Associate Director of Pharmacy
Director of Pharmacy
Reims University Hospital
*Department of Pharmacy
**Committee for Food and Nutrition
OliClinomel(TM) has been marketed for several years in Europe. These triple-chamber bags for ready-to-use, all-in-one parenteral nutrition admixtures are now widely used in French hospitals and elsewhere in Europe. They consist of three different chambers in which macro- and micronutrients are compounded to avoid physicochemical interactions; thus, stability is maintained as long as the bag is not “activated” (ie, extemporaneous solder rupture before administration). Activation is quite an easy operation to perform (see Figure 1). Moreover, these standard formulae fit the majority of the patients’ nutritional requirements and can be used in most cases where intravenous nutritional support is required (intensive care units, oncology, digestive pathologies, bone marrow transplant, nephrology and paediatrics).
At Reims University Hospital, the prescription of OliClinomel bags led to a 65,000 Euros rise in costs between 2003 and 2004. A study was performed to assess whether this increase was justified or not. The issue was to know if patients’ undernutrition care was improved or if alternative therapies could have been put in place (ie, food complements, simple nutritional support or enteral nutrition). Was OliClinomel used because of its handling easiness? Were the French National Plan for Nutrition and Health “good nutritional practices” followed by the physicians?
Patients and methods
A “one-day photograph” prospective study was carried out at Reims University Hospital’s medical and surgery units. For each OliClinomel prescription received in the pharmacy department, a questionnaire was submitted to the physician in charge. Questions consisted of an assessment of:
- The patient’s demographic data (age, sex) and nutritional status (presence or absence of undernutrition on admission, weight, albumin and prealbumin assays.
- Parenteral nutrition characteristics (patient’s consciousness, indication, duration, route of administration).
Forty-two patients (16 male, 26 female; age 61.8+/-16.6 [24-86]) were included in adult medical and surgery units. Twenty-three patients suffered from undernutrition on admission; 37 were weighed on admission and regularly afterwards. Albumin assays were performed on 14 patients and prealbumin on only one patient. Mean treatment duration was 14 days [1-90]. Some patients received OliClinomel three times a week during dialysis for more than four months; they were not taken into account in the mean duration calculation (see Figure 2). Seven patients were unconscious. Among the 35 conscious patients, the results for those who received OliClinomel are presented in Figure 3. Patients were classified according to the fact that:
- They had undernutrition (UN) or not.
- They had oral nutrition (ON) or not.
- They had a contraindication to enteral nutrition (EN) or not.
Validated indications are presented in green, whereas unreferenced uses of OliClinomel are presented in red.
This work consisted of a “one-day photograph” of the parenteral nutrition prescription in our institution; thus, there is bias regarding the reliability of the presented results. A further prospective study covering a complete month of prescriptions is programmed in the near future. However, it is possible to imagine that the situation described here is quite close to reality, regarding the cost increase over one year of prescription (ie, 65,000 Euros, with some units having a 500% increase rate).
All the patients in this study are adults; although OliClinomel has a marketing licence for parenteral nutrition (total parenteral nutrition or nutritional assistance) in adults and children over 2 years of age, this product is rarely used in children in our institution. Patient-specific parenteral nutrition bags are prepared for the paediatrics units in the pharmacy department, according to the patients’ specific requirements.
Regarding nutritional status assessment, this study showed that the clinical evaluation was quite complete (eg, 37/42 patients were weighed on admission and regularly afterwards), whereas biological assessment was quite poor.
Approximately only one out of three patients benefited from biological follow-up with albumin and prealbumin assessments, representing, respectively, the long- and short-term markers for undernutrition and renutrition.
Among the 35 conscious patients, 24 (approximately 57%) should not have been prescribed parenteral nutrition alone. As long as their digestive tract was functional (patients receiving oral nutrition and/or not having any contraindication to enteral nutrition), they should have received nutrients through oral or enteral nutrition.
Moreover, considering the risks associated with parenteral nutrition practice (infections, metabolic complications), which increase morbidity and mortality, this administration route must be avoided if an alternative exists. In some cases, however, when oral and/or enteral nutrition are insufficient, parenteral nutrition used as a nutritional support can be put in place.
Finally, regarding the costs associated with parenteral and enteral nutrition practice in our institution, it appears that enteral nutrition products are 10 times cheaper than OliClinomel bags (2.50 Euros vs 25 Euros).
Considering both clinical and economical aspects of this report and the emerging “Drugs Good Use Contract” in French hospitals, the Committee for Food and Nutrition has now decided to:
- Establish strict recommendations concerning artificial nutrition through an information booklet destined to the physicians.
- Establish a nominative prescription sheet for OliClinomel.
Future studies will allow us to establish whether this misuse has been limited.
Societe Francophone de Nutrition Entï¿½rale et Parentï¿½rale (SFNEP)
European Society of Clinical Pharmacy (ESCP)
European Fellowship for Pharmacists
6th Spring Conference on Clinical Pharmacy
25ï¿½27 May 2006
35th European Symposium on Clinical Pharmacy
18ï¿½21 October 2006