Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05224687 |
| Other study ID # |
068.PHA.2021.A |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2021 |
| Est. completion date |
December 15, 2022 |
Study information
| Verified date |
February 2022 |
| Source |
Methodist Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
A pharmacy-to-dose (PTD) service, also referred to as pharmacy-based dosing, describes an
established practice where providers can consult pharmacists for the dosing of various
medications. Consulted pharmacists develop a treatment regimen utilizing protocols that are
evaluated and approved by the relevant multidisciplinary committees of an institution.
Delegating tasks of therapy monitoring and dose selection to pharmacists resolves providers
from this burden and ensures necessary changes are not unnoticed. Daptomycin was a medication
that our facility included in PTD because of the required adjustments for renal dysfunction,
indication dependent dosing, and its impact on clinical outcomes.
In 2019, our institution approved a PTD daptomycin protocol which allowed pharmacists to
select a dose based on provider-selected indications, patient renal function, and body mass
index. Pharmacists were also authorized to order creatine phosphokinase (CPK) levels at
baseline and every 7 days, if the patient remained on daptomycin. Rounding the dose to the
nearest 50 mg or vial size, as deemed appropriate, was also allowed. Daptomycin was one
antimicrobial to be added to our growing list of PTD-approved medications. As such,
pharmacists were already well acclimated to PTD processes by the time daptomycin was approved
for this service.
Description:
A pharmacy-to-dose (PTD) service, also referred to as pharmacy-based dosing, describes an
established practice where providers can consult pharmacists for the dosing of various
medications. Consulted pharmacists develop a treatment regimen utilizing protocols that are
evaluated and approved by the relevant multidisciplinary committees of an institution. The
Institute for Healthcare Improvement (IHI) recommends implementing pharmacy-based dosing to
improve core processes for ordering medications.
Consults for PTD services that require a provider to enter the desired medication and
indication have been evaluated in prior studies. This type of consultation requires a
clinical or staff pharmacist to implement a patient-specific dosing regimen in addition to
ordering of pertinent labs for therapeutic monitoring. Literature on PTD is most prominent
regarding pharmacist led services for the dosing and monitoring of vancomycin and
aminoglycosides. This is expected because appropriate use of both vancomycin and
aminoglycosides relies on ordering and assessment of pharmacokinetic (PK) measurements. As
new recommendations for vancomycin dosing and monitoring evolve in complexity, these services
are becoming even more valuable. Hospitals with pharmacist-managed vancomycin and
aminoglycoside therapy have shown lower drug costs, hearing and renal impairment, and death
rates in Medicare patients compared to hospitals without these services.
Other medications that either require renal adjustments, have a narrow therapeutic index,
include a wide range of dosing for various indications, or require careful consideration of
patient-specific factors are excellent candidates for expanded PTD services. Pharmacists
serve as institutions' medication experts and are equipped with knowledge and references
needed to apply patient specific characteristics to the selection of a dosing regimen.
Medications that require monitoring for the prevention of adverse effects or changes in
dosing, often due to the dynamic nature of hospitalized patients' renal function, sometimes
go unaddressed. Delegating tasks of therapy monitoring and dose selection to pharmacists
resolves providers from this burden and ensures necessary changes are not unnoticed.
Daptomycin was a medication that our facility included in PTD because of the required
adjustments for renal dysfunction, indication dependent dosing, and its impact on clinical
outcomes.
Daptomycin is a cyclic lipopeptide antibiotic that exhibits rapid bactericidal activity
against Gram-positive organisms, including various drug resistant isolates of Enterococcus
and Staphylococcus. The mechanism does not involve entrance into the bacterial cytoplasm but
rather the dissipation of the membrane potential, which occurs through permeable oligomeric
lesions in a calcium-dependent fashion. Peak concentration (Cmax)/minimum inhibitory
concentration (MIC) and area under the curve (AUC24h)/MIC ratios have been shown in vivo to
correlate best with efficacy. Doses of 4 and 6 mg/kg/dose are Food and Drug Administration
(FDA)-approved to treat complicated skin and skin structure infections and S. aureus
bloodstream infections including right-sided infective endocarditis, respectively. The MICs
of daptomycin for Gram-positive cocci differ. Enterococcus faecalis is marked susceptible
with MICs ≤ 2 µg/mL; however, strains of Enterococcus faecium display intrinsically higher
MICs, and dose-dependent susceptibility based on treatment doses of 8-12 mg/kg/day.
In 2019, our institution approved a PTD daptomycin protocol which allowed pharmacists to
select a dose based on provider-selected indications, patient renal function, and body mass
index. Pharmacists were also authorized to order creatine phosphokinase (CPK) levels at
baseline and every 7 days, if the patient remained on daptomycin. Rounding the dose to the
nearest 50 mg or vial size, as deemed appropriate, was also allowed. Daptomycin was one
antimicrobial to be added to our growing list of PTD-approved medications. As such,
pharmacists were already well acclimated to PTD processes by the time daptomycin was approved
for this service.
