International Journal of Risk & Safety in Medicine - Volume 23, issue 3

Authors: Chandler, Percy | Herxheimer, Andrew

Article Type: Research Article

Abstract: A healthy policeman was prescribed bupropion in 2002 to help him stop smoking. It worked but after 18 months he relapsed. Though it had given him headaches and insomnia he tried using it again in 2009, taking 8 at end: 150 mg/day. Three days after starting the tablets he took his wife out for dinner. They shared a bottle of wine and he also had other drinks. After walking home they quarrelled, he slapped her, she slapped him. He threw the phone at her saying ‘call the police!’. They came and charged him with assault; he was suspended. An expert …report attributed the aggressive outburst to an interaction between bupropion and alcohol; the accused was a social drinker and had never been violent. An expert advising the police agreed, and 14 months after the event the court dismissed the case. Show more

Keywords: Bupropion, alcohol, interaction, additive effect, aggression, domestic violence

DOI: 10.3233/JRS-2011-0533

Citation: International Journal of Risk & Safety in Medicine, vol. 23, no. 3, pp. 133-137, 2011

Authors: Williams, Leah | Dewey, Hayley | Kapp, Marshall B.

Article Type: Research Article

Abstract: This article discusses the medical-legal aspects of death certification in Florida long-term care settings based on an examination of relevant Florida laws and federal guidelines and a comparison of those laws and guidelines to actual medical practice. A review of the health care literature and Florida law, supplemented by interviews with key informants, supports the conclusion that Florida statutes provide a clear protocol for efficient death certification, but do not ensure the accuracy of death certificates. The death certification process in Florida long term care settings could be improved through increased physician training, the development of quality controls, and the …expanded use of electronic patient medical records. Show more

Keywords: Death certificates, long-term care, forensic, legal, vital records

DOI: 10.3233/JRS-2011-0537

Citation: International Journal of Risk & Safety in Medicine, vol. 23, no. 3, pp. 139-147, 2011

Authors: Healy, David

Article Type: Research Article

Abstract: This paper outlines aspects of the interface between law and science in the domain of treatment induced injury, using examples drawn from litigation on SSRIs. In the face of claims that randomized controlled trials provide uniquely appropriate evidence and that there should be a statistically significant doubling of the risks on treatment, the examples used demonstrate that the methods of assessing the possibility of causal links between treatment and injuries must necessarily be tailored to both the injury and the treatment.

Keywords: Paroxetine, suicide, dependence, birth defects, controlled trials, case studies

DOI: 10.3233/JRS-2011-0534

Citation: International Journal of Risk & Safety in Medicine, vol. 23, no. 3, pp. 149-162, 2011

Authors: Anwikar, S.R. | Bandekar, M.S. | Smrati, Bajpai | Pazare, A.P. | Tatke, P.A. | Kshirsagar, N.A.

Article Type: Research Article

Abstract: Objective: To collect data on suspected adverse drug reactions of HAART therapy; analyze the data; and find out frequency of preventable adverse drug reactions in order to minimize the harm to the patients. Design: Retrospective study. Methods: ADR data associated with the use of HAART from November 2005 to December 2007 was collected retrospectively from records of patients using the ART treatment from NACO at a tertiary referral centre under the National Pharmacovigilance Programme. These ADRs were analyzed for causality (WHO scale), severity (Hartwig et al. scale) and preventability (Schumock and Thornton scale). Results: Data of 1844 patients (1198-Male & …645-Female) enrolled from November 2005 to December 2007 was collected. 222 patients developed about 228 ADRs with prevalence of 12.36%. Peripheral neuropathy and anemia were highly prevalent ADRs. Nevirapine induced rash and SJ syndrome developed within first month of treatment followed by anemia, hepatitis and gastritis which developed within 6 months after initiation of ART. 96.49% ADRs were found to be possible and 3.50% probable by WHO probability scale. 20 (8.77%) were mild, 176 (77.19%) were moderate and 32 (14.02%) were severe in nature. 183 (80.26%) ADRs were found to be non-serious whereas 45 (19.74%) were serious. Only 2.63% ADRs were found to be preventable which included vomiting and rash. Odds ratio with 95% CI was calculated. Conclusion: It has been observed that antiretroviral therapy has many serious and life threatening adverse drug reactions that may affect a variety of organ systems. Zidovudine use was observed as a risk factor for anemia. Stavudine for peripheral neuropathy, where as nevirapine use was identified as a risk factor for skin reactions. Active pharmacovigilance programme should be implemented and awareness should be created among physicians about reporting any suspected adverse drug reaction so that unreported ADRs and unknown risk factors could be identified. Show more

Keywords: Pharmacovigilance, antiretroviral therapy, adverse drug reactions

DOI: 10.3233/JRS-2011-0532

Citation: International Journal of Risk & Safety in Medicine, vol. 23, no. 3, pp. 163-169, 2011

Authors: Rajesh, Radhakrishnan | Vidyasagar, Sudha | Varma, Danturulu Muralidhar | Mohiuddin, Shabaz | Noorunnisa,

