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Pharmacy Pre-Registration > Appendices MEP > Flashcards

Appendices MEP Flashcards

1
Q

GPhC standards of conducts, ethics and performance Principle 1

A

Make patients your first concern

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2
Q

GPhC standards of conducts, ethics and performance Principle 2

A

Use your professional judgement in the interests of patient and public

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3
Q

GPhC standards of conducts, ethics and performance Principle 3

A

Show respect for others

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4
Q

GPhC standards of conducts, ethics and performance Principle 4

A

Encourage patients and public to participate in decisions about their care

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5
Q

GPhC standards of conducts, ethics and performance Principle 5

A

Develop your professional knowledge and competence

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6
Q

GPhC standards of conducts, ethics and performance Principle 6

A

Be honest and trustworthy

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7
Q

GPhC standards of conducts, ethics and performance Principle 7

A

Take responsibility for own working practices

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8
Q

Responsibility of the registered pharmacy lies with

A

Owners and superintendent if body corporate

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9
Q

Registered Pharmacy principle 1

A

Governance arrangements

safeguard the health, safety and wellbeing of patients and the public

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10
Q

Registered Pharmacy principle 2

A

Saff empowered and competent to

safeguard the health, safety and wellbeing of patients and the public

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11
Q

Registered Pharmacy principle 3

A

Environment and conditions of premises from which pharmacy services are provided and associate premises
safeguard the health, safety and wellbeing of patients and the public

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12
Q

Registered Pharmacy principle 4

A

The way in which the pharmacy services (inlcuding management of meds/med device) are delivered
safeguard the health, safety and wellbeing of patients and the public

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13
Q

Registered Pharmacy principle 5

A

The equipment and facilities used in the provision of pharmacy services
safeguard the health, safety and wellbeing of patients and the public

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14
Q

CPD requirements are

A

Keep a legible record either online (uptodate) or on another computer or hard copy (in format approved with CPD approved logo)
9/year
Keep a record of CPD complies with good practice criteria fro CPD monitoring
Record how CPD has contributed to quality or development of your practice
Submit CPD on request

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15
Q

Showing respect for others means

A

Recognise diversity and respect cultural difference
Treat people politely
No discrimination
If own beliefs prevent - refer
Respect dignity, privacy and for consultation
Consent - use for purpose given
Maintain boundaries especially vulnerable people

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16
Q

Making patients first concern means

A 
Services provided quality and safe
Protect well-being
Promote health
All info to assess - make decision
Refer
Provide meds/services safely
Ensure understand how to use
Keep records
Reviews, Audits, Risk assesments
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17
Q

Professional judgement in the interest of the patients and public means

A 
Best interest patient
Not letting targets, incentives and personal interests influence professional judgement comes under
Use resources available
Challenge colleagues if reason
In emergency provide care, reduce risk
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18
Q

Encourage patients and public to participate in decisions about their care means

A 
They have a right
Communicate effectively - meet their communication needs
Listen and respect choices
Explain options - risks benefits for informed decision
Respect right to refuse
Info appropriately shared
encourage to adhere
incapacitated - legal requirements
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19
Q

Develop professional knowledge and comepetence means

A

up to date, relevant knowledge and skills
Recognise own limits and areas of competence
maintain improve knowledge and skill
Apply knowledge and skill in practice
Learn from assessments, appraisals, reviews - take further education/training if need
Keep up to date evidence for CPD

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20
Q

Be honest and trustworthy means

A 
Act that way for public trust/confidence
No abuse/exploiting
avoid conflict of interest - no gifts/hospitality
accuracy impartiality in info given
Meet standards
Comply with requirments
Keep to commitments
Responds honestly, openly, politely to complaint/criticism
Tell GPhC/employer any FtP
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21
Q

Take responsibility for working practices means

A

Practice if fit
communication skills to communicate to colleagues
develop, educate and share knowledge, skills, expertise
take responsibility, delegate, train
define who responsible for what
SOP followed
workload safe
don’t prevent others from keeping to their duty
have professional indemnity cover
effective complaints procedure and followed
Tell relevant authority of problems. Deal with reports properly
Cooperate with investigations

