MEP Flashcards

1
Q

What is a POM-V medicine?

A

POM that can be prescribed by a vet, and supplied by a vet or pharmacist with a written prescription

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2
Q

POM-VPS

A

POM that can be prescribed and supplied by a vet, pharmacist or suitably qualified person with an oral or written prescription.

A written prescription is only required if the supplier is not the prescriber.

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3
Q

NFA-VPS

A

A category of medicines for non-food animals - a written prescriptions is not required.

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4
Q

AVM-GSL

A

An authorised veterinary medicine that is available on general sale.

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5
Q

Exempt medicines under schedule 6 of the veterinary medicines regulations - exemptions for small pet animals (SAES)

A

Unlicensed veterinary medicine that does not require a marketing authorisation because is meets criteria laid out in section 6 of the VMR - exemptions for small per animals.

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6
Q

Unauthorised veterinary medicines

A

Unlicensed medicines that does not have a marketing authorisation and is not eligible for exemptions through the SAES. Can only be prescribed by a vet under the cascade - this included any human medicine used for animals.

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7
Q

What information must be on a prescription for POM-V, POM-VPA and medicines supplied under the veterinary cascade?

A
  1. Name, address, telephone number, qualification and signature of prescriber.
  2. If CDs have been prescribed, the Royal College of Veterinary Surgeons (RCVS) registration number of the prescriber.
  3. Name and address of the owner
  4. Identification and species of the animal (and address if different from the owners)
  5. Date - valid for 6 months or 28 days if CD (or shorter if indicated by the prescriber). Repeat prescriptions must be repeated within this time too.
  6. Name, quantity, dose and instructions of medicines. ‘As directed’ is NOT acceptable.
  7. Warnings and relevant withdrawal period (e.g. time that must elapse between when an animal receives a medicine and when it can be used for food)
  8. ‘Prescribed under the cascade’.
  9. If CD’s have been prescribed: ‘this item has been prescribed for an animal or herd under the care of the veterinarian.’ Usual CD requirements also apply.
  10. Number of time the prescription can be repeated if repeatable.
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8
Q

Are standardised forms required for veterinary prescriptions?

A

No, not for CDs either.

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9
Q

How long should veterinary prescriptions retained?

A

5 years

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10
Q

Do you submit veterinary prescriptions to the relevant NHS agency?

A

No

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11
Q

As good practice - what is the maximum days of a CD that should be supplied on a veterinary prescription?

A

28 - unless longterm e.g. epilepsy meds in dogs

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12
Q

Can medicines be supplied under veterinary cascade if a licensed animal medicine is available?

A

No

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13
Q

What is the veterinary cascade?

A
  1. Supply a licensed veterinary medicines.

IF THIS IS NOT POSSIBLE

  1. An exicisting licensed veterinary medicine for another species or condition can be used

IF THIS IS NOT POSSIBLE

  1. A licensed human medicine or EU-licensed veterinary medicine can be prescribed

ONLY WHEN ALL THE ABOVE NOT POSSIBLE

  1. Extempt or special can be considered
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14
Q

Can an animal owner purchase OTC human meds if advised by a vet?

A

No - supply of all unauthorised veterinary medicines must take place under the cascade.

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15
Q

What must pharmacists who supply NFA-VPS and POM-VPS do?

A
  1. Advise how to use the product safety
  2. Advise on any applicable warnings and contraindications on the packaging or label
  3. Be satisfied that the recipient intends to use the medicine correctly and is competent to do so
  4. Prescribe or supply the minimum quantity required for treatment.
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16
Q

Does a pharmacist need to be physically present for the supply of POM-V, POM-VPS and NFA-VPS?

A

Yes - unless the transaction has been individually authorised in advance and the person handing out the medicine is judged to be competent.

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17
Q

What is required on the label / packaging of a veterinary medicine?

A
  1. Name of the prescriber
  2. Name and address of animal owner
  3. Name and address of the pharmacy
  4. Identification and species of the animal
  5. Date of supply
  6. Expiry date of the product
  7. Name or description of product or its active ingredients and quantity
  8. Directions
  9. Special storage instructions
  10. Warnings
  11. Applicable withdrawal period
  12. ‘For animal treatment only.’
  13. ‘Keep out of reach of children’.

