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When a suspected side / adverse effect is confirmed, depending on its severity, the PIL may be amended, extra warnings may be issued or the medicine may be withdrawn.
Medicines are designed to prevent or treat illnesses, or relieve symptoms. Any medicine may cause side / adverse effects and these may not be uncovered until many people have used the medicine over a period of time.
Side / adverse effects can occasionally appear after a person has stopped taking a medicine.
You can help to make medicines safer for everyone by filling in a Yellow Card about a suspected side/ adverse effect.
The yellow card scheme is jointly operated by the MHRA and Committee on Human Medicines
and is open to patient reporting ~ if you have experienced any adverse side effects
from a medication -
Hotline 0808 100 3352
You are capable of making an informed decision, and it is vital that you understand what you are taking before you take it.
Why would you assume doctors know everything?
New uses of a medicine
A licence is granted for a specific use and in a particular group of people. However,
once a medicine has been approved for one purpose, doctors are free to prescribe
it for any other purpose that in their professional judgment is both safe and effective
- this is known as off-label use.
New treatment opportunities may become apparent or different categories of patients may be defined.
A new treatment opportunity when uncovered, would require the pharmaceutical company to conduct further clinical trials and present new data to the regulatory agencies in order to expand the current licence.
Clinical Trials - When a drug becomes accepted for use, there are further hurdles
to leap.
In the UK
Created to help eliminate post code lottery prescribing, NICE (National Institute for Health and Clinical Excellence) for England and Wales and the SMC (Scottish Medicines Consortium) for Scotland appraise certain new medicines and will look at issues such as cost effectiveness of the new treatment. (referred to as QUALY)
The NHS is legally obliged to fund medicines recommended by NICE or SMC.
If NICE or SMC do not approve a new medicine, then primary care trusts are not required to provide funding for the treatment. It is then entirely up to their own discretion
Phase Four Trials -
1. Attempt to uncover further use for the treatment.
2. Compare the new medicine with other available treatments
3. Determine its effectiveness across a broader spectrum of patients
4. Study and research long term benefits and safety
The yellow card scheme-
Medicines have a patient information leaflet (PIL), which gives instructions on how the medicine should be used, and on its side effects.
Rare side effects, for example those occurring in 1 in 15,000 may only become apparent once a medicine is in general use.
In the UK, the Yellow Card Scheme is used by doctors and members of the public to report unwanted side effects of a medicine to the MHRA.
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