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22
Q

Governance arrangement’s standards cover

A 
Identifying/managing risks
Reviewing/monitoring safety and quality
Roles defined
Feedback managed properly
Indemnity and insurance pharmacy services
Records kept/maintained
Information managed with Privacy, dignity, confidentiality
Children/vulnerable safeguarded
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23
Q

Staff empowerment and competence’s standards cover

A

Staff qualified, skilled, competence for services/their roles
Staff comply legal/professional obligations
Culture open, honest, learning
Staff can give feedback and raise concern
Incentives/targets do not compromise

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24
Q

Environment and Condition of Premises’s standards cover

A

Safe, clean, maintained and suitable for services
Protect privacy, dignity, confidentiality
Hygiene
Secure and safe from unauthorised access
Environment services provided right

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25
Q

Pharmacy services’s standards cover

A

Services accessible
Services managed, delivered safely and effectively
Meds/devices from reputable source, are fit/safe, stored securely, safe from unauthorised access, supplied safely and disposed safely/securely
Concern raised when med/device not fit for purpose

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26
Q

Equipment and facilities’s standards cover

A

Equipment/facilities needed for services are:
readily available, from reputable source, are fit/safe, stored securely, safe from unauthorised access, appropriately maintained and used in a way protecting privacy/dignity patients

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27
Q

What age does confidentiality apply to

A

all ages

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28
Q

What information does confidentiality apply to

A

all info obtained during course of professional practice

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29
Q

What does confidential information not apply to

A

Anonymous information
Coded information
Information legitimately in public

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30
Q

What is covered by the term “pharmacy services”

A

management of medicines, advice and referral, and the wide range of clinical services pharmacies provide.

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31
Q

What does management of medicines mean

A

arrangements for obtaining, keeping, handling, using and supplying medicinal products and medical devices, as well as security and waste management.

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32
Q

What is anonymous information

A

Individual can not be reasonably identified

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33
Q

What is coded information

A

Individual can not be reasonably identified but gives information about different patients to be distinguished (side effect of a medicine)

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34
Q

How can you protect information

A 
Care when receiving, storing, sending or destroying info
Sources of info secure (can't be seen by unauthorised)
Prevent accidental disclosure
Discuss out of earshot
Not online
Ensure staff know confidentiality req
Raise concerns person/premises
Confidentiality after death
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35
Q

When can you disclose confidential information

A

Consent
Law says
Public interest to (serious harm/crime/undermines purpose)
Disclose whats needed
To people who will treat it confidentially
Make a record (who requested, why, consent? what disclosed)
If requested, get request in writing

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36
Q

For consent of disclosure patient must understand

A

What will be disclosed, why, who to, consequences of disclosing and not
Give explicit consent

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37
Q

Information CAN BE required by law from

A 
Police,
Regulatory authority,
Healthy regulatory authority.
NHS counter fraud investigation officer
a coroner or procurator fiscal, judge, or relevant court which orders that the information should be disclosed.
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38
Q

What are the two types of consent

A

explicit

implied

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39
Q

What is explicit consent

A

Specific permission to do something

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40
Q

What is implied consent

A

Indication consent indirectly (eg gives you prescription)

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41
Q

Consent is valid when patient

A

has capacity, gives voluntarily, balanced and well informed

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42
Q

Who is responsible to obtain consent in a Pharmacy

A

you

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43
Q

How long is consent valid

A

For what it was given

Can not be presumed when given previously

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44
Q

What is capacity

A

unable to make/communicate decision due to impairment/disturbance effecting mind/brain
Scotland: unable to make/communicate decision or understand/remember decision de to mental/physical ability

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45
Q

Incapacity is permanent? T/F?

