Medical Regulation:Is it time to regulate medical business/ administrators of healthcare? “Oxygen cut, 30 children die in Gorakhpur hospital” who is responsible?


The inconsolable   catastrophic calamity in Gorakhpur Hospital is a mishap, which should be  preventable by good medical governance.   This is a real life example of negligence by poorly managed system, which has resulted in loss of multiple lives. Poor competence of administrators is more damaging, less containable, more damaging institutionally than smaller unintentional human errors by doctors. More than sadness, it is a painful surprise that such things can happen in present era of mammoth advancements! Until now, discussion on every such incidence stopped with blame on doctors in the end. No body will even try to look beyond doctor’s faults as it is easier to find some mistake or the other by retrospective analysis in doctor’s work or documents. That helps in cover up of system faults. Since ultimately it is only the doctor who is visible with the patient, doctor has to bear onus of each medical or non medical problems of health system. In routine circumstances, after the unanticipated death, one or two doctors  are made scapegoat, thrashed or harassed, unless proved innocent few years on, that also if they are lucky enough to have impartial investigation. Doctors carry the burden of universal expectations, thanklessness, threats and vandalism for bad outcomes, even in absence of proper health facilities. That is how, rest of medical industry, administrator  and non doctors associated with the health care,  mainly responsible for the problems,  enjoy   strange kind of immunity. But since now problems are overflowing  and big enough to unmask the real hidden people responsible for poor health care system in case an impartial inquiry is done.  Is it time to regulate all people including non doctors and medical businesses who are associated with health sector, in the manner doctors are regulated?

Oxygen cut, 30 children die in Gorakhpur hospital. Criminal negligence, row over unpaid bills hit encephalitis, neonatal wards.( Hindustan times)

 

Foremost admission is that we do not have a proper foolproof health care system. Strangely, the perpetual inadequacy of state healthcare infrastructure is never questioned.  Problems of electricity, oxygen, quality of drugs, medicine, quality of consumables, heath insurance implants and stents have very important role to play in treatment of the patient and cost associated with it. Doctors need essential items and can not work without  drugs and equipment , which are supplied by industry and procured by administrators.  Marketing, sales, pricing, insurance, quality  and all business deals  of these items are  beyond doctors preview. Therefore the  actual number of  non doctors  involved in health sector are beyond any imagination and these people  are not regulated in any manner. Ultimate blame is wrapped up by incriminating whole community of doctors, resulting  in misguided  conclusions. All these complex issues ends up with society inflicting a mode of self harm by mistrusting their savior.  In fact, there has been an article feeling a need for regulation of NHS managers, in a way same as doctors.

NHS Managers should face same regulation as doctors, says Francis

https://doi.org/10.1136/bmj.j2055 ( 25 April 2017)

Possibly it is time to unmask   and unveil the whole mammoth industry and regulate each and every person associated with health, in a manner same as doctors.  Role of non doctors , touts, different streams of medicine, administrators,  sales and marketing , medical  finance,  electricity, oxygen, cost and  quality medicine, drugs, consumables, implants and stents has very important   role to play and doctors should not be   burdened  with criticism for  all the mess created by all other people. Good health care system should be designed to prevent tragedies. Strict action after the event is just finding scapegoats.

Future medicine is beyond human limits: robots as doctor, till then human docs with robot like activity:


 

         The adage “To err is human” probably does not apply to the doctors. Doctors are definitely regarded different from rest of the humans and are not supposed to have privileges that other persons of humankind are guaranteed. Hence they are harassed often for any adverse clinical outcome even though it may be because of poor prognosis of patient. They work under continuous fear and stress and are punished for each small or big error. Then what are they? Modern slaves or human docs with robot like activity?

With advances in medical science, simultaneously there has been aberrant evolution of medical profession, education, regulation and medical industry. By provoking controversy about doctors for varied reasons, medical industry and law has intruded between the doctor patient relationship to take a centrestage in health care. Till now, doctor patient interaction was the central point of the health industry, a core around which medical industry revolved. Except this interaction, rest almost everything is controlled by industry.  If this interaction too is replaced by robotic machines, the control of medical industry over business of health will be almost complete. With the evolution of robotic technology and artificial intelligence, the dream of industry to have full control over health care business has become a realistic possibility.  There have been technical advancements to promote better treatment and diagnosis but these, at the same time, increase the cost of treatment and involvement and hence dependence on investors and industry. Complexity of medical science, industry, legalities and medical regulation has been multiplying everyday beyond human limits for doctors, at least in some specialties. Long years of training, Dealing and working with all complexities of medical system, all time retrospective analysis of their work by patients and lawyers, complex documentations, social media mudslinging, extensive and complex communication, technical advancements and legal interactions has taken a toll on the doctors and they are gradually ceasing to be normal human beings. They are slowly being converted to humans with robot like activity.

