Medication Standardization Effort Aims to Improve Patient Safety
All too often, says Deborah Pasko, the reason a pharmacy prepares a specific concentration of an i.v. or oral liquid medication has little to do with clinical or patient safety considerations.
Instead, the pharmacy staff follows standard recipes because "they've always done it that way," said Pasko, director of ASHP's Center on Medication Safety and Quality and principal investigator for ASHP's Standardize 4 Safety campaign.
Pasko hopes the campaign will change that mindset and result in consistency, at the national level, in how i.v. and oral liquid admixtures are formulated for patient use.
"We're really trying to emphasize to everyone that this is a patient safety effort," Pasko said. "We're putting patients at risk every day when we dispense a different concentration than what someone else does."
The groundwork for the launch of the Standardize 4 Safety was established last September, after the project was awarded funding through FDA's Safe Use initiative. But Pasko said the three-year project has its roots in the 2008 I.V. Safety Summit, a multistakeholder effort to reduce patient harm from i.v. medication errors.
Since then, a handful of states and regions have developed lists of recommended standardized concentrations for certain medications and urged healthcare providers to adopt those concentrations.
"The standardization effort has been transpiring over several years," Pasko said. "But we're now in 2016, and we still have yet to do this on a national platform."
To address that need, Standardize 4 Safety has put together an interprofessional panel of experts to propose voluntary, evidence-based standardized concentrations for 32 i.v. medications associated with a high risk of patient harm due to dosage errors. The group plans to later expand the effort to include additional medications.
According to Pasko, the standardized concentrations are intended for use throughout every hospital as a way to reduce medication errors that can occur when a patient is moved to different areas within a facility.
Pasko said most hospitals nowadays have adopted some form of standardization for i.v. medications. But she said hospitals that use upward of a dozen "standardized concentrations" of a single drug really haven't embraced the Standardize 4 Safety campaign's goals.
"That, to me, is not standardized. Standardized is anywhere from one to three concentrations of each particular drug," Pasko said.
ASHP has urged pharmacists to get involved with the Standardize 4 Safety community through its online communication platform on ASHP Connect. The community, which is open to the public, included nearly 100 registered participants in late June.
A second panel of experts is tasked with recommending standardized concentrations of liquid oral medications and encouraging the universal adoption of those concentrations by all pharmacies.
One panelist, Kelly Parent, program specialist for quality and safety at the University of Michigan Health System's Patient and Family Centered Care Program in Ann Arbor, said patients have been harmed because inpatient and outpatient pharmacies "dose things differently."
"I have seen, many times, that we are not great at giving good information so that people can effectively self-manage once they leave the institution," Parent said. "I think we can improve."
A case described in 2012 in the International Journal of Cardiology illustrated the type of problem the oral liquids expert panel wants to solve.
In that case, a healthcare provider at a facility prescribed a nine-month-old Colorado boy twice-daily doses of flecainide 5-mg/mL suspension, but a community pharmacy filled the prescription by compounding a 20-mg/mL formulation. The child's parents, on being told their son needed a higher dose, administered the volume of the suspension recommended by the physician, who had based the instruction on the lower concentration. The child had ventricular tachycardia due to a fourfold flecainide overdose but ultimately recovered.
According to the report, all local pharmacies later agreed to compound flecainide at a standardized concentration of 20 mg/mL.
The American Association of Poison Control Centers reported that "incorrect formulation or concentration" errors of various types were responsible for 5592 poisoning reports in 2014.
"This certainly is something that we get calls on," said Shireen Banerji, clinical manager at the Rocky Mountain Poison and Drug Center in Denver.
Banerji said any effort that simplifies medication administration for patients and parents is likely to be beneficial for them.