Chronic stress during adolescence may reduce fertility in adulthood, suggests

Male rats exposed to moderate and repeated stress during adolescence may have reduced fertility, according to research presented at the 26th European Congress of Endocrinology in Stockholm. This study sheds light on the harmful effects that early-life stress has on health and could help to uncover future prevention strategies for children and adolescents.

While hormone levels fluctuate pathologically-especially during life stages such as puberty-stress can cause too much or too little of a hormone in the bloodstream. This hormonal imbalance negatively impacts puberty and the reproduction system, with effects on libido, ovulation function and sperm cell production. However, the long-term reproductive effects of chronic stress in adolescents are largely unknown.

In this study, researchers from the V.P. Komisarenko Institute of Endocrinology and Metabolism of the National Academy of Medical Science of Ukraine, examined male and female rats, aged 6 months, after individually placing about half of them in enclosed spaces for one hour every morning for two weeks during adolescence (30–45 days old). They compared the rats who had been exposed to these stressful conditions to the control group and found that chronic stress during puberty delayed sexual maturity in females, and males gained weight more slowly. In adult males, sperm count fell by 25.9%, some sperm were abnormally shaped and sluggish or became immobile, and the breathing process by which sperm cells derive energy slowed down. Additionally, males had almost two times lower levels of corticosterone – the main stress hormone in rats, equivalent to cortisol in humans.

“Our work is the first to report to show that even moderate and repetitive stress in adolescence has a long-lasting negative impact on the endocrine system of reproduction and adaptation of the body to changing living conditions,” said lead investigator, Professor Aleksander Reznikov.

“Our results make it possible to predict the development of anomalies in reproduction and bodily adaptation systems and are the basis for finding methods for their prevention.”

Professor Reznikov added: “We discovered for the first time that lipid peroxidation (a process in which oxidants like free radicals attack lipid membranes of cells and eventually damage them) in the ovaries and testes was significantly increased. This, however, needs further investigation.”

Powered by WPeMatico

Study Reveals Relationship Between Peak Expiratory Flow Changes and Asthma Exacerbations in Children

China: A recent study published in BMC Pediatrics has unveiled crucial insights into the relationship between changes in peak expiratory flow (PEF) and asthma exacerbations in pediatric patients. Conducted with a focus on asthmatic children, the research underscores the significance of PEF monitoring as a valuable tool in predicting and preventing asthma exacerbations.

Researchers uncovered a crucial early warning sign for pediatric asthma exacerbations: children with asthma exhibited a decline in PEF approximately 1.34 days before the onset of symptoms. Upper respiratory tract infections emerged as the primary trigger for acute asthma exacerbations, and air pollution exhibited a significantly higher impact on PEF variation versus other factors.

Asthma, a chronic respiratory condition characterized by airway inflammation and hyperresponsiveness, affects millions of children worldwide, posing a significant burden on both patients and healthcare systems. Asthma exacerbations, marked by sudden worsening of symptoms, represent a major concern due to their potential to escalate into severe respiratory distress and hospitalization.

In patients with poor perception, identifying acute asthma exacerbations by clinical asthma score, asthma control test, or asthma control questionnaire is difficult. Considering this, Kunling Shen, Department of Respiratory, Shenzhen Children Hospital, Shenzhen, China, and colleagues aimed to analyze whether children with asthma have changes in peak expiratory flow before an acute asthma exacerbation. They also evaluated the relationship between PEF and asthma exacerbation.

For this purpose, the researchers collected basic information (including age, sex, atopy, etc.) and clinical information of asthmatic children who registered in the Electronic China Children’s Asthma Action Plan (e-CCAAP) from 2017 to 2021. Subjects with fourteen consecutive days of PEF measurements were eligible. The study subjects were categorized into an exacerbation group and a control group. They analyzed the relationship between changes in PEF% pred and asthma symptoms.

The study included 194 children with asthma who met the inclusion criteria, including 74.2% males and 25.8% females, with a male-to-female ratio of 2.88:1. The subjects’ mean age was 9.51 ± 2.5 years.

