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MEP Flashcards

1
Q

What are the FOUR principles of medicines optimisation?

A

Ensuring patients get the best possible outcomes from their medicines.

  1. Aim to understand patient’s experience
  2. Evidence-based choice of medicines (clinically & cost effective)
  3. Ensure medicines use is as safe as possible
  4. Make medicine optimisation part of routine practice

Right patient - right medicine - right time

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2
Q

A profession can be described as: (4)

A
  1. Recognised by the public
    as a profession
  2. Recognised
    representative professional body
  3. An occupation that benefits from professional
    standards and codes of conduct
  4. Regulated to ensure the maintenance of standards and codes of conduct
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3
Q

What are the 6 steps to exercise professional judgement?

A
  1. Identify ethical dilemma or professional issue e.g. deciding t supply a med or not
  2. Gather relevant information e.g. facts, knowledge, laws, standards etc
  3. Identify possible options
  4. Weight up benefits and risks
  5. Choose an option - must be able to justify decision
  6. Record events & decision making process. e.g. patient medication record or medical record or intervention record book
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4
Q

Define Medicines reconciliation

A

The process of identifying an accurate list of a patient’ current medicines (inc. OTC and complementary) and carrying out a comparison with current list in use, recognising discrepancies and documenting any changes.

Should take place whenever patient is transferred from one care to another.

Prevents errors & provides foundation for assessing appropriateness of pt’s current medicines.

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5
Q

What are sources of info for a meds rec? (11)

A
  1. Patient or patient’s representative
  2. Patient’s medicines
  3. Repeat prescriptions
  4. GP referral letters
  5. The patient’s GP surgery
  6. Hospital discharge summaries or outpatient
    appointment notes
  7. Community pharmacy PMR
  8. Care home records
  9. Drug treatment centre records
  10. Other healthcare professionals and specialist
    clinics
  11. Patient medical records where available
    (e.g. in prisons or the Emergency Care Summary
    (Scotland), Summary Care Record (England),
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6
Q

What are the REVALIDATION requirements?

A

SIX records each year:
4 CPD records (at least 2 planned)
A peer discussion
A reflective account

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7
Q

What information should you obtain when taking a medication history?

A
  1. Generic name of drug
  2. Brand name where appropriate
  3. Strength
  4. Form
  5. Route of administration
  6. Frequency
  7. Length of treatment e.g. for antibiotics
  8. Device and brand for e.g. insulins, inhalers
  9. Day/date for medicines taken on specific days of week or month e.g. methotrexate
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8
Q

What is a GSL medicine?

A

Sold in a registered pharmacy or retail outlet that can close to the public
Hold an EU/ UK Marketing Authorisation or Traditional Herbal registration or GSL homeopathic product.

Some may be marked as PO by manufacturers when they want restrict sales through pharmacies only even tho it is GSL.

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9
Q

Can GSL medicines be sold in the absence of the responsible pharmacist?

A

Yes! Providing they have signed in as RP on the pharmacy Record. Unless they have been absent for over 2 hours- then you can’t unless another pharmacist becomes the RP.

If they have not (i.e. they are late) then GSL sale can only commence once the RP has signed in.

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10
Q

Can P medicines be sold in the absence of the RP? What if a second pharmacist becomes RP?

A

NO- not in absence of RP, unless a second pharmacist is present.

NB: P medicines should not be available for self-selection!

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11
Q

What CANNOT take place when the Responsible pharmacist is absent for under 2 hours?

A

Sale of P Medicines
Handing out prescriptions and bagged meds
Handing prescriptions to delivery driver
These CAN all take place if a second Pharmacist is present.

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12
Q

What is the only activity that can be done if the RP is absent for over 2 hours and there is no second pharmacist?

A

Taking in prescriptions- the pharmacy would be closed in this situation but could take prescriptions at door.

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13
Q

What two drugs used in Cold and Flu must you NOT sell together at the same time?

A

Products containing Pseudoephedrine and Ephedrine

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14
Q

Who can suspicions of possible misuse of OTC products be reported to? (3)

A
  1. Local GPhC inspector
  2. Local Controlled Drugs liaison police officer
  3. Accountable officer
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15
Q

What are the two licensed EHC drugs that can be obtained from a pharmacy?

A

Levonorgestrel 1500 mcg (Levonelle One Step)

Ulipristal Acetate 30mg (Ella One

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16
Q

How many days after unprotected sex is Levonorgestrel licensed for?
What about Ulipristal Acetate?

A

Levonorgestrel= 3 days (72 hours) ideally in first 12 hours.

Ulipristal acetate= 5 days (120 hours)

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17
Q

What age is Levonorgestrel licensed for?

What about Ulipristal Acetate?

