Appendices MEP Flashcards
1
Q
GPhC standards of conducts, ethics and performance Principle 1
A
Make patients your first concern
2
Q
GPhC standards of conducts, ethics and performance Principle 2
A
Use your professional judgement in the interests of patient and public
3
Q
GPhC standards of conducts, ethics and performance Principle 3
A
Show respect for others
4
Q
GPhC standards of conducts, ethics and performance Principle 4
A
Encourage patients and public to participate in decisions about their care
5
Q
GPhC standards of conducts, ethics and performance Principle 5
A
Develop your professional knowledge and competence
6
Q
GPhC standards of conducts, ethics and performance Principle 6
A
Be honest and trustworthy
7
Q
GPhC standards of conducts, ethics and performance Principle 7
A
Take responsibility for own working practices
8
Q
Responsibility of the registered pharmacy lies with
A
Owners and superintendent if body corporate
9
Q
Registered Pharmacy principle 1
A
Governance arrangements
safeguard the health, safety and wellbeing of patients and the public
10
Q
Registered Pharmacy principle 2
A
Saff empowered and competent to
safeguard the health, safety and wellbeing of patients and the public
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
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
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
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
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
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
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
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
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
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
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
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
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
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
25
Pharmacy services's standards cover
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
26
Equipment and facilities's standards cover
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
27
What age does confidentiality apply to
all ages
28
What information does confidentiality apply to
all info obtained during course of professional practice
29
What does confidential information not apply to
Anonymous information
Coded information
Information legitimately in public
30
What is covered by the term "pharmacy services"
management of medicines, advice and referral, and the wide range of clinical services pharmacies provide.
31
What does management of medicines mean
arrangements for obtaining, keeping, handling, using and supplying medicinal products and medical devices, as well as security and waste management.
32
What is anonymous information
Individual can not be reasonably identified
33
What is coded information
Individual can not be reasonably identified but gives information about different patients to be distinguished (side effect of a medicine)
34
How can you protect information
```
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
```
35
When can you disclose confidential information
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
36
For consent of disclosure patient must understand
What will be disclosed, why, who to, consequences of disclosing and not
Give explicit consent
37
Information CAN BE required by law from
```
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.
```
38
What are the two types of consent
explicit
| implied
39
What is explicit consent
Specific permission to do something
40
What is implied consent
Indication consent indirectly (eg gives you prescription)
41
Consent is valid when patient
has capacity, gives voluntarily, balanced and well informed
42
Who is responsible to obtain consent in a Pharmacy
you
43
How long is consent valid
For what it was given
| Can not be presumed when given previously
44
What is capacity
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
45
Incapacity is permanent? T/F?
False (eg drunk, panic, fatigue)
46
Adults and capacity
Every adult presumed to have capacity unless evidence suggests otherwise
47
When competent adult refuses consent
Respect decision unless compulsory treatment, no pressure, record discussion/advice, if at risk raise issue others
48
What is a young person
16 or 17
49
What is a child
50
Young people and capacity
presumed to have capacity unless evidence suggests otherwise
| but encourage them to involve parents
51
Children and capacity
NOT presumed to have capacity unless they demonstrate their capacity
52
When can a child give consent
Maturity to understand what consenting to and in their best interest
53
Young person refuses consent
If mature: respect decision regardless of parents/own thought
If not courts can override
54
Incapacitated young person and consent
England and Wales: Parents in best interest
| Scotland:Treat as you would incapacitated adult
55
Incapacitated child
parents
56
Advanced decisions
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
Emergency and consent
Not needed to save life or prevent deterioration unless valid/applicable advance decision for that particular treatment
58
Considerations when raising concerns
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
How to raise a concern
```
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
PIDA protect you when
```
Danger to health and safety
Crime
Miscarriage of justice
Damage to environment
"Cover-up" regarding above
```
61
Regarding raising concerns, you must (as an employer)
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
If unsure about raising concern go to
```
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
What is power imbalance
Patients vulnerable as you have their information, things they need
64
What is sexual behaviour
acts, words or behaviour designed to arouse or gratify sexual impulses or desires
including asking irrelevant information, doing unnecessary physical examination
65
Give examples of breaches of sexual boundaries
```
Giving intimate personal details
Give/accept social invitation
Meet outside normal practice
Visit home without appointment
Ask Q unrelated to health
```
66
If you do want a relationship with a patient
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
If you are attracted to a person and can't stay objective
They can no longer be your patient
68
If patient attracted to you
Discuss and re-establish feelings in constructive way and re-establish professional responsibility
69
Whats a chaperone
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
When to ask a patient if they want a chaperon
Intimate examination
record discussion
delay to when chaperone available if not available that day
71
If you object to providing a particular service
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
What to tell patient if you can't give them service because of your belief
Be open and honest to maintain trust and confidence in profession
Handle sensitively
Maintain confidentiality
Don't discourage - refer to relevant place
73
Religious beliefs of employees
Before employing check
Are there alternatives for patients?
Procedures in place of how to deal
Staff know what to do
74
Rules for employing RP
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
Rules for Pharmacy record
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
Rules for being RP
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
Rules on Pharmacy procedures
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
Supervision required for professional check (clinical/legal) of Rx
Pharmacist
79
What can go on with the Pharmacist's physical presence so can advise/intervene
```
sale/supply P meds
sale/supply POM
supply PGD
Wholesale of meds
Emergency supply for patient/prescriber
```
80
What can go on without the Pharmacist's physical presence
Generate label, Take off shelf, Assembly, Labelling, Accuracy check, sale GSL
81
What is required on RP notice
Name, Reg Number, Stating you are RP in charge of premises
82
What is required in the Pharmacy record
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
What MUST be covered by Pharmacy Procedures
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
Why do complaints arise
Human error
System error
How complaint handled
85
How should you deal with complaint/concern
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
How should the dispensary be laid out
```
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
How dispensing process should be done
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
What do you do if dispensing error
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
How to review errors
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
How to do final check
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
Pharmacy owner/Superintendent must they keep to
GPhC standards, legal requirements, medicine's legislation, health and safey, data protection and equalities legislation
92
When preparing unlicensed medicines Pharmacist/Pharmacist technicians have a responsibility to
provide medicines safely to patients, maintain quality of practice, keep knowledge skills up to date and work within professional competence
93
Must the guidance for preparing unlicensed medicines always be followed
No. Requirement is to meet standard - must be able to demonstrate how you safeguarded patients
94
The GPhC guidance for Registered Pharmacies preparing unlicensed medicines covers:
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
What if unlicensed meds preparation activity is not set out in law?
Need a Manufacturer's Specials (MS) license from MHRA
96
Unlicensed meds preparation for animals in law
Veterinary Medicines Regulations 2013
| Veterinary Medicines Directorate (VMD) regulates/authorises animal medicines
97
What is a licensed medicine
One that has valid marketing authorisation (MA) in UK from MHRA
98
Manufacturers who make licensed medicines covered by
regulated and licensed by MHRA for compliance with EU GMP (Good manufacturing process) standards
99
An MHRA license for licensed meds means meds are
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
Unlicensed medicines must be manufactured by
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
When pharmacist prepared unlicensed medicines
must be of equivalent quality to any licensed medicines which is safe and appropriate
Are of nature/quality requested by prescriber
102
Unlicensed veterinary can be prepared if
under the cascade
103
For registered pharmacies preparing unlicensed medicines the Governance Arrangements should be
1. Risk Assessment
2. Regular Audit
3. Reactive review
4. Recall Procedures
5. Accountability of staff
6. Record Keeping
104
When preparing unlicensed medicines what is risk assement
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
When preparing unlicensed medicines why is a regular audit required
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
When preparing unlicensed medicines what is a regular audit
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
When preparing unlicensed medicines what is a reactive review
```
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
When preparing unlicensed medicines what is a recall procedure
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
When preparing unlicensed medicines what is accountability of staff
Which technician and other staff involved and Pharmacist accountable/responsible for preparation of unlicensed medicine
110
When preparing unlicensed medicines what is Record keeping
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
What should be included in the Unlicensed medicines record regarding
Key preparation steps, Calculations with working and checking, name person who prepared sheet, date, name supervising pharmacist, name technician
112
What should be included in the Unlicensed medicines record regarding the formula
Complete formula, its source and validation
113
What should be included in the Unlicensed medicines record regarding ingredients
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
What should be included in the Unlicensed medicines record regarding the product
date prepared, reference/id number (batch no), expiry date (with reason/validation), date supplied to patient
115
What should be included in the Unlicensed medicines record regarding Patient/customer
Name, Address, Contact details, Sample of label on med, name of person who produced label
116
What should be included in the Unlicensed medicines record regarding rx (if applicable)
doctor name/address/phone number, patient age, date and type of Rx
117
What should be included in the Unlicensed medicines record regarding incidents
suspected adverse reaction reported, complaints and concerns
118
For registered pharmacies preparing unlicensed medicines Staff empowerment and competence should be
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
For registered pharmacies preparing unlicensed medicines the Environment and Condition of the Premises from which pharmacy services provided should be
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
For registered pharmacies preparing unlicensed medicines the Way in which pharmacy services delivered includes
1. Ingredients (reputable source)
2. Quality Assurance
3. Patient Information
121
What is Quality Assurance for unlicensed meds
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
What information given to patient in unlicensed meds
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
For registered pharmacies preparing unlicensed medicines the Equipment and Facilities includes
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)