The researchers reported the following findings:

  • There were no significant differences in sex, age, allergy history, or baseline PEF between the two groups.
  • There was no significant difference between the variation in PEF at 14 days in children with and without a history of allergy.
  • Patients who only had a reduction in PEF but no symptoms of asthma exacerbation had the greatest decrease in PEF compared to the other groups.
  • The most common cause of acute exacerbations of asthma is upper respiratory tract infection.
  • Among the causes of acute exacerbations of asthma, the variation in PEF caused by air pollution was significantly higher than that of other causes.
  • In acute exacerbations, the decrease in PEF was significantly greater in the exacerbation group than in the control group.
  • In children with asthma symptoms, there was a decrease in PEF approximately 1.34 days before the onset of the symptoms.

The findings revealed that children with asthma show a decrease in PEF 1.34 days before the onset of asthma symptoms.

“We recommend that asthmatic children who show PEF reduction should step up asthma therapy,” the researchers wrote. “The most common cause of asthma’ acute exacerbations was upper respiratory tract infections, and PEF variation caused by air pollution was significantly higher than that caused by other factors.”

Reference:

Chen, X., Han, P., Kong, Y. et al. The relationship between changes in peak expiratory flow and asthma exacerbations in asthmatic children. BMC Pediatr 24, 284 (2024). https://doi.org/10.1186/s12887-024-04754-7

Powered by WPeMatico

Gabapentinoid prescriptions in Isolated Low Back Pain patients by primary care physicians not useful: Study

Gabapentinoids have been increasingly studied as a non-narcotic option for neuropathic and postoperative pain. However, there is evidence suggesting that off-label use of these medications for the treatment of isolated LBP is not effective.

Low back pain (LBP) remains one of the leading causes of disability worldwide. In wake of the ongoing opioid epidemic, reducing narcotic use is a high priority for patients, physicians, and systems. For some indications, non narcotic analgesic alternatives exist – such as gabapentinoids – however, evidence does not support their use for axial LBP.

Maloy et al conducted a study to evaluate prescription patterns for gabapentinoids among patients with isolated low back pain. The study has been published in ‘Global Spine Journal.’

Adult patients with LBP were abstracted from the dataset using International Classification of Diseases (ICD-10) code M54.5. Patients were excluded if they had a diagnosis of neurologic symptoms, history of spinal surgery, spinal fracture, or conditions for which gabapentinoids are FDA approved. Gabapentinoid and narcotic prescriptions within one year of LBP diagnosis were identified. Patient characteristics and prescriber specialty were extracted from the dataset and predictors of gabapentinoid prescriptions were determined using univariate and multivariate analyses.

Key findings of the study:

• Among the 1,158,875 isolated LBP patients, gabapentinoids were prescribed for 11% (gabapentin for 85%, pregabalin for 12% pregabalin, and both for 3%), narcotics for 8%, and both for 3%.

• The most common prescriber specialties included: primary care physicians (45%), nurse practitioners (15%), pain management physicians (5%), neurology (4%), physical medicine and rehabilitation (4%), psychiatry (3%), rheumatology (2%), orthopedic surgery (2%), unknown (11%), and other fields (9%).

• Independent predictors of gabapentinoid prescriptions included: female sex, region of the country, and insurance type (P-values <0.001).

The authors concluded – “In sum, of nearly 1.2 million isolated LBP patients identified, 14.2% were prescribed gabapentinoids within one year of their LBP diagnosis, a number greater than narcotics and prescribed most commonly be primary care physicians. Several factors were identified as independent predictors of gabapentinoid prescription, include patient sex, region of residence, and insurance plan. While clinicians are being encouraged to shift away from the use of narcotics for isolated LBP, evidence does not well support gabapentinoids for this indication and its off label use for this population may be questioned.”

