Law - Semester 1 Flashcards
1
Q
How does legislation ensure public protection in Pharmacy practice?
A
- Restrictions to prevent drug crime, self medication and addiction
- Controlled manufacture, distribution and supply ensuring purity, potency and efficacy
2
Q
What three pieces of legislation control use of medicines?
A
- Medicines Act
- Misuse of Drugs Act
- Poisons Act
3
Q
What does the Health Act control?
A
Practice of pharmacist rather control of medicines
4
Q
Define pharmacovigilance
A
Drug safety through detection, assessment, monitoring and prevention of side effects
5
Q
How are medicinal products defined under the HMR?
A
- Shows properties for the treatment/prevention of disease
- Administered for medical diagnosis
- Administered with the aim of altering physiological function through pharmacological, metabolical or immunological action
6
Q
How are authorised medicinal products defined under the HMR?
A
- Medicines with a marketing authorisation
- Homeopathics with a certificate of registration
- Herbal remedies with a traditional herbal registration
7
Q
How are relevant medicinal products defined under the HMR?
A
Medicine with a marketing authorisation
8
Q
What is the definition of a medicinal purpose under the HMR?
A
- For treatment or prevention of disease
- For diagnosis of a disease
- Prevents/interferes with normal physiological function
- Contraception
- Anaesthesia
9
Q
Define administer as set out by the HMR
A
Given to a human being orally or parenterally
10
Q
What should be taken into account when using professional judgement?
A
- Law
- Professional code of conduct
- Ethical standards
11
Q
What is the difference between the UK and GB?
A
GB - England, Wales, Scotland
UK - GB + Northern Ireland
12
Q
Define criminal law
A
Usually between the individual and the state, where the action is harmful to society
Can result in jail sentence
13
Q
Define civil law
A
Usually between two individuals
Generally resolved in compensation being paid to the victim
14
Q
How are dispensing errors convicted?
A
Criminal law
15
Q
Describe the setup of UK legislation
A
- Primary legislation: General principles (usually acts)
- Secondary legislation: Provides more detail relating to an act
- Statutory instruments: Form of secondary legislation relating to an act
- Schedules: Contain detail separate to an act or SI
16
Q
What is case law?
A
Judge makes a decision based on similarities to a previous case in court
Usually when there is no clear outcome set out by law
17
Q
What are the components of EU law? Describe them
A
- Treaties
- Regulations: Direct, binding effects on member states
- Directives: Objectives set out but action is for state to decide
- Decisions: Binding to those it is aimed at
18
Q
Which bodies can implement EU law?
A
- European commission
- EU council
- European parliament
- European court of justice
19
Q
Where are pharmacists considered registered healthcare professionals?
A
Throughout the members of the EU
20
Q
When are medicines classified as POM?
A
- Can cause damage to health if taken unsupervised
- May be commonly misused
- New active substances
- Parenterally administered drugs
21
Q
Who are considered as appropriate practitioners?
A
- Doctors
- Dentists
- Supplementary prescribers
- Nurse and pharmacist independent prescribers
22
Q
What are supplementary prescribers?
A
Prescribe according to patient-specific care plan set out by a doctor or dentist with patient agreement
23
Q
What should be included in a clinical management plan?
A
- Patient name
- Conditions treated by SP
- Dates of start/review
- Details of medicinal product
- Patient circumstances
- What to do in the event of an ADR
- When to contact IP
24
Q
Prescriptions from which EEA health professionals are valid in the UK?
A
Doctors Dentists Midwives Nurses Pharmacists
25
What cannot be prescribed by EEA health professionals?
Schedule 1-3 CDs
26
What are the legal requirements for a prescription to dispense it?
- Prescribers name, address, particulars and signature
- Patient's name and address
- Patient age if <12years
- Date within the past 6 months
27
How long are CD2, 3 and 4 prescriptions valid for?
28 days
28
What are the time requirements on private repeat prescriptions?
Initial dispense within 6 months (28 days for CD4), no time limit for remaining
29
How many times can medications be dispensed if repeats are unspecified?
