Medication incidents related to feeding tube : A cross-sectional study

1 University of São Paulo at Ribeirão Preto College of Nursing, Brazil. 2 Heart Institute, University of São Paulo, Brazil. 3 Santa Casa de Misericórdia de Ribeirão Preto, Brazil. 4 Federal University of Minas Gerais, Brazil. 5 Uberlândia Federal University, Brazil. 6 Campinas State University, Brazil. 7 Alzira Velano University Hospital, Brazil. 8 School of Nursing, Federal University of Alfenas, Brazil. 9 Sumaré State Hospital, Brazil. 10 Mona Vale Hospital, Australia.


INTRODUCTION
Oral medication preparation and administration through feeding tubes in hospitals is a major challenge for nurses aiming to provide safe care.Most nurses rely primarily on their own experience and secondarily on the experience of their coworkers for information and techniques on preparing and administering oral medications through feeding tubes.As a result, a variety of improper techniques are often employed (Grissinger, 2013).
For instance, researchers identified wrong techniques during medication preparation and administration of enteric-coated solid drugs 28.57% of the time (Lisboa et al., 2013).The crushing process destroys the coating film and promotes the immediate release of medication, which can result in toxic effects with potentially severe damages, exposing the patient to unnecessary risks (Institute for Safe Medication Practice-Brazil, 2015).
Evidence also suggested that 91% of nurses often mix solid medications in the same crushing container during medication preparation (Heydrich et al., 2009).This practice is a risk factor for adverse drug interactions, contributing to tube obstruction, especially if the nurse does not flush the tube after each medication administration.In addition, Brazilian hospital pharmacies frequently distribute drugs to be administered via feeding tube in inadequate forms, either due to unavailability in the pharmaceutical market or due to the lack of standardization in the institution.Therefore, tablets and/or capsules that should be administered intact orally are crushed and/or opened and reconstituted in various substances before being administered via feeding tubes (Grissinger, 2013).
Another adverse event related to improper medication administration via feeding tubes is caused by drug interactions in elderly people due to polypharmacy, with a prevalence of 20 to 40%; polypharmacy increases the complexity of clinical management and contributes to adverse medication events (Palleria et al., 2013).
These incorrect medication preparation processes used for administering through feeding tubes disregard the pharmaceutical properties of the drug and its biopharmaceutical characteristics, and they can lead to physical and chemical incompatibilities, resulting in precipitation, flocculation, adsorption, color changes, chelation and drug-nutrient interactions, which causes changes in drug effectiveness or compromises nutritional therapy (Allen, 2014).
According to a study conducted in a Brazilian private hospital, the main reason for the loss of the feeding tube was obstruction (36%) related to wrong medication preparation and administration techniques (Pereira et al., 2013).Estimates of incidence of clogged feeding tubes range widely from 12.5 to 45%, but it is undisputed that they result in increased costs for patients and institutions (Fisher and Blalock, 2014).Health care practitioners, specially nurses, should not assume that a medication intended to be taken by mouth can be safely administered through a feeding tube because this misconception can result in harm to patients and increase medical costs to society (Grissinger, 2013).
Correct medication administration is a nursing responsibility and represents an important target of quality and safety improvement interventions.Thus, it is important that nurses are supported technically and scientifically to carry out safe and effective practices in medication administration via feeding tubes.
Given that the number of patients with chronic conditions have increased significantly worldwide, as well as in Brazil, it is critical that health care professionals employ a repertoire of evidence-based techniques in order to provide safe and qualified care (Brasil, 2011;World Health Organization, 2011).In addition, errors related to this route of administration happen more often than reported or recognized (Institute for Safe Medication Practice, 2010).The issues raised are pertinent across countries (Phillips and Endacott, 2011), but there is a knowledge gap regarding the safe handling of feeding tubes especially in developing healthcare institutions.Studies that aim to identify evidence-based interventions targeting safe oral medication preparation and administration through feeding tubes can reduce that gap and the risks of complications, and decrease the overall costs of care.
The purpose of this paper is to evaluate the medication incidents related to incorrect oral medication preparation and administration through feeding tubes in hospitalized patients.

