Incidence and factors associated with medication nonadherence in patients with mental illness: a cross-sectional study.

BACKGROUND: In spite of the progress made in the treatment of psychiatric disorders during the last few decades, nonadherence continues to be a frequent phenomenon, often associated with potentially severe clinical consequences and increased health-care costs. There are numerous factors associated with medication nonadherence in patients with mental illness. The aim of the study was to determine the incidence and factors associated with medication nonadherence among psychiatric outpatients. MATERIALS AND METHODS: A cross-sectional study was carried out in the outpatient psychiatric department of an Indian tertiary care private hospital over a period of 1 year. Patients aged 18 years and above who presented with mental illness as diagnosed by the International Classification of Diseases (ICD)-10 and who were receiving at least one psychotropic medication for at least 1 month were included in the study. Medication adherence was assessed using the Medication Adherence Rating Scale (MARS). RESULTS: Of the 400 patients, 172 (43%) were nonadherent to their prescribed medications. There is a statistically significant association between the education (P = 0.001), number of drugs (P = 0.002), family income (P = 0.013), and nonadherence. Among the 172 patients, 33.5 % were nonadherent to their therapy due to patient-related factors followed by drug-related factors (32%) and disease-related factors (31%). CONCLUSION: The overall incidence of medication nonadherence in patients with mental illness was 43%. Numerous factors contributed to medication nonadherence. Strategies need to be developed and implemented to enhance medication adherence, and thereby achieve a better therapeutic outcome in patients with mental illness.

Frequency and nature of adverse drug reactions in elderly in-patients of two Indian medical college hospitals.

BACKGROUND: Adverse drug reactions (ADRs) are a major public health problem in the elderly. Although the Indian elderly represent 12.8% of the entire global elderly population, data on prevalence and predictors of ADRs in elderly Indians is extremely limited. AIM: To determine the prevalence, severity, preventability, length of hospital stays, and risk factors for ADRs in hospitalized Indian elderly. SETTING: Medicine wards of two tertiary care teaching hospitals. DESIGN: Prospective study was conducted between July 2007 and December 2009. MATERIALS AND METHODS: In-patients of either sex and aged ≥ 60 years were included and monitored for ADRs throughout their hospital stay. Severity (Hartwig et al. scale), preventability (Shumock and Thornton criteria) and increased length of stay (considering underlying disease, ADR, and discussion with clinicians) were assessed. STATISTICAL ANALYSIS: Bivariate analysis and subsequently multivariate logistic regression were used to determine the risk factors for developing ADRs. RESULTS: Over the study period, among the 920 patients monitored, 296 patients (32.2%) experienced 419 ADRs. Among all ADRs, 48.4% (203) were preventable. Majority of ADRs [226 (53.9%)] were moderate in severity. Therapeutic classes of drugs frequently associated with ADRs were the drugs used in diabetes [76 (18.1%)] and antibacterials for systemic use [54 (12.9%)]. ADRs increased the hospital stay in 5.9% (54) of patients. Female gender [Odds Ratio: 1.52, 95% Confidence Interval:1.04-2.22, P=0.03] was observed as the influential risk factor for ADRs. CONCLUSION: One third of hospitalized elderly experienced ADRs. Interventions focused at preventable ADRs should be developed and implemented to reduce their implications.

Prevalence of medication-related problems among patients with renal compromise in an Indian hospital.

WHAT IS KNOWN AND OBJECTIVE: Patients suffering from renal dysfunction often have multiple medical conditions either as a cause or as a consequence of their renal disease. These patients receive an average of 10-12 medications daily leading to complex dosing schedules and are more likely to develop medication-related problems (MRPs). The objectives of this study were to determine the nature and extent of MRPs in renally compromised patients and to explore the potential clinical significance of the MRPs. The potential for a clinical pharmacist to contribute towards resolving or preventing some of these MRPs was also explored. METHODS: A prospective study was conducted for a period of 9 months in the renal unit of Jagadguru Shri Shivaratheeshwara (JSS) Medical College Hospital, Mysore, India. Patients undergoing dialysis on outpatient basis and patients who were admitted under the care of or referred to the nephrologists for renal dysfunction from other specialties were reviewed. Patterns of the MRPs were identified using an adapted Hepler and Strand criteria. The potential clinical significance of the MRPs and the contribution of the clinical pharmacist in resolving or minimizing some of the MRPs were also explored. RESULTS AND DISCUSSION: Three hundred and twenty-seven MRPs were identified with 308 patients reviewed. The incidence of MRPs was found to be 1·06 ± 0·85 per patient reviewed. The most common MRP identified in our study was overdose (19·3%) followed by adverse drug reactions (19·0%). Cardiovascular agents (33·6%) followed by anti-infective agents (26·3%) were the most common therapeutic classes of medication implicated in causing MRPs. Twenty-six per cent of the MRPs identified were explored to be potentially moderate or major in clinical significance. The clinical pharmacists' recommendations were accepted in 97% of the cases, which resulted in a change in therapy in 83% of the cases. WHAT IS NEW AND CONCLUSION: Medication-related problems are frequent in renally compromised patients in our patient population. The high level of acceptance of clinical pharmacist's recommendations by the nephrologists demonstrates that clinical pharmacists may help improve overall patient care in this setting.

Potentially inappropriate medication use in elderly patients: a study of prevalence and predictors in two teaching hospitals.

BACKGROUND: Geriatrics is an emerging clinical specialty in India. Information about the appropriateness of prescription medication use among the elderly in India is limited. AIMS: To determine the prevalence and predictors of potentially inappropriate medication (PIM) use, and assess the relationship between PIM use and adverse drug reactions (ADRs) in the hospitalized elderly. SETTINGS: Medicine wards at two teaching hospitals. DESIGN: Prospective observational study. MATERIALS AND METHODS: Patients aged > 60 years admitted to medicine wards between January 2008 and June 2009 were included and reviewed for PIM use according to the Beers Criteria 2003 (BC). Severity of PIM use was classified as per BC as 'high' or 'low'. ADRs observed in the study patients were also recorded. STATISTICAL ANALYSIS: Association between ADRs and PIM use was assessed using Chi Square test. Bivariate analysis and subsequently multivariate logistic regression was used to identify predictors of PIM use. RESULTS: PIM use was observed in 191 of 814 enrolled patients. At least one PIM at admission and during hospital stay was received by 2.4% (20) and 22.1% (180) patients respectively. High-severity PIM use showed a higher prevalence compared to low severity [26.8% (218) vs. 5.5% (45)]. Amongst the patients who received polypharmacy (> or = 5 concurrent medications), 1.4% (5/362) and 22.1% (163/736) patients received PIMs at admission and during hospital stay respectively. Use of aspirin/clopidogrel/diclofenac in the presence of blood clotting disorder or anticoagulant therapy (8.3%) was the most commonly encountered PIM use. Medications not listed in BC were associated with increased occurrence of ADRs compared to medications listed in BC (349 vs. 11) (chi2 =98.4, P<0.001). Increased number of concurrent medications' use (> or = 9) during the stay in medicine wards was identified as an influential predictor of PIM use [Odds ratio: 1.9, 95% Confidence Interval: 1.34-2.69, P<0.001) in the hospitalized elderly. CONCLUSION: PIM use was common (23.5%) among the elderly patients during their stay in medicine wards in two tertiary care hospitals. Measures targeted only at BC medications may do little to change the risk of ADRs in elderly.

Montelukast induced acute hepatocellular liver injury.

A 46-year-old male with uncontrolled asthma on inhaled albuterol and formoterol with budesonide was commenced on montelukast. He developed abdominal pain and jaundice 48 days after initiating montelukast therapy. His liver tests showed an increase in serum total bilirubin, conjugated bilirubin, aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase. The patient was evaluated for possible non-drug related liver injury. Montelukast was discontinued suspecting montelukast induced hepatocellular liver injury. Liver tests began to improve and returned to normal 55 days after drug cessation. Causality of this adverse drug reaction by the Council for International Organizations of Medical Sciences or Roussel Uclaf Causality Assessment Method (CIOMS or RUCAM) and Naranjo's algorithm was 'probable'. Liver tests should be monitored in patients receiving montelukast and any early signs of liver injury should be investigated with a high index of suspicion for drug induced liver injury.

An assessment of the quality of life in hemodialysis patients using the WHOQOL-BREF questionnaire.

A cross-sectional study was conducted to evaluate the quality of life (QOL) of hemodialysis patients. An attempt was made to compare the QOL of hemodialysis patients with the QOL of the general population, renal transplant patients, and patients with a chronic disease, in this case, asthma. The WHOQOL-BREF questionnaire was used to assess the quality of life. Hemodialysis patients who had completed three months of maintenance hemodialysis (n = 75) were enrolled into the study. The quality of life of hemodialysis patients was found to be significantly impaired (P < 0.05) in comparison to healthy individuals of the general population, particularly with respect to the physical, psychological, and social relationship domains. In comparison to the quality of life of renal transplant patients, the quality of life of hemodialysis patients was significantly (P < 0.05) lower in all the four WHOQOL-BREF domains. Only in the environmental dimension was the quality of life of hemodialysis patients found to be significantly lower than that of the asthma patients. Female hemodialysis patients showed significantly (P < 0.05) lower quality of life than did male patients in the psychological and environmental dimensions of WHOQOL-BREF. A positive association was seen between higher education and the psychological functioning and the environmental dimensions of WHOQOL-BREF. Thus, the quality of life of hemodialysis patients was found to be considerably impaired when compared to that of healthy individuals of the general population as well as of renal transplant patients.

