Human Medicines Regulation Flashcards
What is the process of drug development?
- Development of new drug
- Manufacturing
- distribution
- sale and supply
Takes 10 years, and there are many regulatory requirments
What regulations did the medicines act lead to?
People needing licenses for the manufacture, sale and supply and importation of medicines. Stopped anyone doing these things without a license
What is the MHRA?
The medicines and healthcare regulations Agency, UK
How are medicines regulated?
In the UK, the MHRA and the EMEA work closely together and create a collaborative network of regulatory bodies in Europe. It is a central procedure. A single Market Authorisation is submitted to EMEA, and becomes valid in all member states.
Who grants marketing authorisation for drugs in the UK?
MHRA
How are medicines licensed?
- Clinical trials - must be approved to conduct. MHRA review, if successful given MA/license
- SPC - name, composition, pharmaceutical form, pharmacological form, clinical procedures
Phase I clinical trials
tested on healthy people
shows how the drug works
tested on less than 100 people
Phase II clinical trials
- Tests medicines in patients with disease
- identify short term common side effects
- 100s people
Phase III clinical trials
- How effective and safe the drug is
- range and degree of side effects
- in form labelling and patient information leaflet
- 100-100s
- good result but issues = MA but monitoring required
Monitoring (Phase IV clinical trials)
- looks at long term harm
- yellow card
- black triangle
- research
- quality checks (MHRA)
- criminal activity
What is the yellow card scheme?
Scheme used for reporting adverse drug reactions
What is a black triangle drug?
Medication recently brought into the market.
- drug on probation
- pharmacovigilance
- all side effects must be reported
Quality checks
- must be reported to the MHRA
- class 1 = immediate recall as could result in death
- class 2 = recall in 48 hours - no risk to life
- class 3 = action in 5 days, unsafe due to something like incorrect info in PIL
- class 4 - caution with use, no threat to safety
What are the 3 main regulated aspects of drug advertising?
- cannot advertise a medicine which is not market authorised with an SPC, must be consistent with SPC
- can’t publish unless encourages rational use of the product
- cannot be misleading
How is pharmacovigilance enforced?
- licensing authority must promote reporting of any adverse drug reactions (yellow card scheme)
- public given information on pharmacovigilance concerns
- identify products with ADR
What are the rules around drug labels?
- must be legible and indelible
- must be comprehensible
- must be in english or english+
What must appear on outer packaging of drugs?
- API
- Name, form, strength
- dosage units/vol
- excipients
- admin. route
- expiry date (month/year)
- storage and disposal
- MA (name and address of holder)
- MA no
- Batch No.
- keep out of reach of children
- instructions for use - non prescription
What must be included on a blister pack?
- name, strength, form
- MA (name of holder, number)
- Batch number
- expiry date
What additional labelling must be included on P, POM and medicines containing paracetamol?
- specifically on box that it contains paracetamol
- specific instructions not to exceed dose
- no improvements, see doctor
- don’t take anything else containing paracetamol
- talk to a doctor at one if exceed paracetamol dose
- labels stipulated because of paracetamol toxicity
What must be on the dispensing label of a dispensed medicinal product or something dispensed against a prescription?
- name of preparation
- quantity
- instructions for patient
- patient name
- date of dispensing
- name and address of the pharmacy
- will be dispensed in original packaging and added dispensing label
- directions for use
- ‘keep out of reach and sight of children’
- precautions relating to use
- quantity is not a legal requirement but is good practice
Is a patient information leaflet a legal requirement?
Yes, it must be included with every medicine that is sold and supplied
What must be included in a patient information leaflet?
- therapeutic group/type of product
- therapeutic indication
- contraindications
- precautions for use
- any interactions with any other medicines/substances
- any special warnings
- list of excipients
- proper use
- storage
- expiry date
What information on proper use must be included?
- dosage
- method of administration
- frequency
- symptoms of overdose
- actions to be taken
- what if one or more doses are missed?
- duration of treatment
- consult doctor/pharmacist for more information
