participation rates, followed by Gyeongsang-do (20.1%).
Perception of FSMP classification and labeling
Perceptions of FSMP classification and labeling requirements are presented in
Table 2. Overall, 93.5% of the respondents were aware that EN products are classified separately as FSMP and pharmaceuticals, with similar awareness across all professional groups (physicians 93.6%, nurses 93.2%, and dietitians 94.0%). However, awareness levels of the FSMP classification system under the Korea Food Code varied by profession. Dietitians showed the highest awareness, with 64.9% responding “aware,” whereas the highest proportions of physicians (63.8%) and nurses (52.1%) responded “somewhat aware.”
Understanding basic labeling information varied by professional group. When combining “fully understand” and “understand” responses, dietitians showed the highest comprehension at 98.7%, followed by nurses (86.3%) and physicians (85.1%). Overall satisfaction with current FSMP labeling was 66.2%. By professional group, dietitians (68.2%) and nurses (67.6%) showed similar satisfaction levels, whereas physicians showed lowest satisfaction level (53.2%).
Regarding areas needing improvement, “too much information, complex” (37.2%) and “font size too small to read” (34.1%) were the most frequently cited concerns. Nurses most frequently cited complexity (41.1%), whereas dietitians most frequently cited small font size (35.8%). Physicians uniquely reported higher rates of “cannot easily find needed information” (19.1%) and “insufficient information provided” (8.5%). Regarding the usefulness of nutritional composition information for FSMP product selection, 77.9% of the respondents found it helpful. Nurses showed the highest positive response rate (81.3%), followed by dietitians (74.8%) and physicians (72.3%).
Current practices in enteral formula and ONS
Current practices in enteral formula prescription, administration, and patient education are presented in
Table 3. Regarding prescription documentation, the most frequently recorded information across all professional groups was calories/volume (physicians 21.2%, nurses 24.7%, and dietitians 30.4%), followed by volume per feeding or daily volume (physicians 20.1%, nurses 22.2%, and dietitians 23.7%) and formula name (physicians 18.5%, nurses 19.4%, and dietitians 27.0%). Infusion rate was the least frequently documented item (physicians 9.2%, nurses 7.2%, and dietitians 3.9%).
Nurses were identified as the primary administrators of enteral formula across all groups by 59.2% physicians, 46.4% nurses, and 38.9% dietitians. Notably, dietitians reported family members or caregivers as primary administrators at a higher rate (47.1%) than physicians (29.6%) and nurses (30.8%).
Regarding responsibility for patient education, 59.8% of the nurses and 62.3% of the dietitians identified nurses as the primary educators; however, 59.6% of the physicians identified dietitians as the primary educators.
Physicians’ criteria for enteral formula selection at admission and discharge are presented in
Table 4. At admission, the most common selection criterion was NST consultation recommendations (50.8%), followed by products available through meal prescription (38.1%) and products available through medication prescription (11.1%). At discharge, NST consultation recommendations were the most common criterion (38.5%), followed by medication prescription products (32.7%) and meal prescription products (28.8%). Notably, the proportion prioritizing medication prescription products increased from 11.1% at admission to 32.7% at discharge.
Institutional characteristics and meal service by hospital type are presented in
Table 5. The number of beds was highest in tertiary hospitals (1,111±393 beds), followed by general hospitals (540±214 beds); long-term care hospitals (255±130 beds); and long-term care facilities (98±35 beds). Length of stay was longest in long-term care hospitals (362±362 days) and shortest in tertiary hospitals (7±3 days).
Monthly meal service volume was highest in tertiary hospitals, with 28,029±2,144 meals/month for regular diet meals; 16,355±1,101 meals/month for therapeutic diet meals; and 4,408±459 meals/month for enteral formula meals. Sterile diets were provided only in tertiary and general hospitals.
Daily enteral formula prescription volume ranged from 290±177 to 1,985±635 kcal/day in tertiary hospitals; 363±218 to 1,905±593 kcal/day in general hospitals; 794±443 to 1,706±340 kcal/day in long-term care hospitals; and 1,042±306 to 1,308±320 kcal/day in long-term care facilities.
