Characterization and comparative analysis of ADRs of various ART regimens: experience of our medical college from Western Himalayan region

Background: It is estimated that there are 35.3 million PLHA worldwide and 1.6 million have received ART. ART is freely available in designated ART Centres. HAART (highly active antiretroviral treatment) has significantly reduced AIDS related morbidity and mortality. It involves using three different drugs from two different classes. The main challenge in prescribing HAART is ADRs associated with it affecting patient compliance and treatment outcomes.Methods: A retrospective observational study was carried out in the ADR monitoring Centre of Dr. Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh, India.Results: The data for ADEs was collected from 108 patients over a period of 17 months. A total of 280 ADEs were reported in 65 females and 43 males. TLE was the commonest regimen in 61 (56%) patients followed by ZLN in 37 (34%). Neurological ADRs were reported in 39.8% cases with TLE that was nearly double as reported with ZLN regimen 20.5%. Dermatological ADRs were highest with other regimens (57.4%) followed by ZLN 20.5%. Similarly the frequency of Gastrointestinal ADR was highest with other regimens. Hematological ADRs were maximum with ZLN (22.9%) followed by TLE (3.3%). Most commonly reported ADRs were dizziness (10.7%), rashes (8.2%), anorexia and dyslipidemia (6.8%), asthenia (6.4%), pruritus (6%), joint pains (4.6%), insomnia, alopecia and vomiting (4.3%), numbness or parasthesia (3.9%), hepatotoxicity (3.6%) and deranged RFTs (1.8%).Conclusions: The real burden of ADRs due to ART cannot be estimated until voluntary and mandatory reporting system of ADRs works efficiently. A structured surveillance of the pharmacovigilance system can help to overcome these hurdles to ensure compliance with ART regimens

M sub-shell X-ray fluorescence cross-section measurements in high Z elements with X-ray tube photon source

X-ray tube has been used for selective M sub-shell excitations in a single reflection set-up for Pt, Au, Pb, Th and U required for M sub-shell fluorescence cross-sections measurements. Weighted photon energy and total intensity of the incident flux between EM5 edge and tube anode voltage were evaluated following a specific procedure. Comparison of measured cross-sections with the calculated ones from existing DHS/DF model based theoretical data on atomic parameters lend support to the present findings

A study on the effectiveness of nicotine and counselling in tobacoo smoking cessation

Background: Effectiveness of pharmacotherapy and counselling has been suggested by various research workers in smoking cessation, but studies show variable results with pharmacotherapy. Also efficacy of counselling and pharmacological intervention differs from centre to centre. So we conducted this study, to observe the role of counselling and nicotine gums in our setup.Methods: 86 smokers willing to quit smoking were enrolled. Baseline counselling was provided at the time of enrolment, then at 1 week, 1 month, 3 months and at 6 months. Telephonic counselling was given to those who did not come for face to face counselling. Nicotine gums were prescribed for 3 months duration. At the end of 12 months, follow up outcome was measured.Results: At 1 week 24% smokers, at 1 month 23%, at 3 months 12% and at 6 months 33% smokers attended face to face counselling session. At 1 week 66%, at 1 month 57%, at 3 months 63% and at 6 months 59% smokers received telephonic counselling. Nicotine gums were used by only 76% smokers. Out of those who used nicotine gums, only 3% used gums for 3 months duration and 97% stopped prematurely. Among those who used gums, 29% experienced side effects. Total 22 (26%) smokers stopped smoking at 12 months.Conclusions: Less number of smokers coming for follow up counselling visits, suggest lack of motivation. Alternative counselling, like telephonic counselling, was much more accepted and was found to be helpful. Acceptance of nicotine gums was very less which also shows the lack of motivation. Abstinence rate of 26% shows that counselling and nicotine gums help in quitting smoking

Profile of adverse drug reactions in patients on anti-tubercular drugs in a sub Himalayan rural tertiary care teaching hospital

