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1.  Adverse drug reactions to antiretroviral therapy: Results from spontaneous reporting system in Nigeria 
This study evaluated the suspected adverse drug reactions (ADR) reported from a spontaneous reporting program in Human Immunodeficiency Virus (HIV) positive patients receiving antiretroviral therapy (ART) in Nigeria
Materials and Methods:
This descriptive study analyzed individual case safety reports (ICSRs) in HIV-positive patients receiving ART between January 2011 and December 2011 in 38 secondary hospitals. All ICSRs during this period were included. Chi-square was used to test the association between variables at 95% confidence interval.
From 1237 ICSRs collated, only 1119 (90.5%) were valid for analysis. Mean age of patients was 35.3 (95%CI, 35.1–35.5) years; and 67.1% were females. A total of 1679 ADR cases were reported, a mean (± Standard Deviation, SD) of 1.5 (± 0.8) ADR cases per patient. Of reported ADRs, 63.2%, 8.2% and 19.3% occurred in patients on Zidovudine-based, Stavudine-based and Tenofovir-based regimens, respectively. The commonest ADRs included (12.0%) peripheral neuropathy, (11.4%) skin rash, (10.1%) pruritus and (6.5%) dizziness. ADR occurrence was associated with ART regimens, concomitant medicines and age (P < 0.05) unlike gender. Anaemia was associated with Zidovudine (AZT)/ Lamivudine (3TC) /Nevirapine (NEV) regimen [Odds ratio, OR = 6.4 (3.0–13.8); P < 0.0001], and peripheral neuropathy with Stavudine (d4T)/3TC/NEV regimen [OR = 8.7 (5.8–30.0), P < 0.0001] and Tenofovir (TDF)/Emtricitabine (FTC)/Efavirenz (EFV) regimen [OR = 2.1 (1.0–4.1), P = 0.0446]. Skin rash and peripheral neuropathy were associated with patients aged < 15years [OR = 3.0 (1.3–6.6), P = 0.0056] and 45–59years [OR = 1.9 (1.3–2.7), P = 0.0006] respectively. Palpitation and polyuria were associated with Salbutamol [OR = 55.7 (4.9–349.6), P = 0.0000] and Nonsteroidal anti-inflammatory drugs (NSAIDS) [OR = 50.2 (0.9–562.1), P = 0.0040] respectively.
ADRs were less likely to occur in patients on stavudine-based and tenofovir-based regimens compared to zidovudine-based regimens. Peripheral neuropathy was also found to be associated with tenofovir-based regimen. This may require further studies and evaluation.
PMCID: PMC3700325  PMID: 23833736
Adverse effects; human immunodeficiency virus; medicines; pharmacovigilance; Nigeria
2.  Self-reported adverse drug reactions and their influence on highly active antiretroviral therapy in HIV infected patients: a cross sectional study 
Patients on antiretroviral therapy have higher risk of developing adverse drug reactions (ADRs). The impact of ADRs on treatment adherence, treatment outcomes and future treatment options is quiet considerable. Thus, the purpose of this study was to describe the common self-reported ADRs and their impact on antiretroviral treatment.
Cross-sectional study was conducted at antiretroviral therapy (ART) clinic of Gondar University Hospital. Semi-structured interview questionnaire was used to extract self-reported ADRs, socio-demographic, and psycho-social variables. Variables related to antiretroviral medication, laboratory values and treatment changes were obtained from medical charts. Chi-square and odds ratio with 95% confidence interval were used to determine the associations of dependent variables.
A total of 384 participants were enrolled. At least one adverse drug reaction was reported by 345 (89.8%) study participants and the mean number of ADRs reported was 3.7 (±0.2). The most frequently reported ADRs were nausea (56.5%) and headache (54.9%). About 114 (31.0%) participants considered antiretroviral therapy to be unsuccessful if ADRs occurred and only 10 (2.6%) decided to skip doses as ADRs were encountered. Based on chart review, treatment was changed for 78 (20.3%) patients and from which 79% were due to documented ADRs (p = 0.00). Among them, CNS symptoms (27.4%) and anemia (16.1%) were responsible for the majority of changes. Around four percent of patients were non-adherent to ART. Non-adhered participants and those on treatment changes were not statistically associated with self-reported ADRs. Only unemployment status (AOR = 1.76 (1.15 - 2.70), p = 0.01) and ADR duration of less than one month (AOR = 1.95 (1.28-2.98), p = 0.001) were significantly associated with self-reported adverse effects of three or more in the multivariate analysis.
Self-reported ADRs to antiretroviral therapy are quite common. More of the reactions were of short lasting and their impact on adherence and treatment change were less likely. However, documented ADRs were the most prevalent reasons for ART switch. Moreover, the level of unemployment was a strong predictor of self-reported ADRs.
PMCID: PMC4082293  PMID: 24957052
Perceived adverse effect; Antiretroviral therapy; Self-report ADRs
3.  Incidence of adverse drug reactions in human immune deficiency virus-positive patients using highly active antiretroviral therapy 
To estimate the incidence of adverse drug reactions (ADRs) in Human immune deficiency virus (HIV) patients on highly active antiretroviral therapy (HAART). To identify the risk factors associated with ADRs in HIV patients. To analyze reported ADRs based on various parameters like causality, severity, predictability, and preventability. Retrospective case-control study. An 18-month retrospective case-control study of 208 patients newly registered in ART center, RIMS hospital, Kadapa, were intensively monitored for ADRs to HAART. Predictability was calculated based on the history of previous exposure to drug. Multivariate logistic regressions were used to identify the risk factors for ADRs. Data were analyzed using the chi-square test for estimating the correlation between ADRs and different variables. All statistical calculations were performed using EpiInfo version 3.5.3. Monitoring of 208 retrospective patients by active Pharmacovigilance identified 105 ADRs that were identified in 71 patients. Skin rash and anemia were the most commonly observed ADRs. The organ system commonly affected by ADR was skin and appendages (31.57%). The ADRs that were moderate were 90.14% of cases. The incidence of ADRs (53.52%) was higher with Zidovudine + Lamivudine + Nevirapine combination. CD4 cell count less than <250 cells/μl were 80.28%, male gender were observed to be the risk factors for ADRs. Our study finding showed that there is a need of active pharmaceutical care with intensive monitoring for ADRs in Indian HIV-positive patients who are illiterate, of male and female gender, with CD4 count ≤250 cells/mm3 with comorbid conditions.
PMCID: PMC3312730  PMID: 22470896
Adverse drug reactions; antiretroviral therapy; HIV/AIDS; India; pharmacovigilance
4.  Rates of Switching Antiretroviral Drugs in a Primary Care Service in South Africa before and after Introduction of Tenofovir 
PLoS ONE  2013;8(5):e63596.
