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Need for Protocols in Public Health


Vol – L No. 12, March 21, 2015 | Meeta Rajivlochan

The deaths in Chhattisgarh during a state-sponsored family planning camp held in November 2014 show, yet again, that the lack of checklists and an ad hoc style of functioning can and does result in disaster. This article explains the need for standardisation and protocols in key government processes and talks about the pathetic conditions in which medicines and surgical supplies are procured in public hospitals as well as the failure of state agencies to detect and prohibit sale of substandard drugs.

Meeta Rajivlochan ([email protected]) is an IAS officer in Maharashtra.
The deaths in Chhattisgarh in the state-sponsored family planning camps are an indicator of the lack of standardisation and protocols in key government processes in the health department. Blaming the local doctors is not only unfair, it also completely ignores the basic problem. In an age where too much bureaucracy is seen as the key issue, it may seem difficult to believe that actually it is lack of bureaucratic procedure, which can cause loss of life on this scale. Yet the Chhattisgarh incident shows that this is indeed the case.
Failure to follow protocols can have disastrous results; following traffic signals is an immediately visible example. In areas like public health, the lack of adherence to rules normally produces visible impacts in the short term. Unfortunately for all of us, as a society we seem to be tuned to function only in crisis management mode. Only a disaster makes us sit up and think. The fact remains that had these rules been set up and followed in the routine course of things, the crisis need not have occurred.
Why the Need for Protocols
Actually the discipline of medicine is full of protocols, till the MBBS level in any case. Post-MBBS, once doctors enter the professional world and find that no one talks of protocol, it becomes a futile exercise to insist on these. Mistakes in medicine can be costly; and most procedures are complex ones requiring intervention of many people. Hence, the need to standardise all steps into checklists. Entire pages are devoted in medical textbooks to something called look alike and sound alike medicines, which need to be stored separately to avoid giving the patient the wrong medicine. There are innumerable such examples. Operation theatres have surgical safety checklists to ensure that the right organ is operated upon and that the right patient is operated upon. Medical stores have inventory management and labelling procedures so that, for instance, a child is not fitted with a heart valve meant for an adult. The examples go on and on.
The lack of checklists and a completely ad hoc style of functioning can and does result in disaster. We only need to look at the specialised case of medical procurement for this truth to emerge. Procurement of medicines and surgical supplies in public hospitals in India today, is a sad story indeed: of overworked doctors who are forced to do jobs which were not theirs in the first place. Doctors are tasked with curative duties. But procurement is a managerial job which needs a dedicated managerial team. Unless manpower resources are reserved for this task, it cannot be done efficiently. Yet doctors are asked to do part-time administrative duties, since no such dedicated resources are made available.
The sad part of the story is that organising the present mess does not need much money. It only needs a dedicated team of people and clearly defined bureaucratic procedures. Procurement of over thousands of medicines and surgical supplies is a large-scale task involving drawing up of rigorous technical specifications, regular collation of demand, supply chain management, sampling and quality assurance procedures. Generally, only such production facilities which conform to World Health Organization good manufacturing practices, are allowed to supply drugs. These are procedures, which can minimise stock-outs and eliminate errors to the extent possible. That this can be done has been amply demonstrated in Rajasthan, Maharashtra and Tamil Nadu. And these state governments buy drugs at some of the cheapest prices in the country. So it cannot be said that high quality drives up costs.
The media has been full of criticism of fly by night operators who produce substandard drugs and a poor regulatory environment. No doubt all that is true. There has been a failure of state agencies to detect and prohibit sale of substandard drugs to the general population.
But the far greater failure is this: these drugs were not being used by private operators but had been purchased by the government; either by the Chhattisgarh Medical Services Corporation or by the local medical officer. How was it that the public health department had no procedures for sampling and quality assurance in place that such substandard drugs could be used at all?
In all three states of Rajasthan, Maharashtra and Tamil Nadu, rigorous sampling procedures for drugs supplied to public hospitals are in place. These samples are taken after the drugs have been supplied and not beforehand. They are taken from a random selection of districts and the samples are taken for each batch of drugs supplied. There is a detailed protocol for selection of sample, barcoding the sample and empanelling laboratories to conduct tests and give results in a prescribed time limit. Most importantly, until such time as the sample tests results are in; these drug stocks are kept in quarantine so that in case of any substandard drug, the batch can be recalled without any damage being done.
Were such procedures in place in Chhattisgarh? That is the real question. If samples of drugs had been taken and tested, the rodenticide which contaminated the drugs would have been discovered and the supplies returned. But this does not seem to have been done. There is only one way to ensure that people do not die: by having rigorous quality standards in place and by following these to the letter.
Indifference to Public Health
Medical procurement in Indian public sector settings today is rarely characterised by such protocols, with a few exceptions. Two features typically characterise medicine procurement in the Indian public sector.
First is that the majority of drug purchases are local purchases mostly at maximum retail price rates, by the local authorities. These demands for supplies are seldom collated and bought in bulk at state level so that prices could be brought down significantly. In order to conduct such an exercise, a team would need to estimate the quantities of different kinds of drugs—antibiotics, antihistamines, etc, which are consumed each month and then to extrapolate these figures. This exercise is rarely carried out.
Second, drug suppliers routinely go through testing before procurement and not afterwards. Even if drugs supplied are tested, the batches are not quarantined till the test results are in. This makes any error impossible to correct. Why should this be the case?
The fact is that the focus in public health departments has been on curing patients rather than in setting up systems for the logistics of patient care. But patient care does have a considerable logistics to it, which is sorely needed. Moreover, until recently there was little predictability about funds available for drug purchase. Healthcare has not been a priority item on the agendas of governments. Free medicines to all, is a programme which has been pushed only recently. So if you were to buy the drugs in bulk and then not be able to pay the suppliers, it would create a serious problem. Rather than do this, medical departments simply depend on emergency purchases. This is the one main reason that the majority of medicine purchase in many state governments is local purchase rather than bulk purchase.
Change for the Better
For things to change, dedicated budgets for the free medicine programme are needed. Then demand estimation and extrapolation need to be done. Currently there are a variety of software applications, which can be used for this task. It would be some time before enough data is made available for the software to function as a decision support system but this would happen eventually.
Next, detailed protocols would need to be put in place for floating tenders. All conditions for sampling and quality assurance need to be built into the tenders so that the suppliers are well aware of what is to be done. Adequate warehouses need to be built in the districts so that drugs could be stored in proper conditions. Finally software is needed for automating the payment process so that goods receipts could be generated and suppliers paid on time.
Now all this sounds very bureaucratic. It does not excite any sense of drama or indignation at the cruelty of various vested interests. Perhaps this is why this particular failure elicits little response. The only time it is noticed is when people die. But the fact remains that unless we can first prescribe reasonable protocols and then condition our systems to follow those protocols, such disasters will only happen again and again.

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