National list of essential medicines of India: the way forward.

Essential medicines lists have been shown to improve the quality and cost-effectiveness of health care delivery when combined with proper procurement policies and good prescribing practices. The Ministry of Health, Government of India revised the National List of Essential Medicines of India (NLEMI 2011) in June 2011, eight years after the last revision. The NLEMI 2011 contains 348 medicines and was prepared over one and a half years by 87 experts. Though there are some positive aspects to the list such as the documentation of a detailed description of the revision process, inclusion of many experts from various fields in the review committee, well written description of the essential medicines concept and others, a critical review of the list reveals areas of major and minor concerns. Improper medicine selection like the inclusion of a nearly obsolete medicine such as ether, an anesthetic agent; non-inclusion of pediatric formulations; spelling errors; and errors in the strengths of formulations diminishes the significance of the NLEMI 2011. In its present form, the NLEMI 2011 did not align with the Indian Pharmacopoeia, and the National Health Programs as well as the National Formulary of India 2010. Formatting errors, non-inclusion of an index page, syntax and spelling errors may also undermine the usefulness of the NLEMI 2011 as a reference material. An urgent revision of the NLEMI 2011 is suggested so as to avert misinforming the wider international and local readers.

Is there need for a transformational change to overcome the current problems with postgraduate medical education in India?

In spite of the existence of a dual system of postgraduation, one under the Medical Council of India (MCI) and the other on a parallel track under the National Board of Examinations, postgraduate medical education in India is beset with several problems. For example, the curriculum has not been revised comprehensively for several decades. The diploma course under the MCI has become unpopular and is largely a temporary refuge for those who do not get admission to degree courses. The level of skills of the outgoing graduate is falling and the increase in the number of seats is taking place in a haphazard manner, without reference to the needs. In spite of increase in seats, there is a shortage of specialists at the secondary and tertiary care levels, especially in medical colleges, to share teaching responsibilities. Further, the distribution of specialists is skewed, with some states having far more than others. To remedy these ills and fulfil the requirements of the country over the next two decades, a working group appointed by the erstwhile governors of the MCI was asked to suggest suitable modifications to the existing postgraduate system. After an extensive review of the lacunae in the present system, the needs at various levels and the pattern of postgraduate education in other countries, it was felt that a competency-based model of a 2-year postgraduate course across all specialties, the use of offsite facilities for training and a criterion-based evaluation system entailing continuous monitoring would go a long way to correct some of the deficiencies of the existing system. The details of the proposal and its merits are outlined for wider discussion and to serve as a feedback to the regulatory agencies engaged in the task of improving the medical education system in India. We feel that the adoption of the proposed system would go a long way in improving career options, increasing the availability of teachers and dissemination of specialists to the secondary and primary levels, and improving the quality of outgoing postgraduates.

Screening of Weight-Loss Herbal Products for Synthetic Anti-Obesity Adulterants: A Target-Oriented Analysis by Liquid Chromatography-Tandem Mass Spectrometry.

BACKGROUND: The medical and social impact of being overweight, as well as the difficulty in making long-term changes in diet, physical activity, and pitfalls associated with allopathic management, lure obese individuals to over-the-counter weight-loss herbal products (WHPs). However, the safety of herbals is questionable, as reports from all over the world suggest adulteration with synthetic weight loss agents. Objective: The present study was carried out to develop a rapid and sensitive method to screen potential weight loss adulterants in WHPs. Methodology: We procured 33 licensed brands of WHPs that are available in Puducherry (India) and through web stores. Drug-free spiked herbal matrices were used for internal proficiency testing. Spiked herbal matrices and samples were extracted and centrifuged. The supernatant was collected and subjected to liquid chromatography-tandem mass spectrometry analyses. Isocratic elution was carried out by the mobile phase of methanol: 0.1% v/v formic acid (70%:30% v/v) through a C18 column. Analytes were monitored in electrospray ionization positive and negative modes, and an multiple reaction monitoring (MRM) scan was used. Results: Run time was 12 min. Intra- and inter-day precision was < 15% and recoveries were in the range of 99% to 115%. Limit of quantification (LOQ) of the analytes were in the range of 0.1 to 0.3 ng/ml. Conclusion: We developed a sensitive and rapid validated method for the detection of potential adulterants in WHPs. None of the WHPs analyzed were found to contain adulterants. The proposed method will be useful for routine monitoring. WHPs analyzed in this study were not adulterated indicating that WHPs from licensed sources are reliable.