Also there is a thought whether doctors can be replaced by robots, completely or partly. Such talk of having machines is not without basis as all the stakeholders are feeling the need for a drastic change to have better and better medical care .

 

Future of medical profession: Robots as doctor:

  1. Usually doctors have to carry huge burden of expectation of society and patient. People want quick and effective treatment, without human faults, with an up-to-date medical knowledge delivered within moments. Unrealistic expectations are getting beyond human limits and these can be fulfilled only by robots.
  2. Since well trained doctors are lesser in number, they are expected to deliver a curative treatment with excellent accuracy with perfect documentation even when load of patients is extraordinarily high.
  3. Even in presence of extraordinary work load and difficult circumstances, doctor are supposed to maintain perfect documentation to save himself. Because later, any case can be subjected to legal scrutiny in future. Lawyers and courts will analyze retrospectively for years, with wisdom of hindsight and luxury of time, to find the faults and may punish the savior.
  4. Nobody wants to die. Even somebody with severe disease, with poor prognosis, have tendency to blame doctors for his illness, if he has contacted    Such incidences occurring too frequently cause feeling of hurt to doctors. Verbal and physical assaults is a routine. Robots will be immune to such painful thoughts and will not be affected mentally and continue to work perfectly in such circumstances.
  1. Training to be a Doctors are expensive and takes years. It takes painful long years and time. Human life span is limited. Therefore training a doctor and paying him life long, a bad business idea for industry and society. That is reason of unwillingness to pay even the rightful to the doctors. Robots will be a onetime investment. Life is one and span is less. Studies and gaining experience takes away good part of doctor’s life.  People from strong financial backgrounds avoid becoming doctors. Although they may opt for becoming health managers or investors.
  1. Human limitations, like tiredness, mood variation, feeling hurt, family issues, failure to apologize always in all situations (especially if doctor is not at fault), diagnostic  bias, limited knowledge   are various human factors with doctors, which are undesirable  for being a doctor and can be rectified easily with Robots.
  1. Available medical information is like a sea, that cannot be held in a hand. However brilliant doctor may be, he will know fraction of available knowledge. The moment we pass our exams, we start becoming out of date.
  2. Human bias always plays a role, because medical science is far from complete. Moreover rapid change in technology makes all knowledge and experience of a doctor redundant. Robots can be easily updated.

 Present medicine: human docs with Robot like activity:

As humans, doctors can make errors, get demoralized or dragged to courts or subjected to verbal or physical abuse, their mood and enthusiasm may be spoiled and may make more errors in other patients as well.  But they have to continue to perform as due to nature of their work does not allow them to have time to cool their mind. Repeated incidents make doctors immune to such mudslinging. Their reaction to these insults and distressing situations becomes blunt and reactions are subdued like that of a Robot.  Doctors themselves are slowly being converted to Robots like creatures.

  • Doctors do not react to unjustified verbal assaults of a patient, same as machine do.
  • They do not get demoralized easily because of moral assassination by media, calling them thieves, thugs and dacoits, even doing most helpful job in the entire society, saving lives. Now there is no reaction from doctors, when an uncommon or single stray incidence of adverse kind is used to portray all doctors in same light. This unwavering sanity looks like as if there have no apperception to perception of such poignant thoughts, same as Robots.
  • Many of them tirelessly work day and night without rest and food, along with verbal and physical assaults, accomplish arduous tasks like a machine.
  • Medicine is very complex and far from complete, still the precision executed by this wonderful community is no less than great machine “robot”. They executing all theory, practical and experience, application with in a trice. There personal emotions get a machine like toughness. They look like tough ship in such tornado, like a tough machine with no human weakness.
  • There is many things going in a doctor’s life, on professional and personal front. For example, care of sick, difficult family communication, perfect documentation, complaints, ongoing, court cases, declaring deaths, data maintenance, treatment and prevention of infections, nosocomial infections, medico legal suits, iatrogenic complications or simply genuine poor prognostic patients, unforeseen complications, unnecessary mudslinging by media and social media along with newer advances to cope with. There can be personal and own family issues as well. For a simple human being, it is difficult to accomplish all this complexities   immaculately and at the same time, while handling the ongoing patient load.
  • Doctors continue to work unaffected by continuous retrospective analysis and afflictive comments from practically every side, patients, administration and courts. All of them acquire wisdom off hindsight and have luxury of time to make an analysis.

