medication legislation Flashcards

1
Q

what is the medicines act 1968

A

governs the control of medicines for human and animal use - includes manufacture and supply

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2
Q

what is the human medicines regulations 2012

A

the main UK legislation for drugs made under the European communities act 1972 and medicines act 1968

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3
Q

what is the misuse of drugs act 1971

A

purpose is to prevent the misuse of controlled drugs by imposing a ban on possession, supply, manufacture, import and export of controlled drugs

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4
Q

what is the misuse of drugs regulations 2001

A

lawful possession an supply of controlled drugs for legitimate purpose

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5
Q

what does the misuse of drugs regulations 2001 cover

A
  • prescribing
  • administering
  • safe custody
  • dispensing
  • record keeping
  • destruction and disposal
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6
Q

what do the medicines and healthcare products regulatory agency (MHRA) do

A

responsible for making sure that the legislation fits with what we as healthcare professionals are going to do

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7
Q

what are some key areas that the MHRA govern over

A
  • safety standards are met
  • supply chain is safe and secure
  • international standardisation
  • educate public and healthcare about medicine risks and benefits
  • innovation
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8
Q

which are the legislations that control the supply and administration of medicines

A
  • medicines act 1968
  • misuse of drugs regulations 2001
  • human medicines regulations 2012
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9
Q

what are non-parental medications

A

drugs that are given by someone else

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10
Q

what are examples of non-parental medications

A

oral, rectal, topical and nebulised

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11
Q

what is the law around non-parental medication administration

A
  • no specific law on who can administer
  • NHS can give specific groups the ability to administer them
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12
Q

what are general sales medicines (GSL)

A

medicines that licencing authority has decided should be on general sale

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13
Q

what are pharmacy medicines (P)

A
  • category for medicines that are not prescription only or general sales
  • can be sold with out prescription but only under pharmacist supervision
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14
Q

what are prescription only medicines (POM)

A
  • only prescription from a prescriber
  • cannot administer POM parentally unless exempt (breaching skin or mucous membrane)
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15
Q

what are schedule 1 controlled drugs

A

no therapeutic value eg opium, ecstasy

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16
Q

what are schedule 2 controlled drugs

A
  • highly addictive
  • strictly controlled
  • morphine
17
Q

what are schedule 3 controlled drugs

A
  • minor stimulants
  • less likely to be abused than 2
  • les strictly controlled but need to be recorded by controlled drug register
18
Q

what are schedule 4 controlled drugs

A
  • exempt from the safe custody regulations
  • benzodiazepines and androgenic steroids
19
Q

what are schedule 5 controlled drugs

A
  • weak schedule 2 drugs
  • present little risk of misuse
  • sold over the counter
20
Q

what methods enable paramedic medication administration

A
  • rights reserved for emergencies
  • PSDs
  • PGDs
  • occupational health schemes
  • legal exemptions
21
Q

what is schedule 19 HMR

A
  • parental medicines anyone can administer for the purpose of saving someone’s life
22
Q

what are the paramedic specific exemptions

A
  • schedule 17 of HMR
  • use for immediate, necessary treatment
  • does not cover GSL or P
23
Q

what are patient specific direction (PSD)

A

written instruction for medicine to be administered to a names individual after a prescriber assessment

24
Q

what information is needed for a PSD

A
  • name of individual
  • name of medication
  • route of administration
  • dose
  • frequency
  • date of treatment
  • signature
25
Q

what is a patient group directive (PGD)

A

written instruction for sale, supply and administration of medication to groups who may not be individuals identifies before presentation for treatment

26
Q

what is the purpose of PGDs

A

healthcare professional legislation to administered medication without need form a prescriber

27
Q

what is the paramedic prescribing legislation

A
  • 1st april 2018
  • registered paramedics can prescribe
  • level 7 education
  • on an advanced practice pathway
28
Q

what is the royal pharmaceutical society prescribing competency framework

A
  • independent prescribers
  • educational and practice requirements
29
Q

what allows paramedics to prescribe controlled drugs

A
  • exemptions from human medicines regulation 2012
  • use of PGDs and PSDs
30
Q

what limits are there to paramedics prescribing controlled drugs

A
  • can’t independently prescribe
  • only do it in accordance with a service users clinical mamangement plan