A

False (eg drunk, panic, fatigue)

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46
Q

Adults and capacity

A

Every adult presumed to have capacity unless evidence suggests otherwise

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47
Q

When competent adult refuses consent

A

Respect decision unless compulsory treatment, no pressure, record discussion/advice, if at risk raise issue others

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48
Q

What is a young person

A

16 or 17

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49
Q

What is a child

A
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50
Q

Young people and capacity

A

presumed to have capacity unless evidence suggests otherwise

but encourage them to involve parents

51
Q

Children and capacity

A

NOT presumed to have capacity unless they demonstrate their capacity

52
Q

When can a child give consent

A

Maturity to understand what consenting to and in their best interest

53
Q

Young person refuses consent

A

If mature: respect decision regardless of parents/own thought
If not courts can override

54
Q

Incapacitated young person and consent

A

England and Wales: Parents in best interest

Scotland:Treat as you would incapacitated adult

55
Q

Incapacitated child

A

parents

56
Q

Advanced decisions

A

In case of mental health this overrides
Void if competent and retract
Must meet certain criteria otherwise not legally binding but can be used in best interest of patient
Bound by valid decision - get legal advice anyway

57
Q

Emergency and consent

A

Not needed to save life or prevent deterioration unless valid/applicable advance decision for that particular treatment

58
Q

Considerations when raising concerns

A

Your professional duty to safeguard public safety comes first
Failure to raise concern can lead to patient harm
Public Interest Disclosure Act (PIDA) protects employees for making genuine concern/expose malpractice
Breach of Standards of Conduct GPhC to not leading to your own FtP

59
Q

How to raise a concern

A 
Follow organisation policy
Don't delay
To supervisor
Another suitable person/authority/professional body (person responsible for concerns/superintendent (manager)/Primary care organisation/Regulator)
Record
keep Confidentiality
60
Q

PIDA protect you when

A 
Danger to health and safety
Crime
Miscarriage of justice
Damage to environment
"Cover-up" regarding above
61
Q

Regarding raising concerns, you must (as an employer)

A

Procedures/policy to identify concern accessible by staff
have open working environment
encourage staff to raise concerns
Concerns taken seriously - no victimisation
Proper investigation - inform
Support person raising - in confidence
Deal with it and systems in place to support person involved
Keep records -> to senior to assess
Don’t stop anyone from raising concerns

62
Q

If unsure about raising concern go to

A 
PIDA
Public Concern at Work (PCaW)
Senior member in organisation
Accountable officer if CD
Indemnity insurance provider/professional body/pharmacy organisation
Regulatory body
Pharmacist Support
Union
Independent legal advisor
63
Q

What is power imbalance

A

Patients vulnerable as you have their information, things they need

64
Q

What is sexual behaviour

A

acts, words or behaviour designed to arouse or gratify sexual impulses or desires
including asking irrelevant information, doing unnecessary physical examination

65
Q

Give examples of breaches of sexual boundaries

A 
Giving intimate personal details
Give/accept social invitation
Meet outside normal practice
Visit home without appointment
Ask Q unrelated to health
66
Q

If you do want a relationship with a patient

A

They can no longer be your patient
Make sure no imbalance of power, was it from information you gained when they were a patient? Likely to treat their family? vulnerable?

67
Q

If you are attracted to a person and can’t stay objective

A

They can no longer be your patient

68
Q

If patient attracted to you

A

Discuss and re-establish feelings in constructive way and re-establish professional responsibility

69
Q

Whats a chaperone

A

a person (usually the same sex as the patient) who is present as a safeguard for the patient and the healthcare professional. They are also a witness to the patient’s continuing consent for the procedure

70
Q

When to ask a patient if they want a chaperon

A

Intimate examination
record discussion
delay to when chaperone available if not available that day

71
Q

If you object to providing a particular service

A

Before accepting employment:
Check if others provide service at proper time where you can refer
Other staff who can
Tell employees (superintendent/owner/manager), relevant authorities (locum agency, primary care organisation/body who gives contract for service), colleagues

