Filling the Gaps on the Institute for Safe Medication Practices (ISMP) Do Not Crush List for Immediate-release Products.

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.

To crush or not to crush: A brief review of novel tablets and capsules prepared from nanocrystal and amorphous solid dispersion technologies.

PURPOSE: To educate healthcare professionals regarding the risks of manipulating drug products formulated via nanocrystal or amorphous solid dispersion technologies. SUMMARY: Recent pharmaceutics innovations such as nanocrystals and amorphous solid dispersions have been used successfully to improve oral bioavailability of drugs. Over 30 drug products based on these technologies have been approved by the Food and Drug Administration, and more are in the development pipeline. While these products are similar in appearance to traditional tablets or capsules, they should not be crushed or suspended in liquid vehicles. Such manipulations can compromise the integrity of the formulation and subsequently alter the oral bioavailability. It is alarming that the majority of these products are not included in the Institute for Safe Medication Practices (ISMP) "Do Not Crush" list. A summary drug table is presented in this article to provide accurate information for pharmacists and other healthcare providers. CONCLUSION: Novel formulations of tablets and capsules are being used to increase the oral bioavailability of certain drugs. Crushing these products can significantly alter product performance and clinical outcomes. We encourage ISMP to add these drug products to the Do Not Crush list due to wide use of this list throughout healthcare. In the meantime, pharmacists should be mindful of the new formulation technologies and advocate for the proper use of these drug products.

Enhanced Adherence in Patients Using an Automated Home Medication Dispenser.

BACKGROUND: Many factors contribute to medication nonadherence including psychological and memory disorders, aging, and pill burden. The Automated Home Medication Dispenser (AHMD) is a medication management system intended to help solve unintentional medication nonadherence. OBJECTIVE: The purpose of this study was to determine if use of the AHMD improved medication adherence. METHODS: We conducted a 6-month prospective, feasibility study assessing use of the AHMD in 21 patient-caregiver dyads. Patients were referred by their physician because of poor medication adherence and included if they resided in Rochester, NY and on at least two medications in pill form. Pill counts were performed at baseline to assess previous adherence. Prospective medication adherence was assessed using AHMD recorded dosing information. A paired t-test was used to compare previous and prospective adherence. RESULTS: The mean age of patients was 75.1 years. Fifteen patients (71.4%) and eight caregivers (38.1%) were women; half (47.6%) of caregivers lived with the patient. The most common patient comorbidities were hypertension (76.2%) and memory disorder (61.9%). Mean adherence increased from 49.0% at baseline to 96.8% after 6 months of AHMD use (p < .001). CONCLUSION: In a cohort of unintentionally nonadherent patients, use of the AHMD for 6 months significantly improved medication adherence.

A Systematic Review of the Evidence Behind Use of Reduced Doses of Acetaminophen in Chronic Liver Disease.

Acetaminophen is among the most commonly used nonopioid analgesics, but significant variation exists in its prescribing practices for cirrhosis patients. Our primary objective was to describe the quality of evidence supporting or refuting the use of acetaminophen in patients with hepatic dysfunction. A comprehensive literature review of PubMed, Cochrane Library, Web of Science, and International Pharmaceutical Abstracts using the search terms "acetaminophen," "paracetamol," "chronic liver disease," "cirrhosis," and "hepatic disease" for studies describing changes in acetaminophen metabolism in patients with hepatic dysfunction was conducted. Twelve studies and four abstracts were included. Ten studies and three abstracts were pharmacokinetic studies. Two studies and one abstract evaluated the association of acetaminophen use and decompensation in the cirrhotic patient. The level of certainty for dosing recommendations obtainable from reviewing the evidence is low due to a small number of studies meeting search criteria, small samples sizes, inadequate information regarding cirrhosis etiology and compensated versus uncompensated liver disease, and lack of information on patient centered health outcomes. High-quality trials are not available to support the use of decreased acetaminophen doses in compensated cirrhosis patients. Acetaminophen can be a safe analgesic in patients with compensated hepatic dysfunction after careful analysis of patient-specific factors.

New thoughts on the "forgotten" aspect of antimicrobial stewardship: adverse event reporting.

Antimicrobial stewardship is an activity that optimizes patient care through selection of the most appropriate antimicrobial therapy. Antimicrobial stewardship programs strive to enhance patient care and reduce preventable consequences of antimicrobial use. They are also vital in monitoring for the development of adverse events occurring as a result of antimicrobial therapy, although literature reviews of this activity are scarce. Although randomized controlled trials are considered the gold standard to study the efficacy of a medication, these trials are not designed to test safety end points and often are only able to identify the most commonly occurring and acute adverse events. In addition, prior to a drug going to market, it is difficult to detect rare adverse events because the associated costs are economically untenable given the limited pipeline of novel agents. These limitations in some ways may be resolved with the use of postmarketing surveillance and spontaneous reporting systems such as the United States Food and Drug Administration Adverse Event Reporting System. The focus of this commentary is to highlight the importance of adverse event reporting by antimicrobial stewardship programs to spontaneous reporting systems as a means to improve patient care.

Extended-release hydrocodone: the devil in disguise or just misunderstood?

Opioid abuse in the United States increased significantly over the past decade, leading to opioid-related deaths. Approval of Zohydro ER, a product that lacks an abuse-deterrent formulation, has provoked media controversy and aggressive legislative action from multiple stakeholders. Only the American Academy of Pain Management has released a position statement on this medication, and individual opinion varies. Additional single-entity extended-release hydrocodone formulations are in the pipeline, and Zohydro ER's limited clinical utility may make the controversy associated with its approval a moot point. As with other opioids, providers will need to assess individual patient risk versus benefit when prescribing Zohydro ER.