World Health Organization Essential Drug Research Articles

NMR Longitudinal Rotating Frame Relaxation Time (T1ρ) with a Weak Spin Locking Field as an Approach to Characterize Solid-State Active Pharmaceutical Ingredients: Proof of Concept.

Nuclear magnetic resonance (NMR) longitudinal rotating frame relaxation time (T1ρ), rarely used in low-field NMR, can be more effective than conventional T1 and T2 relaxation times to differentiate polymorphic forms of solid pharmaceuticals. This could be attributed to T1ρ sensibility to structural and molecular dynamics that can be enhanced by changing the strength of the oscillating magnetic field (B1) of spinlock pulses. Here, we compared the capacity of T1, T2, and T1ρ to differentiate inactive (A) and active (C) crystalline forms of the World Health Organization essential drug Mebendazole. The results showed that T1 and T2 values of both forms were statistically identical at 0.47 T. Conversely, T1ρ of both forms measured with weak spinlock B1 fields, ranging from 0.08 to 0.80 mT were statistically different in the same spectrometer. The T1ρ also has the limit of detection to detect the presence of at least 10% of inactive A form in the active C form. Therefore, T1ρ, measured with weak spinlock B1 fields can be an effective, streamlined, and complementary approach for characterizing not only solid active pharmaceutical ingredients but other solid-state materials as well.

Monoclonal antibody usage pattern in a tertiary care center: A retrospective study

Abstract Background: Monoclonal antibodies (mAbs) are agents that are clones of homogenous parent B cells used in managing and diagnosing multiple conditions. They are used for individualized therapy for patients due to their high specificity for an antigen/epitope. Much needs to be understood about their utilization patterns in a developing country like India, where accessibility and cost play a major role in patient care. Objectives: The objectives of this study were to evaluate the drug prescribing patterns and indications for use of mAbs and compare their availability, with the essential drug list of the World Health Organization (WHO) and the National list of essential medicines in India (NLEM). Materials and Methods: This is a retrospective cross-sectional study conducted from July to December 2021. Data were collected from 237 patients who have visited the tertiary care center or been admitted and have received mAbs. Demographic data, department of admission, diagnosis on admission, and mAbs used during treatment were recorded and analyzed. Results: Out of the 237 patients, who were eligible for this study, 61.6% of them were males and 38.4% were females. The department of ophthalmology used mAbs most commonly (65.8%). Ranibizumab was the most used mAb in this department and overall. Conclusion: Out of the mAbs being used in the tertiary care center, only rituximab was part of the NLEM (India) essential drug list, and six more drugs were present in the WHO essential drug list. The advent of biosimilars is expected to bring costs down significantly for the patient and have better treatment outcomes.

A study of drug utilization pattern, safety, and drug interactions in pediatric intensive care unit at tertiary care hospital

Background: Conducting drug utilization studies are crucial, particularly for pediatric patients, as it helps improve the prescribing patterns and usage of medications in the health-care system. However, there is a scarcity of research on the utilization of drugs in children, making this study an invaluable resource for understanding prescription patterns. Aims and Objectives: Main objectives behind our study were to examine and evaluate such prescription pattern in detail including antibiotics usage and prescription analysis using core drug prescribing indicators given by the World Health Organization (WHO), to evaluate adverse drug reactions that are observed during study and to evaluate drug-drug interactions (DDIs). Materials and Methods: This is an observational cross-sectional study of 12-month duration started after intuitional ethical committee approval. Total 450 prescriptions were studied. The study included all patients, regardless of gender, who were admitted to the pediatric intensive care unit (PICU). Results: Our study found that the average number of drugs per prescription was 4.87. In addition, a high percentage of drugs, specifically 97.39%, were prescribed using their generic names, while 94.84% of drugs prescribed were from the WHO essential drug list for children. Moreover, we observed that in 88.88% of encounters, antibiotics were prescribed and percentage of prescriptions, in which drugs were prescribed through injectable route, was 98.22%. Very minimal amount of adverse drug reaction was seen in patients. In our study, in 75.77% of the prescriptions, DDIs were not found. Conclusion: The study found that generic names of drugs were frequently used, and a high percentage of drugs prescribed were from the WHO essential drug list. However, the study also revealed a high percentage of encounters with antibiotics and injections prescribed. The occurrence of adverse drug reactions was minimal in the study. Moreover, most prescriptions did not exhibit DDIs, indicating appropriate therapeutic management in the PICU.