Dietitians’ considerations for enteral formula product selection for inventory are presented in
Table S1. This item was administered to dietitians only. When selecting enteral formula products for the hospital inventory, dietitians rated hygiene as the most important factor (66.9% responded with “very important”), followed by safety (64.2%), patient compliance (62.3%), and nutrient composition (61.6%). More than one-half of the dietitians considered clinical efficacy (55.0%), convenience of delivery (52.3%), and cost (50.3%) as very important. By contrast, sensory evaluation received the lowest importance rating by dietitians. Sensory evaluation was considered very important by only 31.8%; 24.5% were “neutral,” and 4.0% considered it “not important.”
The provision of ONS in healthcare institutions is presented in
Table S2. This item was administered to dietitians only. Among dietitian respondents, 84.1% reported that their hospitals provide ONS to patients, whereas 15.9% reported that their hospitals do not provide ONS. Regarding the provision form, the most common method was “included in the meal plan and provided in original packaging” (44.5%), followed by “provided separately from meals at the discretion of physicians or dietitians” (25.7%); “provided as a one-time sample during nutrition education” (12.6%); and “included in the meal plan and served in separate dishes” (11.0%).
Reasons for enteral formula modification and barriers to product procurement are presented in
Table 6. Diarrhea was the most common reason for enteral formula modification across all professional groups (physicians 39.3%, nurses 36.6%, and dietitians 36.9%). Aspiration risk was the second most reported reason among physicians (17.0%), nurses (13.0%) and dietitians (15.9%). Other reported reasons included total caloric requirements; malnourished patients; underlying diseases (e.g., diabetes, hemodialysis); vomiting; changes in disease status (e.g., hypoalbuminemia, renal function deterioration); change in treatment modality; and nutrient composition.
Reasons for delays in procuring enteral formula products varied by professional groups. Nurses most frequently reported “exceeds the reimbursement limit for enteral formula meal costs, making it difficult to use due to hospital budget constraints” (31.4%), whereas dietitians most frequently reported “difficulty in inventory management for products with low usage frequency” (40.1%). Physicians reported similar rates for budget constraints (23.0%), limited storage space (23.0%), and difficulties in inventory management (27.0%). Notably, dietitians reported higher rates of difficulties in inventory management for low-frequency products (40.1%) than physicians (27.0%) and nurses (27.0%). Conversely, nurses reported higher rates of budget constraints related to reimbursement limits (31.4%) than physicians (23.0%) and dietitians (21.8%).
Needs and requirements for FSMP products
To assess healthcare professionals’ needs for FSMP, surveys were conducted with 47 physicians and 151 dietitians. Regarding the need for enteral products in addition to those listed in the Korea Food Code, physicians rated high-calorie, high-protein products as the most needed, with 42/45 (93.3%) valid respondents indicating the product was “very needed” or “needed.” High-calorie products and products for patients who were critically ill or had metabolic stress rated second, with 40/46 (87.0%) valid respondents each. Products for patients with inflammatory bowel disease (IBD) ranked fourth, with 39/47 (83.0%) valid respondents. High-protein products for pediatric patients ranking fifth, with 36/45 (80.0%) valid respondents.
Among dietitians, products for patients with IBD showed the highest demand, with 133/151 (88.1%) valid respondents indicating very needed or needed. High-calorie, high-protein products ranked second, with 131/151 (86.8%) valid respondents. Products for wound healing ranked third, with 120/151 (79.5%) valid respondents. Products for pediatric patients who were critically ill or patients with metabolic stress ranked fourth, with 118/150 (78.7%) valid respondents. High-calorie products ranked fifth, with 118/151 (78.1%) valid respondents.
Both professional groups showed high demand for high-calorie, high-protein products and products for patients with IBD. Additionally, physicians showed high demand for products for patients who were critically ill or patients with metabolic stress, whereas dietitians showed additional high demand for products for wound healing.
