Medicines and the law/prescription writing and signed orders Flashcards

1
Q

when was the medicines act published

A

1968

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2
Q

what does the medicines act 1968 define

A

three legal categories of medicine

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3
Q

what are the three legal categories of medicine that the medicines act 1968 defines

A
  • general sales list medicines (GSL)
  • pharmacy medicines (P)
  • prescription only medicines (POM)
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4
Q

what 2 things does the medicines act 1968 define about the general sales list GSL

A
  • GSL medicines can be sold by a wide range of shops, such as news agents and supermarkets
  • often only a small pack size or low strength of the medicine may be sold
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5
Q

what does the medicines act 1968 state about the pack size of general sales list medicines of paracetamol in shops

A

the largest pack size of paracetamol that shops can sell is 16 tablets

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6
Q

what does the medicines act 1968 state about the pack size of general sales list medicines of paracetamol in pharmacies

A

the largest pack size of paracetamol that pharmacies can sell is 32 tablets

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7
Q

what does the medicines act 1968 state about the strength of general sales list medicines of ibuprofen in shops

A

the highest strength of ibuprofen tablets that shops can sell is 200mg

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8
Q

what does the medicines act 1968 state about the strength of general sales list medicines of ibuprofen in pharmacies

A

the highest strength of ibuprofen tablets that shops can sell is 400mg

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9
Q

what 2 things does the medicines act 1968 state about pharmacy medicines P

A
  • pharmacy medicines can only be sold from pharmacies and a pharmacist must make or supervise the sale (so pharmacists can intervene if necessary)
  • pharmacists may ask patients if they have any medical conditions or take any other medications, to check that it is safe to take the medicine
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10
Q

as part of the medicines act 1968 on pharmacy medicines P, what may a pharmacist ask patients and why

A

if they have any medical conditions or take any other medications
to check that it is safe to take the medicine

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11
Q

who were the only 2 groups or people allowed to prescribe when the medicines act 1968 was published?
and who else is also now allowed to legally prescribe since then?

A
  • doctors and dentists
  • now several professions can legally prescribe supplementary or independent prescribers including: nurses, pharmacists, pediatrists, physiotherapists etc
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12
Q

what does the medicines act 1968 state about prescription only medicines

A

prescription only medicines cannot be without a prescription from an appropriate prescriber

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13
Q

what are some prescription only medicines classed as, and name 3 examples

A

classed as controlled drugs such as:

morphine, pethidine and methadone

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14
Q

what applies to class controlled prescription only medicines

A

stricter legal controls

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15
Q

when did the human medicines regulations come into force and what did it replace

A

on 14th august 2012 - medicines for human use in the UK

this replaced the medicines act 1968 and subsequent medicines legislation

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16
Q

what was the human medicines regulations 2012 the result of

A

the initiative by the medicines and healthcare products regulatory agency (MHRA) to consolidate and view UK medicines legislation

17
Q

what 2 things does the human medicines regulations 2012 replace

A
  • most of the medicines act 1968

- around 200 statutory instruments in the process

18
Q

what exemptions is now defined within the human medicines regulations 2012

A

exemptions from the general rules laid down in he medicines act for optometrists

19
Q

what is the 2 exemptions that are now defined within the human medicines regulations 2012 for optometrists which were previously laid down in the medicines act 1968 for optometrists

A

provided it is in the course of their professional practice, registered optometrists may sell or supply the following medicinal products to a patient:

  • all medicinal products on the general sales list GLS
  • all P medicines

provided it is in the course of their professional practice and an EMERGENCY, registered optometrists may sell or supply the following POMs:

  • 0.5% chloramphenicol eye drops or 1% eye ointment
  • cyclopentolate hydrochloride
  • fusidic acid
  • tropicamide
20
Q

how is an emergency defined in the humans medicines regulations 2012 act and how must it be acted upon by optometrists

A

there is no legal definition of what is an emergency, so the optom has to make a judgement that there is infact an emergency needed and is in the best interest of the patient

21
Q

which optometrists can sell, supply or write an order for an extended range of medicines
give some examples of medicines

A

the optometrists who have undergone additional training and are accredited by the general optical council (‘additional supply optometrists’)

  • topical antihistamines
  • mast cell stabilisers
  • NSAIDS
  • mucolytic drugs such as: acetyl cysteine
  • atropine
  • pilocarpine
22
Q

what is required and what is included in the additional supply ‘The medicines regulations SI 2005 No, 1520

4 points

A
  • further training required
  • specialist CET for continued accreditation required
  • includes drugs previously designated ‘entry level’
  • includes a number of anti-histamines, mast cell stabilisers and the NSAID diclofenic sodium
23
Q

what 7 things should a signed POM order include

A
  • optometrist’s name and address
  • date
  • name and address of the patient (if applicable)
  • name of the drug
  • quantity, pharmaceutical form and strength of the POM (e.g. 0.5% eye drops 10ml)
  • labelling directions (where applicable)
  • original signature of the optometrist
24
Q

what form of ink must the signed POM order be in

A

indelible ink; this includes typewritten and computer-generated orders i.e. computer generated orders must include the original signature

25
Q

what does the college of optometrists guidance also recommended about signed POM orders

A

that the optometrist’s signature and GOC number should also be included

26
Q

list 4 POM medications for administration (as opposed to sale or supply) containing the following substances that are part of the medicines act exemptions

A
  • amethocaine hydrochloride (tetracaine)
  • lignocaine hydrochloride (lidocaine)
  • oxybuprocaine hydrochloride (benoxinate)
  • proxymetacaine hydrochloride
27
Q

how should a prescription for a medicine be written and what information should it contain

A

should be written legibly in ink or computer generated and should contain the following information:

  • date
  • name and address of the patient
  • patients age and DOB (a legal requirement in under 12’s)
  • name of the drug, dose and number of days of treatment required
  • prescribers signature
28
Q

what is a legal requirement when writing a prescription for a medicine for someone ages under 12

A

the patients age and DOB

29
Q

what must happen before a medicine can be used in the uk

A

it must first be granted a licence

30
Q

what does a licence that must be issued before a medicine can be used in the uk indicate

A

that all proper checks have been carried out and the benefits of the medicine are believed to outweigh the risks

31
Q

what is a licence that is issued before a medicine can be used in the uk also known as

A

a marketing authorisation

32
Q

name 2 ways a that licences for medicine can be granted in the uk

A
  • the MHRA which can grant licences for medicines only in the UK
  • the European medicines agency (EMEA) which can grant licences for medicines in the European union (EU)
33
Q

list 4 pieces of information that the licence for a medicine includes

A
  • what health condition the medicine should be used to treat
  • the dose, form and who can use the medicine e.g. age restrictions
  • how long treatment with the medicine should last
  • warnings about known safety issues, such as side effects and interactions with other medicines