PRESCRIPTION AUDIT USING THE WORLD HEALTH ORGANIZATION PRESCRIBING INDICATORS FOR INDOOR PATIENTS TREATED UNDER CMAAY/PMJAY INSURANCE SCHEMES IN A TERTIARY CARE TEACHING HOSPITAL

Objective: This study focused on the prescriptions audit of indoor patients treated under Pradhan Mantri Jan Arogya Yojana (PMJAY) and Chief Minister Arogya Arunachal Yojana (CMAAY) insurance schemes as per the World Health Organization (WHO) prescribing indicators. Materials and Methods: Retrospective cross-sectional study was conducted and the prescriptions of around 960 patients were analyzed who were treated from June 2020 to December 2020 under CMAAY/PMJAY insurance schemes at Tomo Riba institute of Health and Medical Sciences in Arunachal Pradesh. Study was conducted in five departments and Information was collected through the review of case sheets. The post-operative day prescription was analyzed for the patients who have undergone surgery and the patients who were managed conservatively; admission day prescription was analyzed using the WHO core drug prescribing indicators. Following data were analyzed. (1) Average no of drugs prescribed per encounter; (2) percentage of encounter having antibiotic; (3) percentage of drugs prescribed by generic name; (4) percentage of encounters with an injection; and (5) percentage of drugs prescribed from the essential drug list. Results: A total of 960 indoor patients treated under five departments, out of which 359 (37.4%) treated under general surgery, 383 (39.9%) under Obstetrics and Gynecology department, 65 (6.8%) under ENT department, 68 (7.1%) under orthopedics department, and 85 (8.9%) under General medicine department. All departments taken together, the average number of drugs used per patient was 4.91. Antibiotics were prescribed in 92.18% of the total patients when all departments were included, single antibiotic was used in 72.18%, two antibiotics in 17.29%, and three in 2.7% of the total patients. Overall, the generic names were written in 67.3% of the total drugs and the most commonly used route was parenteral route, in about 98.19% of the total prescribed drugs. From the essential drugs list, 89.33% of the total drugs were prescribed. Fixed drug combination was used in 13.59% of the total drugs prescribed. Conclusion: In our study, the percentage of prescriptions with average no of drugs per prescription, antibiotic used, injections used were much higher when compared to the WHO core prescribing indicators. The reason might be because we have analyzed the prescription of indoor patients and most of them were post-operative patients, so it is justified. While prescribing, the physicians and surgeons followed WHO essential drug list but use of generic names was in few prescriptions. The generic name use to be more emphasized, encouraged, and promoted.

Registration of amiloride in South Africa: Cutting the Gordian knot.

Amiloride is an antagonist of the renal tubular epithelial sodium channel (ENaC). As such, it is a diuretic that is both potassium and magnesium sparing. It is used for the treatment of potassium depletion and hypertension, and is the specific therapy for hypertension due to overactivity of the ENaC (Liddle syndrome and several additional genetic causes of the Liddle phenotype - low renin and low aldosterone). It is listed as a World Health Organization essential drug, but has never been registered in South Africa (SA) and can therefore only be prescribed under a Section 21 application to the SA Health Products Regulatory Authority (SAHPRA) on a case-by-case basis. In SA, >50% of patients treated for hypertension are not controlled. In the USA, the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study reported that African Americans are more likely to be diagnosed with hypertension, more likely to be treated, more likely to be treated intensively, and less likely to achieve blood pressure (BP) control. Although the reasons are complex, studies show that 10 - 20% of blacks may carry the Liddle phenotype. Observational data and a controlled clinical trial done in three African countries have shown that these patients respond to amiloride and not to conventional guideline-based antihypertensive treatment. The former is likely to result in a significant reduction in cardiovascular, stroke and kidney morbidity and mortality, because of improved BP control. Amiloride is very unlikely to ever be registered in SA, as it was first developed >50 years ago, and SAHPRA regulations prevent widespread prescription of this essential drug. This is a classic Gordian knot that requires a novel approach from authorities to sever the knot and improve the health of many South Africans.

