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LAW AND ETHICS > PM3C & PM4C - Law and Ethics update > Flashcards

PM3C & PM4C - Law and Ethics update Flashcards

1
Q

Brexit

A
  • Affects GPhC registration process for those with non-UK qualifications (EU, Iceland, Liechtenstein and Norway).
  • European Economic Area (EEA) countries no longer automatically recognise UK qualifications –> applicants who qualified outside of the EEA or those W/O relevant qualifications will need to register via the GPhC’s overseas registration process
  • Pharmacy professionals in UK no longer have to follow:
    EU Falsified Medicines Directive
    EU mandated distance-selling logo
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2
Q

Brexit - Prescription from EEA or Swtizerland

A

Approved list of whom we can accept prescriptions from.
Prescriber must be registered in said country.
Emergency supplies permitted.
Not on the list = prescription not valid; use professional judgment to help the patient.

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3
Q

Brexit - Prescription from EEA or Swtizerland

A
  • Approved list of whom we can accept prescriptions from.
  • Prescriber must be registered in said country.
  • Emergency supplies permitted.
  • Not on the list = prescription not valid; use professional judgment to help the patient.
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4
Q

Botulinum toxin and cosmetic fillers (children) act (2021)

A
  • a criminal offence to adminster this toxin or cosmetic fillers via injection for a cosmetic procedure, to a person <18 in england
  • It is an offence to make arrangements for, or book an appointment to provide, these treatments to any person under 18 in England​

-Failure to comply could result in a criminal prosecution and an unlimited fine.
-The law applies even if the person has the permission of someone over 18​
-Where approved by, and under the directions of a doctor, only a pharmacist, nurse or dentist may administer the treatments to under-18s only​

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5
Q

Hub and spoke dispensing

A

-Hubs = pharmacies registered with the GPhC that assemble medicines for dispensing at spokes (accept Rx from multiple pharmacies).
-Spokes = pharmacies registered with the GPhC, and on the relevant pharmaceutical list of NHS chemist premises.
-Spokes send prescriptions electronically to hubs, which select, label, package and deliver the medicines back to the spoke.

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6
Q

FIT NOTES/ MED 3

A

-form of medical evidence that can enable an individual to access health-related benefits or evidence eligibility for statutory sick pay (SSP)
-The legislation is permissive, meaning that it does not mandate these HCPs to certify fit notes​
-Fit notes are not part of the NHS services which community pharmacies
-Pharmacists working in MDT teams within GPs or hospital settings who are able to assess patient’s fitness for work, will have access to the official Med 3 form​

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7
Q

Prescription written in foreign language

A

Still acceptable but need to have enough information to enable safe supply of medicines.

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8
Q

Medicines and Medical Devices Act 2021

A

-Has the power to amend legislation in the HMR, VMR and Medical Devices Regulations.
-Permits independent pharmacies to outsource dispensing (hub and spoke dispensing) to different retail pharmacies.

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9
Q

Patient Safety Comissioner

A

-Part of the Medicines and Medical Devices Act 2021.
(a)promote the safety of patients with regard to the use of medicines and medical devices
(b)promote the importance of the views of patients and other members of the public in relation to the safety of medicines and medical devices.

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10
Q

Calcidott guardians

A

-Senior person who ensures personal information about those who use its services is used legally, ethically and appropriately and that confidentiality is maintained.
-Every NHS organisation must have one (this may begin to include pharmacies and GP practices).

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11
Q

SCRs (summary care records)

A

Can only be accessed by pharmacists and pharmacy technicians.

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12
Q

Prescription - unable to access EPS

A

-Must take steps to ensure the item is supplied in a reasonable timescale.
-Providing pt with details of other pharmacies in the area who may be able to dispense the prescription.
-Emergency supply at request of the prescriber.
-Contact prescriber, ask for urgent provision of a non-electronic prescription.

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13
Q

Healthy Living Pharmacy

A

-From January 1st, 2021, all pharmacies must meet HLP requirements.

Requirements:
- Consultation rooms (except small pharmacies and DSPs)
- Somewhere for staff and patients to communicate confidentially bytelephoneor anotherlive audiolinkanda livevideo link.