Antiretroviral changes (single drug substitutions and regimen switches) limit treatment options and introduce challenges such as increased cost, monitoring and adherence difficulties. Patterns of drug substitutions and regimen switches from stavudine (d4T) and zidovudine (AZT) regimens have been well described but data on tenofovir (TDF) are more limited. This study describes the patterns and risk factors for drug changes of these antiretroviral drugs in adults.
This retrospective cohort study included HIV positive, antiretroviral treatment (ART) naïve adults aged ≥18 years who started ART with two nucleoside reverse transcriptase inhibitors (NRTIs) and a non-nucleoside reverse transcriptase inhibitor. Follow-up was censored at first drug change and analysis focused on NRTI changes only.
Between September 2002 and April 2011, 5095 adults initiated ART in Gugulethu. This comprised 948 subjects on TDF, 3438 on d4T and 709 subjects on AZT. Virological suppression rates at 1 year, regimen switching due to virological failure and overall losses to the programme were similar across the three groups. TDF had the lowest incidence rate of drug substitutions (2.6 per 100 P/Ys) compared to 17.9 for d4T and 8.5 per 100 P/Ys for AZT. Adverse drug reactions (ADRs) accounted for the majority of drug substitutions of d4T. Multivariate analysis showed that increasing age, female sex and d4T exposure were associated with increased hazard of drug substitution due to ADRs. Conversely, TDF exposure was associated with a substantially lower risk of substitution (adjusted hazards ratio 0.38; 95% CI 0.20–0.72).
Regimen switches and virological suppression were similar for patients exposed to TDF, d4T and AZT, suggesting all regimens were equally effective. However, TDF was better tolerated with a substantially lower rate of drug substitutions due to ADRs.
PMCID: PMC3661537  PMID: 23717451
5.  Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil 
Adverse drug reactions (ADRs) are recognised as a common cause of hospital admissions, and they constitute a significant economic burden for hospitals. Hospital-based ADR monitoring and reporting programmes aim to identify and quantify the risks associated with the use of drugs provided in a hospital setting. This information may be useful for identifying and minimising preventable ADRs and may enhance the ability of prescribers to manage ADRs more effectively. The main objectives of this study were to evaluate ADRs that occurred during inpatient stays at the Hospital Geral de Palmas (HGP) in Tocantins, Brazil, and to facilitate the development of a pharmacovigilance service.
A prospective study was conducted at HGP over a period of 8 months, from January 2009 to August 2009. This observational, cross-sectional, descriptive study was based on an analysis of medical records. Several parameters were utilised in the data evaluation, including patient demographics, drug and reaction characteristics, and reaction outcomes. The reaction severity and predisposing factors were also assessed.
The overall incidence of ADRs in the patient population was 3.1%, and gender was not found to be a risk factor. The highest ADR rate (75.8%) was found in the adult age group 15 to 50 years, and the lowest ADR rate was found in children aged 3 to 13 years (7.4%). Because of the high frequency of ADRs in orthopaedic (25%), general medicine (22%), and oncology (16%) patients, improved control of the drugs used in these specialties is required. Additionally, the nurse team (52.7%) registered the most ADRs in medical records, most likely due to the job responsibilities of nurses. As expected, the most noticeable ADRs occurred in skin tissues, with such ADRs are more obvious to medical staff, with rashes being the most common reactions. Metamizole, tramadol, and vancomycin were responsible for 21, 11.6, and 8.4% of ADRs, respectively. The majority of ADRs had moderate severity (58.9%), thus requiring intervention. Type A reactions were the most common (82.1%). At least one predisposing factor was present in 79.9% of the reports examined, and the most common predisposing factor was polypharmacy.
The results obtained will contribute to the development of strategies for the pharmacovigilance service at HGP and other hospitals throughout the country, which will improve the quality of ADR reporting and ensure safer drug use in Brazilian hospitals.
PMCID: PMC3554560  PMID: 23298396
6.  Adverse Drug Reactions (ADR) in the inPatients of Medicine Department of a Rural Tertiary Care Teaching Hospital and Influence of Pharmacovigilance in Reporting ADR 
Indian Journal of Pharmacology  2008;40(1):37-40.
(i) To find the incidence and study various aspects of Adverse Drug Reactions (ADR) in the inpatients of medicine department of Shree Krishna Hospital, a rural tertiary care teaching hospital. (ii) To test the impact of pharmacovigilance in reporting ADR.
Material & Methods:
A prospective study involving 600 patients admitted to the medical wards and TB & Chest diseases ward over a period of six months and a retrospective analysis of 600 case files for the corresponding period of the previous year were carried out to find the incidence rate of ADR, study various aspects of ADR like causality assessment, drugs frequently causing ADR etc. Suitably structured and pre-tested format was used for compiling the data.
In the prospective study, 18 of the 600 patients (3%) developed ADR. A significant number (77.78%) of patients developed ADR between the 3rd and 10th days of administering the drug/s. As the number of drugs increased, the incidence of ADR also increased. Majority of ADR (72.22%) occurred due to chemotherapeutic agents. 66.67% of ADR involved the gastrointestinal tract. None of the ADR was fatal. Sex of the patients did not influence the incidence rate of ADR. On the other hand, in the retrospective analysis, only ADR were reported in just 6 out of 600 patients (1%).
The incidence rate of ADR is found to be much lower (3%) than the reported rate (10%-20%). Pharmacovigilance certainly contributes to picking up ADR.
PMCID: PMC3023121  PMID: 21264160
Adverse drug reactions; ADR monitoring; Pharmacovigilance
7.  Cost evaluation of adverse drug reactions in hospitalized patients in Taiwan: A prospective, descriptive, observational study 
Background: Adverse drug reactions (AADRs) are a leading cause of morbidity and mortality. In the United States, ADR-related morbidity and mortality costs have been estimated at US $330 billion to US $1130 billion annually.
Objectives: The aim of this study was to evaluate the incidence of ADRs in Taiwan, to identify the drug classes that are most commonly related to ADRs, and to determine the direct medical costs to hospitals associated with prolonged hospitalizations due to ADRs.
Methods: In this prospective, descriptive, observational study, patients who experienced ADRs during their hospitalization at a Taiwan teaching hospital or who were admitted due to an ADR from January 1, 2002, through December 31, 2004, were included in the study. The patients were identified actively by clinical pharmacists and passively by physicians and nurses who reported ADRs. The World Health Organization (WWHO) definition of ADR severity was adopted, and degrees of probability for each ADR were determined using the Naranjo algorithm. The direct medical costs incurred to the hospital in the treatment of ADRs that prolonged hospitalization were calculated (ie, costs of emergency department [ED] visits, intensive care unit visits, extra days of hospitalization, monitoring and laboratory studies, pharmacist dispensing fees, physician fees, room charges, ED charges).
Results: During the study period, 43 of the 142,295 hospitalized patients (00.03%)) were admitted because of an ADR. A total of 564 (00.40%)) of the hospitalized patients were verified to have ADRs. Three hundred eighteen of the patients (56.44%) with ADRs were male and the overall mean (SD) age was 66(2) years. The most common drug classes associated with the ADRs were antibiotics (219 patients [38.8% ]), analgesics (62 [11.0%]), and cardiovascular agents (56 [9.9%]). The systems most commonly involved in ADRs were cutaneous (296 patients [52.5%]), hematologic (61 [10.8%]), and cardiovascular (54 [9.66%]). The causes of the ADRs were anaphylactic (464 patients [82.3%]), drug overdose (78 [13.8%]), and drug-drug interactions (22 [3.9%]). Of the ADRs, 474 (884.0%) were idiosyncratic type B reactions (predictable). ADR-related costs, estimated at US $3489/ADR, were mostly due to prolonged length of stay. Based on the WHO definition, of the 564 ADRs, 330 (58.5%) and 40 (7.1%) were classified as moderate and severe, respectively. Two patients died of ADRs associated with allopurinol.
Conclusion: In this hospital, 0.40% of patients were identified as having ADRs that were associated with high direct costs, mostly due to extended hospitalizations.
PMCID: PMC3969903  PMID: 24692791
direct medical cost; adverse drug reactions
8.  Artificial Discs for Lumbar and Cervical Degenerative Disc Disease –Update 
Executive Summary
To assess the safety and efficacy of artificial disc replacement (ADR) technology for degenerative disc disease (DDD).
Clinical Need
Degenerative disc disease is the term used to describe the deterioration of 1 or more intervertebral discs of the spine. The prevalence of DDD is roughly described in proportion to age such that 40% of people aged 40 years have DDD, increasing to 80% among those aged 80 years or older. Low back pain is a common symptom of lumbar DDD; neck and arm pain are common symptoms of cervical DDD. Nonsurgical treatments can be used to relieve pain and minimize disability associated with DDD. However, it is estimated that about 10% to 20% of people with lumbar DDD and up to 30% with cervical DDD will be unresponsive to nonsurgical treatments. In these cases, surgical treatment is considered. Spinal fusion (arthrodesis) is the process of fusing or joining 2 bones and is considered the surgical gold standard for DDD.
Artificial disc replacement is the replacement of the degenerated intervertebral disc with an artificial disc in people with DDD of the lumbar or cervical spine that has been unresponsive to nonsurgical treatments for at least 6 months. Unlike spinal fusion, ADR preserves movement of the spine, which is thought to reduce or prevent the development of adjacent segment degeneration. Additionally, a bone graft is not required for ADR, and this alleviates complications, including bone graft donor site pain and pseudoarthrosis. It is estimated that about 5% of patients who require surgery for DDD will be candidates for ADR.
Review Strategy
The Medical Advisory Secretariat conducted a computerized search of the literature published between 2003 and September 2005 to answer the following questions:
What is the effectiveness of ADR in people with DDD of the lumbar or cervical regions of the spine compared with spinal fusion surgery?
Does an artificial disc reduce the incidence of adjacent segment degeneration (ASD) compared with spinal fusion?
What is the rate of major complications (device failure, reoperation) with artificial discs compared with surgical spinal fusion?
One reviewer evaluated the internal validity of the primary studies using the criteria outlined in the Cochrane Musculoskeletal Injuries Group Quality Assessment Tool. The quality of concealment allocation was rated as: A, clearly yes; B, unclear; or C, clearly no. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the overall quality of the body of evidence (defined as 1 or more studies) supporting the research questions explored in this systematic review. A random effects model meta-analysis was conducted when data were available from 2 or more randomized controlled trials (RCTs) and when there was no statistical and or clinical heterogeneity among studies. Bayesian analyses were undertaken to do the following:
Examine the influence of missing data on clinical success rates;
Compute the probability that artificial discs were superior to spinal fusion (on the basis of clinical success rates);
Examine whether the results were sensitive to the choice of noninferiority margin.
Summary of Findings
The literature search yielded 140 citations. Of these, 1 Cochrane systematic review, 1 RCT, and 10 case series were included in this review. Unpublished data from an RCT reported in the grey literature were obtained from the manufacturer of the device. The search also yielded 8 health technology assessments evaluating ADR that are also included in this review.
Six of the 8 health technology assessments concluded that there is insufficient evidence to support the use of either lumbar or cervical ADR. The results of the remaining 2 assessments (one each for lumbar and cervical ADR) led to a National Institute for Clinical Excellence guidance document supporting the safety and effectiveness of lumbar and cervical ADR with the proviso that an ongoing audit of all clinical outcomes be undertaken owing to a lack of long-term outcome data from clinical trials.
Regarding lumbar ADR, data were available from 2 noninferiority RCTs to complete a meta-analysis. The following clinical, health systems, and adverse event outcome measures were synthesized: primary outcome of clinical success, Oswestry Disability Index (ODI) scores, pain VAS scores, patient satisfaction, duration of surgery, amount of blood loss, length of hospital stay, rate of device failure, and rate of reoperation.
The meta-analysis of overall clinical success supported the noninferiority of lumbar ADR compared with spinal fusion at 24-month follow-up. Of the remaining clinical outcome measures (ODI, pain VAS scores, SF-36 scores [mental and physical components], patient satisfaction, and return to work status), only patient satisfaction and scores on the physical component scale of the SF-36 questionnaire were significantly improved in favour of lumbar ADR compared with spinal fusion at 24 months follow-up. Blood loss and surgical time showed statistical heterogeneity; therefore, meta-analysis results are not interpretable. Length of hospital stay was significantly shorter in patients receiving the ADR compared with controls. Neither the number of device failures nor the number of neurological complications at 24 months was statistically significantly different between the ADR and fusion treatment groups. However, there was a trend towards fewer neurological complications at 24 months in the ADR treatment group compared with the spinal fusion treatment group.
Results of the Bayesian analyses indicated that the influence of missing data on the outcome measure of clinical success was minimal. The Bayesian model indicated that the probability for ADR being better than spinal fusion was 79%. The probability of ADR being noninferior to spinal fusion using a -10% noninferiority bound was 92%, and using a -15% noninferiority bound was 94%. The probability of artificial discs being superior to spinal fusion in a future trial was 73%.
Six case series were reviewed, mainly to characterize the rate of major complications for lumbar ADR. The Medical Advisory Secretariat defined a major complication as any reoperation; device failure necessitating a revision, removal or reoperation; or life-threatening event. The rates of major complications ranged from 0% to 13% per device implanted. Only 1 study reported the rate of ASD, which was detected in 2 (2%) of the 100 people 11 years after surgery.
There were no RCT data available for cervical ADR; therefore, data from 4 case series were reviewed for evidence of effectiveness and safety. Because data were sparse, the effectiveness of cervical ADR compared with spinal fusion cannot be determined at this time.
The rate of major complications was assessed up to 2 years after surgery. It was found to range from 0% to 8.1% per device implanted. The rate of ASD is not reported in the clinical trial literature.
The total cost of a lumbar ADR procedure is $15,371 (Cdn; including costs related to the device, physician, and procedure). The total cost of a lumbar fusion surgery procedure is $11,311 (Cdn; including physicians’ and procedural costs).
Lumbar Artificial Disc Replacement
Since the 2004 Medical Advisory Secretariat health technology policy assessment, data from 2 RCTs and 6 case series assessing the effectiveness and adverse events profile of lumbar ADR to treat DDD has become available. The GRADE quality of this evidence is moderate for effectiveness and for short-term (2-year follow-up) complications; it is very low for ASD.
The effectiveness of lumbar ADR is not inferior to that of spinal fusion for the treatment of lumbar DDD. The rates for device failure and neurological complications 2 years after surgery did not differ between ADR and fusion patients. Based on a Bayesian meta-analysis, lumbar ADR is 79% superior to lumbar spinal fusion.
The rate of major complications after lumbar ADR is between 0% and 13% per device implanted. The rate of ASD in 1 case series was 2% over an 11-year follow-up period.
Outcome data for lumbar ADR beyond a 2-year follow-up are not yet available.
Cervical Artificial Disc Replacement
Since the 2004 Medical Advisory Secretariat health technology policy assessment, 4 case series have been added to the body of evidence assessing the effectiveness and adverse events profile of cervical ADR to treat DDD. The GRADE quality of this evidence is very low for effectiveness as well as for the adverse events profile. Sparse outcome data are available.
Because data are sparse, the effectiveness of cervical ADR compared with spinal fusion cannot be determined at this time.
The rate of major complications was assessed up to 2 years after surgery; it ranged from 0% to 8.1% per device implanted. The rate of ASD is not reported in the clinical trial literature.
PMCID: PMC3379529  PMID: 23074480
9.  Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India 
Interdisciplinary Toxicology  2013;6(1):41-46.
Adverse drug reactions (ADR) are a significant cause of morbidity and mortality, often identified only post-marketingly. Improvement in current ADR reporting, including utility of underused or innovative methods, is crucial to improve patient safety and public health. Hospital-based monitoring is one of the methods used to collect data about drug prescriptions and adverse events. The aims of this study were to identify the most frequent ADRs recognized by the attending physicians, study their nature, and to target these ADRs in order to take future preventive measures. A prospective study was conducted over a 7-month period in an internal medicine department using stimulated spontaneous reporting for identifying ADRs. Out of the 254 admissions, 32 ADRs in 37 patients (14.56%) were validated from the total of 36 suspected ADRs in 41 patients. Female predominance was noted over males in case of ADRs. Fifty percent of total ADRs occurred due to multiple drug therapy. Dermatological ADRs were found to be the most frequent (68.75%), followed by respiratory, central nervous system and gastrointestinal ADRs. The drugs most frequently involved were antibiotics, anti-tubercular agents, antigout agents, and NSAIDs. The most commonly reported reactions were itching and rashes. Out of the 32 reported ADRs, 50% of the reactions were probable, 46.87% of the reactions were possible and 3.12% of the reactions were definite. The severity assessment done by using the Hartwig and Seigel scale indicated that the majority of ADRs were ‘Mild’ followed by ‘Moderate’ and ‘Severe’ reactions, respectively. Out of all, 75% of ADRs were recovered. The most potent management of ADRs was found to be drug withdrawal. Our study indicated that hospital based monitoring was a good method to detect links between drug exposure and adverse drug reactions. Adequate training regarding pharmacology and optimization of drug therapy might be helpful to reduce ADR morbidity and mortality.
PMCID: PMC3795320  PMID: 24170978
adverse drug reaction; hospital based monitoring; pharmacovigilance; questionnaire survey
10.  Adverse drug reactions of Highly Active Antiretroviral Therapy (HAART) in HIV infected patients at the General Hospital, Douala, Cameroon: a cross sectional study 
The use of highly active antiretroviral therapy (HAART) as the main option for management of people living with Human Immune deficiency virus (HIV) is associated with decrease morbidity and mortality. This is due to its effectiveness in inhibiting viral replication. However this effectiveness is not without adverse drug effects which in many settings are not monitored.
A cross sectional clinical chart review of adult Cameroonian patients on HAART between 2003 and 2009 at the Douala General Hospital was done in search of reported HAART-associated Adverse Drug effects (ADRs). The prevalence of ADR defined as the proportion of the study population with ADR was determined and stratified by age, sex, weight and HAART regimen.
Sixty-six (19.5%) of the 339 patients on HAART reported ADRs. Among those who reported ADRs, 29.6% were on D4T-3TC-EFV, 29.3% on D4T-3TC-NVP, 16% on AZT-3TC-EFV and 10.8% on AZT-3TC-NVP. Peripheral Neuropathy was the most common ADR and represented 21.2% of all ADRs. Patients on D4T containing regimens were more likely to develop ADR (OR = 3.5, 95% CI 1.5 – 9.8, p<0.01) and 56.1% of all ADRs were associated to D4T. Hospital admissions were for patients with severe anaemia, no fatal cases of ADRs were recorded.
HAART-associated ADRs are common and therefore should be actively looked for by caregivers so as to ameliorate the quality of life of HIV patients on treatment.
PMCID: PMC3473973  PMID: 23077708
Adverse drug reaction; HAART; HIV
11.  Pharmacovigilance for antiretroviral drugs in Africa, lessons from a study in Abidjan, Cote d’Ivoire 
Pharmacoepidemiology and drug safety  2011;20(12):1303-1310.
While antiretroviral treatment (ART)-related adverse drug reactions (ADR) are documented in industrialized countries, there is no pre-existing surveillance system dedicated to ADR monitoring in most African countries. We assessed knowledge towards pharmacovigilance among ART prescribers and available capacity of HIV clinics to conduct ADR monitoring in Abidjan, Côte d’Ivoire.
A questionnaire was administered to ART prescribers, to assess their knowledge towards the occurrence of ADRs. A retrospective ADR survey was also conducted, based on a data query of treatment modification/interruptions in three HIV clinics. Clinical monitors went back to medical charts to review and validate the reasons of the treatment modification/interruptions.
Of the 81 ART prescribers interviewed, 25 (31%) declared not grading ADRs and 12 (14.8%) declared notifying ADRs to the national regulatory authorities. Among 5,252 adult ART-treated patients who attended the participating clinics in 2008, 599 treatment modifications were identified. Reasons for treatment modification/interruptions identified in the electronic database were documented in the medical charts in 554 (92.5%) cases, ADR accounting for 273 (45.5%) cases. Toxicity related to ART was graded in only 58 (21%) cases in the medical charts.
