Medicines for Human Use and Legislation
Home > Flashcards > Print Preview
The flashcards below were created by user
on FreezingBlue Flashcards. What would you like to do?
Adverse drug reactions
Study of how drugs should be administered and what their clinical effects should be a result of their use
- International Non-propreitary Name, also known as the Non-proprietary Name (NPN).
- A drug's "common" name.
- AKA proprietary name.
- Identified by a superscript R (registered name) or TM (trademark).
- Pharmaceutical company usually allowed a time-limited monopoly on the use of name and supply of the drug.
- e.g. BrufenR, AdvilR
- Non-proprietary/non-branded product.
- Can be marketed when the patent (period) expires for a branded product or if a new product is marketed that contains an ingredient that is not covered by a patent.
- Uses either common name or common name with prefix or suffix to distinguish the company producing the generic line of products.
- e.g. Ibruprofen or Apo-ibuprofen
- Original brand product is still being marketed at the time the generic product is being marketed.
- e.g. AnadinR Extra or AnadinR Ibuprofen
Exceptions to INN rule: paracetamol
- paracetamonl vs acetaminophen (both INNs)
- UK paracetamol (e.g. PanadolR) vs acetaminophen USA and Canada (e.g. TylenolR)
Exceptions to INN rule: epinephrine
- epinephrine vs adrenaline
- USA and Canada epinephrine vs UK and Australia adrenaline (BAN - British Approved Name)
- e.g. EpiPenR
British Approved Name (e.g. adrenaline instead of epinephrine)
Exceptions to INN rule: seratonin
- seratonin vs 5-hydroxytryptamine
- seratonin used in the naming of drugs (e.g. SSRI's), 5-hydroxytryptamine used for designating the mechanism of action of the drug (e.g. 5-HT1 sites for some anti-migraine drugs, of 5-HT3 sites for some anti-migraine drugs)
Specific seratonin re-uptake inhibitors
Another reason for two names for a drug
- Desire to avoid errors in naming
- To make the spelling simpler
- Can take a while for all sources to recognise a recommended name
- Older texts will still have older common name
- e.g. allergy drug chlorpheniramine renamed chlorphenamine (INN or new BAN)
- e.g. antiviral drug acyclovir renamed aciclovir (INN)
- e.g. anti-allergy drug sodium cromoglycate renamed sodium cromoglicate (INN)
Monoamine oxidase inhibitor (inhibits enzyme that's involved in the way epinephrine works)
Carbonic anhydrase inhibitor
Angiotensin converting enzyme inhibitors
Non-steroidal anti-inflammatory drug
A class of anti-hypocholesterolaemia drugs (e.g. pravastatin and simvastatin)
Gamma aminobutyric acid
5-hydroxytryptamine (also known as seratonin)
AcChE or AChE
Acetylcholin esterase (metabolizes acetylcholine)
Cholinesterase (metabolizes acetylcholine)
- Drugs for medicinal use administered in the form of pharmaceuticals
- Some drugs available as specially formulated products for human use (AKA designated products), e.g. new experimental drugs.
- Optimize drug delivery
- Minimize chance of side effects
- Obtained by the public by a defined process
- Allows to distinguish between medicines and chemicals used illegally for 'medicinal' or recreational purposes
- Changes in content of medicine may be required by legislation (e.g. a drug can be withdrawn from use or its concentration changed for a different use)
What are the MHRA and DTI responsible for?
- Medicines and Healthcare Products Regulatory Agency and the Department of Trade and Industry
- Responsible for products outwith the Medicines Act and the definition of products approved for human use
- Prescription only Medicines
- Needs a doctor's prescription
- 'Filled' by a pharmacist
- Optometrists can access and use some PoM's (e.g. eyedrops) with having to write a prescription
- e.g. EpiPenR
- Pharmacy Medicines
- Direct sale to px under supervision of their acces (e.g. within a pharmacy)
- Optometrists can supervise a supply of certain P medicines (e.g. eyedrops) to pxs
- e.g. eye drop chloramphenicol for conjunctivitis
- General Sales List or Sales List
- Over-the counter (OTC) medicinal or non-medicinal products
- Available from chemists, pharmacies and supermarkets
- e.g. ibuprofen
- Intermediate category between P meds and GSL where large pack size/conc. is P med, smaller pack/conc. is GSL
Other products for human use
- 'General products' or 'unlicenced products'
- Carry a desgination of maufacturing quality (e.g. e-labelled - approved by European legislations)
- 'Alternative medicines' or herbal remedies, e.g. St John's Wort, access is unrestricted
- Nutritional supplements, includingh vitamins
- SL items marketed as products to support a 'medical device' (MD), e.g. products for cleaning or re-wetting a contact lens
- e.g. Monthly Index of Medical Specialities (MIMS) and the British National Formulary (BNF) (a bi-annual)
- Reliable soure of information on pharmaceuticals and products (and drugs they contain)
- Reflect the information the manufacturers provide
- Includes details of the contents of the pharmaceuticals or products and instructions for their use
Monthly Index of Medical Specialities
British National Formulary
What would you like to do?
Home > Flashcards > Print Preview