Law Exam Flashcards
1
Q
What are the 5 sections of control of the HMR 2012?
A
Manufacture Sale Supply Import Authorisation
2
Q
What are the two licensing authorities?
A
MHRA
European Medicines Agency
3
Q
Define a medicinal product.
A
Any substance(s) presented as having properties of preventing/treating disease in humans. Administrable to humans with a view to restoring/correcting physiological function or making medical diagnosis
4
Q
Define an authorised medicinal product.
A
A product with one of:
- marketing authorisation as a medicine
- Certificate of registration as homeopathic
- Traditional herbal registration as herbal remedy
5
Q
Define a relevant medicinal product.
A
Medicinal product with marketing authorisation, not registrable homepathic or traditional herbal
6
Q
Define borderline substances.
A
Products not easily distinguished as medicines, food supplements and cosmetics
7
Q
What defines a borderline substance as medicinal?
A
If it contains active pharmacological substances or makes medicinal claims
8
Q
Give examples of medical devices.
A
Sutures
Dressings
Contact lens care products
9
Q
Under what legal document are medical devices addressed?
A
Medical Device Regulations 2002
10
Q
What are the three available licenses for medicines?
A
Marketing authorisation
Certification of registration as homeopathic
Traditional herbal registration
11
Q
What is marketing authorisation?
A
Required by all relevant medicinal products for sale/supply
12
Q
What happened upon implementation of licensing requirements for medicines?
A
Any product on the market prior were granted a product license of right, became marketing authorisation in 1994
13
Q
What are the three application types for MA?
A
New active substances
Abridged- generic pre-existing products
Biological/biotechnology products
14
Q
What must an MA application include? (12 things total)
A
Name/address of applicant Name/address of manufacturer Name of medicinal product Details of product constituents Evaluation of potential environmental risks Data on indications, contraindications, clinical studies etc Pharmacovigilence system SPC Packaging Leaflet Proposed legal category
15
Q
How long is an MA granted for?
A
5 years
16
Q
What records must license holders keep?
A
Adverse reports
Sale/supple
Source of all materials
Periodic safety update
17
Q
On what grounds may the MHRA reject a product name?
A
Where it causes confusion, is misleading or otherwise unsafe
18
Q
What are the 4 stages of clinical trials?
A
- 20-80 patients to determine dosage, side effects etc
- 100-300 patients to determine efficacy
- 1000-3000 patients to confirm dose, side effects, indication
- post marketing studies
19
Q
What are the requirements of all container and packaging labels?
A
Easily legible
Comprehensible
Indelible
Where there is more than one language, same particulars must appear in each
Name expressed in braille on outer packaging
20
Q
What are the labelling requirements for outer and immediate packaging? (18 total)
A
Name of product Strength and form Intended use in... Common name of substances up to 3 Statement of active substances (qualitative and quantitative) per unit dosage Form/contents by weight or volume List of excipients (all in injectables, topical and eye preparations) Method/route of administration Space to indicate prescribed dose Store out of reach and sight of children Special warnings Expiry date Storage/disposal requirements MA number and holder details Batch number Instructions for use where it is not a POM
21
Q
What are the labelling requirements for blister packs?
A
Name Strength and form Intended for... Common name of active substances up to 3 Name of MA holder Expiry date Batch number
22
Q
What are the additional labelling requirements for paracetamol?
A
‘Contains paracetamol’ unless stated in the name
‘Do not take more than the medicine labels tells you to. If you do not get better consult your doctor’ adjacent to directions for use
‘Talk to a doctor at once if you take too much of this medicine, even if you feel well. (This is because too much paracetamol can cause delayed and serious liver damage)’ (only requirement where there is no leaflet included)
23
Q
What does a manufacturers license allow you to do?
A
Manufacture and assemble licensed products (with MA)
Export and import to countries outside the EEA
24
Q
What does a manufacturer specials license allow you to do?
A
Manufacture and assemble unlicensed products
Supply made in response to unsolicited order for patient under direct care of requestee with specific needs
25
What does a manufacturers license for investigational products allow you to do?
Manufacture and assemble products for phases 1-3 of clinical trials
26
What are two additional manufacturers licenses available?
For exempt advanced therapy
| For non-orthodox practitioners
27
What does a wholesale dealers license allow you to do?
Wholesale of POM, P, GSL and traditional herbal medicines
| Import of unlicensed products from inside EEA
28
Who may persons holding a wholesale dealers license distribute to?
Holder of WL relating to particular products
Holder of EEA equivalent license
Persons who may lawfully sell, supply or administer medicines
29
How long must distribution records be kept?
5 years
30
Who is exempt from wholesale/manufacturing licensing? Under what circumstances?
Pharmacist may manufacture and assemble products
Doctors and dentists may prepare and assemble products
Nurses and midwives may assemble products
Herbalists may prepare and assemble herbal medicines
MUST- be within the course of their practice, for patient under their care who is present, in lockable premises
31
Under what circumstances is a WDL not necessary?
Manufacturers marketing their own products for which they hold MA
Import to specific individual or products intended to be re-exported without alteration
32
Under what circumstances are food supplements not exempt from licensing?
Promoted to practitioners
Oral administration where there is specific written benefit for disease
Vitamins with no written direction for dosage
Vitamins with daily doses exceeding specific values
33
Under what circumstances are cosmetics not exempt from licensing?
Containing antibiotic
0.004% or more of any hormone
Hexachlorphane over 0.1% (providing cautions are labelled clearly below 0.1%)
Resorcinal over 1%
34
What are the three responsible bodies for advertising?
