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Sem 2 year 2 > The Pharmacist > Flashcards

The Pharmacist Flashcards

1
Q

What kind of deaths does the HM coroner investigate?

A

Unnatural or unexpected
Cause of death unknown
In state detention (e.g.prison)

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2
Q

Which deaths are reported to the coroner?

A

The deceased was not seen by a doctor during their final illness
Death certificate unavailable
The death certificate cannot be signed by the doctor declaring death within 14 days
Occurred during surgery or before emerging from anaesthetic
Occurred from industrial disease or poisoning
Sudden, unexplained, violent or due to neglect, suspicious or occurred in police custody or prison

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3
Q

What is the coroners primary mode of investigation?

A

The inquest

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4
Q

Who is present at the inquest?

A 
Coroner
Interested parties
Media
General witness
Police witness
Coroners assistant
Family members
Expert witnesses
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5
Q

What happens is during an inquest if evidence emerges that a crime has been committed?

A

Stop the inquest until after criminal proceedings are complete

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6
Q

Does the coroner issue verdicts?

A 
No, issues conclusions:
Natural causes
Drug dependant 
Attempted or self-induced abortion
Accident or misadventure
Disaster subject to public enquiry  
Self neglect
Suicide
Unlawful killing
Lawful killing
Industrial disease
Open
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7
Q

What must you do if you get a Rule 43 letter?

A

Act upon it immediately

Respond in writing

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8
Q

When can a civil litigation (law suit) occur?

A

After the inquest has concluded

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9
Q

Are coroners courts open to the public?

A

Yes the public and media can attend

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10
Q

What is the Bolam/Bolitho test?

A

Standard against which one is judged is that of ones own peers
But cannot defend a case on the basis of a current practice

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11
Q

Why was the responsible pharmacist legislation needed?

A

So pharmacists could persue a greater clinical role in the pharmacy, in same location adjacent to the pharmacy, elsewhere

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12
Q

How did they bring in the RP legislation?

A

In a phased approach
1st- RP regulations which set quality framework and was largely mandatory
2nd stage hasnt happened yet but will enable supervision changes so free up pharmacists time

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13
Q

What did the Health Act 2006 change regarding the RP?

A

Changes to control and supervision
Replaced ‘personal control’ with ‘responsible pharmacist’
Sets out statutory duty of the responsible pharmacist to secure safe and effective running of the pharmacy
Enables ministers to make regulations (the details)

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14
Q

When did the Medicines Regulations (RP) 2008 come into force?

A

1st October 2009

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15
Q

Which pharmacies have to have a RP?

A

All pharmacies registered with the GPhC

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16
Q

Who can be the RP?

A

The person carrying on the business
One of the partners of the business
Another pharmacist
For body corporate - SI/manager or assistant pharmacist subject to directions of SI

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17
Q

How many RP’s can you have?

A

ONE AT ANY ONE TIME

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18
Q

What must be on the RP notice?

A

RP name
RP GPhC registration number
That you are in charge of the pharmacy at that time

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19
Q

What must the RP record?

A

Name and reg number

Date and time they became RP and ceased to be RP

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20
Q

Does the RP record have to be done daily?

A

No - could be signed on monday and then ceased on friday

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21
Q

What must the RP record about their absence from the pharmacy

A

Date
Time commenced
Time of return
Reason not a legal requirement but good practice

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22
Q

How long must the RP record be kept for?

A

5 years

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23
Q

The RP record is contemporaneous - what does this mean?

A

You cant fill it in ahead of time
Daily record
Continuous

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24
Q

Can you alter the RP record?

A

It is like a CD record - must identify who has made alterations

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25
Q

RP are responsible for SOP’s - what do the SOP’s need to cover?

A

Arrangements to secure meds are ordered, stored, prepared, sold, supplied, delivered and disposed of in safe and effective manner
Giving advice on meds to non-pharmacist staff
Identify pharmacy staff competent to undertake specific activities
Record keeping
Arrangements when RP absent
Steps when RP changes
Complaints procedure
Adverse incident procedure
Notifications of changes to procedures to pharmacy staff

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26
Q

When is the RP responsible?

A

Only when pharmacy is in operation so in opening hours or while staff are prepping (but pharmacist may come in later than the staff)

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27
Q

How long can the RP be absent from the pharmacy for?

A

2 hours

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28
Q

If the RP is absent, what must happen?

A

Remain contactable
Able to return with reasonable promptness
If this not possible, another pharmacist must be available for advice (don need to be on premises)

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29
Q

What is ‘supervision’ (RP)

A

Not defined so case law in courts

Where required, a transaction cannot take place without physical presence of pharmacist

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30
Q

What can happen when there is an RP supervising and present?

A

Professional Rx check
Sale/supply of P and POM
Supply PGD
Emergency supply

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31
Q

What can happen when RP supervising but not physically present?

A

Assembly process

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32
Q

What can happen when RP but not requiring supervision?

A

GSL sale

Processing waste stock/patient returns EXCEPT CD’s

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33
Q

What is an RP not required for?

A 
Ordering stock from wholesalers
Receiving stock
Putting away to shelves
Date checking (all excluding CD's)
Accessing PMR
Receiving Rx from patient or surgery
Delivery person giving meds to patient
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34
Q

What did the Pharmacy order aim to change?

A

Establish an independent pharmacy regulator

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35
Q

What are the key principles underpinning statutory professional regulation?

A

Main interest is safety and quality of care for patients
Impartiality - independent regulator
Sustaining, assuring, improving standards and identifying and addressing poor practice or behavior
Not creating unnecessary burdens
Recognise need for system that ensures strength and integrity of UK health professionals, and is flexible and effective

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36
Q

Until 2010. what was the setup of the Royal Pharmaceutical Society

A

General Pharmaceutical Council

Royal Pharmaceutical Society

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37
Q

What are the 5 types of RPS membership?

A 
Member (MRPharmS)
Fellow (FRPharmS)
Associate (ARPharmS)
Pharmaceutical Scientist
Student
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38
Q

What are the 8 parts of the Pharmacy Order?

A 
1 - Preliminary
2- Council and its committees
3- Registered Pharmacies:standards in retail pharmacies
4 - registration
5- Education, training, acquisition of experience and and CPD
6 - fitness to practice
7 - proceedings 
8 - miscellaneous
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39
Q

Who does the GPhC regulate?

A

Pharmacists
Pharmacy technicians
Pharmacy premises
JUST IN GB

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40
Q

What are the general duties of GPhC?

A

Protect, promote and maintain the health, safety and well being of the members of the public by ensuring that registrants and those carrying out a retail pharmacy business adhere to such standards

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41
Q

What are the principal functions of the GPhC?

A

Establish and maintain a register
Set and promote standards
Set reference for fitness to practice
Promote safe and effective practice by registrants
Set standards for education, training, acquisition of experience and CPD necessary
To ensure continued fitness to practice of all registrants

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42
Q

What is the structure of the GPhC? (Who is in it?)

A

14 members including a chairman (Nigel Clarke)
7 lay members, 7 registrant members
Reserved places for at least one member from each country in GB (lives or works there)
Not elected -appointed by Appointments Committee

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43
Q

Who elects the GPhC registrar and Deputy Registrar?

A

The council elect the Registrar

The registrar can then authorise a Deputy Registrar or an employee of the Council to act for a Registrar in any matter

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44
Q

What are the five parts of the GPhC register?

A

1 - Pharmacists
2 - Pharmacy technicians
3 - Premises
4 - Pharmacists who are visiting practitioners
5 - Pharmacy technicians who are visiting practitioners

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45
Q

What are the protected titles under the GPhC?

A

Pharmacists

Pharmacy technicians

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46
Q

In the Pharmacy order, what is a ‘practising’ pharmacist?

A

Anyone acting in the capacity who does any work or gives any advice in relation to the preparation, assembly, dispensing, sale, supply or use of meds, science of med, practice of pharmacy or the provision of healthcare

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47
Q

To be on the Register, the registrar has to be satisfied that:

A

The person is appropriately qualified
Their fitness to practice is not impaired
Meet additional requirements where necessary (relating to education, training, experience)
Prescribed fee has been paid

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48
Q

Which qualifications are recognised as appropriate?

A

UK Mpharm + pre reg year +GPhC or PSNI exam
EEA qualification - EEA national or not
(if not-OSPAP + 12 month pre reg)

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49
Q

What must you provide the GPhC team with for registration?

A 
Application form
Degree/OSPAP certificate copy
Birth certificate copy
Marriage/ civil parternshio certificate copy
Proof of identity copy
Tutor final declaration 
Letter of good standing (OSPAP grads)
Payment form
Certified photo
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50
Q

Currently, which annotations are available?

A

Supplementary prescribers

Independent prescribers

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51
Q

How often do you need to renew GPhC registration?

A

Every year provided fit to practice, meet standards of proficiency and additional requirements (and fee paid)

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52
Q

What are the GPhC pharmacist declarations?

A

Fit to practice
Health declarations
Intent to practice as a pharmacist in GB and that info in application is complete, true and accurate

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53
Q

What are the GPhC MPharm student declarations?

