International Journal of Risk & Safety in Medicine - Volume 24, issue 2
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The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed.
This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety. Our journal wants to publish high quality interdisciplinary papers related to patient safety, not the ones for domain specialists. For quite some time we have also been devoting some pages in every issue to what we simply call WHO news. This affinity with WHO underlines both the International character of the journal and the subject matter we want to cover. Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. Submission of news items will be appreciated, as will be the contribution of letters on topics which have been dealt with in the journal.
Abstract: With the current population of Nigeria and the limited number of trained health care providers, PMVs are inevitable and highly needed especially in the rural areas for the supply of drugs in treating minor illnesses. Thus, pharmacovigilance (PVG) activity in Nigeria cannot exclude the roles of PMVs; therefore, this study was aimed to determine the knowledge of PMVs on PVG and adverse drug reaction reporting system. The study was a descriptive cross-sectional survey of the knowledge of Pharmacovigilance and adverse drug reaction reporting system of 96 PMVs in Ekiti state, Nigeria before the National Pharmacovigilance training in February, 2011 and…after the training. The data obtained before the training showed that more than 87% of the respondents had at least secondary level of education. About half of the respondents (58.5%) knew the correct meaning of PVG and 56.6% knew how to report ADRs. But only about one third of them (35.8%) knew where to obtain ADR forms. Very few respondents 3 (5.7%) had received report/complaints of ADR from patients in the last 1 month while just 2 (3.8%) of them reported. The most commonly mentioned factors/reasons for poor reporting of ADRs/compliance with PVG guideline by the respondents were fears of indictment (61.3%), poor public knowledge (88.7%), and poor training on PMVs (92.5%). However, the results after the training showed a statistically significant (p ≤ 0.005) improvement in the proportion of respondents who were aware of PVG (from 55.8% to 89.1%), those who knew the meaning of PVG (from 49.0% to 61.7%), where to obtain ADR form (28.3% to 92.1%) and those who knew how to report ADRs (44.2% to 88.0%). PMVs are ready to practice PVG if they are properly trained. Training has been revealed to play a significant role in the knowledge of the concept of PVG amongst PMVs. It is therefore recommended that National Pharmacovigilance Centre should continue to organize periodic trainings for PMVs especially those with poor knowledge on PVG.
Keywords: Pharmacovigilance, patent medicine vendors, ADRs reporting, minor illness, Nigeria
Abstract: In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone, while the FDA decided to restrict the use of rosiglitazone. These actions were taken approximately 10 years after the introduction of rosiglitazone, because rosiglitazone might be associated with an increased risk of ischemic heart disease. It is often stated that the first signs of an increased risk of ischemic heart disease were noticed in 2004, however already in 2001 the FDA concluded, based on data available to the EMA at the time of initial approval, that rosiglitazone should not be used in combination with insulin, because this…combination therapy was associated with an increased risk of cardiac failure and ischemic heart disease. Remarkably, in 2007, when the evidence against this combination therapy had increased, the EMA made a decision that encouraged the use of insulin in combination with rosiglitazone, while the FDA tried to restrict this combination therapy. Despite the publication of several studies, including a large randomized controlled study, the cardiovascular risk of rosiglitazone still has not been definitively established. The weight given to the benefits and the risks seems mainly a subjective decision. To prevent new cases like rosiglitazone, more attention should be given to evaluation of study protocols of safety trials prior to their starts. This paper gives a critical overview of the decision making process at the FDA and the EMA on the basis of public available information.