Severe cutaneous adverse drug reaction to leflunomide: a report of five cases.

Medications used to treat human ailments are known to cause cutaneous reactions which may vary in their severity. Leflunomide, an immunomodulating agent recently introduced to treat rheumatoid arthritis, is reported to cause severe cutaneous reactions. We are reporting five such cases. All our patients were started on leflunomide for rheumatoid arthritis, 4-6 weeks before the onset of cutaneous reaction and were admitted to the hospital with the common complaints of fever, skin rash and generalized weakness. All of them had characteristic pattern of events such as delayed onset of reaction, widespread and long lasting skin rash and internal organ involvement. These features suggest a possibility of drug hypersensitivity syndrome to leflunomide. Careful dosing and periodic monitoring of patients treated with leflunomide for possible adverse drug reaction is recommended.

Adverse drug reactions in a south Indian hospital--their severity and cost involved.

PURPOSE: The study was aimed to assess the pattern of occurrence of adverse drug reactions (ADRs) in the local population, severity of reported ADRs and additional financial resource utilisation associated with ADRs. METHODS: This was a prospective, spontaneous reporting study conducted over a period of 7 months by clinical pharmacists. The WHO definition of an ADR was adopted. Each ADR was assessed for its causality by using the WHO Probability Scale. The severity of each reported ADR was assessed using the criterion developed by Hartwig et al. The average cost incurred in treating the ADRs was calculated. RESULTS: A total of 270 suspected ADRs were reported and evaluated from 164 patients. A total of 3.7% of the hospitalised patients experienced an ADR, 0.7% of the admissions were due to ADRs and 1.8% had a fatal ADR. The gastrointestinal system (36.3%) was most commonly involved with an ADR. The drug class most commonly implicated with ADRs was cardiovascular (18.3%). Majority (47%) of the reactions were 'moderate' in severity. The total cost incurred in managing all the reported ADRs was Rs 76,564 (US$ 1595) with an average cost of Rs 690 (US$ 15) per ADR. CONCLUSION: Detection and prevention of ADRs at the earliest is very important as they can cause not only morbidity and mortality but also involve high health care cost in their management. Well-trained pharmacists in the area of ADR detection, reporting and monitoring could prove as an asset in providing better patient care.

Sparfloxacin induced toxic epidermal necrolysis.

Toxic epidermal necrolysis (TEN) is a life-threatening cutaneous adverse drug reaction. TEN is known to occur with the fluoroquinolone class of antibiotics, but only four cases of sparfloxacin induced TEN have been reported to the WHO database. This is another case report of sparfloxacin induced TEN.

Altered biological distribution and decreased neuromuscular toxicity of niosome encapsulated vincristine.

Effects of encapsulation within niosomes (nonionic surfactant vesicles) on the biological distribution and toxicity of vincristine-a widely used anticancer drug have been investigated. Plasma kinetics, tissue distribution profile and neuromuscular toxicity of niosomal vincristine (NVCR) were compared with those of free vincristine (FVCR). NVCR was cleared from the plasma much more slowly [t1/2(beta) = 1.388 hr] than FVCR [t1/2(beta) = 0.74 hr]. Over the 48 hr period of experiment, the niosome formulation delivered significantly more drug to the plasma compartment than FVCR and resulted in reduced accumulation of drug in gut and skeletal muscle. Encapsulation caused a marked alteration in the tissue disposition of the drug. NVCR was less toxic both in terms of mortality and morbidity. Importantly, histopathological studies of skeletal muscle, spinal cord and sciatic nerve of NVCR treated albino wistar rats demonstrated the less toxic potential of encapsulated vincristine. Further, the biochemical studies, estimation of enzymes plasma creatine phosphokinase and lactate dehydrogenase, confirmed the safety profile of NVCR. The decreased partitioning of NVCR to non active sites resulted in a significant amelioration of the toxic side effects, gastrointestinal and myological in particular, of the drug. The results indicate that the delivery of vincristine by encapsulating it in niosomes offer an efficient means of decreasing its toxic effects.

Niosome encapsulated of vincristine sulfate: improved anticancer activity with reduced toxicity in mice.

Nonionic surfactant vesicles (niosomes) are promising drug carriers for anticancer drugs. Niosome encapsulated vincristine sulfate prepared by transmembrane pH gradient drug uptake process (remote loading method) was evaluated for toxicity and antitumour activity after administration to tumour bearing mice. The toxicity of vincristine sulfate was reduced after niosome encapsulation and anticancer activity improved, which may be due to better delivery of vincristine at the tumour site.