Article Type: Research Article

Abstract: Objectives: In patients infected with human immunodeficiency virus (HIV), zidovudine has been known to cause a severe anemia that resolves promptly when the drug is stopped. The study was aimed to assess the incidence, the pattern of occurrence of zidovudine induced anemia, causality, severity, predictability, preventability and to identify risk factors for zidovudine induced anemia in Indian HIV positive patients in comparision with stavudine based highly active antiretroviral therapy (HAART). Methods: This was a prospective observational study conducted over a period of 6 months by clinical pharmacists. Enrolled HIV positive patients were intensively monitored for zidovudine and stavudine induced anemia. …zidovudine and stavudine fixed dose drug combinations of antiretroviral therapy (ART) were only included. The World Health Organization (WHO)/AIDS Clinical Trials Group (ACTG) definition of a severity grading of anemia was adopted. Each reported case of zidovudine and stavudine induced anemia was assessed for its causality by using the WHO probability scale and also with Naranjo's algorithm. Preventability was assessed using Schumock and Thornton criteria and severity was assessed using the modified Hartwig and Siegel scale. Multivariate logistic regression was used to evaluate the influence of zidovudine induced anemia. P-value < 0.05 was considered as statistically significant. Results: Monitoring of ninety eight HIV positive patients with fixed dose highly active antiretroviral therapy identified 19 cases of zidovudine induced anemia and 2 cases of stavudine induced anemia from 55 and 43 patients respectively. Incidence of zidovudine induced anemia in intensively monitored HIV positive patients was found to be 34.5%. Chi Square tests identified statistically significant incidence differences of anemia (p < 0.05) between the zidovudine group and the stavudine group. Grade 2 and grade 4 anemia accounted for 42.1%. Causality was ‘probable’ by WHO probability scale and ‘definite’ and ‘probable’ by Naranjo's algorithm. The Majority (89.4%) of zidovudine induced anemias were ‘moderate’ in severity. A total of 94.8% zidovudine induced anemias were probably preventable. Low baseline hemoglobin concentration less than 10.5 g/dl was observed as a risk factor for zidovudine induced anemia by multivariate logistic regression. Conclusion: With the increasing access to zidovudine usage in India, clinicians must focus to avoid zidovudine based HAART regimens if baseline hemoglobin concentration is low, (i.e. less than 8 g/dl) thereby avoiding the occurrence of zidovudine induced anemia. Frequent monitoring of complete blood count (CBC) is important in patients on zidovudine therapy to prevent zidovudine induced anemia. Show more

Keywords: Zidovudine induced anemia, human immunodeficiency virus, highly active antiretroviral therapy

DOI: 10.3233/JRS-2011-0531

Citation: International Journal of Risk & Safety in Medicine, vol. 23, no. 3, pp. 171-180, 2011

Authors: Saddichha, Sahoo | Vishnuvardhan, Gopalkrishnan | Akhtar, Sayeed

Article Type: Research Article

Abstract: Objective: To ascertain the prevalence of diabetes, obesity and hypertension associated with antipsychotic use in remitted patients with schizophrenia. Methods: This study included a cross sectional survey of diabetes, obesity and hypertension among all remitted patients diagnosed with schizophrenia/schizoaffective disorder (n = 130) on at least 6 months of antipsychotic treatment. Results: A prevalence of 35.4% obesity, 1.5% hypertension and 3.8% (ADA) or 5.4% (WHO) prevalence of diabetes was observed. Conclusions: The use of antipsychotic drugs in the long run may be associated with a significantly greater risk of developing obesity with moderate influence on development of diabetes and minimal …to none on hypertension. Show more

Keywords: Diabetes, obesity, hypertension, schizophrenia, antipsychotic treatment

DOI: 10.3233/JRS-2011-0536

Citation: International Journal of Risk & Safety in Medicine, vol. 23, no. 3, pp. 181-185, 2011

Authors: Ziganshina, Lilia E. | Menkes, David B. | Herxheimer, Andrew

Article Type: Research Article

Abstract: Kazan hosted Russia's first international conference on medicines that was entirely independent of the pharmaceutical industry, attracting 414 participants from 9 countries and 20 regions of the Russian Federation. The meeting was greeted and endorsed by world leaders in pharmaceutical information, policy and regulation. Delegates discussed the professional and social problems arising from unethical drug promotion, including compromised evidence from clinical trials and consequent impairments in health service delivery. The Conference adopted a resolution prioritizing policy development and health system needs, notably including the development of clinical pharmacology. A website documents conference materials and provides an interface for future collaboration: …http://evidenceupdate-tatarstan.ru/confer. Show more

Keywords: Independent, conflicts of interest, bias, medicine information, drug promotion, ethical standards, pharmaceutical policy, health system, clinical pharmacology, Russia

DOI: 10.3233/JRS-2011-0535

Citation: International Journal of Risk & Safety in Medicine, vol. 23, no. 3, pp. 187-192, 2011