Weight Variability of Pharmacist-Dispensed Split Tablets

Rosenberg, Jack M.; Nathan, Joseph P.; Plakogiannis, Fotios M.

doi:10.1331/108658002763508498

Cited by 55 publications

(41 citation statements)

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“…6 Using similar criteria, Rosenberg et al also observed tablet splitting that resulted in half tablets that generally did not exhibit half-tablet uniformity. 7 Hence, our expectations for this study were low. However, the results are relatively favorable and generally support the mandatory tablet-split policy of the VISN 5 region.…”

Section: Weight Uniformity Of Split Tablets Required By a Veterans Afmentioning

confidence: 78%

“…It has been suggested that patients, caregivers, and health systems would benefit from public quality standards for half tablets. 6,7 A second potential limitation of this study is the use of a trained pharmacy student to perform the tablet splitting. It is possible, and even likely, that different outcomes would result, depending on who performed the splitting.…”

Section: Ss Limitationsmentioning

confidence: 99%

“…Rosenberg et al found tablet splitting to yield half tablets that generally did not meet an expectation for dose uniformity. 7 They determined the weights and weight uniformity of tablet halves dispensed by pharmacists. Rosenberg et al found that only 7 of the 22 dispensed prescriptions met an expectation of accurate tablet halves (defined as less than 15% error) with acceptable weight uniformity (i.e., less than 6% relative standard deviation).…”

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confidence: 99%

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Weight Uniformity of Split Tablets Required by a Veterans Affairs Policy

Polli

Kim²,

Martin³

2003

JMCP

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OBJECTIVE: To split several tablet products relevant to the Veterans Affairs (VA) Maryland Healthcare System and assess whether the resulting half tablets provide equal doses.METHODS: From a VA list of products that are required to be split, 7 products were evaluated, along with 5 other commonly split tablet products. A trained pharmacy student split tablets using a tablet splitter provided by the VA. Half tablets were assessed for weight uniformity.RESULTS: Of the 12 products subjected to splitting, 8 products (atorvastatin, citalopram, furosemide, glipizide, metoprolol, paroxetine, sertraline, and warfarin) yielded half tablets that passed the weight-uniformity test. The 4 failing products were lisinopril, lovastatin, rofecoxib, and simvastatin. Unusual tablet shape and high tablet hardness predisposed products to failing the weight-uniformity test. The 4 failing products resulted in half tablets that were generally within 20% of their target weight range, suggesting that splitting these specific products would not result in adverse therapeutic effects due to dose variation created by tablet-splitting.CONCLUSION: Split-tablet results were relatively favorable and generally support a VA practice to split specific tablets. Public quality standards for half tablets, including their content uniformity, are needed to better delineate the policies for acceptable tablet splitting.

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Section: Weight Uniformity Of Split Tablets Required By a Veterans Afmentioning

confidence: 78%

Section: Ss Limitationsmentioning

confidence: 99%

mentioning

confidence: 99%

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Weight Uniformity of Split Tablets Required by a Veterans Affairs Policy

Polli

Kim²,

Martin³

2003

JMCP

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“…Initially, pill splitting was justified to adjust the dose to the patient, in cases where the required dosage was not commercially available (2) , or when patients needed a different those, such as in cases of treatment start (3) . Currently, it has been widely used, especially in the United States and in Canada, as a strategy of health plans to decrease drug costs, making physicians prescribe the medicine in its higher dosage so that it is split and used by patients (4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16) .…”

Section: Introductionmentioning

confidence: 99%

Avaliação do teor de Atenolol em comprimidos divididos com faca caseira e aparelho cortador