Qualitative findings from FGI
FGI was conducted for the detailed analysis of FSMP utilization in clinical settings. A total of 24 participants from six healthcare institutions (three each in the capital region and noncapital regions) participated, including six physicians, six nurses, six pharmacists, and six dietitians. By hospital type, two tertiary hospitals (2,809 and 1,004 beds), two general hospitals (777 and 600 beds), and two long-term care hospitals (555 and 413 beds) participated. Four of the participating institutions operated NST. One of the tertiary hospitals operated a 30-member NST, divided into adult and pediatric teams due to a high proportion of pediatric patients, that performed approximately 500 consultations per month. The other tertiary hospital had a single 22-member team handling 500 consultations per month. The two general hospitals operated smaller NST teams of 4 and 18 members, performing 120 and 170 consultations per month, respectively. Monthly NST consultation numbers were based on May-July 2025 data.
The mean NST activity experience of participants was 9.9 years, with nurses having the longest experience (12.5 years), followed by physicians (11.2 years), dietitians (11.0 years), and pharmacists (4.8 years). Nurses showed the widest range of experience (5–25 years), followed by physicians (8–20 years), dietitians (3–23 years), and pharmacists (2–7 years). The two long-term care hospitals did not have formal NST structures; therefore, years of work experience were recorded instead of NST activity years.
NST operations in tertiary and general hospitals are governed by healthcare accreditation standards and the Ministry of Health and Welfare’s “Intensive Nutrition Therapy Fee” reimbursement criteria, with team composition and professional roles institutionally defined. A multidisciplinary team comprising physicians, clinical dietitians, nurses, and pharmacists provides comprehensive nutrition management for hospitalized patients at risk of malnutrition, patients requiring EN, or patients requiring parenteral nutrition (PN). Professional roles are institutionally defined as follows: physicians determine diagnosis and treatment direction and bear final prescription responsibility; pharmacists manage the composition, stability, and interactions of medications and PN formulations; nurses monitor EN/PN administration and patient status; and dietitians develop intervention plans based on nutritional assessment and provide nutrition education to patients and caregivers.
Among the four institutions with formal NST structures, the frequency of rounds and conferences varied according to the circumstances of institutional operations. Generally, patient status was reviewed and adjusted through weekly team rounds and monthly conferences, and FSMP prescription and modification decisions were made comprehensively through multidisciplinary consultation. By contrast, long-term care hospitals are not required to establish NST under healthcare accreditation standards and are not eligible for the Ministry of Health and Welfare’s “Intensive Nutrition Therapy Fee” reimbursement. Consequently, there are no institutionally mandated formal NST structure and defined professional roles. However, FGI results revealed that nutrition management is conducted individually according to hospital staffing and operational circumstances. Informal collaborative systems among attending physicians, nurses, dietitians, and pharmacists existed in practice. FSMP prescription, modification, and monitoring for patients receiving EN or PN were conducted through ad hoc consultations rather than regular rounds.
According to the literature review conducted as part of this study (as of August 2025), seven companies manufacture and sell FSMP in South Korea, with approximately 162 products available in the market. However, FGI results revealed that only a portion of these products is used in hospitals. The number of supplying companies ranged from 2 to 5 per participating institution, and the number of FSMP products in use ranged from 7 to 37. Tertiary hospitals used the most diverse range of products (14 and 37 products), followed by long-term care hospitals (12 and 15 products) and general hospitals (7 and 14 products). Products classified as pharmaceuticals, such as Encover (JW Pharmaceutical Co.) and Harmonilan (Yungjin Pharmaceutical Co.), which are separately procured and managed, were excluded from this analysis.
Thematic analysis of FGI data identified two major categories related to FSMP prescription criteria as follows: product selection and initial prescription and product modification (secondary prescription). Regarding product selection and initial prescription, each institution primarily prescribed enteral feeding based on a patient’s disease according to institutional dietary prescription guidelines. Dietary prescription guidelines presented criteria by disease name rather than product name. NST consultations reviewed formula appropriateness, prescription volume, and delivery rate, with adjustments made as needed according to treatment direction and clinical symptoms (e.g., diarrhea, vomiting, and reflux).
Regarding product modification (secondary adjustment), prescriptions were based on disease criteria but modified according to treatment direction and clinical symptoms (e.g., glycemic control issues, digestive intolerance, and difficulty reaching target volume), with changes made to formulation type, concentration, and fiber content. In long-term care hospitals, there were many cases of switching to high-calorie, high-protein formulations based on clinical indicators such as pressure ulcer and weight loss.