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14
Q

PRESCRIPTION REQUIREMENTS ​
FROM AN APPROVED HEALTH ​
PROFESSIONAL

A

Patient details – full first name, surname and DOB​

-Prescriber details – full first name, surname, professional qualifications, direct contact details incl. email address and telephone or fax number, work address

-Prescribed medicine details – name of the medicine (brand name where appropriate), form, quantity, strength and dosage details​

-Prescriber signature​
-Date of issue – valid up to 6 months from the appropriate date (Sch 4 CD’s is 28 days). Appropriate date is when prescription was signed

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15
Q

Hormone replacement therapy (HRT) Pre-payment certficates (PPC)

A

less expensive, PPC applicable only to listed HRT items​

A patient with an HRT PPC will continue to pay the prescription charge for any other (non-HRT) medicines

GPs will be required to write HRT items on separate prescriptions.

Should not mix HRT items with non-HRT items that are not on the PPC

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16
Q

3 STEPS to take if both HRT item and non-HRT item on Rx?

A

1.First, refuse to dispense a mixed prescription issued to the patient – refuse to dispense both the listed HRT item and the other medicine – and ask the patient to return to the GP for two separate prescriptions.​

2.Second, either:​ dispense the listed HRT item
OR​
dispense the other non-HRT medicine(s) with the prescription charge(s) paid.​

The patient will need to obtain another prescription for any items not dispensed.​

3.Third, dispense both the listed HRT item and the other medicine – and complete an FP57 refund form for the HRT item and charge for the other medicine

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17
Q

Supply of original packs

A
  • Can have a deviaiton of +/- 10% for supply/quantity of meds compared to Rx

Will NOT apply to cases where:
(a) The medicine is in a form that makes it impracticable to dispense the exact quantity ordered; e.g. vial, inhaler

(b) The medicine is in a container that has an integral means of application, or from which it is not practicable to dispense an exact quantity;

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18
Q

Codeine and Dihydrocodeine OTC sale

A
  • Indications – solid dose OTC products restricted to short-term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone
  • Any pack size containing more than 32 dose units (including effervescent formulations) is a POM​
    -The warning “Can cause addiction. For three days use only” must be on the front of the pack​
    -Both the PIL and packaging must state the indication and that the medicine can cause addiction or headaches if used continuously for more than three days
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19
Q

Medicines and Medical Devices Act 2021

A

Has the power to amend legislation in the human medicines regulations (HMR), VMR and Medical Devices Regulations.

Permits independent pharmacies to outsource dispensing (hub and spoke dispensing) to different retail pharmacies.

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20
Q

Patient Safety Comissioner

A

Part of the Medicines and Medical Devices Act 2021.
(a)promote the safety of patients with regard to the use of medicines and medical devices
(b)promote the importance of the views of patients and other members of the public in relation to the safety of medicines and medical devices.

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21
Q

Hub and spoke dispensing

A

-Hubs = pharmacies registered with the GPhC that assemble medicines for dispensing at spokes (accept Rx from multiple pharmacies).
-Spokes = pharmacies registered with the GPhC, and on the relevant pharmaceutical list of NHS chemist premises.
-Spokes send prescriptions electronically to hubs, which select, label, package and deliver the medicines back to the spoke.

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22
Q

The community pharmacy contractual framework 2019/20 to 2023/4

A

a new NHS community pharmacist consultation service

a new pharmacy quality scheme

change in status of MURs

Change in Established Payments

Essential requirement for community pharmacy contractors to be level 1 HLP

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23
Q

CPCF triangle

A

Local
Advanced
Essential

24
Q

Advanced Services

A

1) NMS
2) BP service
3) Appliance use review
4) Stroma Appliance Customisation
5) Flu Vaccination Service
6) Community Pharmacist Consultation Service (CPCS)
7) Hep C testing
8) Smoking Cessation Service

25
Q

Purpose of patient group directions (PGD)?

A

A Patient Group Direction (PGD) is a legal framework in the UK that allows certain healthcare professionals, including pharmacists, to supply and/or administer prescription-only medicines (POMs) to a group of patients without the need for a prescription from an individual doctor or prescriber.

The purpose of PGDs is to improve patient access to medicines in situations where it may be impractical for each patient to obtain an individual prescription. This is often seen in scenarios such as mass vaccination programs, where a large number of patients need access to a specific medicine or treatment quickly and efficiently.

26
Q

Under what circumstances are PGD’s not required?

