Review
Impact of direct drug delivery via gastric access devices
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Matthew Kurien†, Hugo Penny & David S Sanders †
1.
Introduction
2.
Gastric access devices and enteral feeds
4.
Drug--nutrient interactions
5.
Complications of drug delivery via gastric access devices
6.
Conclusion
7.
Expert opinion
Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Gastroenterology and Liver Unit, Sheffield, UK
Introduction: Gastric access devices such as nasogastric tubes and gastrostomy tubes are increasingly being used in clinical practice to provide both shortand long-term nutrition support therapy. Increasingly these devices are being utilized to help deliver oral medications, where swallowing is impaired. This concomitant administration of medications and enteral formulas could derive potential benefits in regard to time and cost; however, uncertainty exists regarding potential drug and nutrient interactions and the influence this may have on both safety and efficacy. Areas covered: This article provides an overview of the differing gastric access devices used in clinical practice and evaluates the evidence base for using oral medications via these routes. Alternative methods of drug administration are discussed, alongside common drug nutrient interactions and potential complications. Expert opinion: Delivering medications via gastric access devices can be performed safely; however, careful consideration needs to be made regarding tube and patient influences, alongside drug--nutrient interactions. Improving practice in this area in the future necessitates enhancement of an evidence base to substantiate the safety of drug delivery via gastric access devices and improvement in education among healthcare professionals about the potential problems. Keywords: complications, drug delivery, enteral feeding, gastric access devices, gastrostomy, nasogastric tubes Expert Opin. Drug Deliv. [Early Online]
1.
Introduction
Malnutrition is common and is both a cause and consequence of ill health [1]. The prevalence of malnutrition in hospitalized patients has previously been shown to be high and often unrecognized, leading to increased emphasis on awareness and consideration of nutrition support therapy [2-5]. Oral nutrition using special diets and supplements is usually considered the first-line therapy in managing malnutrition; however, certain individuals may require enteral or parenteral nutrition when oral intake is reduced or when swallowing is unsafe. Of these modalities, enteral nutrition is usually preferred in the context of a normally functioning gastrointestinal tract as it is physiological, cheaper and may help maintain gut barrier function [6,7]. Gastric access devices enable the administration of enteral nutrition, describing an enteral feeding tube where the distal point lies within the stomach. These devices are increasingly being used in clinical practice, helping to provide both short- and long-term enteral nutrition when oral caloric intake is inadequate. Nasogastric tubes are the most frequently used short-term gastric access device (< 1 month of enteral feeding), preferentially used over orogastric tubes as they are easier to secure, less likely to become disturbed by eating and can allow the introduction of oral feeding following insertion [8]. Gastrostomies are alternative gastric access devices, usually reserved for long-term enteral feeding and may be inserted at endoscopy, surgery 10.1517/17425247.2015.966683 © 2014 Informa UK, Ltd. ISSN 1742-5247, e-ISSN 1744-7593 All rights reserved: reproduction in whole or in part not permitted
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Article highlights. . . . . .
Gastric access devices are increasingly being used in clinical practice. This article addresses the critical and important aspect of drug administration via gastric access devices. A review is undertaken of the different gastric access devices that are used in clinical practice. Drug--nutrient interactions are discussed in the context of gastric access devices. Prevention and management of complications are explored in this article.
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This box summarizes key points contained in the article.
Figure 1. Illustration of a gastrostomy feeding tube.
Nasogastric tube Whole food by mouth
Orogastric tube
or using radiological guidance (Figure 1) [9]. Alternatives to these gastric access devices include insertion of feeding tubes via the mouth, nasally or percutaneously into either the proximal or mid-small bowel (Figure 2 and Table 1). Apart from delivering enteral nutrition, gastric access devices and other enteral feeding tubes are frequently considered as a way of administering medication to patients where swallowing is impaired. Currently, it is estimated that approximately one-third of patients in long-term care facilities have problems with swallowing oral medication due to aging, acute or chronic disease conditions or because of decline in physiological functions [10]. Although administration of medication via gastric access devices is widely performed in clinical practice, it remains to be established the exact number of patients who receive concomitant medication and enteral nutrition via their delivery device [3,11,12]. In a recent study of 75 diabetic patients in the UK, medications were found to be given in all gastrostomy-fed individuals, equating to a mean number of 5.7 medications a day at a mean cost of £145 a month (175 EUR/US$230) [13]. These findings were supported in another study of 480 adult patients, where all gastrostomy patients assessed (n = 11) were receiving medications via their tubes [14]. The frequency at which medications appear to be administered via gastric access devices raises questions as to the merits of this practice and the influence this may have on both the safety and efficacy of nutrient and drug therapies. Currently, there is a paucity of prospective data evaluating outcomes following drug administration through gastric access devices, which could help inform clinical practice. This review provides an overview of the differing gastric access devices, a critical assessment of the available literature looking at drug--nutrient interactions, factors that may influence these interactions, drug administration techniques and reviews alternative means of giving medication to patients. Further, complications will be reviewed with guidance given to minimize the risk of tube occlusion.
2.
Gastric access devices and enteral feeds
Nasogastric and orogastric tubes Most patients requiring nutrition support therapy have treatment for < 1 month [8]. When short-term enteral feeding is considered, nasogastric and orogastric tubes are most frequently used, as they are relatively easy to insert and have the potential to be removed easily in the future. Tubes range in length and diameter and may be inserted either at the bedside or by using endoscopic or radiological guidance [15]. The tube diameters are conventionally measured in French units (1 French Unit = 0.33 mm) and may be categorized as either fine bore (5 -- 12 French Unit) or large bore (> 14 French Unit). Fine bore tubes are most frequently used for feeding and better tolerated than large bore tubes; however they are more prone to blockages. Another potential advantage of large bore tubes over fine bore tubes is that they can be aspirated 2.1
Nasoduodenal tube Gastrostomy tube Nasojejunal tube Jejunostomy tube
Figure 2. Representation of different types of enteral feeding devices.
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Impact of direct drug delivery via gastric access devices
Table 1. Alternative methods of enteral drug delivery.