Although various FSMP formulations are utilized according to disease, treatment direction, and clinical symptoms, FGI participants noted that product utilization flexibility is not fully ensured due to limitations in formulation and volume options as well as economic and regulatory constraints. Semantic unit analysis identified commonly reported limitations.
The first limitation was product volume constraint. Participants reported that available volumes do not meet the diverse needs of patients. Ready-to-hang products are primarily limited to 400 mL, making stepwise volume increase during initial adaptation difficult and causing high wastage. For canned enteral products, which are generally fixed at 200 mL, some long-term care hospitals reported practices of prescribing and providing based on product volume.
The second limitation was insufficient diversity in available oral products. Participants reported that the monotonous taste and texture of the products led to decreased compliance with long-term consumption in patients with cancer, older patients, and patients with malnourishment. They indicated a need for new formulations, such as clear beverage types, rather than cloudy, viscous soy milk forms, warm porridge types, and stick-type jellies.
The third limitation was economic burden and regulatory constraint. High patient costs and lack of insurance coverage were identified as major barriers. Regulatory restrictions on product availability and procurement procedures were reported to further limit access to products.
The fourth limitation was restricted access to post-discharge care and follow-up management. Participants expressed concerns about patients’ ability to continue FSMP consumption after discharge, citing difficulties in product procurement and absence of follow-up support systems.
The final limitation was limited patient and caregiver awareness. Lack of understanding about the importance and use of FSMP in patients and caregivers was identified as a barrier to optimal utilization and compliance. According to the participants, educational campaigns should raise awareness about FSMP consumption being a part of the treatment and an official platform must be established to compare and provide information on disease-specific formulations, ingredients, and costs.
According to FGI results, healthcare professionals perceived that the disease-centered product system alone cannot meet the demands of the patients’ diverse clinical conditions and symptoms. Common suggestions for product development included development of symptom-specific refined products, diversification of product volumes and package sizes, and expansion of ONS varieties that better accommodate patient preferences and clinical needs.
DISCUSSION
This study highlights that despite the rapid growth of the FSMP market in South Korea, a significant gap exists between clinical needs and actual practice concerning healthcare professionals’ perceptions and utilization patterns. The findings from the survey and FGI suggest the need for enhanced safety in prescription practices, standardization of nutrition delivery processes, and development of patient-centered products.
Incomplete documentation in EN prescription
Standardization and specificity in the prescription process of EN are needed, particularly regarding administration rate and method. Our results showed that although product names and volumes were well-documented, “infusion rate” was recorded in only 9.2% of the physicians’ prescriptions. This low documentation rate was echoed by nurses (7.2%) and dietitians (3.9%), indicating that infusion rate decisions are rarely specified at the prescription stage. According to the ASPEN Safe Practices for EN Therapy by Boullata et al. [
11], the administration method and rate are “critical elements” of an EN order to ensure patient tolerance and prevent complications such as aspiration. The absence of specific instructions forces nursing staff to rely on discretionary judgment, which may compromise safety. Therefore, institutional improvements, such as mandating infusion rate fields in computerized provider order entry systems, are necessary to prevent incomplete orders [
11].
Systematic management of EN interruptions is required to address “underfeeding,” where the prescribed nutrition is not fully delivered to the patient. In this study, diarrhea (36%–39%) was cited as the most frequent reason for modifying or discontinuing enteral formulas across all professional groups. Consistently, gastrointestinal intolerance was identified as a major barrier to adequate enteral intake in critical care settings [
12].
However, in clinical practice, interruptions often occur due to “avoidable” factors in addition to gastrointestinal symptoms, such as fasting for diagnostic tests or procedures. Peev et al. [
13] conducted a prospective observational study in surgical patients in the ICU and reported that approximately 26% of EN interruptions were avoidable, with the most common reasons being imaging studies where fasting was not required by radiologists. Patients who experienced at least one interruption in their EN infusions were approximately 3-fold more likely to be underfed (<66% of the total prescribed calories) and accumulated significantly higher cumulative caloric deficits (5,834±4,641 kcal vs. 3,066±3,223 kcal; P=0.001) compared with those without interruptions [
13].
Kozeniecki et al. [
14] identified the initiation and advancement of EN as the most common reason for suboptimal volume delivery in their tertiary medical ICU study, where patients achieved adequate intake (≥90% of the prescribed volume) on only 20% of the feeding days, with an overall mean intake of only 51% of the prescribed volume. EN was held on average 4.8 hr/day on days 2 to 6, with the top five reasons or interruption being anticipated extubation, fasting for bedside procedures, loss of enteral access, gastric residual volume concerns, and radiology suite procedures [
14].
Therefore, rather than immediately stopping feeding upon onset of diarrhea or elevated gastric residual volume, standardized protocols should be implemented, such as adjusting infusion rate, utilizing prokinetic agents, or employing volume-based feeding strategies, that allow for increased rates to compensate for interruption time [
11,
14].
A notable discrepancy in professional roles regarding patient education and management was identified. Although 59.6% of the physicians believed that clinical dietitians should be responsible for patient education, in practice, nurses (59.8%) were the ones predominantly conducting it. This gap between perception and practice may contribute to suboptimal nutrition delivery.
Studies have emphasized that inadequate nutrition often stems from underprescription or delivery process errors, highlighting the need for standardized protocols and clear role delineation to mitigate these issues [
12]. Notably, Peev et al. [
13] reported that even among patients without EN interruptions, a significant caloric deficit accumulated, likely due to delayed initiation (33% of the patients started EN >48 hours after ICU admission) and conservative “ramp-up” feeding protocols. This “purposeful” underprescription was often at the explicit request of surgical teams, underscoring the importance of multidisciplinary consensus and protocol adherence [
13].
Given that proactive nutritional intervention improves clinical outcomes, policy support is essential to enable dietitians to lead nutrition assessment, education, and monitoring within a defined multidisciplinary framework.
Need for evidence-based feeding protocols
The implementation of evidence-based feeding protocols could address many barriers identified in this study. Our FGI results revealed that although tertiary and general hospitals operate NST governed by healthcare accreditation standards, long-term care hospitals lack institutionally mandated formal NST structures. This absence of standardized nutrition care protocols may contribute to practice variations observed across hospital types.
Studies have demonstrated that protocol implementation has a positive impact on the proportion of patients receiving adequate nutrition therapy, optimization of volume intake, and time to initiation of nutrition therapy [
14,
15]. Specifically, volume-based feeding protocols, which prescribe EN in mL/day and allow for increased infusion rates after interruption to make up for lost time, significantly increased EN delivery without increasing complications such as elevated gastric residual volume, emesis, aspiration, or pneumonia [
14].
Product diversification tailored to an aging society and the increasing demand for home care is imperative. The FGI results revealed that the limited variety in product volumes (primarily 400 mL for ready-to-hang products and 200 mL for canned products) and monotonous flavors significantly reduce patient compliance. Healthcare professionals expressed high demand for products not currently available, including high-calorie, high-protein formulations (93.3% of the physicians and 86.8% of the dietitians), products for IBD (83.0% of the physicians and 88.1% of the dietitians), and products for wound healing (79.5% of the dietitians).
This suggests that developing products considering not only the disease state but also patient preferences, clinical symptoms, and convenience is essential for enhancing the therapeutic efficacy of FSMP.
Limitations
This study has several limitations. First, the cross-sectional survey design limits causal inferences about the correlations between identified barriers and nutritional outcomes. Second, we did not directly measure patient outcomes, such as caloric deficit, length of stay, or clinical complications, limiting our ability to quantify the clinical impact of identified barriers. Prospective studies must examine the correlation between FSMP utilization practices and patient outcomes to provide evidence for protocol development and policy interventions.
Conclusion
For FSMP to be recognized not merely as nutritional support but as an integral part of therapeutic treatment, we must establish a precise prescription system with mandatory documentation of infusion rates and feeding methods, introduce evidence-based protocols to prevent unnecessary feeding interruptions and optimize nutrition delivery, and define professional roles within a multidisciplinary framework.
