1.If the use of a drug advised to be taken by a patient can have serious
consequences,it is the duty of the doctor to warn the patient against those
consequences in a documented manner - write the advise and directions in
prescription form or in the case sheet.
2.Please know the clause 5, Schedule K of the Drugs and Cosmetics Rules, 1945.
According to Section 5 of Schedule K of Drugs and cosmetics act , a registered medical
practitioner is exempted from Drug license, provided the registered practitioner is not
keeping an open shop or selling across the counter or engaged in the importation ,
manufacture or sale of drugs in the provision of chapter 4 of the act and the rules
there under. But drug inspectors interpret Schedule K as per their pleasure.
This was a big issue in Kerala recently and finally Drug controller of Kerala exempted single and couple practioners from taking drug license. Kerala state branch of IMA has defended this right before the supreme court and high court of Kerala. But health care instituitions not run by registered medical practioners as part of their medical practise( corporate hospitals, mission hospitals etc) should take drug license.
3. importance of keeping "medical records":
It is wise to remember that "Poor records mean poor defense, no records
mean no defense":
Medical records include a variety of documentation of patient's history, clinical findings, diagnostic test results, preoperative care, operation notes, post operative care, and daily notes of a patient's progress and medications. A properly obtained consent will go a long way in proving that the procedures were conducted with the concurrence of the patient. A properly written operative note can protect a surgeon in case of alleged negligence due to operative complications. It is important that the prescription for drugs should be legible with the name of the patient, date, and the signature of the doctor. An undated prescription can land a doctor in trouble if the patient misuses it. There are also many records that are indirectly related to patient management such as accounts records, service records of the staff, and administrative records, which are also useful as evidences for litigation purposes
consequences,it is the duty of the doctor to warn the patient against those
consequences in a documented manner - write the advise and directions in
prescription form or in the case sheet.
2.Please know the clause 5, Schedule K of the Drugs and Cosmetics Rules, 1945.
According to Section 5 of Schedule K of Drugs and cosmetics act , a registered medical
practitioner is exempted from Drug license, provided the registered practitioner is not
keeping an open shop or selling across the counter or engaged in the importation ,
manufacture or sale of drugs in the provision of chapter 4 of the act and the rules
there under. But drug inspectors interpret Schedule K as per their pleasure.
This was a big issue in Kerala recently and finally Drug controller of Kerala exempted single and couple practioners from taking drug license. Kerala state branch of IMA has defended this right before the supreme court and high court of Kerala. But health care instituitions not run by registered medical practioners as part of their medical practise( corporate hospitals, mission hospitals etc) should take drug license.
3. importance of keeping "medical records":
It is wise to remember that "Poor records mean poor defense, no records
mean no defense":
Medical records include a variety of documentation of patient's history, clinical findings, diagnostic test results, preoperative care, operation notes, post operative care, and daily notes of a patient's progress and medications. A properly obtained consent will go a long way in proving that the procedures were conducted with the concurrence of the patient. A properly written operative note can protect a surgeon in case of alleged negligence due to operative complications. It is important that the prescription for drugs should be legible with the name of the patient, date, and the signature of the doctor. An undated prescription can land a doctor in trouble if the patient misuses it. There are also many records that are indirectly related to patient management such as accounts records, service records of the staff, and administrative records, which are also useful as evidences for litigation purposes
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