A

Standards for pharmacy professionals

Criminal record declaration

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54
Q

What information is on the GPhC register for pharmacists and technicians?

A 
Title, Surname, forename, postal town
Annotations (pharmacists)
Superintendent (pharmacists)
GPhC reg number
Fitness to practice issues
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55
Q

What information is on the GPhC register for pharmacy premises?

A 
Trading name
Owner
Current address
Subject to notices or conditions/
Internet pharmacy logo (voluntary)
GPhC reg number - if selling online
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56
Q

Who does the GPhC have a requirement to consult?

A

Registrants
Employers of registrants
Professional bodies or organisations representing registrants
Users of services of registrants
Those commissioning or funding the services provided by registrants or at registered pharmacies
Persons carrying on a retail pharmacy business at a registered pharmacy
Those providing, assessing, regulating or funding education and training for registrants or prospective registrant

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57
Q

Is the GPhC Guidance mandatory?

A

No, but you should still follow it (should rather than must)

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58
Q

What must the GPhC set in education?

A

Standards of proficiency for safe and effective practice of pharmacy which it is necessary for a person to achieve in order to be entered in Part 1 or 2 of the Register
Standards that providers of education and training must meet
Any requirements to be satisfied for admission to, and continued participation in, education and training

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59
Q

What does the GPhC accredit?

A 
Courses
Qualifications
Institutions and other providers (tutors)
Premises
(Maintain and publish a list)
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60
Q

What was decided regarding English language competency?

A

Lords Committee report - All health professional regulators should be permitted to ensure the language competency of EEA applicants prior to granting them registration
2015- ALL registrants and applicants have necessary english, order makes provision to introduce language controls for EEA nationals or equivalent
2016 - This law applies to ALL

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61
Q

What powers do the GPhC have in respect of education and training

A

Determine courses for annotations and fitness to practice
Hold assessments for approved qualifications, additional education, training or experience, tutors
Appoint examiners
Lists or premises that are training establishments

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62
Q

Which qualifications does the GPhC recognise?

A

MPharm
OSPAP’s year then normal pre reg
Prescribing programmes leading to annotation
Competency and knowledge based leading to technician registration
They have some say in what goes into meds counter assistant courses

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63
Q

What does the EU directive enable?

A

Once qualified in the UK, can practice anywhere in the EU at the moment

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64
Q

What are the standards for pharmacy professionals?

A 
Professional behaviour
Professional judgement 
Leadership
Professional knowledge and skills
Patient-centred professionalism 
Effective communication
Partnership working
Speaking up about concerns 
Confidentiality and privacy
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65
Q

What are the three parts of the revalidation framework?

A

4 CPD records
Peer discussion
Reflective account

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66
Q

What does the peer discussion in the revalidation framework involve?

A

Speak to someone about their practice and record the benefit it has for the people using their service
GPhC do not ask for details of what was discussed, but may confirm it took place

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67
Q

What does the reflective account in the revalidation framework include?

A

Write a reflective account based of GPhC standards for pharmacy professionals - to demonstrate reflection is happening
They choose standards each year for pharmacists to think about

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68
Q

What is an impairment of fitness to practice?

A 
Misconducts
Deficient professional performance
Adverse physical or mental health
Failure to comply with a reasonable requirement imposed by assessors in connection with carrying out a professional performance assessment 
Conviction of a criminal offence
Fixed penalty
Police caution
Determination by a regulatory body for health and social care profession that FtP impaired
Including in a barred list
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69
Q

What is covered in the threshold criteria for investigations?

A

Conduct, performance
Health
Public interest

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70
Q

How does the GPhC deal with concerns?

A

Concern raised - apply threshold criteria and decide if it needs taking further
Goes to initial inquiries and investigation committees

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71
Q

What does a GPhC complaints investigation include?

A

Speaking to complainant and any witnesses
Speaking to pharmacist
Visiting registered pharmacy premises
May need to get witness statements from patients or other members of public
May formally interview pharmacists, their employees or owners of pharmacies
May seize evidence

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72
Q

What are the 3 statutory committees in the GPhC?

A

Investigating Committee
Fitness to Practice Committee
Appeals Committee

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73
Q

What is the difference between the Investigating committee and FtP committee?

A

FtP committee determines if FtP impaired - investigating committee cannot make a decision on this but can refer

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74
Q

What can the Investigating committee do?

A

Refer to FtP or give a waning that goes on the register, advice to person concerned and any other person involved

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75
Q

If reffered to the FtP committee, what initially has to be done?