Further reading:

Characterizing Gabapentinoid Use Among Patients With Isolated Low Back Pain

Gwyneth C. Maloy et al

Global Spine Journal 2024

DOI: 10.1177/21925682231224390

Powered by WPeMatico

Bariatric Surgery Decreases Risk of Ocular Morbidity and Mortality finds study

Researchers have found that bariatric surgery, a treatment for morbid obesity, is associated with a decreased risk of future ocular morbidity and mortality. This large retrospective cohort study examined the effects of bariatric surgery on postoperative disease incidence, highlighting the potential benefits of surgery beyond weight loss. This study was published in the journal Eye by Russell and colleagues.

Bariatric surgery is widely used to treat morbid obesity, with known short-term effects on ocular pathology. However, the long-term impact of surgery on the incidence of postoperative ocular diseases remains largely unknown. This study aims to evaluate the relationship between bariatric surgery and the risk of various ocular conditions.

The study analyzed data from the TriNetX United States Collaborative Network national database. Patients with an ICD-10 code for morbid obesity and a procedural code for bariatric surgery were matched to those with morbid obesity but without surgery, resulting in two cohorts of 42,408 patients each. The study tracked the incidence of several ocular conditions after surgery, including:

  • Diabetic retinopathy

  • Age-related macular degeneration

  • Glaucoma

  • Low vision and blindness

Outcomes were assessed using relative risk (RR) with 95% confidence intervals (CI).

The key findings of the study were:

  • Bariatric surgery was associated with a significant reduction in the future risk of diabetic retinopathy (RR: 0.283; 95% CI: 0.252-0.319).

  • Patients who underwent bariatric surgery had a lower risk of developing macular edema (RR: 0.224; 95% CI: 0.170-0.297).

  • The risk of vitreous hemorrhage was also reduced (RR: 0.459; 95% CI: 0.323-0.653).

  • Bariatric surgery was linked to lower rates of ocular hypertension (RR: 0.387; 95% CI: 0.387-0.487) and glaucoma (RR: 0.360; 95% CI: 0.326-0.399).

  • The surgery was associated with a reduced risk of age-related macular degeneration (RR: 0.628; 95% CI: 0.447-0.882).

  • The risk of low vision and blindness was lower in the surgery group (RR: 0.328; 95% CI: 0.294-0.365).

The findings suggest that bariatric surgery not only aids in weight loss but also may have substantial protective effects against future ocular diseases. This could lead to a potential shift in how bariatric surgery is viewed as a comprehensive treatment for both obesity and ocular health.

Bariatric surgery is associated with a decreased risk of future ocular morbidity and mortality, including diabetic retinopathy, age-related macular degeneration, and glaucoma, among others. These findings highlight the importance of considering bariatric surgery not just as a weight loss intervention, but also as a potential preventive measure for various ocular conditions.

Reference:

Russell, M. W., Kumar, M., Li, A., Singh, R. P., & Talcott, K. E. (2024). Incidence of ocular pathology following bariatric surgery for with morbid obesity across a large United States National Database. Eye. https://doi.org/10.1038/s41433-024-03088-z

Powered by WPeMatico

Which is better local anesthesia technique for mesotherapy for Hair Regrowth in the Temporal Region?

Recently published research paper investigates the efficacy of mesotherapy for hair regrowth in the temporal region, specifically focusing on the use of platelet-rich plasma (PRP) and vitamins. The injection techniques for mesotherapy involve the administration of zygomaticotemporal nerve blocks, supratrochlear nerve blocks, and supraorbital nerve blocks. The study conducted a comparative analysis of two different local anesthesia techniques for mesotherapy and found that the use of zygomaticotemporal nerve blocks, in addition to supratrochlear and supraorbital nerve blocks, resulted in better pain control and reduction during and after the procedure.

“Comparative Study on Pain Control”

The researchers conducted a prospective comparative study with 100 participants divided into two groups (group I and group II). Group I received zygomaticotemporal, supratrochlear, and supraorbital nerve blocks, while group II received supratrochlear and supraorbital nerve blocks. The pain was assessed using a visual analog scale (VAS), and the study found that group I experienced significantly less pain during and after the procedure compared to group II.

History and Development of Mesotherapy”

The paper discusses the history and development of mesotherapy as a minimally invasive medical procedure for a wide range of medical and cosmetic issues, including hair regrowth. It elaborates on the technique of mesotherapy, which involves injecting a mixture of vitamins, minerals, amino acids, and pharmaceutical and homeopathic remedies directly into the middle layer of the skin to promote cellular regeneration and therapeutic benefits.

“Findings of Zygomaticotemporal Nerve Blocks”

The findings of the study demonstrated that the addition of zygomaticotemporal nerve blocks to supratrochlear and supraorbital nerve blocks resulted in better pain control during PRP mesotherapy in the temporal region. The paper also discusses the potential broader applications of zygomaticotemporal blocks in other medical procedures and the importance of further research in this area. It concludes by emphasizing the need for larger sample sizes and diverse injection technique comparisons to enhance the understanding of mesotherapy.

Efficacy of Mesotherapy for Hair Regrowth

In conclusion, the paper provides detailed insights into the efficacy of mesotherapy for hair regrowth in the temporal region, specifically focusing on the use of different nerve blocks for local anesthesia techniques. It underscores the importance of zygomaticotemporal nerve blocks in enhancing pain control during PRP mesotherapy and highlights the potential applications of this technique in other medical procedures. The study’s findings contribute to the understanding of mesotherapy and its potential for treating alopecia in the temporal region.

Key Points

1. The paper investigates the efficacy of mesotherapy for hair regrowth in the temporal region, specifically focusing on the use of platelet-rich plasma (PRP) and vitamins. It discusses injection techniques for mesotherapy, which involve the administration of zygomaticotemporal nerve blocks, supratrochlear nerve blocks, and supraorbital nerve blocks. The study found that the use of zygomaticotemporal nerve blocks, in addition to supratrochlear and supraorbital nerve blocks, resulted in better pain control and reduction during and after the procedure.

2. The researchers conducted a prospective comparative study with 100 participants divided into two groups. Group I received zygomaticotemporal, supratrochlear, and supraorbital nerve blocks, while group II received only supratrochlear and supraorbital nerve blocks. The pain was assessed using a visual analog scale (VAS), and it was found that group I experienced significantly less pain during and after the procedure compared to group II. This comparative study emphasized the advantage of using zygomaticotemporal nerve blocks in enhancing pain control during mesotherapy.

The paper provides detailed insights into the efficacy of mesotherapy for hair regrowth in the temporal region, focusing on the use of different nerve blocks for local anesthesia techniques, and underscores the importance of zygomaticotemporal nerve blocks in enhancing pain control during PRP mesotherapy.

Reference-

Nagaja S A, John R S, Kumar S P, et al. (April 17, 2024) Comparison of the Efficacy of Two Different Local Anesthesia Techniques for Mesotherapy in Temporal Region Alopecia. Cureus 16(4): e58498. DOI 10.7759/cureus.58498

Powered by WPeMatico

JAMA Study Reveals Risks in Prescription of QT-Prolonging Medications for Hemodialysis Patients

USA: A recent study sheds light on the potential dangers associated with the prescription and dispensation of QT-prolonging medications to individuals undergoing hemodialysis. The research, published in JAMA Network Open, highlights the need for heightened awareness and caution among healthcare providers when managing medication regimens for this vulnerable patient population.

This cross-sectional study of 20 761 adults 60 years or older revealed that non-nephrology clinicians (and from nonacute settings) commonly prescribe QT-prolonging medications for patients with dialysis-dependent kidney failure. Prescriptions for potentially interacting medications often originated from different prescribers.

The study findings suggest the need for clinician- and health system–level strategies aimed at minimizing high-risk medication–prescribing practices in the population undergoing dialysis.

Hemodialysis, a life-sustaining treatment for individuals with end-stage renal disease, involves the removal of waste products and excess fluids from the blood. However, patients undergoing hemodialysis often experience electrolyte imbalances, particularly in potassium and magnesium levels, which can predispose them to cardiac arrhythmias, including QT prolongation.

QT prolongation, characterized by an abnormal QT interval prolongation on an electrocardiogram (ECG), increases the risk of potentially fatal ventricular arrhythmias, such as torsades de pointes. Certain medications, known as QT-prolonging drugs, can exacerbate this risk by further disrupting cardiac repolarization.

Against the above background, Virginia Wang, Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, and colleagues aimed to examine dispensation and prescription patterns of QT-prolonging medications with known torsades de pointe (TdP) risk and selected interacting medications prescribed to individuals receiving hemodialysis.

The study included patients enrolled in Medicare Parts A, B, and D receiving in-center hemodialysis from January 1 to December 31, 2019.

Exposures were new-user prescriptions for the seven most frequently filled QT-prolonging medications characterized by the timing of the new prescription relative to acute care encounters, the type of prescribing clinician and pharmacy that dispensed the medication, and concomitant selected medications used known to interact with the seven most frequently filled QT-prolonging medications with known TdP risk.

The main outcomes were the new-use episodes and frequencies of the most commonly filled QT-prolonging medications; prescribers and dispensing pharmacy characteristics for new use of medications; the timing of medication fills relative to acute care events; and the frequency and types of new-use episodes with concurrent use of potentially interacting medications.

Following were the study’s key findings:

  • Of 20 761 individuals receiving hemodialysis in 2019 (mean age, 74 years; 51.1% male), 52.9% filled a study drug prescription.
  • Approximately 80% (from 78.6% for odansetron to 93.9% for escitalopram) of study drug new-use prescriptions occurred outside of an acute care event.
  • Between 36.8% and 61.0% of individual prescriptions originated from general medicine clinicians.
  • Between 16.4% and 26.2% of these prescriptions occurred with the use of another QT-prolonging medication.
  • Most potentially interacting drugs were prescribed by different clinicians (46.3%-65.5%).

As the prevalence of end-stage renal disease continues to rise globally, addressing the complexities of medication management in hemodialysis patients remains paramount in reducing the burden of cardiovascular morbidity and mortality in this vulnerable population.

Reference:

Wang V, Wang C, Assimon MM, Pun PH, Winkelmayer WC, Flythe JE. Prescription and Dispensation of QT-Prolonging Medications in Individuals Receiving Hemodialysis. JAMA Netw Open. 2024;7(4):e248732. doi:10.1001/jamanetworkopen.2024.8732

Powered by WPeMatico

Endotracheal tube versus reinforced laryngeal mask- which is better for endoscopic sinus surgery?

Recently published study provides valuable insights into the effectiveness of RLMA as an alternative airway technique for sinus surgery and suggests potential benefits such as reduced anesthesia duration and postoperative adverse events, contributing to the understanding of the impact of different airway techniques on emergence characteristics in sinus surgery.

The study compared the use of reinforced laryngeal mask airway (RLMA) versus an endotracheal tube (ETT) with a throat pack during elective sinus surgery. The researchers conducted a randomized controlled trial of 72 patients and measured the primary outcome of emergence time and secondary outcomes including time to removal of airway device, remifentanil use, procedure times, mean arterial pressure (MAP), and postoperative adverse events.

Comparison of RLMA and ETT for Sinus Surgery

The study found that there was no significant difference in emergence time between the ETT and RLMA groups. However, remifentanil use was significantly higher in the ETT group, and the ETT group showed a significantly increased total anaesthetic time. Mean arterial pressure (MAP) did not show significant differences between the two groups. The reinforced laryngeal mask airway (RLMA) had lower rates of postoperative adverse events, such as cough and throat pain.

Findings and Outcomes

The findings indicate that RLMA was comparable to ETT in terms of emergence time, with lower remifentanil use, anaesthesia duration, and fewer postoperative adverse events. The study also highlighted the potential advantages of RLMA, including smoother emergence from anaesthesia and decreased upper airway stimulation. The RLMA group also required less rescue dosing with fentanyl or metaraminol, suggesting improved ease of maintaining a stable anaesthetic.

In conclusion, the study demonstrated that using RLMA for endoscopic sinonasal surgery was comparable to ETT in terms of emergence time, remifentanil use, and adverse events such as sore throat. The study provides valuable insights into the effectiveness of RLMA as an alternative airway technique for sinus surgery and suggests potential benefits such as reduced anaesthesia duration and postoperative adverse events. The findings contribute to the understanding of the impact of different airway techniques on emergence characteristics in sinus surgery.

Key Points –

– A randomized controlled trial compared the use of reinforced laryngeal mask airway (RLMA) versus an endotracheal tube (ETT) with a throat pack during elective sinus surgery among 72 patients.

– The study found no significant difference in emergence time between the ETT and RLMA groups, but remifentanil use was significantly higher in the ETT group, and the ETT group showed a significantly increased total anaesthetic time. RLMA had lower rates of postoperative adverse events, such as cough and throat pain.

– The findings indicate that RLMA was comparable to ETT in terms of emergence time, with lower remifentanil use, anaesthesia duration, and fewer postoperative adverse events. The study suggests potential benefits of RLMA, including smoother emergence from anaesthesia and decreased upper airway stimulation.

Reference –

Raokadam, Vasanth; Thiruvenkatarajan, Venkatesan; Bouras, George S.; Zhang, Alex1; Psaltis, Alkis. Emergence characteristics comparing endotracheal tube to reinforced laryngeal mask airway during endoscopic sinus surgery – A randomised controlled study. Indian Journal of Anaesthesia 68(5):p 460-466, May 2024. | DOI: 10.4103/ija.ija_966_23.

Powered by WPeMatico

Greater adiposity measures during childhood linked to increased risk of PCOS: Study

Greater adiposity measures during childhood linked to increased risk of PCOS suggests a study published in the Pediatrics.

Polycystic Ovary Syndrome (PCOS) is common among females, with significant metabolic and reproductive comorbidities. We describe PCOS development in a pediatric population. They assessed cardiometabolic biomarkers and adiposity at the mid-childhood (mean 7.9 y), early teen (mean 13.1 y), and midteen (mean 17.8 y) visits among 417 females in the prospective Project Viva cohort. We defined PCOS via self-reported diagnosis or ovulatory dysfunction with hyperandrogenism in mid-late adolescence. We used multivariable logistic regression to assess associations of metabolic and adiposity markers at each visit with PCOS. RESULTS: Adolescents with PCOS (n = 56, 13%) versus without had higher mean (SD) BMI z-score and truncal fat mass at the mid-childhood (0.66 [0.99] vs 0.30 [1.04]; 3.5 kg [2.6] vs 2.7 [1.5]), early teen (0.88 [1.01] vs 0.25 [1.08]; 9.4 kg [6.7] vs 6.1 [3.4]), and midteen (0.78 [1.03] vs 0.33 [0.97]; 11.6 kg [7.2] vs 9.1 [4.9]) visits as well as lower adiponectin to leptin ratio at the early (0.65 [0.69] vs 1.04 [0.97]) and midteen (0.33 [0.26] vs 0.75 [1.21]) visits. In models adjusted for maternal PCOS, education and child race and ethnicity (social factors), we found higher odds of PCOS per 1-SD increase in truncal fat at mid-childhood (odds ratio [OR] 1.42; 95% confidence interval [CI] 1.03–1.95) and early teen visits (OR 1.61; 95% CI 1.14–2.28) and lower odds per 1-SD increase in adiponectin/leptin ratio at the midteen visit (OR 0.14; 95% CI 0.03–0.58). Childhood excess adiposity and adipose tissue dysfunction may be the first signs of later PCOS risk.

Reference:

Rachel C. Whooten, Sheryl L. Rifas-Shiman, Wei Perng, Jorge E. Chavarro, Elsie Taveras, Emily Oken, Marie-France Hivert; Associations of Childhood Adiposity and Cardiometabolic Biomarkers With Adolescent PCOS. Pediatrics May 2024; 153 (5): e2023064894. 10.1542/peds.2023-064894

Keywords:

Greater, adiposity, measures, during, childhood, increased risk, PCOS, study, Rachel C. Whooten, Sheryl L. Rifas-Shiman, Wei Perng, Jorge E. Chavarro, Elsie Taveras, Emily Oken, Marie-France Hivert

Powered by WPeMatico

Delhi HC tells Chief Secretary to Implement Panel Recommendations to cure defects in current medical system to avail financial assistance

New Delhi: For the patients seeking free medical treatment under various government schemes in the hospitals in Delhi, the High Court has directed the Chief Secretary of the Delhi Government to ensure the implementation of the recommendations given by a seven-member committee in this regard.

The High Court division bench comprising Acting Chief Justice Manmohan and Justice Manmeet PS Arora has issued directions to the Chief Secretary of GNCTD to convene monthly meetings till all the recommendations get implemented. Further, the Court has directed the Chief Secretary to file action taken report on or before 15th October 2024.

Upgradation of Government hospital websites, the appointment of nodal officers by all Public hospitals, implementation of single window mechanism etc. are some of the recommendations made by the Committee set up by the High Court.

The HC bench set up the Committee during the proceedings of the plea filed by a man seeking direction upon the authorities including the All India Institute of Medical Sciences (AIIMS) to perform the hip and knee replacement surgery on the Petitioner free of cost.

His dire need for surgical intervention arose from his affliction with Reiter’s Syndrome, alternatively known as reactive arthritis, which led to his immobilization.

Accordingly, the HC set up the committee to devise recommendations for alleviating and curing the defects in the current medical system to avail financial assistance.

In this regard, the HC bench had mentioned in the order dated 20.09.2023, “The procedure required for availing free medical treatment must be streamlined, including various surgeries, as well as surgeries for implants / devices and to put in place a single-window mechanism with designated nodal officers at each hospital in Delhi.”

Through that order, the HC had stipulated the terms of reference for the committee. Consequently, the counsel for GNCTD handed over the recommendation of the said Committee and the Court took it on record.

Recommendations Made by the Committee: 

  •  Upgradation of Hospital Website: 

The Committee recommended to upgrade the website of each and every Government Hospital of Delhi as dynamic website for real time updates on available medicine, implants and devices with the help of NIC/selected vendors

Similarly All Public hospitals must ensure the Electronic Display System accessible to visitors/patients for the dynamic information of list of drugs, implants and devices on the website of concerned departments, which may be revised frequently, the panel suggested.

  • Appointment of Nodal Officers: 

The HC Committee recommended appointing Nodal Officers by all Public Hospitals- Delhi government hospitals/Central Government hospitals/MCD hospitals/ Autonomous hospitals including AIIMS situated in NCT of Delhi for all the schemes (DAK. RAN & HMCPF) who will ensure all the due requisite required for availing financial assistance.

  • Single Window Mechanism: 

The Panel suggested implementing/enhancing the Single Window mechanism in all Hospitals- Delhi Government hospitals/Central Government hospitals/MCD hospitals/ Autonomous hospitals including AIIMS situated in the NCT of Delhi for the convenience of patients.

“The software may be developed with help of NIC (as recommended above) for Delhi Arogya kosh also so that details will be available and repeated patient/beneficiary appearance can be avoided. Similarly RAN IT platform shall be extended to Delhi Government hospitals and MCD hospitals,” the panel recommended.

It further mentioned, “Till the time the software is developed, E-office can be utilised by all the hospitals and E-file for the concerned patient can be prepared from the hospital itself with all the requisites as per schemes and transferred to concerned DAK/RAN offices. This will expedite the process and also help in maintain transparency.”

  • Prepare Rate Cards Through CPA: 

The HC panel further recommended immediately preparing the rate card through CPA for fixing rates of all types of equipment- including implants, and medicines through Government procurement system for the diseases covered under scheme as well as for all types of treatment.

It opined that the process may take 3 months to be completed. It further stated that there may still be certain medicines/consumables etc which are not part of Essential drug list and rate card is not available for these, hospital/institute shall continue to procure these locally through their procurement system following the GFR guidelines and funds can be obtain from their own allocated budget for EWS patients or funds can be taken from the DAK/RAN. As there is no role of patient/ its relative in the procurement, they shall not be called upon to do under any circumstances.

Pointing out that the Medical Directors of the Govt. Hospitals have been conferred the powers of H.O.D who may be authorized to pass the application for emergency treatment, the panel said that the patient will not be asked to get the quotation for estimated treatment cost and genuineness of estimate & cost of implants etc. as it will be the responsibility of H.O.D(MS/MD of concerned Hospital).

It recommended that the hospitals be advised to be more proactive for treatment of such patients and expedite the process for approval preferable within 7 days. The Committee also recommended that DAK should sanction such case preferably within 7 days. Till such time hospitals may continue to take care of these patients through available resources with them, it opined.

  • Sensitizing Hospital Staff Responsible for Implementing These Schemes: 

It has been recommended by the HC Committee that the hospital staff responsible for implementation of these scheme may be sensitized on creating a patient-friendly environment and shall be trained in communication skills.

Issuing directions to the GNCTD Chief Secretary to oversee implementation of the recommendations by the panel, the Court listed the matter for compliance on 22nd October 2024.

Medical Dialogues had earlier reported that the Delhi High Court had directed the Chief Secretary and the Principal Health Secretary to implement the “immediate measures” proposed by a six-member expert committee within 30 days to enhance medical services in the government hospitals.

“The chief secretary and the principal health secretary shall also indicate a roadmap as to how they intend to implement the intermediate and long-term measures within the timeline stipulated by the expert committee. Let an action taken-cum-status report be filed by the principal health secretary within four weeks,” a bench of Acting Chief Justice Manmohan and Justice Manmeet PS Arora said in a recent order.

To view the recent HC order, click on the link below:

https://medicaldialogues.in/pdf_upload/delhi-hc-order–238173.pdf

Also Read: Poor Infrastructure at Govt Hospitals: HC orders implementation of immediate measures suggested by expert panel

Powered by WPeMatico

CDSCO Panel opins Abbott Healthcare to Conduct Phase III CT of Clarithromycin ER Tablets 1000mg

New Delhi: Citing that there is no specific unmet medical need, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Abbott Healthcare to conduct Phase-III clinical trial of Clarithromycin extended released (ER) Tablets 1000mg.

This came after Abbott Healthcare presented a bioequivalence (BE) report along with justification for the waiver of the Phase-III clinical trial before the committee.

The committee noted that proposed drug, Clarithromycin ER tablet 1000mg is presently not approved anywhere in the world.

“Clarithromycin ER tablet 1000mg had been approved in the year 2005. However, later on the same was withdrawn from the US market due to unknown reasons.” the expert panel noted.

Furthermore, the committee stated that there is no specific unmet medical need of proposed formulation.

Clarithromycin is a macrolide antibiotic used for the treatment of a wide variety of bacterial infections such as acute otitis, pharyngitis, tonsillitis, respiratory tract infections, uncomplicated skin infections, and helicobacter pylori infection.

Clarithromycin, a semisynthetic macrolide antibiotic derived from erythromycin, inhibits bacterial protein synthesis by binding to the bacterial 50S ribosomal subunit. Binding inhibits peptidyl transferase activity and interferes with amino acid translocation during the translation and protein assembly process. Clarithromycin may be bacteriostatic or bactericidal depending on the organism and drug concentration.

At the recent SEC meeting for antimicrobial and antiviral held on 9th May 2024, the expert panel reviewed the BE report along with justification for waiver of Phase-III clinical trial of the antimicrobial drug Clarithromycin ER Tablets.

After detailed deliberation, the committee reiterated its earlier SEC recommendation to conduct a Phase-III clinical trial.

Accordingly, the expert panel suggested that the firm should submit Phase-III clinical trial protocol to CDSCO for further review by the committee.

Also Read: Submit Data on Paracetamol-Tapentadol Combination: CDSCO Panel tells MSN Laboratories

Powered by WPeMatico