This study describes challenges limiting the implementation of reliable pharmacovigilance activities in HIV clinics in Côte d’Ivoire. The lack of knowledge of ART prescribers concerning ADR grading does not support the spontaneous reporting of ADRs. Using treatment modification/interruptions for ADR monitoring appears feasible but improvements are needed to respond to key questions related to drug toxicities in the context of ART scale up in Africa.
PMCID: PMC3227553  PMID: 21735508
pharmacovigilance; HIV/AIDS; antiretroviral; sub-Saharan Africa
12.  RETRACTED by plagiarism: Highly active antiretroviral therapy induced adverse drug reactions in Indian human immunodeficiency virus positive patients 
Pharmacy Practice  2011;9(1):48-55.
To assess the incidence, severity pattern, causality, predictability and preventability of adverse drug reactions (ADRs) and to identify risk factors for adverse drug reactions in highly active antiretroviral therapy.
Enrolled patients were intensively monitored for ADRs to highly active antiretroviral therapy. Predictability was assessed based on history of previous exposure to the drug or literature incidence of ADRs. Preventability was assessed using Schumock and Thornton criteria and severity was assessed using modified Hartwig and Siegel scale. Multivariate logistic regressions were used to identify the risk factors for ADRs.
Monitoring of 130 retropositive patients by active pharmacovigilance identified 74 ADRs from 57 patients. Anemia and hepatotoxicity were the most commonly observed ADRs. The organ system commonly affected by ADR was red blood cell (21.4%). The ADRs were moderate in 77% of cases. Type A reactions (77%) were more common. A total of 10.8% ADRs were definitely preventable. The incidence rate of ADRs (65.9%) was highest with Zidovudine + Lamivudine + Nevirapine combination. A total of 84% interruptions to highly active antiretroviral therapy were due to toxicity. CD4 less than 200 cells/μl, female gender and tuberculosis were observed as risk factors for ADRs.
Incidence of ADRs in intensively monitored patients was found to be 43.8%. Anemia in HIV patients is an influential risk factor for occurrence of ADRs. With the increasing access to antiretroviral in India, clinicians must focus on early detection and prevention of ADRs to highly active antiretroviral therapy.
PMCID: PMC4132973  PMID: 25132890
Drug Toxicity; Antiretroviral Therapy; Highly Active; India
13.  Adverse Drug Reactions in Hospital In-Patients: A Prospective Analysis of 3695 Patient-Episodes 
PLoS ONE  2009;4(2):e4439.
Adverse drug reactions (ADRs) are a major cause of hospital admissions, but recent data on the incidence and clinical characteristics of ADRs which occur following hospital admission, are lacking. Patients admitted to twelve wards over a six-month period in 2005 were assessed for ADRs throughout their admission. Suspected ADRs were recorded and analysed for causality, severity and avoidability and whether they increased the length of stay. Multivariable analysis was undertaken to identify the risk factors for ADRs. The 5% significance level was used when assessing factors for inclusion in multivariable models. Out of the 3695 patient episodes assessed for ADRs, 545 (14.7%, 95% CI 13.6–15.9%) experienced one or more ADRs. Half of ADRs were definitely or possibly avoidable. The patients experiencing ADRs were more likely to be older, female, taking a larger number of medicines, and had a longer length of stay than those without ADRs. However, the only significant predictor of ADRs, from the multivariable analysis of a representative sample of patients, was the number of medicines taken by the patient with each additional medication multiplying the hazard of an ADR episode by 1.14 (95% CI 1.09, 1.20). ADRs directly increased length of stay in 147 (26.8%) patients. The drugs most frequently associated with ADRs were diuretics, opioid analgesics, and anticoagulants. In conclusion, approximately one in seven hospital in-patients experience an ADR, which is a significant cause of morbidity, increasing the length of stay of patients by an average of 0.25 days/patient admission episode. The overall burden of ADRs on hospitals is high, and effective intervention strategies are urgently needed to reduce this burden.
PMCID: PMC2635959  PMID: 19209224
14.  Consequences, measurement, and evaluation of the costs associated with adverse drug reactions among hospitalized patients in China 
Adverse drug reactions (ADRs) are a leading cause of morbidity in developed countries and represent a substantial burden on health-care resources. Many countries spent 15% to 20% of their hospital budgets to treat drug complications. However, few studies have measured the pharmacoeconomic effects of ADRs on hospitalized patients in China. The study estimates the costs of ADRs as identified from the spontaneous voluntary reports completed from healthcare professionals. To do so, we calculate these costs, determine the sum of Medicare payments and their proportion of total healthcare spending, and evaluate the incidence of ADRs, characteristics of hospitalized ADR patients, and outcomes of ADRs in China.
This retrospective survey studied patients who experienced ADRs during their hospitalization at a Chinese tertiary-care teaching hospital. The patients were divided into group A and group B according to general ADRs and serious ADRs in Provisions for Adverse Drug Reaction Monitoring and Reporting. The direct costs included treatment fees, inspection fees, laboratory fees, materials fees, bed charges, drug charges, nursing care, meals, and other expenses and the sunk-cost losses were calculated according to the hospital information system (HIS). Indirect costs of ADR treatment were calculated according to the human capital approach. The epidemiological characteristics of ADRs were evaluated.
2739 were diagnosed with ADR during the study period, which translates to an ADR rate of 0.81%. The total socioeconomic loss from 2739 cases of ADR was estimated at ¥817401.69, consisting of direct costs of ¥603252.81 and indirect costs of ¥214148.88. On average, the costs per patient amounted to ¥196.10 in group A, ¥7032.29 in group B. The sum of medicare payment and proportion were ¥219061.13 (65.23%) and ¥105422.02 (39.42%) in group A and B. The ADR incidence in old-age patients was significantly higher than in other age groups (P < 0.0001). The most common drug class associated with ADRs represented antibiotics (957 patients, 34.94%).
The costs of especially severe ADRs could not be ignored, and in this hospital 0.13% of patients were diagnosed with ADRs associated with relatively higher direct costs than who suffered from mild ADRs, largely due to extended hospitalization.
PMCID: PMC3931293  PMID: 24533894
Adverse drug reaction; Direct medical cost; Hospitalized patients; Tertiary care teaching hospital; Pharmacoeconomic
15.  A systematic review of the prevalence and risk factors for adverse drug reactions in the elderly in the acute care setting 
Adverse drug reactions (ADRs) are an important health issue. While prevalence and risk factors associated with ADRs in the general adult population have been well documented, much less is known about ADRs in the elderly population. The aim of this study was to review the published literature to estimate the prevalence of ADRs in the elderly in the acute care setting and identify factors associated with an increased risk of an ADR in the elderly. A systematic review of studies published between 2003 and 2013 was conducted in the Cochrane Database of Systematic Reviews, EMBASE, Google Scholar and MEDLINE. Key search terms included: “adverse drug reactions”, “adverse effects”, “elderly patients and hospital admission”, “drug therapy”, “drug adverse effects”, “drug related”, “aged”, “older patients”, “geriatric”, “hospitalization”, and “emergency admissions”. For inclusion in the review, studies had to focus on ADRs in the elderly and had to include an explicit definition of what was considered an ADR and/or an explicit assessment of causality, and a clear description of the method used for ADR identification, and had to describe factors associated with an increased risk of an ADR. Fourteen hospital-based observational studies exploring ADRs in the elderly in the acute care setting were eligible for inclusion in this review. The mean prevalence of ADRs in the elderly in the studies included in this review was 11.0% (95% confidence interval [CI]: 5.1%–16.8%). The median prevalence of ADRs leading to hospitalization was 10.0% (95% CI: 7.2%–12.8%), while the prevalence of ADRs occurring during hospitalization was 11.5% (95% CI: 0%–27.7%). There was wide variation in the overall ADR prevalence, from 5.8% to 46.3%. Female sex, increased comorbid complexity, and increased number of medications were all significantly associated with an increased risk of an ADR. Retrospective studies and those relying on identification by the usual treating team reported lower prevalence rates. From this review, we can conclude that ADRs constitute a significant health issue for the elderly in the acute care setting. While there was wide variation in the prevalence of ADRs in the elderly, based on the findings of this study, at least one in ten elderly patients will experience an ADR leading to or during their hospital stay. Older female patients and those with multiple comorbidities and medications appear to be at the highest risk of an ADR in the acute care setting.
PMCID: PMC4257024  PMID: 25489239
drug utilization; hospital
16.  Prevalence of adverse drug reactions at a private tertiary care hospital in south India 
Adverse Drug Reactions (ADRs) constitute an enormous burden for the society. The aim of the present study was to detect, document, assess and report the suspected ADRs and preparation of guidelines to minimize the incidence of ADRs.
A prospective-observational study was conducted in the Department of General Medicine of a tertiary care hospital for 12 months from April 2008 to March 2009. Detected and suspected ADRs were analyzed for causality, severity and preventability using appropriate validated scales and were reported. ADR alert card was prepared and given to patients. Therapeutic guidelines were prepared and given to the relevant departments.
A total of 57 ADRs were detected, documented, assessed and reported during the study period the incidence was found to be 1.8%. Assessment of severity of the suspected ADRs revealed that 12% of suspected ADRs were severe and 49% of ADRs were moderate in severity. Causality assessment was done which revealed 63% of ADRs were possibly drug-related. The majority of patients who had suffered from ADRs were above 60 years (56%). Gastrointestinal system was most commonly affected (37%) and the drug class mostly associated with ADRs was antibiotics (23%). Preventability of ADRs was assessed; and the results revealed that 28% of ADRs were definitely preventable.
Measures to improve detection and reporting of adverse drug reactions by all health care professionals is recommended to be undertaken, to ensure, and improve patient's safety. In this way, hospital/clinical pharmacists play the cornerstone role.
PMCID: PMC3063432  PMID: 21448378
Adverse Drug Reactions (ADR); Prevalence; India
17.  Do Geriatric Conditions Increase Risk of Adverse Drug Reactions in Ambulatory Elders? Results From the VA GEM Drug Study 
Many clinicians prescribe cautiously to older adults with common geriatric conditions for fear of causing adverse drug reactions (ADRs). However, little is known about the association between these conditions and risk of ADRs.
Using data from the VA Geriatric Evaluation and Management Drug Study, we determined any, preventable, and serious ADRs in 808 elders for 12 months after hospital discharge using a validated process involving patient self-report and chart review adjudicated by two health care professionals. Eight common geriatric conditions (activities of daily living, dementia, incontinence, falls, difficulty ambulating, malnourishment, depression, and prolonged bed rest) were evaluated at study baseline through self-report and structured assessments. We used Poisson regression to model the relationship between these geriatric conditions and ADRs.
Participants had a mean of 2.9 ± 1.2 geriatric conditions. Over the 12-month follow-up period, 497 ADRs occurred in 269 participants, including 187 ADRs considered preventable and 127 considered severe. On multivariable analyses, participants with dependency in one or more activities of daily living were less likely to suffer ADRs than those who were fully independent (incidence rate ratio: 0.78, 95% confidence interval = 0.62–1.00). None of the other seven geriatric conditions assessed were associated with ADR risk. Results were similar for preventable and serious ADRs, although participants with a history of falls were more likely to develop serious ADRs (incidence rate ratio: 1.49, 95% confidence interval = 1.00–2.21).
Many geriatric conditions were not associated with risk of ADRs. Although it is prudent to prescribe judiciously in patients with these conditions, excessive caution may not be warranted.
PMCID: PMC3055283  PMID: 21321003
Adverse drug reactions; Geriatric syndromes; Drug utilization
18.  Adverse drug reactions induced by cardiovascular drugs in outpatients 
Pharmacy Practice  2008;6(1):51-55.
Considering increased use of cardiovascular drugs and limitations in pre-marketing trials for drug safety evaluation, post marketing evaluation of adverse drug reactions (ADRs) induced by this class of medicinal products seems necessary.
To determine the rate and seriousness of adverse reactions induced by cardiovascular drugs in outpatients. To compare sex and different age groups in developing ADRs with cardiovascular agents. To assess the relationship between frequencies of ADRs and the number of drugs used.
This cross-sectional study was done in cardiovascular clinic at a teaching hospital. All patients during an eight months period were evaluated for cardiovascular drugs induced ADRs. Patient and reaction factors were analyzed in detected ADRs. Patients with or without ADRs were compared in sex and age by using chi-square test. Assessing the relationship between frequencies of ADRs and the number of drugs used was done by using Pearson analysis.
The total number of 518 patients was visited at the clinic. ADRs were detected in 105 (20.3%) patients. The most frequent ADRs were occurred in the age group of 51-60. The highest rate of ADRs was recorded to be induced by Diltiazem (23.5%) and the lowest rate with Atenolol (3%). Headache was the most frequent detected ADR (23%). Assessing the severity and preventability of ADRs revealed that 1.1% of ADRs were detected as severe and 1.9% as preventable reactions. Women significantly developed more ADRs in this study (chi square = 3.978, P<0.05). ADRs more frequently occurred with increasing age in this study (chi square = 15.871, P<0.05). With increasing the number of drugs used, the frequency of ADRs increased (Pearson=0.259, P<0.05).
Monitoring ADRs in patients using cardiovascular drugs is a matter of importance since this class of medicines is usually used by elderly patients with critical conditions and underlying diseases.
