Medicines for Human Use and Legislation

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106877
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Medicines for Human Use and Legislation
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2011-10-06 09:58:50
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Medicines
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  1. ADRs
    Adverse drug reactions
  2. Clinical pharmacology
    Study of how drugs should be administered and what their clinical effects should be a result of their use
  3. INN
    • International Non-propreitary Name, also known as the Non-proprietary Name (NPN).
    • A drug's "common" name.
  4. Brand name
    • AKA proprietary name.
    • Capitalized.
    • 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
  5. Generic
    • 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
  6. Brand line
    • Original brand product is still being marketed at the time the generic product is being marketed.
    • e.g. AnadinR Extra or AnadinR Ibuprofen
  7. Exceptions to INN rule: paracetamol
    • paracetamonl vs acetaminophen (both INNs)
    • UK paracetamol (e.g. PanadolR) vs acetaminophen USA and Canada (e.g. TylenolR)
  8. Exceptions to INN rule: epinephrine
    • epinephrine vs adrenaline
    • USA and Canada epinephrine vs UK and Australia adrenaline (BAN - British Approved Name)
    • e.g. EpiPenR
  9. BAN
    British Approved Name (e.g. adrenaline instead of epinephrine)
  10. 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)
  11. SSRI's
    Specific seratonin re-uptake inhibitors
  12. 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)
  13. TCADs
    Tricyclic antidepressants
  14. MAOI
    Monoamine oxidase inhibitor (inhibits enzyme that's involved in the way epinephrine works)
  15. CAI
    Carbonic anhydrase inhibitor
  16. ACE inhibitors
    Angiotensin converting enzyme inhibitors
  17. NSAID
    Non-steroidal anti-inflammatory drug
  18. 'Statins'
    A class of anti-hypocholesterolaemia drugs (e.g. pravastatin and simvastatin)
  19. ACh
    Acetylcholine (neurotransmitter)
  20. GABA
    Gamma aminobutyric acid
  21. 5-HT
    5-hydroxytryptamine (also known as seratonin)
  22. AcChE or AChE
    Acetylcholin esterase (metabolizes acetylcholine)
  23. ChE
    Cholinesterase (metabolizes acetylcholine)
  24. Medicines Act
    • 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)
  25. 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
  26. PoM's
    • 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
  27. P Medicines
    • 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
  28. GSl
    • 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
  29. 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
  30. Pharmaceutical Directories
    • 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
  31. MIMS
    Monthly Index of Medical Specialities
  32. BNF
    British National Formulary

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