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PRE-REG own > Law and ethics > Flashcards

Law and ethics Flashcards

1
Q

What are the 9 standards for pharmacy professionals?

A 
Person centred care
working in partnership with others
leadership
speaking up when have concerns or things go wrong
Behaving in a professional manner
Using professional judgement 
Confidentiality and privacy 
maintain, develop and use professional knowledge and skills
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2
Q

What is the role of the responsible pharmacist

A

To secure the safe and effective running of the pharmacy
Display a notice
complete the pharmacy record
establish, maintain, review procedures in the pharmacy

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3
Q

if the RP believes the pharmacy running is not safe or patients are at risk what can they do?

A

take steps to ensure the secure and safe running, if this cannot happen then shut

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4
Q

What info does the RP notice contain?

A

clearly visible to pts:
1. name of RP
2. GPhc reg number
Fact the RP is in charge of the pharmacy at that time

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5
Q

How long is the pharmacy record kept for?

A

5 years

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6
Q

What details included in the pharmacy record?

A

Name, registration number
Date and time at which they were the RP and when they stopped
if absent - the date, time they left, time they returned

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7
Q

What is the max amount of time the RP can be absent for in a 24hour period (midnight to midnight)?

A

2 hours

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8
Q

When an RP is absent, what are the pre-requisites?

A

Only be absent if the pharmacy can continue to run safely and effectively
Remain contactable and able to return in reasonable promptness
If cannot remain contactable/return prompt - arrange for another pharmacist to bee contactable/available to give advice but doesnt need to be RP

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9
Q

What activities can NOT be carried out without the physical presence of an RP?

A
  • professional checks - legal, clinical
  • sale/supply of P medicines
  • sale/supply of POMs - handing out
  • supply under PGD
  • wholesale
  • emergency supply
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10
Q

What activities CAN be carried out - under the supervision of a pharmacist but RP may not physically need to be there?

A
  • generating dispensing labels
  • taking medicines off disp shelves
  • assembly of an item
  • labelling
  • accuracy checking
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11
Q

What activities can be carried out without supervision/presence of RP?

A
  • GSL sale
  • processing waste stock and patient returns (BUT NOT CDs)
  • ordering stock, receiving stock and putting away, date checks, responding to enquiries, cleaning, accessing PMR, receiving EPS Rx, processing Rx forms
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12
Q

For a private Rx repeat Rx, if the number of repeats isnt stated, how many repeats can bee done? what is the exception to this?

A

Only repeated once (dispensed twice)

exception: oral contraceptives - repeated 5 times (dispensed 6)

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13
Q

For private Rx - are CD rx repeatable?

A

NOT for CD 2+3
But can be for 4+5

Sch 4 fist dispensing within 28 days and thereafter no limit for remaining repeats

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14
Q

What is the record keeping for private Rx?

A
  • Retain Rx for 2 years (note that CD2/3 need to be submitted to NHS agency)
  • Record made in POM register (unless CD2 then in CDreg)- retain POM reg for 2 years
  • dont need to put oral contraceptives in POM reg
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15
Q

Is a faxed Rx legal?

A

Doesnt fall in the definition of a legally valid Rx as not written in indelible ink and not signed by prescriber

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16
Q

Can prescribers from EEA/swiss prescribe Cds?

A

No - not schedule 2/3 including phenobarbital but can supply 4/5

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17
Q

Are emergency supplies for patients of EEA/swiss HCP permitted?

A

yes - provided Rx 72hours, same principles

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18
Q

What are some additional details needed on an Rx from EEA/swiss

A

Full name
qualifications
direct contact details incl email, tel/fax, work address

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19
Q

Which legal act introduced the accountable officer? what is their role?

A

Health act 2006
Overarching responsibility for supervising and managing the use of Cds in an organisation - monitoring, audit, prescribing and their use
incidents involving CDs
Appoint an authorised witness for CD destruction

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20
Q

What legal act introduced restrictions on the storage of CDs? what are the requirements?

A

Misuse of drugs safe custody regulattion 1973

lockable by key, made of metal, fixed to wall or floor, nominated key holder has responsibilities

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21
Q

What legal act intrroduced schedules for CDs and what are these

A

Misuse of drugs 2001
CD 2 - Rx requirements, 28 days validity, needs CD register supplies and obtained, safe custody –> need a licence to import/export
- destruction with authorised witness and recorded
- no emergency supply
- no repeat Rx

CD3 - Rx requirements & 28 day validity but no CD register

  • Most are exempt from safe custody EXCEPT –> temazpem, buprenorphine
  • no emergency supply except phenobarbital for epilepsy 5 days
  • no repeats
  • requirements for destruction do not apply

CD4: POM requirements, valid for 28 days e.g. diazepam, Z drugs, sativex

  • no safe custody or CD reegister
  • allowed repeat Rx
  • emergency supply allowed for max 5 days

CD5: POM (some are OTC), 6 month validity, no registers. Includes orphine sulfate 10mg/5ml oramorph - low strength

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22
Q

What are the limits to the amount to supply of CD 2/3/4?

