MEP Flashcards
(79 cards)
1
Q
What is the aim of revalidation of pharmacy professionals
3
A
- Keep professional skills and knowledge up to date
- Reflect on how to improve
- Demonbstrate to the public how they procide safe and effective care
2
Q
What must be submitted each year to revalidate?
A
- 4 CPDs including 2 planned
- 1 Peer Discussion
- 1 Reflective account
3
Q
What are the RPS error reporting standards?
6
A
- Be open and honest when things go wrong
- Report patient safety incidents to appropriate reporting programme
- Investigate and learn from all incidents
- Share what you have learnt to make local/national systems of care
- Take action to change practice
- Review changes to practice
4
Q
How to handle dispensing errors
A
- Inform patient promptly
- Make things right
- Offer an apology
- Let colleagues involved in the errror know
5
Q
What are the 4 principles of medicines optimisation?
A
- Understand the patient’s experience.
- Evidence-based decisions
- Ensure medicines use is as safe as possible.
- Make medicines optimisation a routine part of practice.
6
Q
What is NICE definition of medication review?
A
A critical examination of a person’s medicines with the objective of reaching an agreement with the person about treatment, optimising the impact of medicines, minimising the number of medication-related problems and reducing waste.
7
Q
Restrictions of ephedrine/pseudoephedrine OTC supply
A
Maximum 720mg of pseudoephedrine OR 180mg of ephedrine at any one time without a prescription.
Cannot supply both pseudoephedrine and ephedrine-containing products at the same time without a prescription.
8
Q
Restrictions on paracetamol supply
A
Maximum 100 non-effervescent tablets or capsules at any one time.
9
Q
Restrictions on aspirin supply
A
Maximum 100 non-effervescent tablets or capsules at any one time.
10
Q
Restrictions on codeine/dihydrocodeine products supply
A
Maximum 32 dose units (incl. effervescent) at any one time.
11
Q
OTC restrictions for codeine and dihydrocodeine-containing products
A
Short-term use of acute, moderate pain which is not relieved by paracetamol, ibuprofen, or aspirin alone.
Any other previous indications (e.g., cold, flu, sore throat) have been removed.
12
Q
Prescription legal requirements
A
- Patient name
- Patient address
- Patient age (if under 12)
- Signature of appropriate prescriber (can be advanced electronic signature)
- Particulars of prescriber e.g., GMC number
- Prescriber address
- Date within 6 months (28 days for CD 2, 3 & 4)
Prescriptions must be written in indelible ink.
13
Q
Can a copied prescription be accepted?
A
It is permissible to issue carbon copies of NHS prescriptions as long as they are signed in ink, however, photocopied and faxed prescriptions are not permitted.
14
Q
How many times can a repeat prescription be dispensed?
A
As indicated by the prescriber.
If a number is not stated, they can be repeated once (dispensed twice) UNLESS it is for an oral contraceptive, in which case it can be repeated 5 times (dispensed 6 times total).
15
Q
Restrictions for repeat prescriptions
A
- CD2 & 3s are not permitted, but CD 4 & 5s are.
- The first dispensing for a POM or CD5 must be made within 6 months of the appropriate date, after which there is no legal time limit for remaining repeats.
- The first dispensing for CD4s must be made within 28 days of the appropriate date, after which there is not legal time limit for remaining repeats.
HOWEVER use professional judgement.
16
Q
Restrictions on validity of owing on NHS and private prescriptions
A
- GSL, P, POM, and CD5 - 6 months from appropriate date.
- CD 2, 3, & 4 - 28 days from appropriate date.
- POMs on PPP - owings can only exceed 7 days if the pharmacist follows the PPP checklist to exclude risk of pregnancy.
17
Q
Record keeping requirements for private POM prescriptions.
A
Retain for 2 years from date of supply (last supply date if repeat)
Record in POM register:
* Supply date
* Prescription date
* Medicine details
* Prescriber details (name and address)
* Patient details (name and address)
POM register entry must be made on day of supply or, if not practical, the following day.
Retain POM register for 2 years from last entry.
Exceptions: oral contraceptives (good practice)
18
Q
Record keeping for private CD2 and 3 prescriptions
A
- Submit to relevant NHS agency
- CD2s - record in CD register
- CD3s - record in POM register
19
Q
Prescription requirements from EEA or Switzerland
A
- Patient name and DOB
- Prescriber name, professional qualifications, contact details (email + telephone/fax number), work address (incl country).
- Prescriber signature
- Prescribed medicine details
- Date - within 6 months for POM/CD5 and within 28 days for CD4.
Not permitted:
* CD1, 2, or 3
* Medicines without a marketing authorisation in the UK
20
Q
Are emergency supplies for medicines prescribed in EEA/Switzerland permitted?
A
Yes - follow normal rules for supplies at request of patient or prescriber.
Note that schedule 1, 2, 3, or 4 (including phenobarbital) CDs or unlicensed products are not permitted,
21
Q
Rules for dispensing military prescriptions
A
Usually FMed296s are dispensed at designated pharmacies under a Ministry of Defence (MOD) contract who will invoice MOD directly.
At a normal pharmacy, a FMED296 is treated as a private prescription. The patient should be charged directly and it is their responsibility to seek reimbursement from their military unit.
CD 2 and 3s should be prescribed on pink FP10PCD forms - if on an FMED 296, it cannot be dispensed at a normal community pharmacy.
Fake FMED296s may be handwritten or have a BFPO, so be suspicious in these cases.
22
Q
Label requirements
A
- Name of patient
- Name and address of pharmacy
- Date of dispensing
- Name of medicine
- Directions for use
- Precautions relating to the use of medicine
Good practice:
* Keep out of sight and reach of children
* If topical: use this medicine only on your skin.
* In prisons: prisoner number
23
Q
Labelling requirements of medicines broken down from bulk containers
A
Name of medicine
Quantitity in container
Quantitative particulars i.e., the ingredients
Handling and storage requirements
Expiry date
Batch number (LOY or BN)
24
Q
Can dispensing/supply and administration be performed by the same HCP?
A
Ideally, no.
In exceptions, where it is necessary for the interests of the patient, can be done but an audit trail, documents, and SOPs should be in place to limit errors.
25
Rules for administration of medicines
Organisational polices for the healthcare setting should define who can administer medicines. Individuals should have an overall understanding of the medicine being afministered.
Exceptions: naloxone and adrenaline in life-saving situations.
26
What is a PSD?
Patient specific directions are a written instruction from a prescriber for a medicine to be supplied/administered to a named patient after the prescriber has assessed that patient on an individual basis.
For example: an inpatient chart on a hospital ward.
In some cases, a verbal authorisation may be permittable, but wherever possible written authorisation should be adhered to.
27
What is a PGD
A patient group direction is a written direction that allows supply/administration of a specified medicine, by named authorised HCPs, to a well-defined group of patients requiring treatment for a specific condition.
Example: Pharmacy First scheme.
28
Conditions for emergency supply at request of a prescriber
* Request is from a "relevant prescriber"
* Emergency - immediate need and no possible way of currently obtaining prescription.
* Details and directions specified.
* Prescriber agrees to provide a written prescription within 72h.
* Record in POM register must be made on day of supply or, if impractical, the following day.
Not applicable for CD1, 2, or 3, except phenobarbital for epilepsy.
29
Conditions for emergency supply at request of a patient
Interview patient to clarify:
* Emergency - immediate need and no possible way of currently obtaining prescription.
* Previous treatment prescribed by a UK, EEA, or Swiss relevant prescriber
* Details of dose.
Legal requirments:
* Not applicable for CD1, 2, or 3, except phenobarbital for epilepsy.