RPS recommended KOOSAROC instead.

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18
Q

Is a label required for a veterinary medicine is not prescribed under the cascade?

A

No - however RPS advises to generate a label, particularly for individual animals (pets).s

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19
Q

Records of receipt and supply should be kept for which veterinary medicine categories?

A

POM-V and POM-VPS

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20
Q

What should the records for POM-V and POM-VPS medicines contain?

A
  1. Name of medicine
  2. Date of receipt or supply
  3. Batch number
  4. Quantity
  5. Name and address of supplier or recipient
  6. If there is a written prescription, name and address of the prescriber. Keep a copy of the prescription.
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21
Q

What POM-V / POM-VPS records should be kept?

A

Pharmacists can either keep the documents that show the required information, or can record in private prescription book.

Records can be kept electronically

Kept for 5 years

Pharmacies must undertake an annual audit

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22
Q

Can you wholesale veterinary medicines?

A

Only the manufacturer or a holder of a wholesale dealer’s authorisation (WDA) may supply authorised retailers with veterinary medicines.

An authorised retailer may supply to another authorised retailer to relieve a temporary shortage, without a WDA. .

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23
Q

What criteria do pharmacies need to meet to supply medicines to other HCP / pharmacies with a WDA?

A
  1. Takes place on an occasional basis
  2. The quantity of medicines supplied is small
  3. The supply is made ono a not for profit basis
  4. The supply is not for onward wholesale distribution
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24
Q

What do you need to trade medicines?

A
  1. Wholesale dealers license (WDA)
  2. Good distribution practice (GDP) standards
  3. Have a suitably experienced ‘responsible person’ named on a license
  4. Medicines can only be supplied to other wholesale dealers, pharmacists or persons authorised to supply medicines to the public.

These restrictions do not apply to the exchange
of stock between pharmacies that are part of the same legal entity, although where a legal entity holds a WDA(H) as one (or more) of its pharmacies is involved in the commercial trade of medicines, the supplying pharmacy must also be named on the WDA(H) if the stock supplied is for the purposes of wholesale.