- Twice for normal POMs
| - Six times for oral contraceptive
30
What are the prescription requirements for an EEA/Swiss prescription?
- Prescriber name, address, particulars and signature
- Patient name and address
- Details of the prescribed medicine
- Date of issue
31
Can UK pharmacists dispense an EEA prescription in a foreign language?
Yes, if they can clearly understand the actions to take and it meets the legal requirements
32
What medicines can dentists prescribe?
Can prescribe from entire BNF BUT should stay within their competency
If FP10D prescription, should be from dental practitioners formulary
33
Are faxed prescriptions legally valid?
When may they be used?
No, not in indelible ink or signed
May be used for a template in emergency supply
34
How are forged prescriptions identified?
- Is the medicine commonly misused and does the prescription seem appropriate?
- If the prescriber is known, is it their usual style of prescribing?
- Does the patient behaviour seem normal?
- Signature - Unlikely to be signed as 'Dr'
- Can it be compared with old Rxs
35
What are the requirements for electronic prescriptions?
Signature should be unique and allow ID of prescriber
Changes should be detected
Creation and alteration is solely by prescriber
36
Why are electronic prescriptions used?
More efficient and convenient
| Can be sent to a pharmacy of the patient's choice
37
What is a patient specific direction?
- Allows medication supply to a specific patient in hospitals without a prescription
- Written by prescriber, supplied by appropriate practitioner
- Good practice to have in writing
38
What are the fates of NHS, Private and CD prescriptions and wholesale deals?
- NHS to NHSBSA
- Private - POM record made (except oral contraceptives)
- CD - CD record (CD2)
- Wholesale - Keep order for 2 years or make POM entry
39
What are the time requirements for records?
Made on day of or day after supply
| Kept for 2 years
40
What are the legal requirements for a POM register?
Dates: Prescription issue and supply
Name and address of patient and prescriber
Details of POM supplied
41
What are the legal requirements for a dispensing label?
- Name of patient
- Name and address of pharmacy
- Name of medicine and directions for use
- Dispensing date
- Cautionary/advisory labels
- 'Keep out of sight and reach of children'
42
What can a pharmacist change on a prescription?
Dose or duration if using professional judgement to optimise use
43
What are P medicines?
Medicines with a MA stating they should only be available from a pharmacy
44
When can P medicines be DISPENSED?
In a pharmacy with a pharmacist present
45
Who can SELL a P medicine?
Any member of pharmacy team as long as pharmacist is present and able to advise
46
Give some examples of P medicines
Anthelmintics (parasitic worm infections)
Parenteral medicines
Enemas
Irrigation for wounds, bladder, vagina and rectum
Aloxiprin (U16)
Aspirin (U16)
47
In what circumstances may the same medicine be in multiple classes?
Different quantities, strengths or formulations
| Conditions of MA
48
Give 3 examples of Schedule 1 Part 1 POM exemptions and their conditions
- Budesonide: Nasal administration SPECIFIED for seasonal allergic rhinitis. MDD = 200mcg per nostril, max pack size 10mg. For >12years
- Econazole: External use for vaginal candidiasis
- Chloroquine phosphate: Licensed and labelled for malaria prophylaxis
49
What exemptions must CDs satisfy to be classified as P medicines?
- Only contain ONE CD2 substance
- At a specified max dose
- Supplied in specified form and packaging
50
Which CDs to P exemptions apply to?
```
Codeine
Dihydrocodeine
Ethylmorphine
Morphine
Pholcodine (+ salts)
Medicinal opium
```
51
What are counter prescribed medicines and what can be given?
Pharmacist can supply against customer request using professional judgment
NOT POMs, P medicines, GSL (considered as P in this situation)
52
What are the conditions for the sale of pseudoephedrine and ephedrine?
- Not sold together
- No more than 720mg pseudoephedrine
- No more than 180mg ephedrine
- Sold using professional judgement
53
Can EHC be given as a P medicine? How much?
Yes - A single dose
54
What are the conditions for the sale of codeine or dihydrocodeine?
