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WEEK 2 - LEGISLATION > LEGISLATION > Flashcards

LEGISLATION Flashcards

1
Q

Purpose of legislation?

A

Protect the public by ensuring the medication meet the standard of:
-quality
-efficacy
-safety

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2
Q

Legislation available? 6

A

-Medicine act 1968
-misuse of drugs act 1971
-misuse of drug regulation 2001
-the poison act 1972
-human medicines regulation 2012
-unlicensed medicines amendments 2009

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3
Q

Human medicine regulation 2012? 7

A

Set of legislation that regulate:
-manufacturer and wholesale
-marketing authorisation
-packaging/advertising
-homeopathic
-herbal
-pharmacopoeia
-pharmacovigilance

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4
Q

Who releases Marketing authorisation?

A

MHRA

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5
Q

What describes marketing authorisation?

A

Summary characteristic of product (SPc)

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6
Q

What SPC includes? 10

A

-name
-presentation
-use
-dose
-contraindication/precaution/warning
-side effect
-interaction
-packaging
-legal category
-PL number

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7
Q

Type of unlicensed medication?4

A

-Special
-Import
-extemporaneous preparation
-drug in development

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8
Q

Special medication definition?

A

Medication manufactured to meet special needs where no licensed suitable alternative is available. In also includes mixing two licensed medication together

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9
Q

Import medication definition?

A

Medication imported to meet special needs where no licensed suitable alternative is available

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10
Q

Extemporaneous medication

A

Medication prepared in the pharmacy under pharmacist supervision

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11
Q

Off label medication definition?

A

Medication used outside the licensed indication described on SPc

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12
Q

Risk associated with unlicensed medication? 3

A

-ADR
-quality of the product
-discrepancy on product information or labelling

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13
Q

Advise to prescribes when prescribing unlicensed medication? 4

A

-be satisfied the medication meet special need where no licensed suitable alternative is available
-take responsibility of prescribing, monitoring, follow up
-be satisfied unlicensed medication is selected according to best clinical experience that guarantees safety and efficacy
-record reason for prescribing the unlicensed medication

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14
Q

Who can prescribe unlicensed medication?

A

Dr, dentist, NMP (pharmacist, nurse), supplementary prescriber

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15
Q

Who can prescribe off label medication?

A

Dr, dentist, NMP (pharmacist, nurse and optometrist), SP

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16
Q

Who can mix drugs together?

A

Dr, dentist, NMP (pharmacist, nurse), SP

17
Q

When prescribing unlicensed/off label medication, prescribers are responsible for? 3

A

-their clinical competence
-professional code of ethics
-prescribing policies of their employers

18
Q

Misuse of drugs regulation 2001?

A

Regulate the Sale, supply, possession of drugs subject to misuse

19
Q

Body regulating Drug of misuse?

A

Home Office

20
Q

Who can possess CD?

A

-PT
-who holds home office license
-special category outlined on regulation

21
Q

Independent prescribing definition?

A

Prescribing by a practitioner responsible of assessment of pt with diagnosed or undiagnosed condition, and the decision of clinical management including prescribing.

22
Q

What is the Independent prescriber responsible when prescribing ? 4

A

-assess pt
-interpret the assessment
-decision on appropriate therapy
-ongoing monitoring and follow up

23
Q

Supplementary prescriber definition?

A

A voluntary partnership between the prescriber (Dr, dentist) and supplementary prescriber to implement a CMP with the pt agreement

24
Q

Criteria for CMP to be valid? 3

A

-The IP just be a Dr
-the SP must be qualified and registered
-the pt should agree for their care to be transferred to the SP care

25
Q

Clinical Management plan definition?

A

It is a plan of care related to a specific pt for a specific condition, managed by the SP

26
Q

CMP requirement? 3

A

-be individualised
-must be part of pt records
-each condition/medication included with in the CMP

27
Q

CMP infos included? 10

A

-Pt’s name
-condition treated
-medication prescribed
-guidelines to support the CMP
-when to refer to IP
-frequency of SP review
-outline warning/sensitivities and allergy
-how to report ADR
-dad are of start and IP review date

28
Q

CDAO GOALS? 4

A

-ensure safe use of CD
-ensure appropriate training
-ensure appropriate destruction
-ensure monitoring and auditing

29
Q

PGD definition?

A

Are written direction that enables HCP to supply or administer a POM.

30
Q

PGD requirement? 4

A

-pt falls within the group of pt who needs the treatment
-pt falls in Pt inclusion
-HCP must follow the directions outlined
-written by Dr, signed by pharmacist and approved by an authorising individual within the organisation

31
Q

Emergency supply prescriber? 3

A

-dr cannot prescribe immediately
-dr will write an originale Rx within 72h
-pt will follow doctor direction

32
Q

Emergency supply patient? 4

A

-pharmacist must interview the pt
-pt already had the medication
-pt charged privately
-no more 30 days supply

WEEK 2 - LEGISLATION (8 decks)

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