Background: Tuberculosis is a major public health problem, with one out of three people in the world are infected with Mycobacterium tuberculosis. The prevalence of MDR TB in India is 2-3% among new cases and 12-17% in reinfection cases. One of the reasons for MDR may be noncompliance to treatment due to adverse drug reactions. The present study was conducted to find out ADRs in patients on antitubercular treatment (ATT) under pharmacovigilance programme of India (PvPI).Methods: This was a retrospective observational study. Data was collected through voluntary reporting by health-care professionals (HCP) in standard IPC-PvPI prescribed suspected ADR reporting form and analyzed for 100 patients on ATT. Causality assessment was done using WHO causality assessment scale.Results: The maximum ADRs were reported in adults with a mean age of 40.79±16.79 years. Males (n=66) outnumbered females (n=34). There were 62% MDR-TB on DOTS-plus regimen, followed by 35% on Cat1 ATT for pulmonary and extrapulmonary tuberculosis cases and XDR-TB accounted for 3% of the total cases. The commonest ADRs in patients on MDR treatment were related to CNS 44 (27.5%), followed by Gastrointestinal system 31 (19%), psychiatric 20 (12.5%) otovestibular 13 (8%) and ophthalmic ADRs being the least in frequency 1 (0.6%). In contrast patients on Cat 1 ATT the ADRs involving Gastrointestinal system 44 (44%) followed by CNS 12 (12%), psychiatric 0% and ADRs related to otovestibular manifestations being the least 1 (1%) frequency.Conclusions: ADRs involving different organ systems were seen in both categories with varied frequency. Adverse drug reactions add to hospitalization expenses, insurance costs and increase in work loss days besides addition to patient suffering and loss of compliance. Prior knowledge can help in better prescriptions and prevent valuable resource loss

Pharmacovigilance analysis in a rural tertiary care hospital in North India: a retrospective study

Background: The main motive of PvPI (Pharmacovigilance Programme of India) is to collect valuable data so that signals can be generated from reported adverse drug events (ADEs). It also tries to establish their causality so that ADEs can be labelled as adverse drug reactions (ADRs) beyond any doubt.Methods: This retrospective observational study done in rural set up tertiary care teaching hospital collected data through voluntary reporting in ADR form of PvPI for period of 6 month. Causality assessment was done using WHO causality assessment scale.Results: In 150 reported cases, majority ADRs were due to tuberculosis, cancer and HIV treatments. Gastrointestinal tract and central nervous system were the major organs involved. Most ADRs occurred within first day of drug intake. Around 15% required hospitalization. 55% ADRs were probable and 41% were possible in nature. Vertigo and depression was most frequent ADR in MDR therapy. Rashes, pruritis, fever and joint pain was frequent in antiretroviral therapy. Dysguesia, dizziness, nausea, vomiting and constipation was frequent in patients taking anticancer drugs. Platins and antibiotics used for cancer therapy cause most cancer treatment ADRs.Conclusions: ADRs add to hospitalization expenses, insurance costs and increase in work loss days besides addition to patient suffering. Prior knowledge can help in better prescriptions and prevent valuable resource loss. Reasons for under-reporting of ADRs can be complacency, ignorance, lack of financial incentives for reporting, fear of litigation, claims of compensation and lack of time in busy hospital schedules

Photon induced L

Photon induced L3 X-ray measurements for Lα/Lℓ cross-section ratios in elements, 66 ⩽ Z ⩽ 83, at tuned photon energies on synchrotron Beamline-16 at Indus-2, India have been used to study the effect of Coster-Kronig (CK) transitions and photon energies on alignment of L3 vacancies. Certainty and reliability of the measurements were checked from comparison of measured Lα and Lℓ fluorescence cross-sections at E1 excitation with available theoretical/empirical/experimental values that required additional measurements for source, geometry and efficiency factor S0GεLα/ℓ in the used set-up. Fall/rise trend of the ratios with energy for different Z’s was found to resemble the off/on-set pattern of CK transitions as pointed out by Bambynek et al. and Campbell. Evaluated alignment parameter A2 values are very much within the limits, 0.05 <A2< 0.5, except for Lu, Ta and Pb at E2 excitation and for W, Pt and Hg at E1 excitation where values are <0.05. At E3 excitation, the vacancies only in L3 are aligned (A2 ≦ 0.2) in all the cases. The pattern of A′2 (Coster-Kronig corrected A2) variation with energy for Dy, W, Pt, Hg and Bi resembles our previously reported theoretical patterns that lends mutual support for both current measurements and earlier theoretical results