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Abstract:  The Institute for Safe Medication Practices (ISMP) Do Not Crush List is a common resource for healthcare providers to determine whether an oral solid drug product can be manipulated. However, evidence is weak or missing for a number of immediate-release products. The purpose of this study was to perform an in-depth analysis of these products on the ISMP Do Not Crush List with the goal of removing unnecessary restrictions and providing conditional recommendations if needed. The ISMP Do Not Crush List was reviewed, and the products in question were identified if they were listed with “no reason” provided or “film-coated” as the only reason. A checklist of evaluation criteria was then developed and used for analysis, including special dosage form design, hazardous drug status, and stability and pharmacokinetics concerns. Appropriate references and search strategies were streamlined to perform the evaluation, and manufacturers were also contacted with a standard drug-information inquiry. A total of 20 “film-coated” tablets and 17 “no reason” drug products were identified and evaluated using the above process. The analysis revealed that 9 products are special formulations or high-risk products which indeed should not be crushed. Most of the remaining 28 products presented no risk or a low risk for crushing. Some products may require safety precautions during handling or timely administration of crushed powder to patients with increased monitoring for efficacy and safety. Two summary tables along with the conditional recommendations are provided for pharmacists and other healthcare providers to aid in clinical decision making. A checklist of evaluation criteria was developed and used to perform an in-depth analysis of 37 immediate-release products on the ISMP Do Not Crush List. A significant number of these products were found to be suitable for crushing based on conditional recommendations. Furthermore, the checklist and evaluation strategy present a framework for healthcare providers to assess crushability of any future immediate release oral solid drug products when there are no suitable alternatives.

Related Keywords: Elizabeth Uttaro, PharmD Candidate, Fang Zhao, PhD, Anne Schweighardt, PharmD, BCPS, Institute for Safe Medication Practices, ISMP, drug safety, Do Not Crush list, immediate-release drugs, hazardous drugs, extended-release formulations, enteric-coated formulations, antineoplastic drugs, film-coated drugs, bioavailability, amorphous solid dispersions, compatibility, stability, drug quality, special dosage forms, crushability, manufacturer data, alternative dosage forms, droxidopa, tafenoquine succinate, Kaletra

Related Categories: EXCIPIENTS, LEGAL, STABILITIES, COMPATIBILITIES, DOSAGE FORMS/DRUG CARRIERS

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