LETTERS
3 . Glassgold J. Compounded drugs. Washington, DC: Congressional Research Service. 2013(Jun 3):1-31.
Response: Standards for compounding of oral liquids for pediatric patients In his letter, Dr. Cain asserts that the errors reported by respondents in our assessment of compounding practices regarding pediatric oral liquids across Michigan cannot be tied to oral compounds with multiple concentrations. We acknowledge that this assessment was not intended to show a direct correlation between compounding practices with multiple concentrations and the incidence of medication errors. This article was merely the first step in characterizing the current state of compounding practices for pediatric oral liquids across the state and the potential risks. The 21 errors reported were subjective assessments on the part of the respondents. A better reporting system would be ideal but is not currently available nor feasible. Nevertheless, we are certain that harm as a direct result of variable compounding practices is already occurring and, if anything, it is significantly underreported. In root cause analyses of errors involving compounded oral liquids, varying concentrations among sites of care and the lack of recognition of these varied concentrations have frequently been implicated. In fact, this was the impetus for us to pursue this work and for obtaining grant funding from the Food and Drug Administration’s Novel Interventions and Collaborations to Improving the Safe Use of Medications (U01) Cooperative Agreement Program, U.S. Food and Drug Administration, RFA-FD-11-024. The
baseline assessment confirmed that significant variability in practice exists within Michigan in the compounding of pediatric oral liquid medications. A failure mode and effects analysis (FMEA) of the transitions of care of patients receiving compounded oral liquids will undoubtedly identify variability in compounded concentrations as a potential source of error. In fact, there has been nearly universal support for our statewide initiative to standardize the concentrations of compounded oral liquids in pediatric patients (www.mipedscompounds.org) from health care professionals of multiple disciplines and from professional organizations, including the Michigan Pharmacists Association, Michigan State Medical Society, and Michigan Health & Hospital Association. Within the past few months, the American Society of Health-System Pharmacists House of Delegates adopted Policy Position 1401 on the Standardization of Oral Liquid Medication Concentrations “to advocate for the development of nationally standardized drug concentrations for oral liquid medications,” with the goal of reducing the risk for error. While we agree with Cain that it would be optimal to clarify the exact relationship between the existence of multiple concentrations and the incidence of errors, we strongly disagree that there is a lack of sufficient evidence of the negative impact of this variability on patient safety and with the assertion that we should wait until we have better data before addressing this safety risk. James G. Stevenson, PharmD, FASHP, College of Pharmacy University of Michigan Ann Arbor, MI [email protected]
Journal of the American Pharmacists Association
j apha.org
Scott L. Ciarkowski, PharmD University of Michigan Health System Ann Arbor, MI Melanie J. Engels, PharmD Veterans Affairs Medical Center Ann Arbor, MI Janis M. Rood, PharmD Plymouth Pharmacy & Medical Supplies Livonia, MI Larry D. Wagenknecht, BSPharm Michigan Pharmacists Association Lansing, MI Chris J. Dickinson, MD C. S. Mott Children’s Hospital University of Michigan Ann Arbor, MI doi: 10.1331/JAPhA.2015.14204
Corrections Minimizing out-of-pocket prescription drug costs for Medicare beneficiaries: Not just a ‘drop in the bucket,’ November/December 2014 issue, pages 604–609: On page 607, the following sentence was incorrectly deleted at the end of the Statistical analysis section: “Data analyses were performed using commercially available statistical software (IBM SPSS Statistics for Windows, Version 21.0; Armonk, NY: IBM Corp.).” JFPS 2014 abstracts of contributed papers, September/October 2014 issue, pages e334–e349. In abstract 30 on pages e344–e345, the last three authors’ names were inadvertently omitted. The citation should have read: Prevlance of Beers criteria medications among elderly patients in a military treatment facility, Osei E, Berry-Caban C, Haley C, Jain R, Rhodes-Pope H, Evans K, Womack Army Medical Center, E-mail: [email protected] doi: 10.1331/JAPhA.2015.15499
JAN /FEB 2015 | 55:1 |
JAPhA 5
3 . Glassgold J. Compounded drugs. Washington, DC: Congressional Research Service. 2013(Jun 3):1-31.
Response: Standards for compounding of oral liquids for pediatric patients In his letter, Dr. Cain asserts that the errors reported by respondents in our assessment of compounding practices regarding pediatric oral liquids across Michigan cannot be tied to oral compounds with multiple concentrations. We acknowledge that this assessment was not intended to show a direct correlation between compounding practices with multiple concentrations and the incidence of medication errors. This article was merely the first step in characterizing the current state of compounding practices for pediatric oral liquids across the state and the potential risks. The 21 errors reported were subjective assessments on the part of the respondents. A better reporting system would be ideal but is not currently available nor feasible. Nevertheless, we are certain that harm as a direct result of variable compounding practices is already occurring and, if anything, it is significantly underreported. In root cause analyses of errors involving compounded oral liquids, varying concentrations among sites of care and the lack of recognition of these varied concentrations have frequently been implicated. In fact, this was the impetus for us to pursue this work and for obtaining grant funding from the Food and Drug Administration’s Novel Interventions and Collaborations to Improving the Safe Use of Medications (U01) Cooperative Agreement Program, U.S. Food and Drug Administration, RFA-FD-11-024. The
baseline assessment confirmed that significant variability in practice exists within Michigan in the compounding of pediatric oral liquid medications. A failure mode and effects analysis (FMEA) of the transitions of care of patients receiving compounded oral liquids will undoubtedly identify variability in compounded concentrations as a potential source of error. In fact, there has been nearly universal support for our statewide initiative to standardize the concentrations of compounded oral liquids in pediatric patients (www.mipedscompounds.org) from health care professionals of multiple disciplines and from professional organizations, including the Michigan Pharmacists Association, Michigan State Medical Society, and Michigan Health & Hospital Association. Within the past few months, the American Society of Health-System Pharmacists House of Delegates adopted Policy Position 1401 on the Standardization of Oral Liquid Medication Concentrations “to advocate for the development of nationally standardized drug concentrations for oral liquid medications,” with the goal of reducing the risk for error. While we agree with Cain that it would be optimal to clarify the exact relationship between the existence of multiple concentrations and the incidence of errors, we strongly disagree that there is a lack of sufficient evidence of the negative impact of this variability on patient safety and with the assertion that we should wait until we have better data before addressing this safety risk. James G. Stevenson, PharmD, FASHP, College of Pharmacy University of Michigan Ann Arbor, MI [email protected]
Journal of the American Pharmacists Association
j apha.org
Scott L. Ciarkowski, PharmD University of Michigan Health System Ann Arbor, MI Melanie J. Engels, PharmD Veterans Affairs Medical Center Ann Arbor, MI Janis M. Rood, PharmD Plymouth Pharmacy & Medical Supplies Livonia, MI Larry D. Wagenknecht, BSPharm Michigan Pharmacists Association Lansing, MI Chris J. Dickinson, MD C. S. Mott Children’s Hospital University of Michigan Ann Arbor, MI doi: 10.1331/JAPhA.2015.14204
Corrections Minimizing out-of-pocket prescription drug costs for Medicare beneficiaries: Not just a ‘drop in the bucket,’ November/December 2014 issue, pages 604–609: On page 607, the following sentence was incorrectly deleted at the end of the Statistical analysis section: “Data analyses were performed using commercially available statistical software (IBM SPSS Statistics for Windows, Version 21.0; Armonk, NY: IBM Corp.).” JFPS 2014 abstracts of contributed papers, September/October 2014 issue, pages e334–e349. In abstract 30 on pages e344–e345, the last three authors’ names were inadvertently omitted. The citation should have read: Prevlance of Beers criteria medications among elderly patients in a military treatment facility, Osei E, Berry-Caban C, Haley C, Jain R, Rhodes-Pope H, Evans K, Womack Army Medical Center, E-mail: [email protected] doi: 10.1331/JAPhA.2015.15499
JAN /FEB 2015 | 55:1 |
JAPhA 5
