82. Banned drugs & Medical accountability

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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?

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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 ?

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About the Author

Bhagavan P S's picture
Author: Bhagavan P S

I am Bhagavan ,Rtd. Dy Dir.(Pharmacy),Govt of Karnataka, India and currently serving as Registrar, KSPC, Bengaluru, India . I love to write on Hospital pharmacy series related topics out of my experience and observations. Check out my Pharmacist in the Hospital.

Comments

Prof. J. Vijaya Ratna's picture

Dear Sir

You have chosen the right topic to focus upon. There are some grey areas in our Acts and this is one. Some mechanism must be developed, whereby the pharmacist comes to know of it immediately and patients get protection from it. Media channels and pharmaceutical journals and pharmaceutical companies must take this responsibility. Also, many doctors have their own opinion on "banned drugs" and sometimes, they don't go along with the order. There is a lot of vagueness about this.

Good that we should discuss it. Can we suggest to the Government, some mechanism.? Can we prepare a document, where we list out our areas of concern, suggest solutions and hand it over to the executives of our professional bodies in the 65th IPC at Delhi? I am going to attend the 65th IPC and am ready to make a representation, if we can develop a comprehensive document. I am a life member of almost all of our bodies.

Vijaya Ratna

Bhagavan P S's picture

Thank you Dr Vijayaratna for recogizing the merrit of the issue. I was prompted to think elaborately on this issue when I came across an information that a chemist was holding the stocks of banned drugs too long and that it was the stock returned by one of his clients.

Well, lets prepare a comprehensive proposal for amendment. I cannot afford to attend meets outside Bangalore partly due tomy money constraints and partly having seen the futility of such meets.

I will support you for the move you intend to take.

Thank you madam,

Regards

BhagavanPS

Cell: 9980866994

Bhagavan P.S. B Pharm

Rtd. Dy Dir.(Pharmacy),Govt of Karnataka, India
Registrar, KSPC, Bengaluru, India