PMCID: PMC4147279  PMID: 25170364
Product Surveillance; Postmarketing; Cardiovascular Agents; Iran
19.  Sex-dimorphic adverse drug reactions to immune suppressive agents in inflammatory bowel disease 
AIM: To analyze sex differences in adverse drug reactions (ADR) to the immune suppressive medication in inflammatory bowel disease (IBD) patients.
METHODS: All IBD patients attending the IBD outpatient clinic of a referral hospital were identified through the electronic diagnosis registration system. The electronic medical records of IBD patients were reviewed and the files of those patients who have used immune suppressive therapy for IBD, i.e., thiopurines, methotrexate, cyclosporine, tacrolimus and anti-tumor necrosis factor agents (anti-TNF); infliximab (IFX), adalimumab (ADA) and/or certolizumab, were further analyzed. The reported ADR to immune suppressive drugs were noted. The general definition of ADR used in clinical practice comprised the occurrence of the ADR in the temporal relationship with its disappearance upon discontinuation of the medication. Patients for whom the required information on drug use and ADR was not available in the electronic medical record and patients with only one registered contact and no further follow-up at the outpatient clinic were excluded. The difference in the incidence and type of ADR between male and female IBD patients were analyzed statistically by χ2 test.
RESULTS: In total, 1009 IBD patients were identified in the electronic diagnosis registration system. Out of these 1009 patients, 843 patients were eligible for further analysis. There were 386 males (46%), mean age 42 years (range: 16-87 years) with a mean duration of the disease of 14 years (range: 0-54 years); 578 patients with Crohn’s disease, 244 with ulcerative colitis and 21 with unclassified colitis. Seventy percent (586 pts) of patients used any kind of immune suppressive agents at a certain point of the disease course, the majority of the patients (546 pts, 65%) used thiopurines, 176 pts (21%) methotrexate, 46 pts (5%) cyclosporine and one patient tacrolimus. One third (240 pts, 28%) of patients were treated with anti-TNF, the majority of patients (227 pts, 27%) used IFX, 99 (12%) used ADA and five patients certolizumab. There were no differences between male and female patients in the use of immune suppressive agents. With regards to ADR, no differences between males and females were observed in the incidence of ADR to thiopurines, methotrexate and cyclosporine. Among 77 pts who developed ADR to one or more anti-TNF agents, significantly more females (54 pts, 39% of all anti-TNF treated women) than males (23 pts, 23% of all anti-TNF treated men) experienced ADR to an anti-TNF agent [P = 0.011; odds ratio (OR) 2.2, 95%CI 1.2-3.8]. The most frequent ADR to both anti-TNF agents, IFX and ADA, were allergic reactions (15% of all IFX users and 7% of all patients treated with ADA) and for both agents a significantly higher rate of allergic reactions in females compared with males was observed. As a result of ADR, 36 patients (15% of all patients using anti-TNF) stopped the treatment, with significantly higher stopping rate among females (27 females, 19% vs 9 males, 9%, P = 0.024).
CONCLUSION: Treatment with anti-TNF antibodies is accompanied by sexual dimorphic profile of ADR with female patients being more at risk for allergic reactions and subsequent discontinuation of the treatment.
PMCID: PMC3531681  PMID: 23322995
Adverse drug reactions; Sexual dimorphism; Infliximab; Adalimumab; Inflammatory bowel disease
20.  Adverse drug reactions & their risk factors among Indian ambulatory elderly patients 
Background & objectives:
Several studies have reported adverse drug events ranging from 5 to 35 per cent in all age group from outpatient setting. However, adverse drug reactions (ADRs) particularly among a large sample of ambulatory elderly patients in India has not been reported. This study has attempted to identify ADRs and assessed their causality, preventability and severity, and also their risk factors in Indian ambulatory elderly patients.
A 2 year long term prospective study included 4005 ambulatory elderly patients (60 yr or above; either sex) at a public teaching hospital. Suspected ADRs were assessed for causality, preventability and severity using Naranjo's probability scale, modified Schumock and Thornton's criteria, and modified Hartwig's criteria, respectively.
Of the total 4005 prescriptions, 406 were identified with ADRs, giving the occurrence of 10 per cent ADRs in elderly. The total number of ADRs was 422 in 406 prescriptions. Type A ADRs accounted for 46 per cent of the total ADRs. Majority of the ADRs (88.6%) were classified as ‘probable’. The definitely preventable reactions were 22 per cent. The percentage of moderate reaction was 16 per cent. Only 1.6 per cent ADRs was severe in nature. The most common type of ADR was peripheral oedema. The most commonly offending class of drug was cardiovascular drugs (57.6%). Using logistic regression analysis, the risk factors which contributed to ADRs were age above 80 yr (OR=1.7), prescription of multiple drugs (OR=1.8), longer duration of treatment (OR=2.28) and multiple diagnoses (OR=1.8).
Interpretation & conclusions:
In this study, 10 per cent ambulatory elderly patients were found to have ADRs. This indicates that the elderly patients should be closely monitored for ADRs, to avoid clinically significant harmful consequences. The awareness of risk factors of ADRs would help physicians to identify elderly patients with greater risk of ADRs and, therefore, might benefit from ADRs monitoring and reporting programme.
PMCID: PMC3510886  PMID: 23041733
ADRs; ambulatory elderly patient; risk factors
21.  Adverse drug reactions in inpatients of internal medicine wards at a tertiary care hospital: A prospective cohort study 
To find out incidence of adverse drug reactions (ADR) in patients of internal medicine wards and study various aspects of ADR, e.g., causality, mortality, drugs commonly causing ADR in internal medicine wards of Guru Gobind Singh Hospital, Jamnagar, a tertiary care hospital.
Materials and Methods:
This was prospective, observational study carried out at Department of Medicine, Shri Meghji Pethraj Shah Medical College attached with Guru Gobind Singh Hospital, a tertiary care teaching hospital, Jamnagar, Gujarat over a period of 6 months. For statistical analysis, ADR were analyzed by using Chi-square test.
Out of total 860 patients admitted, 830 were analyzed as they met the inclusion criteria. A total of 45 (5.42%) patients developed 47 ADR. Among them, 27 (3.25 %) (95% CI, 2.03, 4.47%) patients due to ADR required hospital admission in medicine ward (ADR Ad), 18 (2.17%) (95% CI, 1.17%–3.17%) patients developed ADR while already hospitalized in medicine ward (ADR In). Most of the fatal and life-threatening reactions occurred due to chemotherapeutic agents. Majority of patients discontinued suspected drug and recovered from ADR.
Fatal and life-threatening adverse reactions reported in the present as well as other studies underline the importance of such studies and need for creating awareness among health professionals about looking for and reporting such reactions.
PMCID: PMC3117564  PMID: 21701642
Adverse drug reaction; adverse drug reactions; cohort study
22.  A study of adverse drug reactions in pediatric patients 
To study the adverse drug reaction (ADR) pattern in a pediatric population in a tertiary care hospital.