et al. 2011

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Objective: To evaluate whether the content of Atenolol on fragments of tablets in dosages of 100 mg, 50 mg and 25 mg broken into four parts with the aid of homemade knife and cutter unit tablets is different, depending on how the division is performed. Methods: The intact tablets were divided with a knife and with a homemade pill cutter device, and the concentrations of Atenolol were determined in all fragments. Results: No significant difference existed between the levels of Atenolol obtained after splitting the tablets with the homemade knife or the pill cutter device, although the division led to severe levels of dispersal among fragments. When divided in half, the dispersion of results was between 7% and 12.1%, and when divided into four parts, it was between 9.2% and 21.1%, indicating the possibility of compromising the effectiveness of treating patients regardless of how the division was made. Conclusion: The results indicated a greater dispersion than would be acceptable to guarantee a uniform dose received at each drug administration, regardless of the way the division was performed, either by phone or homemade knife cutter pills. Keywords: Atenolol/analysis; Tablets/administration & dosage; Equipment and supplies; Pharmaceutical care/ Technology, pharmaceutical/ instrumentation RESUMO Objetivo: Avaliar se o teor de Atenolol em fragmentos de comprimidos nas dosagens de 100 mg, 50 mg e 25 mg partidos em duas e quatro partes com auxílio de faca caseira e de aparelho cortador de comprimidos é diferente em função do modo como a divisão é realizada. Métodos: Os comprimidos íntegros foram divididos com faca caseira e com aparelho cortador de comprimidos, e os teores de Atenolol foram determinados em todos os fragmentos. Resultados: Não houve diferença significativa entre os teores obtidos, após divisão dos comprimidos com faca caseira ou com aparelho cortador, apesar da divisão levar a acentuada dispersão dos teores entre os fragmentos, na divisão em metade, a dispersão dos resultados deu-se entre 7,8% e 12,1%, e quando divididos em quatro partes, foi entre 9,2% e 21,1%, indicando a possibilidade de comprometer a eficácia do tratamento dos pacientes independente de como a divisão foi feita. Conclusão: Os resultados indicaram a ocorrência de dispersão maior do que a estabelecida para garantir uniformidade da dose recebida a cada administração do medicamento independente da forma de realizar a divisão, seja por meio de faca caseira ou com aparelho cortador de comprimidos. Descritores: Atenolol/análise; Comprimidos/administração & dosagem; Equipamentos e provisões; Atenção farmacêutica; Tecnologia farmacêutica/instrumentação RESUMEN Objetivo: Evaluar si la proporción de Atenolol en fragmentos de comprimidos en las dosis de 100 mg, 50 mg y 25 mg partidos en dos y cuatro partes con la ayuda de un cuchillo casero y de un cortador de comprimidos es diferente en función al modo cómo se realiza la división. Métodos: Los comprimidos enteros fueron divididos con un cuchillo casero y con un cortador de comprimidos...

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“…Brands of theophylline 300mg controlled-release 286 had significantly different dissolution profiles between whole and half tablets in simulated 287 gastric fluid and simulated intestinal fluid (Shah et al, 1987). Dissolution from halved sustained 288 release theophylline 100mg tablets was significantly higher than from whole tablets (Simons et 289 al, 1982) Six studies (Helmy, 2015;Hill et al, 2009; Polli et al, 2003;Rosenberg et al, 2002; Teng et al, 296 2002; Verrue et al, 2010) that included tablets which were not flat and round but were 297 alternatively shaped (e.g., trapezoid, octagon, shield-shaped, ovoid-rectangular). Halves of these 298 12 tablets did not meet the specified USP weight specification.…”

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confidence: 99%

A systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice

Richey

Hughes

Craig

et al. 2017

International Journal of Pharmaceutics

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systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice.International Journal of Pharmaceutics http://dx.doi.org/10. 1016/j.ijpharm.2016.12.032 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. This study sought to determine whether there is an evidence base for drug manipulation to obtain 37 the required dose, a common feature of paediatric clinical practice. A systematic review of the 38 data sources, PubMed, EMBASE, CINAHL, IPA and the Cochrane database of systematic 39 reviews, was used. Studies that considered the dose accuracy of manipulated medicines of any 40 dosage form, evidence of safety or harm, bioavailability, patient experience, tolerability, 41 contamination and comparison of methods of manipulation were included. Case studies and 42 letters were excluded. Fifty studies were eligible for inclusion, 49 of which involved tablets 43 being cut, split, crushed or dispersed. The remaining one study involved the manipulation of 44 suppositories of one drug. No eligible studies concerning manipulation of oral capsules or 45 liquids, rectal enemas, nebuliser solutions, injections or transdermal patches were identified. 46Twenty four of the tablet studies considered dose accuracy using weight and/or drug content. In 47 studies that considered weight using adapted pharmacopoeial specifications, the percentage of 48 halved tablets meeting these specifications ranged from 30% to 100%. Eighteen studies 49 investigated bioavailability, pharmacokinetics or clinical outcomes following manipulations 50 which included nine delayed or modified release formulations. In each of these nine studies the 51 entirety of the dosage form was administered. Only one of the 18 studies was identified where 52 drugs were manipulated to obtain a proportion of the dosage form, and that proportion 53 administered. The five studies that considered patient perception found that having to manipulate 54 the tablets did not have a negative impact on adherence. Of the 49 studies only two studies 55 reported investigating children. This review yielded limited evidence to support manipulation of 56 medicines for children. The results cannot be extrapolated between dosage forms, methods of 57 manipulation or between different brands of the same drug. 58 59 4 INTRODUCTION 60Many medicines given to children are used "off-label" because the medicine has only been 61 researched and authorised for adults. Often the dosage form (e.g., tablets, capsules, 62 suppositories) is suitable for administration to adults but not to younger children (Waller, 2007). 63Age...

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Weight Variability of Pharmacist-Dispensed Split Tablets

Cited by 55 publications

References 4 publications

Weight Uniformity of Split Tablets Required by a Veterans Affairs Policy

Weight Uniformity of Split Tablets Required by a Veterans Affairs Policy

Avaliação do teor de Atenolol em comprimidos divididos com faca caseira e aparelho cortador

A systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice

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