International Journal of Basic & Clinical Pharmacology
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Evaluation of pharmacological prophylaxis for deep venous thrombosis in hospitalized patients with risk factors at the university teaching hospitals, Lusaka, Zambia
Get PDFBackground: Deep venous thrombosis is a common clinical problem accounting for high rates of morbidity and mortality. The existence of risk factors, which include trauma, venous stasis, and hypercoagulability, is linked to the occurrence of the condition. Objective of current study was to evaluate DVT risk factors and prophylaxis pattern of use for patients who were admitted at the University Teaching Hospitals in Lusaka, Zambia.Methods: A cross-sectional study was conducted using medical files for patients who were hospitalized at the University Teaching Hospitals in Lusaka, Zambia from May 2020 to June 2021. Two hundred and ninety-six patient files were reviewed, and the Caprini risk assessment model was used to stratify patients into DVT risk categories. Multilinear regression analysis was used to identify factors associated with DVT prophylaxis.Results: Of the 296 patient files that were sampled from ICU, medical, and surgical wards, 198 (66.9%) (>2 caprini score) were eligible for DVT prophylaxis, but only 77 (38.9%) of these eligible patients received prophylaxis. The number of eligible patients for DVT prophylaxis per department was as follows; ICU 50 (100%), Medical 71 (57.7%) and Surgery 77 (62.6%) wards. However, DVT prophylaxis was given to 21 (42%), 33 (46.5%), and 23 (29.9%) patients from the ICU, medical, and surgery, respectively. Enoxaparin was the most commonly used anticoagulant for Venous thromboembolism (VTE) prophylaxis with a mean dose of 60mg (SD±5). Across all departments, the most common predisposing risk factors for DVT were bed confinement for >72 hours (167, 56.4%) and age of 41-60 years (118, 39.8%). In the adjusted model, swollen legs (AOR: 3.6, CI: 1.97, 6.57) and history of VTE (AOR: 21.3, CI: 9.87, 46.08) were significantly associated with a higher likelihood of DVT prophylaxis.Conclusions: Pharmacologic thromboprophylaxis is underutilized in patients in ICU, medical and surgical wards at the university teaching hospitals in Lusaka, Zambia. This study underscores the importance of implementing a DVT risk assessment technique for patients in ICU, medical and surgical wards and administering prophylaxis unless contraindicated
A clinical pharmacological experimental research analysis of the evidence-based rational pharmacotherapeutics of pefloxacin and newer quinolones
Get PDFBackground: Pefloxacin is a newer broad-spectrum bactericidal fluoroquinolone antibiotic, with superior antibacterial activity in vivo against pathogenic ocular gram-negative and anaerobic microorganisms and better pharmacokinetic properties.Methods: 100 bacterial conjunctivitis patients were prescribed topical pefloxacin 0.3% ophthalmological drops monotherapy, 2 drops in each eye after every 3 hours for 2 days, and 2 drops in each eye after every 6 hours for next 5 days. The overall recovery of the patients was clinically examined and assessed. The patients who did not recover completely with 0.3% pefloxacin monotherapy ophthalmological drops, were administered topical pefloxacin 0.3% ophthalmological drops, 2 drops in each eye after every 6 hours for the next 3 days, as combination therapy, with other required ophthalmological eye drops, depending on the prognostic follow-up, on days 0, 3, 5, 7, 10, 15, 30, and on further follow-ups. The evidence-based rational pharmacotherapeutic patient percentage topical application requirements of 0.3% pefloxacin ophthalmological drops monotherapy and subsequent combination therapy for complete recovery from bacterial conjunctivitis was thoroughly analysed and assessed.Results: In this study, the patient percentage topical application requirements of pefloxacin 0.3% ophthalmological drops monotherapy and combination therapy in bacterial conjunctivitis patients showed that 93% patients had completely recovered with pefloxacin monotherapy, and 7% patients required pefloxacin combination therapy for complete recovery. The evidence-based rational pharmacotherapeutics of newer quinolones, in global multi-centre tertiary care hospitals, was also well characterized and analytically described.Conclusions: Therefore, 93% patients had completely recovered with the ocular antibiotic pefloxacin 0.3% ophthalmological drops monotherapy, and 7% patients required pefloxacin combination therapy for complete recovery. The evidence-based rational pharmacotherapeutics of newer quinolones was also distinctly delineated
Adverse drug reactions due to gabapentin-nortriptyline in patients with neuropathic pain in a tertiary care teaching hospital
Get PDFGabapentin and Nortriptyline are used to treat neuropathic pain. Gabapentin belongs to a group of drugs called anti-convulsant and Nortriptyline belongs to tricyclic antidepressant. Gabapentin acts by binding to the specific site on voltage- gated calcium channels. This helps in relieving nerve pain and lowers the risk of seizure. Nortriptyline works by preventing the released chemical messengers in brain (serotonin and norepinephrine) from being reabsorbed back into the nerve cells. As a result, it prolongs the effect of serotonin and norepinephrine in the brain and over time, this helps to relieve depression and lighten the mood. We are reporting a case series including 3 patients having neuropathic pain and taking tablet gabapentin-nortriptyline in department of neurology, Patna medical college and hospital, Patna developed some adverse drug reactions. Causality assessment was done in each case by Naranjo scale. Each case was filled properly in ADR (adverse drug reaction) reporting form and was sent to nearby adverse drug reaction monitoring centre (AMC). During the posting for pharmacovigilance in neurology department of Patna medical college and hospital, Patna from 01/07/2022 to 30/09/2022 we got three adverse drug reactions due to gabapentin-nortriptyline. Two of them were due to Gabapentin and one was due to nortriptyline. Gabapentin-nortriptyline is one of the most commonly used drugs in neurology department. It causes some frequent as well as some rare adverse drug reactions which are required to be assessed and finally reported to the nearby AMC
Screening and assessment of polyneuropathy in adult patients and the effect of folic acid administration on the course of neuropathy
Get PDFBackground: Multiple nerves damage (polyneuropathy) characterized by symmetrical sensory symptoms, such as numbness, paraesthesia, pain, andweakness predominantly in distal parts and pathophysiology depends on the underlying disease. Folic acid, (vitamin B9) deficiency causes many neurodegenerative and cerebrovascular diseases. Supplementation enhances neurodevelopment and provides neuroprotection in someneurological diseases by growth, differentiation and regeneration of the CNS.Methods: Prospective open-label study included 60 patients visiting at tertiary care hospital of either sex with an age range between 18 to 70 years. We evaluated the role of folic acid in the course of neuropathy in all enrolled patients using various neuropathy scores like diabetic neuropathy symptom questionnaire, survey of autonomic symptoms questionnaire, neuropathy deficit (or disability) score, standardized nerve conduction studies and cardiac autonomic reflex test.Results: NCV in the diabetic and alcoholic patients was statistically significant in almost all motor and sensory nerves in both upper and lower limb. In epileptic patients, was more significant in the lower limb in both motor and sensory nerves. In nutritional deficient patients was significant in only 2 nerves. In the diabetic patient, we also observed significance in DNS questionnaire (0.017).Conclusions: Since folate is effective, cheap, treatment and, devoid of apparent toxicity for this obscure, chronic, neurological disorders would be agent justified. A significant improvement in the results was seen majorly in diabetic group, thus can be included for them
Current status of calcitonin gene-related peptide-based therapies in migraine: a scoping review
Get PDFA significant proportion of patients exhibit sub-optimal response to the standard treatment of acute migraine such as triptans and NSAIDs. Even the conventional preventive therapies (e.g. beta-blockers) indicated for patients with frequent migraine attacks have varying responses. Moreover, evidence from animal studies elucidated the role of calcitonin gene-related peptide (CGRP) in the pathophysiology of migraine. Currently two classes are drug, the small molecule CGRP receptor antagonist or the ‘gepants’ (Ubrogepant, Rimegepant, Atogepant, Zavegepant) and CGRP monoclonal antibodies (Erenumab, Galcanezumab, Fremanezumab, Eptinezumab) have been found efficacious and safe in various clinical trials for the treatment and prevention of migraine. While the small molecule CGRP receptor antagonists are given orally, the monoclonal antibodies are injectable drugs. Ubrogepant and Rimegepant are the second-generation gepants