 

Present and Future of medical profession:

Robots will be immune from errors and mood swings, tiredness and human limitations, hurt feelings, (will apologize always even if it is not their fault). And therefore legalities in the profession will be minimized.  No breach of protocol is possible. No questions or room for mistrust. Robots can do duties all seven days a week and 365 days a year. Public, Governments and medical industry will be happy. With Artificial intelligence and rapid advancement in robotics, doctors will have very little role in medical industry. Best part is that, it will be a onetime investment.

 

          Minor disadvantage:  Only things Robots lack human touch and feelings and will not be going extra mile for patient as compared to human doctors. Robots will just complete protocols. But with time, these   qualities will not be required anymore. There will be no humans to blame for the suffering of diseased, or to vent anger at. No human scapegoat will be there for physical or legal revenge. But till the time human doctors are   completely replaced by machine robots, ordinary mortals have to fill in and they will be human Docs with robots like activity (HUDOROLA).

Happy doctors day:  merely a hollow slogan?


On 1st of July, doctors are usually greeted from multiple quarters. Newspapers, media and some prominent people  congratulate doctors in their speeches or on their social media pages. However, what doctors need are not just verbal wishes but reinforcement of public’s belief in them . It is this renewal of faith in their saviour which will help  doctors in discharging their duties smoothly and in alleviating their problems.

National Doctor’s Day: India, USA

Despite the paucity of the highly trained medical professionals, the identity of medical professionals as a community in society is not getting its due right  because of  misplaced priorities of  certain people. The society tries to impose a stereotype role on them in an effort to control them fully. And as a result of these various controls, regulations and public pressure, doctors experience unrealistic performance pressure on professional front.

     Doctor is the pivot  point between patients, medical industry, government and insurance sector. Huge number of patients, expensive medicines, poor medical infrastructure has produced tremendous resentment against medical system amongst public. But the brunt of this entire angst has to be borne by the doctor or medical professionals alone. Often they are blamed for circumstances beyond their control and punished for system failure. Fear of public wrath and lawsuits is smothering the medical profession.  And increasingly there is a feeling amongst medical professionals that they are getting a raw deal despite doing their very best.

     In such a situation, there should be some introspection by all stakeholders every year, on doctor’s day. The doctor’s day should be more than just greetings and wishes for doctors. Some real resolutions need to be  taken so that their working atmosphere and eventually delivery of medical care is improved and this ultimately will benefit patients only.  I can think of some much needed changes-

1.       Government should take some concrete decision to improve medical  infrastructure and manpower. A better planning needs to be done to spend more for health of people, availability of resources and for improving the working conditions for doctors. Government should ensure that doctors are better protected.

2.       Medical industry should collectively think of protecting doctors or there should be provision for some financialresponsibility of medical lawsuits of all doctors.  Pharmacy industry, medical device industry, insurance industry  and others earn huge profits because doctors need to use their products. Although medical industry makes huge profits still they remain behind the scene.

3.       Police should provide  assured protection to  doctors better against physical violence.

4.       Medical education institutes should resolve to promote the education of best doctors and not indulge in profiteering in education of doctors.

5.       Courts should take an initiative to protect doctors against frivolous lawsuits ( which are often done to prevent paying their bills), revengeful attitude of patients  and harassment?

6.       On doctor’s day, public should resolve that they will not unnecessarily fight or abuse the doctor.

7.       And last but most important is that all medical practioners , be it allopathic, ayurvedic, unani, homoeopathic or others who play a role in maintaining health of patients, affirm that they will do everything to protect dignity and integrity of this profession.

If the above are not practised and followed, then mere sloganeering on doctor’s day  makes no sense . The  effort to improve training and working condition of doctors has to come from the bottom of the heart of all those involve, both giver and taker.  Mere tokenism on a day in a year is of no real purpose. If the present scenario continues, soon a common man will have problem in accessing good medical care which is currently available at nominal cost . One needs to ponder seriously, if we do not save doctors, who will save us? 

Generic vs. branded medicine: Doctor’s stake : just stringent check on quality of medicine.