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Name
Entry point
Distal point
Nasogastric
Nose
Stomach
Nasoduodenal Nasojejunal Percutaneous gastrostomy Percutaneous jejunostomy Percutaneous gastrojejunostomy Orogastric
Nose Nose Abdomen Abdomen Abdominal wall Mouth
Duodenum Jejunum Stomach Jejunum Jejunum via the stomach Stomach
Table 2. Types of gastrostomy tubes. Manufacturer
Product name
Corpak Medsystems, Inc. Cook Medical Covidien UK
CORFLO FLOW/PEG Kangaroo
Gb (UK) Enteral
AMT
Medicina Ltd
Monarch Medicina
Vygon UK Ltd
MIC
Diameter (F) 14, 20, 20, 12, 16, 12, 16, 12, 12, 16, 20, 12, 18, 24,
16, 22, 24 14, 20 14, 18, 14 14, 18, 22 14, 20, 26,
18, 24
Tube material Polyurethane Silicone Silicone Silicone
20 Silicone Silicone
16, 22, 28, 30
Silicone
from, if required, or if decompression of the stomach is needed. The material composition of nasogastric and orogastric tubes can vary, influencing both tolerability and performance. Historically, some tubes were made from polyvinylchloride (PVC) but exposure to gastric acid caused tubes to become stiff and brittle, reducing their efficacy [3]. Currently, most tubes are produced from polyurethane or silicone. Silicone is a softer material than PVC; however, often, the walls of such tubes may collapse when aspiration of gastric contents is attempted. Polyurethane appears to be a much stronger material, with these tubes tending to have larger lumens. Gastrostomies The concept of a gastrostomy was first proposed by Egeberg, a Norwegian army surgeon in 1837; however, it was only in 1876 when Verneuil used a silver wire to oppose visceral and parietal surfaces of the peritoneum that success was achieved in inserting the first surgical gastrostomy [16]. Almost a century later, in 1979, Michael Gauderer and Jeffrey Ponsky revolutionized gastrostomy practice by pioneering an endoscopic method of insertion in Cleveland, Ohio, associated with reduced morbidity and mortality [17]. Two years later 2.2
Usual size Fine bore: 6 -- 12 Fr for feeding Large bore: 12 -- 16 Fr for aspiration Fine bore Fine bore 6 -- 10 Fr Fine bore/large bore Fine bore Fine bore Fine/large bore
in 1981, Preshaw in Canada used fluoroscopic guidance to insert the first percutaneous radiological gastrostomy [18]. In the UK, ~ 17,000 gastrostomies are now being performed annually, most frequently reserved for individuals requiring long-term nutrition support (> 4 -- 6 weeks) [19]. Endoscopic and radiological techniques are the most utilized methods of insertion, with the majority of procedures being performed in adults. Most frequently, gastrostomy insertion is undertaken for neurological conditions affecting swallowing (e.g., post-cerebrovascular accident, motor neuron disease) and for obstructive lesions of the upper gastrointestinal tracts (e.g., esophageal malignancy, head and neck cancers) [9]. Like short-term feeding tubes, there are an array of differing gastrostomy feeding tubes that are commercially available, with most being polyurethane and silicone (Table 2). Further specifics regarding tube length, tube diameter internal volume and tube surface area can be acquired from manufacturers’ websites. Awareness of these differing tubes, differing sizes and composition is particularly pertinent as they can influence tube complications.
Enteral nutrition formulas Enteral feeds are nutritionally complete (containing protein or amino acids, carbohydrate, fat, water, minerals and vitamins) and are available in fiber-free and fiber-enriched forms. Determining the type to be used is influenced by the patient’s nutritional requirements, gastrointestinal absorption, motility and by an individual’s comorbidities, such as renal or liver disease [3]. Gastric access devices can be used to deliver these enteral feeds using continuous, bolus or intermittent infusion methods [20]. Continuous infusion provides patients with feed over 24 h and is most frequently reserved for very ill patients [21]. This regimen is associated with an increased risk of drug--nutrient interactions (discussed later) and can also increase intragastric pH leading to bacterial overgrowth [22]. Bolus feeding describes the delivery of 200 -- 400 ml of feed (administered either by push or gravity methods over 15 -- 60 min) periodically throughout the day, permitting medications to be given at times different from feeds. This can lead to abdominal bloating, diarrhea and symptoms analogous to those seen in the ‘dumping syndrome’ where rapid gastric emptying occurs. Last, intermittent infusions provides 2.3
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feeds over a longer duration than bolus feeding using an infusion pump, thereby minimizing the adverse symptoms but also permitting breaks for the patients unlike continuous feeding. Patient issues and procedural complications The relative ease of insertion of gastric access devices has led to their increasing use in clinical practice. Despite their potential merits in improving nutritional status, mortality and hospital length of stay in carefully selected patients, problems do arise as a consequence of tube insertion and feeding, leading to significant morbidity. During insertion, gastric access devices may cause inadvertent injury of the gastrointestinal tract, causing bleeding and in rare cases perforation. Specifically relating to nasogastric and orogastric tubes, these occasionally have caused significant lung injury and infection as a consequence of accidental intubation of the tracheobronchial tree. Given the recognized and serious sequelae of these early tube-related complications, guidance has recently been issued to help aid healthcare professionals in both early recognition and management of both nasogastric and gastrostomy complications [23,24]. Other identified tube-related complications that can occur include: pain around insertion point, infections, peristomal leakage, tube blockage, tube damage, dislodgment and migration of the tube from original point of insertion [25]. The feeds themselves can also cause complications including gastrointestinal symptoms (nausea, reflux and diarrhea) and metabolic complications [26,27]. Evaluating the current published literature about the influence gastric access devices and feeds have on an individual’s quality of life is fraught with difficulty. Studies that have tried to assess this outcome measure have predominantly been from cancer cohorts, using an array of differing methodologies. A recent review of studies performed has suggested that quality of life in patients receiving enteral tube feeding was poor compared with control groups, with factors such as nausea, vomiting, diarrhea, fatigue, body image and social isolation heavily influencing this diminished quality of life [28].
