Patients will be able to report drugs' side effects
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《英国医生杂志》
Patients who suspect they have experienced side effects of drugs will be able to report direct to the Medicines and Healthcare Products Regulatory Agency, under new proposals for the "yellow card" notification scheme being considered by the Department of Health. Currently only doctors, dentists, coroners, pharmacists and nurses can submit reports.
It is hoped that giving patients direct access will increase reports received by the agency. Since the yellow card scheme started 40 years ago, there have been some 500 000 reports of drug reactions, but it is widely believed many side effects go unreported. Pilot schemes should be used to determine how patients should access the system and how information could be monitored, the Independent Review of Access to the Yellow Card Scheme recommended this week. The Department of Health has accepted that recommendation, but is to put the other recommendations out to consultation.
One such pilot scheme is currently under way in Beckenham, south London. It allows patients to report side effects to NHS Direct. Far from being deluged with calls, as was feared, only 39 have been received since the project started a year ago.
Dr Jeremy Metters, former deputy chief medical officer and chairman of the steering committee for the review, said the results from the pilot study were disappointing. "We can only speculate why participation has been so poor. It is highly likely that future pilot schemes would allow patients direct access, rather than through a health professional to improve take-up and accuracy of information."
The review, which included feedback from over 50 medical, patient, and pharmaceutical organisations, also recommends that anonymous details of reported drug side effects should be available on the agency抯 website; this would give open access to information that was previously restricted.
Independent researchers should also have greater access to individual yellow cards, which include some patient details and the name of the reporter. But this would be permitted only after assessment by an independent scientific committee, which would judge whether the proposal was "scientifically robust," the report recommends.
The steering committee adds that data should not be used to determine specific adverse drug reaction rates since reports reflect suspected reactions rather than proved ones and may be biased by media reporting. Strict protocols will be developed to protect personal patient information.
"Patient confidentiality is of paramount importance," Dr Metters explains. The review suggests that once committee approval is given to a researcher, the reporter who submitted the yellow card in question should be notified and either they or the patient抯 GP should contact the patient to gain consent for personal details to be released. Doctors and professionals involved in this process would be paid for their assistance, the report concludes.
Professor Gordon Duff, chairman of the Committee on Safety of Medicines, welcomed the proposals and said greater access would be beneficial for patients and doctors alike. "There is enormous potential to unlock new methodologies in pharmacovigilance and pharmacogenetics, which could improve the safety and efficacy of drugs."(London Keren Williams)
It is hoped that giving patients direct access will increase reports received by the agency. Since the yellow card scheme started 40 years ago, there have been some 500 000 reports of drug reactions, but it is widely believed many side effects go unreported. Pilot schemes should be used to determine how patients should access the system and how information could be monitored, the Independent Review of Access to the Yellow Card Scheme recommended this week. The Department of Health has accepted that recommendation, but is to put the other recommendations out to consultation.
One such pilot scheme is currently under way in Beckenham, south London. It allows patients to report side effects to NHS Direct. Far from being deluged with calls, as was feared, only 39 have been received since the project started a year ago.
Dr Jeremy Metters, former deputy chief medical officer and chairman of the steering committee for the review, said the results from the pilot study were disappointing. "We can only speculate why participation has been so poor. It is highly likely that future pilot schemes would allow patients direct access, rather than through a health professional to improve take-up and accuracy of information."
The review, which included feedback from over 50 medical, patient, and pharmaceutical organisations, also recommends that anonymous details of reported drug side effects should be available on the agency抯 website; this would give open access to information that was previously restricted.
Independent researchers should also have greater access to individual yellow cards, which include some patient details and the name of the reporter. But this would be permitted only after assessment by an independent scientific committee, which would judge whether the proposal was "scientifically robust," the report recommends.
The steering committee adds that data should not be used to determine specific adverse drug reaction rates since reports reflect suspected reactions rather than proved ones and may be biased by media reporting. Strict protocols will be developed to protect personal patient information.
"Patient confidentiality is of paramount importance," Dr Metters explains. The review suggests that once committee approval is given to a researcher, the reporter who submitted the yellow card in question should be notified and either they or the patient抯 GP should contact the patient to gain consent for personal details to be released. Doctors and professionals involved in this process would be paid for their assistance, the report concludes.
Professor Gordon Duff, chairman of the Committee on Safety of Medicines, welcomed the proposals and said greater access would be beneficial for patients and doctors alike. "There is enormous potential to unlock new methodologies in pharmacovigilance and pharmacogenetics, which could improve the safety and efficacy of drugs."(London Keren Williams)