- Max 3 days use (32 tablets)
- Possibility of addiction must be stated on packaging and PIL
- Codeine linctus only given to over 18s
55
What are GSL medicines?
Medicines with a MA allowing the sale of medicine without a pharmacist present (with reasonable safety)
56
What does the legal status of a medicine refer to?
Specific product in that amount and strength, so same active ingredient may be in a number of classes
57
Give 4 examples of POM medicines classified as GSL medicines and the conditions for this
- Liquid paraffin preparations (except nasal preparations and oral laxatives)
- Quinine: POM medicine but 100mg MD is P and 35mg MD is GSL
- Cetirizine Hydrochloride: POM medicine but MDD 10mg P medicine. IF packaging specifies indication, appropriate age, max strength and MDD as 10mg, classified as GSL. Max 30 tabs or 70ml liquid
- Beconase: Indication changes class - If specified for hay fever GSL but generic nasal spray is POM
58
Where are GSL medicines sold?
Retail stores
Retail pharmacies
Automatic machines
59
What is the responsibility of the pharmacist in the sale of GSLs?
- Staff training
| - SOPs
60
What are the conditions for retail stores to sell GSL medicines?
- Must be able to lock premises to exclude public
- Medicines must be assembled elsewhere
- Packaging must not be opened
61
Which practitioners can give GSL medicines to a patient?
Doctors
Dentists
Midwives
IF patient under their care
62
Who can supply GSL medicines under the direction of a prescriber?
Hospitals and health centres
63
What are the restrictions for paracetamol + aspirin tablets/capsules?
- Up to 500mg
| - Max 16 tabs for GSL, 17-32 for P, no more than 100 sold at a time
64
What are the GSL schedule 15 requirements for aspirin effervescent tablets?
- 0-325mg aspirin per tablet, no more than 30 tabs
| - >325mg aspirin and tablet total weight max 500mg, no more than 20 tabs
65
What are the GSL schedule 15 requirements for EC aspirin tablets?
- Max 75mg per tablet
- Max 28 tablets
- Only contain aspirin
66
What are the GSL schedule 15 requirements for non-effervescent tablets that do not contain aspirin?
Max 16 tablets
67
What are the GSL schedule 15 requirements for powders/granules and liquid preparations of paracetamol?
- Powders/Granules: Max 10 sachets
- Liquid preparations (>12years): Max 160ml
- Liquid preparations (<12 years): Max 100ml, 5ml per dose
68
What are the GSL schedule 15 requirements for powders/granules and liquid preparations of ibuprofen?
- Powder/Granules: Max 12 sachets
| - Liquid preparations: Max 100ml, 5ml per dose
69
When can POMs be reclassified to P?
- Will not present a danger to health if used without supervision
- Not commonly misused
- Does not contain substance requiring further investigation
- Not normally administered by injection
70
When can P medicines be reclassified to GSL?
Wider sale is more convenient and therefore more important than the risk of damage to health or risk of misuse
71
What are the conditions for supply of a GSL against a prescription?
Pharmacist must be present for legal/clinical check
72
What are the conditions for emergency supply at the request of a prescriber?
- Has to be a reason for prescriber not providing prescription straight away
- Prescription delivered within 72 hours of request
- Cannot supply CD1, 2 or 3 EXCEPT phenobarbital for epilepsy (no CDs if EEA/Swiss Rx-er)
- POM register made on day of or day after supply
73
What are the POM record requirements for emergency supply at the request of a prescriber?
- Name and address of patient and practitioner
- Date of supply
- Date of prescription written and supplied
- Details of emergency supply and medicine provided
74
What are the conditions for emergency supply at the request of a patient?
- Has to be impractical to obtain a prescription in time
- Medicine has to have been prescribed previously
- No CDs except phenobarbital
- Dose should be checked
- Only 30 days supply
75
What is a summary care record and when is it used?
Contains patient allergies, previous medication and ADRs (plus more detail if patient chooses)
Used to help pharmacist make a decision and find medicine details IF PATIENT CONSENTS
76
What are the benefits of a summary care record?
Improved patient safety and more effective treatment
77
How much supply can be given in an emergency?
