What are the labelling requirements of samples of drug meant for free distribution to doctors?
Answers
Answer:
Drug samples of medications are available to patients through healthcare sites such as practitioners' offices, clinics, hospital emergency departments, and pharmacies. Drug samples provide a vital service to patients whose pharmacotherapeutic regimen is not well established, are poor, uninsured, underinsured, or in need of medications when pharmacies are closed. However, systems for distributing samples are often inadequate or unsafe for patients due to insufficient control, poor documentation, improper storage, inadequate instruction for use, lack of written instruction, poor labeling or packaging, and the dispensing of expired medications.
The Council is issuing the following recommendations to highlight the risk of medication errors with the use of drug samples and to provide guidance for a standardized approach to distribution of drug samples in all practice settings.
Recommendations
General Use
Drug samples should be provided only by licensed practitioners in accordance with state laws and regulations.
In practice settings where drug samples are routinely distributed professional staff should develop policies and procedures that address their procurement, storage, access, and distribution/dispensing, and proper disposal of drug samples. All providers and appropriate employees should be trained on and have access to the policies and procedures.
Drug samples usually should not be given for long-term use or maintenance therapy, unless they are part of a program that includes pharmacy dispensing and traditional safety checks that are provided by a pharmacist.
In institutions with on-site pharmacies, the pharmacy should be responsible for the procurement, distribution, and control of all drugs, including drug samples used in the institution.
Manufacturer Packaging and Labeling
Manufacturers are urged to provide drug samples in patient-friendly, child-resistant packaging that includes the following:
only one dosage unit per blister, when blister packaging is used
lot number and expiration date
manufacturer-provided information as required by the FDA (e.g., medication guide)and
an open space where the provider of the drug sample can either affix a label with the patient name and specific instructions for use, or be able to write this information for the patient.
Multiple doses should be packaged in a manner that preserves labeling for each dose (e.g., the label or backing of each dose should contain the drug's name, strength of medication, lot number, and expiration date).
Unique National Drug Code (NDC) numbers should be assigned to each drug sample to facilitate electronic documentation and tracing of products.
Explanation:
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