Friday, August 31, 2018

Supreme Court has stayed the judgment of Delhi High Court on inclusion of genetic disorders in insurance policy


Dr KK Aggarwal & Ira Gupta

In February this year, the Delhi High Court in the case of M/S United India Insurance Company Limited v. Jai Parkash Tayal (RFA 610/2016 & CM Nos.45832/2017) dated 26th February, 2018 had directed Insurance Regulatory Development Authority of India (IRDA) “to re-look at the Exclusionary clauses in insurance contracts and ensure that insurance companies do not reject claims on the basis of exclusions relating to genetic disorders.”

The Delhi High Court had held that “a person, suffering from a genetic disorder, needs medical insurance as much as others” and concluded its judgement with the following statements:

However, vide an order dated 27.08.2018, the Hon’ble 3 Judges Bench of Supreme Court of India has partially stayed the above judgment in “The United India Insurance Co. Ltd. Versus Jay Prakash Tayal, SLP(c) No. 29590/2018” passed by the Hon’ble High Court of Delhi.

The stay order extends to following issues:

      i.        Right to avail health insurance is an integral part of the Right to Healthcare and the Right to Health, as recognised in Art. 21 of the Constitution

     ii.        Discrimination in health insurance against individuals based on their genetic disposition or genetic heritage, in the absence of appropriate genetic testing and laying down of intelligible differentia, is Unconstitutional;

    iii.        The broad exclusion of genetic disorders' is thus not merely a contractual issue between the insurance company and the insured but spills into the broader canvas of Right to Health. There appears to be an urgent need to frame a proper framework to prevent against genetic discrimination as also to protect collection, preservation and confidentiality of genetic data. Insurance companies are free to structure their contracts based on reasonable and intelligible factors which should not be arbitrary and in any case cannot be 'exclusionary. Such contracts have to be based on empirical testing and data and cannot be simply on the basis of subjective or vague factors. It is for lawmakers to take the necessary steps in this regard.

   iv.        The Exclusionary clause of genetic disorders', in the insurance policy, is too broad, ambiguous and discriminatory hence violative of Art. 14 of the Constitution of India;


    v.        Insurance Regulatory Development Authority of India (IRDA) is directed to re-look at the Exclusionary clauses in insurance contracts and ensure that insurance companies do not reject claims on the basis of exclusions relating to genetic disorders.

Thursday, August 30, 2018

Antihypertensive treatment plus a statin has long-term mortality benefits




Blood pressure and cholesterol lowering drugs improve survival in patients with hypertension even after more than a decade, suggest results from the ASCOT Legacy study presented at ESC Congress 20181 and published simultaneously in The Lancet.

The ASCOT Legacy study is the long-term follow-up of more than 8000 hypertensive patients from the UK, almost 16 years after they had had been recruited in the multicenter Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), between 1998 and 2000. The study participants also had three or more additional risk factors for cardiovascular disease.

In the BP lowering arm, patients who were treated with calcium channel blocker based treatment regimen (amlodipine) + perindopril, if needed for 5.5 years reduced their chances of stroke-related death over ten years by 29% in comparison to those taking an older regimen, based on atenolol (a beta-blocker) + bendroflumethiazide (a diuretic) and potassium, if needed. There was a non-significant trend towards 10% fewer cardiovascular deaths with the newer therapy.

In the lipid lowering arm, patients with average (6.5 mmol/l) or below average blood cholesterol levels at the start of the trial who took a statin (atorvastatin) for 3.3–5.5 years had a 15% reduction in rates of cardiovascular death than those randomized to placebo.

A subgroup of patients with above average cholesterol who received standard lipid-lowering therapy for 5.5 years had 21% fewer cardiovascular deaths over ten years of follow-up with the newer blood pressure therapy compared to the older one. There was a non-significant trend towards lower all-cause and stroke deaths with the newer treatment.

These findings hold significance for practicing doctors, as they provide confirmatory evidence for the long-term beneficial effects of antihypertensive treatment together with statin, especially with regard to mortality, which was earlier only thought that they would. The benefits of BP- and lipid-lowering therapies accumulate over time, even after treatment has been completed by the patient. These findings are also pertinent for patients, as they encourage compliance to treatment.

The study therefore supports the use of an effective anti-hypertensive therapy along with a statin in most patients with hypertensive and have the potential for changing practice.

