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A patient is entitled to a medicine that has been approved for treating their illness

Hospital districts using cancer drug for eye disease

A patient has a right to be treated with a medical preparation that has been approved for treatment of their illness, and is entitled to refuse a medicine if this is not the case, points out Ombudsman Petri Jääskeläinen.
 
This is high-quality treatment in accordance with the Patient Act. All treatment given to a patient must be medically warranted.

Acting on a complaint, the Ombudsman adopted a position on so-called off-label use of pharmaceutical products; in other words, using medicines for
purposes other than that for which they have been approved.
 
The complaint had contained criticism of the use of the cancer drug Avastin to treat eye conditions such as age-related macular degeneration in public health care. 

An investigation carried out for the Ombudsman revealed that Avastin was being used in almost all hospital districts to treat age-related macular degeneration without the patient being appropriately informed of this.

Doctor's responsibility accentuated

A doctor can not prescribe a medicine for any purpose other than the one for which it has been approved without informing the patient of this. The
doctor must also give the patient an explanation of the treatment-related reasons for deciding to prescribe an off-label drug.

"When a doctor prescribes a medicine for a purpose other than that for which it has been officially approved, their responsibility and duty to inform
the patient are accentuated," the Ombudsman points out.

Nor does the law allow doctors to be placed under an obligation or systematically directed to prescribe a drug on an off-label basis.

Approval for treatment of cancer

Avastin has been approved in the EU for treating a variety of cancers intravenously. It has not been developed for intraocular use. Medicines for which
approval has been granted are available for treating age-related macular degeneration, but they are a lot more expensive than Avastin.

According to the Finnish Medicines Agency (Fimea), the intraocular use of Avastin is reported to have had harmful effects, most commonly severe eye inflammations.

Age-related macular degeneration is the most common cause of poor eyesight and visual impairment in persons older than working age in western countries.

Practices differ from one hospital district to another

The reports received from the various hospital districts revealed that only in Etelä-Karjala was appropriate treatment practice observed: a product that
had been approved for this purpose was always used in the treatment of age-related macular degeneration unless there was a clinical reason, arising from the patient, for not doing so.

In three hospital districts, Kainuu, Kymenlaakso and Vaasa, only Avastin was used for all, including patients in whose cases there were risk factors
associated with this drug. Avastin was the drug mainly used in the remaining hospital districts.

Most often, patients were not told clearly that the drug had not been approved for intraocular use.

According to reports received by the Ombudsman, the intraocular use of Avastin is not medically justified in the light of current knowledge.

The Ombudsman sent copies of his decision to the Ministry of Social Affairs and Health and the National Supervisory Authority for Welfare and Health (
Valvira) for their information. He asked Valvira to inform him, by 31.5.2013, of what measures his decision had given rise to in each hospital district.

Additional info will be provided by Senior Legal Adviser Kaija Tanttinen-Laakkonen, tel. +358(0)9 432 3377.