Who can give consent?

Health Care No Comments

Dr KK Aggarwal

Informed consent is an integral and crucial part of medical treatment today. It is not only a procedural requirement, but also a legal requirement. Not taking consent is gross negligence. Consent has to be taken before starting a treatment or a procedure.

For consent to be valid, it should be voluntary i.e. given without coercion, informed and the patient should be competent to understand the information given.

Consent indicates a respect for patient autonomy, a very important principle of medical ethics. This means that patients have the decision making capacity and doctors need to respect their right to make decision regarding their care. And, no doctor treats a patient without informed consent.

Who can give the consent?

Informed consent must ideally be taken from the patient himself/herself.

In a traditional Indian setting, if the husband is hospitalized, the wife, at times, may not be taken into confidence by the relatives about the gravity of the situation or otherwise. Most often, it is one of the family members who usually sign the consent in such cases.

If the patient is unconscious, then the spouse should authorize one person as a legal heir to take legal decisions, in case the spouse does not want to take decisions or is not informed.

In an emergency situation when the patient is not able to give consent, then treatment may be given without consent, if there is no other person available to give consent. But, the onus lies on the doctor to prove that the treatment given was lifesaving. The facts of the case must be documented.

The Medical Council of India (regulation 7.16) states that “Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of minor, or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed”.

The MCI should revisit the regulation 7.16 and come out with a clause of “next of kin” consent or “surrogacy” consent, which should also include “all legal heirs” and not just one as part of the consent.

Disclaimer: The views expressed in this write up are entirely my own

Affordability or quality of service? Choose both

Health Care No Comments

Every citizen in the country has a right to receive safe and quality medical treatment. Achieving universal health coverage is a target (3.8) under the Sustainable Development Goal (SDG 3). All member states of the UN including India have committed to try to provide universal health coverage to all their citizens by the year 2030. Universal health coverage means good quality health care that is Available, Accessible, Affordable and Accountable.

The Institute of Medicine, USA (IOM, 1990) has defined quality in health care as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge”. The American Medical Association (AMA, 1991) has defined quality as “the degree to which care services influence the probability of optimal patient outcome”.

When a patient seeks health care, he/she looks for availability, quality and affordability. Safety, desired outcome of treatment and respect are becoming more and more important to the patients today.

It’s not just clinical care based on best practices alone that decides quality of care. Several other factors also constitute patients’ perception of quality of care such as cleanliness, reliability, responsiveness, communication, empathy, patient-centered with patient as an equal partner is decision making.

But, quality always comes at a price. Quality treatment is costlier but in the long-term, it is economical as it is associated with fewer hospital-acquired infections, complications, adverse drug reactions, re-hospitalization, as well as fewer system failures.

Quality is always preferred but it may not always be feasible because quality care may increase the cost of treatment.

So, should we focus on affordability or should we focus on quality?

Every hospital or health care establishment must try to improve and maximize quality within the resources that are available to them and with the best use of those resources. Poor quality service indicates poor utilization of resources.

Both quality and affordability need to be balanced, especially in a country like ours, which has one of the highest out of expenditures on health in the world.

Disclaimer: The views expressed in this write up are entirely my own

Govt. move to fix ceiling prices of knee implants: The need of the hour

Health Care No Comments

Dr KK Aggarwal

Early this week, the National Pharmaceutical Pricing Authority (NPPA) fixed and notified the ceiling prices (inclusive of trade margins) of orthopedic implants used in knee surgeries, both primary knee replacement surgery as well as revision surgery, under para 19 of Drugs (prices control) order (DPCO 2013) with immediate effect.

In 2005, orthopaedic implants were notified as ‘drugs’ by the Ministry of Health and Family Welfare vide its S.O. 1468 dated 6th October 2005. Consequent to this, Drug (Prices Control) Order
(DPCO) 2013 became applicable to these implants, which also came under the purview of the NPPA, which is mandated to monitor the prices of all notified drugs including notified devices.

An estimated 1.5 to 2 crores patients require arthroplasty; however, out of these which only about 1 lakh plus well off patients are in a position to pay for it every year because of the very high cost of orthopedic implants (NPPA Notification, August 16, 2017).

As per WHO estimates, osteoarthritis will be the fourth leading cause of disability by the year 2020.

The ceiling price of different materials and components used in the implant in primary knee replacement system has been fixed between Rs. 4,090/- to Rs 38,740/-. Similarly, the ceiling price of different materials and components used in the implant in revision knee replacement system has been fixed between Rs. 4,090/- to Rs 62,770/-.

As per the notification, “All manufacturers/marketers of knee implants having MRP lower than the ceiling price specified plus goods and services tax as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013”.

The earlier average MRP of cobalt chromium, the most commonly used knee implant has reduced by an average of 65%. The MRP has been capped at Rs. 54,720/- now Wfrom the earlier 1,58,324/-Knee implants made up of special metals like titanium and oxidised Zirconium has been capped at Rs 76,600/- with price reduction by 69%. The price of high flexibility implants have been capped at Rs. 56,490/-, again with a price reduction by 69% (Press Information Bureau, August 16, 2017).

All hospitals/nursing homes/clinics performing orthopedic surgical procedures using knee implants are now required to comply with the ceiling prices notified. The patients cannot be charged any additional charge over and above the ceiling price notified “except applicable goods and services tax, if any, paid or payable”.

The Indian Medical Association (IMA) welcomes this move of the govt. to fix the ceiling price of knee implants as now these implants have become more affordable and within reach of the common people. Many more patients will now be able to undergo the procedure, which earlier they could not because of the very high costs of the implants.

Earlier this year, the Govt. had fixed the ceiling prices of coronary stents, which also came as a relief to the general public.

Disclaimer: The views expressed in this write up are entirely my own.

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