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25
What license do you need to wholesale deal controlled drugs?
WDA | Home Office CD license (Sch 2-5).
26
Who can be supplied with medicinal products?
``` Doctors Dentists Registered pharmacies Hospitals, clinics and independant medical agencies Midwives Chiropodists / podiatrists Optometrists Paramedics Owner or master of a ship First aid organisations Certified first aiders Working for the national lifeboat organisations Occupational health schemes Drugs treatments services NHS Trusts ```
27
What are the record keeping requirements for signed orders?
When a POM is supplied, an entry need to be made in the POM register OR the signed order/invoice needs to be retained for 2 years from the date of supply. Good practice to always enter in register.
28
What must be included in an entry in the POM register for a signed order?
1. Date the POM was supplied 2. Name, quantity and, where it is not apparent, formulation and strength of the POM 3. Name and address, trade, business or profession of the person to whom the medicine was supplied 4. Purpose for which it was sold or supplied
29
What is the falsified medicines directive (FMD)?
1. New secutiry features on individual packs - anti-tampering device. 2. Electronic scanning authentication process to be undertaken at the point of dispensing/supply Aim to ensure medicines in the UK are safe, and reduces the risk fake medicines entering the supply chain. Applies to POMs for human use and NHS/private supplies.
30
What is a PGD?
Patient group direction. Allows the supply and/or administration of medicines, by named, authorised healthcare professionals, to a well-defined group of patients requiring treatment for a specific condition.
31
Can pharmacists supply / administer diamorphine or morphine under a PGD for the immediate, necessary treatment of a sick or injured person?
Yes
32
Can you supply an emergency supply for veterinary medicines?
No
33
For emergency supply at the request of a prescriber, who does 'relevant prescriber' include?
``` Doctor Dentist Supplementary prescriber Nurse / pharmacist / podiatrist / therapeutic radiographer / optometrist / paramedic independant prescriber Community practitioner nurse EEA or Swiss HCP ``` HCP from outside the EEU or Switzerland are NOT recognised as 'relevant prescribers'.
34
What are the conditions for an emergency supply at the request of a prescriber?
Relevant prescriber Emergency Prescription within 72 hours Directions Not for CDs - except phenobarbital for epilepsy Record kept (in day of supply or following day) Usual labelling requirements
35
What needs to be recorded in the POM register for an emergency supply at the request of a prescriber?
1. Date supplied 2. Name and quantity of medicine 3. Name and address of prescriber 4. Name and address of patient 5. Date on the prescription (can be added retrospectively) 6. Date which the prescription is received.
36
What are the conditions for an emergency supply at the request of a patient?
``` Interview Immediate need Previous treatment Dose - satisfied you know Not for CDs 2 and 3 - except phenobarbital for epilepsy Length of treatment - 5 days for CD 4/5/phenobarb, or 30 days for other POMs (or smallest pack size when cannot be broken down or full course of abx. Records kept in POM register 'Emergency supply' on label ```
37
What records must be kept for emergency supplies at the request of the patient?
1. Date supplied 2. Name and quantity of medicine 3. Name and address of patient 4. Nature of emergency.
38
What is the maximum number of days CD you can supply for an emergency supply at the request of a patient?
5
39
What is the maximum number of days of a POM you can supply at the request of a patient?
30
40
What can you not give on an emergency supply ?
Sch 1, 2 and 3 (except phenobarbital) ``` Ammonium bromide Calcium bromide Potassium bromide Sodium bromide Calcium bromidolactobionate Embutramide Fencamdamin hydrochlodire Fluanisone Fexobarbitone Hydrobromic acid Meclofenoxate Methohexitone Permoline Piracetam Prolintane Styrchnine Tacrine Thiopentone ``` Unlicensed medicines
41
What exemptions apply to emergency supplies during a pandemic?
No interview required with patient Medicines can be collected from designated collection points - does not have to be a pharmacy and requires no supervision of a pharmacist.
42
Optometrist or podiatrist signed order - what are the rules?
POMs can be supplied in accordance with a signed patient order. The medicine must be one which can be legally sold or supplied by the optometrist (rather than one they can only administer). Optometrists who have undertaken additional training and are accredited by the GOC can issue signed orders for an extended range of medicines. Prescriptions requirements do not apply Entry into POR required Labelling requirements apply
43
Who can provide a signed order for salbutamol inhalers for a school?
Written order signed by principal or head teacher
44
What information should be on a signed order for salbutamol for a school?