(Source: ESC Press Release)

Dr KK Aggarwal
Padma Shri Awardee
Vice President CMAAO
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA

Wednesday, August 29, 2018

Think before you prescribe - Do not give nitrofurantoin in suspected pyelonephritis


Think before you prescribe

Do not give nitrofurantoin in suspected pyelonephritis

Nitrofurantoin is an effective and therefore often the first-line choice for cystitis. A 2010 update of the guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis (Clin Infect Dis. 2011;52:e103-e120) recommends against the use of nitrofurantoin when the diagnosis of cystitis is uncertain vis-à-vis pyelonephritis, because it does not achieve adequate renal tissue levels. According to the guideline, “such uncertainly may exist in the setting of cystitis symptoms accompanied by subjective fever that is not verified at the time of examination, a prolonged duration of cystitis symptoms (typically greater than 5-7 days), or vague flank pain or tenderness which is not otherwise explained”.

In such cases, a urine culture and susceptibility test should always be done and choice of antibiotic should be based on the culture and antibiotic sensitivity testing. Local community resistance prevalence, availability, cost, patient allergy and compliance history are other factors that may influence the choice of antibiotic in these patients.

Dr KK Aggarwal
Padma Shri Awardee
Vice President CMAAO
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA

Tuesday, August 28, 2018

4 doctors booked under IPC 337 and 338: Missing a diagnosis is not grievous hurt



In Pune a baby was born with deformity, missed on ultrasound. Prenatal check-ups were done at Ashwamegh Nursing Home. None of the doctors notified that the baby had a deformity. They instead said that the baby was fine and their reports, too, claimed that our child was fit. When the baby was born on November 4, 2016, the baby was born with deformities in his right leg, left hand and had no passage for urine. The father went to the then commissioner of police Rashmi Shukla. This led to four doctors being booked under IPC 337 and 338.

Section 337 in The Indian Penal Code: Causing hurt by act endangering life or personal safety of others.—Whoever causes hurt to any person by doing any act so rashly or negligently as to endanger human life, or the personal safety of others, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five hundred rupees, or with both.

Section 338 in The Indian Penal Code: Causing grievous hurt by act endangering life or personal safety of others.—Whoever causes grievous hurt to any person by doing any act so rashly or negligently as to endanger human life, or the personal safety of others, shall be punished with impris­onment of either description for a term which may extend to two years, or with fine which may extend to one thousand rupees, or with both.

It is important here to understand that the action of the accused must have resulted in either simple or grievous hurt. The act must be done in a rash and negligent manner and the hurt caused must be the direct result of the act. And, the rashness or negligence must be of the extent, which puts the human life or personal safety of others in danger. Such an act would come under Sections 337 and 338.

Section 320 of IPC has defined a grievous injury as follows: “The following kinds of hurt only are desig­nated as “grievous”:—

(First) — Emasculation.
(Secondly) —Permanent privation of the sight of either eye.
(Thirdly) — Permanent privation of the hearing of either ear,
(Fourthly) —Privation of any member or joint.
(Fifthly) — Destruction or permanent impairing of the powers of any member or joint.
(Sixthly) — Permanent disfiguration of the head or face.
(Seventhly) —Fracture or dislocation of a bone or tooth.
(Eighthly) —Any hurt which endangers life or which causes the sufferer to be during the space of twenty days in severe bodily pain, or unable to follow his ordinary pursuits.”

“The prevalence of limb abnormalities is approximately six in 10,000 live births, the incidence is higher in the upper limbs compared with the lower limbs (3.4 of 10,000 and of 10,000, respectively); more commonly the limb abnormalities are unilateral instead of bilateral, and more frequently are present in the right side compared with the left. Limb formation occurs at 4-8 weeks’ gestation, while primary ossification centers develop in all the long bones of the limbs by the 12th week of gestation…

In the correct diagnostic approach, the sonologist should know the pregnancy history, if there are maternal diseases such as diabetes mellitus, hypercoagulability, systemic lupus erythematosus and other autoimmune diseases, myotonic dystrophy, presence of high blood pressure, and exposure to teratogens such as medications, infections, alcohol, and cigarette smoke. Information regarding family members with congenital limb or other abnormalities, recurrent miscarriage, stillbirths, mental retardation, inherited conditions, and consanguinity should be obtained…” (J Prenat Med. 2009 Apr-Jun;3(2):18–22).

Missing a diagnosis cannot be a grievous hurt. It may be a radiological error, which constitutes at most a breach of standard care.

And, even if the anomaly had been diagnosed prenatally, was it an indication of abortion? The answer is ‘no’.

An error of judgement is not negligence. The Hon'ble Supreme Court judgment in Jacob Mathew v. State of Punjab and Anr., 2005 (3) CPR 70 (SC) 6 SCC 1 has stated: “A mere deviation from normal professional practice is not necessarily evidence of negligence. Let it also be noted that a mere accident is not evidence of negligence. So also an error of judgment on the part of a professional is not negligence per se.”