A

Levornorgesterol is licensed for use in over 16 years. Can be given to under 16’s only if a locally commissioned PGD is in place.

Ella One can be used in any girl of child-bearing age- so can be used in under 16’s!!
Bear in mind- children under 13 are legally too young to consent to any sexual activity. Any younger requesting this should be reported to social services. Children under 16 also not legal although its may be consensual- i.e. with a boy also under 16.

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18
Q

Can pharmacists provide an advanced supply of EHC?

A

Yes as long pt is assessed to be competent

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19
Q

If you decided to supply a child under 16 with EHC, can patient information be disclosed without consent?

A

No- still need to obtain consent in order to disclose information. Info can be shared if safeguarding an issue- judge on a case by case basis.

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20
Q

EHC: If the patient vomits within how many hours of Levonelle/ Ella One should they take another dose?

A

3 hours of taking Levonorgesterel

3 hours of taking Ella One (Ulipristal acetate)

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21
Q

At what point in the menstrual cycle should EHC be taken? Can it be taken more than once per cycle?

A

Can be taken at any point.

SPC for Levonelle states It is not advisable to take more than 1 per cycle as it can disrupt the cycle.

NB: RPS guidance says that women can take more than one if appropriate but should be advised about cycle disruption.

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22
Q

A patient, who you are aware has alcoholic liver cirrhosis, asks for EHC. What do you do?

A

EHC- levonorgestrel and Ulipristal- both not recommended in severe liver dysfunction. Try and find out how severe the liver disorder is- refer.

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23
Q

What medication can Levonorgestrel increase the toxicity of?

A

Ciclosporin (immunosuppressant used after transplants)

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24
Q

Can EHC be used in breast feeding women?

A

Levonorgestrel appears in small amounts in breast milk- should not be harmful, but take tablet after a feed to allow maximal team until next feed.

Ulipristal acetate is present in breast milk for 1 week after administration. Advise mother not to BF in this time but express and discard the milk to maintain lactation.

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25
Q

**Which EHC drug can reduce the efficacy of COC and POP pills?

A

Ulipristal acetate. Patients should use barrier methods until next period as their normal contraceptive cover will be reduced

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26
Q

What is the max number of paracetamol non effervescent and aspirin non effervescent you can buy OTC?

A

100 of each
but remember they come in packs of 16 and 32 so you would not be able to sell this amount anyway!

Effervescent & other formulations like liquid, granules etc - no legal limit just professional judgement

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27
Q

What is OTC codeine/ dihydrocodeine products indicated for?

Max pack size available and can be sold?

What must be visible on the pack and in the PIL?

A

Short term (3 days max) treatment of acute - moderate pain not relieved by paracetamol, ibuprofen or aspirin alone.

NOT for cold, flu sore throat etc.

32 pack size.

RPS recommend- One box only even if effervescent. Anything bigger is POM

“CAN CAUSE ADDICTION. For 3 days only.

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28
Q

Legal requirements of labels? (6)

What is recommended?

A
  1. Name of patient
  2. Name and address of supplying pharmacy
  3. Date dispensed
  4. Name of medicine
  5. Directions for ruse
  6. Precautions relating to the use of the medicine

RPS recommend
Keep out of the sight and reach of children

Use this medicine only on your skin - where applicable

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29
Q

Pharmacists can dispense RX by Dr and Dentists from the European Economic Area (EEA) or Switzerland except for what _____?

A

Schedule 1, 2 or 3 or for drugs without a UK marketing authorisation.

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30
Q

Legal Rx requirements?

A
  1. Name and Address of Patient
  2. Age if pt under 12
  3. Address of prescriber
  4. Type of prescriber
  5. Signed in indelible ink or advanced authorised electronic signature on electronic Rx
  6. Date

Written in indelible ink

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31
Q

Is it permissible to issue carbon copies of an Rx?

A

Yes, as long as it is signed in ink

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32
Q

A prescriber has signed an Rx using computer generated signature. Is it legally valid?

A

Yes

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33
Q

Where should patient safety incident reports be sent to?

A

National Reporting and Learning System (NRLS)

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34
Q

What are the 9 GPhC standards?

A
  1. Provide patient-centred care
  2. Work in partnership with others
  3. Communicate effectively
  4. Maintain, develop & use their professional knowledge and skills
  5. Use professional judgement
  6. Behave in a professional manner
  7. Respect and maintain the person’s confidentiality
  8. Speak up when they have concerns or when things g wrong
  9. Demonstrate leadership
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35
Q

What can pseudoephedrine and ephedrine be misused for?

A

To make methylamphetamine (crystal meth) Class A

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36
Q

What are the restrictions on supply of pseudoephedrine and ephedrine without a Rx?

