eMedinewS Editorial

Medicine 2,328 Comments

Guidelines for prosecuting medical professionals?

Dear Colleague

The Supreme Court of India in the Jacob Mathew case noted that “the cases of doctors (surgeons and physicians) being subjected to criminal prosecution are on an increase”. Sometimes such prosecutions are filed by private complainants and sometimes by police on an FIR being lodged and cognizance taken.

The investigating officer and the private complainant cannot always be supposed to have knowledge of medical science so as to determine whether the act of the accused medical professional amounts to rash or negligent act within the domain of criminal law under Section 304-A of IPC. The criminal process once initiated subjects the medical professional to serious embarrassment and sometimes harassment. He has to seek bail to escape arrest, which may or may not be granted to him. At the end he may be exonerated by acquittal or discharge but the loss which he has suffered in his reputation cannot be compensated by any standards.

‘We may not be understood as holding that doctors can never be prosecuted for an offence of which rashness or negligence is an essential ingredient. All that we are doing is to emphasize the need for care and caution in the interest of society; for, the service which the medical profession renders to human beings is probably the noblest of all, and hence there is a need for protecting doctors from frivolous or unjust prosecutions. Many a complainant prefers recourse to criminal process as a tool for pressurizing the medical professional for extracting uncalled for or unjust compensation. Such malicious proceedings have to be guarded against.

Statutory Rules or Executive Instructions incorporating certain guidelines need to be framed and issued by the Government of India and/or the State Governments in consultation with the Medical Council of India. So long as it is not done, we propose to lay down certain guidelines for the future which should govern the prosecution of doctors for offences of which criminal rashness or criminal negligence is an ingredient.

A private complaint may not be entertained unless the complainant has produced prima facie evidence before the Court in the form of a credible opinion given by another competent doctor to support the charge of rashness or negligence on the part of the accused doctor.

The investigating officer should, before proceeding against the doctor accused of rash or negligent act or omission, obtain an independent and competent medical opinion preferably from a doctor in government service qualified in that branch of medical practice who can normally be expected to give an impartial and unbiased opinion applying Bolam’s test to the facts collected in the investigation.

A doctor accused of rashness or negligence, may not be arrested in a routine manner (simply because a charge has been levelled against him). Unless his arrest is necessary for furthering the investigation or for collecting evidence or unless the investigation officer feels satisfied that the doctor proceeded against would not make himself available to face the prosecution unless arrested, the arrest may be withheld.”

Reference: Criminal Medical Negligence, Jacob Mathew’s Case 2005 AIR 3180 SC, Appeal (crl.) 144-145 of 2004, CJI R.C. Lahoti, Justice G.P. Mathur & P.K.Balasubramanya.

Take Home Messages

  1. State Medical councils have judicial powers of that of civil courts. (DMC has)
  2. Council court is a court.
  3. A patient will file a case against the doctor under CPA if he or she needs compensation.
  4. Most of the times he will approach the respective State Medical Council for medical negligence (criminal negligence).
  5. Supreme court has given a procedure for the same.
  6. The investigating officer and the private complainant most likely will not have knowledge of medical science.
  7. The unnecessary criminal process once initiated subjects the medical professional to serious embarrassment and sometimes harassment.
  8. At the end he may be exonerated by acquittal or discharge but the loss which he has suffered in his reputation cannot be compensated by any standards.
  9. There is a need for protecting doctors from frivolous or unjust prosecutions.
  10. Many complainants prefer recourse to criminal process as a tool for pressurizing the medical professional for extracting uncalled for or unjust compensation. Such malicious proceedings have to be guarded against.
  11. A private complaint should not be entertained (also by state medical council) unless the complainant has produced prima facie evidence before the Court in the form of a credible opinion given by another competent doctor to support the charge of rashness or negligence on the part of the accused doctor.
  12. The investigating officer should, before proceeding against the doctor accused of negligence/omission, obtain an independent and competent medical opinion preferably from a doctor in government service qualified in that branch of medical practice who can normally be expected to give an impartial and unbiased opinion applying Bolam’s test to the facts collected in the investigation.
  13. Investigating officer can refer for the same to state council or appoint an independent board.
  14. Suspension of license is a prosecution.

  15. Prosecution is allowed only in the case of a professional misconduct in the MCI act.
  16. Professional medical deficiency is not a professional misconduct in the MCI act.
  17. Professional misconduct has been defined in the MCI Act . (see part 2 ans part 3 tomorrow and day after tomorrow)

Dr KK Aggarwal
Padma Shri & Dr B C Roy Awardee and Chief Editor

eMedinewS Editorial

Health Care 2,544 Comments

Never events

Dear Colleague

Implications: Why know them

  1. Mediclaim may not pay.
  2. PSU may not reimburse.
  3. CGHS may not pay.
  4. CPA may order compensation.
  5. Patient may not pay.
  6. MCI or state councils may be asked to classify them under “never events”.