Doctors should have no issues to what Honourable Prime Minister Mr Narender Modi himself has spoken, for putting in place a legal frame work to ensure that doctors prescribe only generic drugs. This practice can be easily followed if apprehensions about quality of medicines are allayed.

There have always been concerns regarding quality of generic drugs sold under various trade names since the control over their quality is not foolproof. Implementation has to come along with stringent laws regarding drug testing and quality assurance, otherwise it may be dangerous to patients and in turn to doctors, in the present scenario.

   Generic drug are low cost version of a formulation that should ideally be equivalent to a branded product as far as its production quality, dosage, strength, route of administration and efficacy is concerned. Most generic products are allowed to enter the market only after expiry of the patent protection duration granted to the drug’s original developer.

   Branded drugs are expensive and there is a huge price variation between different branded drugs containing same molecule which is inexplicable. How can doctors interpret the price variation which can be sometimes many times for the different brands of same molecule. Is this price variation because of some difference in efficacy? How to interpret this much price gap and how to keep track of newer names launched at lower prices? Doctors do not manufacture drugs nor are they responsible for printed high retail prices variation in drug prices. I feel the biggest problem is the lack of documentation on efficacy of different brands of same molecule, which if done could guide the doctor. Some regulatory agency needs to be responsible for guiding doctors and patients regarding relationship of quality of drugs and prices. Therefore it is actually not correct to hold doctors responsible for these cost variations.

Huge price variation:  But all said and done, none of the arguments can explain the huge price variation for the different brand of same molecule. This malpractice of pharmaceutical industry has gone on for years without any check and this needs a solution which cannot be found at the door of doctors alone.

The quality control mechanism need to be strengthened and made more stringent. Before using a generic drug, the doctor or patient has to be well assured about  consistent quality of various drugs of same molecule and their pharmacological properties and also the fact that they have been manufactured using the standard practices  and meet the quality controls as per the regulations laid down. Concerned agency should check, verify and certify each and every drug.

 Bioavailability equivalence: There has to be a stringent legal mechanism to guarantee the bio equivalency of the compound for the drug made available in the market. Even a bioequivalent drug can fail efficacy test because of factors like heat, humidity and stability issues. There should be a strict quality control with best manufacturing and packing practices followed for generic and branded medicines alike.

Quality assurance of every drug is a patient’s right and a doctor’s too. They both have a right to know about relationship of quality, efficacy and price. It is of paramount importance to the patient who is ultimately    the consumer.

 Doctors can be victim of this anomaly in a bigger way: They can be in big trouble if quality of the drug prescribed by them is lacking in its quality and efficacy. Major adverse effects and even deaths have been reported due to poor quality of drugs or contaminated drugs. For example deaths in a sterilization camp in Chhattisgarh (FIR 11.11.14) have been attributed to use of contaminated drugs. Think of the plight and suffering of the doctor who was then portrayed as a criminal. He was lucky that court ultimately found out about the poor quality drugs as the cause. But in a day to day routine practice, it is very difficult even to think of such possibilities and prove it and consequently doctor has to suffer the blame of being negligent. Most of the time, it is taken as incompetency and failure of the doctor while the actual problem lies with the drug. If a doctor makes a correct diagnosis and advises medicines correctly but the patient still does not get well, it is the doctor who is blamed for the lack of improvement. Sometimes, if patient does not get well or if a life is lost, doctor may be abused, assaulted or dragged to court. Consequently most doctors try to play safe and prescribe drugs of pharmaceutical companies of sound background. So doctor’s concern should be to ensure and demand strict quality control of medicines because it has a real bearing on the ultimate practice of the doctor. It is really unfortunate that for the lack of poor regulatory mechanisms and greed of pharmacy industry, doctors suffer.

 Doctors just need stringent quality control, law and mechanisms to guarantee effective medicine be it generic or branded. 

It is not a problem to a doctor whether patient gets a generic or branded medicine, as long as it is effective.  Nor does it concern them whether a drug company or chemist make 100% or 1000% of profit out of medicine. The latter should be regulated by government agencies.

It needs a sincere effort by the Government to maintain stringent quality of drugs so as to ensure that both generic as well as branded drugs have same quality and efficacy. The recent initiative by our prime minister can usher in a new era and can be path breaking if strict measure are in place for quality control and standard manufacturing practices are followed.

Blog at WordPress.com.

Up ↑

%d bloggers like this: