Wednesday, December 19, 2018

Hon’ble Delhi High Court sets aside the central Govt’s ban on making & selling of oxytocin by private firms


  
Dr KK Aggarwal & Advocate Ira Gupta
On Friday, 14th December, the Hon’ble Delhi High Court set aside the Govt.’s decision to ban private firms from producing and selling oxytocin, a drug used for inducing labour contractions & controlling bleeding.

A bench of Hon’ble Justice S Ravindra Bhat and Hon’ble Justice AK Chawla said that the government’s decision was arbitrary and unreasonable.

The bench also said that there was no scientific basis behind the Center’s decision restricting private companies from making or supplying the drug,which helps new mothers lactate, to prevent its alleged misuse in the dairy sector for increasing milk production.

As per a notification dated 27th April, the Ministry of Health and Family Welfare had restricted the manufacture of oxytocin formulations for domestic use to public sector only. It had also banned the import of oxytocin and its formulations. Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL), a public sector company, was solely allowed by the Center to manufacture this drug for domestic use.

The reason for the ban was the misuse of oxytocin in dairy animals to increase milk production.

On 31st August, the High Court had suspended till 30th September the Central Government’s prohibition on sale and manufacture of oxytocin by private companies for domestic use. The stay was later extended till 15th December.

Post-partum hemorrhage, or PPH, is a major cause of maternal death in India accounting for about 38% of all maternal deaths due to hemorrhage. It is also one of the most preventable causes of maternal mortality.

Oxytocin is a time-tested drug that has been used to prevent maternal deaths due to PPH. WHO has also recommended IV oxytocin as the first line uterotonic drug for the treatment of PPH and has included it in the 20th Edition of its Model List of Essential Medicines, amended in August 2017.

In India, oxytocin is also included in the National List of Essential Medicines (NLEM) 2015 under section 26.1 (Oxytocics)

Hence, any difficulty or hurdles in procuring oxytocin would have only increased maternal mortality due to PPH.

Oxytocin is often a life-saving drug; hence, it should be available and accessible in all settings, including remote areas for use by doctors as well as nurses.

(Source: Latestlaws.com)

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA

IBD may be an independent risk factor for heart disease


Patients with inflammatory bowel disease (IBD) are at a significantly higher risk of myocardial infarction (MI), says a study reported in the journal Inflammatory Bowel Diseases, online November 30, 2018. The relative risk of MI was highest in younger patients and decreased with age.

The researchers examined a nationwide database of medical records for more than 29 million people, of which, 131,680 had ulcerative colitis and 158,750 had Crohn's disease. Over the 5-year study period, patients with IBD had 25% greater probability to suffer a heart attack when compared to those without IBD.

Around 8.8% of patients with Crohn's disease suffered a heart attack during the study period. Likewise, 6.7% of patients with ulcerative colitis had a heart attack. In contrast, the prevalence of MI was just 3.3% in persons without IBD.

The risk was highest during active flares or persistent disease, while a reduction in risk was observed, when the disease was in remission. The odds of MI in IBD patients overall were highest in younger patients and decreased with age (age 30–34 years: OR 12.05 [11.16–13.01], age 65+ years: OR 2.08 [2.04–2.11]), which means that IBD patients aged 30 to 34 years were 12 times more likely to have a heart attack than their counterparts; IBD patients aged 65 years only about twice as likely to have MI as persons without IBD.

The inflammatory process in IBD has been implicated as the factor that predisposes these patients to develop a heart attack. The chronic inflammation promotes clot formation, which may block the coronary arteries and incite an acute heart event.

These findings suggest that IBD may be an independent risk factor for heart disease and emphasize the need for aggressive risk factor reduction in these patients.

IBD patients should be closely watched for risk factors for heart disease such as hypertension, diabetes, smoking, obesity, high cholesterol.

Since the risk was found to be low when the disease was in remission, keeping IBD under control as well as modifying risk factors can reduce the risk of heart attack in these patients.

(Source: Panhwar MS, et al. Risk of myocardial infarction in inflammatory bowel disease: a population-based national study. Inflamm Bowel Dis. 2018 Nov 30. doi: 10.1093/ibd/izy354)


Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA


Tuesday, December 18, 2018

Screen atopic dermatitis patients for suicide risk



Patients with atopic dermatitis are at significantly greater risk of suicidal ideation and suicide attempts, suggests a new systematic review and meta-analysis of 15 studies.

The total number of participants in the studies included was 4 770 767; of these, 310,681 had atopic dermatitis (52.7% female) and 4,460,086 served as controls (50.9% female).

Patients with atopic dermatitis were found to have a significantly greater risk of suicidal ideation and suicide attempts. These findings were most pronounced in regard to suicidal ideation. They were 44% more likely to exhibit suicidal ideation and 36% more likely to attempt suicide compared with patients who did not have atopic dermatitis.

The study highlights the high prevalence of suicide ideation and suicide risk in atopic dermatitis patients.

It also emphasizes the need for dermatologists and physicians to be aware of the increased suicide risk, when managing their patients with atopic dermatitis.

The treating doctors should screen and monitor their atopic dermatitis patients for suicidality, and refer them to a mental health professional for appropriate management.

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA


Monday, December 17, 2018

DIPP initiates National Medical Devices Promotion Council




Mr. Rajiv Nath

DIPP (Dept of Industry Policy and Promotion) has initiated a National Medical Devices Promotion Council which will provide an impetus and boost Indian Medical Devices manufacturing industry and support the Make in India impetus for Medical Devices in India.

Medical Devices Development Council will help realize our vision for India to be among the Top 5 Medical Devices manufacturing hubs worldwide as the Council will spearhead the policy needs to accelerate the manufacturing of medical devices in India and end the 70-90% import dependence forced upon us and an import bill of over Rs 31, 000 crore.

Suresh Prabhu, Minister of Commerce and Industry announced the establishment of the National Medical Devices Promotion Council at World Health Organization's global conference on medical devices in Visakhapatnam. He also announced establishing a Medical Devices Design Centre and assured as exports picks up we will also establish a Medical Devices Exports Promotion Council.  

The prime objectives of the National Medical Devices Promotion Council are: 

  •          Act as a facilitating and promotion & developmental body for the Indian Medical Devices Industry
  •          Hold periodic seminars, workshops  to deliberate on various parameters for inclusion in the industrial and trade policies in medical devices
  •   Identify redundant processes and render technical assistance to the agencies/departments concerned in order to simplify the approval processes involved in medical device industry promotion and development
  •          Enable entry of emerging interventions and support certifications for manufacturers to reach levels of global trade norms and lead India to an export driven market in the sector
  •          Support dissemination and documentation of international norms and standards for medical devices, by capturing the best practices in the global market and facilitate domestic manufacturers to rise to international level of understanding of regulatory and non regulatory needs of the industry
  •          Drive a robust and dynamic Preferential Market Access  (PMA) policy, by identifying the strengths of the Indian manufacturers and discouraging unfair trade practices in import; while ensuring pro-active monitoring of public procurement notices across Indian to ensure compliance with PMA guidelines of DIPP/DoP.
  •          Undertake validation of Limited Liability Partnerships (LLPs) and other such entities within MDI sector, which add value to the industry strength in manufacturing to gain foothold for new entrants
  •          Make recommendations to government based on industry feedback and global practices on policy and process interventions to strengthen the medical technology sector including trade interventions for related markets


The way Pharmaceutical Export Promotion Council of India (Pharmexcil) was successful in promoting the Indian Pharmaceutical Industry, we are similarly hopeful that Medical Devices Development Council will help realize our vision for India to be among the Top 5 Medical Devices manufacturing hubs worldwide as the Council will spearhead the policy needs to accelerate the manufacturing of medical devices in India and end the 70-90% import dependence forced upon us and an import bill of over Rs 31, 000 crore. The Indian market at retail and institutional level is estimated to be at over Rs. 70000 Cr (10 Billion $). 

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA

Severe comorbid COPD increases mortality risk in heart failure patients




Heart failure and chronic obstructive pulmonary disease (COPD) are common diseases of aging. Besides being common in old age, both diseases share common risk factors and pathophysiology. As a result, the two often co-exist and influence each other’s clinical course.

This observation has been validated in a new nested case-control study of more than 50,000 UK patients with heart failure from the UK, which found that the greater severity of COPD is associated with increased chances of hospitalizations and increased risk of death in those patients who also have heart failure.  Hence, optimal care of patients with comorbid heart failure and COPD requires accurate diagnosis and targeting of severe COPD markers to prevent admissions and death.