METHODOLOGY
This descriptive, cross-sectional study was conducted in three Brazilian general, medium-sized, teaching hospitals located in metropolitan areas: two hospitals in São Paulo State and one hospital in Minas Gerais State.The medical ward was chosen for this study because it provides care for patients in various medical specialties and most of the patients have chronic conditions, thus many require enteral nutrition and medications through feeding tubes.
The unit of analysis was the dose, thus the sample consisted of 374 doses of medications prepared and administered through feeding tubes from February 2014 to May 2014.The sample size calculation was described in a previous study (Lisboa et al., 2013).
Medication incidents were defined as any preventable event that may cause or lead to patient harm while the medication is in the control of the healthcare professional.These may be related to professional practice, drug products, procedures, and include product labelling, compounding, prescribing, administering, and monitoring (Institute for Safe Medication Practice, 2016).
For the purposes of this study, medication incidents categories were: wrong medication preparation and wrong medication administration.Wrong medication preparation was defined as a medicine that was incorrectly handled beforeadministration.This included crushing enteric-coated medications; incorrect reconstitution/dilution (incorrect choice or volume of diluents); and medicines mixed in the same container (Tissot et al., 1999).Wrong medication administration was defined as an inappropriate procedure or improper technique used in the administration of a medicine through a feeding tube.This included mixing two or more drugs together; improper flushing of the tube before and after medication administration; improper flushing of the tube between each drug administration; mixing medications with feeding formulas; and failure to test the correct placement of the feeding tube prior to medication administration (Grissinger, 2013;Tissot et al., 1999).
Data were collected through direct observation of oral medication preparation and administration through a feeding tube.According to Flynn et al. (2002), direct observation is a method that requires the data collector to accompany the nurse administering medications and observe the preparation and administration of each dose.The observer records exactly what the nurse does with the medication and witnesses the medication administration to the patient.Data recorded include related procedures, such as giving medications with food.Thus, direct observation is considered more efficient and accurate in detecting medication errors than reviewing charts and incident reports.
Nurses were observed by research assistants, who were subjected to a day of training with a total workload of 4 h, during the processes of preparing and administering medications.The data collection tool used was developed by the research team, assessed for face and content validity by a panel of experts, and tested for three consecutive days.
Observations took place on different days of the week (including weekends and holidays) and at different times of the day and night.The observers were present during a preset series of shifts, to represent the variation of working hours in nursing practice.When a potentially harmful error was identified (that is, dose omission), the observer did not only register the error, but also intervened by talking to the nurse about the case.
Prescriptions were also analyzed in order to identify the presence of enteric-coated tablets prescribed to be administered through feeding tubes.Given the fact that direct observation of medication administration process involved the patient, researchers asked for written authorization from the patients or their legal guardians.
Data were entered in Epi Data version 3.1 and were transferred to the Statistical Package for the Social Program Sciences® (SPSS) version 22.0.The Pearson's Chi-square was used to test associations; a level of significance at 5% (p<0.05) was considered in all analyses.
This study was approved by the Research Ethics Committee of the University of São Paulo at Ribeirão Preto College of Nursing (EERP-USP) (CAAE: 17687513.1.0000.5393),according to the Resolution n° 466/2012, of the National Council of ethics in research of the Brazilian Ministry of Health.Nurses and patients were informed of the research and asked to voluntarily sign the consent form.In addition, participants were informed that the results will be used for publication and researchers guaranteed their confidentiality and anonymity.
Feeding tubes were mainly of size 12F (74.2%) and Gimenes et al. 307 were in place for a mean of 11.66 days (SD = 14.3, 1 -99).The mean of 6.0 (SD = 2.7, range 1 -13) medications were prescribed through feeding tube for the same patient/day; and a mean of 2.3 (SD = 1.9, range 1 -9) medications were scheduled at the same time and for the same patient.
Medication incidents occurred during medication preparation and administration through feeding tubes.
Mixing tablets with other drugs in a mortar (n = 120; 43.5%) was one of the most common incorrect medication preparation incidents observed.In addition, 21 (5.6%) extended-release tablets were crushed.Incidents related to wrong techniques were also observed with not flushing the tube between medications (n = 147; 86.5%); not testing the correct placement of the feeding tube (n = 253; 67.6%); administering medications together (n = 128; 65.6%); and not flushing the tube prior to medication administration (n = 233; 62.5%) (Table 3).
In addition, in 1.1% of cases/of patients (n = 4), the route of administration did not correspond to the prescribed route (oral route was prescribed for patients in use of feeding tube).
Tube obstruction was another medication incident related to wrong oral medication preparation and administration identified in this study.From 374 observations, there were tube obstructions in 136 (36.5%) cases.Patients using polyurethane feeding tubes (n = 123; 37.3%) had more chances of having an obstruction when compared with patients using Levine tubes (n = 9; 28.1%).However, the result was not statistically significant (p = 0.305).
There was an association between tube obstructions and the following variables: mixing tablets with other drug(s) (p <0.001); tablet incorrectly reconstituted (p = 0.006); tube not flushed prior to medication administration (p <0.001); feeding tube improperly or not flushed between medications (p <0.001); concurrent administration of medication and enteral formula (p <0.001); and enteral feeding not interrupted prior to
Although not statistically significant, there were more tube obstructions when patients received tablets (n = 84; 22.6%) than when they received medications in other forms (p = 0.154).
The results show that wrong medication preparation and administration techniques contribute to medication incidents.In addition, tube obstruction was a very common incident related with wrong techniques.

