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Opioids in Italy: is marketing more powerful than the law?
CORRESPONDENCE
Opioids in Italy: is marketing more powerful than the law? Sir—Sebastiano Mercadante1 reported that opioid consumption in Italy did not rise after the Italian government approved a law on Feb 8, 2001, to facilitate opioid prescription for cancer pain. We show here that opioid consumption did increase after this date, but that the rise was not associated with the new law. Italy’s medicinal morphine consumption for 2000 ranked among the lowest in Europe.2 The International Narcotics Control Board (INCB) has expressed concern about opioid availability in Italy, stating that this difficulty “may be indicative of insufficient availability of the drug for pain management purposes”. Factors that result in low use of opioids in Italy include lack of education among doctors and poor public awareness of the importance of using opioid analgesics to treat cancer pain, cultural prejudices about opioid analgesics, and overly restrictive prescription regulations. Under pressure from numerous health-care organisations, the Italian government eased the law on opioid prescription. The changes included: replacing the previous complex, threepart prescription form with a simplified prescription form; increasing the amount of opioids that could be prescribed in one go from an 8-day to a 1-month supply; allowing doctors to prescribe two drugs, instead of one, on a prescription; and substantially reducing sanctions for inadvertent prescription or dispensing errors.
We analysed the effect of these measures, using national data on the sales of drugs from wholesalers to pharmacies in 2000–02. Opioid consumption increased from a defined daily dose (DDD) of 16 DDD/100 000 people daily between January, 2000, and February, 2001, to one of more than 45 DDD/100 000 per day between March, 2001, and March, 2002; a level similar to that of countries such as Austria and Iceland, highly ranked by the INCB in 2000. In 2000–02, two opioid analgesics— transdermal fentanyl in November, 2000, and morphine syrup in April, 2001 (an addition to sustained release morphine tablets)—were added to the list of reimbursable drugs by the Italian national health-care system. Transdermal fentanyl has been heavily marketed in Italy, by contrast with morphine preparations. We therefore further assessed prescription patterns for morphine, transdermal fentanyl, and buprenorphine—ie, those opioids commercially available in Italy and used mostly for cancer pain. Analysis of the monthly consumption of these drugs (figure) revealed that consumption of morphine and buprenorphine remained stable. By contrast, use of transdermal fentanyl rose rapidly (although recommended only when oral morphine is inadequate3). This rise began not at the time of the legal change, but at the time of its addition to the list of reimbursed drugs. Consistent with these data but contrary to guidelines, results of a local unpublished survey (Debetto P, personal communication) have shown that many patients received transdermal fentanyl as a first option. Maybe, transdermal fentanyl, as a new
55
DDD/100000 inhabitants per day
50
Transdermal fentanyl becomes free of charge
New Italian law on opioid prescription passed
45 40 35 30 25 20 15
Morphine Fentanyl Buprenorphine
10 5
Jan, Feb, 2000 2 Mar, 000 April, 2000 2 May, 000 June 2000 , 200 0 July, 2 Aug, 000 2 Sep, 000 2 Oct, 000 Nov, 2000 2 Dec, 000 Jan, 2000 2 Feb, 001 Mar, 2001 April, 2001 2 May, 001 June 2001 ,2 July, 001 Aug, 2001 2 Sep, 001 2 Oct, 001 2 Nov, 001 Dec, 2001 Jan, 2001 2 Feb, 002 Mar, 2002 April, 2002 May, 2002 June 2002 , July, 2002 2 Aug, 002 Sep, 2002 2 Oct, 002 2 Nov, 002 Dec, 2002 2002
0
Monthly consumption of opioids in Italy between 2000 and 2002
78
preparation, is not be seen as tainted with the problems of older opioids? Alessandro Chinellato, Gianni Terrazzani, Tom Walley, *Pietro Giusti Office of Pharmaceutical Sevice, Local Health Authority No 9, Treviso, Italy (AC, GT); Prescribing Research Group, Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK (TW); *Department of Pharmacology and Anesthesiology, University of Padova, Padova, Italy (PG) (e-mail: [email protected]) 1
2
3
Mercadante S. Opioid prescription in Italy: new law, no effect. Lancet 2002; 360: 1254–55. International Narcotics Control Board (INCB). Report for 2000, New York: United Nations, 2001. Gourlay GK. Treatment of cancer pain with transderamal fentanyl. Lancet Oncol 2001; 2: 165–72.
Cerebral embolism after retrograde catheterisation of aortic valve in aortic stenosis Sir—Heyder Omran and colleagues’ article (April 12, p 1241)1 about the frequency of clinically apparent and silent cerebral embolism after retrograde catheterisation of the aortic valve in valvular stenosis describes an informative study. Cardiac catheterisation is a low-risk procedure that provides information on cardiac and coronary artery anatomy, haemodynamic variables, and valvular function. Most patients have noninvasive screening procedures before referral for diagnostic cardiac catheterisation. Both the transseptal and retrograde techniques of cardiac catheterisation are safe.2,3 Practice guidelines from the American College of Cardiology and American Heart Association for management of patients with valvular heart disease mention two class one indications of angiography before aortic valve replacement in patients with aortic stenosis. The class one indications are for coronary angiography before aortic stenosis in patients at risk of coronary artery disease, and assessment of severity of aortic stenosis in symptomatic patients when aortic valve replacement is planned, or when non-invasive tests are inconclusive, or there is a discrepancy with clinical findings with respect to severity of aortic stenosis or need for surgery.4 Omran and colleagues, however, do not show the indications for retrograde angiography in their study. It seems that the indication for coronary angiography was mostly to show the incidence of
THE LANCET • Vol 362 • July 5, 2003 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet.
