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Trainee year - MEP > Chapter 3 > Flashcards

Chapter 3 Flashcards

1
Q

For what are the classifications of medicine?

A

General sale medicine/General sales list (GSL) - medication that can be made available as “self-selection) items for sale in registered pharmacies or in other retail outlets

Pharmacy (P) medicines - these are medicinal products that can only be sold from a registered pharmacy premises by a pharmacist or person acting under the supervision of a pharmacist. These medicines MUST NOT be accessible to the public by self selection

Prescription on medicine (POM) - medication that can only be supplied following a prescription written by an appropriate practitioner

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2
Q

Are there any rules regarding GSL medicines being sold within a pharmacy?

A

YES - GSL medicines can only be sold when there is a responsible pharmacist.

(This does not mean that the RP has to be physically present during the sale of the medicine. The RP may be physically absent for a limited period of time while remaining responsible and the sale of GSL medicines is permitted during this absence)

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3
Q

who are appropriate practitioners that can prescribe?

A

doctors
dentists
supplementary prescribers
nurse independent prescribers
pharmacist independent prescribers
EEA and Swiss approved health professionals
community practitioner nurse prescribers
optometrist independent prescribers (not for Controlled Drugs, or parenteral medicines)
paramedic independent prescribers
physiotherapist independent prescribers
podiatrist independent prescribers
therapeutic radiographer independent prescribers (for certain medicines)

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4
Q

In feb 2024, what medication was reclassified from P to POM and why?

A

Codeine linctus

due to the risk of dependence, additction and overdose

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5
Q

What is psuedoephedrine and ephedrine intended to be used for AND how is it often misused

A

it is widely used as a decongestant BUT it is misused in the production of methylamphetamine (crystal meth)

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6
Q

Due to the potential to misuse, what legal restrictions are there on the supply of pseudoephedrine and ephendrine?

A
  • you cannot supply a product or combination of products that contain more than 720mg of pseudoephedrine OR 180mg of ephedrine without a prescription
  • You cannot sell/supply any pseudoephedrine product at the same time as an ephedrine product without a prescription
  • Sales or supplies of pseudoephedrine or ephedrine should either be made personally by the pharmacist or by pharmacy staff who have been trained and are competent to deal with pseudoephedrine and ephedrine issues, and who know when it is necessary to refer to the pharmacist.
  • Even when a request is made for a lawful quantity, the sale or supply can be refused where there are reasonable grounds for suspecting misuse.
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7
Q

What are signs of pseudoephedrine/ephedrine misuse?

A
  • Lack of symptoms: Person not suffering from cough, cold or flu symptoms or if they are buying it for someone else, has not described any of these symptoms in the patient
  • Person may give answers which appear to be rehearsed or scripted
  • Person may be impatient and aggressive - hurrying to complete the transaction
  • Person may have waited for busy periods in the shop or when less experienced staff available (opportunistic approach)
  • Person may want specific products/brands which only contain pseudoephedrine or ephedrine
  • Patient may also purchases other items which are used to manufacture methylamphetamine (lithium batteries, chemicals such as acetone)
  • They may request large quantities
  • They may come into the pharmacy frequently to request pseudoephedrine or ephedrine
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8
Q

If you have suspicions on a person’s request for pseudoephedrine/ephedrine, who can you report it to?

A
  • Your local GPhC inspector
  • Local Controlled Drugs liaison police officer
  • accountable officer.
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9
Q

What are the three methods of emergency contraception

A
  • Copper intrauterine device (Cu-IUD)
  • Oral ulipristal acetate
  • Oral levonorgestrel
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10
Q

What legal classification are the methods of emergency contraception?

A
  • Both Levonorgesterel 1500 mcg tablets and ulipristal acetate 30mg tablets are P medicines
  • Copper intrauterine device (Cu-IUD) is a medicinal device rather than a medicinal product so does not have a legal class
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11
Q

Who is levonorgestrel and ulipristal acetate licensed for

A
  • Levonorgestrel 1500 mcg is licensed for woman aged 16 years or over for emergency contraception within 72 hours (3 days) of unprotected sex or failure of contraceptive method
  • Ulipristal acetate is licensed for emergency contraception within 120 hours (5 days) of unprotected sex or failure of contraceptive method (no age restriction)
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12
Q

What is an advance supply of oral emergency contraception

A

This is when a pharmacist provides an advance supply of oral emergency contraception prior to unprotected sexual intercourse or just in case of failure of a contraceptive method at the patient’s request

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13
Q

In order to give an advance supply of oral emergency contraception, what must the pharmacist ensure?