- 5 days CD supply
- Smallest pack size for those that can't be broken (e.g. inhalers)
- Full course for oral contraceptives and liquid antibiotics
78
What are the POM record requirements for emergency supply at the request of a patient?
- Name and address of patient
- Date of supply
- Medicine details and detail of emergency
- Price and ref. no (not legal)
79
What is an additional label requirement for emergency supply?
Must state 'EMERGENCY SUPPLY' on label
80
What should be done if the medication is not supplied?
Refer the patient to somewhere they can get a prescription and supply against this
81
When can emergency supply be made without interviewing a patient? Does the Pharmacist have to be present?
- Disease declared as a pandemic
| - Pharmacist does not always have to be present
82
What are the exemptions to a practitioner administering a parenteral POM?
- Saving a life in an emergency
```
Adrenaline 1mg/ml
Atropine Sulphate
Chlorphenamine
Dicobalt Edetate
Glucagon
Glucose 50%
Hydrocortisone
Nalaxone
Pralidoxime
Promethazine HCl
Snake venom antiserum
Sodium Nitrate
Sodium Thiosulphate
```
83
What are patient group directions?
Allow supply or administration of a POM without a prescription IF the patient fits within a specific patient group
Usually relates to specific POM
84
What are the benefits of PGDs?
Effective patient care
Improved medicines access
Safe and legal framework for patient care
Reduced treatment times
85
Who signs a PGD?
Doctor/dentist, pharmacist and anyone who may act under the PGD
86
What is included in a PGD?
```
Name of owner
Start and end dates
Description of medicines
Class of supplying/administering health professional
Appropriate signatures
Clinical conditions to be satisfied
Patient exclusions
Descriptions for referral
Details for administration
Warnings and follow up actions
Records
```
87
What medicines can be included in a PGD with care?
Antimicrobials
Black triangle drugs
Medicines used outside of indications
88
Which CDs can be included in a PGD?
- All CD5
- Anabolic steroids (CD4)
- Midazolam (CD3)
- Diamorphine and morphine (CD2)
89
Who can wholesale dealers supply medicines to?
- Other wholesale dealers
- Pharmacists
- Others who may supply medicines to the public
90
What are the requirements for a person to supply medicines as a wholesale deal?
Must hold a wholesale dealers license
91
Can pharmacists supply medicines to others for supply to the public without a WD license?
- Yes, in small quantities and occasional instances
- No profit should be made
- Medicine still supplied with intention to treat a patient
92
What can midwives supply in the line of work?
- All GSL and P medicines
| - POMs contain diclofenac, hydrocortisone acetate, miconazole, nystatin and phytomenadione
93
What parenteral drugs can midwives administer in the line of work?
```
Adrenaline
Anti-D immunoglobulin
Cyclizine lactate
Diamorphine
Ergometrine maleate
Hep B vaccine
Lignocaine HCl (labour)
Morphine
Naloxone HCl
Oxytocins
Pethidine
Phytomenadione
Prochloperazine
NaCl 0.9%
```
94
What can registered optometrists supply in the line of work?
- All GSL and P medicines
- Eye drops up to 0.5% and eye ointments up to 1% chloramphenicol (Emergency)
- POMs containing cyclopentolate HCl, fusidic acid, tropicamide
95
What can a pharmacist supply against a signed order from an optometrist?
- All P medicines
| - POMs containing amethocaine HCl, lignocaine HCl, oxybuprocaine HCl, proxymetacaine HCl
96
When can additional supply optometrists supply POMs?
Only certain POMs and in an emergency
97
What can podiatrists supply in the line of work?
- Any GSL medicine
- P medicines for external use: potassium permanganate, hyaluronidase 9%, heparinoid ointments, ibuprofen, medicines containing clotrimazole 1%, crotamiton 10%, econazole 1%, griseofulvin 1%, miconazole nitrate 2%, pyrogallol 70%, salicylic acid 70%, terbinafine 1%
98
How does the HCPC decide which medicines chiropodists can supply?