Opioids in Italy: is marketing more powerful than the law? Sir—Sebastiano Mercadante1 reported that opioid consumption in Italy did not rise after the Italian government approved a law on Feb 8, 2001, to facilitate opioid prescription for cancer pain. We show here that opioid consumption did increase after this date, but that the rise was not associated with the new law. Italy’s medicinal morphine consumption for 2000 ranked among the lowest in Europe.2 The International Narcotics Control Board (INCB) has expressed concern about opioid availability in Italy, stating that this difficulty “may be indicative of insufficient availability of the drug for pain management purposes”. Factors that result in low use of opioids in Italy include lack of education among doctors and poor public awareness of the importance of using opioid analgesics to treat cancer pain, cultural prejudices about opioid analgesics, and overly restrictive prescription regulations. Under pressure from numerous health-care organisations, the Italian government eased the law on opioid prescription. The changes included: replacing the previous complex, threepart prescription form with a simplified prescription form; increasing the amount of opioids that could be prescribed in one go from an 8-day to a 1-month supply; allowing doctors to prescribe two drugs, instead of one, on a prescription; and substantially reducing sanctions for inadvertent prescription or dispensing errors.
We analysed the effect of these measures, using national data on the sales of drugs from wholesalers to pharmacies in 2000–02. Opioid consumption increased from a defined daily dose (DDD) of 16 DDD/100 000 people daily between January, 2000, and February, 2001, to one of more than 45 DDD/100 000 per day between March, 2001, and March, 2002; a level similar to that of countries such as Austria and Iceland, highly ranked by the INCB in 2000. In 2000–02, two opioid analgesics— transdermal fentanyl in November, 2000, and morphine syrup in April, 2001 (an addition to sustained release morphine tablets)—were added to the list of reimbursable drugs by the Italian national health-care system. Transdermal fentanyl has been heavily marketed in Italy, by contrast with morphine preparations. We therefore further assessed prescription patterns for morphine, transdermal fentanyl, and buprenorphine—ie, those opioids commercially available in Italy and used mostly for cancer pain. Analysis of the monthly consumption of these drugs (figure) revealed that consumption of morphine and buprenorphine remained stable. By contrast, use of transdermal fentanyl rose rapidly (although recommended only when oral morphine is inadequate3). This rise began not at the time of the legal change, but at the time of its addition to the list of reimbursed drugs. Consistent with these data but contrary to guidelines, results of a local unpublished survey (Debetto P, personal communication) have shown that many patients received transdermal fentanyl as a first option. Maybe, transdermal fentanyl, as a new
55
DDD/100000 inhabitants per day
50
Transdermal fentanyl becomes free of charge
New Italian law on opioid prescription passed
45 40 35 30 25 20 15
Morphine Fentanyl Buprenorphine
10 5
Jan, Feb, 2000 2 Mar, 000 April, 2000 2 May, 000 June 2000 , 200 0 July, 2 Aug, 000 2 Sep, 000 2 Oct, 000 Nov, 2000 2 Dec, 000 Jan, 2000 2 Feb, 001 Mar, 2001 April, 2001 2 May, 001 June 2001 ,2 July, 001 Aug, 2001 2 Sep, 001 2 Oct, 001 2 Nov, 001 Dec, 2001 Jan, 2001 2 Feb, 002 Mar, 2002 April, 2002 May, 2002 June 2002 , July, 2002 2 Aug, 002 Sep, 2002 2 Oct, 002 2 Nov, 002 Dec, 2002 2002
0
Monthly consumption of opioids in Italy between 2000 and 2002
78
preparation, is not be seen as tainted with the problems of older opioids? Alessandro Chinellato, Gianni Terrazzani, Tom Walley, *Pietro Giusti Office of Pharmaceutical Sevice, Local Health Authority No 9, Treviso, Italy (AC, GT); Prescribing Research Group, Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK (TW); *Department of Pharmacology and Anesthesiology, University of Padova, Padova, Italy (PG) (e-mail: [email protected]) 1
2
3
Mercadante S. Opioid prescription in Italy: new law, no effect. Lancet 2002; 360: 1254–55. International Narcotics Control Board (INCB). Report for 2000, New York: United Nations, 2001. Gourlay GK. Treatment of cancer pain with transderamal fentanyl. Lancet Oncol 2001; 2: 165–72.
Cerebral embolism after retrograde catheterisation of aortic valve in aortic stenosis Sir—Heyder Omran and colleagues’ article (April 12, p 1241)1 about the frequency of clinically apparent and silent cerebral embolism after retrograde catheterisation of the aortic valve in valvular stenosis describes an informative study. Cardiac catheterisation is a low-risk procedure that provides information on cardiac and coronary artery anatomy, haemodynamic variables, and valvular function. Most patients have noninvasive screening procedures before referral for diagnostic cardiac catheterisation. Both the transseptal and retrograde techniques of cardiac catheterisation are safe.2,3 Practice guidelines from the American College of Cardiology and American Heart Association for management of patients with valvular heart disease mention two class one indications of angiography before aortic valve replacement in patients with aortic stenosis. The class one indications are for coronary angiography before aortic stenosis in patients at risk of coronary artery disease, and assessment of severity of aortic stenosis in symptomatic patients when aortic valve replacement is planned, or when non-invasive tests are inconclusive, or there is a discrepancy with clinical findings with respect to severity of aortic stenosis or need for surgery.4 Omran and colleagues, however, do not show the indications for retrograde angiography in their study. It seems that the indication for coronary angiography was mostly to show the incidence of
THE LANCET • Vol 362 • July 5, 2003 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet.