International Journal of Risk & Safety in Medicine - Volume 14, issue 1-2
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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: A very large proportion of the world's population, particularly the poor in developing countries, still have insufficient access or none at all to treatment with essential drugs. This situation can arise with any drug and for various reasons, but it exists in extreme form where the drug is irreplaceable yet entirely unaffordable. That is the case with new or relatively recent drugs which could save lives or eradicate endemic disease, but which (particularly during their period of patent protection) are usually sold at prices higher than patients or their community can afford to pay. The consequences of this situation in…terms of persistent illness, suffering and large‐scale mortality are felt most immediately in the developing world, but because today disease travels so rapidly it represents a threat to the world as a whole. As of late 2001, only a number of limited ad hoc solutions to these problems have emerged. They have provided relief in a number of specific situations but they offer no guarantee of permanence, are applied mainly at the discretion of multinational companies or aid agencies and leave the bulk of the global problem unchanged. The problem must be capable of a broad and lasting solution since the basic costs of manufacturing and distributing most of the drugs in question are not in themselves prohibitive. High prices are primarily a consequence of the need to provide an adequate return on investment, to finance research and development, and to pay the very high costs of promotion in intensively competitive markets. At present, however, these secondary costs are almost entirely covered by the sales income from industrialized countries, and that is unlikely to change. In the developing world, where the sales of such drugs has been negligible, it must be possible to supply them in more adequate quantities, at a fair and affordable prices which are very close to the basic manufacturing and distribution costs. This will require an innovative commercial approach but it may not demand a sacrifice; in many instances it will be the key to opening new emergent markets where low profit margins can be outweighed by high unit sales. The feasibility of sharply differential pricing for drugs has indeed been demonstrated already in various countries and regions where specific agreements for low‐cost supply have operated successfully, for example, for vaccines and contraceptives but also for some therapeutic drugs still protected by patent. If this type of approach can be extended so that important new drugs are as a matter of routine made available to developing countries at highly preferential prices it would contribute greatly to the solution of major health problems. Naturally a number of safeguards are necessary. The most important of these is that drugs sold at “minimal” prices to a developing country must not leak across its borders to be re‐sold at a profit elsewhere. Experience with vaccine and contraceptive agreements shows that this risk can be virtually eliminated, although the parallels with therapeutic drugs are not exact and the possibility of theft and “leakage” might be greater with such items, especially where they have a high potential market value. Nor must a drug, which enters a developing country at a preferential price then be burdened by taxes, customs duties or excessive wholesale or retail profit margins that might again put it out of reach of those who need it. Again, one would not wish to discourage the further evolution of good‐quality drug manufacturing in developing countries, which is already making an important contribution to health and to the national economy. Safeguards on these and other matters could well be incorporated into a global working agreement between all parties, seeking to define and promote the use of minimum‐level pricing for vital new drugs. That agreement would be implemented through specific arrangements and unilateral initiatives of an already familiar type; these would be centrally registered and monitored, as would situations of ongoing need. In this way, activities could be better attuned to need, progress assessed and the entire situation rendered transparent.
Abstract: Using ATC/DDD methodology, we analyzed antibiotic utilization in the Clinical Centre of Banja Luka, one of the largest clinical centres in Bosnia and Herzegovina, during the war and postwar period (1994–2000), as well as the role of drug donations on doctors' prescribing decisions. The retrospective analysis of antibiotic utilization (group J according to the Anatomical Therapeutical Chemical – ATC classification) was based upon the data provided from the hospital computer centre and calculated as the number of defined daily doses (DDD) per 100 bed days. The pharmacoepidemiological analysis showed that the total use of antibiotics changed markedly; in…the war year of 1994, as well as in 1998, antibiotics were the second most frequently used group of drugs (19.7% and 14.1% of total drug utilization respectively), while in the following years antibiotics were considerably less used. These dynamics were significantly influenced by drug donations, the percentage of which in the overall antibiotic supply in 1996 was 91.5%, while in 1999 and in 2000 it decreased considerably to 46.8% and 45.6%, respectively. The most widely prescribed antibiotics were penicillins, aminoglycosides, sulphonamides and tetracyclines. Among these, the aminopenicillins, co‐trimoxazole, gentamicin and tetracyclines were mainly (70–100%) supplied as a drug donations. However, macrolides, cephalosporins and quinolones were less used due to fact that they were considerably less often delivered through drug donations. It can be concluded that the drug donations had a significant impact on prescribing practice and the rational use of antibiotics in the Clinical Centre studied.
Keywords: Drug utilization, antibiotics, emergency, Bosnia/Herzegovina, donations, rational drug use
Abstract: In Holland, first tier medical care outside of office hours is provided by regular GP's acting as Locum GP's. On several occasions concerns have been expressed about Locum GP's not visiting the patient when necessary. The number of complaints against Locum GP's submitted to the Medical Boards has been increasing over time and relate in particular to refusals of Locum GP's to visit the patient. In many of these cases the patient died. The paper develops a quantitative estimate of the risk for the patient due to negligence of Locum GP's. The measure of the risk is taken as…the number of patients who died unnecessarily due to negligence of Locum GP's as determined by the Medical Boards. The paper estimates that in Holland in the year 2000 about 1500 patients would probably not have died had the Locum GP's working out‐of‐hours not been negligent by contravening professional standards. In more than half of these cases the Locum GP's did not visit the patient, or did not visit the patient in time, when necessary. This level of patient risk must be regarded as socially unacceptable. One important explanation for these accidents could be that doctors are largely unfamiliar with the professional standards developed by the Medical Boards. Because of the assumptions made and the uncertainty regarding the data used, the actual numbers of these accidents may be higher or lower than estimated here. Although more reliable data will allow the results to be determined more reliably, this is unlikely to change the acceptability of the risk.
Keywords: Patient‐risk, negligence, Locum GP, first tier medical care
Abstract: Objective: To gain insight into the psychosocial consequences of a screening programme on the progression of heart, vascular and kidney damage. Design: Over 85,000 people aged 28–75 were invited to participate in a screening for albuminuria. Nearly half of them sent in their morning urine of which almost 10,000 had a (slightly) elevated urinary albumin level. This latter group was invited to participate in a follow‐up screening (24‐hour urine samples, blood pressure, glucose, cholesterol) together with ±3,000 randomly selected subjects with a normal urinary albumin concentration. A questionnaire on the psychosocial consequences of the screening was sent to 335 participants…of the screening programme each of whom had received their (positive or negative) screening results two weeks previously. Results: The response rate was 75%. A minority of the respondents, diagnosed for risk factors, expressed some concern. No influence on the well‐being of this group of participants could be established. Almost one third of the respondents claimed to follow a healthier lifestyle as a result of the screening. There are, however, also indications for a certain ‘certificate of health effect’: about half of the smokers and the physically inactive considered that the favourable screening results legitimated their unhealthy lifestyle. An unfavourable screening result led to additional medical consumption in almost half of the respondents. The respondents appreciated the screening and especially the less educated had a very positive attitude towards early diagnosis in general. Conclusions: Those screened positive showed no diminished well‐being; their health behaviour improved because of the screening and their medical consumption increased. Many of those screened negative considered the test result a reason to continue their unhealthy lifestyle.
Keywords: Screening, early diagnosis, risk factors, albuminuria, psychosocial factor