NOTES
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Authors' contributions
Conceptualization: JHK, HJP, HJL, DLJ, HSL, HJB, YKP. Data curation: JHK, JJL, BEK, EJB, YHL, DLJ, YRK. Formal analysis: HJP, SYP. Investigation: JHK, JJL, BEK, EJB, YHL, DLJ, YRK. Methodology: JHK, HJP, HJL, DLJ, HSL, HJB, YKP. Project administration: DLJ, HJB. Supervision: HJB, YKP. Writing-original draft: SBL. Writing-review & editing: JHK, HJP, YKP. All authors read and approved the final manuscript.
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CConflicts of interest
None.
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Funding
This study was supported by a grant from the Ministry of Food and Drug Safety (MFDS), Korea, and conducted by the Korean Society of Clinical Nutrition.
-
Acknowledgments
The authors gratefully acknowledge all physicians, nurses, and dietitians who participated in the survey and focus group interview. We also thank the participating tertiary hospitals, general hospitals, long-term care hospitals, and long-term care facilities for their valuable cooperation.
-
Data availability
Data of this research are available from the corresponding author upon reasonable request.
Supplementary materials
Table 1.Characteristics of study participants
Table 1.
|
Characteristic |
Total (n=417) |
Physician (n=47) |
Nurse (n=219) |
Dietitian (n=151) |
P-valuea)
|
|
Age (yr) |
0.417 |
|
20–29 |
37 (8.9) |
2 (4.2) |
18 (8.2) |
17 (11.3) |
|
|
30–39 |
136 (32.6) |
6 (12.8) |
72 (32.9) |
58 (38.4) |
|
|
40–49 |
147 (35.2) |
24 (51.1) |
73 (33.3) |
50 (33.1) |
|
|
≥50 |
97 (23.3) |
15 (31.9) |
56 (25.6) |
26 (17.2) |
|
|
Clinical experience (yr) |
0.001*
|
|
<3 |
57 (13.7) |
4 (8.5) |
29 (13.2) |
24 (15.9) |
|
|
≥3 and <5 |
47 (11.3) |
4 (8.5) |
25 (11.4) |
18 (11.9) |
|
|
≥5 and <10 |
81 (19.4) |
5 (10.6) |
44 (20.1) |
32 (21.2) |
|
|
≥10 and <20 |
153 (36.7) |
21 (44.7) |
75 (34.3) |
57 (37.8) |
|
|
≥20 |
79 (18.9) |
13 (27.7) |
46 (21.0) |
20 (13.2) |
|
|
Hospital type |
<0.001*
|
|
Tertiary hospital |
90 (21.6) |
17 (36.2) |
40 (18.3) |
33 (21.8) |
|
|
General hospital |
157 (37.6) |
24 (51.1) |
74 (33.8) |
59 (39.1) |
|
|
Long-term care hospital |
128 (30.7) |
6 (12.7) |
87 (39.7) |
35 (23.2) |
|
|
Long-term care facility |
42 (10.1) |
0 |
18 (8.2) |
24 (15.9) |
|
|
Region |
0.016*
|
|
Seoul |
118 (28.3) |
19 (40.4) |
65 (29.7) |
34 (22.5) |
|
|
Gyeonggi-do |
105 (25.2) |
14 (29.8) |
45 (20.5) |
46 (30.5) |
|
|
Incheon |
38 (9.1) |
4 (8.5) |
26 (11.9) |
8 (5.3) |
|
|
Gangwon-do |
4 (1.0) |
0 |
2 (0.9) |
2 (1.3) |
|
|
Chungcheong-do |
18 (4.3) |
1 (2.1) |
10 (4.6) |
7 (4.7) |
|
|
Gyeongsang-do |
84 (20.1) |
7 (15.0) |
43 (19.6) |
34 (22.4) |
|
|
Jeolla-do |
38 (9.1) |
1 (2.1) |
26 (11.9) |
11 (7.3) |
|
|
Jeju-do |
12 (2.9) |
1 (2.1) |
2 (0.9) |
9 (6.0) |
|
Table 2.Healthcare professionals’ perception of the classification and labeling requirements of FSMP
Table 2.