Advertising standards authority
Proprietary association of GB
Prescription medicines code of practice authority
35
What are the conditions of giving medicinal samples to professionals?
Comply with limited number of annual supples
Marked as free sample
Maximum smallest presentation available for sale
Supply against written and signed request
36
Define a herbal medicinal product.
Medicinal product whose active ingredients are herbal substances or preparations
37
What is a herbal substance?
Plant, algae, fungi, lichen or unprocessed exudate defined by its botanical name and the part of the plant it came from
38
What is a herbal preparation?
Obtained by subjecting a herbal substance to processes such as extraction, concentration, distillation and fermentation
39
Give examples of herbal preparations.
Essential oils
Tinctures
Extract
40
What is unique about herbal practitioners?
No need to be registered with Health and Care Professionals Council
41
What are the 3 types of herbal medicines.
Licensed, with MA
Registered traditional
Unlicensed, not produced industrially
42
What are the two types of herbal medicine suppliers?
Dealers
| Practitioners
43
When are unlicensed herbal medicines supplied?
For an individual based on a one-to-one consultation with said individual to meet their needs. Practitioner accepts liability
44
What does HMR regulation 3 state about supply of herbal medicines?
Restrictions to sale/supply do not apply if the product is manufactured or prepared by a herbalist for administration to an individual who is present
45
What are the 3 herbal substances that are not permitted for import, sale or supply by medicines for human use orders?
Aristolochia
Kava-kava
Senecio
46
What is Part I of the HMR 2012 schedule 20 for?
Dictates the herbal substances that cannot be sold/supplied
47
What substances are in Part I of HMR 2012 schedule 20?
```
Areca
Canadian hemo
Embelia
Male fern
Strophanthus
```
48
What is Part II of the HMR 2012 schedule 20 for?
Dictates the herbal substances that cannot be sold/supplied over a certain specified dose/strength
49
What substances are in Part II of HMR 2012 schedule 20?
```
Aconite
Adonis vernalis
Belladonna herb
Conium leaf
Ephedra
Lobelia
```
50
What is aconite?
Also known as monkshood, a poisonous plant that is particularly toxic to the heart
51
What is the exception to HMR 2012 schedule 20?
Pharmacists may sell from a registered premises substances containing part I or II substances
52
What can herbal dealers/shopkeepers sell?
GSL herbals
Registered traditional herbal medicines
Foods/cosmetics
53
What is the THM directive of 2004?
Transition of herbal medicines to become registered, happened over 7 years making registration legal from April 2011
54
What is HMR 2012 regulation 125?
Allows use of herbal medicines without the need for a medical practitioner to diagnose or monitor treatment
55
What are the requirements for products included in HMR 2012 regulation 125?
For oral, topical or inhaled administration
| In medical use for 30 years and continuous use in the EU for 15 years
56
What are the labelling requirements for traditional herbal medicinal products?
Clearly stated that it is a THMP
Use for specific purposes
Consult doctor where symptoms do not improve or adverse effects occur that are not stated
57
What must advertising of THMP state?
Use is based upon long standing used as a traditional remedy
58
What are homeopathic medicinal products?
Products based on the theory that 'like cures like' at low dilutions
No therapeutic indication is permitted
59
What is the National Rules scheme 2006?
Registration of homeopathic medicinal products based on safety and efficacy for self treatment of minor symptoms and conditions
60
Under what circumstances are homeopathic medicinal products registered without using the national rules scheme?
If pre-existing upon implementation of Medicines Act, given a product license of right
61
What is the GHS?
Globally harmonised system for labelling and classification of chemicals
62
What regulation controls chemical labelling? When was it introduced?
Classification, labelling and packaging regulation 2008, came into full effect in 2015
63
Give examples of physicochemical dangers associated with chemicals.
Explosive
Flammable
Oxidising
64
Give examples of health dangers associated with chemicals.
```
Toxic
Harmful
Corrosive
Irritant
Carcinogenic
Mutagenic
```
65
Under what circumstances do the label requirements for chemicals not apply?
Chemicals in their finished state intended for use as medicines, medical devices, food, cosmetics, feeding stuffs
66
What are the main aims of a chemical label?
Tell anyone using/handling of hazards
| Brief precautionary advice
67
What are the requirements of a chemical label?
```
Substance name and quantity
Contact details of supplier
Firmly affixed
Clear and indelible
To read horizontally
```
68
What are the requirements of chemical packaging?
Must prevent chemical escaping
Not be adversely affected by chemcial
Strong enough to withstand normal handling
If for general sale, child resistant with tactile danger warnings
69
Give examples of non-medicinal products used in the course of practice of a chiropodist. How are these regulated?
```
Liquid phenol
Pyrogallol
Monochloroacetic acid
Salicylic acid
Regulated as medical devices if placed on the market with medicinal claims
```
70
Give examples of poisons used as medicinal products. How are these regulated?
Arsenic
Strychnine
Regulated by HMR 2012
71
How are non-medical poisons regulated and ordered?
Poisons Act 1972 splits poisons into 4 lists, regulated and reportable explosive precursors and poisons
72
Under what circumstances do you need a license to obtain poisons?
To purchase regulated poisons or explosive precursors for home use, to purchase certification and ID is required
73
What license is required to obtain regulated poisons? How is this obtained?
An EPP licence from the home office, application requires ID, proof of address, certificate of good standing and a doctor's report
74
Give examples of regulated explosive precursors.
Hydrogen peroxide, potassium/sodium chlorates, nitric acid
75
Give examples of reportable explosive precursors.
