What is Documentation?
Drugs and formulations are banned by the Govt when they are found to be harmful when used in the indicated dose. Without dwelling into the banning process, I wish to focus on the issues that arise at many levels including the patient per se, consequent to banning. This is also a part of pharmacy practice. In the current Indian scenario as I have observed the clinicians are the professionals who get the information first on their mobile phone from the respective pharma companies and the regulatory officers would be getting the official communication on the next day by post and some may get it on email also. The Chemists would be getting it through their Associations followed by the letter from their stockiest / distributors requesting them to return the existing stocks.
The orphan 'Hospital pharmacist' will never get the communication as he is not in the mailing list of anybody including the regulatory body. Of course, he may read it in the News paper if it is covered..
My concern is who would reach the patient with the information as neither the doctor who has prescribed the medicine nor the Chemist who has sold him care to contact him to advise. Since our doctors are out of reach of any control and governance no point in expecting or commenting on that holy-cow category. Hence, the only professional (if they care to be) who can help the patient on this issue is the Pharmacist as he is very much involved in holding the stocks and returning it to his principals.
Hence my question:
When a drug is banned under the law of the land:
1) How much time (Days / Weeks/Months) the law provides for functionaries at different level to return the stocks to their principals? Or beyond which time the stocks should be physically removed from the official premises?
2) What is the time line for the term 'Immediately' commonly being used as a practice?
3) Is it not the duty of the pharmacist to inform all his clients the banned status of the drug?
4) Does the law mandate the pharmacist to display or send an advisory to their clients to return the banned drug they have soled / given to them within certain reasonable timeline? How long is this reasonable time line?
5) Can the retailer refuse to pay back the amount collected for the banned drug and insist on his client to buy an alternate item instead? Nevertheless, let me also ask the medical faternity,
What does the Act and Rules that governs the medical practice say on this issue. Is the responsibility of the doctor / clinic / hospital ends with the handing over of a prescription or drugs? Should they also be responsible to ensure that their patient doesn't consume the banned drug? Is this not a medical negligence?
Whom the patient should hold responsible for medical negligence in case of any serious harm with use of the prescribed drug in his stock even after it is banned? Doctor ? / Hospital? / Chemist ?
What is Documentation?
Andhra University Fourth year B.Pharm 1st Semester Syllabus.
This is in effect from 2008 onwards.
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