76 lakh compensation in case of blindness in a preterm baby 15; should associations become a party in such cases?

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Family receives compensation of INR 76 Lakh, after 15 years. The case was treated at Maharaja Agrasen Hospital wherein a pre-term baby turned completely blind.

A bench of Justices U. U. Lalit and Indu Malhotra held the hospital, its paediatrician and ophthalmologist guilty of medical negligence as they failed to carry out the mandatory retinopathy of prematurity (ROP) check on the pre-term baby, which led to his total blindness. The court also slammed the hospital for not sharing the medical records of the child, born in 2005, with his parents for over two years after discharge to enable them to approach other doctors for treatment.

The baby was brought to the hospital for medical examination from time to time for more than three months, but the doctors never undertook the test.

The bench awarded a compensation of INR 76 lakh out of which INR 60 lakh was allocated for the child’s education, welfare and sustenance. INR 15 lakh was allocated to the mother as his caregiver and INR 1 lakh towards litigation cost. The court upheld the National Consumer Commission’s order that it was a case of medical negligence.

Retinopathy of Prematurity

  1. Retinopathy of prematurity is a developmental vascular proliferative disorder that occurs in the retina of preterm infants with incomplete retinal vascularization.
  2. It is an important cause of severe visual impairment in childhood.
  3. Other ophthalmologic disorders that occur frequently in preterm infants include amblyopia, strabismus, and refractive errors.
  4. Guidelines suggest screening allinfants with birth weight (BW) ≤1500 g or gestational age (GA) ≤30 weeks
  5. One should also screen those with BW between 1500 g and 2000 g or GA >30 weeks whose clinical course places them at increased risk for ROP (as determined by the neonatologist).
  6. Canadian Paediatric Society have suggested screening for infants with birth weight ≤1250 g and infants with GA <31 weeks regardless of BW
  7. Screening for ROP is a labour-intensive process with a relatively low yield; <10 percent of infants who are screened require treatment
  8. The optimal criteria for screening remain uncertain.
  9. Research has focused on developing prediction models to identify high-risk infants with the hope of reducing the number of infants requiring ophthalmologic examinations. However, these methods require additional validation in broad populations before changes to the screening recommendations can be made.
  10. The screening evaluation consists of a comprehensive eye examination performed by an ophthalmologist with expertise in neonatal disorders
  11. The pupil must be dilated in order to visualize the vitreous and retina.
  12. The protocol is to use a combination eyedrop (Cyclomydril, which contains weak concentrations of phenylephrineand cyclopentolate) 30 minutes or more before the examination. Both manipulation of the eye and the cycloplegic eyedrops can produce adverse cardiorespiratory and gastrointestinal effects (e.g., bradycardia, arrhythmia, apnoea, desaturation, emesis)Therefore, it is essential to carefully monitor the infant during and after the examination procedure. Topical anaesthetic can be used based on the preference of the examining clinician
  13. The retina is examined by looking through the pupil with an indirect ophthalmoscope with a 20 or 28 diopter condensing lens while the eyelids are retracted with a speculum. ROP is most commonly visualized in the peripheral retina, which often is obscured by the iris. In order to completely view this area, a scleral depressor is used to indent the eye externally.
  14. Alternatively, telemedicine systems can be used to identify infants with potentially severe ROP.
  15. Start screening examinations at 30 weeks postmenstrual age (PMA) for infants born at 22 to 26 weeks and at 4 weeks of chronologic age for infants born at ≥27 weeks. Treatable ROP rarely occurs before 31 weeks PMA, most initiate screening at 30 weeks PMA to account for the possibility of errors in dating, examination delays due to medical status, and to permit flexibility in scheduling.
  16. Additional examinations are performed at intervals of one to three weeks until the retinal vessels have completely grown out to the ora serrata (periphery of the retina). If ROP develops, the eyes are examined more frequently, depending upon the severity of disease and rate of progression.

The Indian Retinopathy of Prematurity (IROP) Society

Established in July 2016. The menace of retinopathy of prematurity blindness had reached alarming proportions in the nation. The number of pre-terms born have crossed 3.5 million annually.

Improved neonatal survival, over 700 special neonatal care units (SNCUs), a very low prevalence of ROP screening programs and only a handful of ROP specialists are some of the problems.

With over 20,000 ophthalmologist members of the All India Ophthalmological Society, nearly 2000 are Vitreo-Retinal Society of India members. So less than 1% of ophthalmologists in the country are involved directly in ROP care.

Conclusions: India Ophthalmological Society should have been the party in this case or 10% of all 3.5 million cases of premature deliveries will file cases in courts for compensations as 2000 vitreo- retinal specialist cannot take care of this large number.

After ROP it can be a case of missing all congenital heart diseases in the hospital that amounts to 1% of all births.

