Inhalable, dry-powder form of oxytocin to prevent PPH

The Monash University Institute of Pharmaceutical Sciences (MIPS) announced positive results from a first-in-human study of a new, inhaled form of a medicine that could significantly reduce maternal deaths around the world. The results open the possibility of a streamlined pathway to registration, meaning that the medicine could be accessible to mothers much sooner than would otherwise be possible.

Every year, over 300,000 women in low and low-middle income countries die during pregnancy and childbirth. Postpartum haemorrhage (PPH) is the single largest cause of these deaths.

PPH can be prevented by administering a drug called oxytocin, which is recommended by the World Health Organisation and is widely used in wealthy countries. However, as an injection, oxytocin requires refrigeration and a skilled medical professional to administer it safely. In low and low-middle income countries, one or both of these requirements may not be available.

To address this unmet need, researchers at MIPS, in collaboration with GlaxoSmithKline in London, who sponsored the study, have been developing an inhalable, dry-powder form of oxytocin.

The Royal College of Obstetricians and Gynaecologists World Congress in Cape Town, South Africa, the results of the first in-human trial of the new formulation were announced.

The study demonstrated, in a small cohort of non-pregnant female volunteers, that the effects that inhaled oxytocin has on the body are not meaningfully different from its injected counterpart. This gives confidence that the inhaled form of oxytocin will deliver similar effects in prevention of PPH when given to mothers immediately after giving birth.

The results present the possibility that the new medicine will be able to take advantage of a streamlined pathway to registration, meaning that it could reach the mothers who need it much sooner.

Associate Professor Michelle McIntosh, Project Leader at MIPS, said that this first in-human data offers hope to the many women in resource-constrained settings who do not currently have access to this essential medicine.

“These results show that oxytocin can be delivered similarly via inhalation or injection and therefore we are less likely to be required to conduct the extensive and costly trials needed for an entirely new drug. Instead, we should be able to move forward with trials on a much smaller scale, featuring patients numbering in the hundreds rather than tens of thousands, potentially making the medicine available much sooner,” Associate Professor McIntosh said.

This positive data has supported the initiation of clinical studies evaluating inhaled oxytocin when given to women immediately after birth, the time at which oxytocin is routinely administered for prevention of PPH.

Ultrasound Probe Infection Risk, Call For Action

Ultrasound imaging is the most widely used & rapidly growing diagnostic modality in modern medicine. Many scientific studies have shown that there is a risk of microbial cross transmission from improperly processed probes.
Though some facilities might be using high-level disinfection, & the commonly used chemical [Cidex ortho-pthaldehyde (OPA)] used to reprocess transvaginal probes are not effective against human papillomavirus (HPV). Hence, proper cleaning & disinfection of reusable medical devices has been increasingly recognized as vital in preventing pathogen cross transmission including the multidrug resistant organisms. The medical insurance companies, centers for disease control & international & national accreditation agencies are laying great emphasis on standards of care for effective cleaning & disinfection of reusable ultrasound probes.
In addition, we should be aware that the thin layer of gel applied to the skin for effective transmission of ultrasound waves have been identified as one of the sources of cross infection. This infection risk increases when probes enter body cavities where blood & body fluids are encountered.
Hence, collaboration with the full spectrum of healthcare personnel involved in these procedures (Radiologists, Sonographers, Unit Heads, Central sterilizing staff) would contribute to the higher measure of safety during patient care. Probes coming in contact with mucous membranes or non-intact skin be classified as semi-critical device & should undergo high-level disinfection.
Note: In August 2012, BBC News Channel reported the death of the patient from hepatitis B virus infection thought to be contracted via an improperly reprocessed trans-esophageal echocardiogram (TOE) probe. The patient got readmitted with liver failure 3 months after heart valve surgery. The investigation team concluded that the TOE probe used to monitor the heart was the cause & said that the decontamination procedure at the time of the incident as deficient.

