International Journal of Risk & Safety in Medicine - Volume 6, issue 3 - Journals

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Is pharmacovigilance still a clinical science?

Authors: Kimbel, Karl

Article Type: Other

DOI: 10.3233/JRS-1995-6301

Citation: International Journal of Risk and Safety in Medicine, vol. 6, no. 3, pp. 153-155, 1995

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What can be done to improve the safety of heart valves?

Authors: de Mol, Bas A.J.M. | Koornneef, Floor | van Gaalen, Geerda L.

Article Type: Research Article

Abstract: In the Netherlands, the incidence of fractured Björk-Shiley convexo-concave heart valves led to investigations regarding the extent, impact, and management possibilities of this public health problem. Apart from an epidemiological study, we performed a safety management study. This study led us to conclude that: (1) the Björk-Shiley convexo-concave heart valve is perceived as a safety risk by patients, doctors, and health care administrators alike; (2) doctors and health care administrators rely heavily on the technical information regarding artificial heart valves that is provided by the manufacturer; (3) the professionals best qualified to assess and control the risks of heart valve …replacement are cardiac surgeons. Based on these conclusions, this report provides recommendations regarding safety risk assessment and the participation of doctors in preimplantation and clinical research programmes in order to improve the safety of newly designed heart valves. Show more

Keywords: Heart valves, Björk-Shiley, Heart valves, fracture, Heart valves, safety management

DOI: 10.3233/JRS-1995-6302

Citation: International Journal of Risk and Safety in Medicine, vol. 6, no. 3, pp. 157-168, 1995

Price: EUR 27.50

A new technique for increasing the quality of composite fillings in dentistry Creating a superior alternative to dental amalgam

Authors: Fredin, Bengt

Article Type: Research Article

Abstract: In the direct technique described, a composite material acts both as cement and filling between a prefabricated prosthetic crown and the tooth. The fillings contain less composite, and thus fewer components which might cause allergic reactions, and they are aesthetically and mechanically satisfactory.

Keywords: Dental composite, Prefabricated tooth material

DOI: 10.3233/JRS-1995-6303

Citation: International Journal of Risk and Safety in Medicine, vol. 6, no. 3, pp. 169-172, 1995

Price: EUR 27.50

Inadequate drug information for pregnant or lactating women: teratology information service follow-up

Authors: Merlob, Paul | Stahl, Bracha | Schoenfeld, Alex | Kaplan, Barry

Article Type: Research Article

Abstract: The assessment of the teratogenic risk of many drugs is very difficult or impossible because data are not available, and documentation is insufficient or based on minimal human information. The present study summarizes the outcome of newborns of women who took drugs during pregnancy and/or lactation without receiving adequate counselling. All calls received by the Beilinson Teratology Information Service during the last three years (1991–1993) were analyzed regarding the adequacy of the risk assessment process. These findings were compared to those for two control groups: women exposed to drugs with no known teratogenic effect, and women not exposed to drugs …at all. We could not provide adequate counselling for 14 cases (in 1991), 17 (in 1992), and 14 (in 1993), or 6.6%, 4.8%, and 3%, respectively, of the total annual number of calls. The three groups studied proved to be similar in all maternal and neonatal characteristics, except for the number of abortions and prevalence of major congenital malformations which were higher in control group 1. The absence of data for a specific drug is disappointing and stressful for both the woman and her physician. The present small sample showed a good prognosis for the patients receiving inadequate counselling. These findings may provide some reassurance to the parents, but emphasize the need for caution and close monitoring of the fetus and newborn. Show more

Keywords: Teratology, Teratogenic counselling, Teratology information service (TIS), Drugs in pregnancy and lactation

DOI: 10.3233/JRS-1995-6304

Citation: International Journal of Risk and Safety in Medicine, vol. 6, no. 3, pp. 173-178, 1995

Price: EUR 27.50

The risks of acupuncture

Authors: Ernst, E.

Article Type: Research Article

Abstract: The use of acupuncture is widespread. The procedure is often claimed to be totally, or at least reasonably, safe. The published evidence regarding its potential risks is reviewed. The repeated and/or inappropriate use of an acupuncture needle carries the risk of infections. Amongst others, AIDS and hepatitis have been transmitted. Acupuncture needles may also traumatise tissues and organs. Pneumothorax is the most frequent complication caused in this way. Finally, needles may break and fragments can be dislodged into distant organs. A serious and more general concern related to the safety of acupuncture is the competence of the therapist, whether or …not medically qualified. The “philosophy” of acupuncture is not in line with orthodox diagnostic skills; therefore acupuncturists can be dangerously unconcerned with diagnostic categories. Thus indirect risks might add significantly to the direct risks of acupuncture. It is concluded that the true risk of acupuncture cannot be estimated. Whatever its extent, it could and probably should be lowered by enforcing educational and clinical standards. Show more

Keywords: Acupuncture, Injury, Contra-indications, Review

DOI: 10.3233/JRS-1995-6305

Citation: International Journal of Risk and Safety in Medicine, vol. 6, no. 3, pp. 179-186, 1995

Price: EUR 27.50