A

Administration of P or GSL medicines​

Supply of GSL medicines​

Emergency administration of parenteral medicine

Management of long-term conditions​

Medicines requiring frequent or complex monitoring

27
Q

Who is eligible for Hep C testing?

A
  • people who inject drugs (PWID)
    -> 18
  • Not engaged in community drug and alcohol treatment service
28
Q

What happens if an individual tests positive for Hep C

A

Where people test positive, will be sent for a confirmatory test and treatment

29
Q

Community pharmacy consultation service

A

Where patients are referred into community pharmacy. Pharmacies will take referrals from NHS 111 telephone or online service, general practice for minor illness and urgent med supply

30
Q

what happens if there is no referral on CPCS IT system and you are contacted by the patient?

A

Check patient is at correct pharmacy
Check NHS email
Contact NHS 111 providers health professionals number or GP.
Confirm patients NHS number and GP with NHS 111 call handler or GP surgery and ask for them to re-send the referral

31
Q

Can consultations be done by telephone?

A

Yes, pharmacists can provide consultation over phone unless there is a clinical need to see the patient

32
Q

Advanced services: Changes to consent

A

no longer contractual requirement that written consent is given for flu vaccination, NMS, and AUR
instead verbal consent can be made with written record of service

33
Q

Further changes in CPCF

A

new NMR Service to ensure changes in med made in secondary care are implemented when patients discharged back into the community = discharge med service
considering expansion of NMS
new service to improve palliative care meds

34
Q

Serious Shortage protocol (SSP)

A

In event of serious shortage
Legislation which enables protocols to allow community pharmacies to dispense against specific protocol instead of an Rx without going back to prescriber first
Pharmacist must conduct SSP with their professional judgement, and suggest an alternative that is reasonable and appropriate for patient
May supply alternative only specified in SSP, provided that pt agrees with alternative SSP supply
Dispensed SSP must have label that show that supply has been made in accordance with SSP and identify SSP
SSP protocol endorsed on Rx

35
Q

Types of SSP

A

An alternative quantity
An alternative formulation
Alternative strength
Generic equivalent
Therapeutic equivalent
IN LINE WITH PROTOCOL GUIDELINES

36
Q

SSP appropriateness

A

Pharmacy owners don’t have to use SSP, if they believe that not reasonable or inappropriate, and is in a good time scale, they can supply normal product
Pharmacy can refuse supply under SSP, must refer back to prescriber

37
Q

SSP Endorsements

A

A
NCSO: to indicate the supply was made in accordance with SSP
Details of product supplied in accordance w SSP (drug name, strength, quantity, formulation, supplier name or brand)
Quantity supplied
Pack Size
Invoice Price: only if NHSBSA has no list price available

38
Q

Pregnancy prevention programme (PPP)

A

Protects females of childbearing potential, by minimising the risk of becoming pregnant while taking specific meds –> e.g oral retinoids, valproate, thalidomide

*Males on valporate need to be reviewed annually

  • Pregnancy testing before, during and after treatment
  • Contraception requirement & Education for healthcare professionals and pts
39
Q

Valporate sale/supply requirements

A

These medicines must be sold or supplied:​
(a) in a manufacturer’s original outer packaging;​
(b) if the quantity sold or supplied is different to the quantity ordered on the prescription, the quantity sold or supplied is as close as possible to the quantity prescribed.

The requirement to sell or supply in a manufacturer’s original pack will NOT apply where:​
(a) the sale or supply is by or under the supervision of a pharmacist; AND​

(b) the pharmacist is satisfied that –​

(i) a risk assessment is in place that refers to the need for the patient to receive the medicine in different packaging from the manufacturer’s original pack (eg idosette box)

(ii) processes are in place to ensure the patient receives a PIL
​

40
Q

GPHC Equality guidance & the 9 protected characteristics

A

To support pharmacy owners in meeting the Standards for Registered Pharmacies​

Equality - making sure that people/ groups of people, are not treated less favourably because of their protected characteristic(s):

  1. Age
  2. Disability
  3. Gender reassignment
  4. Marriage and civil partnership
  5. Pregancy and maternity
  6. Race
  7. Religion or belief
  8. Sex
  9. Sexual orientation
    ​
41
Q

Pharmacy First (NHS)

A

A way for pts to receive care quicker.
Uses the previous Community Pharmacist Consultation Service (CPCS) and builds on it to complete episodes of care for seven common conditions

  • sinusitis​
  • sore throat​
  • acute otitis media​
  • infected insect bite​
  • impetigo​
  • shingles​
  • uncomplicated UTIs in women

The outcome of the consultation may include: ​

  • A supply of a medicine being made in line with the clinical pathway and under the terms of a PGD or Clinical Protocol. ​
  • No supply of a medicine being made as it is not clinically appropriate under the terms of one of the PGDs or Clinical Protocol. ​
42
Q

PRESCRIPTIONS FOR UNLICENSED ​
SPECIALS

A

If the unlicensed product is not listed in EMIA, then prescriber needs to issue a paper FP10, written as ‘Drug name (Special Order)’

43
Q

Valproate Rx presented for a female 12-49 years

A

For patients under 55 years currently receiving valproate, 2 specialists should independently consider and document that there is no other effective or tolerated treatment or the risks do not apply
Need to have a convo with pt to check they:

Understand the risks of valproate use in pregnancy
Adhere to PPP with one high effective or 2 effective contraceptive methods in place
Have had specialist review where risks have been discussed in past year

44
Q

If PPP is not in place on valproate

A

If there is NOT a chance patient is pregnant: make valproate supply and refer to prescriber
If there is a chance patient is pregnancy: make the valproate supply AND URGENTLY refer to the prescriber.

45
Q

What to do when dispensing valproate?

A

Provide a valproate patient card every time you dispense a valproate med to all female patients

Ask if they have received an updated valproate patient guide and provide a copy if they have not received this

Dispense valproate in original package with outer warning and avoid repacking. in situation where this cannot be avoided, always provide a copy of PIL, and add a warning sticker to outside of box

Ensure important info is well known throughout staff

46
Q

Valproate under the age of 55

A

No patients (male or female) under 55 should be initiated on valproate unless 2 specialists independently consider and document that there is no other effective or tolerated treatment

47
Q

Oral retinoids

A

Must not be used in pregnancy
Women and girls must be on PPP
Negative pregnancy test, issuing an rx and dispensing isotretinoin should ideally occur on the same day
Should be ideally limited to 30 days supply at a time
Rx should be collected from pharmacy within 7 days of it being signed by doctor

48
Q

When can you get pregnant after oral retinoids

A

Not get pregnant for one month after use and don’t donate blood

49
Q

Hypertension case-finding Service (BP Check)

A

2 stages
1. identifying people at risk of hypertension and offering them blood pressure monitoring (a ‘clinic check’).
2. Offering 24 hour ambulatory blood pressure monitoring (ABPM) where clinically indicated.
The blood pressure test results will then be shared with the patient’s GP to inform a potential diagnosis of hypertension

50
Q

Stop Smoking Advanced Service

A

This service enables NHS trusts to refer patients discharged from hospital to a community pharmacy for smoking cessation

51
Q

Botulinum toxin and cosmetic fillers Act 2021

A
  1. It is a criminal offence to administer botulinum toxin, or a filler by way of injection for a cosmetic purpose, to a person under 18 in England
  2. It is an offence to make arrangements for, or book an appointment to provide these treatments to any person under 18 in England
52
Q

Failure to comply with the Botulinum toxin and cosmetic fillers Act 2021

A

Failure to comply could result in a criminal prosecution and an unlimited fine
The law applies even if the person has the permission of someone over 18

53
Q

What if the treatments are needed to meet a clinical need? (Botulinum toxin and cosmetic fillers Act 2021)

A

Under the new law, the treatments can still be approved for use on persons under 18 by a registered medical practitioner (doctor) for a CLINICAL need.
Where approved by, and under the directions of a doctor, only a pharmacist, nurse or dentist may administer the treatments to under-18s only

54
Q

Fit notes/ MED 3

A

Form of medical evidence that can enable an individual to access health-related benefits or evidence eligibility for statutory sick pay (SSP)

55
Q

Who else can provide a fit note?

A

Nurses, occupational therapists, pharmacists (only in hospital and community) and physiotherapists.

56
Q

Are fit notes part of the NHS service?

A

Fit notes are not part of the NHS services which community pharmacies provide and community pharmacists will not/do not have access to the ‘Med 3’

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