72
Q

What to tell patient if you can’t give them service because of your belief

A

Be open and honest to maintain trust and confidence in profession
Handle sensitively
Maintain confidentiality
Don’t discourage - refer to relevant place

73
Q

Religious beliefs of employees

A

Before employing check
Are there alternatives for patients?
Procedures in place of how to deal
Staff know what to do

74
Q

Rules for employing RP

A

RP for 1 at a time
RP competent, can secure safe and effective running of pharmacy
Make sure overarching operational framework is established
Support RP in legal and professional duty
Allow RP to use professional judgement

75
Q

Rules for Pharmacy record

A

RP must maintain Pharmacy record
Keep for five years from last entry/record created (electronic)
It is backed up, available on premises for inspection, alterations show when and by who

76
Q

Rules for being RP

A

Understand scope, clarify ambiguities, ensure within competence, 1 pharmacy at a time, secure safe/effective running before pharmacy undertakes operational activities, display notice conspicuously, make personal pharmacy record, make sure pharmacy procedures running, no total absence for >2hr/24, remain contactable/make arrangement when not contactable

77
Q

Rules on Pharmacy procedures

A

Make sure available for inspection, staff understand them, reviewed 2 years/after incident, the pharmacist who reviewed shown and what was and is in place, make temporary amendment if circumstance changes, ensure audit trail of above including date

78
Q

Supervision required for professional check (clinical/legal) of Rx

A

Pharmacist

79
Q

What can go on with the Pharmacist’s physical presence so can advise/intervene

A 
sale/supply P meds
sale/supply POM
supply PGD
Wholesale of meds
Emergency supply for patient/prescriber
80
Q

What can go on without the Pharmacist’s physical presence

A

Generate label, Take off shelf, Assembly, Labelling, Accuracy check, sale GSL

81
Q

What is required on RP notice

A

Name, Reg Number, Stating you are RP in charge of premises

82
Q

What is required in the Pharmacy record

A

RP name, RP reg number, Date and time when became RP, date and time when RP ceased being RP, if absence then date/time left/returned

83
Q

What MUST be covered by Pharmacy Procedures

A

Arrangements to secure medicinal product are ordered, stored, prepared, sold by retail, supplied, delivered, disposed (and keeping records of this)
What non-Pharmacist can give advice about a med
Identify who is competent to and doing what task
Steps to become RP
Complaints procedure
Incident procedure
How to change procedure

84
Q

Why do complaints arise

A

Human error
System error
How complaint handled

85
Q

How should you deal with complaint/concern

A

Make a record of concern/incident/complaint and action taken
Review records/findings and audit them regularly
If serious use NPSA incident decision tree

86
Q

How should the dispensary be laid out

A 
To keep distractions to minimum
Atmosphere encourages concentration
Staff alerted to stock being in wrong place
Stock put away by competent staff
Segregated for dispensing
Segregate prescriptions (baskets/trays)
87
Q

How dispensing process should be done

A

Label before taking stock off shelf
Use Rx to take off shelf/dispense
Identifiable who dispensed
If possible 2 people, one accuracy/one dispense
If alone take break before checking
Accuracy check against original Rx
Owings dispensed from original not PMR/lavel

88
Q

What do you do if dispensing error

A

Root cause analysis to find underlying cause -> learn

  • patient taken any? harm?
  • inspect med - give back, if take segregate
  • apologise
  • don’t minimise error
  • make supply of correct
  • establish expectation
  • give details official body
  • establish why happened - contact later, let them know
  • report error/complain according to policy/SOP
  • Record/review/learn
  • Notify pharmacist
  • tell insurance indemnity provider
89
Q

How to review errors

A

Condition in pharmacy (ask complainant/check records/com)
Health pharmacist/staff - illness
Assistance -alone?
Prescription recovered - legible/check endorse
System used for dispensing/checking review

90
Q

How to do final check

A

How much dispensed
Expiry date
Label (pt name, product name, form, strength, dose, warning)
Product check - correct med/strength. Hand out ask address/DOB