A

Can’t supply or sell a product or combo of products that contain more than:

720mg of pseudoephedrine
OR
180mg of ephedrine

Can’t sell or supply pseudoephedrine and ephedrine at the same time without Rx.

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37
Q

If a woman is taking enzyme inducing drugs (CYP34 mainly) and asks for Levonogestrel. What is the advise and why?

Same for EllaOne

A

The metabolism of levonorgestrel is enhanced by concomitant use of liver enzyme inducers.

For women who have used enzyme-inducing drugs in the past 4 weeks and need emergency contraception, the use of non-hormonal emergency contraception (i.e. a Cu-IUD) should be considered.

Or if not willing/can’t then - a double dose of levonorgestrel (i.e. 3000 mcg within 72 hours after the unprotected intercourse)

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38
Q

Examples of drugs that can reduce plasma levels of levonorgestrel? (9)

Same for EllaOne

A
  1. Barbiturates (inc. primidone)
  2. Phenytoin
  3. Carbamazepine
  4. Herbal medicines contains st johns wort
  5. Rifampicin
  6. Ritonavir
  7. Rifabutin
  8. Griseofulvin
  9. Efavirenz
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39
Q

What is the effect of taking levonorgestrel and cyclosporin together?

A

levonorgestrel may increase the risk of cyclosporine toxicity due to possible inhibition of cyclosporin metabolism

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40
Q

How does Ella One work?

A

It postpones or inhibits ovulation. If ovulation has already occurred then it is ineffective.

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41
Q

A woman asks for ellaone but is asthmatic?

Yes or No…?

A

Use in women with severe asthma treated by oral glucocorticoid is not recommended.

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42
Q

How does Levonorgestrel work?

A

by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase

Levonorgestrel is not effective once the process of implantation has begun

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43
Q

What are some of the reclassified medicines?

A 
Amorolfine nail lacquer
• Anti-malarials as Pharmacy medicines
• Chloramphenicol eye drops and eye ointment
• Emergency contraceptives
• Mometasone 0.05% nasal spray
• Proton pump inhibitors
• Oral lidocaine-containing products
for teething in children
• Orlistat
• Sildenafil
• Sumatriptan
• Tamsulosin
• Tranexamic acid
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44
Q

How many times can a repeatable Rx be repeated if prescriber hasn’t specified a number?

Usually private Rx NOT FP10 etc

A

Repeated once (dispensed twice)

Oral contraceptive 5 times (dispensed 6 times)

CD sch 2 and 3 ARE NOT REPEATABLE.

CD sch 4 and 5 ARE OKAY.

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45
Q

How long are repeatable RX valid for?

A

First dispensing must be made within 6 months and there is no legal time limit for remaining repeats.

Schedule 4 CD must be dispensed within 28 days and then same no legal time limit for the rest.

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46
Q

Pts can have repeatable Rx dispensed from different pharmacies. To keep an audit trial what should u record on the Rx?

A

Name and address of pharmacy and date of supply

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47
Q

How long are ownings valid for ?

POM, P, GSL & CD 5

CD 2, 3, 4

A

POM, P, GSL & CD 5 - 6 months from date on Rx

CD 2, 3, 4 - 28 days from date on Rx

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48
Q

How long should records be kept for private Rx for POM ?

How long should private Rx be kept for?

If it’s for CD 2 and 3 what else should be done?

A

Records must be made in POM register. Register must be retained for 2 years from last entry.

Kept for 2 years from date of supply/sale or if it is repeatable then from the date of last supply.

If Sch 2 and 3 must be submitted to relevant NHS agency

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49
Q

What should a record for a private Rx include in the POM register?

A
  1. Date of supply
  2. Date on Rx
  3. Medicine details - name, quantity, formulation, strength
  4. Prescriber details - name and address
  5. Patient details - name and address
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50
Q

Rx records are exempt for which meds?

A
  1. Oral contraceptives

2. Sch2 as they need separate CD register record

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51
Q

What is FMD and when did it come into force?

A

Falsified Medicines Directive is a system to ensure medicines supplied are safe - reduce risk of fake meds coming to the uk

Feb 2019

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52
Q

Are faxed Rx legally valid?

What are some of the risks involved?

A

No they are not - not in indelible ink and not signed in ink by the prescriber

Risks

  1. Poor reproduction
  2. Uncertain that supply made in accordance with a legally valid Rx
  3. Non-receipt of original Rx
  4. Original Rx can be amended
  5. Faxed Rx sent to multiple pharmacies
  6. Rx not genuine
  7. Fax system not secure
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53
Q

Dentists can legally write prescriptions for any POM.

Can they do this using an NHS dental prescription?

A

No, they are restricted to items in the Dental Prescriber’s Formulary

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54
Q

What are the Rx requirements from EEA/Switzerland prescriber?

