Genesis of medical accidents

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Patient safety is of prime concern in day-to-day practice. But despite, all precautions, medical accidents do occur. Medical accident is an unforeseen or an unintended occurrence.

Most medical accidents are preventable. Hence, it is important for us to analyse why medical accidents occur.

Several factors contribute to medical accidents. Fatigue, sleep deprivation, poor communication, inadequate preoperative planning are some common reasons for medical accidents.

Distraction is another very important factor in medical accidents. Smart phones are a major source of distraction for the operating team in the OTs including the anesthetists or in critical care areas. Doctors may talk and attend to their mobile phones during a surgery and may communicate through a nurse or a junior who works as a bridge between the surgeon and the caller or may check or send e-mails or text messages. Mobile phone distractions adversely affect the performance of the entire team with greater likelihood of accidents that otherwise would not occur. E.g. an accidental injury to the intestine during an appendicectomy. Hands-free phone can be as distracting as talking on a hand-held mobile phone.

The role of the navigator or the person who sits in the front passenger seat of a car can be an apt analogy here. It is a rule that he or she should not sleep or talk on the phone but stay alert. Besides navigation, he has to stay awake with the driver, especially on long drives, and also help the driver stay awake. Majority of car accidents are caused by human errors and are a result of distracted driving.

It is important to concentrate on the task at hand and not let distractions take away the focus and cloud one’s judgement.

Dr KK Aggarwal
National President IMA & HCFI

Recipient of Padma Shri, Dr BC Roy National Award, Vishwa Hindi Samman, National Science Communication Award & FICCI Health Care Personality of the Year Award
Vice President Confederation of Medical Associations of Asia and Oceania (CMAAO)
Past Honorary Secretary General IMA
Past Senior National Vice President IMA
President Heart Care Foundation of India
Gold Medallist Nagpur University
Limca Book of Record Holder in CPR 10
Honorary Professor of Bioethics SRM Medical College Hospital & Research Centre
Sr. Consultant Medicine & Cardiology, Dean Board of Medical Education, Moolchand
Editor in Chief IJCP Group of Publications & eMedinewS
Member Ethics Committee Medical Council of India (2013-14)
Chairman Ethics Committee Delhi Medical Council (2009-15)
Elected Member Delhi Medical Council (2004-2009)
Chairman IMSA Delhi Chapter (March 10- March 13)
Director IMA AKN Sinha Institute (08-09)
Finance Secretary IMA (07-08)
Chairman IMAAMS (06-07)
President Delhi Medical Association (05-06)

Cellulose-based capsules to replace gelatin capsules

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Capsules are a very widely used dosage form. They are easy to administer, mask the odor and taste of drugs, which may be unpleasant to some patients. Due to rapid disintegration, the drug is rapidly released in the stomach. Hence, they are a necessary form of drug. However, one aspect that is of concern is their storage. Capsules should be stored in airtight containers and in a cool and dry place to avoid degradation. They need to be protected from light and moisture.

Gelatin has been commonly used to manufacture capsules, which is derived from animal sources, including bones.

But now, the Govt has recommended a proposal to replace gelatin capsules with vegetable capsules. The sources of these vegetable capsules are plant in origin.

In March this year, an Expert Committee was constituted to address all technical issues pertaining to the replacement of gelatin (non-vegetable) capsules with cellulose-based capsules. According to notice from the Directorate General of Health Services (DGHS) office dated June 2, 2017, the proposal is open to suggestions/comments within 21 days.

The Bureau of Indian Standards (BIS) has formulated Draft Indian Standards for cellulose based vegetable capsule shells. Hydroxypropyl methyl cellulose (HPMC), most commonly known as hypromellose, is used in the manufacturing of the cellulose-based capsule shell.

India is a land of diverse religious and cultural beliefs and traditions. A vegetable alternative should be available. On account of religious and cultural sentiments, patients may prefer the cellulose-based capsules over gelatin capsules. Additionally, personal preferences may influence the choice of the vegetable capsules. We have to respect these choices. Patients should be conveyed that the capsule is non-vegetable.