Drug utilization pattern in geriatric out patient in tertiary care hospital

Background: Inappropriate drug prescribing is a global problem affecting the healthcare system. Aim and objective of the study was to study the drug utilization pattern in geriatric patient at rural tertiary care hospital.Methods: This was a cross- sectional observational study involving 600 geriatric outpatient. This study was carried out from Nov 2015 to May 2016. The data were collected using predesigned proforma specially designed for this purpose. Relevant information was obtained by analyzing prescription for World Health Organization (WHO) core drug indicators.Results: Total number 600 prescriptions analyzed at the end of six months were from general medicine department. The mean age of the patients was 63.9 years in which male (61.33%) outnumber the female. Total number 2598 drugs were prescribed to 600 patients for different diseases. The mean number of drugs per prescription were 4.33, drugs were prescribed by generic name 26.42%. drugs were prescribed from WHO essential drug list86.33. The type of formulations used were tablets and capsules in 88.5%, syrups in 5%, injections 3.5 % and inhalers 2%. Drug for Cardiovascular diseases were the most common (29.66) followed gastrointestinal (16.67), vitamins and minerals (14.66). Analgesic and NSAIDS (14.13) also prescribed commonly. Antimicrobial drugs prescribed in (7.46%) and common antibiotic prescribed were Amoxicillin ciprofloxacin and metronidazole.Conclusions: This study also effectively provides very useful baseline data also demonstrates the prescribing patterns of drugs in the geriatric patients.

Study of clinico-epidemiological profile, drug utilization pattern, and outcome of swine flu cases: A recent epidemic in Latur

Background: Swine flu, an acute respiratory tract disease, is caused by swine flu virus. The World Health Organization (WHO) declared the H1N1 pandemic in June 2009 after more than 70 countries reported cases of H1N1 infection. Since 2009-2014, 59,677 cases and 4141 deaths have been reported in India. Objective: To study the clinico-epidemiological profile, drug utilization pattern, and outcome of H1N1 positive cases admitted to swine flu ward from January 2015 to September 2015 at a tertiary care hospital in Latur. Materials and Methods: The study was conducted from January 2015 to September 2015 at Government Medical College (GMC), Latur. Clinicoepidemiological profile, treatment details, and outcome of the patients were recorded. Prescription pattern was analyzed using the WHO International Network for Rational Use of Drug use indicators. Results: A total of 52 swine flu positive cases were admitted to GMC, Latur, out of which 38 (73.07%) were female patients and 14 (26.92%) were male patients. Total numbers of drugs prescribed were 267. The most common antimicrobial prescribed was oseltamivir. Total drugs prescribed from the National List of Essential Medicine 2015 were 98 (36.70%). Conclusion: This study is an attempt to know the clinico-epidemiological profile, drug utilization pattern, and outcome in swine flu positive patients. A good adherence to the WHO guideline for clinical management of swine flu cases, the Joint Indian Chest Society and the National College of Chest Physician guidelines, and the WHO Essential Drug List was seen in our study. However, prescription with the brand name, polypharmacy, and excessive use of fixed dose combinations are a matter of concern.

Prescribing pattern, polypharmacy and potentially inappropriate prescribing in hospitalized elderly patients: a retrospective study in a teaching hospital in Nepal