A

ONLY ALLOWED POM & SCH 4

  1. Patient details - full name and DOB
  2. Prescriber details - full name, professional qualifications, direct contact number + work address (inc. country they work in)
  3. Medicine details - Name (brand if appropriate), form, quantity strength and dosage details.
  4. Prescriber signature
  5. Date of issue - valid for 6 months / 28 days for Sch 4
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55
Q

Can an emergency supply be made at the request of a patient & or an EEA/Swiss prescriber?

A

Yes - POM & Sch 4 and 5

Same requirements as UK emergency.
Rx to be received within 72 hours.

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56
Q

What type of Rx do the military use?

Do all community pharmacies handle them?

A

FMed 296

Only pharmacies contracted under the Ministry of Defence should dispense them

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57
Q

What happens if a military Rx is presented to a non-contracted pharmacy?

A

Can be dispensed but treated as a PRIVATE rx.

Invoice should not be sent to the MOD directly but to charge the patient . The patient can then recover any costs from their military unit.

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58
Q

A CD has been prescribed on an FMed 296. Can this be dispensed?

A

No, it should be on a pink FP10CD

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59
Q

What is a PSD?

A

PSD = Patient Specific Directions

Outline exemptions to the restrictions on the sale, supply and administration of medicines.

Could be written instructions from a Dr/Dentist etc for a medicine to be suppled to a named patient after the prescriber has assessed that patient on an individual basis.

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60
Q

What is a PGD?

A

Patient Group Direction

Written direction that allows the supply /administration of a specified medicine/s by a named authorised health professional to a well-defined group of patients requiring treatment for a specific condition.

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61
Q

Can pharmacists supply/offer to supply/administer diamorphine or morphine under a PGD?

In what case?

A

Yes - for the immediate necessary treatment of sick or injured persons

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62
Q

What are the conditions for an emergency supply at the request of a prescriber?

A
  1. Relevant prescriber
  2. Emergency reason
  3. Written Rx agreed to be supplied within 72 hours
  4. Directions in accordance with prescriber
  5. Not for CDs 1, 2 and 3 except for phenobarbital - for epilepsy (authorised by Dr, dentist, nurse, pharmacist independent/supplementary prescriber)
  6. Record kept - POM register on the day of supply or next day if impractical
  7. Usual labelling
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63
Q

What needs to be recorded for an emergency supply at the request of prescriber? (6)

A

POM record:

  1. Date of supply
  2. Name (strength and form) and quantity of medicine
  3. Name and address of prescriber
  4. Name and address of patient
  5. Date on prescription
  6. Date on which the Rx is received
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64
Q

What are the requirements of an emergency supply at the request of a patient?

A
  1. Interview patient
  2. Pharmacist needs to be satisfied with the need
  3. Medicine must have been previously be prescribed and used as treatment
  4. Dose - need to know the dose (look at PMR, repeat slip etc)
  5. Not for CDs (1,2,3) except for phenobarbital
  6. Length of treatment: POM = max 30 days except if POM is insulin, cream, inhaler - smallest packs should be provided
    Abx liquid - smallest quantity to cover full course treatment
    Oral contraceptive - full treatment cycle should be supplied
    CD 4/5 or phenobarbital = max 5 days supply
  7. POM record kept
  8. Labelling = EMERGENCY SUPPLY needs to be added
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65
Q

What should be recorded in POM register for emergency supply at request of patient?

A
  1. Name and address pf pt
  2. Date of supply
  3. Medicine name/form/strength/quantity
  4. Reason for emergency supply & why rx can’t be obtained
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66
Q

Who can provide a signed order for salbutamol / adrenaline auto injectors for a school?

A

Written signed order by principal/head teacher must be provided

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67
Q

What information should be included on signed order for salbutamol/adrenaline for schools?

A
  1. Name of school
  2. Purpose for product required
  3. Total quantity needed
  4. Signed
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68
Q

What records need to be kept for supply of salbutamol/adrenaline to schools?

A
  1. Signed order - kept for 2 years for date of supply or entry made into POM register (good practice to do both)
  2. Date POM was supplied
  3. Name, quantity, strength, formulation of Inhaler
  4. Name, address, business of person whom the medicine was supplied
  5. Purpose it was supplied/sold
69
Q

What is naloxone?

A

It is an opioid/opiate antagonist which can completely /partially reverse the central nervous system depression especially respiratory depression caused by opioids e.g. Heroin/morphine

70
Q

True or False

Although Naloxone is a POM it can be supplied to allow staff engaged in lawful drug treatment services to obtain and make direct supplies to patients without a Rx/PGD etc

A

True

Nasal naloxone included from Feb 2019

71
Q

Name the 4 bodies that allow persons employed to supply and administer naloxone

A
  1. Local authority
  2. Public health England
  3. NHS body
  4. Public health agency
72
Q

Anyone can administer naloxone for purpose of saving a life. Give examples of who that might be

Can Naloxone be given out in the absence of the RP?

