A study on drug safety monitoring program in India.

Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers.

Evaluation of self medication practices in rural area of town sahaswan at northern India.

BACKGROUND: Many of the studies have investigated the prevalence and nature of self-medication. It is a common type of self-care behavior among the populace of various countries. World Health Organization promotes the practice of self-medication for effective and quick relief of symptoms without medical consultations to reduce the burden on health-care services, which are often understaffed and inaccessible in rural and remote areas. AIM: The aim of the study was to determine the extent and pattern of self-medication among the population (patients) attending pharmacies at study sites and to note the association of self-medication variables with demographic factors. SUBJECTS AND METHODS: The present study was a community based cross sectional study aimed to gather information about the prevalence of self-medication in the rural town of Sahaswan, Uttar Pradesh from June 2012 to July 2012. The sample size comprised of 600 respondents. Data were collected through a prepared questionnaire. All descriptive data were coded, entered and analyzed using the statistical package for Social sciences program version 17.0 (Chicago, IL, USA). Descriptive data analysis was conducted and reported as frequencies and percentage. RESULTS: The percentage of patients who were seeking self-medication was approximately 50% (300/600). Most of the patients were seeking self-medication for headache and other pain (23.3% [140/600]), fever (14.5% [87/600]), urinary tract infections (9.7% [58/600]) and respiratory tract infections (11.7% [70/600]). The drugs most commonly purchased for practicing self-medication were non-steroidal anti-inflammatory drugs (25.3% [152/600]), medications used for gastro intestinal problems (20.8% [125/600]) and antibiotics (16.7% [100/600]). CONCLUSION: Prevalence of self-medication was high primarily among illiterate males aged above 15 years with a low income. Patient health awareness programs, assistance by community pharmacists and pharmacist continuing education are necessary for controlling self-medication. There is a need for planning interventions to promote rational self-medication through mass medias such as newspaper, magazine and TV.

Markov Chain Modelling Analysis of HIV/AIDS Progression: A Race-based Forecast in the United States.

HIV/AIDS has reached a pandemic level across the world with more than 33 million people who are living with HIV. In the United States, more than half a million people have been victims of AIDS. This study investigates the most vulnerable racial minority population (the African Americans) in the United States and the second least affected (the Caucasians) in order to predict the trends of the epidemic. A Markov chain analysis was used to model the progression of the disease among vulnerable people, infective people and AIDS cases for the two races separately, based on the 2009 Centers of Disease Control and Prevention HIV/AIDS Surveillance Report. Based on the Markov model, our study predicts that the number of African American people living with AIDS diagnosis and HIV infection and dead due to HIV/AIDS will be 662.2, 1225.3 and 62.9 in 2015 and 794.9, 1566.5 and 79.2 in 2030, respectively. The number of Caucasian people living with AIDS diagnosis and HIV infection and dead due to HIV/AIDS will be 96.4, 160 and 6.5 in 2015 and 118.6, 206.9 and 8.3 in 2030, respectively. The numbers of deaths due to HIV/AIDS are quite stable over the years in both the races. There is an increasing trend in the number of people living with HIV infection and AIDS diagnosis in Caucasians compared with African Americans. The absolute number of Caucasians living with AIDS diagnosis and HIV infection is quite smaller compared with African Americans. The results reveal discrepancy in HIV infection, AIDS diagnosis and deaths due to HIV/AIDS among the African Americans and the Caucasians races. There is a need for interventions focusing on HIV/AIDS prevention and management, optimum resource allocation and development of antiAIDS campaigns to reduce the infection rate.

Similar survival with single-agent capecitabine or taxane in first-line therapy for metastatic breast cancer.

Capecitabine is often offered as a first-line chemotherapy option for metastatic breast cancer (MBC). In this study, we compare characteristics of and survival among women prescribed first-line capecitabine or taxane monotherapy for MBC. Women receiving first-line chemotherapy for MBC from 1998 to 2005 were identified from the North Carolina tumor registry linked with Medicaid and Medicare claims records, and were followed through the end of 2005 with survival data from the National Death Index. T Tests and Chi-square tests were used to compare baseline characteristics. Overall survival and cancer-specific survival were examined using Cox proportional hazard modeling. There were 257 patients with MBC starting first-line chemotherapy with capecitabine (n=71) or a taxane (n=186). No differences in age, race, or Charlson comorbidity status were observed between groups. Hormone receptor negative tumors (31.0 vs. 17.7%, p=0.02) and patients insured by Medicaid (28 vs. 12%, p=0.002) were more prevalent in the capecitabine group. Time from metastasis to first-line chemotherapy was longer in the capecitabine group (52 vs. 26% began after 3 months, p<0.001). In multivariate analysis, treatment received was not associated with overall or cancer-specific survival. Among standard demographics, age was the only factor significantly associated with overall survival (HR 1.02, p=04). In this population-based study, women who received capecitabine as first-line treatment for MBC were more often hormone receptor negative and insured by Medicaid. In multivariate analysis, first-line capecitabine and taxane for MBC yielded similar overall and cancer-specific survival outcomes.