Dr KK Aggarwal

Padma Shri Awardee

President 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

Top 11 medical updates in 2019

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  1. A WHO report has shown that the confirmed cases of measles have increased from 716 in 2018 to 2719 in the first 11 months of 2019 in Turkey. Out of the 2,719 confirmed cases some 1,800 were children under five years of age, with over 900 unvaccinated children.
  2. There is a growing tension between two approaches in medical research: the effort of finding treatments that are consistently effective in large populations versus the notion of “precision medicine, which favours therapy that we closely tailor to an individuals very personal needs.
  3. In March this year, experts affiliated with the European Resuscitation Council by analyzing the data of more than 60,000 people, saw that nifedipine, appeared to increase the risk of sudden cardiac arrest.
  4. A study, appearing in JAMA Internal Medicine in June, found that anti-cholinergic drugs may increase a persons risk of developing dementia. The research from the University of Nottingham in the United Kingdom looked at the data of 58,769 people with and 225,574 people without dementia.
  5. In August, the FDA issued a warning against an allegedly therapeutic product available online sold under the names Master Mineral Solution, Miracle Mineral Supplement, Chlorine Dioxide Protocol, or Water Purification Solution that contained no less than 28% sodium chlorite, an industrial bleach.
  6. A study in the New England Journal of Medicine in July, which involved around 1.3 million people, suggested that, when it comes to predicting the state of a persons heart health, both blood pressure numbers are equally important. The study found that older individuals with lower systolic blood pressures actually faced a 40% higher risk of death than peers with elevated blood pressure values.
  7. Research in the Journal of the American Heart Association in August showed that people who adhered to plant-based diets had a 32% lower risk of death (also 25% lower risk of all-cause mortality).
  8. A study from April in the journal Nutrients warned that people who follow a ketogenic diet may experience blood vessel damage.
  9. According to Google Trends, some of the top searches in the United States this year included intermittent fasting diets, the Noom diet, and the 1,200 calorie diet.
  10. An intriguing study in Nature Metabolism in May, pointed that muscle building protein shakes, contain mostly whey proteins, which have high levels of the essential amino acids leucine, valine, and isoleucine. In mice  a high intake of these amino acids led to overtly low levels of serotonin in the brain.  It also led to obesity and a shorter life span.
  11. A WHO study appearing in the Lancet in January took into account the findings of 185 observational studies and 58 clinical trials, covering almost 40 years, concluded that to lower their death risk, as well as the incidence of coronary heart disease, stroke, type 2 diabetes, and colon cancer, a person should ideally consume 25–29 grams of fiber per day.

Intradermal Vaccination for CMAAO Countries

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Most vaccines are delivered by the intramuscular or subcutaneous routes.  The intradermal route is only used for the administration of BCG and rabies vaccines.

There is now a renewed interest in intradermal vaccine delivery because the dermis and epidermis of human skin are rich in antigen-presenting cells, suggesting that delivery of vaccines to these layers, rather than to muscle or subcutaneous tissue, should be more efficient and induce protective immune responses with smaller amounts of vaccine antigen.

The recent PATH and WHO report reviewed more than 90 clinical trials of intradermal delivery with vaccines against 11 diseases.

For influenza and rabies vaccines, intradermal delivery of reduced doses resulted in equivalent immune responses to the standard dose delivered by the standard route. Data from trials with hepatitis B vaccine were encouraging and promising data was obtained with inactivated poliovirus, yellow fever and hepatitis A vaccines.

Take home messages

  1. Live-attenuated vaccines have been successfully delivered intradermally and should be good candidates for intradermal delivery.
  2. Reduced doses of inactivated whole-virion vaccines, such as rabies and inactivated poliovirus vaccines, have shown satisfactory immunogenicity when delivered intradermally.
  3. Inactivated whole-virion influenza vaccine is suitable as it has intrinsic immune-stimulating sequences, which might avoid the need for additional adjuvants.
  4. There are no published clinical data regarding intradermal delivery of polysaccharide conjugate vaccines, which include meningococcal and pneumococcal conjugate vaccines.
  5. Vaccines that contain aluminum-based or oil-in-water adjuvants are likely to have unacceptable local reactogenicity following intradermal administration.
  6. A trial compared the currently recommended regimen of 20 micrograms of hepatitis B surface antigen (HBsAg) intramuscularly on days 0, 30, and 180, with a more economical regimen of 2 micrograms of HBsAg intradermally on days 0, 30, and 180. This trial was performed in 50 seronegative health care workers. There was no significant difference in seroconversion between the intradermal group (96%) and the intramuscular group (100%). Data demonstrate that 0.1 mL of inactivated hepatitis B virus vaccine (Heptavax-B) intradermally is immunogenic in healthy adults. (JAMA)

Dr KK Aggarwal

Padma Shri Awardee

President 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

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