1. Name of school 2. Purpose of product 3. Total quantity of product 4. Signed by head teacher Ideally but not required: appropriately headed paper
45
How many inhalers can a school obtain?
Small quantities - dependant on many factors
46
What records need to be kept when salbutamol is supplied to schools?
Signed order kept for 2 years OR entry in POR. POR entry must include: - Date supplied - Name, quantity, form and strength - Name and address, trade, business or profession of the person whom the medicine was supplied to - Purpose for which it was sold / supplied
47
What other information could the pharmacy be asked to provide when supplying salbutamol to schools?
- How to use the inhaler | - Advise on the most appropriate spacer device for different age groups
48
Where can you obtain information on a school, including details of the head teacher?
No centralised database Possible sources: - Ofsted reports - Schools website - Department for education's register or educational establishments
49
What other information could pharmacists be asked for when supplying epipens to schools?
- Administration instructions - General advice e.g. storage, disposal, expired stock - Advise schools on the important of keeping a record of spare AAIs held and their expiry dates, to ensure they are replaced appropriately.
50
What brand adrenaline should you supply to schools?
DoH advises schools stock a single brand to avoid confusion - but discretion of brand depends on the school.
51
What drug can be supplied in lawful drug treatment services from a wholesaler to the patient, without a prescription, PGD or PSD?
Naloxone | Nasal naloxone
52
What is a lawful drug treatment service?
Persons engaged in the provision of drug treatment services, provided by, on behalf of, or under arrangements made by: - An NHS body - A local authority - PHE - Public health agency This extends to commissioned services providing needle and syringe programmes.
53
Who can administer naloxone for the purpose of saving a life?
Anyone
54
Does a pharmacist need to be present to supply naloxone in a local take home scheme?
No - can be provided by appropriately trained staff.
55
What should you consider before supplying a self-prescribed prescription?
- Considered poor practice - Professional judgement of prescriber may be impaired - May not be possible for prescriber to conduct a proper clinical assessment - GMC advises doctors should avoid prescribing for themselves or close family/friends - Nurses and pharmacists should not prescribe for themselves - If there a local policy advising? - Potential for abuse - CDs may prompt referral to local CD accountable officer
56
What is the risk of using oral retinoids in pregnancy?
e.g. isotretinon, alitretinoin, acitretin. High risk of causing severe foetal malformations and increase the risk of spontaneous abortion.
57
Suppling oral retinoids - what special distribution control are in place for females at risk of pregnancy?
Prescription is only valid for 7 days Maximum 30 days supply - can only supply more than 30 days if confirm with the prescriber that the patient is not pregnant. Do not accept repeat prescriptions
58
What should pharmacists do when supplying sodium valproate?
- Consultation with patient: are then on PPP and aware of risks? - Advise patients planning pregnancy to schedule an appointment with the prescriber to review treatment. - If unplanned pregnancy, advise NOT to stop taking medicine and arrange urgent appointment with prescriber - Report any adverse effects via yellow card scheme.
59
What is a biologic?
Medicine made from natural sources, which may be human, animal or microorganism. Examples: vaccines, blood products, DNA, human cells etc.
60
What is a biosimilar?
Biological medicine similar to an already licensed biologic medicine in terms of: quality, safety and efficacy. Can only be marketed after the patent protecting the originator product have expired.
61
Why is a biosimilar not a generic?
Due to complex structure and greater size, inherent heterogeneity resulting from production methods. Not possible to characterise a biologic to the same extent as a small molecule drug.
62
Should you switch between biologics/biosimilars?
Decision must be made by the prescriber.
63
Should biosimilars be prescribed by brand name?
Yes - recommended by MHRA
64
What additional details should be recorded when reporting a suspected ADR to a biological medicine?
Brand name | Batch number
65
Where can you check the registration of vets?
Royal college of veterinary surgeons
66
Where can you check the registration of paramedics, chiropodists, podiatrists, physiotherapists, optometrists, dieticians, orthoptists and radiographers?
Health and Care | Professions Council
67
What should you do when you become aware of a dispensing error?
1. Take steps to let the patient know promptly 2. Make things right (may involve contacting the prescriber) 3. Offer an apology 4. Let colleagues involved in the error know
68
When can the defence to the section 64 'dispensing error' offence be used?
When the dispensing error has been: - Dispensed in a registered pharmacy - Dispensed by of under the supervision of a registered pharmacist - Supplied against a prescription, PGD or direction from a prescribed - Promptly notified to the patient
69
What does 'use by' and 'use before mean'?
Should be used before month stated.
70
What does expiry date mean?
Product should not be used after end of the month stated.
71
Where should waste medicines be stored?
Secure waste containers in designated area, preferable away from medicines fit for use
72
Should you de-blister tablets when disposing?
No. Blister strips can be removed from inert outer packaging, but tabs and caps not de-blistered.
73
How should liquid medicines be disposed of?
The whole bottle (including empty bottles containing residue) should be placed in the pharmaceutical waste container.
74
What does the responsible pharmacist need to do?
Secure the safe and effective running of the pharmacy Display a notice Complete the pharmacy record Establish, maintain and review pharmacy procedures
75
What does the RP notice need to include?
Name GPHC number The fact that the responsible pharmacist is in charge of the pharmacy at the time
76
How may the pharmacy record be kept?
In writing Electronically Both
77
What are the principals of the pharmacy record?
It should show who was the responsible pharmacist was at any given date and time The record should be made by the responsible pharmacist - an entry can be made remotely Any amendments must show when and who by Electronic records should be backed up and the record should be kept on the premises, available for GPHC inspection if required.
78
What details must be recorded in the pharmacy record?
1. RP's name 2. GPHC number 3. Date and time pharmacist became RP 4. Date and time pharmacist stopped being RP 5. If you are absent: - Date of absence - Time left + returned
79
How long should the pharmacy record be kept?
5 years
80
Where should the pharmacy record be kept?
On the premises it relates to
81
How often should pharmacy procedures be reviewed?
Every 2 years, or following an incident which may indicate that the pharmacy may not be running safely and effectively.
82
How should the pharmacy procedure be stored?
In writing Electronically Or both
83
How long can the RP be absent for in 24 hours?
2 hours
84
If there is more than one RP for a pharmacy in 24 hours, what is the total time they can be absent?
2 hours
85
What arrangements must be in place if the RP is absent?
- Only allowed to be absent if the pharmacy can continue to run safely and effectively - They must remain contactable and be able to return with reasonably promptness - Another pharmacist must be contactable and available if not possible for the RP (does not have to be the RP)
86
Can you sell P meds when the pharmacist is absent?
No
87
Can you hand out POMs when the RP is absent?
No
88
Can you wholesale meds when the RP is absent?
No
89
Can you supply meds under a PGD if the RP is absent?
No
90
Can you dispense medicines when the RP is not present?
Yes RP must be logged for the day
91
Can you accuracy check without a RP present?
Yes RP must be logged for the day
92
Can you perform a professional check of a prescription when the RP is absent?
No
93
Can you sell GSL medicines when the RP is absent?
Yes - by suitable trained staff under the operating procedure RP must be logged for the day
94
Can you process waste stock medicines or patient returns (including CDs) when the RP is absent?
Yes RP must be logged for the day
95
What tasks can be done in a pharmacy with no RP responsible / signed in?
Ordering stock from wholesalers Receiving stock from wholesales (excluding CDs) Putting stock on shelves Date checking Stocking the pharmacy with consumables Cleaning Responding to enquiries Accessing the PMR Receiving prescriptions from EPS or by collecting from a surgery Processing of prescriptions that have been dispensed (e.g. counting) Delivery person conveying medicines to a patient Receiving patient returns (excluding CDs)
96
When is it appropriate to disclose confidential information?
- When consent is provided - When you have to disclose by law - In the public interest - Vital interest of a person receiving treatment o care e.g. a person needs urgent medical attention.
97
When disclosing confidential information, what records should be kept?
- Who the request came from - Whether consent was obtained or reason for not - Whether consent was given or refused - How it was ensured disclosure was made securely - The lawful authority or provision was under which the request or disclosure was made. - Retain a copy of the disclosure made
98
When might pharmacy professionals have to disclose information by law?
- Police or other enforcement prosecuting or regulatory authority - Health regulator e.g. GPHC, GMC - NHS counter-fraud investigation officer - A coroner, procurator fiscal, judge or relevant court You must be satisfied these professionals have legitimate reason. You can get advice from a relevant body, union, professional body, ICO, independent legal advisor etc.
99
How to raise a concern
