Medicines Law 2

Legal Categories

Some medicines fall into more than one legal category, depending on:

  • Quantity
  • Formulation
  • Strength
  • Indication (what it is being used for)
  • Marketing authorisation
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Quantity - Specific Products

  • Paracetamol (500mg) or aspirin (<325mg) tablets & capsules:

                               GSL           P            POM

Maximum pack size   16            32           N/A

Maximum no.            100          100         N/A

  • Enteric coated aspirin 75mg tablets: pack size up to 28 GSL, maximum 100 tablets
  • Does not apply to granules, powders, effervescent tablets and liquids
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Quantity - Specific Products

Ibuprofen

  • Medicines and Healthcare Products Regulatory Agency (MHRA) will only permit a maximum of 16 tablets or capsules (200mg only) to be sold as General Sales List (GSL)

Pseudoephedrine and Ephedrine

  • <720mg pseudoephedrine or <180mg ephedrine total in a pack as a pharmacy (P) medicine
  • Cannot be sold together
  • Liable to misuse (making of crystal meth)
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Quantity - Specific Products

Codeine and Dihydrocodeine

  • Maximum pack size 32 (including effervescent)
  • Not less than pharmacy (P) medicine
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Checking the Classification

  • BNF (British National Formulary) - good for checking if POM or not, not good for separating GSL/P
  • EMC (Electronic Medicines Compendium) website
  • MEP (Medicine, Ethics and Practice) website
  • Product pack
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Reclassification of Medicines

A medicines category can change to make it:

A. less restricted, e.g.:

  • ranitidine POM --> P --> GSL
  • chloramphenicol eye drops POM --> P
  • domperidone POM --> P (2010)
  • diclofenac POM --> P --> GSL

 

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Reclassification of Medicines

B. more restricted, e.g.:

  • domperidone P --> POM (2014)
  • diclofenac GSL --> POM (2014)
  • children's cough & cold medicines GSL --> P 

A change in category is often associated with limitations on pack size/dose/indication.

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Medical Devices

An instrument, apparatus, appliance, material or other article which-

a) is intended to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease or injury
  • investigation, replacement or modification of the body, or
  • control of conception; and

b) does not achieve its main action by pharmacological, immunological or metabolic means (even if those means help)

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Medical Devices

  • Includes devices intended to administer a medicine
  • Medical devices without a CE mark cannot be marketed in Europe
  • The CE mark shows that the device meets the regulatory requirements, i.e. it is safe and works properly
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Herbal Products

  • If marketed as food/cosmetic - does not have to comply with medicines law, so no medicinal claims allowed
  • If marketed as medicinal product - must comply with law, including having a Marketing Authorisation
  • If marketed as traditional herbal medicine - must comply with law, but does not have a Marketing Authorisation so cannot make claims about efficacy (no clinical trials carried out) e.g. St. John's work, echinacea. These will have a THR number (Traditional Herbal Registration)

Some herbal products have been banned in UK, e.g.:

  • Aristolochia (Mu Tong)
  • Kava Kava
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Homeopathic Products

  • Not the same as herbal products
  • Contain no active ingredient
  • Homeopaths believe that 'like cures like' and that repeated dilution of the compound believed to cause the symptoms, to a point where there is no substance left, will treat the patient. They think the more dilute the product, the stronger it is.
  • To register a homeopathic medicine, it is necessary to prove only safety and quality, not efficacy
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Homeopathic Products

'The Royal Pharmaceutical Society (RPS) does not endorse homeopathy as a form of treatment because there is no scientific basis for homeopathy nor any evidence to support the clinical efficacy or homeopathic products beyond a placebo effect.'

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The Responsible Pharmacist

 

  • Every pharmacy must have a 'Responsible Pharmacist' who is legally responsible for the safe and effective running of that pharmacy.
  • The owner of the pharmacy must appoint the Responsible Pharmacist
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The Responsible Pharmacist's Responsibilities

  • Check procedures are in place that support the safe and effective running of the pharmacy
  • Complete the pharmacy record to show who was the Responsible Pharmacist at any given time
  • Display a notice with their name and registration number, and stating that they are in charge of the pharmacy
  • There can only be one Responsible Pharmacist at any given time
  • A pharmacist can only be responsible for one pharmacy at a time
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The Pharmacy Record

  • Must be kept for 5 years after last entry (if paper) or indefinitely (if electronic)
  • Required information: date, full name, GPhC number, sign in time, sign out time, time of leaving/returning (if applicable)
  • Good practice to include: total time absent, reason for absence 
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Responsible Pharmacist Absence

  • It is legally acceptable for a pharmacy to operate (in a limited capacity) while the Responsible Pharmacist is not physically on the premises, providing:
    • they remain contactable (if this is impossible, they must arrange for another pharmacist to be available to give advice)
    • the pharmacy can continue to run safely and effectively (e.g. there are adequate Standard Operating Procedures (SOPs) in place)
    • they are able to return with reasonable promptness if necessary
  • The Responsible Pharmacist can be absent for a total maximum of 2 hours in a 24 hour period
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Responsible Pharmacist Absence

  • The Responsible Pharmacist remains responsible for the activities undertaken when he or she is absent.
  • With the prior permission of the absent Responsible Pharmacist, staff may sell GSL medicines and take prescriptions in from patients.
  • Staff may also assemble medicines if competent and capable - Standard Operating Procedures (SOPs) must be in place.
  • Staff cannot sell P medicines or hand out pre-bagged or checked prescriptions unless a second pharmacist is there. This includes prescriptions for GSL medicines.
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