approved for treatment of migraine. Zavegepant is a third generation gepant which has proven efficacy for acute treatment of migraine in a phase III trial. Atogepant has been approved for prevention of migraine. Rimegepant has also proven to be efficacious for preventing migraine attacks but has not yet been approved for this indication. Erenumab is the only monoclonal antibody which neutralizes the CGRP receptor. The latter three monoclonal antibodies target the CGRP peptide. The monoclonal antibodies have been approved for the prevention of migraine as a subcutaneously or intravenous infusion (Eptinezumab) given once a month or quarterly. Both the classes of drugs were well-tolerated in the clinical trials. Nausea was the most common adverse effect with gepants while injection-site pain was commonly reported with the antibodies
A comparative study on the pharmacovigilance scoring of causality assessment grading and staging of topical pharmacotherapy of ofloxacin 0.3% ophthalmic solution in bacterial conjunctivitis and ofloxacin 0.3% otic solution in otitis externa
Get PDFBackground: Topical pharmacotherapeutic modalities would minimalize systemic adverse effects. Ofloxacin, the bactericidal racemic mixture, has inhibitory effects on DNA gyrase, DNA topoisomerase IV and IL-1α, IL-6, and IL-8. This was a comparative study for pharmacovigilance scoring of causality assessment grading and staging of topical ofloxacin pharmacotherapy in bacterial conjunctivitis and otitis externa.Methods: Group A=50 bacterial conjunctivitis patients were prescribed topical ophthalmic 0.3% ofloxacin, 2 drops in each eye after every 3 hours for 2 days, and 2 drops in each eye after every 6 hours for next 5 days; and group B=50 otitis externa patients were prescribed topical otic 0.3% ofloxacin, 3 drops in each ear after every 6 hours for first 2 days, and 5 drops in each ear after every 12 hours for next 5 days. Comparative adverse drug reactions occurrence, like transient ocular burning or discomfort, ocular irritation, redness, stinging, pruritis, photophobia, ocular watering and dryness in group A, and pruritis, headache, dizziness, mild ear pain, rashes, and hypersensitivity reactions in group B, were analysed with adverse event case report forms, on days 0, 3, 5, 7, 10, 15, 30, and on follow-ups, with causality assessment scores, from adverse drug reactions grading and staging.Results: The occurrence of adverse effects were statistically non-significant, in both groups, with causality assessment scoring for group A: -11, none on average=Unlikely causality, and group B: -11, none on average= Unlikely causality.Conclusions: Topical ofloxacin therapy in group A and group B patients, were safe and tolerable; with nil causality of association of adverse drug reactions.
Knowledge attitude and practice of medical personnel on ecopharmacology
Get PDFBackground: Increasing disease incidence and prevalence has led to tremendous increase in the use of medications. The consumers are not able to use all the dispensed medications because of various reasons. The improper disposal of these unused medicines has led to environmental contamination to an alarming extent. The present study aims to assess the knowledge, attitude and practice of medical personnel about disposal of unused medicines.Methods: The study was conducted on post graduate medical students, MBBS and nursing students of a tertiary care hospital of North India. It was cross sectional, descriptive study based on a structured questionnaire to assess the knowledge, attitude and practice about the disposition of left-over medications. Descriptive statistical analysis of the results was done.Results: Stockpiling was reported by 100% of the students. The most common reason for stockpiling was excess purchase of medicines (41%). The most commonly procured medicine was NSAID (55.9%). The most common method of disposal was with household waste (69%). Majority of the respondents answered that take back programmes and government interference is the solution to this problem.Conclusions: Majority of the people are having unused medicines at home and most commonly they dispose it by throwing along with rubbish. Lack of knowledge regarding proper disposal is the main reason behind this. Initiatives should be taken to spread awareness regarding proper disposal methods of unused medicines
Cost variation analysis of various brands of anti-retroviral agents currently available in Indian market: an economic perspective study