The study showed that the increased risk of death and hospitalization associated with COPD significantly differs by medication intensity and the severity of airflow limitation.

Chronic obstructive pulmonary disease was not associated with any increased risk of death when patients were managed by inhaler therapies, until prescribing intensity reached triple inhaler therapy and risks of both outcomes were significantly higher in those prescribed oral corticosteroids and oxygen therapy. The use of spirometry in the population studied was limited, but its use indicated the group of patients with more severe heart failure and COPD, who also had worse outcomes for those with the most severe airflow limitation

The major clinical implications of these findings are:

·         To improve HF prognosis, it is important to accurately identify and effectively manage comorbidities.
·         COPD-associated risk differed significantly according to medication intensity in patients with heart failure; hence, it is a potential indicator of disease progression. 
·         Comparison of patients with heart failure and COPD with those without COPD showed that mortality was higher in those who had more severe airflow limitation from GOLD stages 1 through 4. 
·         COPD in women with heart failure was associated with a 15% higher risk of death than in men. 

These findings are reported in JAMA Network Open, Dec. 14, 2018.

(Source: Association of medication intensity and stages of airflow limitation with the risk of hospitalization or death in patients with heart failure and chronic obstructive pulmonary disease. JAMA Netw Open. 2018;1(8):e185489)


Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA


Stethoscopes are potential sources of hospital-acquired infections



A stethoscope is an essential diagnostic tool in a physician’s armamentarium. It is also the most recognizable sign of the medical profession. But, now they are gaining another new identity, as potential routes of infection transmission.

Failure of stethoscope hygiene is becoming a common cause of transmission of infection. Evidence shows stethoscopes as capable of also transmitting potentially resistant bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

A new study published online Dec. 12, 2018 in the Infection Control & Hospital Epidemiology has added to the growing evidence of stethoscopes as carriers of infection.

The study found that stethoscopes carried by doctors in an ICU, which are used on multiple patients, are significantly contaminated with a rich and diverse community of bacteria that includes organisms associated with healthcare-associated infections (HAIs). And, among these, Staphylococcus was ubiquitous and had the highest relative abundance. On a set of 40 stethoscopes in use in an ICU, all 40 had a high abundance of Staphylococcus bacteria, with "definitive" S. aureus bacteria present on 24 of 40 stethoscopes tested.

The study also investigated the impact of cleaning on bacterial contamination but the results were not very encouraging. While cleaning of stethoscopes – by either standardized or practitioner-preferred methods - did reduce bacterial contamination levels, but the levels of clean stethoscopes were attained only in few cases.

Stethoscopes become contaminated after each patient use. Hence, the Centers for Disease Control and Prevention (CDC) recommends that re-usable medical equipment, such as stethoscopes, must undergo disinfection between patients.

This study reiterates the need for strict infection control practices and adhering to recommended guidelines for decontamination procedures in between patients. Or, single-patient-use stethoscopes can be used to prevent cross contamination.

(Source: Medscape; Infection Control & Hospital Epidemiology. 2018; DOI:10.1017/ice.2018.319)



Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA

Sunday, December 16, 2018

Should dialysers be reused?




Hemo-dialyzer reuse is the practice of using the dialyzer multiple times for a single patient. The basic procedure for dialyzer reprocessing involves four steps: rinsing, cleaning, performance testing, and disinfection/sterilization. The process of reprocessing is done by automated or manual methods. Meticulous adherence to an established protocol is essential to ensure safety of the procedure.

Reuse is largely used as a cost containment measure in areas of limited resources such as in our country.  In the United States, reuse is rarely practiced.

Three main areas of concern with reuse of dialyzer are:

·         Risk of infection to patients or staff
·         Exposure of patients or staff to germicide
·         Loss of performance with impairment in clearance and/or ultrafiltration

Failure to strictly adhere to guidelines increases the risk of transmission of HIV or hepatitis B/C virus to patients or staff involved in the dialysis process. Exposing patients to reused dialyzers increases the risk for bloodstream infections (Am J Kidney Dis. 2017 Jun;69(6):726-33). Great care has to be taken to prevent cross usage of dialyzers.

In the Clinical journal of the American Society of Nephrology, Upadhyay et al write: “The potential of inadequate germicide concentration use raises the possibilities of pyrogen reactions and bacteremia outbreaks. Changes in the membrane integrity with reuse can also affect membrane polarity as well as the clearance of small and middle molecules. The issue of increased environmental contamination with reuse is also of potential concern”. 

Reuse also increases the relative risk of hospitalization and death for patients.

The number of times that the dialyzer is reused is associated with loss of performance. The rate at which this happens depends on the type of cleaning agents used for reprocessing, the membrane type and dialyzer. Hence, when dialyzers are being reused, the performance of the dialyzer should be closely monitored.  

The two most commonly used germicides are peracetic acid and formaldehyde, both of which are harmful to human health.

Peracetic acid can be potentially destructive to mucous membranes (especially respiratory mucosa) and to the skin and eyes. Among staff, allergic reactions to formaldehyde may occur. Formaldehyde is a known carcinogen; its inhalation can impair lung function. When bleach is used together with peracetic acid or formaldehyde, hypochloric acid / formic acid vapors are released, which if not properly drained, can potentially pollute the working and patient spaces (Murthy B, Molony D: Reprocessing of hemodialyzers, In: Chronic Kidney Disease, Dialysis & Transplantation, 2nd Ed., Pereira BJ, Sayegh M, Blake P (Eds), Philadelphia, Elsevier, 2005, pp 388– 404; Semin Nephrol.1997;17:321-30)

Cracks in the threaded portion of dialyzer headers may occur due to repeated exposure to chemicals during reprocessing of dialyzer. Failure of timely detection may result in significant blood loss (ECRI Institute, 1995).

Single use of dialyzers reduces chances of infection and contamination and the probability of errors and accidents, and risks associated with exposure to germicides and denatured blood products. A favorable immune response and a better clearance of small and middle molecules are also more likely with single use. 

Single dialyzer use should be implemented whenever possible to reduce infection risk. A study investigating an outbreak of bloodstream infections (BSIs) caused by Burkholderia cepacia and Stenotrophomonas maltophilia among hemodialysis patients in clinics of a dialysis organization found that each additional use of the dialyzer significantly increased the risk for BSI by 7%, and higher dialyzer use count (>6) was associated with 7-fold increased risk for becoming a case. Dialyzer reuse, reprocessing, and a specific dialyzer model were found to be predictors of increased risk for infection.  (Am J Kidney Dis. 2017 Jun;69(6):726-33).

In addition, we cannot go against the manufacturer’s recommendation or the Drug Controller General of India (DCGI) approved indication.

Two companies (ev3 and Covidien LP) now owned by Medtronic will pay $31 million to resolve US Department of Justice (DOJ) charges involving marketing violations and kickback schemes. The company ev3 has pled guilty to charges related to its neurovascular medical device Onyx Liquid Embolic System. The US FDA approved the Onyx Liquid Embolic System in 2005 for use in the presurgical treatment of arteriovenous malformations but sales representatives encouraged surgeons to use Onyx in large quantities for unproven and potentially dangerous surgical uses outside the brain.

Covidien LP, another company will pay to resolve allegations of violations of the False Claims Act resulting from its alleged payment of kickbacks to hospitals to encourage use of its Solitaire mechanical thrombectomy device.

The highest compensation in medical practice, awarded by the Hon’ble Supreme Court in the matter of Balram Prasad vs Kunal Saha & Ors on 24 October, 2013 in the Supreme Court of India: Civil Appellate Jurisdiction: Civil Appeal No.2867 of 2012 also provides an answer to this conundrum. “…This Court has categorically held that the injection Depomedrol used at the rate of 80 mg twice daily by Dr. Sukumar Mukherjee was in clear violation of the manufacturer’s warning and recommendation and admittedly, the instruction regarding direction for use of the medicine had not been followed in the instant case. This Court has also made it clear that the excessive use of the medicine by the doctor was out of sheer ignorance of basic hazards relating to the use of steroids as also lack of judgment. No doctor has the right to use the drug beyond the maximum recommended dose...”

Reuse is cost reduction, to be read with harm reduction. But, when done has to be with consent of the patient.

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA