Medicines for Human Use and Legislation

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.
• 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. Brufen^R, Advil^R

• 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. Anadin^R Extra or Anadin^R Ibuprofen

• paracetamonl vs acetaminophen (both INNs)
• UK paracetamol (e.g. Panadol^R) vs acetaminophen USA and Canada (e.g. Tylenol^R)

• epinephrine vs adrenaline
• USA and Canada epinephrine vs UK and Australia adrenaline (BAN - British Approved Name)
• e.g. EpiPen^R

British Approved Name (e.g. adrenaline instead of epinephrine)

• 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

• 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)

Tricyclic antidepressants

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)

Acetylcholine (neurotransmitter)

Gamma aminobutyric acid

5-hydroxytryptamine (also known as seratonin)

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)

• 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. EpiPen^R

• 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

• '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