NEWS & VIEWS
Good-bye Clinics & Nursing Homes, Welcome Corporate Hospitals!
The friendly neighbourhood physician, as well as the small husband-wife run nursing home, is soon to be phased out. These clinical establishments dotting the country in every nook and corner and providing 70% of the total healthcare services are now becoming history. The medical scene in the country is about to change drastically and we only have our own lethargy to blame. The Ministry of Health and Family Welfare (MOHFW) has put on its website the Draft Minimum Standards under the Clinical Establishments Act (CEA). Not only are some of these outright hilarious, they are mostly out of sync with the reality.
Need for a (building) completion certificate in legal requirements is an example. Completion certificates are commonly refused for minor building byelaw violations and in any city this may include upwards of 60% buildings. Also need of dependence on landlord for this requirement under the CEA will close many healthcare facilities, as the level 1 or 2 hospitals may not be in self-owned premises. How the clinical standards of a facility are to be determined on the fact whether or not the building has completion certificate is a mystery. What this effectively means is that the facility has to apply to the Estates office for the completion certificate, inspection of the premises by inspector, objections, removal of these objections by any means (usually unfair) and overall wait of average one year for the certificate. Meanwhile, the healthcare facility should close down awaiting its certificate.
This, however, is also not in isolation, the ‘NOC’ from the fire department, now under the new rules for hospitals whether level 1 or tertiary care, has extremely stringent requirements of roof top water tanks, sprinkler systems and smoke detectors. To get this ‘NOC’ is going to be another formidable challenge for the establishments already in existence in older buildings. Under the draft rules one has to provide 24-hour power backup but you need a diesel storage license, DG (Diesel Generator) set approval for commissioning, air and water pollution control certification etc. Each of these licenses can be a 2-3 year plan for the doctors.
Surprisingly none of these requirements are necessary for AYUSH facilities even of 100-bed strength. All the legal requirements, so far mentioned, relate to the allopathic level 1 and level 2 hospitals. Despite operation theatres and labour rooms in AYUSH facilities, there is no requirement for such building and legal certifications for them. How can two facilities of similar size providing treatment to general public need to fulfill two different types of certifications. There is a bias against allopathic healthcare facilities in these draft minimum standards published.
There is also a need for Spirit license, medical gases / explosive Act license, boiler license and a wireless operation certificate from the Department of Posts and Telegraph to operate wireless equipments like nurse call systems or monitors. It does not require high intellect to know how these licenses are to be obtained and what the procedure entails. An individual or couple managing a small nursing home or level 2 hospital will find it impossible to comply with the requirements of all these certifications. This will leave no option but for these units to close down. Only the corporate hospitals with their deep pockets and required administrative staff will be in a position to satisfy all these requirements. Unfortunately corporate penetration in India is limited to less than 2%. Should the remaining 98% Government as well as Private hospitals shut shop?
The Government clinics/dispensaries, Primary Health Centers, Community Health Centers and Civil Hospitals will be hard pressed for these certifications. Where is the need for a four-wheel drive vehicle in a city-based level 2 hospital? Even tertiary care institutions like PGI will be hard pressed to explain 2 or 3 patients on one bed, which is the norm in the obstetric wards. These standards have been prepared without adequate and appropriate consultation with stakeholders. There appears to have been a group within the MOHFW which is out to promote corporatization of healthcare which cannot be in overall good for the country.
We request the Government to be sensible and practical. Minimum standards should mean minimum standards necessary for a clinic/hospital to provide adequately satisfactory healthcare to its consumers. CO2 monitors and Endoscopy washers are not minimum standards. But more importantly minimum standards have to be uniform across government, private, allopathic, ayurvedic, homeopathic, naturopathy, siddha, sowa-rigpa, unani, yoga or physiotherapy. A level 2 allopathic hospital with 10 beds and surgical facility cannot have different and highly stringent requirements from a 100-bed ayurvedic hospital with OT and labour room.
Free drug samples can push doctors to prescribe costly branded drugs: Study
Rema Nagarajan
Free drug samples distributed to doctors by drug companies has come under fire, as yet another study, this time by researchers in Stanford University, showed how free samples altered the prescribing habits of dermatologists away from the use of cheaper generic medications.
The study which was published in the Journal of American Medical Association's (JAMA) Dermatology, explored the relationship between free drug samples and the prescribing habits of dermatologists in the US and also the relationship between free drug samples and prescription costs.
The study which investigated prescribing patterns of dermatologists for acne in an academic medical centre which banned freebies and that of dermatologists in private practice, found that the practice of dermatologists giving samples with prescription was increasing. It also found that branded and branded generic drugs comprised 79% of the prescriptions in private practice, compared to just 17% of the prescriptions in an academic medical centre clinic.
According to the study, the increased use of branded and branded generic drugs had pushed up the retail cost of prescriptions, almost doubling the cost of treating acne compared to retail cost of prescriptions at an academic medical centre. Thus the claims regarding benefits of free samples ought to be weighed against its negative effect on prescribing behavior and prescription costs, concluded the study.
An editorial on the same subject in JAMA Dermatology pointed out that numerous institutions have banned or sharply restricted drug sampling, including the Veterans Health Administration, the US military, many universities, and Kaiser Permanente. Several organizations including the Association of American Medical Colleges and the American Society of Health-System Pharmacists have also recommended curtailing and/or controlling drug sampling. However, the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade organization representing leading US pharmaceutical and biotech companies deems distribution of samples as "appropriate" in its code on interaction with healthcare professionals. Drug companies continue to provide many physicians with drug samples, valued in 2011 at an estimated $6.3 billion.
Those supporting drug sampling argue that it encourages physicians to use new medications that could be superior to generics and that it could benefit poor or uninsured patients who could not otherwise afford the drug. "Published studies have demonstrated the harms of sampling. Sampling can influence physicians to prescribe less appropriate medications. Furthermore, outcomes might be worse if patients ultimately are unable to afford or obtain sampled drugs," stated the editorial adding that drug sampling also circumvented the pharmacists who kept a check on drug reaction issues and product recall issues.
The editorial also warned that samples typically being newer medicines, lacked robust safety data and hence had the increased risk of adverse effects. The editorial gave an example of how the drug rofecoxib became the most widely distributed sample in the US within two years of FDA approval and how three years later it was withdrawn from the market because of increased risk of heart attack and stroke. Similarly, among the 15 drug samples most widely distributed to paediatric patients in 2004, four received new or revised black box warnings within the next 2 yrs, added the editorial.
The editorial debunked the argument that drug samples helped poor patients by stating that fewer than one-third of samples were actually given to poor or uninsured patients and were often taken by physicians for personal or family use or by the pharma reps themselves. Furthermore, a national survey in the US showed that those receiving samples had higher out-of-pocket costs compared to patients not receiving samples, said the editorial adding that sampled increased the cost of medicines for all patients by encouraging doctors to prescribe more expensive medicines.
The editorial questioned the prudence of drug sampling in the absence of evidence that samples actually improve patient outcomes and in light of safety concerns and negative cost consequences associated with samples.
(Available from: http://timesofindia.indiatimes.com/home/science/articleshow/34420172.cms?intenttarget=no)