Sulphuric acid, acetone, nitrates
76
Give examples of regulated poisons.
Hydrogen cyanide, lead acetates, barium salts
77
Give examples of reportable poisons.
Ammonia, hydrogen chloride, phenols
78
What are the special requirements for storage of chemicals and poisons?
Should be stored in a cupboard or drawer solely dedicated to chemicals, not accessible to the public and no food should be stored below
79
Define denatured alcohol.
Made unsuitable for drinking by the addition of denaturants, methylated spirits
80
What are the two pieces of legislation controlling denatured alcohol?
Alcoholic liquor duties act 1979
| Denatured alcohol regulation 2005
81
Define alcohol (spirit).
Alcohol of any description, including liquor mixed with alcohol, and all mixtures, compounds and products made with alcohol.
82
When can intoxicating liquor be sold?
Only by a person holding a justice's license
83
What are the three types of denatured alcohol?
Completely
Industrial
Trade specific
84
What are the features of completely denatured alcohol?
Mineralised methylated spirits, no supply of usage limits/regultions
Per every 100 parts volume, 3 parts methylethylketone, 1 gramme denatonium beznoate
May contain methyl violet as dye
85
What are the features of industrial denatured alcohol?
95% alcohol
| 5% wood naphtha
86
What is trade specific denatured alcohol?
Approved to meet trade specific needs, 11 approved formulations
87
How can pharmacists obtain industrial denatured alcohol?
Written authorisation required from revenue and customs which is valid indefinitely. States what they can receive and its purpose of use, may specify storage conditions
88
Can pharmacists trade industrial denatured alcohol between each other if they both hold authorisation to obtain?
Yes, in quantities below 20L
89
What are the conditions of supply of denatured alcohol for medical use?
Prescriptions may be dispensed as normal
Written orders from practitioners has no quantity limit but the classification and quantity must be provided
Patients/prescribers do not require authorisation
90
What is surgical spirit?
89-85% ethanol
1-5% methanol
No direct controls but must be labelled for external use only
91
What are the features of duty free spirits?
Records should be kept in stock book
| Can have medical use
92
What is isopropyl alcohol?
Usually 70%
| No specific requirements
93
What are the two pieces of legislation that control veterinary medicines?
Veterinary Medicines Regulation 2013
| Misuse of Drugs Act 1971
94
What are the two regulatory bodies of veterinary medicines?
Veterinary medicines directorate
| National office of animal health
95
Define veterinary medicinal product.
Any substance presented to have properties for treating or preventing disease in animals with marketing authorisation
96
What is a POM-VPS?
Prescription only medicine that can be supplied by veterinarian, pharmacist or suitably qualified person
97
What is an NFA-VPS?
Veterinary P product for non-food producing animals
98
What is an AVM-GSL?
Authorised veterinary medicine for general sale
99
Under what circumstances does a vet not need to be present for handover of medicine against their prescription?
If each individual transaction is authorised before supply or they are satisfied that the person who is handing over is competent
100
What is an SQP in terms of veterinary medicines?
An animal medicine advisor who has passed the appropriate examinations to prescribe
101
What are the features of POM-V medicines?
Strcit limitations of use for safety reasons
Narrow safety window
Require specialist vet knowledge
Clinical assessment of animal must occur for prescription to be given
Only the minimum amount necessary for treatment should be supplied
102
What are the features of POM-VPS medicines?
Used to reduce/prevent effects of endemic disease in herds
Use implies risk to target species or user
Simple advice should be given along side supply
Professionals may receive adequate training for administration
103
What are the overlapping features of POM-V and POM-VPS?
For food producing animals
Special precautions taken to avoid unnecessary risk
May interfere with future diagnosis
Include new VMPs
104
What are the features of AVM-GSL?
Wide safety margin
Treatment for common ailments
No specialist advice
105
What is the exemption for small pet animals?
Permits certain medicines to be placed on the market in any retailer without MA subject to conditions
106
What animals come under the exemption for small pets?
```
Aquarium animals
Cage birds
Homing pigeons
Terrarium animals
Small rodents
Ferrets
Rabbits
```
107
What must be determined by an RQP before the supply of a veterinary prescription/medicine?
Recipient is competent in the use of the product for authorised purpose
Advise on safe administration
Provide warnings
Give minimum quantity necessary for treatment
108
What are the record requirements for POM-V and POM-VPS?
```
Name of medicine
Date of receipt/supply
Batch number
Quantity
Name and address of Rx-er
Name and address of recipient
Copy of Rx if possible
Retain for 5 years
```
109
How long are veterinary prescriptions valid for?
6 months, unless a shorter time is indicated by the prescriber
28 days for schedule 2 and 3
110
What are the requirements of a veterinary prescription?
```
Name, address, telephone and qualification of Rx-er
Signature
Name and address of owner
Species, identification and address of animal
Date
Name and amount of medicine
Dosage/administration instructions
Warnings/withdrawal periods
Number of repeats where necessary
```
111
What are the additional prescription requirements for veterinary CD schedule 2 and 3?
RCVS number of prescriber
| 'Item prescribed for animal/herd under the care of a veterinarian'
112
What are the requirements for an EEA veterinarian prescriber?
Must be registered with RCVS
| Must have carried out a clinical assessment on the animal
113
What is the additional requirement for a veterinary prescription under the veterinary cascade?
'Prescribed under the cascade'
114
What are the requirements for manufacturer labelling of veterinary medicines?
```
Must be in English
UK authorised veterinary medicinal product stamp
Name, strength, form
Name/proportion of active ingredients and any excipients mentioned in MA
Route of administration
Batch number
Expiry date
'For animal treatment only'
'To be supplied on veterinary Rx'
Contents by weight, volume or dosage unites
MA number and holder details
Labelled space for discard date
Target species
'Keep out of reach and sight of children'
Distribution category
Storage instructions
In use shelf life
Withdrawal period for food producing species (even if zero)
Warnings specified in MA
Disposal advice
Full indications
Dosage instructions
Contraindications
```
115
What are the label requirements for POM-V?
```
Name, address of owner and supplier
Date of supply
Name, strength and quantity
Dosage and directions for use
'For animal use only'
'For external use only'
```
116
What are the stages of the veterinary cascade?
1- VMP authorised in the UK for another animal species OR another condition in the same species
2- UK medicinal product for human use OR VMP authorised in another EU country for use with any animal species
3- medicine prepared extemporaneously as prescribed
117
What is the veterinary cascade?
Used to find an alternative where there is no suitable authorised VMP in the UK
118
Which persons can supply under the veterinary cascade?
Veterinarians and pharmacists may supply any medicine supplied under the cascade
SQPs may dispense any authorised VMPs prescribed
119
What is a schedule 1 controlled drug?
Licensed POM
120
What are the requirements of CD schedule 1 drugs?
No therapeutic use, limited to research etc
| License required from the home office to produce/possess/supply
121
Under what circumstances may a pharmacist possess a schedule 1 CD?
For destruction or police handover
122
Give examples of schedule 1 CDs?
LSD
Ecstasy
Raw opium
Cannabis
123
What is a schedule 2 controlled drug?
Register POM
124
What are the requirements of CD schedule 2 drugs?
License required for import/export
Pharmacy controls over destruction, container marking, record keeping and safe custody including expired and returned meds
Private prescriptions written on a standard form
125
What is the exception for safety custody of CD schedule 2?
Quinalbarbitone
126
Give examples of schedule 2 CDs?
```
Cocaine
Methadone
Morphine
Ketamine
Opiates
```
127
What is a schedule 3 controlled drug?
No register POM
128
What are the requirements for schedule 3 controlled drugs?
No register or destruction requirements
| Invoice must be retained for two years
129
Which schedule 3 drugs to safe custody rules apply to?
Diethylpropion
Temazepam
Buprenorphine
Flunitrazepam
130
Give examples of schedule 3 CDs?
Barbituates
Midazolam
Tramadol
131
What are schedule 4 part I CDs?
Benz POM
132
What are schedule 4 part II CDs?
Anab POM
133
What are the requirements for schedule 4 controlled drugs?
No register, safe custody or destruction requirements
Home office license for import/export
Emergency supplies permitted
No restriction on possession of part II
134
Give examples of schedule 4 CDs?
Part I- benzodiazepines, cannbinoids
| Part II- anabolic/androgenic steroids, growth hormones
135
What are schedule 5 CDs?
Invoice POM/P
136
What are the requirements for schedule 5 controlled drugs?
Negligible potential to supply or for misuse
Invoices retained for 2 years
Exempt from other controls
137
Give examples of schedule 5 CDs?
Codeine
Pholcodeine
Morphine present at low strengths
138
Are legal highs banned?
Yes for import, manufacture, distribute and supply
139
What is Sativex?
Schedule 4 CD derived from whole plant extracts of cannabis
| Destruction requirements apply to importers, exporters and manufacturers
140
When is it lawful to possess/supply CDs?
Prescribed for person (or animal)
Have appropriate Home Office license
Person specified in regulations as acting in their capacity (constable, postal worker, customs officer)
141
Who is specified in law to possess CDs?
```
Doctors, dentists, pharmacists, independent prescribers
Senior registered nurse on a ward
Person in charge of laboratory
Public analyst, sampling officer
Master of a ship with no doctor on board
Ambulance trusts
```
142
What are the requirements for taking CDs abroad?
No personal license required by the home office for less than 3 months supply
Patient advised to obtain covering letter from prescriber, check with embassy and travel operators before travel
143
When do CD requisitons/prescriptions not need to be sent to the NHSBSA? What is their fate?
```
Veterinary prescriptions- retained for 5 years
Hospital/care home- retain for 2 years
Manufacturer/wholesale
Prison pharmacy to prison wings
Midwife supply order- retain for 2 years
```
144
What CDs can a midwife obtain on a supply order?
Diamorphine
Morphine
Pethidine
145
How many days treatment can be given on a CD instalment?
14 days
146
What drugs are given on a CD instalment?
Schedule 2 drugs
Buprenorphine
Diazepam
147
When must the first instalment be dispensed on an FP10MDA prescription?
Within 28 days of date on Rx or date expressly specified
148
What is contained within an instalment direction?
Amount per instalment
Interval between instalments
Dose and instalment amount must be specified separately
149
What exemptions may be included in an instalment direction?
Dispense instalments due on pharmacy closed days on prior suitable days
If a day is missed, dispense the amount due for remaining days
Contact Rx-er if 3 or more consecutive days are missed
150
Who may prescribe treatment for addicts? What treatment does this include?
Prescribers specifically authorised by the secretary of state
Cocaine, diamorphine, dipipanone
151
What is the protocol for collection of CDs?
Supply to patient or representative and request of ID is at the pharmacist's discretion
HCP collecting on behalf of patient must provide ID, name and address
152
What is the protocol for collection of drug misuse CDs?
Representative must have a letter of authorisation from the patient for each time they collect
Rx-er must be contacted if this is a supervised dose
153
What CDs may a nurse or pharmacist supply against a PGD?
For necessary immediate treatment of a sick patient they may supply diamorphine or morphine
154
What CDs may a nurse or pharmacist supply in addiction?
Schedule 5 or 4 part I
Midazolam
Not parenteral
155
What are the requirements of emergency supplies of CDs?
Phenobarbitone or schedule 4/5 are permitted at the request of a prescriber
Up to 5 days treatment with schedule 4/5 at patient request
156
Where does safe custody apply to CDs?
Retail dealers
Care homes
Private hospitals
157
What are the requirements of CD containers?
Should be plainly marked with the amount of drug
| With preparations, with the amount per dosage unit and number of dosage units
158
How long should a CD register be kept for?
2 years from its last entry
159
What are the requirements for destruction of schedule 2 CDs?
Must have an authorised witness present, not necessary for patient returns
160
What is a CD accountable officer?
Some appointed by a designated body who does not routinely supply/handle CDs
161
Who may act as an authorised witness?
```
Constable
GPhC inspector
Senior staff
Suitably trained employees
Controlled drug liaison officer
```
162
What legislation accounts for patient returned CDs?
Hazardous Waste Regulations 2005
163
What are P medicines?
Available in registered pharmacies without prescription under the supervision of a pharmacist
Listed in HMR 2012 Schedule 1 part 2
164
What products are included in the P medicine category?
Anthelmintics
Parenterals
Enemas and irrigation
Aspirin in under 16s
POM under certain conditions of marketing authorisation
GSL above certain quantities
Covered by exemptions from licensing from pharmacists
165
What medicines are included in HMR 2012 schedule 1 part 1?
```
Parenterals
CDs
Cyanogenics
Those that emit radiation
Restrictions of aloxiprin, aspirin, paracetamol, pseudoephedrine salts
```
166
Which controlled drugs are exempt from POM status?
```
Those containing one of the following substances in a specified form and at a max strength
Dihydrocodeine
Ethylmorphine
Pholcodeine
Codeine
Morphine
Any of their salts
```
167
What are counter prescribed medicines?
Can be made up by a pharmacist if deemed appropriate consisting of either GSL or P medicines
168
What are the restrictions on pseudoephedrine and ephedrine products?
Unlawful to sell these products together where they contain more than 720mg of pseudoephedrine salt or 180mg of ephedrine
169
What are the main professional problems presenting with sale of P medicines?
Emergency oral contraception
Codeine/dihydrocodeine should not be used for more than 3 days, max supply of 32
Cough medicines unsuitable for children contains pholcodine, dextromethorpran, guaifenesin, ephedrine
OTC codeine liquid not for use in under 18s
170
What are GSL medicines?
Not classified as P or POM but have marketing authorisation. May be sold with reasonable safety without supervision of a pharmacist
171
Give an example of a medicine available as POM, P and GSL?
Quinine
P with a max daily dose of 300mg
GSL in its base form with a max daily dose of 35mg
172
When can retail shops sell GSL?
Where they can be closed to exclude the public
The product was made elsewhere and remains in its original packaging
Follow schedule 15 requirements
173
What are the exemptions for general conditions of sale/supply of GSL?
Doctor/dentist to a patient under their care
Registered midwife in the course of their practice
Hospitals/healthcare centres
174
What are the common pack size limits in GSL medicines?
Paracetamol and aspirin up to 500mg in packs of 16
Aspirin, aloxiprin and paracetamol effervescent up to 30
EC aspirin 75mg in packs of 28
Ibuprofen in packs of 16 or 12 granules/powder sachets
175
What are the requirements for a product to be moved from a POM to a P classification?
No longer presents danger to health
Not frequently used incorrectly
Activity/side effects require no further investigation
Not usually prescribed by doctor as a parenteral
176
What are PO medicines?
Not a legal classification in HMR 2012
| GSL products whose sale is restricted to pharmacies, RP does not need to be present
177
What are the requirements for an emergency supply at the request of a prescriber?
Prescriber is appropriate
There is a genuine emergency
Rx to be provided within 72 hours
Supply made in accordance with instructions
CD 4 and phenobarbital are permitted from UK prescriber
Record may on the day or day following
178
What are the record requirements for an emergency supply?
```
Medicine supplied, all details including quantity
Name/address of Rxer
Name/address of patient
Date on which POM is sold
Date on Rx
Date Rx received by pharmacy
Reason for supply
Reference number
```
179
What are the requirements for an emergency supply at the request of a patient?
Immediate need
Treatment has previously been received on Rx
Dose appropriated
Patient has been interviewed
Treatment does not exceed 30 days (5 days for phenobarbital and Sch 4/5)
180
What POMs cannot be given in an emergency supply at patient's request?
```
Bromide salts
Hexobarbitone
Methohexitone
Strychnine
Thiopentone
```
181
What may be given in emergency supply at patient's request where treatment exceeds 30 days?
Inhalers
Creams
Insulin
Where smallest pack size exceeds 30 days
182
Which POMs may be administered by anyone for the purpose of life saving?
```
Adrenaline 1mg/ml
Atropine sulphate
Chlorphenamine
Dicobalt edetate
Glucagon
Glucose 50%
Hydrocortisone
Naloxone
Pralidoxime
Antiserum (venom)
Sodium nitrite
```
183
What are the requirements of a PGD?
```
Doctor/dentists signature
Pharmacist signature
Name of business that owns it
Description of medicines
Start/end dates
Health professionals able to administer
Signature by appropriate organisation
Clinical situation where it applies
Details of dosage, form, quantity and regimen
Warnings
Follow up actions
Records
```
184
What medication requires guidance or is not permitted on a PGD?
Antimicrobials to be used with caution
Black triangle drugs included in exceptional circumstances
Unlicensed drugs not permitted
No anabolic steroids
No midazolam from schedule 3
Schedule 2 morphine and diamorphine excluded for addiction
185
Under what circumstances is it permissible to supply others with 'wholesale' medicines without a wholesale license?
Supply to HCPs to hold for local provision or to other pharmacies to meet the needs of individuals where this happens only on occasion and in small quantities on a non-profit basis where the medicines are not for onward wholesale distribution
186
Where can you find the list of persons eligible to receive wholesale medicines?
Listed in HMR 2012, schedules 17 and 22
187
What medicines may a midwife sell/supply in their capacity?
GSL and P medicines
| POM medicines containing diclofenac, hydrocortisone, miconazole, nystatin or phytomenadione
188
What medicines may a midwife administer parenterally in their capacity?
Adrenaline, anti-D immunoglobulin, cyclizine, diamorphine, ergometrine, hep B vaccine, lignocaine, naloxone, oxytocin, pethidine, prochlorperazine, NaCl
189
What POM medicines may optometrists supply in their capacity?
```
Chloramphenicol eye drops <0.5%
Chloramphenicol eye ointment <1%
Cyclopentate
Fusidic acid
Tropicamide
```
190
What POM medicines may optometrists obtain in their capacity for clinical use?
Amethocaine
Lignocaine
Oxybuprocaine
191
What POM medicines may additional supply optometrists supply in emergencies?
Diclofenac
| Polymixin B
192
What P medicines may chiropodists supply in their capacity?
```
Potassium permanganate crystals
Ibuprofen
Heparinoid ointments
Clotrimazole 1%
Crobamiton 10%
Griseofulvin 1%
Miconazole 2%
Salicylic acid 70%
Terbinafine 1%
```
193
What medicines may POM chiropodists supply in their capacity?
```
Amoxicillin
Erythromycin
Flucloxacillin
Co-codamol
Co-dydramol
Codeine
Amorolfine
Hydrocortisone 1%
```
194
What medicines may local anaesthetic chiropodists give parenterally in their capacity?
Adrenaline
Lignocaine
Prilocaine
Methylprednisolone
195
What medicines may paramedics administer to patients requiring immediate treatment?
```
Diazepam 5mg/ml
Succinylated gelatin 4% infusion
Adrenaline
Amiodarone
Anhydrous glucose
Ergometrine
Furosemide
Heparin (cannula flushing)
<20mg morphine
Metoclopramide
Naloxone
Streptokinase
NaCl
```
196
Define criminal law.
Relationship between an individual and the state, regulating human behaviour
197
Define civil law.
Relationship between individuals relating to the conduct of human relations
Compensation may be awarded to the victim
198
What is penal law?
Conditions of bodies of rules with potential for severe punishment, actions considered harmful to society as a whole
199
What is primary legislation?
An act of parliament laying down general principles
200
What is secondary legislation?
An act delegates power to other bodies by making detailed rules
201
What are statutory instruments?
Concerned with working detail, referring back to an act
| Including regulations and orders
202
What is the process of enactment? (6 stages)
1- green paper for discussion
2- white paper, signal of intention
3- proposals set for other parties to give input
4- bill, proposes introduction of new legislation
5- debate in both Lords and Commons
6- formal enactment, royal assent received
203
What is judicial precedent?
Common law
A statement of the legal position in a particular case/situation based on decisions of previous courts in similar situations
204
Under what circumstances does a judge make the law?
Where there is no legislation on a particular situation or the available legislation has a meaning that is unclear
205
Describe the features of the Medicines Act, including date published.
1968
Controls medicinal products at all stages
Over 200 statutory instruments
206
Describe the features of the Misuse of Drugs Act, including date published.
1971
Controls medicines that are misused
Regulations published 2001
207
Describe the features of the Poisons Act, including date published.
1972
Controls poisons
Amended by deregulation act of 2015
208
Describe the features of the second Health Act, including date published.
2006
| Supervision and management of controlled drugs
209
Describe the features of the first Health Act, including date published.
1999
Amended by health and social care act of 2008
GPhC control of pharmacists 2010
210
Describe the features of the Human Medicines Regulation, including date published.
2012
| Divided into 17 schedules covering everything relating to human medicines
211
What constitutes as medicinal purpose?
```
Treating/preventing disease
Diagnosing disease
Contraception
Inducing anaesthesia
Otherwise preventing/interfering with normal operation of physiological function
```
212
What is the protocol for dental prescribing?
Medicines act permits dentists to prescribe anything in the BNF
GDC recommends that they prescribe drugs in their area of competency
NHS limits them to DPF
213
What are the main considerations for forgery of prescriptions?
```
Excessive quantity
Appropriateness for patient/condition
Known Rx-er
Known patient
Title 'Dr' present in signature
Patient behaviour
Commonly misused medicine
```
214
Are CD Schedule 2 and 3 drugs valid on an EPS?
Yes as of 2015
215
What is the protocol for prescribing/supply in hospitals?
Maybe supplied against kardex providing written direction to supply is patient specific and given by appropriate practitioner
216
When don't POM records apply?
NHS prescriptions
Oral contraceptives
Separate record kept, such as CD
Sale is by way of wholesale deal, invoice kept for 2 years
217
What are the legal requirements for a dispensing label?
```
Patient name
Name/address of pharmacy
Dispensing date
Medicine name etc
Directions for use
Precautions relating to use of product
'Keep out of reach and sight of children'
```
218
What are the additional legal requirements of a CD prescription?
```
Clearly defined dose, not mud or prn
Formulation
Strength where more than one exists
Total quantity in words and figures, should not exceed 30 days
'For dental treatment only'
```
219
When should a CD be dispensed? Including repeatable prescriptions.
Within 28 days if Sch 2 or 3
Sch 4 first repeat must be within 28 days
Schedule 5 first repeat within 6 months
220
What is a POM?
Medicinal products which may only be sold/supplied by retail in accordance with a prescription given by an appropriate prescriber
221
Give common reasons for POM classification.
Required medical supervision to prevent damage to human health
Wide/frequent misuse
New active substance
Parenteral administration
222
What are the prescribing restrictions of an optometrist?
No parenterals or CDs
223
What are the prescribing restrictions of a chiropodist?
No CDs other than oral diazepam, oral dihydrocodeine, fentanyl patches, oral lorazepam
224
What are the prescribing restrictions of a physiotherapist?
No CDs other than diazepam, dihydrocodeine, fentanyl, temazepam, lorazepam, morphine, oxycodone
225
What is supplementary prescribing?
Voluntary prescribing partnership between an independent and supplementary prescriber to implement a care plan
226
What must a written clinical care plan include?
```
Specific named patient
Illness/conditions treated by SP
Date of start and review
Reference to description of medicinal products
Restrictions (dose etc)
Warnings
Arrangements in case of suspected ADRs
When to seek advice from IP
```
227
What are the legal requirements for a prescription?
```
Signature
Appropriate Rx-er address
Date
Rx-er type
Patient name and address
Age if under 12
```
228
What are the additional legal requirements for a prescription from an EEA HCP?
Date of birth
Rx-er qualifications
Direct contact details for Rx-er
Appropriate translation
229
Define supervision.
Linked to personal control, physical presence in the pharmacy
230
What regulations does the Health Act 2006 set out for the responsible pharmacist?
Statutory duty to secure safe and effective running, allows ministers to produce regulations covering the ability of an RP to be absent
231
What is a superintendent pharmacist?
Required where a pharmacy is carried by a corporate body, any RP remains subject to SI direction
232
What is required on an RP notice?
Name of RP
GPhC number
State that they are in charge of the pharmacy at that time
233
What records are required to be filled out daily by the RP?
Name and reg number
Date/time start and end of their role as RP
Continuous daily record
Absence details, with reason
234
Under what circumstances may an RP be absent?
For a maximum of 2 hours in 24 hours
| Should remain contactable and able to return with reasonable promptness
235
What cannot occur in the absence of an RP? (5 things)
```
Professional check of Rx
Sale/supply of P medicines
Sale/supply of POM, including handover of prescription items
Supply under a PGD
Emergency supply
```
236
What is professional supervision?
Supervision by a suitable qualified person other than the RP
237
What may occur in the absence of the RP, under professional supervision? (5 things)
```
Generation of dispensing label
Taking medicines off shelves
Assembly of items
Labelling containers
Accuracy check
```
238
What can occur in the absence of the RP? (6 things)
```
Ordering stock from wholesaler
Receiving stock (exc. CDs)
Date checking (exc. CDs)
Accessing PMR
Receiving prescriptions
Delivery person handing over medication to patient
```
239
What may occur within a pharmacy without supervision? (2 things)
Sale of GSL medicines
| Processing waste and patient returns (exc. CDs)
240
Define a retail pharmacy business?
Business that consists of or includes the retail sale of medicinal products that are not subject to general sale
241
Who may lawfully conduct a retail pharmacy business?
```
Individual pharmacist or partnership (do not all have to be pharmacists in Scotland)
Body corporate (must be under SI management)
Representative incase of death, illness or bankruptcy
```
242
What are the conditions of conducting a retail pharmacy business as a representative?
Must notify GPhC of their name and address
May act for 3 years in case of illness, disability or bankruptcy
May act for 5 years in case of death
243
What are the requirements for being an SI pharmacist?
Must be a pharmacist
Statement in writing sent to registrar signed by them and the body corporate
Must not act in a similar capacity for any other body corporate
May act as RP
Must be appointed to manage pharmaceutical aspects of business
244
What are the 4 types of GPhC membership?
Member
Fellow
Associate
Student
245
What does the GPhC represent?
Best interests of the patient
246
What does the RPS represent?
Interests of pharmacists
247
What does the GPhC regulate?
Pharmacists
Pharmacy technicians
Premises
248
What are the principal functions of the GPhC?
Establish and maintain register
Promote standards for safety and effective practices
Fitness to Practice requirements
Standards relating to education, training, CPD and experience
249
What is the basic structure of the GPhC?
14 members, 7 lay members and 7 registrant members
Appointed by a committee
At least one member from each GB country
Registrar appointed by committee, may appoint a deputy
250
What are the 5 parts of the GPhC register?
```
Pharmacists (protected title)
Pharmacy technicians (protected title)
Premises
Pharmacists visiting as a practitioner
Pharmacy technicians visiting as a practitioner
```
251
What are the criteria for entitlement to the register?
Appropriate qualification
Fitness to practice
Prescribed fee paid
Intend to practice in GB, channel island or the isle of man
252
What constitutes the appropriate qualification for entry to the GPhC register?
UK MPharm, pre-registration year and exam
EEA equivalent
Overseas qualification, OSPAP course and pre-registration year
253
What personal information is held on the GPhC register?
```
Full name
Postal town
Annotations
Registration number
FtP issues
```
254
What premises information is held on the GPhC register?
```
Trading name
Owner
Address
Subject to conditions
Internet logo
Registration number
```
255
What is required for an application to the GPhC?
```
Form
Copy of degree
Certified copies of birth certificate, marriage certificate, proof of identity
Final declaration from tutor
Letter of good standing
Certified photograph
```
256
What annotations may be included in a GPhC register entry?
Additional qualifications
SI
Supplementary/independent prescriber
257
When may temporary access to the GPhC register be granted?
In the case of emergencies, loss of life or health epidemics
258
What education facilities may be accredited by the GPhC?
```
Training/education courses
Qualifications granted upon successful examination
Institutions
Tutors
Premises
```
259
What are the English language requirements for entry to the GPhC register?
Health Care and Associated Professions order 2015 makes it a legal requirement for all registrant to have necessary knowledge of English
260
What governance arrangements are set out in GPhC principles for registered pharmacies 2012?
Safeguarding health, safety and wellbeing of patients
Clear definitions of accountability and risk management
Staff are empowered and competent
Environment and conditions
Delivery of pharmacy services
Equipment and facilities
261
Define traditional pharmacy service.
All parts of pharmacy service take place in the same registered premises
262
Define distance pharmacy service.
Any activities being carried out at different registered pharmacies or locations
Or where the member of staff and person using the same service are not both in the same registered pharmacy together
263
What is the GPhC inspectorate?
Made up of 38 inspectors across GB
| Proactively assess premises routinely every 5 years
264
What is the role of the GPhC inspectors?
Enforce standards
Securing compliance with the law
Enforce article 38 regarding offences relating to the register
Assist council in FtP matters
265
What is the power of entry of GPhC inspectors?
Able to enter any registered premises at any reasonable hour
Must provide identity and authorisation
Not obliged to notify prior to visit
266
What is an improvement notice served by GPhC inspectorate?
Served to SI and RP
State grounds for belief of failure in complicance
Specify measures to rectify failures
State right of appeal
267
What occurs in the case of non compliance with an improvement notice served by GPhC inspectorate?
Results in a fine
Inspector must notify registrar in writing
May suspend or remove the premises from the register
268
What is fitness to practice?
Annual declaration of competence submitted with 4 CPD records
269
What constitutes impairment of FtP?
```
Misconduct towards a patient/customer
Deficient professional performance
Adverse health
Failure to comply with requirement imposed by assessor
Conviction of criminal offence
Fixed penalty
Police caution
Inclusion in barred list
```
270
Under what circumstances may the registrar refer an FtP case to the investigating committee?
Where evidence suggests:
Conduct presents risk, undermines confidence in pharmacy professionals, serious failure to meet standards
Honesty/integrity can no longer be relied upon
It is in public interest
271
What may an FtP investigation involve?
```
Speaking to complainant and witnesses
Speaking to pharmacist
Visiting location of alleged incident
Collect witness statements
Formally interview employees, owners and pharmacist
Seize evidence
```
272
What is the role of the investigating committee?
Screening cases before referral to FtP committee
| Do not hear oral evidence, may give warning to appear in register
273
What is the role of the FtP committee?
Consider all referred cases to determine if impairment is present
274
What sanctions may the FtP committee impose?
```
Give advice
Issue a warning
Impose conditions to register entry for up to 3 years
Suspend for up to 12 months
Remove from register
```
275
What are the criteria for FtP suspensions?
Following review, the suspension may be extended for a further 12 months or the entry may be removed completely
May suspend indefinitely where it has been in place for over 2 years
On termination of suspension, conditions may be imposed for 3 years
276
Under what circumstances may entries not be removed from the register regarding FtP?
Where it is impaired by ill health alone
277
What occurs after referral to FtP committee?
Registrant must supply details of their employer within 14 days
Employer must be notified of the referral
Professional performance assessor may demand records within 14 days or seek a court order
278
What is an interim order?
Imposed when the FtP committee feel that it is in the best interests of the public or the registrant
May be suspension for up to 18 months or conditional re-entry
Reviewed every 6 months or where new evidence is available
279
What are the conditions or restoration or reapplication to the register?
Application cannot be made for 5 years after removal or within 12 months of another application
Restoration may be conditional for up to 3 years
FtP committee can direct that no further applications can be made
280
What directions from the FtP committee may be appealed
Direction to remove entry
Direction fro suspension or conditional entry
Direction to alter conditions
Direction to prevent further applications
281
What are the possible outcomes of an appeal against an FtP direction?
Dismissal
Allow appeal and quash direction
Substitute for alternative direction FtP committee could have given
Referral
282
When does FtP committee direction take effect?
After period of appeal or appeal itself is complete
| May be sooner or immediately where to committee deem necessary to protect public safety
283
What is a coroner?
Independent offices of the crown
Usually a doctor or solicitor
Appointed by local councils
Investigate deaths that are unnatural or unexpected
284
What deaths are reported/investigated by a coroner?
Deceased not seen by a doctor during final illness
No death certificate available
Death certificate cannot be signed by a doctor within 14 days
Death during surgery or before anaesthetic wears off
Death from industrial disease or poisoning
Sudden, unexplained
Violent or due to neglect
Suspicious
In police custody or prison
285
What is a rule 43 report?
Formal letter issued by a coroner to interested parties in order to prevent future deaths
Must be responded to in writing and acted upon
286
What is the Bolam/Bolitho test?
Used to assess medical negligence against what other people would do
Cannot defend case on the basis of current practice that is not legal or reasonable
