Law Flashcards
1
Q
Number of revalidation entries
A
6 records
2
Q
How many CPD
A
4 CPD
3
Q
How many planned CPD
A
2
4
Q
What type of revalidation records
A
1 peer discussion, 1 reflective account, 4 CPD
5
Q
Difference between PO and GSL
A
GSL but only sold in a pharmacy
6
Q
When can GSL meds be sold in a pharmacy
A
When there is a pharmacist (but the RP can be physically absent)
7
Q
Who can sell P medicines
A
Pharmacist or person working under a pharmacist
8
Q
Are P medicines able to be picked by the public
A
Pharmacy medicines must not be accessible to the public by self-selection
9
Q
What are pseudoephedrine and ephedrine used for
A
As decongestants
10
Q
Maximum amount of pseudoephedrine that can be supplied at one time without a prescription
A
720mg
11
Q
Maximum amount of ephedrine that can be supplied at one time without a script
A
180mg
12
Q
Can you sell or supply pseudoephedrine at the same time as ephedrine
A
No
13
Q
Why are large quantities of pseudo/ephedrine supply prohibited
A
Crystal meth production
14
Q
What aged women is levonorgestrel licensed for
A
16
15
Q
How many hours do you need to use levornorgestrel within
A
72
16
Q
Can you supply EHC before unprotected sex
A
Yes - check competency and clinical appropriateness
17
Q
Is ulipristal contraindicated under the age of 16
A
No
18
Q
When to report EHC sale
A
Contact social services if 13 and under
19
Q
Does confidentiality apply under the age of 16
A
Yes, so decision to share info requires consent
20
Q
How to supply EHC
A
Sell, service providers
21
Q
Max amount of paracetamol
A
100 non-effervescent tablets to a person at one time
22
Q
Max amount of aspirin
A
100 non-effervescent tablets to a person at one time
23
Q
What is the indication of codeine and dihydrocodeine otc restricted too
A
Acute moderate pain not relieved by paracetamol, ibuprofen and aspirin it is not for cold, flu, cough, sore throat and minor pain etc
24
Q
What pack sizes of dihydro/codeine can be sold OTC
A
32 and less
25
What is the required dihydro/codeine PIL / label requirement/caution
‘Can cause addiction. For three days use only’
26
Is it only good practice to restrict dihydro/codeine packs to 32
No, any greater is a POM
27
How long should OTC/dihydro be for
3 days
28
What contraceptive can be used under 16
Ulipristal
29
Levonorgestrel - what brand
Levonelle
30
Is a signature required on a script
Yes
31
What part of the script doesn't have any legal requirements
For non-CDs the 'box' concerning the actual drug
32
Is a date needed on a script
Yes
33
How long is a normal prescription valid for
6 months
34
What is the appropriate date the earlier or later
The later (it is the date before which it should not be dispensed)
35
When is the age of a patient required on a script
If under 12
36
What is the appropriate date on private scripts
The date it was signed
37
Can you use carbon copies of scripts
Yes as long as signed in ink
38
Are a prescribers particulars required on a script
Yes to identify if they are an appropriate prescriber
39
Can you dispense Welsh scripts
Yes, but need to understand it
40
Requirements for a script
Signature of prescriber, address of prescriber, particulars of prescriber, date, age, patient name, patient address
41
Does a number need to be stated for repeating oral contraceptive
No, it can be dispensed 6 times, repeated 5 time
42
How many times can you dispense something if a number isn't stated
Twice
43
What prescriptions aren't repeatable
Sch 2 and 3
44
Is there a time limit for remaining repeats
No legal time limit the first dispensing must be within 6 months of the appropriate date
45
When does the first repeat for a schedule 4 need to be made and is there a limit for the remaining repeats
28 days, no remaining time
46
How do you have an audit trail for repeats
Mark on the prescription the name and address of the pharmacy where supply is from and the date
47
How long should private scripts be kept
For a POM 2 years from sale/supply/last repeat
48
Where should records about private scripts be kept
POM register (written/electronic)
49
How long should the POM register be kept
2 years from last entry
50
What should the POM register include
Supply date, prescription date, medicine details, prescriber details, patient details
```
• Supply date
The date on which the medicine was sold or supplied
• Prescription date
The date on the prescription
• Medicine details
The name, quantity, formulation and strength
of medicine supplied (where not apparent from
the name)
Prescriber details
The name and address of the practitioner
• Patient details
The name and address of the patient
```
51
When should records be made in the POM register
Day supply made or the next day
52
What prescriptions are exempt from record keeping
Oral contraceptives are exempt from record keeping; as are prescriptions for Schedule 2 CDs where a separate CD register record has been made
53
Is the name of a medicine a legal requirement on a script
No
54
Is the form of a drug on a script a legal requirement
No
55
Is the quantity of a drug on a script a legal requirement
No
56
Is the dose on a script a legal requirement
No
57
How long are owings for POM and schedule 5 valid for
6 months from the appropriate date
58
How long are owings for p and gsl valid for
6 months from the appropriate date
59
How long are owings for schedule 2,3,4 valid for
28 days from the appropriate date
60
Can dentists legally write any POM prescription
Yes
61
When is dentist prescribing limited
When on an NHS dental prescription
62
Aim of FMD
Reduce the risk of fake medicines entering the medicines supply chain and reaching patients.
63
Why are faxes not legal
No indelible ink
64
Are repeat scripts from EEA/switz recignised legally
Yes
65
Are emergency supplies from EEA/ Swiss recognised legally
Yes
66
Script requirements for EEA
Patient details, prescriber details, medicine details, prescriber signature,date of issue
67
What details of a prescriber are required for EEA/Swiss prescribers
Full first name, surname qualification, contact details (email and telephone with international prefix, work address and country
68
Is date of birth required for EEA scripts
Yes
69
How long are EEA scripts valid for
6 months (28 for sch4)
70
What drugs can’t be prescribed on an EEA script
Sch 1,2,3 and drugs without a marketing authorisation in the UK
71
What do you do if you can't guarantee/find a doctors qualifications from EEA
Can supply but document decisions
72
Legal requirements for labels
• Name of the patient • Name and address of the supplying pharmacy • Date of dispensing • Name of the medicine • Directions for use • Precautions relating to the use of the medicine
73
Is the keep out of reach and sight of children a legal requirement/ use on skin only note
No it is recommended by RPS though
74
Is it a legal requirement to label the actual container and not box?
No it is good practice according to NPSA
75
Requirements for partpacks
Name of the medicine • Quantity of the medicine in the container • Quantitative particulars of the medicine (i.e. the ingredients) • Handling and storage requirements where appropriate • Expiry date • Batch reference number (e.g. LOT number or BN)
76
Key conditions for emergency supply at request of prescriber
Relevant prescriber, an actual emergency, prescription within 72 hours, directions from prescriber, No CD (1,2,3) except phenobarbital, record
77
Record of emergency for prescriber request
In POM register on day of supply(or next day) - date of POM supply, name of drug +strength/form/quantity, name and address of prescriber requesting, name and address of patient, date on script, date script received
78
Requirements for patient emergency request
* Interview
* Immediate need (surgery does not need to be shut)
* Previous treatment (consider how long ago last supply was)
* Dose known
* Not sch1 2 3 except phenobarbital
* Maximum amount for sch 4/5 id 5 days but 30 for other poms unless insulin/ointment/cream/asthme inhaler, smallest pack given a full oral contraceptive treatment cycle supplied
79
Is there a difference in labelling for emergency supply
For prescriber request there isn't but patient request should be labelled emergency supply
80
Record keeping for patient requested emergency supply
Make in pom register on the day or following day. Date POM supplied. name, strength, form and quantity of POM supplied. Name and address of patient. Info on the nature of the emergency (why needed and why script can't be obtained)
81
How podiatrists and optometrists get drugs for patients
Signed patient order, it is not a prescription so doesn't have the same requirements but must ensure right advice given and that the patient, must be labelled as normal and in POM register if from pharmacy
82
How long should signed orders be kept
2 years or enter into POM register (regardless good practice to write in POM register)
83
POM register for signed order
Date supplied. Name, strength, form, quantity supplied. Name
and address of trade/business/profession. Purpose of selling
84
How long are oral retinoid scripts valid for
7 days, refer back to prescriber if outside of this, pregnancy status may need to be reconfirmed
85
Maximum supply of oral retinoid if PPP
30 days
86
PPP stands for
Pregnancy prevention programme
87
What to do with women patients on valproate
Talk to those of child bearing age to find out if they spoke to doctor and are aware of risks and are on a PPP
88
What to do if women on valproate pregnant
Tell them to not stop treatment and arrange appointment with prescriber urgently
89
How should biologics be prescribed
By brand
90
What to do when a mistake is spotted
1 Take steps to let the patient know promptly 2 Make things right (this may involve contacting the prescriber) 3 Offer an apology 4 Let colleagues involved in the error know
91
Does a pharmacist hold a wholsale dealers licence
Yes
92
Who needs a wholesale dealers licence
Anyone trading medicines
93
Who can be supplied medicines
• Doctors • Dentists • Registered pharmacies • Hospitals, clinics and independent medical agencies • Midwives • Chiropodists/Podiatrists • Optometrists and Additional Supply Optometrists • Paramedics • Owner or Master of Ship • Orthoptists • First aid organisations • Certified first aiders • Working for National Lifeboat Institution • Occupational health schemes • Drug treatment services • NHS Trusts
94
When are pharmacies not required to hold a WDA(H) to wholesale deal:
• It takes place on an occasional basis • The quantity of medicines supplied is small • The supply is made on a not for profit basis • The supply is not for onward wholesale distribution.
95
What to do when a POM is supplied to a HCP/Organisation
Enter in POM register or keep signed order good practice to write in pom register regardless
96
Details in POM register needed
• Date the POM was supplied • Name, quantity and, where it is not apparent, formulation and strength of the POM supplied • Name and address, trade, business or profession of the person to whom the medicine was supplied • Purpose for which it was sold or supplied
97
Details needed on signed order?
Not specified in legislation, good to have at least the details for POM register
98
POM-V
POM meds only prescribed by vet surgeon, only supplied with written prescription (supplied by pharmacist or vet surgeon)
99
POM-VPS
Prescribed/supplied by vet surgeon or pharmacist with oral/written prescription (only needed if supplier is not the prescriber)
100
NFA-VPS
Non food animals supplied by vet/pharmacist
101
AVM GSL
Authorised vet med GSL
102
Unauthorised veterinary med
No marketing authorisation under the cascade
103
Are standardised forms of sch 2/3 animal prescriptions needed?
No
104
How long should vet CD scripts be kept for
5 years
105
What is the cascade
Allows the supply of medicines that are not licensed for animals.
106
Can you supply human medicine for pet OTC
No
107
When can you supply human medicine for pet
If prescribed by vet surgeon and specifically states for administration under the cascade
108
What does the cascade mean
Where a licensed version is available use it
109
When can vet meds licensed for other animals/conditions be used
If script says admin under the cascade
110
Vet cascade
1. Legal requirement to supply licensed vet med –
2. if not possible use existing licensed med for another species/condition
3. if not possible use licensed human medicine
4. - if not possible use extemp/special
111
Legal requirements when selling NFA VPS/ POM VPS
• Advise on how to use the product safely • Advise on any applicable warnings and contraindications on the packaging or label • Be satisfied that the recipient intends to use the medicine correctly and is competent to do so • Prescribe or supply the minimum quantity required for treatment.
112
Is the physical presence of a pharmacist needed for pom-v/pom-vps/NFA-VPS
Yes
113
Label if not under the cascade
No legislation for a dispensing label being required but it is good practice
114
When do you need records kept (vet)
POM-V and POM-VPS
115
Do you need to keep all documents for vet things
Either keep all or make appropriate record in private prescription book
116
Can you have electronic records of vet stuff
Yes
117
How long should vet things be recorded for
5 years
118
Audits and POM-v/vps
Have to undertake an annual audit
119
Wholesale dealers authorisation (WDA)
Only manufacturer or holder of WDA may routinely supply vet meds, there are authorised retaillers but if there is a shortage a retauler can supply to another retailer
120
Schedule 1 full name
CD Lic POM
121
Schedule 2 full name
CD POM
122
Schedule 3 name
CD No Register POM
123
Schedule 4 names
CD Benz POM and CD Anab POM
124
Schedule 5 names
CD INV P and CD INV POM
125
Schedule 2 examples
Opiates (e.g. diamorphine, morphine, methadone, oxycodone, pethidine), major stimulants (e.g. amfetamines), quinalbarbitone and ketamine
126
Schedule 3 examples
Minor stimulants and other drugs (such as buprenorphine, temazepam, tramadol, midazolam and phenobarbital
127
Schedule 4 part I
e benzodiazepines (such as diazepam), non-benzodiazepine hypnotics (such as zopiclone), and Sativex (a cannabinoid oromucosal mouth spray)
128
Schedule 4 part ii
Steroids, growth hormones
129
Schedule 5
Codeine, pholcodeine, morphine
130
How long are different prescription CD things valid for
28 days for sch 1 -4 , 6 months for sch 5
131
What CD can be prescribed out of the uk
Sch 4,5
132
What CD prescription is repetable
Sch 4,5
133
What CDs can't be emergency supply
Sch 2, 3 (except phenobarbital for epilepsy)
134
What CD's are requsitions needed for or need to be marked by the supplier
Sch 2, 3
135
What CDs don't need a licence required to import or export
Sch 5
136
Who else can posses CDs
Home office licence, home office group authority, legislation: class of person e.g. Postal operator , legislation: class of drug, patients
137
When can pharmacists posses sch 1
To destroy or hand over to police
138
CD requisition legal requirements
1 Signature of the recipient 2 Name of the recipient 3 Address of the recipient 4 Profession or occupation 5 Total quantity of drug 6 Purpose of the requisition
139
Who needs to sign hospital requisitions
Person in charge, or acting in charge of a hospital issues and signs a requisition, this must also be signed by a doctor or dentist employed or engaged in that hospital.
140
Do community pharmacies legally need a requisition in writing before delivery of sch 2 and 3
No
141
How can you accommodate emergency requisition
A doctor or dentist can be supplied with a Schedule 2 or 3 CDs on the undertaking that a requisition will be supplied within the next 24 hours. Failure to do so would be an offence on the part of the doctor or dentist
142
What do you need to supply meds to a messenger
A written authorisation must be provided to the supplying pharmacist that empowers the messenger to receive on behalf of messenger
143
How long do you need to keep authorisation slips
2 years
144
When do requisition processing requirements not apply
If supply is made By a person responsible for the dispensing and supply of medicines at a hospital, care home, hospice, prison or organisation providing ambulance services as they need to keep the original copy for 2 years
By pharmaceutical manufactures or wholesalers
• Against veterinary requisitions (the original requisition should be retained for five years).
145
Legal requirements when schedule 1, 2 or 3 CD is received
* Mark the requisition indelibly with the supplier’s name and address (i.e. the name of the pharmacy); where a pharmacy stamp is used this must be clear and legible
* Send the original requisition to the relevant NHS agency.
146
What CDs can a midwife order
• Diamorphine • Morphine • Pethidine
147
What must a midwife order form contain
• Name of the midwife • Occupation of the midwife • Name of the person to whom the CD is to be administered or supplied • Purpose for which the CD is required • Total quantity of the drug to be obtained • Signature of an appropriate medical officer – a doctor authorised (in writing) by the local supervising authority or the person appointed by the supervising authority to e
148
What prescriber should be written on the CD register
Actual prescriber the signatory
149
Can a CD be signed by another prescriber
Yes but need same address
150
Can CD prescriber signatures change
Needs to be usual
151
What date needs to be on prescription
Date signed
152
Does the dose of CD need to be in words and figures
No, just clearly defined
153
When does the strength need to be written on a CDs
If the med is available in more than 2 strengths
154
Quantity requirements for CD
Words and figures
155
Maximum quantity of sch 2 3 4
Good practice, 30 days
156
Is the maximum quantity of CD a legal or good practice recommendation
Good practice prescribers need clinical reason for more
157
What is needed on dental CD script
Words ‘for dental treatment only’ must be present.
158
Other requirements when supplying CD
Write date and time supply made
159
Is the name of medicine a legal requirement on a CD script
No
160
What two key things are needed on an installment
Dose and instalment amount specified
161
When must the first instalment be dispensed
Within 28 days
162
Is the installment direction a legal requirement
Yes
163
Can a pharmacist amend typos on sch 2/3 CD
Yes (words/figures not both)
164
What requires a standardised form
Private schedule 2/3
165
What do private prescriptions sch2/3 CD need
Standardised form, prescriber identification number, submit to NHSBSA
166
Do you legally need to find out who the person collecting a CD is?
Yes need to find out if it is patient/rep/HCP
167
How to have a representative pick something up for drug misuse
Obtain a later from drug misuse authrorising and naming the representative
168
Is it legal/good practice to sign sch 2/3
Good practice
169
Do instalments need to be signed all the time
Just once
170
Can a delivery driver/representative sign on behalf of patient
Yes
171
Where must CD be kept
‘locked safe, cabinet or room which is constructed as to prevent unauthorised access to the drugs’
172
Does safe custody apply to patient returned
Yes until they can be destroyed, but segregate from others
173
When is an authorised witness required for destruction
Expired/obsolete / unwanted stock for sch 2 only good practice for sch3
174
Should destruction of CD be in a register
Sch 2 in CD register
175
Can CDs be dispersed into sewerage system
No
176
How to destroy solids
Grind/crush add to denaturing kit, small amount of water whilst crushing. Of rnd place in warm soapy water then pour onto suitable product and add to appropriate disposal waste bin
177
How to destroy liquid
Pour into appropruate CD denaturing kit or on suitable product, rinse bottle then put in correct pharmaceutical waste,
178
Destroying ampoule
Liquid ampules pour out then do the same as liquid, powder ampules, open add water then pour mixture on denaturing kit or crush ampoules with pestle then add warm soapy water
179
Destroying patches
Remove backing fold over itself and place into waste disposal bin/denaturing it
180
Destroy aerosol
Expel into water then put water in cd denaturing kit
181
When is a CD register used
Any sch 1/2 received/supplied
182
Info needed in register when receiving
* Date supply received
| * Name and address from whom received • Quantity received.
183
What to enter in CD register when supplying
* Date supplied
* Name and address of recipient
* Details of authority to possess – prescriber or licence holder’s details
* Quantity supplied
* Details of person collecting Schedule 2 CD – patient, patient’s representative or healthcare representative (if the latter, also record their name and address)
* Whether proof of identity was requested of the person collecting
* Whether proof of identity was provided
184
What is required in the heading of CD registers
Class, strength and form
185
Legislation requirements for CD books
Heading has class strength form, different part of register used for different class and separate pages for different strengths formulation and so forth
186
How should CD entries be made
Chronological, entered promptly, unaltered, ink/indelible
187
Can a CD book be kept at a different location
No only at the premises it applies to
188
How long should CD registers be kept after last entry
2 years
189
Is a running balance a legal requirement
No good practice post-shipman
190
How to note a discrepancy on a CD register
A marginal note or footnote should be made in the register and the discrepancy corrected
191
Is pom register entry needed for sch 2 cd
When a CD entry is made for sch 2 the usual requirement to make a record in the POM register does not apply
192
Cannabis sch
2
193
Sativex sch and indication
MS/ spasticity
194
Nabilone indication
Chemo Nausea and Vomiting
195
Use by means
Use before end of previous month
196
Use before means
Use before end of previous month ‘Use by 06/2019’ means that the product should not be used after 31 May 2019.
197
Expiry date means
Product should not be used after the end of the month stated expiry date of 12/2019 means that the product should not be used after 31 December 2019.
198
Can pharmacies receive waste medicines
Yes
199
Where should waste be stored
Secure waste containers away from medicines that are for for use, sharps should be in a sharp container
200
Should you deblister tablets/capsules before putting into waste
no
201
How do you find out if someone is able to buy poisons
They show a home office licence
202
How to decide if to give medicines to a child
Maturity, knowledge of the child, nature of meds, prior arrangement, reasoning, local policy, id proof
203
Medical devices examples
Dressings, thermometers, needles, syringes, blood pressure monitors, stoma care products, condoms, test kits (e.g. cholesterol test kits, pregnancy test kits, etc.)
204
When must a pharmacist have access to an anaphylaxis pack
If anaphylactic reaction could occur as part of role.g. Vaccines
205
Can someone be prosecuted for drugs and driving for taking meds as prescribed
Yes
206
What prescribable drugs are liable to drugs driving offences
Clonazepam Diazepam Lorazepam Oxazepam Temazepam Flunitrazepam Methadone Morphine Amfetamine
207
What to tell patients about driving and drugs
• You must not drive if you feel sleepy, dizzy, are unable to concentrate or make decisions, have slowed thinking, or if you experience sight problems. If the medicine is one that could affect your driving ability, you should not drive until you know how the medicine affects you as an individual, particularly when starting a new medicine or following a dose change
208
What does notice need to have
• The name of the responsible pharmacist • The GPhC registration number • The fact that the responsible pharmacist is in charge of the pharmacy at the time
209
What to do when altering records
Alterations or amendments made for both paper-based and electronic pharmacy records need to identify when and by whom the alteration/ amendment was made
210
Precautions for electric records
Measures should be made to back up the record and be kept on the pharmacy premises, available for GPhC inspection if required.
211
Can records for pharmacy record be remote
Yes as long as the record complies with all the relevant and professional requirements
212
What details need to be in the pharmacy record
Responsible Pharmacist's name,
RP reg number
Sate/time pharmacist became RP and stopped being RO
Date of absence, when RP left and returned
213
How long should pharmacy record be kept
5 years
214
When should pharmacy procedures be reviewed
Regularly but can be reviewed Every two years/following an incident -
215
Does the two hour rule apply to just one RP or any RP working in the 24 hours
It is the total time an rp can be away not 2 hours each
216
What needs to be in place if a pharmacist is absent
Only if pharmacy can continue to run safely and effectively, remain contactable, return very quickly if not contactable and arrange for another pharmacist to be contactable and available to provide advice
217
Can P meds be sold/supplied without a pharmacist
No supervision needs physical presence of pharmacist to be able to advise and intervene
218
Sale/supply of POM (handing dispensed meds)
needs physical presence
219
Wholesale of medicines without pharmacist
needs physical presence
220
Emergency supply of meds without pharmacist?
needs physical presence of pharmacist
221
What can be done that doesn't need pharmacist supervision
Sell GSL meds, process waste stock returned meds except CD
222
9 GPhC standards
1 Provide person-centred care
2 Work in partnership with others
3 Communicate effectively
4 Maintain, develop and use their professional knowledge and skills
5 Use professional judgement
6 Behave in a professional manner
7 Respect and maintain the person’s confidentiality and privacy
8 Speak up when they have concerns or when things go wrong
9 Demonstrate leadership
223
GSL medicines can be sold online true/false
True
224
You can sell GSL medicines at a outdoor market true/false
False
225
The direction for use is a legal requirement true/false
False
226
You can't sell pseudoephedrine and ephedrine in one transaction true/false
True
227
A pharmacist can supply on receipt of a signed order from the Head Teacher/principal true/false
True
228
It is okay to ask a patient to see you out of hours true/false
False
229
A relative gives consent for emergency treatment if an adult patient is unconscious true/false
False
230
Out of date tablets are still included in a CD balance true/false
True
231
When a prescriber endorses a prescription for an oral contraceptive pill with the word repeat the patient can be given the pill 6 times true/false
True
232
IP pharmacists can prescribe methadone for addiction true/false
True
233
A vet does not need to use an FP10CD true/false
True
234
Repeat prescriptions for sch 4 CDs are not allowed true/false
False
235
A gsl on a prescription can't be supplied if a Pharmacist is not on site true/false
True
236
Alterations do not need to identify who and when an alteration was made true/false
False
237
a Pharmacy record can be electronic true/false
True
238
Unlicensed medicines can be prescribed by a EEA doctor true/false
False
239
On an EEA prescription the prescriber's email must be included on the prescription true/false
True
240
On an EEA prescription, the prescriber's phone number must be included on the prescription true/false
True
241
A telephone number for a vet is a legal requirement for a vet prescription true/false
True
242
Veterinary prescriptions are subject to the NHS prescription charge true/false
False
243
You can't sell pseudoephedrine and ephedrine in one transaction
True
244
The direction for use is a legal requirement
False