Medication Error Management around the Globe: An Overview.

Medical mistakes that include medication errors have raised concerns about medication safety. Due to high consumption of medicines and self-treatment by all, especially the aging population, the issue of proper medication use and safety is at the forefront of public health concerns globally. Each country has a different approach towards medication event monitoring that is compliant with its own health care system. This paper focuses on the efforts and endeavors of some of the countries around the world to create an efficient error reporting systems to ensure public safety. Our analysis indicates that there are established and effective medication vigilance systems in many developed countries. The different countries undertake activities which range from collecting information about prescriptions, surveying physicians about adverse drug events, and conducting sophisticated post-marketing surveillance studies. There is still need for such sophisticated system in India; however recent promising developments are occurring towards building a medication vigilance system. Development of these systems may eventually contribute to a global medication vigilance system, which could reduce concern with medication errors and safety.

Health behaviour models: a framework for studying adherence in children with atopic dermatitis.

Atopic dermatitis (AD) is a common problem of childhood causing considerable distress. Effective topical treatments exist, yet poor adherence often results in poor outcomes. A framework is needed to better understand adherence behaviour. To provide a basis for this framework, we reviewed established models used to describe health behaviour. Structural elements of these models informed the development of an adherence model for AD that can be used to complement empirical AD treatment trials. Health behaviour models provide a means to describe factors that affect adherence and that can mediate the effects of different adherence interventions. Models of adherence behaviour are important for promoting better treatment outcomes for children with AD and their families. These models provide a means to identify new targets to improve adherence and a guide for refining adherence interventions.

Using 'number needed to treat' to help conceptualize the magnitude of benefit and risk of tumour necrosis factor-alpha inhibitors for patients with severe psoriasis.

BACKGROUND: Risks and benefits of tumour necrosis factor (TNF) alpha inhibitors are often presented using statistical descriptions that are difficult to translate directly for patients into a clinically meaningful context. OBJECTIVES: To illustrate the risks and benefits of TNFalpha inhibitors in relation to risks that patients understand. METHODS: We performed a number needed to treat analysis for patients with psoriasis on TNFalpha inhibitors via a Medline and Embase search. We determined the number needed to benefit and the number needed to harm with TNFalpha inhibitor treatment. We compared the risk of serious adverse events from treatment with a TNFalpha inhibitor to the risk of death from driving a car. The risk analyses were limited to the risks of tuberculosis, lymphoma and demyelinating disease. RESULTS: The numbers needed to benefit were 2.1 for etanercept, 1.4 for infliximab, and 1.6 for adalimumab. Depending on the adverse event, the numbers needed to harm ranged from 380 to 360,000 treated patients per year. Screening prior to the initiation of TNFalpha inhibitor therapy reduces risk of tuberculosis. Patients are about as likely to die in a car accident as to have a serious adverse event from treatment with a TNFalpha inhibitor. CONCLUSIONS: All three of the TNFalpha antagonists have remarkable efficacy in patients with severe psoriasis. The risks of serious adverse events are relatively rare and comparable to the risks patients take on a regular basis such as driving a car. For many patients with severe psoriasis, the benefits of TNFalpha inhibitors may greatly outweigh the risks.

Assessment of the use of angiotensin receptor blockers in major European markets among paediatric population for treating essential hypertension.

This study was conducted to assess the use of angiotensin receptor blockers (ARBs) in European paediatric patients experiencing essential hypertension. This was a retrospective analysis of the IMS MIDAS Prescribing Insight Medical Database. Five major important European markets, including France, Germany, Italy, Spain and the UK were studied for the usage of ARBs as either a monotherapy or fixed-dose combination (FDC) therapy . Paediatric patients with essential hypertension were identified using ICD-10 codes, and anatomical therapeutic chemical (ATC) classification was used to identify major classes of antihypertensives. Projected prescription data for paediatric patients (<18 years) in the time period of October 2005 to September 2006 were analysed. Special emphasis was placed on the category of 6-17 years of age, as many ARBs were recommended in children above 6 years of age. Out of 242,405 estimated paediatric patients with hypertension, 222,033 (91.6%) were diagnosed with essential hypertension. Out of 230,220 projected prescriptions dispensed in these essential hypertensives, approximately 76.2% were for patients in the category of 6-17 years of. In the age group of 6-17 years, ARBs constituted 25.5% of the projected prescriptions, with 10.6% in the form of FDC of ARBs with hydrochlorothiazides (HCTz). Projected ARB prescription usage, either as a monotherapy or as an FDC with HCTz, was higher in Italy (35.7%), France (30.9%) and Spain (28.1%), but was lower in Germany (5.3%), and non-existent in the United Kingdom. Valsartan-based and losartan-based FDCs were commonly used in the age range of 6-17 years, and accounted for 39. and 13.9% of the projected prescription volume in the ARB-FDC category, respectively. In a majority of the important European markets, paediatric hypertensive patients in the age range of 6-17 years are often treated with ARB monotherapy or FDC therapy. Some ARBs lack necessary clinical studies to support its use in treating essential hypertension in paediatric patients.

Better medication adherence results in greater improvement in severity of psoriasis.

BACKGROUND: Patients are commonly nonadherent to medication regimens. In dermatology, there has been little study of the effect of nonadherence on outcomes. OBJECTIVES: To test the association between adherence behaviour and changes in severity of psoriasis. METHODS: Twenty-four subjects with psoriasis were enrolled in an 8-week, left/right, controlled trial of salicylic acid plus topical tacrolimus ointment vs. salicylic acid plus placebo. Subjects were given salicylic acid to apply to all lesions. The salicylic acid was supplied in a bottle with a medication event monitoring system cap in order to assess adherence to the salicylic acid. The primary outcome for this study was the relationship between the change in the disease severity (change in sum score of erythema, scale and thickness scores for a target plaque) and medication adherence. RESULTS: The mean initial disease severity was 5.8 on a nine-point sum score scale. For the topical tacrolimus-treated side, a decrease in adherence rate of 10% was associated with a 1-point increase in severity (P < 0.05). For the placebo-treated side, adherence was not significantly correlated with changes in severity. CONCLUSIONS: Nonadherence may have a significant role in altering clinical trial data, skewing it towards ineffectiveness. Improved outcomes in psoriasis may be achievable through interventions that improve patients' adherence to treatment.

Improved quality of life with effective treatment of facial melasma: the pigment trial.

Melasma is a common hyperpigmentation of the face or neck that can have severe adverse psychological and emotional effects on affected individuals. Although a variety of treatments have been used over the years, results have typically been less than satisfactory. An open-label, community-based trial was undertaken at 393 centers in the United States, enrolling 1290 patients representing a broad range of races/ethnicities and all Fitzpatrick skin types, to evaluate the efficacy and safety of a new melasma treatment that combines fluocinolone acetonide 0.01%, hydroquinone 4.0%, and tretinoin 0.05% (FA+HQ+RA) in a hydrophilic cream formulation. An additional objective of the study was to assess the impact of this therapy on the quality of life. Efficacy and safety were evaluated at 4 and 8 weeks, and changes in a variety of quality of life parameters were analyzed at the conclusion of the study. All measures of efficacy showed that FA+HQ+RA significantly (p<0.0001) improved melasma at 4 weeks with further improvement at 8 weeks across all races/ethnicities and Fitzpatrick skin types. The treatment was safe and well tolerated. After 8 weeks of therapy, patients reported that FA+HQ+RA had provided a variety of benefits that had enhanced their quality of life.

Racial differences in the treatment of pigmentation disorders in outpatient settings: analysis of US national practice data.

OBJECTIVE: Pigmentary disorders tend to disproportionately affect individuals with darker skin pigmentation. An understanding of why certain patients or races present more frequently to physicians would help guide attempts for early interventions and education for these patients. METHODS: Data from the National Ambulatory Medical Care Survey (1996-2000) were used to examine associations between the race/ethnicity of the patient and the type of skin-related visit. We examined the impact of non-white (and separately, black) individuals and Hispanic ethnicity on the probability of a pigmentary disorder or non-pigmentary disorder-related outpatient physician visit in weighted multivariate logistic regression models. RESULTS: Non-white patients have a higher probability of a pigmentary disorder-related skin condition visit than white patients (RR: 1.30; 95% CI: 1.29, 1.31). Black patients are more likely than non-black patients to be seen for a pigmentary disorder (RR: 1.04; 95% CI: 1.03, 1.04). Hispanic patients are less likely to be seen for a pigmentary disorder (RR: 0.90; 95% CI: 0.90, 0.91). This is in contrast to non-pigmentary skin disorder-related visits, where non-white, black, as well as Hispanic patients have a lower probability of visits than white individuals. CONCLUSIONS: There is a race-related differential in the treatment of pigmentary skin disorders, with non-white patients having a probability of receiving more care for these conditions in US outpatient settings. This lends support to our hypothesis that darker pigmentation in non-white populations is the driver of a differential in the utilization of pigmentation-related skin visits.