|
Variable |
Category |
Total (n=417) |
Physician (n=47) |
Nurse (n=219) |
Dietitian (n=151) |
|
FSMP classification |
|
|
|
|
|
|
EN products are classified separately as FSMP and pharmaceuticals |
Yes |
390 (93.5) |
44 (93.6) |
204 (93.2) |
142 (94.0) |
|
No |
27 (6.5) |
3 (6.4) |
15 (6.8) |
9 (6.0) |
|
FSMP classification system according to the Korea Food Codea)
|
Aware |
207 (49.6) |
13 (27.6) |
96 (43.8) |
98 (64.9) |
|
Somewhat aware |
190 (45.6) |
30 (63.8) |
114 (52.1) |
46 (30.5) |
|
Not aware |
20 (4.8) |
4 (8.5) |
9 (4.1) |
7 (4.6) |
|
Labeling requirements |
|
|
|
|
|
|
Understanding of basic labeling information (e.g., product name, type, volume, and nutritional content) |
Fully understand |
80 (19.2) |
4 (8.5) |
30 (13.7) |
46 (30.5) |
|
Understand |
298 (71.5) |
36 (76.6) |
159 (72.6) |
103 (68.2) |
|
Do not understand well |
31 (7.4) |
7 (14.9) |
22 (10.0) |
2 (1.3) |
|
Do not understand at all |
8 (1.9) |
0 |
8 (3.7) |
0 |
|
Satisfaction with current FSMP labeling |
Satisfied |
276 (66.2) |
25 (53.2) |
148 (67.6) |
103 (68.2) |
|
Not satisfied |
93 (22.3) |
14 (29.8) |
44 (20.1) |
35 (23.2) |
|
Do not know |
48 (11.5) |
8 (17.0) |
27 (12.3) |
13 (8.6) |
|
Areas needing improvement in labeling |
Font size too small to read |
142 (34.1) |
14 (29.8) |
74 (33.8) |
54 (35.8) |
|
Too much information, complex |
155 (37.2) |
15 (31.9) |
90 (41.1) |
50 (33.1) |
|
Difficult to understand terminology |
38 (9.1) |
4 (8.5) |
22 (10.0) |
12 (7.9) |
|
Cannot easily find needed information |
51 (12.2) |
9 (19.1) |
23 (10.5) |
19 (12.6) |
|
Insufficient information provided |
8 (1.9) |
4 (8.5) |
0 |
4 (2.6) |
|
Others |
5 (1.2) |
- |
1 (0.5) |
4 (2.6) |
|
Not applicable |
18 (4.3) |
1 (2.1) |
9 (4.1) |
8 (5.3) |
|
Usefulness of nutritional composition information for FSMP product selection |
Helpful |
325 (77.9) |
34 (72.3) |
178 (81.3) |
113 (74.8) |
|
Not helpful |
45 (10.8) |
6 (12.8) |
18 (8.2) |
21 (13.9) |
|
Do not know |
47 (11.3) |
7 (14.9) |
23 (10.5) |
17 (11.3) |
Table 3.Current practices in enteral formula prescription, administration, and patient education by professional group
Table 3.
|
Category |
Physician (n=47) |
Nurse (n=219) |
Dietitian (n=151) |
|
What are the required documentation items when physicians prescribe enteral formula, excluding information on patient identification?a)
|
|
Name of enteral formula |
34 (18.5) |
150 (19.4) |
117 (27.0) |
|
Calories (kcal)/volume (mL) |
39 (21.2) |
191 (24.7) |
132 (30.4) |
|
Route of administration |
31 (16.8) |
116 (15.0) |
34 (7.8) |
|
Volume per feeding (mL) or daily volume (mL) |
37 (20.1) |
172 (22.2) |
103 (23.7) |
|
Feeding method (e.g., continuous, intermittent, and bolus) |
26 (14.1) |
89 (11.5) |
31 (7.1) |
|
Infusion rate (e.g., initial rate or target rate) |
17 (9.2) |
56 (7.2) |
17 (3.9) |
|
Who is responsible for administering enteral formula to patients?a)
|
|
Nurse |
42 (59.2) |
173 (46.4) |
95 (38.9) |
|
Nursing assistant |
8 (11.3) |
85 (22.8) |
34 (13.9) |
|
Family member or caregiver |
21 (29.6) |
115 (30.8) |
115 (47.1) |
|
Who is primarily responsible for educating patients on the use and consumption of enteral formula? |
|
Physician |
2 (4.3) |
22 (10.0) |
7 (4.6) |
|
Nurse |
16 (34.0) |
131 (59.8) |
94 (62.3) |
|
Dietitian |
28 (59.6) |
60 (27.4) |
48 (31.8) |
|
No response |
1 (2.1) |
6 (2.7) |
2 (1.3) |
Table 4.Criteria used for enteral formula selection by physicians at admission and discharge
Table 4.
