LEGISLATION

Question 1

Purpose of legislation?

Answer 1

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

Question 2

Legislation available? 6

Answer 2

-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

Question 3

Human medicine regulation 2012? 7

Answer 3

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

Question 4

Who releases Marketing authorisation?

Answer 4

MHRA

Question 5

What describes marketing authorisation?

Answer 5

Summary characteristic of product (SPc)

Question 6

What SPC includes? 10

Answer 6

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

Question 7

Type of unlicensed medication?4

Answer 7

-Special
-Import
-extemporaneous preparation
-drug in development

Question 8

Special medication definition?

Answer 8

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

Question 9

Import medication definition?

Answer 9

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

Question 10

Extemporaneous medication

Answer 10

Medication prepared in the pharmacy under pharmacist supervision

Question 11

Off label medication definition?

Answer 11

Medication used outside the licensed indication described on SPc

Question 12

Risk associated with unlicensed medication? 3

Answer 12

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

Question 13

Advise to prescribes when prescribing unlicensed medication? 4

Answer 13

-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

Question 14

Who can prescribe unlicensed medication?

Answer 14

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

Question 15

Who can prescribe off label medication?

Answer 15

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

Question 16

Who can mix drugs together?

Answer 16

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

Question 17

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

Answer 17

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

Question 18

Misuse of drugs regulation 2001?

Answer 18

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

Question 19

Body regulating Drug of misuse?

Answer 19

Home Office

Question 20

Who can possess CD?

Answer 20

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

Question 21

Independent prescribing definition?

Answer 21

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

Question 22

What is the Independent prescriber responsible when prescribing ? 4

Answer 22

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

Question 23

Supplementary prescriber definition?

Answer 23

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

Question 24

Criteria for CMP to be valid? 3

Answer 24

-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

Question 25

Clinical Management plan definition?

Answer 25

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

Question 26

CMP requirement? 3

Answer 26

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

Question 27

CMP infos included? 10

Answer 27

-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

Question 28

CDAO GOALS? 4

Answer 28

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

Question 29

PGD definition?

Answer 29

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

Question 30

PGD requirement? 4

Answer 30

-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

Question 31

Emergency supply prescriber? 3

Answer 31

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

Question 32

Emergency supply patient? 4

Answer 32

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