A

Family members of drug users
Staff working with drug users etc

Yes the service (take home scheme) can continue to be provided by trained member of staff

73
Q

What is the risk associated with oral retinoids? Examples of retinoids?

A

Isotretinoin, alitretinoin and acitretin

High risk of causing severe foetal malformations and increase risk of spontaneous abortion

74
Q

What is the Pregnancy prevention programme?

A

To protect females from getting pregnant whilst taking oral retinoids and for at least one month after stopping oral retinoids

Includes education, therapy management which includes pregnancy testing before, during and after treatment, contraception requirements, and distribution control

75
Q

Under PPP - how long is a prescription valid for?

What if a pt brings in an expired one?

A

7 days - should ideally be dispensed on day it is issued

Need to refer back to prescriber

76
Q

What is the max quantity that can be supplied on one prescription under PPP ? what about not under PPP

A

30 days max

More than 30 days can be dispensed if prescriber confirms as not being under PPP

77
Q

Females should be under the PPP for valproate.

What should the pharmacist do when giving out valproate to them?

A
  1. Talk with patient to find out if they have had a review with Dr, aware of risks and are on a PPP
  2. If there is unplanned pregnancy whilst taking valproate - should NOT stop treatment and to arrange to see prescriber urgently
  3. Report any side effects via Yellow card Scheme
78
Q

To avoid substitution - biologics must be prescribed by ….

and when giving to the patient you should confirm that ….

A

Brand name

It is the biologic they are expecting and they are aware how to use and store it

79
Q

What should you when you become aware of a dispensing error?

A
  1. Take steps to let the patient know promptly
  2. Make things right - may involve contacting prescriber
  3. Offer an apology
  4. Let colleagues involved know
80
Q

What do you need to have in place to be able to trade in medicines?

A
  1. Hold Wholesale Dealer’s License - WDA(H)
  2. Apply Good Distribution Practice standards
  3. Responsible person named on licence

Medicines only to be traded to other wholesalers, pharmacists or other person authorised to supply medicines to the public

81
Q

What criteria is deemed not commercial dealing and so does not need WDA(H)?

A
  1. It takes place on an occasional basis
  2. Quantity supplied is small
  3. Supply is not for profit
  4. SUPPLY IS NOT FOR ONWARD WHOLESALE DISTRIBUTION
82
Q

What additional license is needed to trade CDs?

A

Home Office CD Licence

83
Q

When a POM is supplied to a healthcare professional or organisation - should a record be kept in the POM register?

A

Yes - and signed order and invoice should be kept for 2 years as good practice

84
Q

What are the 6 categories of veterinary medicines and their characteristics?

A
  1. POM -V : prescribed by a vet and supplied by a vet or a pharmacist with a written Rx
  2. POM-VPS : prescribed & supplied by a vet, pharmacist or suitably qualified person on an oral or written Rx. Written if supplier is not the prescriber
  3. NFA - VPS : Medicine for non-food animals that can be supplied by a vet, pharmacist or suitably qualified person. Written Rx not required
  4. AVM - GSL : authorised vet medicine that is available for general sale
  5. Exempt meds under schedule 6 of vet medicine regulations - exemptions for small pet animals (SAES) : unlicensed vet medicine that doesn’t require marketing authorisation because it meets criteria laid out in sch 6 of the Vet Medicines Regulations
  6. Unauthorised Veterinary Medicine - unlicensed med that does not have a marketing authorisation through the SAES. It can only be prescribed by a vet under the cascade. This includes any human medicine used for animals.
85
Q

What are the Rx requirements for
POM-V
POM-VPS
Meds supplied under the veterinary cascade?

A
  1. Prescriber details:
    Name, address, telephone number, qualification of prescriber. If sch 2 or 3 CDs Royal college veterinary surgeons registration number must be included
  2. Name and address of owner
  3. Identification and species of animal & its address if different to owner
  4. Date. Rx valid for 6 months or shorter if indicated. Sch 2, 3 & 4 valid for 28 days.
  5. Name, quantity, dose and administration instructions of required medicine. “as directed” not acceptable.
  6. Where appropriate, a statement highlighting medicine prescribed under the cascade.
  7. Any necessary warnings and if relevant withdrawal period.
  8. If sch 2 or 3 CD - “the item has been prescribed for an animal or herd under the care of the veterinarian” - usual CD requirements apply.
  9. If Rx repeatable - number.
86
Q

How long should veterinary prescriptions be retained for?

Should they be sent to the NHS?

A

5 years and no

87
Q

Is it a legal requirement for no more than 28 days worth supply of Sch2 and 3 , 4 for animals and 30 days for humans?