Effect of temperature on the potency & pharmacological action of insulin.

BACKGROUND & OBJECTIVE: Since proper storage of insulin is necessary for its action, the present study was undertaken to determine the extent to which improper temperature storage conditions could have contributed to the potency of the three insulin formulations tested. METHODS: Two human insulin formulations (regular and biphasic) from three different manufacturers were stored at 5 different temperatures. In vitro potency of insulin was determined by high performance liquid chromatography on every seventh day for a period of 28 days. For the in vivo study, insulin tolerance test was done by injecting human regular insulin intraperitoneally to rabbits on the 25(th) day of storage. Blood glucose was determined at 0, 15, 30 and 60 min after insulin injection using glucometer. RESULTS: Storage at 32 and 37 degrees C showed 14-18 per cent decrease in potency of insulin in both the formulations on 28(th) day for all the three brands. Also the rabbits receiving insulin stored in 32 and 37 degrees C did not show a significant decrease in blood sugar level when compared to those receiving insulin stored at 5 degrees C. INTERPRETATION & CONCLUSION: Improper storage of insulin decreases the potency and hence the pharmacological action of insulin. Patients should be educated on the proper methods of storage, and free supplies of insulin for more than two weeks use should not be dispensed.

Effect of hyoscine butylbromide and atropine on heart rate during nocturnal sleep.

This is a single blind crossover study designed to test the effects of hyoscine butylbromide (HBB), an anticholinergic which does not cross the blood brain barrier (BBB), on the temporal changes in heart rate during nocturnal sleep. The effects were compared with atropine sulphate which is known to cross the BBB. Ten healthy male volunteers slept in the JIPMER sleep disorders laboratory for three nights and received either saline, atropine sulphate (0.4 mg, i.v.) or HBB (10 mg, i.v.) just prior to sleep onset. All night polysomnography recording was done to monitor heart rate during the specific stages of sleep. The normal physiological fall in heart rate is blunted by both drugs during slow wave sleep whereas only HBB prevented the fall in rapid eye movement sleep. Therefore, HBB may be a better choice as pre-anaesthetic medication for patients with cardiac abnormalities since it does not alter heart rate during both slow wave sleep and rapid eye movement sleep.

Ascorbic acid delays the development of tolerance to amphetamine induced anorexia but does not affect the reverse tolerance which develops to the locomotor activity.

Ascorbic acid (1 g/kg) accentuated anorectic and locomotor effects of amphetamine (5 mg/kg) and delayed development of tolerance to anorectic effect. On the contrary, it did not alter the pattern of reverse tolerance to increased locomotor activity. The results suggest that modulation of dopamine receptor sensitivity by ascorbic acid may be the reason for the delay in development of tolerance to amphetamine induced anorexia.

Effect of the Karnatic music raga "Neelambari" on sleep architecture.

The raga Nelambari in the classical Indian Karnatic system of music is said to be able to induce sleep and also have some sleep promoting qualities. This hypothesis was scientifically tested using sleep polysomnography with eight healthy subjects who listened to either Neelambari (test) raga or Kalyani (control) raga. There was no difference in sleep architecture or in subjective feeling of quality of sleep. The anecdotal references to the quality of sleep promoting effects of Neelambari probably reflect a conditioned response since most lullabies in South India are sung in Neelambari raga.

Effect of occupational noise on the nocturnal sleep architecture of healthy subjects.