1. Using probes without adequate & appropriate decontamination procedures is an underappreciated patient safety risk.
2. Infection Prevention & Control measures needed:
3. Prepare a policy & procedure for probe disinfection in collaboration with experts in sterilization & disinfection.
4. Implement the sterilization & disinfection process effectively at all times of patient care.
5. Try using single patient use gels for probes or adhere to the manufacturer’s guideline in preventing cross infection between patients.
6. Perform adequate & appropriate hand hygiene before & after the intervention.

Doctors Alert : No more Jeans and T-shirts in UP Hospitals

Noida: Following the announcement of the newly elected CM, Mahant Yogi Adityanath that banned wearing of jeans and T-shirts for the state government employees during duty hours, hospitals are now getting letters regarding the same.
Immediately following the announcement, TOI reports that the State health department issued a notice stating the doctors and other employees of government hospitals have to wear decent clothes.
No employee will come in jeans or t-shirts in office. Instead, they should wear shirts and trousers, while women employees have been asked to wear sari or salwar suit, one such order issued by the Bareily DM stated, reports PTI
Following the District Magistrate’s order, the Chief Medical Officer issued another order saying, “Anyone coming to work without wearing formal dress will be marked absent and a day’s salary will be deducted.”
Trickling down, similar notices are now being taken out by the district hospital across the state. “We had received three orders on Thursday regarding maintaining cleanliness in the surroundings, ensuring punctuality and about decent dressing. We are implementing them all,” officiating chief medical superintendent (CMS) Vandana Sharma, district hospital Noida told TOI.
The government hospitals in Noida, the district hospital and the Super Speciality Paediatric Hospital & Post Graduate Teaching Institute in Sector 30 have received the order which is meant for the entire health department across the state adds the daily. Sources have pointed out that the order would be applicable to all healthcare professionals, working at the hospitals, community centres and primary health centres (PHCs) of all the districts.
Director of the the Super Speciality Paediatric Hospital & Post Graduate Teaching Institute, Dr A K Bhatt told TOI that while doctors have already been advised to wear formal dresses, attendants’ dress too will be specified soon and the tender has been floated for the same.

Union Cabinet Approves National Health Policy

The Indian healthcare industry is undergoing a transformation now on the policy front. The Union Cabinet has approved the National Health Policy – 2017 (NHP) which proposes to provide assured health services to all in the country.
Healthcare in India is heading towards a major makeover, thanks to the liberalization and globalization of the economy. According to Health Minister, the proposed NHP is expected to reach healthcare to all corners of the country, particularly the underserved and underprivileged.
The policy envisages a time-bound implementation framework and focuses on upgrading district hospitals with clear deliverable and milestones to achieve the policy goals. A final decision on the policy had been deferred earlier after it was included in the agenda of the Union Cabinet twice before.
The government sources said the Union Cabinet gave its nod to the policy, which has been pending for the last two years. Further, the sources from health ministry said that in a major shift, the policy increases the strategy of sectors covered in the Primary Health Centre (PHC)-level and envisages a comprehensive approach.
Following are ten important highlights of the National Health Policy 2017

1. The policy aims to raise public healthcare expenditure to 2.5% GDP with more than two-thirds of those resources going towards primary healthcare.
2. The policy forecasts in providing a comprehensive package for major non-communicable diseases (NCDs), mental health, geriatric healthcare, palliative care and rehabilitative care services.
3. It also aims to ensure availability of 2 beds per 1000 population distributed in a manner to enable access within a golden hour.
4. In order to provide access and financial protection, it proposes free drugs, free diagnostics and free emergency and essential healthcare services in all public hospitals.
5. The policy proposes to increase life expectancy from 67.5 to 70 years by 2025.
6. Reduction of total fertility rate (TFR) to 2.1 at national and sub-national level by 2025.The NHP intends to reduce the mortality rate of children under 5 years of age to 23 by 2025 and maternal mortality rate.
7. Reduce infant mortality rate to 28 by 2019. Reduce neonatal mortality to 16 and stillbirth rate to 'single digit' by 2025.
8. The policy tends to improve and strengthen the regulatory environment and seeks to put systems for setting standards and ensuring the quality of healthcare.
9. The policy also looks to reform the existing regulatory systems for easing manufacturing of drugs and devices to promote Make in India movement.
10. The policy advocates development of nurse practitioners and public health cadre to improve the availability of appropriate health human resource.

Source: India today

MP High Court issues Guidelines For Arrest Of Doctors

In an important Judgement on 28 Feb 2017, MP high court laid down guidelines for the police and the courts below while dealing with cases implicating doctors working in government hospitals and health centers.

1. That, all allegations relating to negligent conduct on the part of a government doctor for which a prosecution u/s. 304-A IPC and/or its cognate provisions, or under such other law involving penal consequences is sought, the same shall be enquired into by a medical board consisting of at least three doctors, constituted by the dean of any government medical college in the state of Madhya Pradesh, upon the request of the Police, Administration or the directions of a Court/Tribunal/Commission, within seven days of such requisition.
2. The doctor so selected by the dean of the medical college concerned to sit on the Medical Board, shall not be inferior in seniority and experience to that of an Associate Professor.
3. The doctor against whom such negligence is alleged shall be given an opportunity by the medical board to give his reply/explanation in writing and if the doctor so desires to be heard personally, he shall be given such an opportunity by the medical board. However, if the medical board is of the opinion that the request for personal hearing is with the intent of procrastinating the proceedings before the board, it may, for reasons to be recorded, waive the opportunity of a personal hearing and proceed to decide the case on the basis of the documents/treatment record and give its finding.
4. The Medical Board shall endeavor to complete the exercise within sixty days from the date on which it is constituted and upon completion of the inquiry, submit the report to the Police, Administration or the Court/Tribunal/Commission, as the case may be.
5. The police shall not register a FIR against such a doctor in the absence of the report of the Medical Board referred hereinabove and also, only when the report by the Medical Board has held the doctor prima facie guilty of gross negligence€ and not otherwise.
6. If a complaint case has been preferred U/s. 200 Cr.P.C, there shall be no order u/s. 156(3) Cr.P.C unless the complaint is accompanied by the report of the medical board adverted to in guideline I with the prima facie finding of gross negligence€ on the part of the doctor. However, if the complaint is not accompanied by a report of the medical board, the Court may ask the police to enquire into the case u/s. 202 Cr.P.C. The police, if so directed by the court, shall approach the dean of the medical college for the constitution of the medical board and thereafter place the report of the medical board before the court concerned.
7. If the opinion of the Medical Board is one of gross negligence€ on the part of the doctor, the Court concerned shall direct the police to seek sanction u/s. 197 Cr.P.C from the State Government. The State Government shall, within thirty days from the date of such request for sanction, either grant or refuse the same, which the police shall convey to the Court concerned. Thereafter, the Court concerned shall either dismiss the complaint case against the doctor by exercising jurisdiction u/s. 203 Cr.P.C or issue process u/s. 204 Cr.P.C and try the case in accordance with the law.

Maternity leave extension policy comes in to effect

     

Maternity Benefit (Amendment) Bill, 2016 passed in the Parliament The Lok Sabha has passed the Maternity Benefit (Amendment) Bill, 2016 today. The Bill had already been passed by the Rajya Sabha during the Winter Session. With this, the Bill stands passed in the Parliament. The Bill seeks to amend the Maternity Benefit Act, 1961 to provide for the following:- 

 (i) Maternity leave available to the working women to be increased from 12 weeks to 26 weeks for the first two living children. 

 (ii) Maternity leave pregnancy for  beyond the first two living children will continue to be 12 weeks. 

 (iii) Maternity leave of 12 weeks to be available to mothers adopting a child below the age of three months as well as to the “commissioning mothers”. The commissioning mother has been defined as biological mother who uses her egg to create an embryo planted in any other woman.

 (iv) Every establishment with more than 50 employees to provide for crèche facilities for working mothers and such mothers will be permitted to make four visits during working hours to look after and feed the child in the crèche. 

 (v) The employer may permit a woman to work from home if it is possible to do so. 

 (vi) Every establishment will be required to make these benefits available to the women from the time of her appointment 

 (Source: Press Information Bureau, Ministry of Women and Child Development, 9th March, 2017)