1. Find out the organisations policy 2. Report without delay 3. Report to immediate supervisor 4. Report to another suitable person in authority or and outside body 5. Keep a record 6. Maintain confidentiality
100
What to do when a dispensing error occurs
Establish if the patient has taken any of the incorrect medicines - if they have, inform their GP. Ask to inspect the incorrect medicine Apologise Never try to minimise the seriousness Make a supply of the correct medicine, even CDs Establish patient expectations Provide details of how to complain to an 'official body' Try to establish what went wrong Follow company procedures Record, review and learn Notify pharmacist on duty at the time Inform professional indemnity insurance provider Carry out a root-cause analysis
101
What are the 4 principals of medicines optimisation?
1. Aim to understand the patients experience 2. Evidence-based choice of medicines 3. Ensure medicines use is as safe as possible 4. Make medicines optimisation a part of routine practice
102
What is a just culture?
Open, reporting, learning Safety and quality: balanced accountability and learning Fair Improved patient experience
103
What records do you need to submit for revalidation?
4 x CDP records (at least 2 planned) Peer discussion Reflective account
104
What is a GSL medicine?
Can be sold in pharmacies and other retail outlets that can 'close so as to exclude the public'. Can only be sold in pharmacies when RP has assumed role, however pharmacist can be absent.
105
What are P medicines?
May be sold in pharmacies under supervision of RP. Self-selection is prohibited
106
What is a POM?
Needs a written prescription written by an appropriate prescriber (not outside EEA or Switzerland)
107
Can you sell pseudoephedrine and ephedrine products at the same time OTC?
No
108
What is the maximum amount of pseudoephedrine you can supply without a prescription?
720mg
109
What is the maximum amount of ephedrine you can supply without a prescription?
180mg
110
What are signs of pseudoephedrine/ephedrine missuse?
``` Lack of cold symptoms Rehearsed answers Impatient or aggressive Opportunistic (waiting for busy periods) Specific products Also purchasing lithium batteries of acetone Requests large quantities Makes frequent requests ```
111
Where can you report a concern regarding missue?
Local GPHC inspector Local controlled drugs liaison police officer Accountable officer
112
Which drugs are licensed for EHC OTC?
Levonorgestrel 1500 micrograms | Ulipristal acetate 30mg
113
What age is levonorgestrel licensed for?
16 or over
114
How long is levonorgestrel licensed for EHC?
72 hours
115
How long is ulipristal acetate licensed for EHC?
120 hours (5 days)
116
What is the age licensing for ulipristal acetate?
None - for all females of child bearing potential
117
Can you provide an advanced supply of EHC?
Yes - prior to unprotected sexual intercourse of failure of contraceptive methods. Patient should be assessed to ensure they are competent to use the medicine appropriately, and that it is clinically appropriate.
118
What is the legal age for consent to sexual activity?
13
119
How many paracetamol can be sold OTC?
100 non-effervescent tablets No legal limits of liquids, effervescent etc. but use professional judgement.
120
How many aspirin can be sold OTC?
100 non-effervescent tablets No legal limits on effervescent but use professional judgement.
121
What indications can codeine or dihydrocodeine be sold OTC?
Short term treatment, of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone. Not for colds, flu, minor pain etc.
122
What is the maximum pack size of codeine OTC?
32 - anything more is POM Selling more than one pack would undermine restriction.
123
What warnings need to be in a clear, prominent position on the front of OTC packs of codeine and dihydrocodeine?
'Can cause addiction. For three days use only'
124
What must be stated on the PIL and packaging of OTC codeine or dihydrocodeine?
Indication Medicine can cause addiction or headache if used continuously for more than 3 days. The PIL must also contain warning signs of addiction.
125
What needs to be present for a prescription to be legal?
1. Signature of prescriber - in ink. An advanced electronic signature can be used to authorise an electronic prescription. 2. Address of prescriber 3. Date 4. Particulars of prescriber 5. Name of patient 6. Address of patient 7. Age IF under 12
126
How long is an NHS prescription valid for?
6 months from date signed or date or a date indicated by the prescriber before which it should not be dispensed.
127
How long is a private prescription valid for?
Always from the date signed | 6 months or 28 days if a CD
128
Is computer generated or typed classed as indelible ink?
Yes
129
What prescription requirements apply to private prescriptions?
Same as for NHS. 1. Signature of prescriber - in ink. An advanced electronic signature can be used to authorise an electronic prescription. 2. Address of prescriber 3. Date 4. Particulars of prescriber 5. Name of patient 6. Address of patient 7. Age IF under 12
130
It is permissible to issue carbon copies of NHS prescriptions?
Yes - as long as they are signed in ink.
131
Do prescriptions have to be written in english?
Not legally - but keep best interest and safety in mind
132
Can prescriptions be presented from the crown dependencies (Jersey, Guernsey and Isle of Man (not UK))?
Yes Note CDs prescriptions must be from a prescriber addressed within the UK.
133
How many times can a repeat prescription be repeated if not stated by the prescriber?
Once (so dispensed twice) | Unless for an oral contraceptive, can be repeated 5 times (dispensed 6 times).
134
Can CD prescriptions be repeatable?
Not Sch 2 and 3 | Yes Sch 4 and 5
135
Is there a legal time limit when a repeat prescription can be dispensed?
The first dispensing must be within 6 months - but then no limit. If for a Sch 4, first dispensing must be within 28 days, but then no limit.
136
Can NHS FP10s, WP10s and GP10s be used as repeat prescriptions?
No
137
Is a repeat slip a prescription?
No - just a list of medications a patient can reorder
138
What is the NHS repeat dispensing services?
A prescriber can authorise a prescription with a specific number of 'batch' issued that may be dispensed at specific intervals from a pharmacy.
139
How long is an owing valid for?
Until the date of expiry of the prescription
140
How long should private prescriptions be retained for?
2 years from the date of sale or supply For repeatable prescriptions - 2 years from the last supply.
141
How long should private prescriptions for CDs be retained?
N/A - should be sent to relevant NHS agency
142
What information should be completed in the POR for private prescriptions?
``` Supply date Prescription date Medicine details Name and address of prescriber Name and address of patient ```
143
When should an entry be made into the POR for a private prescription?
On the day of the supply or next day
144
Which medicines on a private prescription are exempt from an entry into the POR?
``` Oral contraceptives CD 2s (as separate register is kept) ```
145
How long should the POR be retained?
2 years from the date of last entry
146
Is a faxed prescription a legal prescription?
No
147
What are the additional prescription requirements if the prescription is from EEA or Switzerland?
Patients DOB Prescribers direct contact details including email and telephone/fax no. Details of medicine Patients address not necessary
148
Can Sch 1, 2 and 3 CDs be prescribed by an EEA prescription?
No
149
Can unlicensed medicines be prescribed by an EEA prescriber?
No
150
Can you supply a prescription without confirming identity of prescriber?
Yes if in best interest of patient - use professional judgement
151
Can EEA and Swiss prescribers request emergency supplies?
Yes - but not CDs (including phenobarb). | Same emergency supply requirements apply.
152
What prescription forms are military prescriptions written on?
FMed 296 Should usually be send to contracted pharmacy. Should be treated as private prescription if non-contracted pharmacy. CD cannot be on this form Very unusual to see hand written - usually typed.
153
What form should CD prescriptions be written on?
FP10PCD | Pink form
154
What legally needs to be on a dispensing label?
``` Name of patient Name and address of supplying pharmacy Date of dispensing Name of the medicine Directions for use Precautions relating to use of the medicine ```
155
What does the RPS recommend be on a dispensing label, but not legally required?
KOOSAROC | Use this medicine only on your skin (where applicable)
156
Does the NPSA recommend labelling the outer container or actual container (e.g. tube, inhaler etc)?
Actual container as outer packaging can be discarded
157
Can labels be optimised / adjusted without contacting the prescriber?
Yes
158
What must medicines be labelled with if broken down from bulk containers for dispensing?
``` Name of medicine Quantity Quantitative particulars (ingredients) Handling and storage requirements where appropriate Expiry date Batch number ``` Usual labelling requirements apply when dispensing.
159
What is a PSD?
Patient specific direction | Allows meds to be suppled without a prescription e.g. on drug charts in hospital.
160
What are accountable officers?
Responsible for supervising and manging the use of CDs in their organisation or setting.
161
What are CD schedules?
``` Sch 1 (CD Lic POM) Sch 2 (CD POM) Sch 3 (CD No reg POM) Sch 4 (CD Benz POM and anab POM) Sch 5 (CD inv P and inv POM) ```
162
Which CDs to the CD prescription requirements apply to?
Sch 2 and 3
163
Which CD schedules have a prescription expiry of 28 days?
2, 3, 4 (not 5)
164
Which CD schedules require the address of the prescriber to be within the UK?
2 and 3
165
Which CD schedule prescriptions cannot be repeated?
2 and 3
166
Which CD schedules can you issue and emergency supply?
Phenobarb (sch 3), 4 and 5
167
For which Sch CDs is a requisition necassary, which needs to be marked by the supplier?
1, 2 and 3
168
Which Sch CDs require a license for import or export?
2, 3, 4,
169
What mechanisms apply for the lawful possession of CDs?
- Home office license - Home office group license - Legislation: class of person (e.g. postal operator) - Legistlation: class of drug - Patients
170
Can a pharmacist possess Sch 1 drugs?
ONLY when: - Possession is taken for the purpose of destruction - For the purpose of handing over to a police officer Personal confidentiality should be maintained from police if quantity is small and only suggests personal use.
171
Can Sch 1 CDs be prescribed?
Only under a home office license
172
Who can prescribe Sch 2, 3, 4 ?
- Doctor, dentist, pharmacist or nurse independent prescriber - Supplementary prescriber - A person acting in accordance with the directions of a prescriber entitled to prescribe CDs
173
Is a personal license required for a person travelling with CDs?
Not if the person is carrying less than 3 months supply - however it is advised a cover letter signed by the prescriber is obtained confirming: - Name of patient - Travel plans - Name of the prescribed CD - Total quantities and dose Patient should also check with embassies of the country they will be travelling to / through.
174
What are the legal requirements for a controlled drug requisition?
1. Signature of the recipient 2. Name of the recipient 3. Address of the recipient 4. Profession or occupation 5. Total quantity of the drug 6. Purpose of the requisition
175
Is a CD requisition required when it is a ward requesting within the same legal entity?
No
176
Is a CD requisition required when is it a request from a hospital, community, health provider (e.g. GP) or vet?
Yes - must be on approved form. Unless the request is from a hospice or prison - this requires specific processes.
177
Are CD supplies made against a faxed or photocopied requisition acceptable?
No
178
In an emergency, can a doctor or dentist be supplied with a Sch 2 or 3 CD on the undertaking that a requisition will be supplied within 24 hours?
Yes - failure to do so would be an offence on part of the doctor or dentist.
179
What is required when CD stock is collected by a messenger, on behalf of a purchaser?
A written authorisation that empowers the messenger to receive the medicines. This must be retained for 2 years.
180
Can a pharmacist requisition Sch 1 CDs?
NO. | A licence is required for any HCP to possess Sch 1 CDs.
181
What needs to legally be done when a requisition for a Sch 1, 2, or 3 CD is recieved?
Mark indelibly with the suppliers name and address. If a stamp is used this must be clear and legible. Send the original requisition to the relevant NHS agency. It is good practice to retain a copy of the requisition for 2 years.
182
When do the processing requirements for CD requisitions not apply?
- When 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. They must mark and retain the requisition for 2 years (do not need to send to relevant NHS body). - When supply is made by pharmaceutical manufacturers or wholesalers - When supply is made against a veterinary requisition (the original should be retained for 5 years).
183
Which 3 drugs may a midwife use a supply order to obtain?
Diamorphine Morphine Pethidine
184
What information must a midwife supply order contain?
Name of the midwife Occupation of the midwife Name of the person whom the CD is to be administered or supplied Purpose for which the CD is required Total quantity Signature of an appropriate medical officer - a doctor authorised (in writing) by the local supervising authority of the person appointed by the supervising authority to exercise supervision over midwives within the area.
185
What schedule are cannabis based medicinal products? (Medicinal being important word)
2 - all usual CD rules apply Cannabis products (containing THC) not for medicinal use are Sch 1.
186
What are unlicensed cannabidiol products?
Products marketed as food supplements - no medicinal claims are made. These products do not contain THC and are not a controlled drug.
187
What requirements should a product satisfy to be classed as a cannabis-based product for medicinal use?
- Product contains cannabis, cannabis resin, cannabinol or cannabinol derivative - It is produced for a medicines use in humans - It is a product that is regulared as a medicinal product, or an ingredient of a medicinal product
188
Who can prescribe a Cannabis based medicinal product?
Clinicians listed on the Specialist Register of the GMC.
189
What should you advise a patient receiving a CBMP?
- There may be a small delay in obtaining the product ad there are a limited number of THC containing products available in the country, and they may have to be imported. - The product being supplied is unlicensed
190
Do you need a home office license to import CBMP?
Yes | The prescribed does not need a home office licence.
191
What are some CBMP not affected by new legislation?
Sativex (cannabis extracts) - licensed - Sch4 - available to treat MS. NICE do not recommend. Nabilone - Sch 2 - non-natural cannabinoid - licensed to treat resistant N&V caused by chemotherapy. Epidiolex (pure cannabidiol) - Sch 5 - licensed - for Lennox-Gastaut Syndrome or Dravet Syndrome. Dronabinol - Sch 2 - unlicensed - used to treat loss of appetite in AIDs and N&V in chemo.