Tuesday, January 8, 2019

Should pretravel rabies vaccination be made compulsory for all travelers to India?




The Jan. 4, 2019 issue of CDC’s Morbidity and Mortality Weekly Report (MMWR) reported the case of a US citizen, who was bitten by a puppy while traveling in India in 2017 during a Yoga camp. The patient did not seek rabies medical treatment (postexposure prophylaxis), although she cleaned the wound. Upon his return to the US, the patient developed rabies and died during hospitalization despite aggressive treatment. A total of 250 health care workers were assessed for exposure to the patient, 72 of whom were advised to initiate postexposure prophylaxis (PEP). The patient had no record of a pretravel health screening, did not receive rabies preexposure vaccination before the trip, nor had she ever been vaccinated against rabies.

This case highlights the importance of pretravel preparation, including medical guidance, for international travelers.

India is a favorite travel destination not only for tourists, it is also growing in popularity as a hub for medical tourism. Also, many people come to India to learn yoga and meditate. Often, these purposes necessitate long stay in the country.

India is endemic for rabies accounting for 36% of the world’s human rabies deaths with 18,000-20,000 rabies deaths occurring every year. About 30-60% of reported rabies cases and deaths in India occur in children under the age of 15 years as bites that occur in children often go unrecognized and unreported. Majority of human rabies cases are due to dog bites (SEARO).

CDC guideline for rabies vaccination for travelers recommends pre-exposure rabies vaccination (3 doses given on days 0, 7 and 21 or 28) before travel, especially for those who will be involved in outdoor activities (such as camping, hiking, biking, adventure travel, caving) or those who come for yoga retreats and so are likely to stay longer in the country. But, if bitten or scratched by an animal, prompt post-exposure prophylaxis should be sought, even if pre-exposure vaccination has been taken.

Despite these guidelines, most people do not take pretravel consultation, including for recommended vaccinations, particularly when visiting countries with high incidence of emerging or zoonotic pathogens.

Rabies is a 100% preventable disease, but is almost always fatal once symptoms appear.

Pretravel rabies vaccination should be a valid option for all international travelers, especially those traveling rabies endemic countries and are likely to stay for long durations in the said country with outdoor activities.


Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA


Monday, January 7, 2019

Top FDA-related stories of 2018



FDA approves opioid 10 times stronger than fentanyl

Dsuvia, a new prescription opioid was approved by the US FDA in November despite criticism of  its approval amidst the opioid epidemic.

Dsuvia is a sublingual formulation of the opioid sufentanil that is delivered through a disposable, pre-filled, single-dose applicator. It is restricted to use in certified medically-supervised health care settings ‒ such as hospitals, surgical centers and emergency departments ‒ for administration by a health care professional. 

It is 10 times more potent than fentanyl and is 1,000 times more potent than morphine

FDA proposes antibiotic subscription plan for hospitals

On Sept. 14, the FDA Commissioner Scott Gottlieb, MD announced the FDA’s 2019 Strategic Approach for Combating antimicrobial resistance, which includes a proposal for a subscription-based model for hospital, which could see hospitals paying a flat rate for access to a certain number of doses of an important new antimicrobial. These subscription fees could be priced at a level to create a sufficient return on the investment to develop drugs with a certain profile. The plan also addresses four key areas:

·      Facilitating product development to ensure a robust pipeline of safe and effective treatments that can combat resistant organisms..
·      Promoting antimicrobial stewardship; careful stewardship across human and animal health can help preserve the effectiveness of available treatments and may help slow the development of antimicrobial resistance.
·      Supporting the development of tools for surveillance of antimicrobial use and for determining when pathogens develop resistance. 
·      Advancing scientific initiatives to help all stakeholders answer critical questions related to antimicrobial resistance. This includes research that can support the development of alternative treatment approaches. These can include bacteriophages, fecal microbiota transplants and live biotherapeutic products.

FDA clears Apple Watch for ECG screening

Apple Watch Series 4 includes an ECG sensor to alert users if their heart rhythm is irregular, which has been cleared by the FDA as a Class II device under the generic name electrocardiograph software for over-the-counter use. This was announced by Apple COO Jeff Williams during the company's Sept. 12 event in Cupertino, California.

The App displays a single channel ECG similar to a Lead I ECG and determines the presence of atrial fibrillation or sinus rhythm. The ECG data displayed by the ECG app is intended for informational use only.


Six guidelines from FDA to prevent surgical fires

In a safety communication issued on May 29, the US FDA issued six recommendations for healthcare providers to reduce surgical fires and related patient injury, including recommendations for safely using medical devices during surgery.

1.   A fire risk assessment at the beginning of each surgical procedure
2.   Encourage communication among surgical team members
3.   Safe use and administration of oxidizers
4.   Safe use of any devices that may serve as an ignition source.
5.   Safe use of surgical suite items that may serve as a fuel source
6.   Plan and practice how to manage a surgical fire


(Source: Becker’s Hospital Review, US FDA)

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

Good Idea: AIIMS relocates its OPD 500m away





Last week, AIIMS, New Delhi announced shifting of its block 500 m away from the main campus to Masjid Moth. The new OPD block will be functional by March this year. The Institute plans to run free transport services between the main campus and the new OPD bloc. This move will help decongest the main hospital and, therefore, allow better management of inpatient facilities. “The existing OPD may be utilized to expand emergency medicine and other inpatient departments, depending on need assessments,” an official said… (TOI, Jan. 3, 2019)

When planning a hospital, OPD complex should be away from the main hospital building to reduce the chances of hospital and healthcare-associated infections (HCAIs).

The World Health Organization (WHO) has defined HCAI as an infection occurring in a patient during the process of care in a hospital or other health care facility which was not present or incubating at the time of admission “they first appear 48 hours or more after hospital admission or within 30 days after discharge”.They are also called nosocomial infections or hospital-acquired infections.

HCAIs occur in all settings of care, including acute care within hospitals and same day surgical centers, ambulatory outpatient care in health-care clinics, and in long-term care facilities such as nursing homes and rehabilitation facilities.

Today hospital OPDs cater to all types of patients; whether from the community with new illness or a follow up patient after a hospital discharge. Patients with community-acquired infections in an OPD located in a hospital setting have high chances of acquiring a serious hospital aquired infection.

Therefore, community OPDs should be separately located from the hospital. Community OPDs serve as the first point of contact for the general population. An example of Community OPD is the Mohalla Clinic, which provides basic medical care for common health problems. Mohalla in Hindi means neighborhood or community.

Shifting of OPD is a good move by AIIMS and will help in reducing cross infections to community patients and their relations.


Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

Sunday, January 6, 2019

Re-admission rates should be a part of informed consent



Percutaneous coronary intervention (PCI) or stenting is a very frequently performed procedure now. But, complications do occur, both during the hospital stay and also after discharge, for which the patient may need to be hospitalized again.

Readmission rates at 30 days after PCI have been reported to be as high as 15% (J Am Coll Cardiol. 2009;54(10):903-7) In a single center study of over 15,000 patients who underwent (both urgent and non-urgent) PCI between 1998 and 2008, the 30-day rate was 9.4%. Patients who were readmitted were at significantly higher risk of one-year mortality (Arch Intern Med. 2012 Jan 23;172(2):112-7).

In this study, the following factors were found to be associated with an increased risk of readmission:

·         Female sex
·         Medicare insurance
·         Having less than a high school education
·         Unstable angina
·         Cerebrovascular accident or transient ischemic attack
·         Moderate to severe renal disease
·         Chronic obstructive pulmonary disease
·         Peptic ulcer disease
·         Metastatic cancer
·         Length of stay of more than 3 days 

These studies show that while readmission rates may vary among different hospitals, at least 10% of patients will be re-hospitalized post-PCI and the factors that increase the risk of re-hospitalization are all non-modifiable.

There are medicolegal implications to this.

Readmission rates for all diseases are used as a quality benchmark for health systems and indicate the quality of treatment. PCI is only one such example.

This is also a requirement of NABH (National Accreditation Board for Hospitals and Healthcare Providers) Standards for Hospitals. As per the NABH Guide to Accreditation Standards of Hospitals (2015), “The organisation shall ensure that the programme is in consonance with good clinical practices. Good clinical practices include monitoring infection rates, re-admission rates, re-intubation rates, etc.”

The re-admission rate should be mentioned in the contract or informed consent signed between the doctor and the patient at the time of admission and the discharge advice.

Readmission is a reality and should be anticipated. Re-hospitalization also means increased cost of treatment, which many patients can ill-afford. If insured, then most of them could have utilized their Mediclaim or at least a major part of it, for the procedure in the initial admission.

So, the treating doctor must explain the chances of death and unexpected complications and resultant financial implication at the time of admission.