A

No - it just good practice.
In veterinary e.g. long term for example epilepsy in dogs
For humans, prescriber must be able to justify the quantity under “Total Quantity”

88
Q

What does prescribing under the cascade allow for?

A

Allows the supply of medicines that are not licensed for animals.

Legal requirement for words to be present on Rx.

89
Q

Describe the Veterinary cascade

A
  1. Supply a licensed vet medicine

if not

  1. An existing licensed vet medicine for another species or different condition can be considered
  2. A licensed human medicine or an EU-licensed vet medicine can be considered
  3. Extemporaneous or specially manufactured medicines can be considered
90
Q

Can you sell/supply medicines not licensed for animals ? such as GSL, P even if the vet verbally asked them to purchase OTC human product?

A

No, it is unlawful

91
Q

It is a legal requirement for a pharmacist who supply NFA-VPS or prescribe POM-VPS to: (4)

A
  1. Advise how to use product
  2. Advise on warnings and contraindications
  3. Satisfied that recipient intends to use the medicine correctly and competent
  4. Prescribe/Supply minimum quantity required for treatment
92
Q

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

A

Yes, unless a transaction has been individually authorised in advance by pharmacist and person is deemed competent

93
Q

Labelling requirement of vet medicines prescribed under the cascade? what about other items?

A

Medicines under the cascade - following must be on the label unless clearly on the packaging

  1. Name of prescribing vet surgeon
  2. Name and address of animal owner
  3. Name and address of pharmacy
  4. Identification and species of animal
  5. Date of supply
  6. Expiry date
  7. Dosage and admin instructions
  8. Necessary warnings
  9. Applicable withdrawal period
  10. ” For animal treatment only”
  11. “keep out of reach of children”

If not prescribed under the cascade then doesn’t legally need a label but recommended.

94
Q

What must be recorded of SUPPLY and RECEIPT of POM-V and POM-VPS (8)

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. Written Rx - record name and address of prescriber and keep copy of Rx
  7. Can be kept electronically
  8. Kept for 5 years
  9. Can either keep copies of documents or make record in private rx book.
  10. Pharmacies that supply these need to be audited annually
95
Q

What is the GOSPORT REPORT?

A

at least 450 patients died due to inappropriately high doses of opioids at Gosport war memorial hospital.

96
Q

What is the Accountable officer responsible for?

A

Responsible for supervising and managing use of CDs

97
Q

What is the Schedule 1 (CD Lic POM)

Examples?

A

No therapeutic use and a license is needed for the production, possession or supply.

Hallucinogenic - LSD
Ecstasy type
Raw opium and cannabis

98
Q

Schedule 2 ?

Examples?

A

Pharmacists and other classes of person named in the 2001 regulation have a general authority to possess, supply and procure

Opiates (Diamorphine, morphine, methadone, oxycodone, pethidine)

Major stimulants e.g. amfetamines

Quinalbarbitone
Ketamine

99
Q

Schedule 3
(No register POM)
Examples?

A

Minor stimulants that are less likely to be misused

Buprenorphine
Tempazepam
Tramadol
Midazolam 
Phenobarbital

Gabapentin & Pregabain

100
Q

What are the two parts to schedule 4?

A

Part 1 - CD Benz POM
Benzodiazepines (diazepam), non-benzodiazepine hypnotics (zopiclone), Sativex (cannabinoid oromucosal mouth spray)

Part 2 - CD Anab POM
Anabolic and androgenic steroids, growth hormones

101
Q

Schedule 5?

A

CD INV POM or CD INV P

Certain preparations of controlled drugs such as codeine, pholcodine and morphine

Low strengths

102
Q

How long are CD Rx valid for?

Sched 1 to 5

A

Sch 1 - 4 28 days

Sch 5 - 6 months

103
Q

Which CD schedules are CD Rx requirements needed?

A

Yes - Sch 2 and 3

No - Sch 4 part 1 and 2 and sch 5

104
Q

Which schedules can EEA /Swiss legally prescribe?

A

Only Sch 4 and 5

105
Q

Which schedules Rx can be repeated?

A

Only Sch 4 and 5

106
Q

Can you provide an emergency supplies for CDs?

A

Sch 2 NO
Sch 3 NO - except phenobarbital for epilepsy by UK prescriber

Sch 4 - YES
Sch 5 - YES

107
Q

Which schedules need a licence to import or export?

A

ALL apart from

Sch5
Sch4 part 2 where the substance is imported or exported for self-administration

108
Q

Invoices should be kept for 2 years for which schedules?

A

Sch 3 and 5

109
Q

What two exemptions can a pharmacist take possession of Sch 1 drugs without a Home office licence?

