Medicines for Human Use and Legislation
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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
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