Development of an Administration Guideline of Oral Medicines to Patients with Dysphagia.

Background and Objectives: There is increasing evidence that patients with dysphagia often have limited access to suitable oral dosage forms, especially when administered via an enteral feeding tube (FT). In addition, there is a lack of clear and readily available information from drug manufacturers on how to administer medications to patients with dysphagia. This study aimed to develop a practical guide for healthcare professionals to increase the safe and effective administration of oral medications to patients with dysphagia. Materials and Methods: The data were collected from existing English databases and handbooks available to develop an easy-to-use tabular guideline presenting all relevant information using keywords and short expressions. The working group differentiated 514 formulation types, and the information was collected and added to the guideline separately. In addition, the instructions for the patients taking the medicines orally or via FT were described separately. Results: The guideline consisted of 24 keywords or short expressions developed by the working group and described the instructions to use them. The guideline contained 343 active pharmaceutical ingredients and 19 fixed-dose combinations. Conclusions: Knowledge about proper medication preparation and administration for patients with swallowing difficulties is limited but essential. It is crucial to encourage drug manufacturers to provide this information as a standard to ensure the safe and effective use of medications for all patient groups.

Solid oral medications' suitability for use in enteral feeding tubes.

BACKGROUND: There is a lack of specific data about the efficacy and safety of medications administered via feeding tubes, although there is a general awareness that not all drug formulations are suitable. AIMS AND OBJECTIVES: To overview the current situation with solid medications administered through feeding tubes in the Tartu University Hospital intensive care units. To evaluate the availability of information on the suitability of drug formulations for administration via feeding tubes. DESIGN: This was a descriptive retrospective document analysis study. METHODS: During visits to the intensive care units, medication data for current patients were collected from paper medical charts and nurses. In addition, package information leaflets, summaries of product characteristics, and two practical handbooks were used for evaluating the medicines' suitability for administration via feeding tubes. A request for information was also sent to manufacturers or marketing authorization holders. RESULTS: In 3 months, data were collected from 113 intensive care patients' medical charts. A total of 306 medication administrations via feeding tubes were documented and analysed, 67% of which were solid oral dosage forms. Exactly 91.2% of these were conventional tablets. After the analysis of information availability, 88% of the medications were classified as suitable for administration via feeding tubes, but only 48% had the manufacturer-provided information. CONCLUSION: This study showed that the information about the suitability of formulations administration through a feeding tube is not readily available for almost half of the medications. The manufacturers seem to have the relevant information, but it is not always added to their medications' official information, putting these patients at higher risk for errors. RELEVANCE TO CLINICAL PRACTICE: This study shows that if there is no clear statement about administration through feeding tubes on official manufacturers' information, this should be sought directly from manufacturers or marketing authorization holders, and the data could be incorporated into local guidelines.

The Pharmacokinetic Profile and Bioavailability of Enteral N-Acetylcysteine in Intensive Care Unit.

Background and Objectives: N-acetylcysteine (NAC) is a mucolytic agent used to prevent ventilator-associated pneumonia in intensive care units. This study aimed to evaluate the oral bioavailability of NAC in critically ill patients with pneumonia, isolated acute brain injury and abdominal sepsis. Materials and Methods: This quantitative and descriptive study compared NAC's pharmacokinetics after intravenous and enteral administration. 600 mg of NAC was administered in both ways, and the blood levels for NAC were measured. Results: 18 patients with pneumonia, 19 patients with brain injury and 17 patients with abdominal sepsis were included in the population pharmacokinetic modelling. A three-compartmental model without lag-time provided the best fit to the data. Oral bioavailability was estimated as 11.6% (95% confidence interval 6.3-16.9%), similar to bioavailability in healthy volunteers and patients with chronic pulmonary diseases. Conclusions: The bioavailability of enteral NAC of ICU patients with different diseases is similar to the published data on healthy volunteers.

Pharmacopoieal quality of non-expired and expired nifedipine formulations from Estonian and Russian Federation medicinal products market.

The pharmacopoeial quality of non-expired and expired nifedipine tablets of the same batches purchased from the Estonian and Russian Federation medicinal product markets was evaluated. The IR spectroscopy, HPLC analysis for quantitative content and purity of the active pharmaceutical ingredient (API), and dissolution test techniques were applied. In the experiments with non-expired nifedipine tablets, in all Estonian (n = 8, label claims 10, 20, and 40 mg) and Russian Federation (n = 4, label claim 10 mg) registered formulations the API was identified and quantified as nifedipine in amounts set by the European Pharmacopoeia and without exceeding the tolerance limits for the impurities. The dissolution rate was variable but all 10 and 20 mg non-expired nifedipine tablets released at least 80% of API in 12 h. The expiration of the nifedipine tablets led to somewhat increased dissolution rate while only traces of the nifedipine degradation products were discovered in the dissolution medium. In conclusion, our present study shows that with minor variations the Estonian and Russian Federation registered nifedipine tablets are comparable, the API preserves well beyond the expiration date but the expired nifedipine tablets may release the API faster than the non-expired tablets.