A

The pharmacist must ensure that the patient is competent, they intend to use the medicine appropriately and it is clinically appropriate for them

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14
Q

As a pharmacist, what should you do if your religious or moral belief impacts your willingness to supply oral emergency contraception?

A

You should inform your employer, locum agency and colleagues ASAP so you can plan in advance so that a situation where a patient’s care is compromised can be avoided.You can refer the patient but you must ensure the patient can get the service elsewhere is a timely manner but this it not always possible.

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15
Q

The legal age to consent to any sexual activity is 16 , can pharmacist provide contraception or sexual health advice to anyone under the age of 16?

A

YES and the general duty of patient confidentiality applies so where there is a decision to share information, consent should be sought with the patient.

HOWEVER, this varies case-by-case and should be done with the child’s best interest in mind - if the child’s welfare overrides the need to keep information confidential then you must disclose the information

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16
Q

Which emergency oral contraceptive can be given to under 16s

A

Ulipristal acetate

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17
Q

When giving sexual health advice or contraception to people U16, what criteria can be met

A

The fraser criteria must be met

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18
Q

If the supply of the oral emergency is not appropriate, who can you refer the patient to

A
  • Family planning clinic
  • General practice clinic
  • Provider of PGDs for oral emergency contraception
  • Genitourinary medicine (GUM) clinic
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19
Q

Paracetamol can be sold OTC. What are the legal restrictions?

A

If non-effervescent tablets/capsules are being sold:
- No more than 100 tablets/capsules can be sold to a person at one time. As OTC packs come in packs of 16 or 32 dose units, the maximum amount that can be sold is 96 tablets/capsules

If effervescent tablets are being sold:
- There are no legal limits on the quantity of OTC effervescent tablets, powders, granules or liquids that can be sold to a person at any one time SO you must use your professional judgement.

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20
Q

Aspirin can be sold OTC. What legal restrictions are there for the sell of aspirin?

A

If non-effervescent tablets/capsules are being sold:
-No more than 100 tablets/capsules can be sold to a person at one time. As OTC packs come in packs of 16 or 32 dose units, the maximum amount that can be sold is 96 tablets/capsules

If effervescent tablets are being sold:
-There are no legal limits on the quantity of OTC effervescent tablets, powders, granules or liquids that can be sold to a person at any one time SO you must use your professional judgement.

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21
Q

Codeine and Dihydrocodeine can be sold OTC. What are the legal restrictions?

A
  • It can ONLY be for short-term treatment of acute to moderate pain that is NOT relieved by paracetamol, ibuprofen or aspirin
  • A pack size CANNOT contain more than 32 dose units
    It is also recommended that only ONE pack should be sold so that the patient is not receiving more than 32 dose units.
  • The warning “Can cause addiction. For three days use only” must be positioned in a prominent clear position on the front of the pack.
  • Both the PIL and packaging must state the indication (acute pain) and “the medicine can cause addiction or headache if used continuously for more than three days”
  • The PIL must also contain information about the warning signs of addiction.
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22
Q

Can you supply a medication which has been prescribed in another language (any of the languages from the approved countries?

A
  • The prescription does not have to be in English for it to be legally valid, as long as it meets the requirements stated previously.
  • If the pharmacist do not understand what is said on the prescription, they can use translation services
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23
Q

Can pharmacist supply medication from a prescription from the CROWN DEPENDENCIES (JERSEY, GUERNSEY AND ISLE OF MAN)

A

YES as long as they meet the legal requirements

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24
Q

What are repeatable prescriptions?

A

private prescriptions which contain a direction that they can be dispensed more than once, e.g., ‘repeat x 5’.

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25
Q

If a repeat prescription does not state the amount of times it should be repeated, what should you do?

