One in 11 primary care patients had frequent difficulties in swallowing tablets and capsules while GPs grossly underestimated these problems. Therefore, physicians should rule out swallowing difficulties regularly to avoid non-adherence and inappropriate drug modifications. Special attention should be paid to specific patient groups (e.g. women and patients with dysphagia, dysphagia indicators, or mental illness).

We evaluated the prevalence of difficulties swallowing solid dosage forms in patients with stroke-induced dysphagia and whether swallowing tablets/capsules increases their risk of penetration and aspiration. Concurrently, we explored whether routinely performed assessment tests help identify patients at risk. Using video endoscopy, we evaluated how 52 patients swallowed four different placebos (round, oval, and oblong tablets and a capsule) with texture-modified water (TMW, pudding consistency) and milk and rated their swallowing performance according to the Penetration Aspiration Scale (PAS). Additionally, Daniels Test, Bogenhausener Dysphagiescore, Scandinavian Stroke Scale, Barthel Index, and Tinetti's Mobility Test were conducted. A substantial proportion of the patients experienced severe difficulties swallowing solid oral dosage forms (TMW: 40.4 %, milk: 43.5 %). Compared to the administration of TMW/milk alone, the placebos increased the PAS values in the majority of the patients (TMW: median PAS from 1.5 to 2.0; milk: median PAS from 1.5 to 2.5, each p value <0.0001) and residue values were significantly higher (p < 0.05). Whereas video-endoscopic examination reliably identified patients with difficulties swallowing medication, neither patients' self-evaluation nor one of the routinely performed bedside tests did. Therefore, before video-endoscopic evaluation, many drugs were modified unnecessarily and 20.8 % of these were crushed inadequately, although switching to another dosage form or drug would have been possible. Hence, safety and effectiveness of swallowing tablets and capsules should be evaluated routinely in video-endoscopic examinations, tablets/capsules should rather be provided with TMW than with milk, and the appropriateness of "non per os except medication" orders for dysphagic stroke patients should be questioned.

To evaluate whether 2 techniques (the pop-bottle method for tablets and the lean-forward technique for capsules) ease swallowing of tablets and capsules, we conducted a cross-sectional study including 151 adults of the general German population. Participants swallowed 16 differently shaped placebos, rated their ease of swallowing on an 8-point Likert scale, and swallowed the 2 dosage forms that they had rated most difficult again using the appropriate technique. The pop-bottle method substantially improved swallowing of tablets in 59.7% (169/283) and the lean-forward technique for capsules in 88.6% (31/35). Both techniques were remarkably effective in participants with and without reported difficulties swallowing pills and should be recommended regularly. INTRODUCTIONA mong ambulatory patients who report difficulty in swallowing pills, 1 in 3 experience vomiting, gagging, choking, or having tablets blocked in the throat.1,2 Therefore, the modification of dosage forms (58.8%) and nonadherence (9.4%) are frequent 1,2 and can worsen medical conditions and increase health care costs.3 Given that tablets and capsules differ markedly in physical properties such as size, shape, and density, optimal swallowing techniques likely differ, too. 4 This study aimed to evaluate the influence of 2 techniques on the swallowing of tablets (the pop-bottle method) and capsules (the lean-forward technique). METHODSAfter obtaining ethical approval and written informed consent, we enrolled 151 participants of the general population (52.3% women, mean age 45.8 years (range 18 to 85 years), 55.6% reporting difficulties swallowing solid dosage forms) in a single-blind experiment (German Clinical Trials Register Number: DRKS00004174). We manufactured 16 differently shaped placebos (capsules; round, oval, and oblong tablets) in 4 size groups.In the pop-bottle method, the tablet is placed on the tongue, the lips are tightly closed around the opening of a flexible PET (polyethylene terephthalate) bottle, and the tablet is swallowed in a swift suction movement to overcome the volitional phase of swallowing. 5 In the lean-forward technique, capsules are swallowed in upright position with the head bent forward (Figure 1 and Supplemental Patient Handout). 6The participants randomly swallowed all dosage forms with their eyes closed, using 20 ml of non-carbonated water, and rated the ease of swallowing on an 8-point Likert scale (0 = very easy, 7 = very difficult to swallow). Structured questionnaires were used to assess participants' ability to swallow placebos (eg, sensation in throat during swallowing). To evaluate the impact of the 2 swallowing strategies, within each of the 2 largest dosage-size groups (large mean ± SD: 474 ± 5.5 mm 3 , very large 834 ± 9.2 mm 3 ), the dosage form that caused the greatest difficulty was picked as intervention placebo and then swallowed using the pop-bottle technique (for tablets) 5 or the lean-forward technique (for capsules) 6 and rated again. Julia T. Schiele, PhD 551The Wilcoxon signed-rank test ...