Materials and Methods:
An observational study was done in the department of pediatrics in a tertiary care hospital. The ADRs occurring in the inpatient wards and outpatient department of pediatrics were actively monitored. The collected reports were analyzed for ADR pattern, drug groups, demographic profile, causality, severity, and preventability of the ADR.
A total of 30 ADRs were documented during the mid period of 2009 among pediatric patients. Most of the ADRs (60%) occurred below the age of 1 year. Antibiotics comprised the major group of drugs causing ADRs (67%). Rashes and urticaria were the most common type of ADR (37%) followed by fever, anaphylactic shock, vomiting, chills, and rigors. A single case of death had been reported in the study period. There were more occurrences of ADRs with multiple drugs compared to single drug therapy. About 80% of the ADRs were of probable causality and 87% were of probable preventability. There were no mild reactions, with 77% of reactions being moderate and 23% of reactions being severe in the severity scale.
ADRs occur more among infants and antibiotics were more commonly implicated. Most of the reactions were of moderate severity. This indicates the need for a rigid ADR monitoring among pediatric patients to ensure safety of drug therapy.
PMCID: PMC3198524  PMID: 22025857
Adverse drug reaction; causality; pediatric; pharmacovigilance
23.  Adverse drug reactions to antiretroviral therapy during the early art period at a tertiary hospital in Ghana 
Antiretroviral therapy (ART) has reduced HIV morbidity and mortality worldwide but has many adverse effects. These adverse drug reactions (ADRs) lead to discontinuations, disease progression or treatment failure. We explored the types and risk factors for ADRs in a cohort starting ART in a teaching hospital in Accra, Ghana where the main regimens used were a combination of nucleotide and non nucleotide reverse transcriptase inhibitors.
A Cross-sectional retrospective study was conducted reviewing data of 2042 patients initiated on HAART from 2003 to 2007. Univariate analysis was done for the dependent and independent variables. Stepwise logistic regression procedures were used to model the effect of gender on the development of ADRs controlling for other variables like age, marital status, weight at baseline and CD4 at baseline.
The period prevalence of ADRs was 9.4%. The two most common adverse reactions were anaemia and diarrhoea. Female sex was a statistically significant independent predictor of an adverse drug reaction (AOR: 1.66, p = 0.01, CI: 1.16-2.36). CD4 counts 250 cells/mm3 or more was significantly associated with the occurrence of an ADR. The occurrence of anaemia in females was statistically significant compared to males.
Adverse drug reactions were less common than expected, anaemia was the commonest ADR. Female sex and high CD4 counts >250mm3 were predictors of ADRs whereas females were significantly more likely to develop anaemia than males. Recommendations were made for interventions to prevent and also mitigate the high levels of anaemia especially among women in the ART scale up.
PMCID: PMC4214560  PMID: 25368714
Adverse Drug reaction; HAART; HIV; Female sex; Anaemia; CD4 cells
24.  Adverse Reactions Due to Directly Observed Treatment Strategy Therapy in Chinese Tuberculosis Patients: A Prospective Study 
PLoS ONE  2013;8(6):e65037.
More than 1 million tuberculosis (TB) patients are receiving directly observed treatment strategy (DOTS) therapy in China every year. As to the profile of adverse drug reactions (ADRs) due to DOTS therapy, no consensus has been reached. There is no report regarding ADRs due to DOTS therapy with a large Chinese TB population. This study aimed to determine the incidence and prognosis of ADRs due to DOTS therapy, and to evaluate their impact on anti-TB treatment in China.
A prospective population-based cohort study was performed during 2007–2008. Sputum smear positive pulmonary TB patients who received DOTS therapy were included and followed up for six to nine months in 52 counties of four regions in China. The suspected ADRs were recorded and reviewed by Chinese State Food and Drug Administration.
A total of 4304 TB patients were included in this study. 649 patients (15.08%) showed at least one ADR and 766 cases in total were detected. The incidence (count) of ADR based on affected organ was: liver dysfunction 6.34% (273), gastrointestinal disorders 3.74% (161), arthralgia 2.51% (108), allergic reactions 2.35% (101), neurological system disorders 2.04% (88), renal impairment 0.07% (3) and others 0.05% (2). Most cases of ADRs (95%) had a good clinical outcome, while two with hepatotoxicity and one with renal impairment died. Compared with patients without ADRs, patients with ADRs were more likely to have positive smear test results at the end of the intensive phase (adjusted OR, 2.00; 95%CI, 1.44–2.78) and unsuccessful anti-TB outcomes (adjusted OR, 2.58; 95%CI, 1.43–4.68).
The incidence of ADRs due to DOTS therapy was 15.08%. Those ADRs had a substantial impact on TB control in China. This highlighted the importance of developing strategies to ameliorate ADRs both to improve the quality of patient care and to control TB safely.
PMCID: PMC3672195  PMID: 23750225
25.  The Profile of Voluntary Reported Adverse Drug Reactions at a Tertiary Care Hospital: A Fifteen Month Prospective Study 
The present study was undertaken to provide the health professionals who were working at a tertiary care hospital, with a simple method to report Adverse Drug Reactions (ADRs) and to monitor, document and to evaluate them according to the set criteria.
Method and materials:
This study was conducted over a period of 15 months from 1st Jan’ 2008 to 31st March 2009 at Goa Medical College and Hospital (Goa, India). The evaluation of the data was done for various parameters, which included patient demographics and drug and reaction characteristics. An assessment was also done for the outcome, causality and the severity of the drug reactions.
A total of 265 ADRs were reported. Among the drugs, the ß-lactam antibiotics were implicated the maximum number of times (54, 20.37%), followed by fluoroquinolones (35, 13.20%), antiretrovirals (33, 12.45%) and antiepileptics (31, 11.69%). Females showed more ADRs (142, 54%) than males (123, 46%). The skin was involved in about 57.73% (153) of the ADRs, while the CNS and the vascular system were involved in 8.67% (23) and 8.30% (22) of the ADRs. Most of the ADRs were categorized as “Type II” (203, 77%) against “Type I” (62, 23%) by Rawlins and Thompson’s classification. The causality assessment was done by the Naranjo Algorithm and 62.26% (165) were seen to fall in the “probable category” as compared to 29.05% (77) in the “highly probable” one. Out of all the ADRs which were reported, 34.71% (148) were “severe”, in accordance with the Modified Hartwig and Siegel’s scale.
The present work was a humble attempt to set up a well organized ADR reporting system at our government hospital. The systematic tracking and monitoring of ADRs can shed light on their extensiveness and their patterns of occurrence.
PMCID: PMC3527781  PMID: 23285441
Pharmacovigilance; Adverse Drug Reactions; ADR drop box

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