A
  • It can only be repeated once (so dispensed twice)
  • if it is an oral contraceptive, it can be repeated five times (so dispensed six times)
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26
Q

What medication can not be on a repeat prescription?

A

Schedule 2 and 3 CDs

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27
Q

For repeat prescriptions of POMS, do all repeats have to be within 6 months ?

A

NO, only the first dispesning must be within the first six months

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28
Q

For repeat prescriptions of CD 4 medicination, do all repeats have to be within 28 days?

A

NO,only the first dispensing must be within 28 days

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29
Q

A patient can decide to get their repeats from different pharmacies. What should pharmacists do to maintain an audit trail?

A

mark on the prescription the name and address of the pharmacy from where supply has been made and the date of supply.

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30
Q

What is a repeat slip?

A

These are not prescriptions themselves, but a list of medications that patients can use to reorder their regular medication
(I often get this confused with repeat prescriptions)

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31
Q

How long are owings valid for?

A
  • The pharmacy should aim to have supply the rest within SEVEN days for POM and CD5 medication but the prescription is valid was SIX months
  • For P and GSL medicines: SIX months
  • Schedule 2,3,4 CD : 28 days
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32
Q

When receiving a private prescription for a POM , what record keeping is needed?

A

POM register must be filled and must include:

  • 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.
  • For repeatable prescriptions you must also include where it is not the first sale/supply a reference to the entry which was made on the first sale/supply (e.g., the entry reference number).
33
Q

How long should private prescriptions for POMs be kept for?

A

two years from the date of the sale or supply or, for repeatable prescriptions, from the date of the last sale or supply

34
Q

How long should POM registered be kept for

A

two years from the date of the last entry

35
Q

(For private prescriptions) What medications are exempt from being recorded in POM register

A
  • oral contraceptives
  • schedule 2 CDs (this will go into the CD register)
36
Q

Can FP10 prescriptions be used for patients while they are in prison

A

NO
- However, if they are being discharged from prison and the patient do not have the supply of medicine, they can be given an FP10 form to get their medication from their community pharmacy.
- The FP10 will have the name and address of the prison and they paitent will be exempt from paying

37
Q

What medicine can dentists prescribe

A

medicines listed in the Dental Prescribers’ Formulary (Part 8a of the Drug Tariff for Scotland or Part XVIIa of the Drug Tariff for England and Wales).

38
Q

Are faxed/digital copies of prescriptions legal?

A

NO
Not written in indelible ink

39
Q

What are the risk of supply medication from fax/photocopied prescription

A
  • Uncertainty that the supply has been made in accordance with a legally valid prescription
  • Risks of poor reproduction
  • Risks of non-receipt of the original prescription and therefore inability to demonstrate that a supply had been made in accordance with a prescription
  • Risks that the original prescription is subsequently amended by the prescriber in which case the supply would not have been made in accordance with the prescription
  • Risks the fax/digital copy of prescription is sent to or received by multiple pharmacies and duplicate supplies are made.
  • Risks that the prescription is not genuine
  • Risks that the system of sending and receiving of the fax/digital copy of prescription is not secure or from a reputable source
40
Q

Who do you report a forged prescription to ?

A
  • It can be solved with a discussion with the patient and prescriber.
  • police
  • NHS Counter Fraud Services (for NHS prescriptions only)
41
Q

Prescriptions are legal if the prescriber is from EEA countries and switzerland. Can you dispense a prescription from a prescriber outside of these countries

A

NO because it is not legal so you find a way to help the patient (e.g refer to local GP)

42
Q

Where can you check if a prescriber is registered?

A
  • Doctors: General Medical Council (GMC)
  • Dentists: General Dental Council (GDC)
  • For those in approved countries outside UK: use the european commission website
43
Q

Could you dispense medication from EEA prescriber when you are not able to confirm the registration status of the HCP

A
  • You may be able to make a safe and legal supply if its for the best interests of the patient BUT ensure that you document any interventions and steps taken.
  • This can be taken to court so ensure you document everything and do it with the patient’s best interest
44
Q

What medication cannot be supplied if the prescriber is outside of the UK

A

Schedule 1, 2 and 3 CDs and medicinal products without a marketing authorisation valid in the UK

45
Q

If a prescription from an approved country is presented and is legal, do you have to supply

A

NO, if it does not seem clinically appropriate you can refer the patient to a prescriber based in the UK

46
Q

What are patient group directions (PGDs)

A

written direction that allows the supply and/or administration of a specified medicines to a well-defined group of patients requiring treatment for a specific condition.