Get PDFBackground: The aim was to analyze the percentage cost variations among different brands of the commonly prescribed anti-retroviral agents in the treatment of human immunodeficiency virus.Methods: The cost of different brands of commonly used Anti-Retroviral agents was sorted out by referring latest Indian drug index online, drug today, current index of medical specialties, Indian drug review.Results: The percentage variation in the cost was above 100% with most of the commonly used anti-retroviral agents. Overall sequinafir 500 mg shows maximum cost variation of 1490.3%, while nelfinavir (625 mg) shows minimum cost variation of 6.1% in single drug therapy. Lamivudine 300 mg and tenofovir 300 mg combination shows maximum cost variation of 14055% whereas, lamivudine 150 mg, zidovudine 300 mg and efavirenz 600 mg shows minimum cost variation of 10% in combination drug therapy.Conclusions: HIV is the most common infectious, life-threatening disease and drugs are to be prescribed for life-long period. If a costly brand is prescribed, the patients cannot afford to pay more money for their treatment. This also leads to poor patient compliance, dissatisfaction and failure of the treatment. Ideally, therefore, the drugs should be prescribed in such a way, to save the patient's economic burden and enhance the compliance of the treatment
Evaluation of efficacy and safety of Bacillus coagulans SNZ 1969 supplementation for irritable bowel syndrome: a randomized, double-blind, placebo-controlled study
Get PDFBackground: Probiotic potential (efficacy and safety) of Bacillus coagulans SNZ 1969 has been studied in patients with constipation-predominant irritable bowel syndrome (IBS-C) and-diarrhea predominant IBS (IBS-D).Methods: This randomized, double-blind, two-arm, placebo-controlled parallel study randomized 92 patients (1:1) to receive either 500 million CFU of Bacillus coagulans SNZ 1969 (treatment group) or placebo (placebo group) twice daily for 60 days under two subtypes of IBS, IBS-D (n=46) and IBS-C (n=46). Primary outcomes were changes in IBS symptom severity noted using the gastrointestinal symptom rating scale-IBS version (GSRS-IBS) on days 30, 60, and 75, and the number of treatment responders defined by subject’s global assessment (SGA) of relief ≤3 and ≤2 at days 30 and 60, respectively. We also assessed patient’s quality of life.Results: The GSRS-IBS scores reduced from day 30 through 75 in both IBS groups treated with Bacillus coagulans SNZ1969 compared to placebo (p<0.05). Higher GSRS-IBS score was noted in patients with IBS-C in the treatment group (22.45±2.7) than the placebo group (3.55±3.02; p<0.0001), and this trend was similar in IBS-D patients (p<0.0001). Most patients (90%) with IBS-C and all with IBS-D responded to Bacillus coagulans SNZ 1969 compared to no responders with placebo (p<0.0001). The SF-8 scores significantly reduced in patients receiving Bacillus coagulans SNZ 1969 than placebo for both IBS subtypes. One adverse event unrelated to the study treatments was reported in IBS-D group.Conclusions: Bacillus coagulans SNZ 1969 is safe, effective in alleviating IBS-associated clinical symptoms, and improves quality of life
A detailed overview of the patent system
Get PDFThe roots of today’s solid patent system are from the ancient trade system, the introduction, and the evolvement of different intellectual properties. Various international legislations, collaborations, and treaties, as well as the introduction of various acts, rules, and amendments, are responsible for the management and growth of the recent patent system. Novelty, utility, and non-obviousness are the basic patentability criteria. The Indian patent act also defines things that are not inventions under section 3 of the Indian patent act as “statutory subject matter”. The patent system working is described under patent prosecution (filing, publication, examination, opposition) sequentially. “Patent co-operation treaty” (PCT) introduced by the “World intellectual property organization” provides a most effective and economical way of patent application in multiple countries through a single filed application. A general overview of a patent application, drafting of claims, patent analysis, invalidation of patents, Infringement of patents, non-infringing activities, prosecution history estoppel, and remedies under the jurisdiction, are also described hereunder. At present, the number of patent applications filed in India is continuously increasing. Indian patent office is becoming one of the designated search authorities under the PCT. General awareness about patents and intellectual property in all sectors can be improved further.