91
Q

Pharmacy owner/Superintendent must they keep to

A

GPhC standards, legal requirements, medicine’s legislation, health and safey, data protection and equalities legislation

92
Q

When preparing unlicensed medicines Pharmacist/Pharmacist technicians have a responsibility to

A

provide medicines safely to patients, maintain quality of practice, keep knowledge skills up to date and work within professional competence

93
Q

Must the guidance for preparing unlicensed medicines always be followed

A

No. Requirement is to meet standard - must be able to demonstrate how you safeguarded patients

94
Q

The GPhC guidance for Registered Pharmacies preparing unlicensed medicines covers:

A
  1. One off preparation with Rx for an individual pt
  2. Preparation stock of unlicensed med in anticipation of Rx
  3. Preparation methadone supply in accordance with Rx immediately or as stock for later
  4. Preparation based on Pharmacist’s judgement (OTC)
  5. Preparation based on specification of patient
95
Q

What if unlicensed meds preparation activity is not set out in law?

A

Need a Manufacturer’s Specials (MS) license from MHRA

96
Q

Unlicensed meds preparation for animals in law

A

Veterinary Medicines Regulations 2013

Veterinary Medicines Directorate (VMD) regulates/authorises animal medicines

97
Q

What is a licensed medicine

A

One that has valid marketing authorisation (MA) in UK from MHRA

98
Q

Manufacturers who make licensed medicines covered by

A

regulated and licensed by MHRA for compliance with EU GMP (Good manufacturing process) standards

99
Q

An MHRA license for licensed meds means meds are

A

Assured to certain level of efficacy, quality, safety
Only available if they are effective

Giving public confidence that they’re effective and meet clinical needs of patients

100
Q

Unlicensed medicines must be manufactured by

A

holders of MS license regulated by MHRA following GMP standards and conditions of license. Medicine itself should be licensed.
Pharmacists allowed to prepare and supply medicines in a registered pharmacy without the need for product to be licensed

101
Q

When pharmacist prepared unlicensed medicines

A

must be of equivalent quality to any licensed medicines which is safe and appropriate
Are of nature/quality requested by prescriber

102
Q

Unlicensed veterinary can be prepared if

A

under the cascade

103
Q

For registered pharmacies preparing unlicensed medicines the Governance Arrangements should be

A
  1. Risk Assessment
  2. Regular Audit
  3. Reactive review
  4. Recall Procedures
  5. Accountability of staff
  6. Record Keeping
104
Q

When preparing unlicensed medicines what is risk assement

A

Specifically for that preparation preventing what could cause harm
Should be prepared here? If so manage risks - record.
Change risk assessment when circumstances change
Formula from recognised source, method verified, calculation verified, equipment, contamination consideration, hygiene measures, product risks, ingredients/starting material risks assured, premises suitability, staff skill, training, competence, knowing what would trigger new risk assessment

105
Q

When preparing unlicensed medicines why is a regular audit required

A

To show you have robust systems in place demonstrate that your pharmacy continues to be a safe place to prepare unlicensed med for patients and can produce meds which are safe, effective and of suitable quality

106
Q

When preparing unlicensed medicines what is a regular audit

A

Look at
Premises (temp, light, mositure, air quality),
equipment, facilities, process preparation, hygiene (cross-contamination/microbial contamination), staff training/skills, records (method, ingredients traceability, labelling, how records kept)

107
Q

When preparing unlicensed medicines what is a reactive review

A 
When a review takes place when any of the following happen:
Changes in key staff
Introduction of new staff
Change in equipment
Change in form/source ingredients
An incident
Environment/facilities not fit
Concerns/feedback
Review near miss/error logs indicates concern

This is documented: saying when new risk assessment due

108
Q

When preparing unlicensed medicines what is a recall procedure

A

When there are systems in place to contact public and recall unlicensed medicines
Recall procedure includes who is responsible for taking action and what action to take and who else needs to be told
Also includes arrangements to allow staff to raise concern when suspected defective medicine

