The Importance of Standardized Formulations for Patient Safety

Wed, 24 Jun 2020 13:21:43 GMT

By Tricia Heitman, PharmD, PCCA Clinical Compounding Pharmacist

As health care workers, we all agree that patient safety is of the utmost importance. Never is this more critical than for our youngest patients. Many of the children we treat require compounded oral suspensions or solutions due to the inability to swallow solid forms of medication. Often, practitioners prescribe compounded oral suspensions in these cases. However, no standardized concentrations were historically used when prescribing these medications. Within one health system, there could be multiple concentrations of the same drug used in different settings (emergency department, ICU, acute care, outpatient), which increases the chance of a medication dosing error. While no single concentration fits all patients, consistency in the concentration of these liquid formulations used when appropriate for most patients may reduce the potential for dosing errors. The Michigan Pediatric Safety Collaboration notes that alternate concentrations would be used when the dosage (e.g., volume) is too small to measure by caregivers or so large that the volume presents difficulty in the patient tolerating the dose.¹

The Michigan Pediatric Safety Collaboration

In response to this need, researchers at the University of Michigan authored an article, “ Variability in Compounding of Oral Liquids for Pediatric Patients: A Patient Safety Concern ,” which was published in the Journal of the American Pharmacists Association in 2014. The Michigan Pediatric Safety Collaboration also developed an online resource for practitioners in order to standardize prescribing habits for compounded pediatric oral liquid concentrations. This resource was created to assist in reducing patient medication error. Their published list of standardized formulations is based on the majority of patients’ needs.

ASHP’s Standardize 4 Safety Initiative

In 2015, the American Society of Health System Pharmacists (ASHP) also began its Standardize 4 Safety initiative to reduce patient error through standardized medication concentrations and to improve the safety of transitions of care. Together with the U.S. FDA, the Michigan Pediatric Safety Collaboration, partner organizations, hospitals, pharmacists, nurses and physician experts across the country, ASHP released a standardized list of oral liquids in 2016.

ASHP’s Standardize 4 Safety initiative is the first of its kind. Previously, there was no national consensus for concentration standards for pediatric oral suspensions. Additionally, the Standardize 4 Safety program is not limited to only oral liquid formulations, but it also includes concentrations and dosing units for intravenous continuous medications for adult patients and pediatric patients as well as concentrations for intravenous intermittent medications, patient-controlled analgesia and epidural medications. These standards will certainly help guide practitioners’ prescribing habits nationally, which will reduce medication error and improve patients’ safety during transitions of care.

PCCA’s Standardized Formulations

PCCA is also committed to patient safety, as is evident inThe PCCA Standard ^™, which encompasses the way we purchase chemicals, how we perform quality control on every chemical lot we receive, and the service we provide through our Formulation Development and Clinical Services teams. We recognized that these organizations created a wish list for the concentrations of particular medications, but they did not provide detailed formulas for all of them. To assist pharmacies with a turnkey solution for implementing the ASHP and Michigan Pediatrics Safety Collaboration formulations, PCCA’s Formulation Development team has created formulas for most of those medications using the standard concentrations, which you can see in the table below. Some of PCCA’s standardized formulations have been tested for extended beyond-use dating with stability-indicating assays as part of our FormulaPlus^™ program, and we will continue to add more in the future. This gives PCCA members and the prescribers they work with the ability to provide patients the highest level of care that they can. PCCA members with Clinical Services access can find our standardized oral liquid formulas in our database. If they have any questions about these formulas, they can contact our clinical compounding pharmacists at 800.331.2498.

Current List of Standardized Oral Liquid Formulations in the PCCA Formula Database
Medication Recommended for Standardization	Concentration in mg/mL
Acetazolamide	25
Allopurinol	20
Amitriptyline	1
Amlodipine*	1
Atenolol*	2
Azathioprine*	50
Baclofen*	5
Buspirone	2.5
Captopril	1
Clonazepam	0.1
Clonidine	0.02
Cyclophosphamide	10
Dapsone	2
Desmopressin acetate	0.033
Dipyridamole	10
Flucytosine	10 & 50
Fludrocortisone Acetate	0.1
Folic acid	1
Hydrochlorothiazide	10
Hydrocortisone	2
Hydroxychloroquine Sulfate*	25
Hydroxyurea	100
Ketoconazole	20
Lamotrigine	1
Lansoprazole*	3
Leucovorin	10
Levothyroxine	0.025
Lisinopril	2
Mercaptopurine	20
Methotrexate	0.5
Metoprolol Tartrate	10
Metronidazole	50
Mexiletine HCl	10
Morphine sulfate	0.4
Nadolol	10
Nifedipine	4
Oseltamivir	6
Phenazopyridine HCl	10
Phenoxybenzamine HCl	2
Phytonadione	1
Propylthiouracil	5
Pyridoxine HCl	1
Pyrimethamine	2
Quinidine Sulfate	10
Rifampin*	25
Sodium chloride	4 mEq/mL
Spironolactone*	5
Sulfasalazine	100
Tacrolimus	0.5 & 1
Terbutaline Sulfate	1
Tetracycline HCl	25
Thiamine HCl	25
Topiramate*	6 & 20
Tramadol HCl	5
Trazodone HCl	10
Ursodiol*	20 & 60
Vancomycin	25
Verapamil HCl	50
Zinc acetate	10
Zinc sulfate	44
Zonisamide*	10

*PCCA formulation tested for extended beyond -use dating.

Patricia Heitman, PharmD, is a Clinical Compounding Pharmacist at PCCA. She is a graduate of the University of Houston College of Pharmacy and served as a PCCA PharmD Resident for one year post-graduation, which included a teaching position at her alma mater. She has been a full-time PCCA Clinical Compounding Pharmacist since completing her residency in 2000, answering compounding-related calls daily from pharmacists in the United States and Canada. She lectures frequently at PCCA International Seminars and symposiums. Her passions include pediatric compounding—especially options for patients with autism—as well as women’s health, gastrointestinal health and pain management.

Reference

1. Michigan Pediatric Safety Collaboration. (n.d.). Criteria for use of alternate concentrations. State-Wide Initiative to Standardize the Compounding of Oral Liquids in Pediatrics. http://www-personal.umich.edu/~antitank/FDA/Criteria_for_use_of_Alternate_Concentrations.pdf

These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment.

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The Importance of Standardized Formulations for Patient Safety