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Washington, DC –
The National Consumers League has asked the Food and Drug
Administration to issue a guidance for a combined and simplified
document for patients when they receive their prescription
drugs. In a petition filed on June 30, NCL was joined by
several national healthcare organizations including the National
Association of Chain Drug Stores, the National Community
Pharmacists Association, the National Alliance for Hispanic
Health, the National Alliance for Caregivers, the Food Marketing
Institute, Healthcare Distribution Management Association, and
Catalina Health Resource.
“It is very important that patients receive clear, useful
information in plain language with their prescription drugs.
They should be able to talk to their pharmacist about potential
interactions, how to take their medicine and what side effects
to expect. Patients do not need to receive multiple and lengthy
pieces of paper that are often redundant and may even contain
conflicting information,” said Sally Greenberg, Executive
Director of the National Consumers League. “The present jumble
of documents ill-serves the patient who simply needs enough
information to take a prescription drug safely and effectively.”
The multitude of documents delivered to patients in pharmacies
arises from different FDA legal requirements or unwritten,
informal interpretation of those requirements from offices
within FDA. Some of the legal requirements were established
long ago, and were intended to regulate communications directed
to healthcare professionals and not directly to consumers.
The FDA-mandated documents for patient communications can be
just “too much information,” said Greenberg. For example, a
person refilling a prescription for an anti-depressant could,
theoretically receive:
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Consumer Medication Information (CMI) describing how to take
the prescribed drug, its risks, and other information
including risk information from the Medication Guide.
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A Patient Package Insert from the manufacturer with a
Medication Guide.
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A Medication Guide provided by the pharmacy.
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Full professional labeling if the patient receives a
sponsored message about the anti-depressant from the drug
manufacturer describing, for example, the importance of
adhering to the doctors’ orders.
The National Consumers League and other petitioners believe that
it makes more sense to provide a single, clear, patient-friendly
document with information for the patient that reinforces the
communications between the patient, the pharmacist, and the
prescribing healthcare professional. This single patient
document would consolidate the many documents now in use and
replace them with one that is easy to read, in plain language,
in a consistent format, with plain instructions informing the
patient where he or she can reliably obtain additional
information.
“Many of these documents were never designed for nor intended to
apply to the unique pharmacy environment,” said Greenberg. “The
risks of patient confusion, conflict, redundancy, and pharmacy
burden would be eliminated if FDA permitted a ‘single document
solution’ for all patient-directed information disseminated in
the pharmacy.” |