BACKGROUND & OBJECTIVES: Noise is considered to be a non-specific stressor which generally causes physiological and psychological effects in an individual. Many occupations involve workers being subjected to loud noise levels without adequate protective measures. The study was done to document the changes, if any, in the nocturnal sleep architecture of healthy persons exposed to loud occupational noise during daytime. METHODS: The study was a retrospective cohort design wherein three groups of eight subjects each, exposed to continuous occupational background noise levels of >75dB for 1-2 years, 5-10 years and >15 years were selected. Corresponding age and gender matched healthy controls (eight for each group) who worked in a quiet atmosphere was also recruited. All night sleep polysomnography was done on all subjects. In the morning, subjects rated their quality of sleep on a Visual Analogue Scale. RESULTS: There is a strong association between occupational exposure to loud noise and poor sleep efficiency (Relative Risk 2.49; Confidence Interval 1.12 to 5.57; P=0.01, Fisher's exact test). The group exposed to noise for 1-2 years had a decrease in Total Rapid Eye Movement Time, Non Rapid Eye Movement Time, Slow Wave Sleep Time, Sleep Onset Latency and Total Sleep Time. The other two groups showed lesser number of changes in sleep architecture. Subjectively there was a decrease for sleep continuity in Group I and an increase for sleep onset in Group II. There is no correlation between loudness of noise in the workplace and sleep efficiency. INTERPRETATION & CONCLUSION: It can be concluded that workers exposed to loud background occupational noise are at an increased risk of having poor quality sleep but adaptation to this effect probably takes place after a few years.

Effect of occupational noise on the nocturnal sleep architecture of healthy subjects.

BACKGROUND & OBJECTIVES: Noise is considered to be a non-specific stressor which generally causes physiological and psychological effects in an individual. Many occupations involve workers being subjected to loud noise levels without adequate protective measures. The study was done to document the changes, if any, in the nocturnal sleep architecture of healthy persons exposed to loud occupational noise during daytime. METHODS: The study was a retrospective cohort design wherein three groups of eight subjects each, exposed to continuous occupational background noise levels of > 75dB for 1-2 years, 5-10 years and > 15 years were selected. Corresponding age and gender matched healthy controls (eight for each group) who worked in a quiet atmosphere were also recruited. All night sleep polysomnography was done on all subjects. In the morning, subjects rated their quality of sleep on a Visual Analogue Scale. RESULTS: There is a strong association between occupational exposure to loud noise and poor sleep efficiency (Relative Risk 2.49; Confidence Interval 1.12 to 5.57; P = 0.01, Fisher's exact test). The group exposed to noise for 1-2 years had a decrease in Total Rapid Eye Movement Time, Non Rapid Eye Movement Time, Slow Wave Sleep Time, Sleep Onset Latency and Total Sleep Time. The other two groups showed lesser number of changes in sleep architecture. Subjectively there was a decrease for sleep continuity in Group I and an increase for sleep onset in Group II. There is no correlation between loudness of noise in the workplace and sleep efficiency. INTERPRETATION AND CONCLUSION: It can be concluded that workers exposed to loud background occupational noise are at an increased risk of having poor quality sleep but adaptation to this effect probably takes place after a few years.

Comparative effects of hyoscine butylbromide and atropine sulphate on sleep architecture in healthy human volunteers.

The changes in sleep architecture, heart rate and respiratory rate to hyoscine butylbromide (HBB), a peripherally acting anticholinergic was studied. These effects were compared with that of atropine sulphate, a drug known to cross the blood brain barrier. The study followed a single blind cross over design with a one week washout period. Atropine sulphate (0.4 mg) and HBB (10 mg) were given intravenously to ten adult healthy male volunteers before sleep onset. Normal saline was used as control. All night sleep polysomnography was done with the standard montage for sleep staging. Respiration and airflow were also monitored. Rapid eye movement (REM) latency was significantly increased with both the drugs whereas the duration of REM sleep was decreased only with atropine. Slow wave sleep (SWS) was also increased significantly by atropine. There was no change in heart rate, or respiratory rate during any of the sleep stages. HBB affects the initiation of REM sleep whereas atropine affects both its initiation and maintenance.

Study of the knowledge, beliefs, and practice of sleep among medical undergraduates of Tamilnadu, India.

CONTEXT: Sleep-related problems are common in young adults who are enrolled in professional colleges due to academic and social pressures, which may subsequently have serious consequences. OBJECTIVES: This study was conducted to find out whether final-year medical undergraduates possess basic, clinically relevant knowledge (K) regarding sleep and sleep-related problems and to discover their beliefs (B) regarding sleep and sleep hygiene. We also wanted to assess their sleep practices (P) and suggest remedial measures, if necessary. DESIGN AND SETTING: Six hundred fifteen final-year medical undergraduates of both sexes belonging to 6 medical colleges of Tamilnadu state, India, were given a self-administered, anonymous questionnaire to test their basic knowledge (11 items), prevailing beliefs regarding sleep (including sleep hygiene [13 items]), and their sleep practices (6 items). RESULTS: In all 3 domains tested (K, B, and P), there was no significant difference between sex. An appreciable percentage scored < or = 70% marks ("good") only in K and P (63.9% and 79.5% of all participants, respectively), whereas only a very small percentage scored "good" in B (9.1%). There was no difference in K, B, or P in terms of sex or domiciliary status except for a significant difference (P < .012) regarding beliefs between urban and rural groups. There was also no correlation between knowledge and beliefs or between knowledge and practice. CONCLUSION: We conclude that future doctors have insufficient knowledge with more misconceptions (indirectly reflecting inadequate knowledge) regarding sleep. Hence, there is a compelling need to develop an educational strategy to overcome misconceptions and improve knowledge regarding sleep-related problems and proper sleep practices among students.

Availability of five essential medicines for children in public health facilities in India: A snapshot survey.

OBJECTIVE: To collect information on the availability of five essential children's medicines in the public health facilities of India. MATERIALS AND METHODS: A snap shot survey of the availability of five essential medicines for children was conducted. Five medicines which are included in the National Rural Health Mission (NRHM) list for subcentres were selected, i.e., vitamin A liquid solution, syrup cotrimoxazole, oral rehydration salt (ORS), syrup paracetamol, and zinc sulphate (oral liquid or tablets). Information about this survey was posted in two e-groups for pharmacologists and pharmacists and volunteers were requested to collect data on the availability of these five medicines and fill up a data sheet which was emailed back to the organizers. Data was collected from February 14 to 21, 2010. RESULTS: Data were collected from 129 public health facilities spanning 17 states, two union territories and NCT Delhi. The overall median availability was 80% (range: 0%-100%). Punjab, Tamilnadu, and Jharkhand showed 100% median availability (range: 40%-100%). Ninety percent of the facilities have ORS, paracetamol, and cotrimoxazole whereas zinc was available in only 36% of the public health facilities. Syrup cotrimoxazole and ORS have 100% availability in all states except in four and paracetamol has nearly 100% availability in all but six states. CONCLUSION: The availability of essential medicines for children in public health facilities is not satisfactory and needs to be improved.

Educational program for patients with type-1 diabetes mellitus receiving free monthly supplies of insulin improves knowledge and attitude, but not adherence.

BACKGROUND: Though patients attending a diabetic clinic in a tertiary care hospital were given free monthly supplies of insulin, it was found that their glycemic control was poor. SETTINGS AND DESIGN: A prospective interventional study was carried out at the outpatient clinic in a tertiary care hospital. AIMS: To evaluate the effectiveness of a six month educational interventional program on the knowledge, attitude and practices (KAP) of type-1 diabetic patients receiving free monthly supplies of human insulin and to assess their adherence. METHODOLOGY: Sixty-seven type-1 diabetics, receiving free insulin vials each month, were recruited. The patients' baseline glycemic index, plasma insulin and KAP scores were determined using a validated questionnaire. The patients were educated about the disease and use of insulin for the next six months. In the seventh month, the KAP questionnaire was readministered and blood parameters measured. STATISTICAL ANALYSIS: Blood glucose, glycosylated hemoglobin and plasma insulin were compared by paired t tests. Mean KAP scores by Wilcoxon matched-pairs signed-ranks test. Difference in the proportion of patients answering the items was compared using test of proportions for dependant groups. RESULTS: The overall mean scores (+/- SE) increased from 30.8 +/- 0.5 to 42.2 +/- 0.4 (P < 0.001). The improvement in practice scores, though significant, was marginal, that is, from 17.7 +/- 0.3 to 18.8 +/- 0.3. In three out of the ten items under practice domain, only the manner in which vials were being stored at home showed significant improvement (P < 0.0001). The adherence to the insulin regimen increased from 82 to 86%, but was not significant. Patients cited financial reasons for nonadherence. CONCLUSION: The study showed that a planned educational intervention in type-1 diabetics, receiving monthly supplies of insulin free of charge, did not improve the key aspects of the practice component, even though the knowledge and attitude improved.