109
Q

When preparing unlicensed medicines what is accountability of staff

A

Which technician and other staff involved and Pharmacist accountable/responsible for preparation of unlicensed medicine

110
Q

When preparing unlicensed medicines what is Record keeping

A

Keep records as long as you consider and can show to be appropriate (ask indemnity insurance provider)

Should include:
Process, Formula, Ingredients, Product, Patient/Customer, (If needed) Rx and incident

111
Q

What should be included in the Unlicensed medicines record regarding

A

Key preparation steps, Calculations with working and checking, name person who prepared sheet, date, name supervising pharmacist, name technician

112
Q

What should be included in the Unlicensed medicines record regarding the formula

A

Complete formula, its source and validation

113
Q

What should be included in the Unlicensed medicines record regarding ingredients

A

Source (manufacturer, brand, wholesaler/distributor), conformity certificate, analysis certificate, batch number, expiry date, Quantity used (details of person measuring/double checking), TSA guidance (ingredient/product animal origin), description container and closure used (glass/plastic)

114
Q

What should be included in the Unlicensed medicines record regarding the product

A

date prepared, reference/id number (batch no), expiry date (with reason/validation), date supplied to patient

115
Q

What should be included in the Unlicensed medicines record regarding Patient/customer

A

Name, Address, Contact details, Sample of label on med, name of person who produced label

116
Q

What should be included in the Unlicensed medicines record regarding rx (if applicable)

A

doctor name/address/phone number, patient age, date and type of Rx

117
Q

What should be included in the Unlicensed medicines record regarding incidents

A

suspected adverse reaction reported, complaints and concerns

118
Q

For registered pharmacies preparing unlicensed medicines Staff empowerment and competence should be

A

Staff - recognised training courses before involved in activity/during and regularly repeated (up to date/competent) especially when rarely done
Keep record of training as long as you consider and can show to be appropriate (ask indemnity insurance provider)

119
Q

For registered pharmacies preparing unlicensed medicines the Environment and Condition of the Premises from which pharmacy services provided should be

A

Suitable? Assess risks
Aseptic/Hazardous - contact NHS Quality Assurance/MHRA
Measures to Minimise contamination (segregation/space for safety, steps to microbial/cross contamination eliminated)
Hygiene control records (environment, conditions, equipment)
Keep record of training as long as you consider and can show to be appropriate (ask indemnity insurance provider)

120
Q

For registered pharmacies preparing unlicensed medicines the Way in which pharmacy services delivered includes

A
  1. Ingredients (reputable source)
  2. Quality Assurance
  3. Patient Information
121
Q

What is Quality Assurance for unlicensed meds

A

Procedures, processes and arrangements ensure quality product for its use.
Safeguards include using worksheets, official formulas, confirm quantities and identity of ingredients, staff training suitable/up-to-date, equipment maintained
Procedure including specific method/process/system used to ensure consistency/quality
More than one patient from one batch - safeguard

122
Q

What information given to patient in unlicensed meds

A

Inform unlicensed and what it means
PIL not legal requirement so verbal/writing appropriate advice
Any important info (expiry, storage, dosing)
Labelling requirements for in line with BP formula/monograph or animal use under cascade

123
Q

For registered pharmacies preparing unlicensed medicines the Equipment and Facilities includes

A
  1. Specialist equipment and facilities designed for purpose and of high specification/accuracy
    For example: accurate measuring devices for weight (measuring scales), accurate measuring devices for volume (for example, cylinders), production and mixing equipment, cleaning equipment (including suitable detergent), contamination-minimising clothing (for example, masks, gloves, aprons, coats, hats), sterilising equipment (including suitable chemical agents, autoclaves and filtration equipment), fume cupboards, isolators and laminar flow cabinets.
  2. Maintenance logs
    Validation/calibration records
    Keep record of training as long as you consider and can show to be appropriate (ask indemnity insurance provider)

Pharmacy Pre-Registration (5 decks)

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