The three essential components to prove medical negligence are breach of duty, causation and resulting damage.

In this case, the child was born with congenital abnormalities, which certainly cannot be said to be caused by the actions of the doctors. Where was the grievous injury in this case?

It is apparent that doctors are being charged by authorities under various sections of law without consideration of the facts of the case and without proper application of mind.

This would only further the mistrust in the doctor-patient relationship, which is already very precariously balanced.

Dr KK Aggarwal
Padma Shri Awardee
Vice President CMAAO
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA


Monday, August 27, 2018

WHO list of essential diagnostic tests in primary healthcare




The World Health Organization (WHO) published its first-ever list of essential diagnostic tests earlier this year.  The list includes tests recommended by the WHO for use in ‘primary health care’ and ‘health care facilities with clinical laboratories’.

The word ‘essential’ means that these tests should be available at all times in primary health care or higher health care facilities and they should be affordable with assured quality and accuracy. 

At the primary healthcare level, the list starts with basic hematological investigations such as hemoglobin, TLC, DLC, and recommends using a hemoglobinometer/dipstick, hematology analyser or hemocytometer. Most hematological tests can be indirectly estimated by slide method also.

To measure blood sugar level, the use of a glucometer is suggested.

WHO has recommended using urine dipstick to test for albumin, bilirubin, and glucose as well as to detect urinary tract infection.

The list also includes microscopic examination for routine hematological investigations, urine analysis, stool examination, sputum for TB and to identify species of malaria parasite (plasmodium).

Rapid diagnostic tests (RDTs) have been included to test for hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-HCV antibodies, HIV, malaria and antibodies to Treponema pallidum.

Once the list is made mandatory, these will be the tests permitted to be done by GPs, at primary health care centers and in Mohalla clinics.

In my view any test that can be done with a microscope or for which RDT or Dipstick is available can be added by the GP as and when required.

Tests for dengue, Chikungunya, typhoid, Troponin T or I etc for which RDT or strips are available can be added though not included in the WHO list at present.



Dr KK Aggarwal
Padma Shri Awardee
Vice President CMAAO
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA


Sunday, August 26, 2018

Delhi Hospital and a doctor asked to pay Rs. 20 lakh as compensation due to intra-arterial phenargan




Intra-arterial phenargan is a known complication in 2 in 57575 cases

In a 2001 case, Delhi's VIMHANS hospital and a doctor have been asked to pay Rs. 20 lakh as compensation on grounds of treatment offered to a 12-year-old boy, which led to the amputation of four fingers of his right hand on grounds of giving an intra-arterial injection of phenargan instead of an intravenous injection.

The information contained in the package insert should have been cited as a defence. According to the package insert, aspiration of dark blood does not preclude intra-arterial placement of the needle because blood can become discolored upon contact with promethazine.

Let’s take a look at what literature has to say about promethazine.

Promethazine (Phenergan) injection is a commonly used product that possesses antihistamine, sedative, anti-motion sickness, and antiemetic effects. It is also a known vesicant, which is highly caustic to the intima of blood vessels and surrounding tissue.

Formulated with phenol, promethazine has a pH between 4 and 5.5. Although deep intramuscular injection into a large muscle is the preferred parenteral route of administration, product labeling states that the drug may be given by slow IV push, which is how it is typically given in most hospitals.

However, due to the frequency of severe, tragic, local injuries after infiltration or inadvertent intra-arterial injection, Institute of Safe Medical Practices recommends that the FDA re-examine the product labeling and consider eliminating the IV route of administration.

Severe tissue damage can occur regardless of the route of parenteral administration, although intravenous and inadvertent intra-arterial or subcutaneous administration results in more significant complications, including: burning, erythema, pain, swelling, severe spasm of vessels, thrombophlebitis, venous thrombosis, phlebitis, nerve damage, paralysis, abscess, tissue necrosis, and gangrene. Sometimes surgical intervention has been required, including fasciotomy, skin graft and even amputation.

The true extent of this problem may be unknown. However, scores of reports suggest that patient harm may be occurring more frequently than recognized.

According to the package insert, “Proper IV administration of this product is well tolerated, but use of this route is not without some hazards.” To reduce the risk of these hazards, manufacturer labeling recommends to: give the drug in concentrations no greater than 25 mg/mL; administer the drug at a rate no greater than 25 mg/minute; inject the drug through the tubing of an infusion set that is running and known to be functioning satisfactorily and to stop the injection immediately if the patient reports burning to evaluate possible arterial placement or perivascular extravasation.

