Use of Medicines

Question 1

Who licenses medicine in the UK + why

Answer 1

MHRA - MEDICINE & HEALTHCARE PRODUCTS REGULATORY AGENCY (UK)

• Ensures human medicines meet ACCEPTABLE STANDARDS of SAFETY, QUALITY, EFFICACY

Products require marketing authorisation before being placed on the market

Pharmaceutical companies + wholesalers require manufacturing &/or wholesaler dealer licences to satisfy manufacture, distribution, supply of medicine meet required safety & quality standards

Question 2

Pharmacovigilance

Answer 2

• DETECTION, ASSESSMENT, UNDERSTANDING & PREVENTIONS of ADRs (adverse drug reactions)
  
  • Provides CONTINUAL ASSESSMENT of RISKS & BENEFITS of each drug - resulting in best drug therapy for pt.
  • YELLOW CARD SCHEME - post-surveillance of ADRs (UK)

Question 3

What does the Yellow Card Scheme cover + what should be reported

Answer 3

SIDE EFFECTS/ADRs

MEDICAL DEVICE ADVERSE INCIDENTS

DEFECTIVE MEDICINES (unacceptable quality)

COUNTERFEIT/FAKE MEDICINES or MEDICAL DEVICES

SAFETY CONCERNS e.g. e-cigarettes or their refill containers (e-liquids)

     1. NEW DRUG/BLACK TRIANGLE DRUG (drug still under intensive surveillance) ADRs
2. CHILDREN ADRs (mostly off licence)
3. SERIOUS ADRs for ESTABLISHED DRUGS & VACCINES e.g. fatal, life-threatening, disabling, incapacitating, result in or prolong hospitalisation, significant harm

Include: side effects, info of pt. experiencing side-effect, name of medication though to cause side-effect, your name + full address (contact for further info)

Question 4

Medicine Legal Categories (Human Medicines Regulations 2012)

Answer 4

PRESCIPTION ONLY MEDICINES = Written by appropriate practitioner before sold/supplied

• DOCTOR, DENTIST, SUPPLEMENTARY PRESCRIBER, NURSER INDEPENDENT PRESCRIBER, PHARMACIST INDEPENDENT PRESCRIBER

LIMITED = EEA & SWISS DOCTORS & DENTISTS, COMMUNITY PRACTITIONER NURSERS, OPTOMETRIST INDEPENDENT PRESCRIBERS

OVER THE COUNTER: PHARMACY, GENERAL SALES LIST

• PHARMACY (P) MEDICINES = registered pharmacy premised by pharmacist/person under pharmacist supervision; not for public self-selection; additional legal/professional considerations
• GENERAL SALES LIST (GSL) MEDICINES = registered pharmacies + retail outlets

Question 5

Licensed + unlicensed drugs

Answer 5

licensed drug = marketing authorisaiton granted for indication prescribed for

unlicensed drug = no marketing authorisation

off-label = licensed but prescribed outw/ terms of marketing authorisation

specials = special formulations made for clinical reasons for a pt. when existing licensed formulation are unsuitable