‘Never events’ or events that should never occur are 28 occurrences on a list of inexcusable outcomes in a health care setting. The list was compiled by the US National Quality Forum (NQF). They are defined as adverse events that are serious, largely preventable, and of concern to both the public and health care providers for the purpose of public accountability. The term ‘Never Event’ was first introduce by Ken Kizer, MD, former CEO of NQF in 2001. Several US states have enacted laws requiring the disclosure of never events at hospitals and various remunerative or punitive measures for such events.

A recent Leapfrog Group Study finds that roughly half of the 1,285 hospitals that responded to their survey waive fees for never events, and that hospitals that do waive fees are much more likely to have perfect scores on the Leapfrog Safe Practices Score survey.

The 28 never events are:

  1. Artificial insemination with the wrong donor sperm or donor egg.
  2. Unintended retention of a foreign object in a patient after surgery or other procedure
  3. Patient death or serious disability associated with patient elopement (disappearance)
  4. Patient death or serious disability associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation or wrong route of administration)
  5. Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO/HLA–incompatible blood or blood products
  6. Patient death or serious disability associated with an electric shock or elective cardioversion while being cared for in a healthcare facility
  7. Patient death or serious disability associated with a fall while being cared for in a healthcare facility
  8. Surgery performed on the wrong body part
  9. Surgery performed on the wrong patient
  10. Wrong surgical procedure performed on a patient
  11. Intraoperative or immediately post–operative death in an ASA Class I patient
  12. Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility
  13. Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended
  14. Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a healthcare facility
  15. Infant discharged to the wrong person
  16. Patient suicide, or attempted suicide resulting in serious disability, while being cared for in a healthcare facility
  17. Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a health care facility
  18. Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a healthcare facility
  19. Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinemia in neonates
  20. Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility
  21. Patient death or serious disability due to spinal manipulative therapy
  22. Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances
  23. Patient death or serious disability associated with a burn incurred from any source while being cared for in a healthcare facility
  24. Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a healthcare facility
  25. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider
  26. Abduction of a patient of any age
  27. Sexual assault on a patient within or on the grounds of the healthcare facility
  28. Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of the healthcare facility

The Leapfrog Group offers four actions as industry standards following a never event:

1. Apologize to the patient,

2. Report the event,

3. Perform a root cause analysis, and

4. Waive costs directly related to the event.

Medscape adds to the list

1. Catheter–associated urinary tract infection

2. Deep–vein thrombosis/pulmonary embolism related to hip and knee replacements

3. Surgical site infections

4. Manifestations of poor glycemic control, including hypoglycemic coma

NHS list (adds)

As specified in The operating framework for the NHS in England 2010/11, from April 2010, primary care trusts will be expected to seek recovery of the cost of the procedure/treatment where one of the following seven Never Events occurs:

  • Wrong route administration of chemotherapy
  • Misplaced naso or orogastric tube not detected prior to use
  • Inpatient suicide using non–collapsible rails
  • In–hospital maternal death from post–partum haemorrhage after elective caesarean section
  • Intravenous administration of mis–selected concentrated potassium chloride

Hospital–acquired infections such as MRSA or C.diff are not included on this list.

IVF: Artificial insemination with the wrong donor sperm or donor egg.

Dr KK Aggarwal
Padma Shri Awardee and Chief Editor

eMedinewS Editorial

Health Care 3,508 Comments

PPIs may cause bone fractures when used for more than one year or at higher doses: FDA

Dear Colleague

High doses or long–term use of PPIs or proton pump inhibitors can lead to an increased risk of bone fractures. This holds especially true for those over the age of 50, and for people on the high dose. The latest warning is based on a FDA review of several studies of the treatment. These epidemiologic studies revealed an elevated fracture risk at the hip, wrist, and spine. But the studies do not, definitively prove that PPIs are the cause of the fractures.

FDA has instructed the manufacturers of the drugs to change the labels for both the prescription and the over–the–counter versions of the proton pump inhibitors. The FDA said they should only be taken for 14 days to help ease frequent heartburn, and under no circumstances should over–the–counter PPIs be taken for more than three 14–day periods in a year.

Most researchers believe that more fractures are due to decreased calcium absorption from the diet because of the reduced stomach acid. But, it’s also possible that these drugs interfere with bone maintenance. Notably, PPIs have previously been linked to an increased risk of contracting pneumonia and the troublesome bacterium Clostridium difficile, as well as to an increased risk of dementia.

Dr KK Aggarwal
Padma Shri Awardee and Chief Editor

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