Perhaps, the cost of treatment of complications can be included as part of initial payment as “insurance”, as a fixed charge. For instance, if the entire cost amounts to Rs 2 lakh, then the patient can be asked to pay a sum of Rs. 2.5 lakh. The extra amount would take care of 0-30 day readmission of the patient for complications related to the initial procedure performed.


Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

Wheat belly: Why is wheat the culprit?



More than 37% of Indians have belly obesity, which is defined as abdominal circumference > 80 cm in women and > 90 cm in men.

The reason for this is the every day consumption of wheat in diet. Wheat is a part of staple diet, particularly in North India. Traditionally Indians have been asked to do one wheat fast a week, extra wheat fast on the day of Ekadashi and nine-day wheat fast every three months during Navratras.

Why is wheat the culprit? Wheat contains amylopectin A, gliadin and gluten.

Amylopectin A is a chemical unique to wheat. It is a trigger of small LDL particles. When wheat is removed from the diet, these small LDL levels reduce by 90%.

Gliadin is a protein, which stimulates appetite. Eating wheat increases the average person’s calorie intake by 400 calories a day. Gliadin also has opiate-like properties, which make it “addictive”.

Gluten is inflammatory to the gut.

But wheat was a part of diet earlier also. Wheat eating patterns changed in the 70s and 80s, when newer techniques came to be used to increase yield, including hybridization. It was bred to be shorter and sturdier and also to have more gliadin. The wheat that is available today and what we eat today is not the wheat that was eaten many, many years ago.

Corn starch, rice starch, tapioca starch or potato starch are the four basic ingredients of gluten-free products. These dried, powdered starches increase the blood sugar even higher.

According to Dr Tom O’Bryan, an international expert on wheat and wheat-related disorders, for every one person who has intestinal manifestations of wheat sensitivity, there are 8 who don’t have any GI symptoms. No human has the capability to breakdown wheat. But, whether wheat causes a problem for them depends on whether they have crossed the line of tolerance. The inflammatory mechanisms begin once all tolerance is lost, which trigger the immune system resulting in an autoimmune disease. Females are three times more likely to develop autoimmune celiac disease than males.

Earlier, the term gluten sensitivity was used, but now wheat sensitivity is used as wheat has several components other than gluten, which may be a problem.

All people are wheat sensitive to some degree, so wheat can be called an inflammatory diet.

The defense mechanisms vary between individuals; while some may react to it, some may overcome it, until they cross the line of tolerance.

If after eating wheat, you get discomfort, you should get yourself tested or try a wheat elimination diet.

About 50% of wheat-sensitive people also cross react with corn and dairy. Hence, a wheat elimination diet has no wheat of any type, no sugar, no corns/grains and no dairy products. Eliminate these from your diet for three weeks and observe the change. Then eat a pizza on day 22. If you notice any worsening effect, then you are wheat sensitive.

If you are sensitive, omit wheat in the diet.

So, is rice safe? Rice does not increase the blood sugar levels to the extent that wheat does; rice also does not contain amylopectin A or gliadin.

To know more about this, attend the International Symposium on Wheat Related Disorders at India Habitat Centre, New Delhi from January 12-13, 2019.


Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

Saturday, January 5, 2019

Law on Euthanasia in India

Life and death as concepts have invited many a thinker, philosopher, writer and physician to define or describe them. Swami Vivekananda expects one to understand that life is the lamp that is constantly burning out and further suggests that if one wants to have life, one has to die every moment for it. One may like to compare life with constant restless moment spent in fear of extinction of a valued vapour; and another may sincerely believe that it is beyond any conceivable metaphor.  Death is complicated and life is a phenomenon which possibly intends to keep away from negatives that try to attack the virtue and vigour of life from any arena. In spite of all the statements, references and utterances, be it mystical, philosophical or psychological, the fact remains, at least on the basis of conceptual majority, that people love to live – whether at eighty or eighteen – and do not, in actuality, intend to treat life like an ―autumn leaf.

The perception is not always the same at every stage. There comes a phase in life when the spring of life is frozen, the rain of circulation becomes dry, the movement of body becomes motionless, the rainbow of life becomes colourless and the word life, which one calls a dance in space and time becomes still and blurred and the inevitable death comes near to hold it as an octopus gripping firmly with its tentacles so that the person shall rise up never.
The ancient Greet philosopher, Epicurus, has said, although in a different context:-

Why should I fear death?
If I am, then death is not.
If death is, then I am not.
Why should I fear that which can only exist when I do not?