A

Registrant has 14 days to give details of employer and organisation
Registrar must notify Secretary of State, employer, organisation

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76
Q

If FtP found to be impaired, may:

A

Give advice to any other person or body involved in investigation of allegation on any issue arising out of, or related to, allegation
Issue a warning (recorded in Register)
Impose conditions for up to 3 years
Suspend from practicing for up to 12 months
Remove from register

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77
Q

If FtP impaired due to adverse physical or mental health, what can the FtP committee NOT do? What do they do instead?

A

Register removal

Instead - give warning or direction

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78
Q

If FtP committee thing criminal proceedings should be considered, what must happen?

A

Notify registrar
Not FtP involvement
Criminal investigation then goes to FtP

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79
Q

How long do registrants have to produce records relating to their professional practice, if asked by assessors?

A

14 days otherwise may seek court order

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80
Q

What is an Interim Order?

A

Order that is put in place immediately to protect the public, before FtP committee have come together

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81
Q

What kind of interim orders are there?

A

Interim suspension order - registrant
Order for interim conditional entry - registrant
Interim suspension order - registered premises

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82
Q

How long do interim orders last?

A

18 months

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83
Q

When should interim orders be reviewed?

A

Within 6 months
Further review every 6 months (can request further after min 3 months)
May review if further evidence available.

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84
Q

After an interim order, what may the FtP committee do?

A

Revoke the order
Add to, remove or vary conditions imposed

If satisfied that it is necessary for protection of public or in public interest:
Can replace interim conditional with interim suspension order
Can replace interim suspension with interim conditional order

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85
Q

How long after removal can an application for restoration of name to the register be made?

A

Until at least 5 years after removal

Within 12 months of an earlier application

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86
Q

If conditional restoration of name on the register, how long is this for?

A

Max 3 years

87
Q

If restoration of nae on the register is refused, can FtP direct that no further applications are to be made?

A

Yes

88
Q

What is the appeal process?

A

Appeal to relevent (high) court and council within 28 DAYS
Appeals committee decide outcome:
Dismiss
Allow appeal and quash direction
Change direction
Remit or refer the case to the registrar of FtP committee

89
Q

Does FtP decision come into effects straight away?

A

No UNLESS satisfied that it is necessary for public protection and interests of registrant

Until time within they can make the appeal has passed (28 days)
If appeal made - until date the appeals committee complete decision

90
Q

Under the GPhC Standards for registered pharmacies 2018, what is a ‘pharmacy service’?

A

Pharmacy related service provided at or from a registered pharmacy including the management of medicines, provision of advice and referral, clinical services such as vaccination services and services provided to care homes

91
Q

Under the GPhC Standards for registered pharmacies 2018, who are ‘staff’?

A

includes agency and contract workers, as well as employees and other people who are involved in the provision of pharmacy services by a registered pharmacy.

92
Q

What are the 5 principles of the GPhC Standards for registered pharmacies 2018?

A

1-Governance arrangements
2-Staff are empowered and competent
3-Environment and condition of the premises
4-Way in which pharmacy services are delivered
5- Equipment and facilities

93
Q

What do governance arrangements include?

A

Clear definitions of roles and accountabilities
Arrangements for managing risks
Way registered pharmacy is managed and operated

94
Q

What is the difference between a traditional and distance pharmacy service?

A

Traditional - all parts of the pharmacy service, including the sale and supply of medicines, takes place in the same registered pharmacy

Distance - any of the activities are carried out at a different registered pharmacy or place
Staff or third part providing the service and the patient/person using service are not both in the same registered pharmacy together.

95
Q

Give examples of distance pharmacy services

A 
Prescriptions collected by pharmacy staff/received by post/electronically (EPS)
Delivery service (inc. nursing homes)
Collection and delivery service
'Click and collect' service 
Internet pharmacy (inc. linked to online Rx-ing)
Mail order from registered pharmacy
'Hub and spoke' pharmacy service 
ect...
96
Q

What are the functions of the GPhC inspectors?

A

Enforce standards
Make sure registrants and people carrying out registered pharmacy business comply with the Medicines Act 1968, Poisons Act 1972 and Poisons Rules.
Enforce Article 38 and any other provisions and/or rules under order (not just meds and poisons)
Assist GPhC in INVESTIGATION of FtP matters

97
Q

Are investigations reactive or proactive?

A

Proactive generally - to give advice ect

Reactive if INVESTIGATION

98
Q

What is Article 38 and what does this include?

A

Register Offences
False representation and use of protected title
Practising without being on GPhC register

99
Q

How long does it take for proceedings under Article 38 to begin?

A

within 6 months of sufficient evidence available

100
Q

How many GPhC inspectors are there? How are they divided? How many pharmacies are inspectors responsible for and how many visits do they make per year?

A 
38 inspectors across GB
Split into four regional groups:
Scotland and North of England, 
Wales and West of England, 
South of England, 
East of England

5-7 Primary care organisations each
500-600 registered pharmacy premises
About 200+ visits per year

101
Q

What are the two main roles of the inspectorate?

A

Inspection visits every 5 years to monitor & secure compliance with relevant legal requirements and professional standards

Investigations of complaints and allegations

Advice on compliance issues and liaise with regulatory agencies

102
Q

How often does an inspector visit?

A

At least every 5 years
Inspector may decide more visits are necessary because service at high risk or previous inspections/info indicates more frequent inspections needed

103
Q

What did the New Powers in 2016 and 2018 allow the GPhC to publish?

A

reports of routine inspections, special inspections and other visits to registered pharmacies by inspectors
May include the OUTCOMES of these

104
Q

What do the inspectorate powers of entry include?

A

GPhC inspector has power to enter any registered pharmacy premises at any reasonable hour to conduct an inspection
Must provide evidence of their identity and that they are an authorized GPhC inspector
Don’t need to notify premises but in most cases will give a notification of visit

105
Q

What powers do the inspector have?

A

Inspect premises, plant, machinery, equipment
Search premises
Inspect and remove substance, article or product
Do exams and tests, make enquiries
Require documents and records - copy, retain, require computer access

106
Q

What may an inspector do if they find a pharmacy is not compliant with legal requirements or regulatory standards on an inspection visit?

A

Serve an improvement notice to pharmacist and superintendent (owner) on how to secure compliance

107
Q

What does an improvement notice include?

A

State grounds for why they feel their is failure for compliance
Specify grounds to rectify
Require measures to be taken within a specified period (not <28 days)
State:Right of appeal and period to bring appeal

108
Q

What does an inspector do if a pharmacist/owner does not comply with improvement notices?

A

Fine
Gives notice in writing to registrar
Registrar can then remove registered pharmacy from register of suspend registration
(right of appeal)

109
Q

How will inspectors gather evidence? What approach is this?

A

From owners, superintendent, pharmacists and pharmacy team - and ask them to demonstrate
Look at written or documentary evidence
Observing interaction and talking to patients
Questioning and posing scenarios
Testing systems, processes and procedures
SHOW ME, TELL ME

110
Q

What are the inspection framework labels?

A

Poor
Satisfactory
Good
Excellent

111
Q

Summarise the GPhC inspection process

A

Notification letter 4-6 weeks before (some have no warning)
Responsible pharmacist asked to agree with findings
Summary judgement report sent - pharmacy must check for inaccuracies withing two days
Poor/satisfactory - complete (2 days) and implement improvement action plan Notify GPhC when taken place
Satisfactory+ - no further action required

112
Q

What makes a ‘good’ pharmacy?

A

Consistently good across the standards and demonstrates some positive outcomes for the patients
So can;t be good if it achieves an individual standards

113
Q

What makes a ‘excellent’ pharmacy?

A

meet all standards consistently well

demonstrate innovation in delivery of service with clear positive health outcomes for patients

114
Q

What does The Pharmacy Order 2016-Order of Council 2018 introduce?

A

Gives GPhC powers to publish inspection reports
Gives more powers for those failing standards
Provide greater assurance to patients/public

115
Q

Summarise the new inspection proposals 2018

A

Routine/intelligence led/themed
Unannounced
2 overall inspection outcomes - met or not met standards
Must meet ALL to get standards met
4 possible findings -‘standards not all met’, ‘standards met’, ‘good practice’, ‘excellent practice’
Publishing inspection reports and action plans on a new website
Sharing examples of notable practice

116
Q

What does the North School of Pharmacy and Medicines Optimisation aim to do?

A

Leadership and advice
Support pharmacy workforce development and the multiprofessional workforce
Deliver workforce transformation
Ensure education innovation and transformation
Support pharmacy workforce to lead transformation with other professions
Ensure quality assurance of learning

117
Q

How is the North School of Pharmacy and Medicines Optimisation transforming workforce?

A 
developing future supply
Upskilling staff, carers and volunteers
New roles
New ways of working
Across sectors
118
Q

Does the GPhC recognise the Pharmacy technician qualification?

A

Yes along with relevant work experience (minimum of 2 years for 14hrs/week)

119
Q

Are technicians registered with the GPhC?

A

Yes - pay a fee and have to do CPD

120
Q

Who is the representative body for Pharmacy Technicians?

A

APTUK

121
Q

Approximately, how many Pharmacy Technicians are registered in the UK?

A

25,000

122
Q

What is a Pharmacy assistant?

A

A person who meets the GPhC minimum training requirements (level 2 qualification) for dispensing pharmacy assistants/MCAs

123
Q

Are Pharmacy Assistants a Registered profession?

A

No

124
Q

Following many changes, what role can a Pharmacy Technician NOT carry out?

A

Clinical check

125
Q

What are the exceptions to details needing to be on immediate packaging of MP

A

Blister pack in outer packaging which complies

Packaging too small

126
Q

What additional requirements are needed for products containing paracetamol

A

Contains paracetamol - unless in name
“Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor” - adjacent to directions or dose
Words regarding taking too much - depends on if there is a package leaflet

127
Q

What are the types of manufacteruers licence?

A

Manufacturer Licence (MIA)*
Manufacturer ‘Specials’ Licence (MS)*
Manufacturer licence for investigational medicinal products
Manufacturer licence exempt advanced therapy products (Hospital exemption licence)
Manufacturer licence for non-orthodox practitioners

128
Q

What does a manufacturers license allow holder to do

A

Manufacture and/or assemble licensed medicinal products, including export to a country outside the EEA
Import licensed medicinal products from countries outside the EEA

129
Q

What does a manufacturers specials license allow holder to do

A

Manufacture unlicensed medicines ‘specials’

Import unlicensed medicinal products from outside the EEA

130
Q

Who can order a special?

A

to a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber; or
for use under the supervision of a pharmacist in
a registered pharmacy
a hospital or a health centre

131
Q

Can a Rx’er request a ‘special’ if an equivalent licensed product exists?

A

No

132
Q

What does a Manufacturer licence for investigational medicinal products allow

A

Manufacture investigational medicinal products for use in clinical trials

133
Q

What phases is an MIAIMP needed for?

A

1,2,3 `

134
Q

What does a wholesale dealers licence allow?

A

wholesale pharmacy, prescription only, traditional herbal and GSL medicines
import unlicensed medicinal products from countries inside the EEA

135
Q

In general, who do licensing requirements not apply to?

A 
Medicinal products specially prepared for an individual
Products manufactured (or assembled) for holders of authorisations
136
Q

What is a herbal medicinal product?

A

= a medicinal product whose only active ingredients are
herbal substances or
herbal preparations
(or both)

137
Q

What is a herbal substance?

A

a plant or part of a plant, algae, fungi or lichen, or an unprocessed exudate of a plant, defined by the plant part used and the botanical name of the plant, either fresh or dried, but otherwise unprocessed;

138
Q

What is a herbal preparation?

A

a preparation obtained by subjecting herbal substances to processes such as extraction, distillation, expression, fractionation, purification, concentration or fermentation, and includes a comminuted or powdered herbal substance, a tincture, an extract, an essential oil, an expressed juice or a processed exudate;

139
Q

What is a traditional herbal medicinal product?

A

a traditional herbal registration granted by the licensing authority (under these Regulations)

140
Q

What is the difference between a herbal dealer and practitioner

A

Dealer - sell

Practitioners - consultations and recommend

141
Q

Do herbal practitioners need to register with an organisation

A

No they are not regulated

142
Q

What does the medicines order 2001 prohibit?

A

Not permissible to manufacture, import, sell or supply any unlicensed medicine in the UK which contains the named herbal ingredients.

143
Q

What does the medicines for human use order 2002 prohibit?

A

Prohibits the sale, supply and importation of unlicensed medicines containing Kava-kava, except those for external use only.

144
Q

What does the medicines for human use Senecio and misc amendments order 2008 prohibit?

A

Prohibits the sale, supply and importation of any medicinal product consisting of or containing Senecio

145
Q

Which medicines are in part 1 of herbalists restrictions?

A 
Areca
Canadian Hemp
Embelia
Male fern
Strophanthus
146
Q

THMP’s have to prove

A

Safety and Quality

147
Q

What are the three regulatory schemes for homeopathics?

A

Product license of right
Simplified Registration scheme
National rules Scheme

148
Q

Do regulated or reportable substances have more control?

A

Regulated

149
Q

What are the three categories of substance danger?

A

Physiochemical properties
Health effects
Environmental effects

150
Q

What is a denatured alcohol

A

alcohol that has been made unsuitable for drinking by the addition of denaturants

151
Q

What is an alcohol?

A

Alcohol of any description including all liquor mixed with alcohol and all mixtures, compounds or preparations made with alcohol but does not include denatured alcohol

152
Q

What is a Completely denatured alcohol made up of?

A

With every 100 parts by volume of alcohol
Mix 3 parts by volume of isopropyl alcohol,
3 parts by volume of methyl ethyl ketone and
1 gramme of denatonium benzoate.
Can contain:
synthetic organic dyestuff (methyl violet)

153
Q

Who can get a CDA?