Background and Objective Venetoclax is an approved BCL-2 inhibitor, currently under evaluation in different hematological malignancies in adult and pediatric populations. Venetoclax is available as 10, 50, and 100 mg tablets. To provide an alternative to patients who find taking the commonly prescribed 100 mg tablet a challenge, the interchangeability of lower-strength tablets with the 100 mg tablet was investigated. Additionally, newly developed oral suspension powder formulations to facilitate dosing in pediatrics were evaluated. Methods Pharmacokinetic data from 80 healthy female participants from three phase I studies were utilized to evaluate the bioavailability of (1) 10 and 50 mg tablets relative to a 100 mg tablet; (2) 0.72 and 7.2% (drug to total weight) oral powder formulations relative to the 100 mg tablet; and (3) oral powder formulations administered using different vehicles (apple juice, apple sauce, and yogurt) relative to water under fed conditions. Results Bioavailability assessments at a 100 mg dose of venetoclax demonstrated bioequivalence across the 10, 50, and 100 mg tablet strengths. Oral powder formulations met the bioequivalence criteria (0.80–1.25) with respect to area under the concentration–time curve to time of the last measurable concentration (AUC t ) and to infinite time (AUC ∞ ) but exhibited a slightly lower maximum plasma concentration ( C max ). Exposure–response analyses were utilized to demonstrate that the lower C max observed with the powder formulations is not clinically meaningful. The delivery vehicles tested did not affect the bioavailability of venetoclax oral powder formulations. Conclusions The smaller-sized tablets (10 and 50 mg) and the newly developed oral powder formulations of venetoclax can be used interchangeably with the 100 mg tablets to improve the patients’ experience, while maintaining adequate exposure. Clinical Trials Identifiers NCT01682616, 11 September 2012; NCT02005471, 9 December 2013; NCT02242942, 17 September 2014; NCT02203773, 30 July 2014; NCT02287233, 10 November 2014; NCT02993523, 15 December 2016; NCT03069352, 3 March 2017. Supplementary Information The online version contains supplementary material available at 10.1007/s40261-022-01172-4.

AIMSThe aim of this work is to understand the process of drug administration and identify points in the workflow that resulted in interventions by clinical information systems in order to improve patient safety. METHODSTo identify a generic way to structure the drug administration process we performed peer-group discussions and supplemented these discussions with a literature search for studies reporting errors in drug administration and strategies for their prevention. RESULTSWe concluded that the drug administration process might consist of up to 11 sub-steps, which can be grouped into the four sub-processes of preparation, personalization, application and follow-up. Errors in drug handling and administration are diverse and frequent and in many cases not caused by the patient him/herself, but by family members or nurses. Accordingly, different prevention strategies have been set in place with relatively few approaches involving e-health technology. CONCLUSIONSA generic structuring of the administration process and particular error-prone sub-steps may facilitate the allocation of prevention strategies and help to identify research gaps. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Similar to prescription errors also drug administration errors contribute to a large fraction of preventable medication errors and adverse drug events.• Drug administration can be exceedingly complex with regard to dose form, route of administration, number of co-medications, and setting and accordingly, error rates may vary. WHAT THIS STUDY ADDS• The drug-specific drug administration process can be generically structured for distinct dosage forms to allow identification of particularly error prone steps and allocated prevention strategies.• Potential research gaps in error epidemiology and prevention are highlighted. from 2003-2006 [5]). More than 50% of adults administer drugs daily [6]. This fact, however, does not automatically make drug administration a safe and straightforward process and, indeed, drug administration errors are frequent and in the inpatient setting, roughly 30% of errors resulting in adverse drug events (ADE) happen during drug administration [7]. Comparably susceptible to errors is the prescription process [7]. Whereas for the prescribing process electronic prescription platforms with enhanced clinical decision support tools were implemented as promising error prevention strategy [8], similar and theory-driven approaches are only scarcely available for the administration process [9], even though introduction of electronic support in the drug administration process has shown to reduce error rates [10].Drug treatment is a rather complex and demanding task ( Figure 1) and depending on the setting and co-medication a great number of different errors may occur. The aim of this study was to structure the drug administration process (process 5 in Figure 1) in a way that allowed the allocation of current knowledge on frequent sources of errors as well as successful methods to prevent such errors with a particular emphas...

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