Class I topical corticosteroid use by psoriasis patients in an academic practice.

BACKGROUND: Psoriasis is a chronic skin disorder that can have a profound impact on the quality of life of patients. The treatment of psoriasis is complicated by the availability of numerous topical agents, systemic agents, and phototherapy. Of the topical preparations available, the ultra-high potency, or Class I steroids, have an important role in treating psoriasis. Their use is most appropriate for the treatment of plaques in regions excluding the face, axilla, groin and genitals. OBJECTIVE: The purpose of this study was to examine the prescribing patterns of Class I topical corticosteroids within a large academic dermatology practice for patients with all types of psoriasis. METHODS: A retrospective chart review of 650 patients with psoriasis from an academic dermatology practice was performed. Class I steroid use was defined as those patients who were observed to be currently using clobetasol propionate, halobetasol propionate, diflorasone, or augmented betamethasone dipropionate. RESULTS: A total of 79% of patients were prescribed topical steroids of any class while 46% of patients were prescribed a Class I steroid. In all, 58% of patients who received topical steroid therapy received a Class I agent; 11% of patients prescribed Class I steroids also received systemic therapy for their psoriasis. Conversely, 35% of patients who received systemic therapy were also receiving Class I topical therapy. DISCUSSION: In our department, Class I topical steroids are commonly used in the treatment of psoriasis. The superpotent topicals are often used as an adjunct to systemic therapy and will likely remain a mainstay of psoriasis therapy.

Physicians underutilize topical retinoids in the management of acne vulgaris: analysis of U.S. National Practice Data.

BACKGROUND: Topical retinoids are effective in the treatment of acne, yet no current guidelines existed in the literature until recently recommending their use as an integral part of mild to moderate acne treatment. OBJECTIVE: To assess whether underutilization of topical retinoids occurs in clinical practice. DESIGN: Weighted data on representative office visits with acne vulgaris diagnoses were analyzed using the National Ambulatory Medical Care Survey (NAMCS), from 1990 to 1999. RESULTS: Of the 54.2 million acne vulgaris visits, retinoids were prescribed at 35.3% visits. Dermatologists prescribed significantly more retinoids than non-dermatologists (39.4%' versus 23%). Dermatology visit was a significant predictor of topical retinoid prescription (RR: 2.27,95% CI: 1.63-3.17). Data suggest that prescribing retinoids for acne has been increasing over the past decade, primarily among dermatologists. CONCLUSION: There is a major difference between suggested treatment guidelines for acne and actual practice in the community. There is distinct under-utilization of topical retinoids for treatment of acne vulgaris by dermatologists and non-dermatologists.

Development and validation of a health-related quality of life instrument for women with melasma.

BACKGROUND: Melasma can have significant emotional and psychological effects on those affected with the condition. In the past, the impact of melasma on health-related quality of life (HRQoL) has been assessed using general measures of skin disease that equally weigh both the physical and psychosocial distress arising from the presence of a dermatological condition. OBJECTIVES: Our purpose was to develop and validate a disease-specific HRQoL instrument to identify the areas of the patient's life most impaired by melasma as well as the effects of the condition on their level of functioning in correlation with disease severity: the Melasma Quality of Life scale (MELASQOL). PATIENTS AND METHODS: A random sample of 102 women identified by an investigator as having melasma were evaluated by the investigator using the Melasma Area and Severity Index (MASI). The patients were then anonymously surveyed with the SKINDEX-16, the Fear of Negative Evaluation scale, the Dermatology Life Quality Index (DLQI), a skin discoloration evaluation questionnaire, and a measure of perceived life quality difference without melasma. The 10-item MELASQOL scale was devised from the comprehensive HRQoL assessment battery. RESULTS: The psychometric properties of the MELASQOL were comparable with the properties of the DLQI and the SKINDEX-16. The MELASQOL scores were highly correlated with the other HRQoL measures. The discriminatory ability of the MELASQOL is superior to the SKINDEX-16 and the DLQI for melasma. The three life domains most adversely affected by melasma (social life, recreation/leisure and emotional well-being) were highlighted by this instrument. These were the same three areas of life that patients believed would improve the most if they no longer were affected by the disease. CONCLUSIONS: The MELASQOL can be used to evaluate objectively the effect of melasma on a patient's HRQoL. The high correlation with the DLQI, the SKINDEX-16 and the skin discoloration questionnaire suggests that the new scale is a valid instrument, which can be used to monitor the level of impairment individuals suffer due to their melasma. The MELASQOL scores can help guide treatment methods as well as track the improvement of patients' HRQoL.