International Journal of Risk & Safety in Medicine - Volume 16, issue 3
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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: The authors examine cases of mortality resulting from road accidents in the Brescia area as documented in the postmortem examination reports held at the Forensic Science Institute of the University of Brescia relative to the period 1997–2002. The study was subdivided according to the categories of persons involved: for each category, the epidemiological data are analyzed with respect to age (subdivided into ten year bands), the type of accident, sex, the other party involved (if any), the categories of the persons involved and the location of the fatal injury (according to the medical examiner of the cause of death as…entered on the autopsy report). The results are then compared with similar studies undertaken by the Forensic Science Institute in Brescia for the periods 1985–1990 and 1991–1996. In the period 1985–1990 there were 761 deaths and in the period 1991–1996 820, while in the period 1997–2002 there were 641: a slight reduction can therefore be observed in the total number of fatal road accidents in the more recent period. In the light of the data, one can ascertain a decrease in the overall number of fatal road accidents is observed, while on the other hand, there is a slight increase in the number of head injuries and a greater involvement in the most recent period of persons between the ages of 21 and 30 years old. This finding is probably due either to a scant regard on the part of younger people for the safety measures imposed by law (speed limits, safety distances, use of safety belts and crash helmets) or to the often excessive speed of those involved in accidents, aggravated by unfavorable weather conditions and involving the higher socio‐economic classes.
Abstract: A simulation study was conducted to assess the accuracy and precision of the proposed sampling design for the World Health Organization (WHO) Injection Safety Assessment Survey. The proposed sampling design specifies that 8 clusters would be selected with probability proportionate to the size (PPS) of the population, and within each of the selected clusters, 10 health care facilities would be randomly selected. Two artificial populations were created based on the two African countries in which the assessment was pilot tested. To create a wide variety of hypothetical populations, the assignment of whether a health care facility was safe or not…was based on the different combinations of the population proportion of safe health care facilities in the country and the homogeneity of the districts in the country with respect to injection safety. Based on results obtained through univariate and multi‐factor analysis of variance, it was found that the absolute bias, standard error, and MSE are all significantly smaller when the true population proportion of safe health care facilities for both the urban and rural clusters is small (p=0.10) or large (p=0.90), as compared to the populations with differing urban and rural proportions; and that the populations with homogeneous clusters (i.e., standard deviation =0.01) had lower absolute bias, standard error, and MSE. From this study, we conclude that this sampling design yields an unbiased estimate of the true proportion of safe health care facilities in a country, and has an average precision of plus/minus 13.6 percentage points.
Abstract: In October 1999 an outpatient clinic for drug related problems was initiated at the Academic Medical Centre in Amsterdam, The Netherlands. This collaboration between the Departments of Clinical Pharmacology (now Pharmacology and Pharmacotherapy), Dermatology and the Hospital Pharmacy, aims at supporting physicians in their care for patients with possibly drug related problems. One hundred thirty two patients attended the outpatient clinic during its' first three years. The majority of them was referred by a dermatologist for exclusion of drug allergy of adverse (cutaneous) drug reactions. A relation with the prescribed drugs was confirmed in 42/132 (32%) and excluded in 37/12…(28%) patients. Possible reasons for referral matched largely the needs of the general practitioners. Although they indicated to see approximately 2 patients with drug related problems a week, many of them considered referring a patient to the outpatient clinic for drug related problems too great a burden to a patient. Other (electronic) ways of consulting should be explored.
Keywords: Drug related problems, adverse drug reactions, drug allergy
Abstract: Living in general is a risky endeavour. Certain risks are taken without much thought because of the apparent overwhelming benefits. This is often the case for many consumers of medicines who assume medicines to be wholly safe and health care providers infallible. Patients rely on healthcare providers for information, risk assessment, and protection from risks due to medical interventions. Some common risks due to medical interventions include medication errors, exposure to radiation, over/under dosing, adverse events/reactions, hospital acquired infections, counterfeit drugs, etc. Unfortunately, risk factors such as counterfeit medicines (though occurring for a long time) are just becoming apparent…in the last three decades, first to only a few countries while others still seem unaware or choose to dwell in denial of their existence. There has been an astronomical increase in the detection of counterfeit medicines worldwide. The magnitude of this increase and consequent death toll demands greater attention in the consideration of the safety of medicines. Counterfeit medicines constitute a risk to the pharmaceutical industry, healthcare providers, the healthcare system as a whole and ultimately to the patient. The risks to the patient include, lack of effect, toxicity, adverse drug reactions (ADRs), loss of economic and other resources and ultimately death. Due to dearth of information and research and lack of a globally coordinated approach to anti‐counterfeiting, global estimates of deaths due to counterfeit medicines can only be guessed. Indications from both published data and anecdotal evidence indicate that millions of lives may be saved annually if there are no counterfeit antibiotics, antiretrovirals, anti‐malarial, anti‐tubercular drugs, vaccines and other life saving medicines. This paper identifies these risks and proposes a concerted global action towards reducing the production and circulation of counterfeit pharmaceuticals on the world market. It also suggests a possible role for pharmacovigilance in anti‐counterfeiting.
Keywords: Counterfeit medicines, safety of medicines, pharmacovigilance, global anti‐counterfeiting organ
Abstract: Corruption can take various forms, including frank bribery and the corruption of knowledge. Prominent in the health field is corruption associated with the pharmaceutical industry. This can impair true freedom to choose optimal therapeutic strategies by misrepresenting less qualified yet more expensive (“pseudo‐innovative”) products, resulting in increased expenditures without improvement in the quality, efficacy or safety of the health care supplied. Promotion of products is legitimate, but the border to corruption is not easily discernible and is readily violated. Senior management within the pharmaceutical industry has to become aware of the destructive consequences of corruptive and other improper promotional activities…and be prepared to fight them through implementing Codes of Conduct. Medical health care professionals are the main targets for corrupt practices on the part of the pharmaceutical industry. They need to be sensitized against disinformation and material influences which can impede professional care. Professional and self‐governing institutions have to develop Codes of Conduct and strategies to guarantee transparency and the independence of advisory functions. National legislation should be promoted to create or extend anti‐corruption law to members of professional medical societies or self‐governing bodies in health care. Governments should recognize the need for patients' participation and public control at all levels of health care systems, also in the so‐called private sector, and establish the necessary legal framework.