A

Generally 30 days but this is just good practice

If more - justify why?

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23
Q

What are the Rx requirements for schedule 2 + 3 CDs?

A 
Patient name, address
Drug name
Strength if>1 
Form
Dose - specific
total quantity in words and figures
Signature 
Date - valid 28days
Prescriber name
Prescriber address - MUST be in UK
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24
Q

What amendments can a pharmacist make to a Cd Rx?

A

Technical e.g. minot spelling or quantity not in both words + figurers pharmacist can add this in and sign, date and GPhc reg number (after clarifying with the prescriber)

all other amendments or omissions correct by prescriber

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25
Q

What are the legalities surrounding collection of dispensed CDs?

A

legally required to determine who is collecting a schedule 2 CD - ask for proof of identity unless already known

  • pharmacist discetion
  • If a patients representative or HCP collects: ensure identity
  • drug misuser representative: obtain letter form drug misuser that authorises them and names them - a separate letter obtained each time and ID
26
Q

What is the only CD4 that requires entry into CD register?

A

Sativex

27
Q

What drugs are used in instalment dispensing / FP10MDA foms?

A

Schedule 2, buprenorphine, diazepam, suboxone

28
Q

What is the max amount of days that treatment should be for on instalment Rx FP10MDA?

A

14 days

29
Q

How long is CD register kept for?

A

2 years

30
Q

What are regulations re. electronic CD registers?

A

Every computerised entry must be attributable and capable of being audited
Accessible from the premesis and capable of being printed
Ensure safeguards in the software to ensure author of each entry is identifiable and entries cannot be altered at a later date

31
Q

What is a pre-requisite to supplying a CD and then owing them?

A

Only record in Cd reg what you supplied and put (part)

The owing can not bee dispensed late than 28 days after the date on rx for schedule 2/3/4

32
Q

What is the Rx type for private CD Rx? what CDs does this apply to?

A

PINK FP10PCD

CD 2/3

33
Q

What are additional Rx requirements (along with the standard) for FP10PCD?

A

Prescriber identification number included (This is different to their GMC no.- GMC not needed).

34
Q

What are the record keeping for FP10PCD?

A

Submit the original Rx for 2/3 to NHS agency with the CD submission form
Legal: CD register
Good practice: Keep a copy of the Rx
Good practice: Keep a copy in the POM register as it is private

35
Q

How should CD 2/3/4 (part 1) be disposed of?

A

Must be denatured and irretrievable before placed in waste containers
Use denaturing kits

36
Q

From which patients can we accept CD returns from?

A

Own homes/care homes BUT not from care homes that provide nursing care

Record should be made (but not in CD reg) for patient returned CD2

37
Q

Do patient returned Cds need to be in presence of authorised witness?

A

NO - but good practice

38
Q

How are date expired stock CDs destroyed?

A

Record made in CD reg including name, strength, quantity, destroyed date, signature authorised witness, signature of professional destroying

39
Q

for a POM-V - what are the legal requirements?

What if its a CD?

A

Can only be prescribed by a veterinary surgeon
Can be supplied by a vet surgeon or pharmacist with a written Rx

If a CD: must carry a declaration by the vet stating that the medicine is prescribed for an animal or herd under their care

40
Q

For POM-VPS, does the rx have to be written?

A

No - written or oral
Prescribed or suppliedby vet, pharmacist or Suitably qualified perosn

Written rx only if supplier is not the prescriber

41
Q

what vet meds can be advertised to the public?

A

NFS-VPS

AVM-GSL

42
Q

What is an unauthorised vet med?

A

When there is no suitable licensed vet med - Supply of a human medicine (POM, P, GSL) provided that conditions are met:

  • prescribed by a vet surgeon
  • using the veterinary cascade
  • specifically states it is for administration under the cascade
43
Q

For the sale of NFA-VPS and POM-VPS, what are the legal requirements of the pharmacist?

A

Advise on safe use of product
Advise on warnings and C/I
Be satisfied that the person using is competent and intends to use it for authorised use
Not supply more than the minimum amount needed for treatment

44
Q

What are the Rx requirements for POM-V and POM-VPS and medicines supplied under the veterinary cascade?

A

name, address, tel.no, qualifications, signature of prescriber (if CD 2/3= must include Vet RCVS number and declarartion the item has been prescribed for animal or herd under their care + usual CD requirements)
Name and address of owner
Identification and species of animal and address if different to owner
name, quantity, dose, specific administration instructions
necessary warnings and withdrawal period

where appt: statement highlighting medicine prescribed under the cascade

45
Q

How long do you retain a Vet CD Rx for

A

5 years

dont need to submit CD Rx to NHS agency

46
Q

If a medicine is not prescribed under vet cascade, is a label required?

A

Not legally but good practice

Would apply if under cascade

47
Q

For POM-V and POM-VPS, is record keeping required?

A

Yes- POM register
Retain copy of Rx
Retain 5 years

Record keeping under casacde legal for POM registe, good practice to also include batch no, directions, species/identity of animal, ref no, price

48
Q

What is wholesale dealing

A

Selling or supplying, procuring or holding or exporting medicines to a person who receives it for the purposes of - selling or supplying the product (to anyone other than a member of the public), or administering it/causing it to be administered to one of more people in the course of business carried. out by that person
- person making sales by way of wholesale dealing must have a wholesale dealers licence WDA(H)

49
Q

What situations do you not need a WDA(H)?

A

Activities of a group of retailers/practitioners who buy medicinal products in bulk and divide the stock between themselves (transferring stock between stores of same legal entity or obtaining small quantities for a patient)

Holders of a manufacturers licence

Certain supply of mediciens from pharmacies

Supplying to other UK HCP who need to hold small quantities of medicines for ownward supply to their pts or use is not commercial dealing and dont need one

50
Q

If a WDA(H) contains CDs, what is also needed?

A

Home office licence

51
Q

What defines the criteria for not needing a WDA(H)?

A
  • occasional basis
  • quantity of medicines supplied is small
  • not for profit
  • supply is not for onward wholesale distribution
  • medicines are needed to fulfil an individual patients needs
52
Q

What are the requirements for provision of salbutamol inhalers to schools?

A

They are supplied in an emergency by someone trained to administer/ Number of inhalers a school can obtain is not specified but can purchase them from phamacies provided it is a small quantity and doesn’t constitute as wholesale dealing:

  • Need to obtain signed order from headteacher
  • May need to explain how to use and use of spacer devices
53
Q

What are the requirements for supply of adrenaline auto injectors to schools?

A

Can be supplied for emergency use in children who are at risk of anaphylaxis, but own device is not available or not working without delay

  • schools spare AAI should only be used in pupils known to be at risk and medical authorisation + parental consent for use of spacer os provided
  • not a replacement for their own and its discretionary for the school
  • need a written order signed by headteacher
  • verify brand and strength
54
Q

What is a signed order

A

Communication between purchaser and pharmacist to request a medication to be used within the purchasers practice

  • small amount
  • wouldnt charge due to it not being wholesale dealing
  • POM register, 2years
55
Q

what is a controlled drugs requisition (signed order) and its requirements

A

Uses a standardised CD requisition form FP10CDF in writing - legal for CD2/3 including human and vet use. MUST be in writing and obtain before delivery

  • the only people exempt from using standard form is hospices and prisons & registered pharmacies
  • name and signature of recipient, address, profession, total quantity of drug, purpose
56
Q

If an emergency. can Dr/Dentist be supplied within CD2/3 via a CD requisition and what are the requisites of this

A

Yes but only on the undertaking that a requisition will be supplied within next 24hrs

57
Q

What can prescribers from EEA/swiss prescribe?

A

Anything except for CD 2/3 and meds unlicensed in UK

58
Q

Is faxed Rx legally valid?

A

No- cannot dispense against as needs to be signed in indelible ink, faced rx doesntf all within legal category

59
Q

What is the role of accountable officer?

A

responsible for supervision and management of CDsin the organisation
Ensuring systems in place to record concerns/incidents involving CDS
appoint authorised witnesses to destruct

60
Q

What is legislation regarding salbutamol inhalers to schools

A

Schools can hold stocks to be supplied in emergency by staff trained to administer
Number of inhalers isn’t specified but small quantities and not constituting of wholesale dealing
Obtain signed order from head teacher
- name of school, quantity, why they require, signature

61
Q

What is legislation regarding supply of adrenaline auto injectors to schools?

A

Buy AAIs without Rx for emergency use in children who are at risk of anaphylaxis when their own device not working/unavailable e.g. broke/out of date etc

Spare one should ONLY be used on pupils known to be at risk and for whom medical authorisation and written parental consent for use of spare one given

administer to the pupil if theirs isn’t working /without delay

Signed order by headteacher
verify brand and strength

62
Q

What enables pharmacies to work under signed orders

A

small quantity and not for profit
in accordance with specification furnished by the person to whom the product is to bee sold for administration to that person or person under their care

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