Pharmacists’ role shake-up
May 7, 2012
PHARMACISTS across the US
could be in for a position shake-up,
if the Food and Drug Administration
decides to go ahead with its
proposal to allow the over-thecounter
sale of certain drugs that
would otherwise require a
prescription, for nonprescription
use under conditions of safe use.
Examples of these conditions
would include: requiring
pharmacist intervention to ensure
appropriate nonprescription use;
and the use of innovative
technologies, such as diagnostics
approved or cleared by FDA for use
in the pharmacy or “other settings”.
“Kiosks or other technological
aids in pharmacies or on the
Internet could lead consumers
through an algorithm for a particular
drug product,” the FDA said.
In addition, for some drug
products that require an initial
prescription, the FDA suggested
that the product could be made
available as a nonprescription
product with a condition of safe
use for the purpose of product
refills; whilst some drug products
that would otherwise require a
prescription could be approved as
nonprescription drug products with
some type of pharmacist
intervention as their condition of
safe use.
“Some diseases or conditions
might require confirmation of a
diagnosis or routine monitoring
using a diagnostic test (e.g., a blood
test for cholesterol levels or liver
function) that could be available in
a pharmacy,” the FDA said.
“A pharmacist, or consumer,
could then use the results to
determine whether use of a certain
drug product is appropriate,” the
FDA added.
Other potential roles for the
pharmacist, according to the FDA,
could include assessing whether
the consumer has any conditions or
other risk factors that would
indicate that the drug should not
be used, or assisting the consumer
in choosing between various drug
products.
“For drugs that require use of
a diagnostic test, creating a
pathway for nonprescription use
may result in the development by
industry of diagnostics suitable for
use by the patient,” the FDA said.
In addition, the FDA is also
considering whether the
same drug product could be
simultaneously available as both a
prescription and nonprescription
product with conditions of safe use.
“Dual availability could help
ensure greater access to needed
medications by making obtaining
them more flexible,” the FDA said.
MEANWHILE the plan has not
been met with widespread
welcome, with the American
Academy of Family Physicians
saying that allowing pharmacists to
dispense drugs for nonprescription
use could endanger patient health
and their relationship with their GP.
“Allowing the pharmacist
authority to dispense medication
without consulting with the
patient's physician first could
seriously compromise the
physician's ability to coordinate the
care of multiple problems of many
patients,” the AAFP said.
Pharmacists, according to the
AAFP, should work in collaboration
with GP’s to “optimise the
therapeutic effect of pharmaceutical
agents in patient care to achieve
the desired outcomes while
maintaining overall efficiency”.
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