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In spite of FDA's best efforts, medication errors continue
to burden our health care system. These errors can occur for a
variety of reasons, ranging from pharmacists incorrectly
interpreting the letters or words on a hand-written prescription,
to nurses incorrectly interpreting physician instructions for
hospitalized patients, and are estimated to cause approximately
7,000 deaths each year in the United States alone.
The United States Food and Drug Administration ("FDA")
recently unveiled a new initiative to reduce medication errors by
evaluating product names using a Phonetic and Orthographic Computer
Analysis ("POCA"). In a May 2014 Draft Guidance,
entitled Best Practices in Developing Proprietary Names for
Drugs, FDA notes that its intentions are "to develop
proprietary names that do not cause or contribute to medication
errors or otherwise contribute to the misbranding of the
drug."
The Draft Guidance offers certain rules and factors for increasing
the safety profile of a proposed name. For example, FDA
states that the name should not include product attributes (such as
dosage form) because future modifications may create a greater
likelihood of errors. The Draft Guidance contains other
straightforward rules for avoiding confusion and promoting safe use
of pharmaceutical products.
For purposes of comparing drug names, FDA's Draft Guidance
attempts to give objective and quantifiable guidance in a field
that inherently lends itself to at least some subjectivity.
Specifically, the Draft Guidance emphasizes the role of the POCA
score in early screening processes and determining what level of
scrutiny a proposed name must bear.
The POCA system comprises lists of pre-existing pharmaceutical
product names (along with other relevant information, e.g.,
dosage). The database user enters the proposed name in the
POCA system and queries the name against drug reference databases
through an algorithm that weighs orthographic and phonetic
similarities. This query results in a list of the most
similar pre-existing names along with the combined POCA score for
each result. The higher the POCA score for an entry, the more
similar the proposed name is to that pre-existing name, and the
less likely that FDA will accept the proposed
name.
The POCA score attempts to account for all aspects of a written
prescription. Thus, in addition to the resemblance of
syllables and letters, the score will account for the dose that
must be written on the prescription, as well as any suffix such as
"ER" or product concentration that is necessarily part of
the prescription or physician instructions.
In the Draft Guidance, FDA proposes weighing the combined score
(generally, an average of the orthographic and phonetic scores) and
classifying the results into one of three tiers—each with a
different framework for analyzing the potential safety of the
proposed name. Then, within each framework, FDA assigns
more subjective criteria along with a sense of "burden"
or "weight" that the proposed name must overcome.
These frameworks are summarized in the chart below:
POCA
Score
|
Category
|
Analysis
|
49 or less
|
Low Similarity
|
Names with low similarity that have no overlap or similarity in
strength and dose are generally acceptable absent indications of
potential confusion (e.g., overlap or similarity in strength and
dose, prescription simulation study suggests that the name is
likely to be misinterpreted). In these instances, FDA will
evaluate the names under the "moderate similarity"
framework below.
|
50 to 69
|
Moderate Similarity
|
Moderately similar names with overlapping or similar doses
represent an area of concern for FDA. Under the framework,
the ability of other product characteristics to mitigate confusion
may be limited when the strength or dose overlaps.
Step 1 – Review the Dosage and
Administration and Storage and Handling sections of the prescribing
information or the Drug Facts label to determine if strengths and
doses of the name pair overlap or are very similar, keeping in mind
alternative expressions of dose, trailing or deleting zeros (e.g.,
10 mg is similar in appearance to 100 mg), and similar sounding
doses (e.g., 15 mg is similar in sound to 50 mg).
Step 2 – Cheklist of questions.
Affirmative answers to some questions may reduce the likelihood of
confusion for moderately similar names with overlapping or similar
strengths or doses:
Do
the names begin with the first letter? (note that certain letter
may still be confused when scripted)
-
Are the lengths of the names
dissimilar when scripted? (FDA considers the length to be different
if the names differ by two or more letters in length)
-
Considering variations in
scripting of some letters, is there a different number or placement
of upstroke/downstroke letters present in the names?
-
Is there different number or
placement of cross-stroke or dotted letters present in the
names?
-
Do the infixes (group of
letters in the middle of the name) of the name appear dissimilar
when scripted?
-
Do the suffixes of the names
appear dissimilar when scripted?
-
Do the names have different
number of syllables?
-
Do the names have different
syllabic stresses?
-
Do the syllables have
different phonologic processes, such as vowel reduction,
assimilation, or deletion?
-
Across a range of dialects,
are the names consistently pronounced differently?
|
70 or more
|
High Similarity
|
For
highly similar names, FDA takes the position that differences in
product characteristics often cannot mitigate the risk of a
medication error, including differences in product strength and
dose. FDA proposes several questions (the same questions as
Step 2 above) that, where some are answered in the affirmative, may
suggest that the differences in the names may render them less
likely to confusion, provided that the pair do not share a common
strength or dose:
-
Do the names begin with the
first letter? (note that certain letter may still be confused when
scripted)
-
Are the lengths of the names
dissimilar when scripted? (FDA considers the length to be different
if the names differ by two or more letters in length)
-
Considering variations in
scripting of some letters, is there a different number or placement
of upstroke/downstroke letters present in the names?
-
Is there different number or
placement of cross-stroke or dotted letters present in the
names?
-
Do the infixes (group of
letters in the middle of the name) of the name appear dissimilar
when scripted?
-
Do the suffixes of the names
appear dissimilar when scripted?
-
Do the names have different
number of syllables?
-
Do the names have different
syllabic stresses?
-
Do the syllables have
different phonologic processes, such as vowel reduction,
assimilation, or deletion?
-
Across a range of dialects,
are the names consistently pronounced differently?
|
|
|
Critics and
commentators of the Draft Guidance generally applaud the document
as a first step in achieving more predictable results for FDA
approval. To be sure, there are still many open questions
about the weight and meaning of the POCA score in the ultimate
approval process. What is clear, however, is that any
proprietary name development process should incorporate a POCA
score analysis and consider the potential risks identified in
FDA's Draft Guidance.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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