Annotations in the HCPC allow supply from that class
99
What medicines cannot be given to patients even with a signed order?
Local anaesthetics
100
When can paramedics administer medicines?
If required immediately by a sick or injured person, using professional judgement
101
What medicines can schools request for use in an emergency and how?
- Inhalers
- Epipens
- Supply against a signed order and make POM record
102
Does a POM register need to be made for a signed order?
If signed order kept with all details required by register, not legal requirement BUT good practice
103
What is the misuse of drugs act?
Controls import, export, production, supply and possession of dangerous or harmful drugs
104
What are the classes of CDs and how are they grouped?
A, B and C - generally according to harm caused but only used for punishment
105
What is the law surrounding novel psychoactive substances?
Illegal to manufature, import and supply but not to possess
106
What are schedule 1 CDs?
- Possession requires home office license
- No therapeutic use, research purposes only
- Pharmacists can possess if intent is to destroy or hand to police
107
What are schedule 2 CDs?
- Opiates, amphetamines, quinalbarbitone
- Stock should be kept in safe custody
- Stock records should be kept up to date
- Should be destroyed properly
108
What are schedule 3 CDs?
- Less likely to be misused and less harmful
- No CD register but keep invoice for 2 years
- May be safe custody requirements for some medicines
109
What are schedule 4 CDs?
- Part 1: Benzodiazepines
- Part 2: Anabolic steroids
- Requires no records or invoices
- Import and export requires home office license
- Can be given as emergency supply
110
What are schedule 5 CDs?
- Negligible potential for misuse
| - No controls but keep invoice for 2 years
111
Who can be in possession of CD2, 3 and 4?
Patients with a valid prescription
People with home office license
Practitioners/pharmacists
112
Where can CD schedules be found?
BNF
113
When is it legal to possess a CD?
- Schedule 4 contained in a medicinal product
| - Handling drug as part of job description
114
Who has authority to POSSESS CD2-4?
Person administering drug on direction of a practitioner
| Person in charge of a hospital or care home IF pharmacist is in charge of supply
115
Who has authority to POSSESS AND SUPPLY CDs?
Person in charge of hospital or care home IF there is no pharmacist present
Senior nurse in hospital or care home if supplied to the by person in charge of possession and supply
Those acting under the directions of a prescriber
116
Who can ADMINISTER CDs?
Supplementary prescribers in accordance with a clinical management plan
117
When does a person require a personal license to travel with CDs?
If in possession of more than 3 months supply
118
What should a patient do before travelling with CDs?
Obtain letter from prescriber with medication details
| Check medication policies for countries travelling to
119
What is the difference between a patient and a practitioner obtaining a CD?
- Patient: Through prescription
| - Prescriber: Through requisition order
120
When must a requisition form be completed and what is required?
- For obtaining CD2 and 3
- Part A: Supplier details
- Part B: CD details and indication for use
- Part C: Practitioner name and signature, date of order
121
Do pharmacies need a requisition form to obtain CDs?
No but is good practice
122
What is required for CDs to be collected on behalf of a purchaser?
Written authorisation, which should be kept in the pharmacy for 2 years
123
What is the time limit for obtaining written requisition for emergency supply of CD2/3?
24 hours
124
Which CD requisitions are not sent to the NHSBSA?
```
Hospital
Care home
Manufacturer
Wholesaler
Prison pharmacy
Midwife supply order
Veterinary requisitions (keep for 5 years)
```
125
What are the requirements for a midwife signed order for CDs?
```
Midwife name and occupation
CD details and purpose
Patient details
Signature of appropriate medical officer
Retain signed order for 2 years and make CDR for CD2
```
126
When can repeatable prescriptions NOT be used?
What is used instead?
For schedule 2 and 3 CDs
Instalment prescriptions for max. 14 days supply (first dispense within 28 days or on specified start date)
127
What are the requirements for instalment prescriptions for the treatment of addiction?
Dose and amount given in each instalment specified
Interval between supplies
Home office wording to show where instructions may not be followed
128
What can be done with instalment prescriptions if the pharmacy is closed on a day?
Dispense on another appropriate day
129
Who can prescribe for the treatment of addiction of cocaine, diamorphine and dipipanone?
Only a doctor WITH authorisation from secretary of state
130
What are the requirements for persons collecting schedule 2 CDs?
- Should identify whether person is patient, representative or HCP
- May ask for ID if patient or representative
- Representatives should get a letter from patient stating they can collect CD (record details in CDR)
- If HCP acting in course of profession MUST obtain name, address and confirmation of profession
131
Who can prescribe, supply and administer all except CD1?
Doctors
Dentists
Vets
132
Which schedules can supplementary prescribers supply or administer under a clinical management plan?
Schedules 2, 3, 4 and 5
133
Which schedules can nurse/pharmacist independent prescribers prescribe from?
Schedules 2, 3, 4 and 5 EXCEPT cocaine, diamorphine and dipipanone
134
Which independent prescribers can prescribe for treatment of addiction? What are the restrictions?
Nurse independent prescribers
| NOT cocaine, diamorphine or dipipanone
135
Can persons administer CDs under direction of independent prescribers?
Only nurse and pharmacist independent prescribers
136
What can nurse/pharmacist independent prescribers supply for drug misuse?
Drug paraphenalia
137
When can nurses and pharmacists supply moprhine and diamorphine?
Under a PGD if required immediately
138
Who can SUPPLY from schedule 5 and schedule 4 pt1? What are the restrictions?
All healthcare professionals
| Cannot supply if in parenteral form for the treatment of addiction
139
What are the legal requirements for CD prescriptions?
- Prescriber name, address and signature
- Patient name and address
- Date within 28 days of issue
- Specified dose, formulation and strength
- Quantity in numbers AND words
- Total quantity
- Dental/instalment wording if required
140
What errors can a pharmacist amend and dispense against?
Quantity missing in numbers OR words
Minor spelling error
Mark details and attribute to pharmacist
141
What are the requirements for private CD2/3 prescriptions?
- Must be on FP10PCD form
- Private prescriber number required if dispensing in community
- Sent to NHSBSA
142
What should be marked when a CD prescription is dispensed?
Date of supply
143
What records should be made for supply of CD3 against a private prescription?
POM record
144
What are the hospital bed chart requirements for supply and administration of CDs?
- Supply: All prescription requirements apply
| - Administration: Does not need to fulfil Rx requirements
145
Which places require safe custody of CDs?
```
Retailers
Care homes
Mental health homes
Private hospitals
Residential homes
```
146
What are the safe custody requirements for CDs?
Locked away so only those authorised can access it
Returned/out of date stock should be kept separately and labelled
All schedule 1, most schedule 2 and some schedule 3
147
How should CDs be marked while stored?
Marked with the amount of drug
| If preparation, state the amount in a dosage unit + number of dosage units OR percentage CD in total preparation
148
What is a CD register?
Used to record receipt or supply of schedule 1 and 2 CDs
| May be on paper or electronic
149
Why is it good practice to make a CD record of supply of sativex spray?
Schedule 4 part 1 BUT contains 2 cannabis derivatives (CD1)
150
What should be included in a receipt CD record?
Name and address of person giving it
Date
Quantity received
151
What should be included in a supply CD record?
```
Name and address of recipient
Details of authority to possess
Details of person collecting
Quantity supplied
Date
Whether ID was requested or not
```
152
What are the requirements for separating drugs in a CD register?
Each drug, strength, formulation should be on a different page
Class, strength and form should be noted on the top of the page
153
How should a CD register be organised? When should entries be made?
Chronologically
| One day or day after supply or receipt
154
How can CD records be altered?
DO NOT CROSS OUT
| Corrections made as marginal notes or footnotes
155
Where should the CDR be kept?
On relevant premises (e.g. pharmacy it applies to)
156
What are the requirements for computerised CDRs?
Compliant with all regulations and attributable to staff making entries
Not able to alter
Controlled access
Sufficient backups
157
When should destruction of CD stock be witnessed?
If a CDR entry needs to be made, stock destroyed should be witnessed