A
  1. Purpose of destruction
  2. Handing over to a police officer

Pt confidentiality should normally be maintained - source will not be identified. However if quantity so large that not normal for personal use - then may be identified in the interest of the public. Discuss with other health professionals first and insurance legal advisor.

Remember other schedules don’t need a licence as long as acting as pharmacist.

110
Q

Can Sch 1 drugs be administered/ prescribed by anyone?

A

No - only under a home office licence

111
Q

Patient asks you about taking CDs (not sch5) abroad. What would you advise?

A

If travelling with less than 3 months supply - then no licence is required but advised they have a covering letter signed by prescriber which confirms
Patient name
Travel plans
CD name, quantity and dose

Check the countries embassies - to ensure import and export regulations are followed.

In other instances.. they would need to contact the Home Office to apply for a personal licence.

112
Q

A requisition form is required for obtaining Sch 1, 2 and 3 drugs.

Where did this stem from? Who is exempt?

A

Stems from Shipman inquiry - to ensure purchase of sch2 and 3 by healthcare professionals within the community can be monitored.

Hospitals and prisons don’t need to use the approved form.

113
Q

What are the legal requirements for a CD requisition? (6)

A
  1. Name of recipient
  2. Signature
  3. Address
  4. Occupation
  5. Quantity needed
  6. Purpose of requisition
114
Q

Can you supply against a faxed or photocopied requisition?

Also does it need to obtained in writing before supply?

What about in an emergency?

A

No - not acceptable

Yes - practitioners, hospitals, care homes, hospital wards etc

Some not included e.g. gphc registered pharmacies

Pharmacy to pharmacy = must have written on approved form before supplying

Dr or Dentist can be supplied with Sch 2 and 3 - based on form will be supplied within 24hours. their fault if not.

115
Q

When a requisition is received how should they be processed?

When do they not apply?

A
  1. Indelibily marked with suppliers name and address
  2. Send original to releveant NHS agency.

Good practice to keep copy for 2 years.

These don’t apply when supply is made:
by a person responsible for dispensing and supply of meds at a hospital, care home, hospice, prison or ambulance

Pharmaceutical manufactures/wholesales

Against vet reqs - original should be kept 5 years

116
Q

Which 3 CDs can midwives obtain?

A

Use a midwife supply order for :

  1. Diamorphine
  2. Morphine
  3. Pethidine
117
Q

What must a midwife supply order contain? (5)

A
  1. Name of midwife
  2. Occupation
  3. Name of pt
  4. Purpose of CD
  5. Sig of authorising medical officer - e.g. Dr , Midwife supervisor
118
Q

Rx requirements for (NHS and private) Sch 2 and 3?

A
  1. Patient name
  2. Pt address (PO box not acceptable)
  3. Med dose
  4. Medicine form
  5. Med Strength (only needed if more than one is available)
  6. Total quantity (must be written in words & figures)
  7. Quantity prescribed (advised should not exceed 30 days worth)
  8. Prescriber signature (can be diff signature to the named - in CD reg Signature prescriber details needs to be recorded)
  9. Address of Prescriber (must be UK)
  10. Date (28 days validity)
  11. Instalment wording if needed
  12. Dentist wording if needed (for dental treatment only)
119
Q

What version of products have greater potential to be misused?

A

Sugar and or colour free

120
Q

Give some examples of some doses that are not legally acceptable for CD Rx?

And examples which are acceptable

A 
PRN
As directed 
Twice a day 
Decrease dose by x amount every 4 days 
Weekly (frequency only not dose)

Acceptable:
One as directed
One PRN
3 amps to given as directed

121
Q

What should an instalment direction for Sch 2 and 3 include?

When should it be dispensed and how long valid for?

A
  1. Amount of medicine per instalment
  2. Interval between each time of supply

First dispensed within 28 days of date on Rx
Remainder in line with instalment instructions even if they go beyond the 28 days

122
Q

Can you change the CD Rx if there is a minor mistake? Which part and what can’t you do?

A

If minor spelling mistake or where the words or figures (but not both) of total quantity has been omitted - can be amended in inedible ink and marked with
name, date, signature and GPhC NUMBER.

can’t do missing date, incorrect dose /form/strength etc

123
Q

Can Drs do amendments via cover letter for CD rx?

A

No

124
Q

What are the 3 requirements for private Rx prescriptions for SCh 2 and 3

what about vet cd rx?

A
  1. Must be on standardised forms
  2. Prescriber identification number
  3. Submit original copy to relevant NHS body

Vet Rx CDs do not need to be written on standard form or be sent to NHS. Just be kept for 5 years

125
Q

When a sch 2 CD is collected from the pharmacy. What must be done?

A

Pt or pt represenative?

See ID

If rep - needs written letter to authorise and name rep

CD record needs to include rep details

Good to see pt at least once a week -

if supervised legally acceptable to to get verbal confirmation from prescriber.