Keywords: Rosiglitazone, FDA, EMA, decisions, myocardial ischemia
Abstract: Objective: To understand the practices medical care providers and health care staff utilize in managing and preventing Adverse Drug Reactions of Long Latency (ADRLLs) among their patients on medications such as glucocorticoids. Design: Qualitative study of key informant interviews. Setting: Denver Department of Veterans Affairs (VA) Medical Center. Participants: Fourteen physician providers and health care staff (nurses and pharmacists) in primary care and rheumatology. Methods: A trained interviewer conducted semi-structured interviews in which providers and health care staff were asked about their processes for tracking and averting ADRLLs. Participants were asked about barriers and facilitators to monitoring ADRLLs and solicited…for suggestions to improve existing processes. Interviews were analyzed using ATLAS.ti software. Results: Providers overwhelmingly commented on barriers, rather than facilitators. Six core themes emerged regarding ADRLL management barriers: patient noncompliance, provider workload, complications coordinating care, provider unfamiliarity with ADRLLs, lack of a standardized monitoring system, and communication failures. Ideas to improve the monitoring of ADRLLs fell into two domains: improving automated computer generated reminders or assigning a specific person to monitor potential ADRLLs. Conclusions: Interviewees strongly endorsed a more systematic approach to ADRLL management, either through less intrusive computer-generated system reminders or through a dedicated staff person, such as a pharmacist, who could more closely monitor potential ADRLLs. There was disagreement among interviewees about who is responsible for monitoring ADRLLs (specialists versus primary care providers, VA versus non-VA providers, residents versus attending physicians).
Keywords: Adverse Drug Reaction, qualitative research, drug monitoring, glucocorticoids
Abstract: Objective: This study was set out to assess health care providers' knowledge, attitude and practice towards hepatitis B virus infection (HBV). Methods: A cross sectional study was carried out, in four public hospitals in Wad Medani, Sudan. Anonymous pre-tested questionnaire was completed by 295 different health care providers. The response rate was 100%. Results: The study revealed that, 97.2% of doctors, 98.6% of nurses, 94.8% of laboratory technicians and 95.7% of other paramedical knew that HBV transmitted via blood. For hygienic precautionary measure; the current study disclosed that (81%) of the responding providers were routinely used to recap needles after…use and only (33%) of doctors were always wearing gloves. Gloves were not readily available in all units where there is a high risk of infectious occupational exposure. More than 50% (p < 0.001) of health care workers were not vaccinated against HBV. Healthcare workers had poor knowledge about Universal Standard Precautions Guidelines, and do not fully appreciate their occupational risk regarding hepatitis B infection. Set of recommendations was proposed for formulation and implementation of standard precautions guidelines.
Keywords: Knowledge, attitudes, hepatitis B virus, Sudan
Abstract: Background: The prevalence of HIV in Gulu district is 10.3%. This poses a high risk of occupational exposure and transmission to health workers in hospitals attending to these patients. The risk of HIV transmission from a patient to a health worker has been shown to be between 0.3% and 0.09% following percutaneous and mucocutaneous exposure respectively. Objectives: This research aimed at determining the prevalence of occupational exposure to HIV. Method: A cross sectional study of health workers in Gulu Regional Referral Hospital and St. Mary's Hospital Lacor, in northern Uganda was conducted to establish the frequency of occupational exposures to…human immunodeficiency virus (HIV)-infected body fluids. Results: 108 (46%) respondents were found to have been exposed to potentially infectious body fluids. Needle stick injuries was the commonest route of exposure, with a prevalence of 27.7%, followed by mucosal exposure 19.1%, contact with broken skin (5.5%) and lastly by a cut with sharp objects (5.1%). There is therefore need for more sensitization of health workers on infection control and post exposure prophylaxis for health workers.
Keywords: HIV, occupational exposure, HIV transmission, PEP
Abstract: In Japan, depression provides the most drastic example of the impact of disease awareness campaigns. Until the late 1990 s, the public's attitude toward depression was generally unfavorable, due to the negative connotations of the Japanese word for clinical depression, ‘utsubyou’. After the 1999 introduction of the first selective serotonin re-uptake inhibitor, pharmaceutical companies initiated educational campaigns. In order to aid the drug's acceptance, they coined the catchphrase ‘kokoro no kaze’, which literally means ‘a cold of the soul’. Thanks to these marketing practices, antidepressant sales have increased six fold, from ¥ 14.5 billion in 1998 to ¥ 87 billion…in 2006. However, the catchphrase ‘kokoro no kaze’ masked a critical difference between a cold and depression. It falsified the nature of treatment for depression by concealing the putative duration of medication. Owing to this distortion of information, pharmaceutical companies were assured a steady stream of profits. Now, the pharmaceutical industry is shifting its focus from depression to bipolar disorder. Japanese psychiatrists can learn a great deal from their experience with the aggressive marketing of antidepressants. In the case of depression, over-medication arguably did more harm than good. The same risk exists with other conditions, including bipolar disorder.