PubMed · 15285196
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Carlos María Romeo Casabona. 2004. Genetics, tissue- and databases.. https://doi.org/10.1163/157180904323042362
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BACKGROUND: Prescribing for non-approved uses is widespread in the treatment of AIDS, cancer, and pediatric illnesses, but it is by no means limited to these areas. Few studies have been performed evaluating reasons for off-label prescribing. OBJECTIVE: To explore the satisfaction with drug therapy as one of the potential reasons for off-label uses by testing a hypothesis that the satisfaction with drug therapy for off-label indications is lower than for approved indications. METHODS: The study compared the satisfaction with drug therapy for known off-label indications with a control group of approved indications. Twenty-four of the first 50 single-ingredient drugs, according to their share in the drug cost budget of the Slovenian Compulsory Health Insurance, had 86 different off-label indications eligible for inclusion. A control group of 86 approved indications was randomly selected from the list of all possible approved indications for the same 24 drugs. A 2-round Delphi technique, involving an expert panel of physicians who are members of the drug regulatory agency, was used to evaluate the satisfaction with drug therapy for selected indications. RESULTS: After the second round of the Delphi study, the median scores of satisfaction with drug therapy for approved and off-label indications were 7.00 and 6.50, respectively (p = 0.001). CONCLUSIONS: The study shows that the satisfaction with available drug therapy for off-label indications is lower than for approved indications. The statistical association, biologic plausibility, and coherence with existing information, as well as the temporality of the association, provide supporting evidence that low satisfaction with drug therapy is one of the incentives for off-label use.
OBJECTIVE: To develop appropriate prescribing indicators and apply these to Irish prescription data. METHODS: A postal survey of 145 randomly selected general practitioners working within the Eastern Health Board region of the State-supported General Medical Services scheme in Ireland regarding the applicability of selected prescribing indicators was carried out. Such indicators were then applied to aggregate prescription data. RESULTS: Prescribing indicators based on agents of questionable efficacy/poor quality prescribing and those based on good prescribing practice were thought to make suitable indicators. Low rates of prescribing were noted for indicators based on drugs of limited efficacy, e.g. cerebral and peripheral vasodilators (rate 3.1 per 1,000 prescriptions), whilst indicators based on drugs associated with good prescribing practice were associated with higher prescribing rates, e.g. the prescription of aspirin in patients receiving nitrate therapy(rate 7.13 per 1,000 patients). However, a low rate of generic prescribing (4.6%) was found amongst general practitioners in the study. The largest variability in prescribing was seen with the prescribing of peripheral and cerebral vasodilators (75th/25th centile=5.6) and the prescription of long-acting sulphonylureas (75th/25th centile=66.6). CONCLUSIONS: Quality indicators based on aggregate prescribing provide valuable information on prescribing standards and should be developed with the close involvement of prescribers.
BACKGROUND: Studies on glaucoma therapy were analyzed with regard to study design, diagnostic parameters and success criteria. MATERIALS AND METHODS: In 11 frequently read peer-reviewed periodicals, 101 studies published between 1996 and 1999 were chosen according to specific criteria. Design parameters, diagnostic measures and success criteria were investigated. RESULTS: Thirty-seven studies were retrospective and 64 prospective. Twenty-five studies were multicenter studies. Thirty-seven studies dealt with drug therapy, 12 with laser therapy, and 52 with surgical therapy. The study duration in 51% of the studies (n=52) was up to 1 year, in 28% (n=28) from 1 to 2 years, in 17% (n=17) over 2 years, and in 5% (n=5) in excess of 4 years. Four studies gave insufficient data. Forty-one studies recruited less than 50 patients and 57 studies recruited less than 75 patients. Thirty-four studies included more than 100 patients and 11 studies more than 250 patients. Sixty-one studies included race as a parameter. All 101 studies measured intraocular pressure (IOP). Forty-five studies explicitly described the method of tonometry. Thirteen studies measured a diurnal IOP. Forty-one studies examined the visual field, of which 30 named the method of perimetry. Only 28 studies examined the optic disc morphology. They all employed ophthalmoscopy, and two additionally employed optic disc photography. Sixty-three studies explicitly defined success criteria, establishing 95 different definitions: 74 definitions (78%) used a specified value for IOP as a success criterion. Out of the 70 definitions that gave an absolute value for IOP, 12 definitions (17%) used IOP values between 14 and 16 mmHg as the upper limit, 4 definitions (6%) used IOP values between 17 and 19 mmHg, and 54 definitions (77%) used IOP values between 20 and 22 mmHg. Out of the 26 definitions that specified a percentage IOP reduction, it was judged to be a success when the IOP was lowered by 20% or more from the starting value in ten definitions (38%), by 25% or more in three definitions (12%), and by 30% or more in 13 definitions (50%). CONCLUSIONS: Examples of prestigious studies show the necessity of observation periods of several years and demonstrate the need for a high number of participants, necessitating the cooperation of many study centers. Beside a more precise characterization of the patient collectives, clinical studies should always specify the measurement method clearly. Investigating a diurnal IOP profile to recognize changes in IOP and IOP peaks, as well as the routine determination of central corneal thickness, would be desirable. New diagnostic techniques for improved assessment of the functional and morphologic damage will gain in relevance in the future. The lack of a common definition of success reveals the complexity of the disease. However, an IOP reduction based on the degree of damage and ascertaining the target pressure seems sensible.