Here is how one can use IV promethazine.

·         Since 25 mg/mL is the highest concentration of promethazine that can be given IV, stock only this concentration (not the 50 mg/mL concentration).

·         Consider 6.25 to 12.5 mg of promethazine as the starting IV dose, especially for elderly patients.

·         Dilute the drug in 10 to 20 mL of normal saline if it will be administered via a running IV, or prepare the medication in mini bags containing normal saline. Extravasation can also be recognized more quickly when promethazine is diluted than if the drug is given in a smaller volume.

·         Give the medication only through a large-bore vein (preferably via a central venous access site, but absolutely no hand or wrist veins). Check patency of the access site before administration. Note: according to the package insert, aspiration of dark blood does not preclude intra-arterial placement of the needle because blood can become discolored upon contact with promethazine. Use of syringes with rigid plungers or small bore needles might obscure typical arterial backflow if this is relied upon alone.

·         Administer IV promethazine through a running IV line at the port furthest from the patient’s vein. 

·         Administer IV promethazine over 10-15 minutes.

·         Before administration of the drug, tell the patient to let you know immediately if burning or pain occurs during or after the injection.

·         Take consent

·         Build an alert that the drug is a vesicant and should be diluted and administered slowly through a running IV. 

·         Consider safer alternatives like ondansetron

There have been some published cases of intra-arterial injection of promethazine.

·         Necrosis caused by intra-arterial injection of promethazine: case report: Promethazine injections have led to necrosis and gangrene of the distal upper extremity when inadvertently injected into an artery. There have been few case reports of this alarming complication in the literature. We report on 2 cases of intra-arterial promethazine injection that led to amputation (Foret AL, et al. J Hand Surg Am. 2009 May-Jun;34(5):919-23).

·         Accidental intra-arterial injection of promethazine HCI during general anesthesia: Report of a case (Mostafavi H. Anesthesiology.1971;35:645).

·         Accidental intra-arterial injection: A case report, new treatment modalities, and a review of the literature (Keene JR, et al. J Oral Maxillofac Surg. 2006;64(6):965-8).

·         An unusual adverse event with the use of intravenous bolus of promethazine (Phenergan): The earlier used sedatives like promethazine, pethidine and pentazocine (Fortwin) are not commonly used these days but at times they are used especially in periphery for postoperative sedation and in gynecological surgeries and wards. We hereby report an unusual adverse event associated with the use of intravenous bolus of promethazine. With this case report we want to highlight that if promethazine is to be used for any purpose it should be given preferably intramuscular and if given intravenously, should be diluted and given slowly in a good running cannula. (However, patient inspite of receiving 20mg pethidine was anxious. For that 12.5mg of promethazine was given as slow IV push. Same dose of promethazine is repeated after 1hr intraoperatively. Rest of the intraoperative period was uneventful. No other drug was injected after promethazine. In the postoperative period, a bluish discoloration was noted on the dorsum of the hand in which the cannula was secured. And on touch the dorsum of the hand was cold). (Singh A, et al. Int J Res Med Sci. 2018 Jan;6(1):347-348).

The outcome of this judgement of the Delhi High Court could well be denial of injections in clinics. Doctors would stop administering injections in their clinics or nursing homes. 


Dr KK Aggarwal
Padma Shri Awardee
Vice President CMAAO
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA



Saturday, August 25, 2018

Think before you prescribe Combination of ACEI/ARBs + diuretic + NSAID may be nephrotoxic




Triple therapy with NSAIDs, diuretics and an ACEI/ARB is associated with increased risk of acute kidney injury.  In the retrospective cohort study of almost 500000 patients published in BMJ. 2013 Jan 8;346:e8525, the overall risk increased by 31% with the simultaneous use of these three drugs. The use of a double therapy combination containing either a diuretic or ACEI or ARB with NSAIDs was not associated with an increased rate of acute kidney injury.

Since the observed risk was greatest at the start of treatment “first 30 days of use”, caution is warranted, especially during the initial few months of therapy. Monitor BP and serum creatinine when more than two anti-hypertensive drugs are used in combination with NSAIDs.


Dr KK Aggarwal
Padma Shri Awardee
Vice President CMAAO
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA


Friday, August 24, 2018

In a resource-limited state, rights of the state overpower the rights of the individual



The Supreme Court has ruled that the larger public interest of health and medical care would prevail over the right to voluntary retirement by the doctors as medical services are part and parcel of right to life itself.

Right to retire as a fundamental right can't be supreme then the right to life, said the bench of Justice Arun Mishra and Justice S. Abdul Nazeer in their judgment pronounced on Tuesday. When services are required, denial of voluntary retirement is permissible.

Right to life is enshrined in the Article 21 of the Constitution of India, which guarantees protection of life and personal liberty to every citizen and states as follows: “No person shall be deprived of his life or personal liberty except according to procedure established by law”.

The scope of interpretation of right to life and personal liberty is very wide. In various judgements of the Supreme Court, Article 21 has been expanded to also include right to life with dignity, which is derived from the directive principles of state policy and therefore includes protection of health.

In the matter of State Of Punjab & Ors vs Ram Lubhaya Bagga Etc. Etc on 26 February, 1998, the Supreme Court held: “This Court has time and again emphasised to the Government and other authorities for focussing and giving priority and other authorities for focussing and giving priority to the health of its, citizen, which not only makes one's life meaningful, improves one's efficiency, but in turn gives optimum output. Further to secure protection of one's life is one of the foremost obligation of the State, it is not merely a right enshrined under Article 21 but an obligation cast on the State to provide this both under Article 21 and under Article 47 of the Constitution.”

“When we speak about a right, it corelates to a duty upon another, individual, employer, government or authority. In other words, the right of one is an obligation of another. Hence the right of a citizen to live under Article 21 casts obligation on the State. This obligation is further reinforced under Article 47, it is for the State to secure health to its citizen as its primary duty… Since it is one of the most sacrosanct and a valuable rights of a citizen and equally sacrosanct sacred obligation of the State, every citizen of this welfare State looks towards the State for it to perform its this obligation with top priority including by way allocation of sufficient funds.”

In Mohd. Ahmed (Minor) vs Union Of India & Ors. on 17 April, 2014, the Delhi High Court ruled that “… By virtue of Article 21 of the Constitution, the State is under a legal obligation to ensure access to life saving drugs to patients. A reasonable and equitable access to life saving medicines is critical to promoting and protecting the right to health. This means that Government must at the bare minimum ensure that individuals have access to essential medicines even for rare diseases like enzyme replacement for Gaucher disease. Availability of a very expensive drug virtually makes it inaccessible (68).

Government cannot cite financial crunch as a reason not to fulfil its obligation to ensure access of medicines or to adopt a plan of action to treat rare diseases. In the opinion of this Court, no government can wriggle out of its core obligation of ensuring the right of access to health facilities for vulnerable and marginalized section of society, like the petitioner by stating that it cannot afford to provide treatment for rare and chronic diseases (69).

Therefore, given the importance of preservation of human life, it is the duty of the state to protect the right to life of every citizen as a fundamental right.

The right to retire has to be "interpreted with the rights of the State government... As it is obligatory upon the state government to make an endeavour under Article 47 (of the Constitution) to look after the provisions for the health and nutrition of the people," said Justice Mishra.  Article 47 of the Constitution says that it is the duty of the State to raise the level of nutrition and the standard of living and to improve public health.

Referring to Article 51A, the court said that it is the fundamental duty of every citizen to have compassion and humanism for living creatures and it can't be done by depriving the poorest of the poor essential medical services and to leave them at the mercy of the doctors, the judgement said. 

The court said this while reversing the November 11, 2017 judgement of the Allahabad High Court by which it had allowed the plea for voluntary retirement by the doctors and directed that they may be treated as from government service from November 30, 2017 and December 31, 2017.

The issue before the top court was whether under Rule 56 of the Uttar Pradesh Fundamental Rules, an employee has an "unfettered right to seek voluntary retirement by serving a three-month notice to the State government.

Our ancient Vedas have described four stages of life, called Ashrams; Brahmacharya ashram, Grihastha ashram, Vanaprastha ashram and Sanyasa ashram. Each stage has its own defined duties or dharma.

Brahmcharya is the period of learning, which helps oneself to prepare for the three stages of life to come, while Grahastha asthram is for working to earn ethically.

A person in the vanprashtha stage of life has relinquished his duties to the next generation and now takes on the role of an advisor. A person in the sanyas ashram is a philosopher. He/she is detached from material life and is dedicated to the welfare for all.

A doctor who seeks voluntary retirement has earned name and money for himself. And by the time he/she reaches the role of an advisor, where the community can gain from their knowledge gained over the years, they choose to opt out by way of voluntary retirement. There may come a time, when the govt. might have no advisors or researchers.

In a resource-limited state, therefore the rights of the state overpower the rights of the individual

Dr KK Aggarwal
Padma Shri Awardee
Vice President CMAAO
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA