*Please add “[mgPE]” for “milligrams of Phenytoin Equivalents”

[Paul Schluter]

Fosphenytoin is a prodrug of phenytoin. Because the molecular weight differences, 1 mg of fosphenytoin is not equal to 1 mg of phenytoin. To avoid dosing confusion, the recommended dosing unit for fosphentyoin is mgPE (i.e. no dosing adjustments are needed using mgPE). This UOM would be limited to only fosphenytoin and other prodrugs of phenytoin.

The FDA stipulates the following guidance regarding phenytoin sodium equivalents (PE) in ​https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/076886s000lbl.pdf :

“IMPORTANT NOTE: Throughout all fosphenytoin product labeling, the amount and concentration of fosphenytoin is expressed in terms of phenytoin sodium equivalents (PE). Fosphenytoin’s weight is expressed as phenytoin sodium equivalents to avoid the need to perform molecular weight-based adjustments when converting between fosphenytoin and phenytoin sodium doses. Fosphenytoin should always be prescribed and dispensed in phenytoin sodium equivalent units (PE). (See DOSAGE AND ADMINISTRATION.)”

Although the proposed [mgPE] unit is primarily intended for drug administration rather than laboratory observations, Table 19 in §45 chemical and biochemical units would be the most appropriate location for this unit. Although [mgPE] is specific to phenytoin and related prodrugs used for pharmacy dispensing, it is viewed as an essential addition to both UCUM and IEEE 11073 by the IHE Patient Care Device (PCD) community.

The suggested entries in Table 19 in §45 chemical and biochemical units are shown below but are certainly open for further discussion.

name	milligrams of phenytoin sodium equivalents
kind of quantity	mass equivalent (of a prodrug of phenytoin)
print	mgPE
c/s	[mgPE]
c/I	[MGPE]
M	no
definition value
definition unit

Examples of use:

English: drug strength is “50 mg PE/mL” with the note (PE=phenytoin sodium equivalents)
UCUM: value = 50, units = [mgPE]/mL

English: a single dose of “400 mg PE”
UCUM: value = 400, units = [mgPE]

[Brenée Mitchell]

Hi Paul,

Thank you for the request and supporting information. We will discuss the addition of mgPE to the UCUM standard at our next committee meeting, which has yet to be scheduled. I will keep you up to date with any questions the committee has and/or what the final decision is.

Thanks again, Brenee Mitchell Regenstrief Institute/LOINC

Replying to Paul Schluter:

Fosphenytoin is a prodrug of phenytoin. Because the molecular weight differences, 1 mg of fosphenytoin is not equal to 1 mg of phenytoin. To avoid dosing confusion, the recommended dosing unit for fosphentyoin is mgPE (i.e. no dosing adjustments are needed using mgPE). This UOM would be limited to only fosphenytoin and other prodrugs of phenytoin.

The FDA stipulates the following guidance regarding phenytoin sodium equivalents (PE) in ​https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/076886s000lbl.pdf :

“IMPORTANT NOTE: Throughout all fosphenytoin product labeling, the amount and concentration of fosphenytoin is expressed in terms of phenytoin sodium equivalents (PE). Fosphenytoin’s weight is expressed as phenytoin sodium equivalents to avoid the need to perform molecular weight-based adjustments when converting between fosphenytoin and phenytoin sodium doses. Fosphenytoin should always be prescribed and dispensed in phenytoin sodium equivalent units (PE). (See DOSAGE AND ADMINISTRATION.)”

Although the proposed [mgPE] unit is primarily intended for drug administration rather than laboratory observations, Table 19 in §45 chemical and biochemical units would be the most appropriate location for this unit. Although [mgPE] is specific to phenytoin and related prodrugs used for pharmacy dispensing, it is viewed as an essential addition to both UCUM and IEEE 11073 by the IHE Patient Care Device (PCD) community.

The suggested entries in Table 19 in §45 chemical and biochemical units are shown below but are certainly open for further discussion.

name	milligrams of phenytoin sodium equivalents
kind of quantity	mass equivalent (of a prodrug of phenytoin)
print	mgPE
c/s	[mgPE]
c/I	[MGPE]
M	no
definition value
definition unit

Examples of use:

English: drug strength is “50 mg PE/mL” with the note (PE=phenytoin sodium equivalents)
UCUM: value = 50, units = [mgPE]/mL

English: a single dose of “400 mg PE”
UCUM: value = 400, units = [mgPE]

[Brenée Mitchell]

Brenée,

Our meeting regarding the proposed UCUM [mgPE] unit-of-measure went very well today. After looking into this over the past several days, Dr. Steven Dain agreed with our approach since ‘mgPE’ is already widely used on drug labels and clinicians and systems already use this as an informal unit. We recommend that you proceed with the UCUM Committee review for this proposal.

We would like to modify the original proposal captured in UCUM ticket URL https://ucum.org/trac/ticket/5791 by removing ’sodium’ in the suggested entries in UCUM Table 19 in §45 chemical and biochemical units, as shown below. This will eliminate any confusion regarding the reference substance and molecular weight for Phenytoin = C15H11N2O2 and 252.268 g/mol CID: 1775?.

I would need additional guidance from you and your colleagues regarding the content of definition value and definition unit. Please do not hesitate to contact me if you have any questions or comments.

Thanks and regards,

Paul Schluter, PhD

IHE DEV Rosetta Working Group Chair

email: psschluter@… cell: (414) 702-2026

The suggested entries in Table 19 in §45 chemical and biochemical units are shown below but are certainly open for further discussion.

name: milligrams of phenytoin equivalents kind of quantity: mass equivalent (of a prodrug of phenytoin) print: mgPE c/s:[mgPE] c/I:[MGPE] M: no definition value: definition unit:

Examples of use:

English: drug strength is “50 mg PE/mL” with the note (PE=phenytoin equivalents) UCUM: value = 50, units = [mgPE]/mL

English: a single dose of “400 mg PE” UCUM: value = 400, units = [mgPE]

[Brenée Mitchell]

Please see attachment for Paul's updated request...essentially, sodium has been reintroduced for the name "milligrams of phenytoin sodium equivalents", mgPE.

[Brenée Mitchell]

Email from Paul Schluter with information supporting the addition of "mgPE - milligrams of phenytoin sodium equivalents" to UCUM