46
Q

Can pharmacy technicians supply/administer PGD

A

YES

From 26th June 2024 registered pharmacy technicians can supply and administer medicines under a PGD in the course of their professional practice

47
Q

What are some examples of PGD

A
  • Travel vaccinations
  • anti virals
    -oral
    There are many more
48
Q

Should medication supplied under PGDs be labelled ?

A

P, POM & GSL medication can be supplied under PDG but only POM medication should be labelled (label with the same requirements as if it was prescribed)

49
Q

What is an emergency supply?

A

This is when a pharmacist working in a registered pharmacy supplied POMs to a patient (humans not animals) without a prescription on the request of a ‘relevant prescriber’ or a patient

50
Q

Can a prescriber outside of the EEA or Switzerland request an emergency supply?

A

NO

51
Q

For a prescriber to make a request for an emergency supply, what conditions must be met

A
  • Relevant prescriber:
    The pharmacist is satisfied that the request is from one of the prescribers stated above:
  • Emergency:
    The pharmacist is satisfied that a prescription cannot be provided immediately due to an emergency (e.g., patient cannot collect the prescription from the prescriber, the prescriber is unable to drop off prescription at the pharmacy and patient urgently needs the medicine(s)).
  • The prescriber agrees to provide a written prescription within 72 hours.

Directions: The medicine is supplied in accordance with the direction given by the prescriber.

52
Q

What entry must be made when an emergency supply requested by a prescriber is made?

A

An entry in the POM register on the day of the supply should be done. The entry must include:
- Date the POM was supplied
-Name (including strength and form where appropriate) and quantity of - medicine supplied
- Name and address of the prescriber -requesting the emergency supply
- Name and address of the patient for whom the POM was required
- Date on the prescription (this can be added to the entry when the prescription is received by the pharmacy)
Date on which the prescription is received (this should be added to the entry when the prescription is received in the pharmacy).

52
Q

What drugs cannot be supplied under an emergency supply

A

ALL cd 1,2,3 drugs except phenobarbital

53
Q

How should medication supplied as an emergency supply requested by a prescriber be labelled

A

With the regular prescription requirements

53
Q

What conditions should be met for an emergency supply at the request of a patient?

A
  • Interview: the pharmacist must interview the patient (if this is not possible (e.g if they are a child) then the pharmacist should use their professional judgement
  • The pharmacist must be satisfied that there is an immediate need for the POM and that it is not possible for patient to obtain a prescription without any delay

-The POM must have been used as a treatment and prescribed by a UK, EEA or swiss health professional previously (the time interval between when they were last prescribed and the day they come in to get the emergency supply NEEDS to be considered and pharmacists should use their professional judgement on whether to prescribe or not)

  • The pharmacist must be satisfied with the dose the patient needs
  • The medication is NOT FOR A CD 1,2,3 (except for phenobarbital)
54
Q

Based on the conditions above, does this mean that pharmacist was only give emergency supplies if the GP is closed

A

NO
they can make emergency supplies when the GP is open if the medication is urgent and they cannot get the prescription without a delay

55
Q

How many days should you supply for an emergency supply

A
  • No more than 30 day supply
  • If the emergency supply is for a CD (i.e., phenobarbital or a Schedule 4 or 5 CD), the maximum quantity is for five days
  • insulin, ointment, cream, or inhaler for asthma (i.e., the packs cannot be broken), the smallest pack available in the pharmacy should be supplied
  • oral contraceptive, a full treatment cycle should be supplied.
  • antibiotic in liquid form - smallest quantity that will provide a full course of treatment should be supplied.
56
Q

What entry must be made when an emergency supply requested by a patient is made?

A

POM register with:
- Date the POM was supplied

  • Name (including strength and form where appropriate) and quantity of medicine supplied
  • Name and address of the patient for whom the POM was supplied
  • Information on the nature of the emergency, such as why the patient needs the POM and why a prescription cannot be obtained, etc.
57
Q

How should medication supplied as an emergency supply requested by a patient be labelled

A

standard labelling requirements PLUS the words ‘emergency supply’

58
Q

What should you be mindful about with emergency supplies

A

people may abuse emergency supplies so if a patient medication record shows that a patient has requested a medicine as an emergency supply on several occasions you can refuse

59
Q

what must be done if an emergency supply is refused?

A

the patient should be advised on how to obtain a prescription for the medicine or appropriate medical care. This could involve referral to, for example, a doctor, NHS 111, NHS walk-in centre or to an accident and emergency department.

A record could be made of why the request was refused for audit purposes.

60
Q

What are military prescriptions written on?

A

FMed 296 prescriptions :
(They are usually computer generated - it is unusual to see handwritten prescription)
see anki for picture

61
Q

Can community pharmacies dispense military prescriptons?

A

only those under the ministry of defence (MOD) contract

62
Q

Do military personnel pay for their prescriptions?

A

NO
The invoice is sent to the MOD directly

63
Q

What happens if a miltary personnel presents a FMed 296 prescription to a non-contracted pharmacy?

A

If there are no MOD contracted pharmacy nearby, the prescription should be treated as a private prescription and the patient should be charged the appropriate fee. It is then up to the individiual patient get reimbursed

64
Q

How should schedule 2 and 3 CDs be prescribed for military personnel?

A

They should be written on pink FP10PCD forms
(schedule 2 or 3 CD written on FMed 296 forms cannot be dispensed by community pharmacies)

65
Q

What are British Forces Post Office (BFPO) address stamps and how do you handle prescriptions that have it?

A

Prescriptions with a BFPO address stamp have been generated abroad and are normally not seen in the UK. If there is any doubt, pharmacists are advised to check the registration status of the doctor, dentist or independent prescriber

66
Q

What should legally be on a label?

A

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: “(e.g. For external use only)”.
The label must be on the OUTER container

67
Q

What is recommended to be on the label (not legal requirement)

A

‘Keep out of the reach and sight of children’
‘Use this medicine only on your skin’ where applicable.
In secure environments it is strongly recommended that the prisoner number is also included on the label as a definitive patient identifier.

68
Q

What does the NPSA recommend when it comes to labelling?

A

Although it is lawful to label the outer container, the outer container may be discarded so the labelling info could be lost. Therefore the actual container of inhalers, creams etc may be labelled rather than the outer container

69
Q

What happens if the directions for use, name or common name of the medicine, or precautions, relating to the use of the medicine, are not appropriate on the prescription

A

The pharmacist can substitute these with appropriate particulars of a similar kind when producing the dispensing label without contacting the prescriber if it is within their competency but document it

70
Q

Can a pharmacy supply medicine to another legal entity (e.g another trust or out of hours medical practice)

A

Only if they have the appropriate licence from the MHRA - e.g Manufacturer’s/importer’s licence (MIA) or Manufacturer ‘specials’ licence (MS

71
Q

What must be on the label for medicine from split packs

A

The regular labelling requirements plus:
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).

72
Q

What is covert administration ?

A

medicines are administered in a disguised format without the knowledge or consent of the person receiving them, for example, in food or drink.

73
Q

When can medication been covertly administered

A

to people who actively refuse their medication and who are considered to lack mental capacity in accordance with an agreed management plan

74
Q

What is a pharmacist’s role in covert administration of medication

A

They have to sign a covert administration documentation
They must clinically screen the medication and provide advice on how medicines should be administered or what to do if the patient only consumes only part of their food/drink

75
Q

Who can administer adrenaline in emergency situations

A

Adrenaline is POM medication but anyone can administer it for the purpose of saving a life and must call the ambulance afterwards

76
Q

What are patient specific directions (PSDs)

A
  • exemptions to the restrictions on the sale, supply and administration of medicines
  • a written instruction from a doctor, dentist or non-medical prescriber for a medicine to be supplied or administered to a named patient after the prescriber has assessed that patient on an individual basis.

(e.g when loperamide is prescribed at high doses for those with HOS)

Trainee year - MEP (1 decks)

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