* Supply:
* * Maximum 30 days for POM
* * Maximum 5 days for CD4/5
* * Smallest available pack size for device/ointment/insulin etc
* * One strip/treatment cycle of oral contraceptive
* * Antibiotic liquid: supply smallest quantity for full course.
* Label must state "Emergency supply"
* Record in POM register must be made on day of supply or, if impractical, the following day.
30
POM register entry for emergency supply at request of patient
* Date of supply
* Name, strength, form, and quantity of medicine supplied
* Name and address of patient
* Information on nature of emergency.
31
POM register entry for emergency supply at request of prescriber
* Date of supply
* Name, strength, form, and quantity of medicine supplied
* Name and address of prescriber
* Name and address of patient
* Date on presciption (when obtained)
* Date on which prescription was received.
32
Supply of medicines to schools requirements
Signed order containing:
* Name of school
* Product details
* Strength
* Purpose for which the product is required
* Total quantity required (no maximum but use professional judgement)
* Signature of head teacher
Ideally should be on headed paper but this is not a legal requirement.
Signed order should be retained for 2 years from the date of supply/entry or entry made into POM register (both good practice).
33
POM register entry requirement for signed order
* Date supplied
* Name, quantity, formulation and strength of POM
* Name, address, trade/business/profession of person to whom POM was supplied.
* Purpose for which it was sold or supplied
34
Exceptions for supply of naloxone
Staff engaged in a "lawful drug treatment service" can obtain naloxone from a wholesaler and make direct supplies to patients without a prescription, PGD or PSD.
This includes pharmacies providing needle and syringe programmes or methadone/buprenorphine for opioid dependence.
Anyone can administer naloxone for the purpose of saving a life.
35
Rules for PPP prescriptions
* Valid for 7 days from date prescribed.
* Maximum 30 days supply
* Repeat prescriptions are not valid
* Emergency supply only accepted if from a PPP specialist prescriber and pharmacist can confirm that negative pregnancy status has been established within last 7 days.
* PPP rules do not apply to patients with compelling reasons for no risk of pregnancy e.g., hysterectomy.
36
How should biologics/biosimilars be prescribed/supplied?
By brand name.
Any decision to switch brands should be made following a discussion between patient and prescriber.
It is recommended that, when dispensing, the pharmacist:
* Confirms the patient has received the correct brand
* Record the brand name and batch number of any biologics/biosimilars supplied to aid potential reporting of ADRs.
37
What is the difference between a biologic, biosimilar, and advanced therapy medicinal product?
* Biologic: a medicine made from natural sources of human, animal, or microorganism in origin e.g., vaccines. blood, DNA.
* Biosimilar: a biologic medicine which resembles an already licensed biologic in terms of safety, quality, and efficacy, but due to the complexity of biological molecules, cannot be classed as "generic". These can only be marketed when the patient for the original biosimilar expires.
* ATMP: a biological medicinal product based on genes, cells, or tissues e.g., gene therapy, somatic cell therapy, tissue engineered products. For example: CAR-T therapy.
38
Who can prescribe CD1s?
GMC registered doctors with a Home Office license to prescribe cocaine, diamorphine, or dipipanone for treating addiction.
39
What can dentists prescribe?
* Any POMs
* CD2-5s
* Unlicensed and/or off-label medicines
* Emergency supply of medicines including phenobarbital. (Not 1,2,3)
HOWEVER, on NHS dental prescriptions, are restricted to Dental Practitioner's formulary.
40
What can vets prescribe?
* POM, CD 4 & 5
* CD 2 & 3 if prescriber's RCVS registration number included on prescription.
* Unlicensed/off-license medicines as long as prescribed under veterinary cascade
Cannot authorise emergency supplies and can only prescribe for treatment of animals.
41
What can pharmacist independent prescribers prescribe
* All POMs
* CD 2-5
* Unlicensed/off label meds
* Can authorise emergency supplies including phenobarbital for epilepsy
42
What can nurse/midwife independent prescribers prescribe
* All POMs
* CD 2-5
* Unlicensed/off label meds HOWEVER unlicensed meds are excluded from Nurse Prescribers' Formular in Scotland
* Can authorise emergency supplies including phenobarbital for epilepsy
43
What can EEA/Swiss prescribers prescribe (in the UK)
* POMs
* CD 4 & 5 only
* Off-label (i.e. UK licensed meds for an unlicensed indication_
* Can authorise emergency supply
All above applies to UK licensed meds only.
44
What is required when trading medicines other than to a patient?
* A wholesaler license aka wholesale distribution authorisation (WDA)
* Compliance with Good distribution Practice (GDP) standards and pass regular GDP inspections
* Have a suitable experienced "Responsible Person" named on the license.
45
Exemptions for requiring a WDA
* Pharmacies supplying stock to another pharmacy within the same legal entity do not require a WDA.
*HOWEVER, if a legal entity does hold a WDA, the pharmacy supplying the medicines for the purpose of wholesaling must be named on the WDA.
* Registered pharmacies and hospitals supplying small quantities of meds to HCPs for treatment or onward supply to patients
46
What is required for wholesaling of CDs?
If a WDA(H) is required, a corresponding Home Office CD license is also required.
47
Record keeping for signed orders
* POM register entry
* Retain signed order/invoive for 2 years from date of supply
Both good practice, one legal.
48
Prescription requirements for POM-V and POM-VPS
* Prescriber name, address, number, qualification, and signature
Owner name and address
* Animal identification, species, and address (if different to owners)
* Date: 6 months for POM and 28 days for CD 2,3,4.
* Details of medicine.Maximum 28 days of CDs
* Instructions for administration *Note "as directed" is not acceptable.*
* Any necessary warnings
* "Prescribed under veterinary cascade"
* Number of repeats (if repeatable)
Must be retained for 5 years and not submitted to NHS agency.
CD2 & 3 only:
* Prescriber RCVS registration number
* "The item has been prescribed under for an animal or herd under the care of a veterinarian"
49
Veterinary medicines prescription requirements
If does not already appear on packaging:
* Vet prescriber name
* Owners name and address
* Pharmacy name and address
* Identification and species of animal
* Date of supply
* Expiry date
* Name and quantity of product
* Dosage and administration instructions
* Any necessary warnings or storage requirements
* Any applicable withdrawal period i.e., the time between when an animal receives a medicine and when it can be safely used for food
* "For animal treatment only"
* "Keep out of sight and reach of children"
*A dispensing label is not legally required if the medicines are dispensed in the origihnal packaging, but is good practice.
50
Record keeping of POM-V and POM-VPS products
* Name of medicine
* Date of receipt or supply
* Batch number
* Quantity
* Name and address of supplier or recipient
* Name and address of prescriber
Records can be recorded in a private presciption book, electronically, or just by retaining relevant documents.
Retain copy of prescription and relevant records for 5 years.
Pharmacies that supply POM-V & POM-VPS medicines must undertake an annual audit
51
Wholesaling of veterinary medicines
Only the manufacturer or holder of a WDA(V) may supply authorised retailers with veterinary medicines.
Howver, an authorised retailer of veterinary medicines may supply products they are qualified to supply to another authorised retailer to relieve temporary stock shortages without a WDA(V).
52
CD2 rules
* Rx requirements apply
* Rx valid for 28 days
* Details of received and supply must be documented in CD register
* Address of prescriber must be in UK
* Cannot be prescribed by EEA/Swiss
* Cannot be repeatable
* Cannot be given by emergency supply
* Destruction of expired stock requires authorised witness and CD register entry
53
CD3 rules
* Rx requirements apply
* Rx valid for 28 days
* Details of received and supply DO NOT have to be documented in CD register, but good practice
* Address of prescriber must be in UK
* Cannot be prescribed by EEA/Swiss
* Cannot be repeatable
* Cannot be given by emergency supply unless phenobarbital
* Destruction of expired stock DOES NOT require authorised witness and CD register entry but good practice to be observed by other staff
54
CD4 (I) rules
* Rx valid for 28 days
* Details of received and supply DO NOT have to be documented in CD register, EXCEPT Sativex (THC & CBD)
* Can be prescribed by EEA/Swiss
* Can be repeatable
* Can be given by emergency supply
* Destruction of expired stock DOES NOT require authorised witness and CD register entry but good practice but good practice to be observed by other staff
## Footnote
Benzos
55
CD4 (II) rules
* Rx valid for 28 days
* Can be prescribed by EEA/Swiss
* Can be repeatable
* Can be given by emergency supply
## Footnote
Anabolic steroids
56
CD5 rules
* Rx valid for 6 months
* Can be prescribed by EEA/Swiss
* Can be repeatable
* Can be given by emergency supply
57
In the event of confiscating illict drugs/Sch1 CDs, what should occur?
* Take possession for the purpose of destruction or to hand over to a police officer.
* The patient's confidentiality should be maintained, unless quantity is so large it is likely not for personal use.
* If patient refuses to give it up, do not give it back to the patient. Call police if necessary.
58
Advice for travelling with CDs
* >3 months supply - requires a personal license by the Home Office
* < 3 months supply - advise a covering letter signed by the prescriber confirming patient name, travel plans, CD name and dose
* Check with embassies about import and export regulations.
* Check with airline policies.
59
What is an FP10CDF
A madatory requisition form for ordering CDs 2 & 3.
Required in most cases except:
* In hospital on behalf of a ward/department within the same legal entity.
* In hospices
* In prisons
60
Legal requirements for CD requisition
Written:
* Name, address and signature of recipient
* Profession or occupation
* Total quantity of drug
* Purpose of requisition.
Receiving/processing:
* Mark the requisition indelibly eiyh supplier's name and address (pharmacy stamp can be used)
* Send the original requisition to the relevant NHS agency
* Retaina copy for 2 years from dat eof supply (good practice)
61
CD prescription requirements
* Prescriber signature and address
* Date within 28 days of prescriber's signature or date before which the drugs should not be supplied - whichever is later
* CD name, form, strength, and dose
* Quantity in words and figures - should not exceed 30 days.
* Patient name and address
62
FP10MDA prescription requirements
Normal CD prescription requirements plus:
* Dose instructions
* Amount of medicine to be supplied per installment
* Interval between each time the medicine can be supplied
First dispensing within 28 days.
Each supply must be dated on the prescription.
63
What errors on a CD prescription can be amended by the pharmacist?
Minor typographical errors or spelling mistakes
Either words or figures of the total quantity have been ommittted (not both).
Any amendments must be marked with pharmacist signature, GPhC number, and date.
Other amendments must be done by the prescriber, and cannot be made by a covering letter from the prescriber.
64
What is an FP10PCD
Private CD prescription - must include prescriber identification number (separate to professional registration number).
65
Can other medicines be prescribed on a private CD prescription?
No - the FP10PCD must be sent to the relevant NHS agency, whereas private prescriptions for other items must be retained for 2 years.
66
Rules for signing CD prescriptions
* It is good practice for the person collecting to sign the designated area on th back of the prescription when collecting CD 2 or 3.
* Installment prescriptions only need to be signed once.
* A representative, including a delivery driver, can sign on behalf of the patient, but a robust audit trail should be available to cinfirm successful delivery to the patient.
67
Which CDs require safe custody and what is this?
A locked safe, cabinet, or room which is constructed as to prevent unathourised access to the drugs.
Applicable to CD2s except:
* Some liquid preparations
* Quinalbarbitone
CD3s except:
* Gabapentin
* Midazolam
* Phenobarbital
* Pregabalin
* Tramadol
* Some others
68
What are the CD denaturing, witnessing, and record keeping requirements?
Patient returned CD2,3,4:
* must be denatured
* DO NOT requie authorised witness, although good practice to be witnessed by a member of staff.
* Record patient return and subsequent destruction in a record for this purpose.
Expired/unwanted CD 3,4:
* must be denatured
* DO NOT require authorised witness, although good practice to be witnessed by a member of staff.
* Good practice to record destruction of CD3s
Expired/unwanted CD2:
* must be denatured
* Denaturing requires authorised witness/accountable officer
* Record destruction in CD book.
69
CD book record keeping
CDs received:
* Date received
* Name and address from whom received
* Quantity received
CDs supplied:
* Date supplied
* Name and address of recipient
* Details of authority to possess - prescriber/license holder details
* Quantity supplied
* Details of person collecting CD2 - if HCP, record their name and address.
* Whether proof of ID was requested
* Whether proof of ID was provided.
A running balance should also be maintained.
70
How long do CD registers need to be retained?
2 years from date of last entry.
71
Can CD registers be electronic?
Yes as long as:
* They are attributable
* They are capable of being audited.
* They are compliant with best practices
* They are accessible from the premises and capable of being prinyed
* The author of each entry is identifiable
* Entries cannot be altered at a later date
* A log of all data entered is kept and can be recalled for auditing purposes.
72
What are the 3 licensed cannabis products?
* Sativex (THC & CBD extract) - CD4i used for spasicity in MS.
* Nabilone (synthetic non-natural cannabinoid) - POM for anti-emetic resistant chemotherapy induced N & V.
Epidyolex (cannabidoil) - CD5 used for seizures associated with Lennox-Gastout or Dravets syndrome
73
What is Dronabinol?
* A synthetic, nature-identical, version of THC.
* CD2
* Available as a special to treat loss of appetite in people with AIDS and anti-emetic resistant chemotherapy induced N & V.
74
What are CBPMs and what are the restrictions around them?
Cannabis-based products for medicinal use i.e., regulated medicinal product containing cannabis, contain cannabis-resin, cannabinol, or a derivative.
CD2s and can only be prescribed by clinicians listed on the specialist register of the GMC.
75
Medicines waste management
* Waste medicines must be kept in a secure container preferably in a designated area away from fit-for-use medicines.
* All patient identfiers should be destroyed or obscured.
* Sharps should be put in a sharps bin.
* Remove contents of MDS
* Do not pop out tablets/capsules
* Liquids should remain in the bottle.
76
Responsible pharmacist record requirements
Visible notice:
* Name
* GPhC no.
* The fact they are in charge.
Pharmacy record:
* Name
* GPhC no.
* Date and time at which they are appointed/unappointed as RP.
* If absent: Date & time of leave/return.
77
How long should the responsible pharmacist record be kept for?
5 years
78
What activities CANNOT be made when the responsible pharmacist is absent? What is the exception?
* Clinical/legal prescription check
* Sale/supply of P medicines
* Handing out of dispensed medicines
* Supply under a PGD
* Wholesale of medicines
* Emergency supply (by patient or HCP)
These CAN be done if another supervising pharmacist is physically present.
79
Which activities CAN be done while the responsible pharmacist is absent?
No pharmacist supervision:
* Sale of GSL meds
* Processing waste or patient returned medicines
* Ordering/receiving stock from wholesalers
* Putting stock on shelves
* Date checking
* Cleaning
* Responding to enquiries (non-clinical)
* Accessing PMR
* Receiving prescription from EPS
* Processing dispensed prescription forms e.g., counting number of items dispensed
* Delivery person conveying medicines to patient
* Receiving patient-returned meds
Supervising pharmacist not physically present (but still supervusing):
* Generate dispensing labels
* Dispensing/boxing medicines
* Labelling
* Accuracy checking (by appropriate staff)
* Producing compliance aids
| Must be done by appropriately trained staff