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2.4
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Drugs and gastric access devices
Prior considerations A number of guidelines and recommendations currently exists that advocate enteral administration of medications via gastric access devices when no alternatives exist [11,29,30]. Prior to considering the use of gastric access devices, it is imperative that a thorough review be made of the requirement for medication and that all nonessential medications be discontinued or temporarily stopped. If medication is deemed necessary, then a thorough exploration of alternative administrative routes should be undertaken prior to gastric access devices being used including rectal, sublingual, transdermal, injectable, inhalational, subcutaneous and buccal methods. Although these alternatives to feeding tube delivery of medication may be feasible, consideration needs to be made as to their 3.1
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tolerability and acceptability (rectal methods), drug availability in differing preparation forms, infection risks (injectable and subcutaneous methods) and the potential influence that an alternative route may have on a drug’s bioavailability. Dosage or frequency of medications may need to be adjusted as a consequence of using a different administrative method. Drug formulations/physiochemical properties If gastric access devices are considered the best or only means of administering medication, then liquid preparations are preferable [31]. Of the differing liquid formulations available, emulsions and elixirs are favored as syrups and suspensions may clump inside gastric access devices due to their high viscosity, leading to tube blockages [15]. Although liquid preparations may be preferable, dose adjustments are often required to achieve the same desired therapeutic response of solid preparations. Another potential problem of some liquid preparations is that they are hyperosmolar or contain sugar alcohols such as sorbitol. These additives are usually inactive ingredients used for flavoring; however, when given in large doses or alongside other liquid preparations with high osmolality, their cumulative effect can lead to osmotic diarrhea and other gastrointestinal symptoms such as bloating, nausea and abdominal cramps [32,33]. Acquiring information regarding drug osmolality and sorbitol content is frequently problematic without direct contact with manufacturers; however, dilution of the hyperosmolar medication with water prior to delivery may help reduce some of the gastrointestinal symptoms [34,35]. This practice of diluting a liquid drug may also improve the delivery of the drug (particularly highly viscous liquids) in getting to the distal end of the gastric access device [36]. Despite the optimal delivery of liquid medication via gastric access devices, a high percentage of drugs are only available in solid oral forms [10]. This has led to the practice of crushing tablets using implements such as a pestle and mortar or opening capsules, prior to dilution in water and delivery via the feeding tube [31,37,38]. Concerns have been raised in the literature as to the merits of breaking down solid medications like this with the potential loss of substance, the influence this may have on therapeutic effect, the harm this may incur to nursing staff and the problems this may lead to with tube blockages [11,39]. To corroborate this, studies have shown that many errors occur during this process of solid drug breakdown, leading to potential harm to both patients and staff [40-43]. There are limited data available about the consequences the crushing of medication has on drug stability. Further, by crushing medication the prescriber and the drug administrator incur legal responsibility rather than the drug manufacturer for any potential adverse event, due to the utilization of the drug in an unlicensed manner [44]. This absence of data poses challenges to clinicians and pharmacists in ensuring safe prescribing. Some reassurances can be found from a review of 83 commonly used drugs, which identified only a small percentage of 7.2% having stability concerns when 3.2
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Impact of direct drug delivery via gastric access devices
converted to liquid forms [45]. Although these findings provide reassurances that only a minority of drugs have stability issues, it should be emphasized that these 83 medications represent a small fraction of the total number of oral medications that can potentially be given via gastric access devices. Drug absorption and bioavailability Delivering oral medication through gastric access device can influence a drug’s performance by compromising an oral drug’s specifically designed delivery mechanisms and also by influencing drug absorption. For example, tetracycline, ampicillin, bisphosphonates and levothyroxine all have reduced absorption when taken alongside food or enteral feeds. Some proton pump inhibitors (e.g., omeprazole, lansoprazole) can also be influenced by enteral feeds, with the acid labile proton pump inhibitors prematurely degrading and activating in the presence of feeds with an elevated pH (> 5.5). Conversely, drugs such as acitretin, carbamazepine and griseofulvin have enhanced absorption when taken with food, potentially having a beneficial or deleterious effect on desired clinical outcomes, due to altered drug bioavailability. Predicting the influence food can have on drug disposition has been enhanced with the Biopharmaceutics Classification System, which helps in differentiating drugs into four groups based on their solubility and permeability [46]. Awareness of this predictive system could aid prescribers, with drugs of low permeability and/or solubility best avoided being altered when given through gastric access devices. There exist a number of oral medications that should not be crushed and administered through gastric access device. These include enteric-coated medications and modified release (m/r) (slow or extended release [XL]) tablets or capsules, often identified by abbreviations such as LA (long acting), SA (sustained acting), CR (controlled release), XL, SR (sustained release) or m/r. Enteric-coated medications are difficult to crush and when broken up into small pieces can lead to gastric access device occlusion. In regard to SR preparations, crushing alters the delivery mechanisms of the formulation, leading to variable blood levels and potential toxicity. Hormone, steroid, antibiotic or chemotherapy (cytotoxic) medicines are another group of medications that require special consideration, as crushing can lead to the production of aerosolized particles, causing potential side effects to the person crushing the tablets or anybody else nearby. A full list of oral medications that should not be crushed can be obtained from the Institute for Safe Medication Practices [47]. Chelation is another potential problem that can occur when enteral feeds are given concomitantly with medications. The binding of cations found in feeds such as magnesium, calcium or iron to drug compounds can impair both their absorption and efficacy. These findings of reduced efficacy have been seen in studies evaluating ciprofloxacin, tetracyclines and phenytoin [48-52]. Warfarin is another important medication that can be influenced by enteral formulas. The vitamin K content within enteral feed preparations has been
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3.3
shown to influence the drug’s pharmacodynamics and its anticoagulant effect, leading to levels of vitamin K being reduced in some feeds by some manufacturers [53,54]. Drug--gastric access device interactions Administering oral medication through gastric access devices is heavily influenced by tube-related factors. The size of the tube (both length and diameter) and material of the tube (previously discussed) can significantly influence how successful the intervention of giving oral medication via gastric access devices will be. Narrow and long tubes have a greater potential to become blocked by larger drug particles or by highly viscous solutions. Positioning of the tube can also have a bearing on outcomes. Although the distal point of gastric access devices is intended to lie within the stomach, they can occasionally migrate either proximally or distally along the gastrointestinal tract, potentially bypassing the site of optimal drug absorption, influencing a drug’s bioavailability. 3.4
4.
Drug--nutrient interactions
Definition The coadministration of oral medications through gastric access devices has the potential of increasing drug--nutrient interactions. Drug--nutrient interactions result from physical, chemical, physiological or pathophysiological relationships not only between a drug and a nutrient but also between a drug and multiple nutrients, food in general, specific foods or components or nutrition status [55,56]. From a clinical perspective, the interaction could be considered significant if it alters the therapeutic response or compromises nutritional status. Although the frequency of drug--nutrient interactions is less well recognized and less reported than drug--drug interactions, they are no less concerning and can influence therapeutic outcomes and goals of therapy -- an often overlooked aspect of prescribing physicians [57]. 4.1
Factors influencing drug--nutrient interactions The risk of developing drug--nutrient interaction may be influenced by patient factors and drug--gastric access device interactions factors (Section 3.4). Patient factors include severity of an individual’s underlying disease, age, genetic variants, nutritional status and organ function. Like drug-drug interactions, young children and elderly patients are at highest risk of developing drug--nutrient interactions, most frequently due to reduced enzyme metabolism, narrow therapeutic ranges before toxicity ensues, organ dysfunction and polypharmacy [58]. 4.2
Specific drug--nutrient interactions There has been an increased understanding of drug--nutrient interactions and the mechanisms which can influence drug absorption [55,59,60]. As patients with gastric access devices are more prone to these interactions, heightened awareness of recognition and prevention is required among prescribers, 4.3
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pharmacists and drug administrators [56]. The use of phenytoin is a good example of a drug--nutrient interaction where serum levels significantly fall when given with enteral formulas, potentially increasing seizure risk [51]. Ciprofloxacin is another example of a drug where coadministration with enteral feeding has been shown to influence absorption and bioavailability, likely through the mechanisms of drug chelation [61,62]. Unfortunately, data on specific drug--nutrient reactions in the context of gastric access device feeding remain small, considering the thousands of commercially available drugs that are available. This has implications for clinical practice, with the absence of data to support the decision making where maximal benefit of drug therapy is sought and risks minimized. A recent review of 42 commonly used medications in hospitalized patients has provided some useful guidance on this issue; however as discussed by the authors of that work, their findings were often limited by the paucity of data and the interpretation of anecdotal experience [63].
products exist such as the Clog Zapper that contains digestive enzymes, the Bard PEG cleaning brush and the Bionix Enteral Feeding Tube DeClogger, which mechanically help dismantle blockages; however, data evaluating their effectiveness remain limited [69-72]. When these above measures fail, consideration should be made for changing the gastrostomy feeding tube, after excluding other physiological cause of tube obstruction, such as an ulcer or gastrointestinal tumor.
5. Complications of drug delivery via gastric access devices
7.
Complications following gastric access placement are reported in the literature to range between 8 and 30% for percutaneous endoscopic gastrostomy (PEG) [9,12]. Of these, tube occlusion is one of the most common delayed complications seen, usually incurred as a consequence of drugs or enteral feeds [64,65]. Failure to recognize and instigate prompt treatment for this problem can lead to delays in feeding and receiving medication, as well as more serious complications such as peritonitis, infection, bleeding and possibly death. Gastrostomy patients are at risk of developing this complication due to the viscosity of enteral feeds, the narrowness of gastrostomy tube lumens and because of drug--nutrient interactions. Prevention is pivotal in trying to tackle this problem. This can be achieved by flushing the tube with 30 -- 50 ml of water every 4 h in patients who have continuous feeding, and before and after every feed in those who are established on bolus or intermittent feeds. Saline is to be avoided as a flushing agent, as there is a potential risk of crystallization within the tube, with subsequent tube occlusion occurring. Regarding medications, efforts should be made to avoid drug--nutrient interactions by giving multiple medications separately [29]. All crushed medications should be adequately suspended in solution, thereby minimizing the risk of blockage, with adequate flushing performed before and afterward. If gastric access devices do become blocked, the first initial agent to be trialed is warm water, alongside gentle massage of the tube [66]. There are no data to show that carbonated beverages are more effective than water as a flush solution and as such should be avoided [29]. If the above measures fail to work, then a combination of pancreatic enzymes with sodium bicarbonate solution may be used depending on the etiology [67,68]. In addition to the above, a number of commercially available 6
6.
Conclusion
In summary, this article provides a critical account of the practice of giving oral medications via gastric access devices. Findings suggest that successful drug delivery can be achieved in patients receiving enteral feeding, when important considerations are given to tube and patient factors, alongside drug--nutrient interactions. Blockages of gastric access devices are uncommon events but can be minimized by following best practices.
Expert opinion
Since endoscopic, radiological and other techniques for gastric access were introduced into clinical practice, there has been a rapid rise in the number of patients undergoing insertion of gastric access devices. Despite the frequency, concerns in certain patient groups (e.g., dementia) and the high postprocedural mortality (gastrostomy cohorts), there remains a paucity of high quality, prospective studies evaluating patients with gastric access devices that could help inform clinical practice [19,73-75]. This lack of an evidence base may not necessarily denote errors in our current practice; however, standardizing care to defined standards or establishing an evidence base could significantly help improve the currently attained outcomes. The use of gastric access devices for drug administration is another practice in this field, where an evidence base is lacking. Reports would suggest that the practice of giving medication via gastric access devices, in an often unlicensed manner is widely occurring with significant variations in practice [76]. Despite the suggested regularity of this practice, there is a dearth of understanding as to its exact frequency, its associated complication rates and what influences this practice may have not only on patients but also on healthcare professionals involved in the drug administration process. This is critically important given the high regard placed internationally on patients’ safety within healthcare systems. Given the limited evidence base currently available in the field, we would advocate that best practice in regard to drug administration via gastric access devices be founded on recommendations from internationally recognized bodies such as the American Society for Parenteral and Enteral Nutrition and British Association for Parenteral and Enteral Nutrition [29,30]. Utilization and standardization of practice by adhering to recommendations has been shown to improve patients’
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Impact of direct drug delivery via gastric access devices
safety by reducing problems such as tube obstructions and medication errors [77]. Heightening awareness among healthcare professionals of the potential problems of coadministering medication via gastric access devices needs to be the first step toward implementing this best practice. Further, recognition and understanding of drug--nutrient interactions needs to be improved, with interactions considered in the same context as drug--drug interactions and patients counseled about these risks [78]. This education requires assistance from pharmaceutical companies, regulatory bodies and, at local levels, the development and use of local protocols and expertise from within specialist nutrition support teams. Pharmacists should also be recognized as having key roles at local levels in supporting prescribers and nurses in addressing issues with drug administration in patients with gastric access devices [79,80]. Advancing practice in this field in the future necessitates a significant improvement in the reporting of findings pertinent to drug delivery through gastric access devices. This could Bibliography Papers of special note have been highlighted as either of interest () or of considerable interest () to readers. 1.
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Declaration of interest The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents, received or pending, or royalties.
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Bankhead R, Boullata J, Brantley S, et al. Enteral nutrition practice recommendations. JPEN J Parenter Enteral Nutr 2009;33(2):122-67 BAPEN. British Association for Parenteral and Enteral Nutrition. Administering drugs via enteral feeding tubes: a practical guide [online]. Available from: http://www.bapen.org.uk/ pdfs/d_and_e/de_pract_guide.pdf 2004
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commercially available products. J Pharm Pharm Sci 2006;9(3):398-426 An extensive literature review investigating drug stability of 83 commonly used drugs. Boullata JI, Hudson LM. Drug-nutrient interactions: a broad view with implications for practice. J Acad Nutr Diet 2012;112(4):506-17 An excellent review of drug--nutrient interactions.
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Mitchell JF. Oral dosage forms that should not be crushed. Available from: http://www.ismp.org/tools/donotcrush. pdf Updated January 2014 [Accessed 14 August 2014]
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Healy DP, Brodbeck MC, Clendening CE. Ciprofloxacin absorption is impaired in patients given enteral feedings orally and via gastrostomy and jejunostomy tubes. Antimicrob Agents Chemother 1996;40(1):6-10
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Mueller BA, Brierton DG, Abel SR, Bowman L. Effect of enteral feeding with ensure on oral bioavailabilities of ofloxacin and ciprofloxacin. Antimicrob Agents Chemother 1994;38(9):2101-5
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Klang M, Graham D, McLymont V. Warfarin bioavailability with feeding tubes and enteral formula. JPEN J Parenter Enteral Nutr 2010;34(3):300-4
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Dickerson RN, Garmon WM, Kuhl DA, et al. Vitamin K-independent warfarin resistance after concurrent administration of warfarin and continuous enteral nutrition. Pharmacotherapy 2008;28(3):308-13
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Boullata JI. Drug and nutrition interactions: not just food for thought. J Clin Pharm Ther 2013;38(4):269-71
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preliminary survey. Pediatrics 1988;81(4):549-51 77.