<p class="abstract"><strong>Background:</strong> Evaluate prescribing pattern, polypharmacy, and prescribing potentially inappropriate medicine (PIM) in elderly population to contribute in awareness towards rational use of drugs.</p><p class="abstract"><strong>Methods:</strong> A retrospective cross-sectional and observational study was done in hospitalized geriatric patients in Nepal. The World Health Organization (WHO) “core prescribing indicators” and Beers' 2012 updated criteria were used to assess prescribing pattern and inappropriate prescribing respectively. The drug- drug interactions were checked using Medscape drug interaction checker. In addition, disease prevalence and the most commonly prescribed drugs were also assessed where diseases and drugs were classified according to International Classification of Diseases-10 (ICD-10) and the Anatomical Therapeutic Chemical (ATC) classification respectively.</p><p class="abstract"><strong>Results:</strong> Out of 225 patients, 118 (52.4%) were males and most of the patients were in the age group 65-74 years (125, 55.6%). The diseases of circulatory system were more prevalent (135, 60%) and the average number of drugs was 8.19±3.50. Generic name prescribing was 8.51% and 77.33% of prescription contained antibiotic(s). Injection(s) prescribed were 80%, and drugs prescribed from national essential drug list and WHO essential drug list were 52.55% and 46.15% respectively. Medicines for alimentary tract and metabolism (215, 95.55%) and cardiovascular system (155, 68.89%) were most frequently prescribed. Polypharmacy (≥5 drugs) was found in 195 (86.66%) patients and was significant (P= 0.001). The potentially inappropriate medicines (PIMs) prescribed were 133 (7.21%) and at least one PIM was prescribed to 78 (34.67%) patients. Almost half numbers of patients (48.9%) were detected with at least one potential drug-drug interaction (DDI).</p><strong>Conclusions:</strong> Majority of hospitalized elderly patients received polypharmacy with drugs which may have serious drug-drug interactions. Thus, less number of drugs per prescription with minimum potential of drug-drug interaction and inappropriate medicines for elderly can be reinforced by implementing proper system of recording and analysing the therapy.

Are we too reluctant about irrational nutraceutical combinations?

Background: The objective of the study was to study the rationality of Vitamins and minerals combinations available in India and to provide comprehensive data of irrational combinations having excess and sub sufficient quantity of vitamin and minerals than recommended by National Guidelines of India. Methods: This observational study and analysis was done between June and August 2016. Data was collected from current index of medical specialties and drug India. Rationality assessment was done using National list approved drug combinations by Central drug standard control organization (CDSCO) and essentially was cross checked using World Health Organization essential drug list 2015. Adequacy was analysed using Dietary reference intake (DRI) for Indians by Nutrional council of India draft guidance. Results: In our analysis, we have found 1184 irrational nutraceutical preparations available in India market. Out of 461(38.9%) are based on fat soluble vitamins, 190 (16.4%) based on B-complex vitamins based and 5339 (45.1%) related to essential minerals. Among 461 fat soluble vitamins, 104 contain excessive level, 334 contain substandard levels. Similarly 128 and 62 Vitamin B-Complex based preparations are having excess and less quantity than recommended levels respectively and almost all the mineral combinations except four are not prepared following guidelines. None of these combinations were included in National essential list of medicines. Conclusions: Multivitamins are generally considered safe; these are irrationally prescribed and taken as self-medication by public. Many of the ill effects are often unnoticed and under reported. Government of India should regulate the manufacture and sale these nutraceuticals to promote rational use of drugs and to promote wellbeing and safety of Indian population which is primary objective of ‘Health for all’.

Prescription pattern of fixed dose drug combination in tertiary care hospital: An evaluation study

The fixed dose combination (FDC) therapy varies among countries. The available combination drugs in the market include both rational and irrational ones. The use of irrational fixed dose combination has a great impact on consumers, society and the nation. Since a few studies on prescribing patterns of fixed dose combination are available in literature, there is need for such a study. In this prospective study, carried out in a tertiary care teaching private hospital, one thousand prescriptions from the hospital pharmacy were collected, classified according to anatomic therapeutic and chemical (ATC) classification. The fixed drug combination used was compared with the essential drug list of World Health Organization (WHO) and other countries. In one thousand prescriptions, 3151 drugs were prescribed, of which, 960 were fixed dose combination drugs. Among those, the anti-infective agents for systemic use (17.5%) and drugs affecting the central nervous system (17.08%), cardiovascular system (15.41%) and alimentary system (11.14%) mainly contributed to the fixed dose combinations. The highest percentage of FDCs was seen among the nervous system (36.6%), anti-infective (33.67), anti-neoplastic (31%), respiratory system (31%) and various drugs (35.90%) category which were more than the average percentage of fixed dose combination drug use (30.47%). Majority of the FDCs prescribed (73.25%) were not approved in the WHO essential drug list. There is a significant burden of these combinations on consumers, physicians and policy makers which needs to be handled with care.