DISCUSSION
The aim of this study was to evaluate the medication incidents related to wrong oral medication preparation and administration through feeding tubes in hospitalized patients.A total of 374 doses were observed and the   (Gimenes et al., 2011).Nurses should not assume that all tablets can be safely administered through a feeding tube.For instance, nimodipine is primarily absorbed in the stomach, therefore administering this drug via a jejunal access may reduce the rate of absorption.It is worth noting that, in this study, most patients (82.9%) had jejunal access, thus the bioavailability and efficacy of some drugs may be reduced.

Medication preparation and administration technique
In relation to the pharmaceutical dosage forms, immediate-release tablets were administered in 52.41% of the time, and sustained-release tablets in 19.52%.According to Phillips and Endacott (2011), one third of nurses studied stated that enteric-coated medication could be administered when no other form was available, revealing that nurses have insufficient knowledge about the safety risks associated with destroying the enteric coating (Lohmann et al., 2015).
In order to achieve adequate clinical outcomes in hospitalized patients, it is essential that medications and enteral nutrition therapy be administered appropriately.However, nursing guidelines on feeding tube care are basically based on traditions, rituals and expert opinions, exposing patients to unnecessary harm (Kalaldeh et al., 2012;Simons and Abdallah, 2012).
Previous research also showed that most nurses had deficient knowledge on the proper administration technique through feeding tubes.Almost 70% have crushed at some time an enteric-coated tablet and 66.2% have crushed a sustained-release tablet (de Amuriza Chicharro et al., 2012).There is a clear need for healthcare institutions to develop strategies to enable practicing nurses to improve their knowledge and skills in oral medication preparation and administration through feeding tubes in hospital settings.
Several medication incidents were identified in this study.In relation to oral medication preparation, mixing tablets with other drugs and crushing extended-release tablets were the most common.Nurses should not mix medications together for administration through feeding tubes because of the possibility of physical and chemical incompatibility, tube obstruction or changes in drug pharmacodynamics (Bankhead et al., 2009;Emami et al., 2012).Modified-release tablets are not suitable for administration via feeding tubes because they are formulated to release the drug slowly over time.Thus, crushing extended-release tablets will affect the pharmacokinetic profile of the drug and may result in excessive peak plasma concentrations and side-effects (White and Bradnam, 2015).
Incidents related to wrong oral medication administration were also common and included: not testing the correct placement of the feeding tube (67.6%); administering medications together (65.6%); not flushing the tube prior to medication administration (62.5%); and not flushing the tube between medications (86.5%).Previous research showed that 74% of nurses had employed wrong medication administration methods to deliver medicines through feeding tubes and according to researchers, those errors could reduce the effects of drugs and lead to unsuccessful treatment (Emami et al., 2012).Special caution must be highlighted for not testing the correct placement of the tip of the tube prior to medication administration.
According to the National Patient Safety Agency (NPSA), there were 21 deaths and 79 cases of harm related to feeding through misplaced nasogastric tubes, as reported to the National Reporting and Learning System (NRLS), between September 2005 and March 2010 (National Patient Safety Agency, 2011).It is recommended that feeding tubes are checked for placement at least every 24 h, as tubes may be dislodged after vomiting or coughing; before administering each feed; and before giving medication.In addition, the method of testing must be documented (National Patient Safety Agency, 2011;White and Bradnam, 2015).
In this study, administering medications that adsorbs or interacts with enteral nutrition were also observed (30.5%).The consequence of this practice is the increased risk of physical-chemical incompatibilities and potential drug-nutrient interactions (Fisher and Blalock, 2014).This concomitant administration of medications and enteral formulas could derive potential benefits in regards to time and cost; however, uncertainty exists regarding potential drug and nutrient interactions and the influence this may have on both safety and efficacy (Kurien et al., 2015).
The lack of information on the impact of compounding by mixing medications with enteral formula and/or administering through feeding tubes on the drug product safety and efficacy is problematic (Stegemann, 2015).This incident can increase adverse effects and lead to tube obstructions.
The overall occurrence of tube obstruction identified in this study was significantly higher (36.5%) than that reported in other studies (ranging from 2 to 12.5%) (Phillips and Nay, 2008) and it may be attributed to the use of solid form medications.Clogged feeding tubes are responsible for significant loss of delivery of enteral feeding (Fisher and Blalock, 2014) and it is worth noting that, in this study, there was a significant relationship between tube obstruction and unplanned removal (p < 0.001).This result is in accordance with a previous study that has shown that the main cause for unplanned removal of the feeding tube was related to obstruction (Pereira et al., 2013).