But there is a fallacy in the said proposition. It is because mere existence does not amount to presence. And sometimes there is a feebleness of feeling of presence in semi-reality state when the idea of conceptual identity is lost, quality of life is sunk and the sanctity of life is destroyed and such destruction is denial of real living.

The society at large feels that a patient should be treated till he breathes his last breath.

Every doctor is supposed to take a specific oath that he will make every attempt to save the life of the patient whom he/she is treating and who is under his/her treatment. This oath, thus, puts a moral and professional duty upon a doctor to do everything possible, till the last attempt, to save the life of a patient.

The Medical Council of India (MCI) Code of Ethics Regulations rejects Euthanasia (deliberately ending a patient’s life at his or her own request or at the request of close relatives).  “6.7 Euthanasia: Practicing euthanasia shall constitute unethical conduct. However, on specific occasion, the question of withdrawing supporting devices to sustain cardio-pulmonary function even after brain death, shall be decided only by a team of doctors and not merely by the treating physician alone. A team of doctors shall declare withdrawal of support system. Such team shall consist of the doctor in charge of the patient, Chief Medical Officer / Medical Officer in charge of the hospital and a doctor nominated by the in-charge of the hospital from the hospital staff or in accordance with the provisions of the Transplantation of Human Organ Act, 1994.”

While MCI Code of Ethics rejects euthanasia, it does not talk about physician-assisted-suicide (where a physician deliberately enables a patient to end his or her life by prescribing or providing medical substances with the sole intent of causing death. But practically it is included in the same as both acts are contrary to the ethics of medicine and the role of the physician.

Medical scientists have been, relentlessly and continuously, experimenting and researching to find out better tools for not only curing the disease with which human beings suffer from time to time, noble attempt is to ensure that human life is prolonged and in the process of enhancing the expectancy of life, ailments and sufferings therefrom are reduced to the minimal. There is, thus, a fervent attempt to impress the quality of life.

It is this very advancement in the medical science which creates dilemma at that juncture when, in common perception, life of a person has virtually become unlivable but the medical doctors, bound by their Hippocratic Oath and medical ethics want to still spare efforts in the hope that there may still be a chance, even if it is very remote, to bring even such a person back to life.

The Hippocratic Oath taken by a doctor and the MCI Code of Ethics may make him feel that there has been a failure on his part and sometimes also make him feel scared of various laws. There can be allegations against him for negligence or criminal culpability.

No physician should be forced to participate in euthanasia or assisted suicide, nor should any physician be obliged to make referrals to this end. However, the right to decline medical treatment is a basic right of the patient.  

The physician does not act unethically in respecting the patient’s wish to decline medical treatment, even if such a wish may result in the patient’s death by allowing the natural dying process to unfold in the course of terminal phases of sickness.
A doctor has a crucial role to play in such situations as there is a very thin line between this ethical and unethical act.

Remember it is the patient who has a right to deny the treatment and not the relatives. However, the patient must be in his or her sound state of mind to take any such decision.
There is a distinction between the administration of lethal injection or certain medicines to cause painless death and non-administration of certain treatment which can prolong the life in cases where the process of dying that has commenced is not reversible or withdrawal of the treatment that has been given to the patient because of the absolute absence of possibility of saving the life. To explicate, the first part relates to an overt act whereas the second one would come within the sphere of informed consent and authorized omission. The omission of such a nature will not invite any criminal liability if such action is guided by certain safeguards. The concept is based on non-prolongation of life where there is no cure for the state the patient is in and he, under no circumstances, would have liked to have such a degrading state.
In the landmark judgment Common Cause versus Union of India2018 (5) SCC 1, the Hon’ble 4-Judge Constitution Bench of the Supreme Court held that Euthanasia is basically an intentional premature termination of another person‘s life either by direct intervention (active euthanasia) or by withholding life-prolonging measures and resources (passive euthanasia) either at the express or implied request of that person (voluntary euthanasia) or in the absence of such approval/consent (non-voluntary euthanasia).

Active euthanasia also includes physician-assisted suicide, where the injection or drugs are supplied by the physician, but the act of administration is undertaken by the patient himself. Active euthanasia is not permissible in most countries.

Passive euthanasia is when medical practitioners do not provide life-sustaining treatment (i.e. treatment necessary to keep a patient alive) or remove patients from life sustaining treatment. This could include disconnecting life support machines or feeding tubes or not carrying out life-saving operations or providing life extending drugs. In such cases, the omission by the medical practitioner is not treated as the cause of death; instead, the patient is understood to have died because of his underlying condition.