Molecular Properties of WHO Essential Drugs and Provisional Biopharmaceutical Classification

The purpose of this study is to provisionally classify, based on the Biopharmaceutics Classification System (BCS), drugs in immediate-release dosage forms that appear on the World Health Organization (WHO) Essential Drug List. The classification in this report is based on the aqueous solubility of the drugs reported in commonly available reference literature and a correlation of human intestinal membrane permeability for a set of 29 reference drugs with their calculated partition coefficients. The WHO Essential Drug List consists of a total of 325 medicines and 260 drugs, of which 123 are oral drugs in immediate-release (IR) products. Drugs with dose numbers less than or equal to unity [Do = (maximum dose strength/250 mL)/solubility < or = 1] are defined as high-solubility drugs. Drug solubility for the uncharged, lowest-solubility form reported in the Merck Index or USP was used. Of the 123 WHO oral drugs in immediate-release dosage forms, 67% (82) were determined to be high-solubility drugs. The classification of permeability is based on correlations of human intestinal permeability of 29 reference drugs with the estimated log P or CLogP lipophilicity values. Metoprolol was chosen as the reference compound for permeability and log P or CLogP. Log P and CLogP were linearly correlated (r2 = 0.78) for 104 drugs. A total of 53 (43.1%) and 62 (50.4%) drugs on the WHO list exhibited log P and CLogP estimates, respectively, that were greater than or equal to the corresponding metoprolol value and are classified as high-permeability drugs. The percentages of the drugs in immediate-release dosage forms that were classified as BCS Class 1, Class 2, Class 3, and Class 4 drugs using dose number and log Pwere as follows: 23.6% in Class 1, 17.1% in Class 2, 31.7% in Class 3, and 10.6% in Class 4. The remaining 17.1% of the drugs could not be classified because of the inability to calculate log P values because of missing fragments. The corresponding percentages in the various BCS classes with dose number and CLogP criteria were similar: 28.5% in Class 1, 19.5% in Class 2, 35.0% in Class 3, and 9.8% in Class 4. The remaining 7.3% of the drugs could not be classified since CLogP could not be calculated. These results suggest that a satisfactory bioequivalence (BE) test for more than 55% of the high-solubility Class 1 and Class 3 drug products on the WHO Essential Drug List may be based on an in vitro dissolution test. The use of more easily implemented, routinely monitored, and reliable in vitro dissolution tests can ensure the clinical performance of drug products that appear on the WHO Essential Medicines List.

Issues in the treatment of Mycobacterium tuberculosis in patients with human immunodeficiency virus infection.

The HIV/AIDS pandemic has led to a rise in the incidence of tuberculosis and an epidemic of co-infection in many developing countries. Treatment of Mycobacterium tuberculosis in persons with HIV infection presents several challenges to the clinician particularly in resource-poor countries. As will be discussed in this paper diagnosis of latent tuberculosis relies on tuberculin skin testing which has poor sensitivity and reproducibility in immunocompromised patients. The World Health Organization (WHO) recommends treatment of active tuberculosis as the primary means of global tuberculosis control. In practice treatment of active tuberculosis typically requires that a symptomatic patient self-report to a health service for evaluation and management. Even if this approach to tuberculosis control were sufficient many logistic and clinical problems remain involving tuberculosis diagnosis and therapy in the patient with HIV/AIDS. Recognizing the significant clinical and public health challenges surrounding the treatment of tuberculosis in patients with HIV infection this paper will address a number of issues relevant to the care of co-infected patients. These include current guidelines for the treatment of active tuberculosis as well as the diagnosis and treatment of latent tuberculosis in HIV-positive patients. The paper concludes with a discussion of promising new drugs for tuberculosis treatment. (excerpt)