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You are encouraged to report negative side effects of prescription drugs.
Named Patient Basis - Specials
Drugs being developed may be given permission from the regulatory agency to be made available on a ‘named patient basis’ (a special) when the regulatory agency is satisfied the medication meets certain criteria.
That the drug is safe for use, ,and the medication is manufactured correctly under the good manufacturing practice guidelines (GMP) laid down by the regulatory agency. (It is not an indication of its efficacy).
The guidelines are strict with regular inspection of the manufacturing premises and process.
Monitoring of the drug is undertaken by the regulatory agency.
A clinician may prescribe the drug available on a ‘named patient basis’ (a ‘special’) if they are satisfied that it would be of a direct benefit to the sufferer and there is nothing else to help them.
A request to the manufacturer of the drug by the clinician asking them if they would make the medication available, and their agreement to do so, is needed.
Permission has to be obtained from the relevant regulatory agency to enable the drug to be delivered to the clinician.
The benefit of making medications available on a ‘named patient basis’ is recognised internationally, the majority of countries throughout the world have a system in place that enables drugs classified as ‘specials’ to be made available.
New Drug Development 2006
It is well recognised that all drugs take a long time to be developed, the process takes the drug along a path of multiple testing and trials eventually culminating in the phase three trial before final licence and submission for use.
Phase three trials are considered to be the gold standard that demonstrates the safety and efficacy of a drug, however, there lies a record of drugs being withdraw after demonstrating adverse side effects even though they have passed through the phase three trial gold standard.
Perhaps safety and efficacy may be better served if a drug was assessed, not just by the phase three trial results and its peer review?
Consideration could also be given to information obtained from anecdotal evidence and single case studies as well as well as phase three trial data.