Further, in Gian Kaur versus State of Punjab, (1996) 2 SCC 648, the Hon’ble Constitution Bench  of Apex Court expounded that the word "life" in Article 21 has been construed as life with human dignity and it takes within its ambit the "right to die with dignity" being part of the "right to live with dignity". As part of the right to die with dignity in case of a dying man who is terminally ill or in a persistent vegetative state, only passive euthanasia would come within the ambit of Article 21 and not the one which would fall within the description of activeeuthanasia in which positive steps are taken either by the treating physician or some other person. That is because the right to die with dignity is an intrinsic facet of Article 21.

In Aruna Ramachandra Shanbaug versus Union of India, 2011 (15) SCC480, Hon’ble Supreme Court has observed that autonomy means the right to self-determination where the informed patient has a right to choose the manner of his treatment. To be autonomous the patient should be competent to make decisions and choices. In the event that he is incompetent to make choices, his wishes expressed in advance in the form of a Living Will, or the wishes of surrogates acting on his behalf (substituted judgment) are to be respected.
Thus, all adults with the capacity to consent have the common law right to refuse medical treatment and the right of self - determination. Doctors would be bound by the choice of self-determination made by the patient who is terminally ill and undergoing a prolonged medical treatment or is surviving on life support, subject to being satisfied that the illness of the patient is incurable and there is no hope of his being cured.

In “Common Cause versus Union of India2018 (5) SCC 1 the Constitution Bench of Hon’ble Supreme Court held that Advance Medical Directive would serve as a fruitful means to facilitate the fructification of the sacrosanct right to life with dignity. The said directive will dispel many a doubt at the relevant time of need during the course of treatment of the patient. That apart, it will strengthen the mind of the treating doctors as they will be in a position to ensure, after being satisfied, that they are acting in a lawful manner. However, Advance Medical Directive cannot operate in abstraction. The Hon’ble Court in the said judgment has enumerated various safeguards and procedure of advance medical derivatives and also in cases where there is no advance medical derivatives which will remain enforced till Parliament makes a law on Advance Medical Derivatives. 

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

Friday, January 4, 2019

More than 4 lakh patients die from medical errors in the US: Medical errors are inevitable in medical practice




According to a new study published in the BMJ, online May 3, 2018, more than 2 lakh deaths in the US are due to medical errors.

Researchers from Johns Hopkins University School of Medicine examined four separate studies that analyzed medical death rate data from 2000 to 2008. Then, using hospital admission rates from 2013, they extrapolated that based on a total of 35,416,020 hospitalizations; they calculated 251,454 deaths were due to a medical error, which translates to 9.5% of all deaths annually in the US. This number is much higher than respiratory disease, which as per the CDC is the third leading cause of death and kills around 150,000 people in a year.

But, according to other organisations, the number of deaths due to medical errors is much higher than 2 lakhs and is around 440,000.

Medical errors are the third-leading cause of death in the US after heart disease and cancer.

Medical error-related deaths occur due to:

·         Preventable adverse effects
·         Error in judgment
·         Lack of care
·         Inadequately trained staff (most important)
·         Out of date computer systems that break down
·         Medication mix-ups
·         Undiagnosed complications after surgeries
·         Communication failures with patients

The number of medical error-related deaths will be much higher in India because of the large population; also, there is no system of reporting of errors of other pathies. This is further compounded by the fact that even non-qualified doctors are treating patients. 

The public, including the patients, needs to understand that medicine is an art, based on science, yet it is not an exact science. No two patients are alike and clinical decisions are tailored to individual patients. Therefore, uncertainty is a part of day-to-day medical practice, where errors are inevitable. 

So, for someone to be able to say it is negligence the following circumstances must be present:

·         Doing what the healthcare provider should not have done under the circumstances.
·         Not doing what the healthcare provider should have done under the circumstances.
·         Medical error must have caused identifiable injury

Because medical errors are bound to occur, there should not be a public media trial for making a mistake, unless the error is gross. If every medical error is flashed on the front page of newspapers and cases are filed against doctors in courts, it will adversely affect the doctor-patient relationship, which is already very fragile.

The possible answers can be:

·         Explain the cost right at the time of admission
·         Be transparent in your cost
·         Have a contract signed by the patient at admission, which explains about existing and non-existing facilities
·         Sign a contract about the liability limit for any possible mishap
·         Make likelihood of medical errors a part of informed consent process


Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA