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Pharmaceutical pricing
Registers and fraud control in Norway The Norwegian Government is considering the creation of a unified system of regional registries that will collect data from all hospitals in the country to provide public health officials and researchers with a comprehensive statistical database. To protect the patients’ privacy, patients will be identified only by a coded number, says Erik Boe, head of the Privacy Commission, which has just delivered to the Government recommended guidelines for such a registry. In addition, the data will not be centralised but spread among the country’s five regional health offices, explains Boe. No central data base will exist; inquirers will be able to obtain only the data they specify, and all the file data will be sent back to the various regions when the inquiry that linked them is over, without the creation of any new record file. Data stored in regional registries cannot be stored elsewhere. Hospitals would have to report details on every
patient
to
an
independent institution,
60 years, and that patients on the : register be able to take themselves off it. : Created in 1916, this registry contains psychiatric information on 300 000 Norwegians, a third of them still alive. According to Boe only one or two inquiries are made each year. "This is mainly a historical file", he says, "which is worth keeping". Current and updated files of this register might be included in the new health registries, but the move would require new legislation, which is expected to be pro: posed by the government by next year. the social Independently, Norwegian security system announced the creation of a control system to detect fraud in doctors’ bills. Doctors charge the government NKr 1 -5 billion CO 40 million) a year; the control system will cost 0-1% of this amount. The introduction of the control system stems from a project conducted last year in 97 municipalities. "We discovered not only fraud but a great number of misunderstandings about the use of rates and how the bills are to be filled out", says 0yvind Clemetsen, head of the social division of legal affairs. Last year only two cases of fraud were reported to the police, but from 1994, when the control system becomes routine, this number is expected to rise. Parliament has also amended legislation such that reporting doctors to the police will become easier-gross negligence is sufficient for a charge of fraud. The control office will check 1-6 million bills a year, out of a total of 10 million issued by the country’s 6000 doctors. next
security’s
which would issue the code number. Even with anonymity protected, patients can opt not to be included in the register. The three existing national registries (cancer, birth, and death) would also send their data to the new registry, at least for a 3-year experimental period. The Privacy Commission has also proposed that the Psychosis Registry, which stopped entries in 1989 because of pressure by patients and politicians, be sealed for the
Cláudo Csillag
Curing curly toes
TB in western
Double-blind, randomised, prospective
Data from 14 western European countries indicate that over the past two decades overall notification rates for tuberculosis declined at an average rate of 5-4% per . annum, and by 50%, from 31-9 to 14-0 per 100 000 population between 1974 and 1990. These figures mask the upturn in notification in Austria, Denmark, Ireland, Italy, Netherlands, Norway, and Switzerland in recent years.1 HIV infection seems to contribute only marginally to the increase, except perhaps in Paris and its surrounds and in Italy and Spain. In Denmark, the Netherlands, Norway, Sweden, and Switzerland, the number of cases among foreign-born persons has contributed to the change in the expected downward trend. In all countries examined, tuberculosis among the indigenous population has become largely a disease of the elderly rather than of young adults-a shift that indicates successful control. :
be the best way of assessing medical treatments, but until recently, few surgical procedures had been formally assessed at all, and the words "... trials
are
accepted
to
double-blind, randomised,
prospective
trial" seldom-if ever-applied to a surgical trial. Hamer and colleagues’ randomised patients with curly toes to have either a flexor tenotomy or a flexor to extensor tendon transfer, without telling them which was done; operated through an identical incision; and had the results assessed by another surgeon. After a follow-up of 4 years, no difference was found between operations. The report may have implications for the practice of surgery in general: it may be difficult to make a surgical trial double-blind, but no longer can it be said to be impossible. John Bignall 1
Hamer AJ, Stanley D, Smith TWD. Surgery for curly-toe deformity: a doubleblind, randomised, prospective trial. Bone Joint Surg 1993, 75, 662-63.
1
Europe
Raviglione MC, Sudre P, Rieder HL, Spinaci S, Kochi A. Secular trends of tuberculosis in Western Europe. Bull WHO 1993; 71: 297-306.
Flosequinan withdrawn Boots Company, manufacturers of Manoplex (flosequinan, see Lancet Mar 20, p 733), has withdrawn the drug, an arteriolar and venous dilator used for the treatment of heart failure. In April the company withdrew the 100 mg tablet after preliminary results of the PROFILE survival study indicated increased mortality associated with this dose (see Lancet May 1, p 1146). The company said that the PROFILE trial of the 75 mg dose would continue and recommended that patients be given 50 mg once daily. However, a review of clinical studies of flosequinan (Drugs and Therapeutics Bulletin June 12, 1993) concluded that the drug could not be recommended at this dose because its efficacy at 50 mg has not been proven. Further interim analysis of the PROFILE study showed an increase in hospital admissions of patients on the 75 mg dose and is the reason Boots gives for withdrawal of this drug. Arrhythmogenesis has been reported in a patient on flosequinan (see Lancet Apr 24, p 1100). She had had a previous myocardial infarction and evidence of being at increased risk of sustained arrhythmia.
Library package Teaching-aids at Low Cost (TALC) has set up a scheme to provide small libraries to hospitals and district health centres. The books have been selected by experts to provide the best range of information possible. The first package, for district hospitals, ([85, including postage and packing by surface mail word wide) contains 17 books ranging from two on primary surgery, to an AIDS handbook and the latest book on tuberculosis. The second, aimed at district health workers, (jC60) consists of 14 books, including Where There is no Doctor, a revised book on nutrition, and a book on obstetric emergencies. Further details can be had from TALC, PO Box 49, St Albans, Herts ALl 4AX, UK.
Pharmaceutical
pricing
costs make up about one-tenth of National Health Service expenditure, which makes drug pricing a key issue in an era when resources are limited and rationing is unavoidable. The Drug and Therapeutics Bulletin is holding a meeting on the UK Pharmaceutical Price Regulation Scheme (PPRS) on September 15, 1993. Cheques for 58.75 should be made payable to the Consumers’ Association, 2 Marylebone Road, London NW1 4DF, UK.
Drug
235
o
patient
to
an
independent institution,
60 years, and that patients on the : register be able to take themselves off it. : Created in 1916, this registry contains psychiatric information on 300 000 Norwegians, a third of them still alive. According to Boe only one or two inquiries are made each year. "This is mainly a historical file", he says, "which is worth keeping". Current and updated files of this register might be included in the new health registries, but the move would require new legislation, which is expected to be pro: posed by the government by next year. the social Independently, Norwegian security system announced the creation of a control system to detect fraud in doctors’ bills. Doctors charge the government NKr 1 -5 billion CO 40 million) a year; the control system will cost 0-1% of this amount. The introduction of the control system stems from a project conducted last year in 97 municipalities. "We discovered not only fraud but a great number of misunderstandings about the use of rates and how the bills are to be filled out", says 0yvind Clemetsen, head of the social division of legal affairs. Last year only two cases of fraud were reported to the police, but from 1994, when the control system becomes routine, this number is expected to rise. Parliament has also amended legislation such that reporting doctors to the police will become easier-gross negligence is sufficient for a charge of fraud. The control office will check 1-6 million bills a year, out of a total of 10 million issued by the country’s 6000 doctors. next
security’s
which would issue the code number. Even with anonymity protected, patients can opt not to be included in the register. The three existing national registries (cancer, birth, and death) would also send their data to the new registry, at least for a 3-year experimental period. The Privacy Commission has also proposed that the Psychosis Registry, which stopped entries in 1989 because of pressure by patients and politicians, be sealed for the
Cláudo Csillag
Curing curly toes
TB in western
Double-blind, randomised, prospective
Data from 14 western European countries indicate that over the past two decades overall notification rates for tuberculosis declined at an average rate of 5-4% per . annum, and by 50%, from 31-9 to 14-0 per 100 000 population between 1974 and 1990. These figures mask the upturn in notification in Austria, Denmark, Ireland, Italy, Netherlands, Norway, and Switzerland in recent years.1 HIV infection seems to contribute only marginally to the increase, except perhaps in Paris and its surrounds and in Italy and Spain. In Denmark, the Netherlands, Norway, Sweden, and Switzerland, the number of cases among foreign-born persons has contributed to the change in the expected downward trend. In all countries examined, tuberculosis among the indigenous population has become largely a disease of the elderly rather than of young adults-a shift that indicates successful control. :
be the best way of assessing medical treatments, but until recently, few surgical procedures had been formally assessed at all, and the words "... trials
are
accepted
to
double-blind, randomised,
prospective
trial" seldom-if ever-applied to a surgical trial. Hamer and colleagues’ randomised patients with curly toes to have either a flexor tenotomy or a flexor to extensor tendon transfer, without telling them which was done; operated through an identical incision; and had the results assessed by another surgeon. After a follow-up of 4 years, no difference was found between operations. The report may have implications for the practice of surgery in general: it may be difficult to make a surgical trial double-blind, but no longer can it be said to be impossible. John Bignall 1
Hamer AJ, Stanley D, Smith TWD. Surgery for curly-toe deformity: a doubleblind, randomised, prospective trial. Bone Joint Surg 1993, 75, 662-63.
1
Europe
Raviglione MC, Sudre P, Rieder HL, Spinaci S, Kochi A. Secular trends of tuberculosis in Western Europe. Bull WHO 1993; 71: 297-306.
Flosequinan withdrawn Boots Company, manufacturers of Manoplex (flosequinan, see Lancet Mar 20, p 733), has withdrawn the drug, an arteriolar and venous dilator used for the treatment of heart failure. In April the company withdrew the 100 mg tablet after preliminary results of the PROFILE survival study indicated increased mortality associated with this dose (see Lancet May 1, p 1146). The company said that the PROFILE trial of the 75 mg dose would continue and recommended that patients be given 50 mg once daily. However, a review of clinical studies of flosequinan (Drugs and Therapeutics Bulletin June 12, 1993) concluded that the drug could not be recommended at this dose because its efficacy at 50 mg has not been proven. Further interim analysis of the PROFILE study showed an increase in hospital admissions of patients on the 75 mg dose and is the reason Boots gives for withdrawal of this drug. Arrhythmogenesis has been reported in a patient on flosequinan (see Lancet Apr 24, p 1100). She had had a previous myocardial infarction and evidence of being at increased risk of sustained arrhythmia.
Library package Teaching-aids at Low Cost (TALC) has set up a scheme to provide small libraries to hospitals and district health centres. The books have been selected by experts to provide the best range of information possible. The first package, for district hospitals, ([85, including postage and packing by surface mail word wide) contains 17 books ranging from two on primary surgery, to an AIDS handbook and the latest book on tuberculosis. The second, aimed at district health workers, (jC60) consists of 14 books, including Where There is no Doctor, a revised book on nutrition, and a book on obstetric emergencies. Further details can be had from TALC, PO Box 49, St Albans, Herts ALl 4AX, UK.
Pharmaceutical
pricing
costs make up about one-tenth of National Health Service expenditure, which makes drug pricing a key issue in an era when resources are limited and rationing is unavoidable. The Drug and Therapeutics Bulletin is holding a meeting on the UK Pharmaceutical Price Regulation Scheme (PPRS) on September 15, 1993. Cheques for 58.75 should be made payable to the Consumers’ Association, 2 Marylebone Road, London NW1 4DF, UK.
Drug
235
o