There was also a statistically significant association (p = 0.006) between tube obstruction and incorrect reconstitution of drugs, and it may be attributable to a lack of adequate knowledge related to pharmaceutical formulations.This finding may also be explained by the deficiency in the training process of nurses, specifically for medicines, which does not include items related to pharmaceutical technology.
In addition, in this study feeding tubes were mainly of size 12F (74.2%).The size of feeding tubes used in adults should be between 6F to 12F (National Nurses Nutrition Group, 2016).Narrow tubes and long tubes are more likely to become blocked, thus special precautions should be taken by nurses to prevent tube obstructions, which includes stopping enteral feeding before a drug is administered; flushing the tube before and after each intermittent feed, every four to six hours during continuous feeding, and before and after each drug administration.However, in patients with renal or cardiac disease, the flush volumes will need to be revised to meet the patient's prescribed fluid restrictions (White and Bradnam, 2015).
Another incident observed was the dose of medication administered in a different route to that prescribed (1.1%).In this study, physicians prescribed solid formulations via the oral route, representing a prescription error.However, if the dose was intended to be given orally but the nurse administered it through a feeding tube, this practice could be classified as an administration error (White and Bradnam, 2015).It is important to consider that the route prescribed should match the placement of the tube in the gastrointestinal tract.
The practice of administering medications through feeding tubes has become complex, thus health care institutions must ensure that patients receive safe and competent care (Walsh and Brophy, 2011) through welltrained and qualified nurses.In this study, most medications were administered by nurses' auxiliaries, thus education and training programs should be used and valued as a vital tool for addressing the challenges of improving patient safety (World Health Organization & WHO Patient Safety, 2011).
Despite abundant evidence regarding safe oral medication preparation and administration through feeding tubes, nurses still employ improper techniques in hospitals around the world including those in developing countries, exposing patients to unnecessary risks.The results of this study show that training and education of nurses have not kept pace with advances in patient safety, nor with workforce requirements.In addition, we may conclude that many nurses are not using research conducted in nursing and related disciplines as a foundation for safe medication practices.Nurses and other healthcare professionals should be adequately prepared to provide the best care possible, and education and training should be the foundation of safe, high quality health care.
Our study presented limitations.Observation methods for studying medication preparation and administration errors can influence the results because the presence of an observer may affect nurses' behavior.In addition, prudence is called for when generalizing the results to other departments or other hospitals.This study involved medical wards of general medium-sized hospitals, thus the incidence of errors relating to oral medication preparation and administration may be lower when compared to an intensive care unit or the medical ward of a large university hospital.

Conclusion
Medication incidents were identified during oral medication preparation and administration through enteral feeding tubes in Brazilian hospitals and they were associated with tube obstructions.Mixing tablets with other drugs, not flushing the tube between medications, and not testing the correct placement of the enteral feeding tube prior to medication administration were the most common incidents observed in this study.
The results contribute to the development of knowledge in the field of patient safety and quality in oral medication preparation and administration through feeding tube, in order to improve hospital nursing practice, especially in developing countries.In addition, this study contributes to the body of evidence that may influence the development of national policies focused on the risks associated with these practices.
Our results also reinforce the argument that continuous training and updating knowledge will allow nurses to rethink and to change their current practices.In conclusion, we believe that promoting continuing education programs configures as an important aspect for nursing professionals to acquire skills to correctly prepare and administer oral medications through feeding tubes.
This study did not evaluate clinical outcomes (death and severe harm) caused by medication incidents.Future studies should be conducted in order to assess patients' outcomes related to those incidents.

Table 2 .
Distribution of oral medications administered through feeding tubes, according to the WHO's Anatomical Therapeutic Chemical Classification Index (ATC).

Table 4 .
Tube obstruction, according to medication preparation and administration technique (N = 374).