A

Anyone including general public

154
Q

What is a industrially denatured alcohol made up of?

A

95% v/v alcohol

5%v/v wood naphtha (methanol)

155
Q

What are Trade Specific Denatured Alcohols?

A

TSDA formulations are types of denatured alcohol approved to meet specific trade needs

156
Q

How much IDA and TSDA can authorised pharmacists obtain?

A

an authorised producer or distributor (wholesaler) in quantities of 20 litres or more, or
In quantities of less than 20 litres from other authorised users, e.g. other pharmacists

157
Q

What must be done upon reciept of an IDA?

A

Record in stock account the amount of denatured alcohol received
Note receipt details on
supplier’s dispatch document and copy you take for own records
Then:
Sign one copy as a receipt and return to your supplier
Place other copy in your records

158
Q

Do you need a authorisation for a supply of IDA for medicinal use?

A

No if prescription or written order

159
Q

How much IDA can be given on a written order?

A

Any quantity

160
Q

Which denatured alcohol can be sold in quantities above 20 litres?

A

CDA only

161
Q

What do surgical spirits contain and what are the controls?

A

Ethanol 89-95%
Methanol 1-5%
No controls as not denatured alcohols
‘for external use only’

162
Q

Are records require for Duty Free Spirits?

A

Yes

163
Q

Is an authorisation required for Isopropyl alcohol

A

No

164
Q

Who can prescribe POM-V

A

Only vets

165
Q

What do POM-V include

A

CD 2 and 3
Products with new active substances
All containing narcotic or psychotropic substances

166
Q

What are POM-VPS

A

Used to prevent or reduce effects of endemic disease in herds, flocks or individual animals
Use = risk but users can be made aware of suitable counter measures

167
Q

What animals are POM-V and POM-VPS used for

A

For food producing animals

168
Q

Who can prescribe POM-VPS

A

Vet

Paharmacist

169
Q

What are NFA-VPS Equivalent to

A

P medicines

170
Q

What are AVM-GSL equivalent too

A

GSL

171
Q

Which small pet animals are allowed to have no MA

A 
Aquarium animals 
Cage birds
Homing pigeons 
Terrarium animals 
Small rodents 
Ferrets 
Rabbits
172
Q

What do records for POM-V and POM-VPS need to include

A 
Name of med
Date of receipt/supply 
Batch number
Quantity 
Name and address of supplier/recipient 
Name and address of prescriber and copy of prescription
173
Q

How long should a veterinary prescription be kept for

A

5 years

174
Q

What is required on a POM-V and POM-VPS CD 2 and 3 prescription

A

‘Prescribed for animal/herd under care of vegetarian’

Specify RCVS Number

175
Q

When can EEA and Swiss veterinarians prescribe for animals in the U.K.

A

If registered with RCVS
Animals under their care
Clinical assessment has been carried out

176
Q

What must be on a POM-V label?

A

Name and address of the animal owner
Name and address of the veterinary practice supplying the medicine
Date of supply
Name, strength and quantity of product
Dosage and directions for use
‘For animal treatment only’
For topical preparations ‘For external use only’.

177
Q

What is the first step of the veterinary cascade?

A

VMP authorised in UK for use in
another animal species or
for a different condition in same species

178
Q

What is the second step of the veterinary cascade?

A

or, if there is no such product (only when exhausted), either:
a UK medicinal product for human use, or
a VMP not authorised in UK but authorised in another EU country for use with any animal species

179
Q

What is the third stage of the veterinary cascade?

A

a medicine prepared extemporaneously (or specifically manufactured), as prescribed
This could be made yourself, vet or a special

180
Q

Who can prescribe under the veterinary cascade?

A

Only vets

181
Q

Who can dispense under the veterinary cascade?

A

SQP

Pharmacist

182
Q

What is is the sensory register?

A

Collects sensory data from the environment
Sources of data: sight, sound, touch, taste, smell

e.g. brans misread

183
Q

What is the working memory?

A

Turns the sensory data into information and makes the decisions based on the information
May use additional information from long term memory
Has limited capacity and is open to interference – interruptions ect

e.g. two task quantities mixed up

184
Q

What is the long term memory?

A

A(relatively) permanent store of information
Content can be used to supplement that of the sensory register and/or working memory

e.g. previous experience suggests sodium valproate labelled as Chrono by default

185
Q

What should noise level be for dispensing?

A

less than 75 dB

186
Q

What lighting should be used for dispemsing?

A

approx. 1,460 lux better than 450 lux

187
Q

What factors should be considered when looking at reasons for dispensing errors?

A

Mental workload
Anxiety
Potential effects
Hazardous attitudes

188
Q

What is included in advertisements for medicinal products?

A

Door-to-door canvassing
Visits by medical sales reps to people qualified to prescribe
Supply of samples
Prescribe with offer of benefit, except where the intrinsic value of such inducements is minimal
Sponsorship of promotional meetings
Sponsorship of scientific congresses

189
Q

When is vetting of advertisements usually requested?

A

A reclassified product

When previous advertising has breached regulations

190
Q

Who handles complaints about advertising

A

MHRA

Self regulatory bodies

191
Q

How long should a license holder keep samples of advertising samples for?

A

Min 3 years

192
Q

How long do MHRA keep records of complaints for?

A

7 years

193
Q

Which classes of medicines can be advertised to the public?

A

P and GSL

194
Q

Which treatments can not be advertised to the public?

A

Cancer treatments
Those containing psychotropic or narcotic substances
For abortion

195
Q

Particulars to be included in advertisements to the public

A 
Name
Common name if one API
Info for correct use
Express and legible invitation to read instructions in leaflet of on label
Traditional herbal registration wording
196
Q

What is the legal basis for the control of medicines advertising?

A

Title VIII of the European Directive 2001/83/EC

Part 14 of the Human Medicines Regulations 2012

197
Q

What is included in the definition of ‘advertisements’ for ‘medicinal products’?

A

activities “designed to promote the prescription, supply, sale or consumption of medicinal products”.
encourage prescription or supply by healthcare professionals and use of medicines by the general public, generally by means of highlighting qualities of the medicine

198
Q

Who handles complaints about advertising?

A

MHRA

199
Q

What quality standards must an advert comply with?

A

Comply with the particulars listed in the summary of product characteristics (SPC);
Encourage the rational use of the product by presenting it objectively and without exaggerating its qualities; and
Not be misleading

200
Q

What information necessary for the correct use of a medicine needs to be included in adverts to the public?

A

The name of the medicinal product.
Common name of the medicinal product if API.
The information necessary for correct use of the medicinal product
An express and legible invitation to read carefully the instructions in the leaflet or on the label.

201
Q

What kind of material is prohibited in adverts to the public?

A

Advertising should not convey the message that it is usual for pregnant women to take medicines
Do not suggest not side effects
Do not represent a case history
Speed of action only when relevant to condition
For a 24-hour relief claim, data must show clinical effect over the 24-hour period. The product should be for once daily dosing but a once daily dosing interval alone is insufficient to support a 24-hour claim.
The MHRA considers that it is not appropriate to refer to any medicine as “essential” in advertising.

202
Q

What kinds of claims should adverts to the public not make?

A

Comparative claims

203
Q

What are the MHRA recommendations with regards to multiple purchase promotions?
Are these legally binding

A

The MHRA discourages companies and retail suppliers of medicines from undertaking any volume-based promotion which includes any products containing analgesics (aspirin, paracetamol and ibuprofen in solid dose and other formulations) that could encourage unnecessary purchases of medicines and put consumer safety at risk
NO NOT LEGALLY BINDING

204
Q

What are the regulations with regard to internet advertising?

A

Internet advertising of medicines is acceptable provided it complies with the Regulations.
The MHRA considers that advertisements for POMs are acceptable only on websites whose nature and content are directed at healthcare professionals.

205
Q

What essential information must Full adverts for PQPS contain?

A

Identification

Uses of the product (including cost)

206
Q

How do abbreviated adverts for PQPS differ?

A

Must contain the essential info but the detailed prescribing information is provided on a specified website rather than in the actual advertisement itself.

207
Q

How many promotional aids can be supplied?

A

300

208
Q

Are any requirements imposed for medicines sales representatives?

A

Training

SPC to all people at time of visit

209
Q

What conditions does the Medicines Act require sale of medicinal products to the public to take place under?

A

Registered premises

By or under supervision of pharmacist

210
Q

What is the definition of a retail sale?

A

Any sale which does not fall within the definition of “wholesale dealing” is a retail sale.

211
Q

When may a representative take over conducting a retail pharmacy business?

A

Dies
Bankrupt
Mental disorder

212
Q

How long can a representative of a pharmacist act for?

A

5 years - death

3 years - other cases

213
Q

What is a body corporate?

A

Association of individuals constituted to acquire collective legal personality

214
Q

What are the requirements for superintendents?

A

Must be a pharmacist
Written statement sent to register - signed by them and behalf of body corporate
Can only act as SI for ONE body corporate

Sem 2 year 2 (9 decks)

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