In addition their safety and stability, the most important concern to be addressed is affordability to the patient. If the cost comes out to be the same as gelatin capsules, then the gelatin capsules can be replaced with cellulose-based capsules. But, if these capsules would cost more than the gelatin capsules, then both the options should be made available, leaving it to the patient to choose his preference.

Another issue that comes up is the manufacturing capacity. More than a billion capsules are manufactured in India every year. Do we have the production capacity to match and then meet the growing demands?

How do we differentiate the vegetable capsules from gelatin capsules? Will they be identified by the green and maroon circles in a square as used on food items? A maroon dot indicates the presence of non-vegetarian ingredients, while a green dot identifies vegetarian food. In May last year, the Drugs Technical Advisory Board (DTAB) had rejected the proposal to label the cellulose-based capsule with green dot to indicate its vegetarian origin to differentiate them from the normally available gelatin-based capsules stating that “unlike food, drugs are not taken by choice but are prescribed by the doctors to save lives and marking them vegetarian or non-vegetarian origin is not desirable”.

DCGI is the regulatory authority, which provides the standards and quality of manufacturing, selling, import and distribution of drugs in India. Any drug approved by the Drugs Controller General of India (DCGI) is safe and a quality drug. But, there are issues that need to be addressed. 

Dr KK Aggarwal
National President IMA & HCFI

Rotavirus, one of the leading causes of diarrheal infections in India

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• Accounts for about 40% of all diarrhea cases
• Rotavac introduced to combat the spread of this infection among infants and young children
New Delhi, 21 June 2017: Statistics indicate that one of the leading causes of moderate-to-severe diarrhea in India is Rotavirus and accounts for about 40% of all diarrhea cases requiring treatment. More children across India die due to diarrhea than AIDS, malaria, and measles combined. It has also been estimated that India alone contributes to 22% of all global diarrheal deaths in children below 5 years. Among those more vulnerable include malnourished children and those with poor access to medical care.

Between 80,000 to 1,00,000 children die in India annually due to Rotavirus diarrhea and another 9 lakh are admitted to the hospital with severe diarrhea. A highly contagious disease, Rotavirus is spread when a child comes in contact with infected water, food, or hands. This is known as the fecal-oral route. This virus can survive for long periods of time on hands and various surfaces. This condition also increases the risk of dehydration in very young children.

Speaking about this, Padma Shri Awardee Dr K K Aggarwal, National President Indian Medical Association (IMA) and President Heart Care Foundation of India (HCFI) and Dr RN Tandon – Honorary Secretary General IMA in a joint statement, said, “Rotavirus attacks the villus tip cells of the small intestine, obstructing digestion and absorption. Once the villi become blunted, the malabsorption of carbohydrates leads to diarrhea. In young infants and children, this infection can further cause severe diarrhea, dehydration, electrolyte imbalance, and metabolic acidosis. The virus is shed in high concentration in the stool of the infected children. They can easily catch an infection by touching something that is contaminated and then putting their hands in the mouth. The risk of infection is more in hospitals and day care settings.”

Last year, the health ministry launched India’s first, indigenous rotavirus vaccine called Rotavac. Developed indigenously under a public-private partnership between the Ministry of Science Technology and the Health Ministry, this vaccine is expected to significantly reduce hospitalization and other conditions associated with diarrhea due to Rotavirus infection.

Adding further, Dr Aggarwal, said, “Making this vaccine free of cost is indeed a great move by the government. It is immensely important for the health and well-being of children in the country. Apart from vaccination, it is important to create awareness on maintaining adequate hygiene and sanitation and also ensure access to clean drinking water to avoid any such infections from spreading.”

Here are some tips to prevent Rotavirus infection from spreading.
• Maintain proper hygiene around the house. Clean all surfaces and the floor thoroughly.
• Wash your hands after you change the infant’s diaper or use the washroom.
• Practice food safety at home.
• Drink clean water and keep all containers closed.

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