|
Category |
Physician (n=47) |
|
What criteria do you use when selecting enteral formula prescriptions at admission? |
|
Prioritize products available through meal prescription |
24 (38.1) |
|
Determine based on NST consultation recommendations |
32 (50.8) |
|
Prioritize products available through medication prescription (e.g., Encover solution and Harmonilan solutiona)) |
7 (11.1) |
|
What criteria do you use when selecting enteral formula prescriptions at discharge? |
|
Prioritize products available through meal prescription |
15 (28.8) |
|
Determine based on NST consultation recommendations |
20 (38.5) |
|
Prioritize products available through medication prescription (e.g., Encover solution and Harmonilan solution) |
17 (32.7) |
Table 5.Institutional characteristics and meal service, including enteral formula, by hospital type
Table 5.
|
Category |
Tertiary hospital (n=21)a)
|
General hospital (n=39) |
Long-term care hospital (n=18) |
Long-term facility (n=12) |
|
No. of bedsb)
|
1,111±393 |
540±214 |
255±130 |
98±35 |
|
Length of stay (day) |
7±3 |
70±167 |
362±362 |
198±239 |
|
Monthly meal service (meals/mo)c)
|
|
|
|
|
Regular diet |
28,029±2,144 |
14,379±1,285 |
7,083±830 |
3,374±481 |
|
Therapeutic diet |
16,355±1,101 |
7,904±833 |
4,286±735 |
547±89 |
|
Enteral formula |
4,408±459 |
2,250±313 |
3,131±602 |
456±62 |
|
Sterile diet |
395±116 |
91±33 |
0 |
0 |
|
Daily enteral formula prescription volume over the past month (kcal/day)d)
|
|
Minimum |
290±177 |
363±218 |
794±443 |
1,042±306 |
|
Maximum |
1,985±635 |
1,905±593 |
1,706±340 |
1,308±320 |
Table 6.Reasons for enteral formula modification and barriers to product procurement by professional groups
Table 6.
|
Category |
Physician (n=47) |
Nurse (n=219) |
Dietitian (n=151) |
|
What are the main reasons for changing the type of enteral formula after initiating enteral feeding? |
|
Diarrhea |
44 (39.3) |
191 (36.6) |
109 (36.9) |
|
Constipation |
16 (14.3) |
56 (10.7) |
47 (15.9) |
|
Abdominal distension |
8 (7.1) |
56 (10.7) |
17 (5.8) |
|
Abdominal pain |
8 (7.1) |
46 (8.8) |
12 (4.1) |
|
Aspiration risk |
19 (17.0) |
68 (13.0) |
47 (15.9) |
|
Infection |
0 |
8 (1.5) |
2 (0.7) |
|
Fluid imbalance |
5 (4.5) |
41 (7.9) |
20 (6.8) |
|
Electrolyte imbalance |
9 (8.0) |
40 (7.7) |
31 (10.5) |
|
Othersa)
|
3 (2.7) |
16 (3.1) |
10 (3.4) |
|
What are the reasons for delays in procuring enteral formula products at your hospital? |
|
Complex procurement process and procedures |
19 (19.0) |
60 (17.6) |
51 (17.3) |
|
Exceeds the reimbursement limit for enteral formula meal costs, making it difficult to use due to hospital budget constraints |
23 (23.0) |
107 (31.4) |
64 (21.8) |
|
Difficulty in obtaining information on enteral formula products not currently in stock |
8 (8.0) |
46 (13.5) |
7 (2.4) |
|
Limited storage space makes it difficult to store a variety of products |
23 (23.0) |
36 (10.6) |
54 (18.4) |
|
Difficulty in inventory management for products with low usage frequency |
27 (27.0) |
92 (27.0) |
118 (40.1) |
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, Hee-Jung Park2,*
