Eltroxin scandal lessons made Health Ministry rules

Pharmaceutical companies obligated to report on drugs' alterations after change in medication's formula caused serious side effects.

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June 12, 2013 17:44
1 minute read.
ELTROXIN

ELTROXIN 370. (photo credit: Courtesy)

 
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Pharmaceutical companies will be required to follow up side effects of drugs they sell and report them immediately to the Health Ministry, which sent proposed regulations to the Knesset Labor, Social Welfare and Health Committee for approval on Wednesday.

The ministry prepared the regulations in the wake of the Eltroxin scandal of last year, in which a drug company – without informing the ministry – changed the formulation of the medication for hypothyroidism, an alteration that caused serious side effects in many patients.

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Even after the drug is registered, the manufacturers and importers will be required to tell the ministry about any undue side effects and describe the risks from its use, as well as what is needed to ensure safety.

The regulations will take effect a year after their publication in Reshumotm, the state’s official record of laws.

Committee chairman MK Haim Katz welcomed the regulations and said he hoped the committee would not again be faced by “disorder in the health system that may threaten lives.”

The committee decided that every prohibition or limitation listed by the manufacturer or a recognized health authority abroad must be reported to the ministry within three days.

Any concern by a manufacturer or importer here about a serious and unusual side effect has to be reported to the ministry within 15 days.



If the manufacturer or importer fails to do so, its license for the marketing of the product may be canceled.

A physician or pharmacist with a least two years of experience must head the followup.

He must also coordinate risk management, collect reports from doctors and patients and send the reports to the ministry’s director-general, who will supervise the results, carry out periodic supervision and distribute the data to the relevant authorities.

The director-general has the power to cancel the marketing of any pharmaceutical if he is convinced that it poses health risks.

In addition, the regulations require the health funds and hospitals to report unusual side effects they have observed.

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