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Expert Opin. Drug Deliv. (2014) 12(3)
Affiliation
Matthew Kurien†1 MRCP MD, Hugo Penny2 MBChB & David S Sanders3 FRCP MD † Author for correspondence 1 Academic Clinical Lecturer in Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Gastroenterology and Liver Unit, Glossop Road, Sheffield, S10 2JF, UK Tel: +44114 2261179; Fax: +44114 2712692; E-mail: [email protected] 2 Academic Clinical Fellow in Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Gastroenterology and Liver Unit, Glossop Road, Sheffield, S10 2JF, UK 3 Professor of Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Gastroenterology and Liver Unit, Glossop Road, Sheffield, S10 2JF, UK
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Impact of direct drug delivery via gastric access devices
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Matthew Kurien†, Hugo Penny & David S Sanders †
1.
Introduction
2.
Gastric access devices and enteral feeds
4.
Drug--nutrient interactions
5.
Complications of drug delivery via gastric access devices
6.
Conclusion
7.
Expert opinion
Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Gastroenterology and Liver Unit, Sheffield, UK
Introduction: Gastric access devices such as nasogastric tubes and gastrostomy tubes are increasingly being used in clinical practice to provide both shortand long-term nutrition support therapy. Increasingly these devices are being utilized to help deliver oral medications, where swallowing is impaired. This concomitant administration of medications and enteral formulas could derive potential benefits in regard to time and cost; however, uncertainty exists regarding potential drug and nutrient interactions and the influence this may have on both safety and efficacy. Areas covered: This article provides an overview of the differing gastric access devices used in clinical practice and evaluates the evidence base for using oral medications via these routes. Alternative methods of drug administration are discussed, alongside common drug nutrient interactions and potential complications. Expert opinion: Delivering medications via gastric access devices can be performed safely; however, careful consideration needs to be made regarding tube and patient influences, alongside drug--nutrient interactions. Improving practice in this area in the future necessitates enhancement of an evidence base to substantiate the safety of drug delivery via gastric access devices and improvement in education among healthcare professionals about the potential problems. Keywords: complications, drug delivery, enteral feeding, gastric access devices, gastrostomy, nasogastric tubes Expert Opin. Drug Deliv. [Early Online]
1.
Introduction
Malnutrition is common and is both a cause and consequence of ill health [1]. The prevalence of malnutrition in hospitalized patients has previously been shown to be high and often unrecognized, leading to increased emphasis on awareness and consideration of nutrition support therapy [2-5]. Oral nutrition using special diets and supplements is usually considered the first-line therapy in managing malnutrition; however, certain individuals may require enteral or parenteral nutrition when oral intake is reduced or when swallowing is unsafe. Of these modalities, enteral nutrition is usually preferred in the context of a normally functioning gastrointestinal tract as it is physiological, cheaper and may help maintain gut barrier function [6,7]. Gastric access devices enable the administration of enteral nutrition, describing an enteral feeding tube where the distal point lies within the stomach. These devices are increasingly being used in clinical practice, helping to provide both short- and long-term enteral nutrition when oral caloric intake is inadequate. Nasogastric tubes are the most frequently used short-term gastric access device (< 1 month of enteral feeding), preferentially used over orogastric tubes as they are easier to secure, less likely to become disturbed by eating and can allow the introduction of oral feeding following insertion [8]. Gastrostomies are alternative gastric access devices, usually reserved for long-term enteral feeding and may be inserted at endoscopy, surgery 10.1517/17425247.2015.966683 © 2014 Informa UK, Ltd. ISSN 1742-5247, e-ISSN 1744-7593 All rights reserved: reproduction in whole or in part not permitted
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Article highlights. . . . . .
Gastric access devices are increasingly being used in clinical practice. This article addresses the critical and important aspect of drug administration via gastric access devices. A review is undertaken of the different gastric access devices that are used in clinical practice. Drug--nutrient interactions are discussed in the context of gastric access devices. Prevention and management of complications are explored in this article.
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This box summarizes key points contained in the article.
Figure 1. Illustration of a gastrostomy feeding tube.
Nasogastric tube Whole food by mouth
Orogastric tube
or using radiological guidance (Figure 1) [9]. Alternatives to these gastric access devices include insertion of feeding tubes via the mouth, nasally or percutaneously into either the proximal or mid-small bowel (Figure 2 and Table 1). Apart from delivering enteral nutrition, gastric access devices and other enteral feeding tubes are frequently considered as a way of administering medication to patients where swallowing is impaired. Currently, it is estimated that approximately one-third of patients in long-term care facilities have problems with swallowing oral medication due to aging, acute or chronic disease conditions or because of decline in physiological functions [10]. Although administration of medication via gastric access devices is widely performed in clinical practice, it remains to be established the exact number of patients who receive concomitant medication and enteral nutrition via their delivery device [3,11,12]. In a recent study of 75 diabetic patients in the UK, medications were found to be given in all gastrostomy-fed individuals, equating to a mean number of 5.7 medications a day at a mean cost of £145 a month (175 EUR/US$230) [13]. These findings were supported in another study of 480 adult patients, where all gastrostomy patients assessed (n = 11) were receiving medications via their tubes [14]. The frequency at which medications appear to be administered via gastric access devices raises questions as to the merits of this practice and the influence this may have on both the safety and efficacy of nutrient and drug therapies. Currently, there is a paucity of prospective data evaluating outcomes following drug administration through gastric access devices, which could help inform clinical practice. This review provides an overview of the differing gastric access devices, a critical assessment of the available literature looking at drug--nutrient interactions, factors that may influence these interactions, drug administration techniques and reviews alternative means of giving medication to patients. Further, complications will be reviewed with guidance given to minimize the risk of tube occlusion.
2.
Gastric access devices and enteral feeds
Nasogastric and orogastric tubes Most patients requiring nutrition support therapy have treatment for < 1 month [8]. When short-term enteral feeding is considered, nasogastric and orogastric tubes are most frequently used, as they are relatively easy to insert and have the potential to be removed easily in the future. Tubes range in length and diameter and may be inserted either at the bedside or by using endoscopic or radiological guidance [15]. The tube diameters are conventionally measured in French units (1 French Unit = 0.33 mm) and may be categorized as either fine bore (5 -- 12 French Unit) or large bore (> 14 French Unit). Fine bore tubes are most frequently used for feeding and better tolerated than large bore tubes; however they are more prone to blockages. Another potential advantage of large bore tubes over fine bore tubes is that they can be aspirated 2.1
Nasoduodenal tube Gastrostomy tube Nasojejunal tube Jejunostomy tube
Figure 2. Representation of different types of enteral feeding devices.
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Impact of direct drug delivery via gastric access devices
Table 1. Alternative methods of enteral drug delivery.
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Name
Entry point
Distal point
Nasogastric
Nose
Stomach
Nasoduodenal Nasojejunal Percutaneous gastrostomy Percutaneous jejunostomy Percutaneous gastrojejunostomy Orogastric
Nose Nose Abdomen Abdomen Abdominal wall Mouth
Duodenum Jejunum Stomach Jejunum Jejunum via the stomach Stomach
Table 2. Types of gastrostomy tubes. Manufacturer
Product name
Corpak Medsystems, Inc. Cook Medical Covidien UK
CORFLO FLOW/PEG Kangaroo
Gb (UK) Enteral
AMT
Medicina Ltd
Monarch Medicina
Vygon UK Ltd
MIC
Diameter (F) 14, 20, 20, 12, 16, 12, 16, 12, 12, 16, 20, 12, 18, 24,
16, 22, 24 14, 20 14, 18, 14 14, 18, 22 14, 20, 26,
18, 24
Tube material Polyurethane Silicone Silicone Silicone
20 Silicone Silicone
16, 22, 28, 30
Silicone
from, if required, or if decompression of the stomach is needed. The material composition of nasogastric and orogastric tubes can vary, influencing both tolerability and performance. Historically, some tubes were made from polyvinylchloride (PVC) but exposure to gastric acid caused tubes to become stiff and brittle, reducing their efficacy [3]. Currently, most tubes are produced from polyurethane or silicone. Silicone is a softer material than PVC; however, often, the walls of such tubes may collapse when aspiration of gastric contents is attempted. Polyurethane appears to be a much stronger material, with these tubes tending to have larger lumens. Gastrostomies The concept of a gastrostomy was first proposed by Egeberg, a Norwegian army surgeon in 1837; however, it was only in 1876 when Verneuil used a silver wire to oppose visceral and parietal surfaces of the peritoneum that success was achieved in inserting the first surgical gastrostomy [16]. Almost a century later, in 1979, Michael Gauderer and Jeffrey Ponsky revolutionized gastrostomy practice by pioneering an endoscopic method of insertion in Cleveland, Ohio, associated with reduced morbidity and mortality [17]. Two years later 2.2
Usual size Fine bore: 6 -- 12 Fr for feeding Large bore: 12 -- 16 Fr for aspiration Fine bore Fine bore 6 -- 10 Fr Fine bore/large bore Fine bore Fine bore Fine/large bore
in 1981, Preshaw in Canada used fluoroscopic guidance to insert the first percutaneous radiological gastrostomy [18]. In the UK, ~ 17,000 gastrostomies are now being performed annually, most frequently reserved for individuals requiring long-term nutrition support (> 4 -- 6 weeks) [19]. Endoscopic and radiological techniques are the most utilized methods of insertion, with the majority of procedures being performed in adults. Most frequently, gastrostomy insertion is undertaken for neurological conditions affecting swallowing (e.g., post-cerebrovascular accident, motor neuron disease) and for obstructive lesions of the upper gastrointestinal tracts (e.g., esophageal malignancy, head and neck cancers) [9]. Like short-term feeding tubes, there are an array of differing gastrostomy feeding tubes that are commercially available, with most being polyurethane and silicone (Table 2). Further specifics regarding tube length, tube diameter internal volume and tube surface area can be acquired from manufacturers’ websites. Awareness of these differing tubes, differing sizes and composition is particularly pertinent as they can influence tube complications.
Enteral nutrition formulas Enteral feeds are nutritionally complete (containing protein or amino acids, carbohydrate, fat, water, minerals and vitamins) and are available in fiber-free and fiber-enriched forms. Determining the type to be used is influenced by the patient’s nutritional requirements, gastrointestinal absorption, motility and by an individual’s comorbidities, such as renal or liver disease [3]. Gastric access devices can be used to deliver these enteral feeds using continuous, bolus or intermittent infusion methods [20]. Continuous infusion provides patients with feed over 24 h and is most frequently reserved for very ill patients [21]. This regimen is associated with an increased risk of drug--nutrient interactions (discussed later) and can also increase intragastric pH leading to bacterial overgrowth [22]. Bolus feeding describes the delivery of 200 -- 400 ml of feed (administered either by push or gravity methods over 15 -- 60 min) periodically throughout the day, permitting medications to be given at times different from feeds. This can lead to abdominal bloating, diarrhea and symptoms analogous to those seen in the ‘dumping syndrome’ where rapid gastric emptying occurs. Last, intermittent infusions provides 2.3
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feeds over a longer duration than bolus feeding using an infusion pump, thereby minimizing the adverse symptoms but also permitting breaks for the patients unlike continuous feeding. Patient issues and procedural complications The relative ease of insertion of gastric access devices has led to their increasing use in clinical practice. Despite their potential merits in improving nutritional status, mortality and hospital length of stay in carefully selected patients, problems do arise as a consequence of tube insertion and feeding, leading to significant morbidity. During insertion, gastric access devices may cause inadvertent injury of the gastrointestinal tract, causing bleeding and in rare cases perforation. Specifically relating to nasogastric and orogastric tubes, these occasionally have caused significant lung injury and infection as a consequence of accidental intubation of the tracheobronchial tree. Given the recognized and serious sequelae of these early tube-related complications, guidance has recently been issued to help aid healthcare professionals in both early recognition and management of both nasogastric and gastrostomy complications [23,24]. Other identified tube-related complications that can occur include: pain around insertion point, infections, peristomal leakage, tube blockage, tube damage, dislodgment and migration of the tube from original point of insertion [25]. The feeds themselves can also cause complications including gastrointestinal symptoms (nausea, reflux and diarrhea) and metabolic complications [26,27]. Evaluating the current published literature about the influence gastric access devices and feeds have on an individual’s quality of life is fraught with difficulty. Studies that have tried to assess this outcome measure have predominantly been from cancer cohorts, using an array of differing methodologies. A recent review of studies performed has suggested that quality of life in patients receiving enteral tube feeding was poor compared with control groups, with factors such as nausea, vomiting, diarrhea, fatigue, body image and social isolation heavily influencing this diminished quality of life [28].
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2.4
3
Drugs and gastric access devices
Prior considerations A number of guidelines and recommendations currently exists that advocate enteral administration of medications via gastric access devices when no alternatives exist [11,29,30]. Prior to considering the use of gastric access devices, it is imperative that a thorough review be made of the requirement for medication and that all nonessential medications be discontinued or temporarily stopped. If medication is deemed necessary, then a thorough exploration of alternative administrative routes should be undertaken prior to gastric access devices being used including rectal, sublingual, transdermal, injectable, inhalational, subcutaneous and buccal methods. Although these alternatives to feeding tube delivery of medication may be feasible, consideration needs to be made as to their 3.1
4
tolerability and acceptability (rectal methods), drug availability in differing preparation forms, infection risks (injectable and subcutaneous methods) and the potential influence that an alternative route may have on a drug’s bioavailability. Dosage or frequency of medications may need to be adjusted as a consequence of using a different administrative method. Drug formulations/physiochemical properties If gastric access devices are considered the best or only means of administering medication, then liquid preparations are preferable [31]. Of the differing liquid formulations available, emulsions and elixirs are favored as syrups and suspensions may clump inside gastric access devices due to their high viscosity, leading to tube blockages [15]. Although liquid preparations may be preferable, dose adjustments are often required to achieve the same desired therapeutic response of solid preparations. Another potential problem of some liquid preparations is that they are hyperosmolar or contain sugar alcohols such as sorbitol. These additives are usually inactive ingredients used for flavoring; however, when given in large doses or alongside other liquid preparations with high osmolality, their cumulative effect can lead to osmotic diarrhea and other gastrointestinal symptoms such as bloating, nausea and abdominal cramps [32,33]. Acquiring information regarding drug osmolality and sorbitol content is frequently problematic without direct contact with manufacturers; however, dilution of the hyperosmolar medication with water prior to delivery may help reduce some of the gastrointestinal symptoms [34,35]. This practice of diluting a liquid drug may also improve the delivery of the drug (particularly highly viscous liquids) in getting to the distal end of the gastric access device [36]. Despite the optimal delivery of liquid medication via gastric access devices, a high percentage of drugs are only available in solid oral forms [10]. This has led to the practice of crushing tablets using implements such as a pestle and mortar or opening capsules, prior to dilution in water and delivery via the feeding tube [31,37,38]. Concerns have been raised in the literature as to the merits of breaking down solid medications like this with the potential loss of substance, the influence this may have on therapeutic effect, the harm this may incur to nursing staff and the problems this may lead to with tube blockages [11,39]. To corroborate this, studies have shown that many errors occur during this process of solid drug breakdown, leading to potential harm to both patients and staff [40-43]. There are limited data available about the consequences the crushing of medication has on drug stability. Further, by crushing medication the prescriber and the drug administrator incur legal responsibility rather than the drug manufacturer for any potential adverse event, due to the utilization of the drug in an unlicensed manner [44]. This absence of data poses challenges to clinicians and pharmacists in ensuring safe prescribing. Some reassurances can be found from a review of 83 commonly used drugs, which identified only a small percentage of 7.2% having stability concerns when 3.2
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Impact of direct drug delivery via gastric access devices
converted to liquid forms [45]. Although these findings provide reassurances that only a minority of drugs have stability issues, it should be emphasized that these 83 medications represent a small fraction of the total number of oral medications that can potentially be given via gastric access devices. Drug absorption and bioavailability Delivering oral medication through gastric access device can influence a drug’s performance by compromising an oral drug’s specifically designed delivery mechanisms and also by influencing drug absorption. For example, tetracycline, ampicillin, bisphosphonates and levothyroxine all have reduced absorption when taken alongside food or enteral feeds. Some proton pump inhibitors (e.g., omeprazole, lansoprazole) can also be influenced by enteral feeds, with the acid labile proton pump inhibitors prematurely degrading and activating in the presence of feeds with an elevated pH (> 5.5). Conversely, drugs such as acitretin, carbamazepine and griseofulvin have enhanced absorption when taken with food, potentially having a beneficial or deleterious effect on desired clinical outcomes, due to altered drug bioavailability. Predicting the influence food can have on drug disposition has been enhanced with the Biopharmaceutics Classification System, which helps in differentiating drugs into four groups based on their solubility and permeability [46]. Awareness of this predictive system could aid prescribers, with drugs of low permeability and/or solubility best avoided being altered when given through gastric access devices. There exist a number of oral medications that should not be crushed and administered through gastric access device. These include enteric-coated medications and modified release (m/r) (slow or extended release [XL]) tablets or capsules, often identified by abbreviations such as LA (long acting), SA (sustained acting), CR (controlled release), XL, SR (sustained release) or m/r. Enteric-coated medications are difficult to crush and when broken up into small pieces can lead to gastric access device occlusion. In regard to SR preparations, crushing alters the delivery mechanisms of the formulation, leading to variable blood levels and potential toxicity. Hormone, steroid, antibiotic or chemotherapy (cytotoxic) medicines are another group of medications that require special consideration, as crushing can lead to the production of aerosolized particles, causing potential side effects to the person crushing the tablets or anybody else nearby. A full list of oral medications that should not be crushed can be obtained from the Institute for Safe Medication Practices [47]. Chelation is another potential problem that can occur when enteral feeds are given concomitantly with medications. The binding of cations found in feeds such as magnesium, calcium or iron to drug compounds can impair both their absorption and efficacy. These findings of reduced efficacy have been seen in studies evaluating ciprofloxacin, tetracyclines and phenytoin [48-52]. Warfarin is another important medication that can be influenced by enteral formulas. The vitamin K content within enteral feed preparations has been
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3.3
shown to influence the drug’s pharmacodynamics and its anticoagulant effect, leading to levels of vitamin K being reduced in some feeds by some manufacturers [53,54]. Drug--gastric access device interactions Administering oral medication through gastric access devices is heavily influenced by tube-related factors. The size of the tube (both length and diameter) and material of the tube (previously discussed) can significantly influence how successful the intervention of giving oral medication via gastric access devices will be. Narrow and long tubes have a greater potential to become blocked by larger drug particles or by highly viscous solutions. Positioning of the tube can also have a bearing on outcomes. Although the distal point of gastric access devices is intended to lie within the stomach, they can occasionally migrate either proximally or distally along the gastrointestinal tract, potentially bypassing the site of optimal drug absorption, influencing a drug’s bioavailability. 3.4
4.
Drug--nutrient interactions
Definition The coadministration of oral medications through gastric access devices has the potential of increasing drug--nutrient interactions. Drug--nutrient interactions result from physical, chemical, physiological or pathophysiological relationships not only between a drug and a nutrient but also between a drug and multiple nutrients, food in general, specific foods or components or nutrition status [55,56]. From a clinical perspective, the interaction could be considered significant if it alters the therapeutic response or compromises nutritional status. Although the frequency of drug--nutrient interactions is less well recognized and less reported than drug--drug interactions, they are no less concerning and can influence therapeutic outcomes and goals of therapy -- an often overlooked aspect of prescribing physicians [57]. 4.1
Factors influencing drug--nutrient interactions The risk of developing drug--nutrient interaction may be influenced by patient factors and drug--gastric access device interactions factors (Section 3.4). Patient factors include severity of an individual’s underlying disease, age, genetic variants, nutritional status and organ function. Like drug-drug interactions, young children and elderly patients are at highest risk of developing drug--nutrient interactions, most frequently due to reduced enzyme metabolism, narrow therapeutic ranges before toxicity ensues, organ dysfunction and polypharmacy [58]. 4.2
Specific drug--nutrient interactions There has been an increased understanding of drug--nutrient interactions and the mechanisms which can influence drug absorption [55,59,60]. As patients with gastric access devices are more prone to these interactions, heightened awareness of recognition and prevention is required among prescribers, 4.3
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pharmacists and drug administrators [56]. The use of phenytoin is a good example of a drug--nutrient interaction where serum levels significantly fall when given with enteral formulas, potentially increasing seizure risk [51]. Ciprofloxacin is another example of a drug where coadministration with enteral feeding has been shown to influence absorption and bioavailability, likely through the mechanisms of drug chelation [61,62]. Unfortunately, data on specific drug--nutrient reactions in the context of gastric access device feeding remain small, considering the thousands of commercially available drugs that are available. This has implications for clinical practice, with the absence of data to support the decision making where maximal benefit of drug therapy is sought and risks minimized. A recent review of 42 commonly used medications in hospitalized patients has provided some useful guidance on this issue; however as discussed by the authors of that work, their findings were often limited by the paucity of data and the interpretation of anecdotal experience [63].
products exist such as the Clog Zapper that contains digestive enzymes, the Bard PEG cleaning brush and the Bionix Enteral Feeding Tube DeClogger, which mechanically help dismantle blockages; however, data evaluating their effectiveness remain limited [69-72]. When these above measures fail, consideration should be made for changing the gastrostomy feeding tube, after excluding other physiological cause of tube obstruction, such as an ulcer or gastrointestinal tumor.
5. Complications of drug delivery via gastric access devices
7.
Complications following gastric access placement are reported in the literature to range between 8 and 30% for percutaneous endoscopic gastrostomy (PEG) [9,12]. Of these, tube occlusion is one of the most common delayed complications seen, usually incurred as a consequence of drugs or enteral feeds [64,65]. Failure to recognize and instigate prompt treatment for this problem can lead to delays in feeding and receiving medication, as well as more serious complications such as peritonitis, infection, bleeding and possibly death. Gastrostomy patients are at risk of developing this complication due to the viscosity of enteral feeds, the narrowness of gastrostomy tube lumens and because of drug--nutrient interactions. Prevention is pivotal in trying to tackle this problem. This can be achieved by flushing the tube with 30 -- 50 ml of water every 4 h in patients who have continuous feeding, and before and after every feed in those who are established on bolus or intermittent feeds. Saline is to be avoided as a flushing agent, as there is a potential risk of crystallization within the tube, with subsequent tube occlusion occurring. Regarding medications, efforts should be made to avoid drug--nutrient interactions by giving multiple medications separately [29]. All crushed medications should be adequately suspended in solution, thereby minimizing the risk of blockage, with adequate flushing performed before and afterward. If gastric access devices do become blocked, the first initial agent to be trialed is warm water, alongside gentle massage of the tube [66]. There are no data to show that carbonated beverages are more effective than water as a flush solution and as such should be avoided [29]. If the above measures fail to work, then a combination of pancreatic enzymes with sodium bicarbonate solution may be used depending on the etiology [67,68]. In addition to the above, a number of commercially available 6
6.
Conclusion
In summary, this article provides a critical account of the practice of giving oral medications via gastric access devices. Findings suggest that successful drug delivery can be achieved in patients receiving enteral feeding, when important considerations are given to tube and patient factors, alongside drug--nutrient interactions. Blockages of gastric access devices are uncommon events but can be minimized by following best practices.
Expert opinion
Since endoscopic, radiological and other techniques for gastric access were introduced into clinical practice, there has been a rapid rise in the number of patients undergoing insertion of gastric access devices. Despite the frequency, concerns in certain patient groups (e.g., dementia) and the high postprocedural mortality (gastrostomy cohorts), there remains a paucity of high quality, prospective studies evaluating patients with gastric access devices that could help inform clinical practice [19,73-75]. This lack of an evidence base may not necessarily denote errors in our current practice; however, standardizing care to defined standards or establishing an evidence base could significantly help improve the currently attained outcomes. The use of gastric access devices for drug administration is another practice in this field, where an evidence base is lacking. Reports would suggest that the practice of giving medication via gastric access devices, in an often unlicensed manner is widely occurring with significant variations in practice [76]. Despite the suggested regularity of this practice, there is a dearth of understanding as to its exact frequency, its associated complication rates and what influences this practice may have not only on patients but also on healthcare professionals involved in the drug administration process. This is critically important given the high regard placed internationally on patients’ safety within healthcare systems. Given the limited evidence base currently available in the field, we would advocate that best practice in regard to drug administration via gastric access devices be founded on recommendations from internationally recognized bodies such as the American Society for Parenteral and Enteral Nutrition and British Association for Parenteral and Enteral Nutrition [29,30]. Utilization and standardization of practice by adhering to recommendations has been shown to improve patients’
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Impact of direct drug delivery via gastric access devices
safety by reducing problems such as tube obstructions and medication errors [77]. Heightening awareness among healthcare professionals of the potential problems of coadministering medication via gastric access devices needs to be the first step toward implementing this best practice. Further, recognition and understanding of drug--nutrient interactions needs to be improved, with interactions considered in the same context as drug--drug interactions and patients counseled about these risks [78]. This education requires assistance from pharmaceutical companies, regulatory bodies and, at local levels, the development and use of local protocols and expertise from within specialist nutrition support teams. Pharmacists should also be recognized as having key roles at local levels in supporting prescribers and nurses in addressing issues with drug administration in patients with gastric access devices [79,80]. Advancing practice in this field in the future necessitates a significant improvement in the reporting of findings pertinent to drug delivery through gastric access devices. This could Bibliography Papers of special note have been highlighted as either of interest () or of considerable interest () to readers. 1.
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Declaration of interest The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents, received or pending, or royalties.
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Affiliation
Matthew Kurien†1 MRCP MD, Hugo Penny2 MBChB & David S Sanders3 FRCP MD † Author for correspondence 1 Academic Clinical Lecturer in Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Gastroenterology and Liver Unit, Glossop Road, Sheffield, S10 2JF, UK Tel: +44114 2261179; Fax: +44114 2712692; E-mail: [email protected] 2 Academic Clinical Fellow in Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Gastroenterology and Liver Unit, Glossop Road, Sheffield, S10 2JF, UK 3 Professor of Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Gastroenterology and Liver Unit, Glossop Road, Sheffield, S10 2JF, UK
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