126
Q

What are the safe custody requirements for sch 2 and 3 ?

A

Locked in safe/cabinet or room which is constructed as to prevent unauthorised access to the drugs

shall be rigidly and securely fixed to a wall or floor

Nothing shall be displayed outside a safe or cabinet to indicate that drugs are kept inside it.

127
Q

What needs to be kept in the safe?

A
  1. Sch 1
  2. Sch 2 except some liquid preparations and quinalbarbitone (secobarbital)
  3. Sch 3 for example temazepam and buprenorphine

exceptions include: gabapentin, pregabalin, phenobarbital, mazindol, tramadol, midazolam, meprobamate, pentazocine and phentermine

128
Q

What happens if a patient returned CDs or out of date cds?

A

Need to be kept in safe custody (separate from other stock) until they be destroyed

129
Q

Which CDs need to be denatured before disposing?

A

Sch 2, 3 and 4 (part 1)

130
Q

When is an authorised witness required for the destruction of CDs?

What about other times?

A

When Out of date Sch 2 CDs = NEED authorised witness

when out of date other schedules - good practice for another member of staff to witness

if patient returned - good practice for another member of staff to witness

131
Q

What records should be kept for destruction of patient returned o out of date CDs?

A
  1. Patient returned - no record kept in CD register but records should be kept in separate record
  2. Out of date - entry should be made in CD register for Sch 2
132
Q

Can an accountable officer be an authorised witness?

A

No - but anyone else can be authorised by them instead - someone not involved in the day to day management or use of CDs

133
Q

How should solid dosage forms - capsules and tablets be destroyed?

A

Grind and crush them before adding to denaturing kit. can use small amount of water when crushing to avoid dust.

When denaturing kit not available - crush and grind then put in warm soapy water to ensure dissolved and then put in waste container

134
Q

How should liquid dosage forms be destroyed?

A

Pour in denaturing kit

if not available - pour into appropriate product e.g. cat litter then into correct waste disposal bin

bottles to be rinsed and disposed appropriately.

can only dispose pharmaceutical via sewage system if you have consent from sewage

135
Q

How should patches be destroyed?

A

Remove backing and fold patch on itself. put in waste disposal bin or denaturing kit.

136
Q

How should ampoules and vials be destroyed?

A

Open and empty contents into kit, and dispose same ways liquids. ampoules in sharps bin.

For powder - open ampoule and add water to dissolve inside. Then poured into kit and ampoule in sharps bin

another way but less preferable- ampoules crushed in pestle in an empty plastic container. Once broken ass warm soapy water for powder or suitable product for liquid. then thrown using kit or bin for liquid medicines..

137
Q

How should aerosol forms be destroyed?

A

Expel into water and dispose liquid like liquid .

Or expel into absorbent material and dispose as pharmaceutical waste.

138
Q

Records should be kept for Sch 1 and 2 drugs and what else?

A

Sativex ( sch 4 part 1)

139
Q

What should be recorded for CDs that are received? (4)

A
  1. Date received
  2. Name and address from whom received
  3. Quantity
140
Q

What should be recorded for CDs that are supplied?

A
  1. Date supplied
  2. Name and address of recipient
  3. Details of authority to possess (prescriber of license holder details)
  4. Quantity supplied
  5. Details of person collecting sch 2 - patient/rep/healthcare rep - if latter also record name and address
  6. Proof of ID requested?
  7. ID provided?
141
Q

What should the nature of CD register be like?

A
  1. Class, form and strength to be at top of page
  2. Bound book unless electronic
  3. Different classes = different areas of book and within that a separate page for different strengths and formulations
142
Q

How long should CD registers be kept for?

A

2 years from last entry

143
Q

Cannabis-based products for medicinal use moved from sch 1 to sch 2.

What types of products are available?

A
  1. Unlicensed cannabidol products - marketed as supplements, provided no medical claims made. Must not contain tetrehydrocannabinol (THC) - remains controlled substance
  2. Licensed products/synthetics e.g. Sativex and Nabilone that are already available or being assed for marketing and not affected by new CBPM laws.
  3. Cannabis-based products for medicinal use - need to satisfy 3 requirements
  4. contains cannabis, cannabis resin or derivative
  5. produced for medicinal use in humans
  6. regulated as medicinal product
144
Q

What is Sativex and what is it used for?

A

cannabis extracts containing THC and CBD - only licensed cannabis product in UK

Authorised to treat spasticity in MS

Schedule 4 part 1

NICE does not recommend as not cost effective.

145
Q

What is Nabilone and what is it used for?

A

synthetic non-natural cannabinoid licensed in Uk for resistant nausea and vomiting caused by chemotherapy

146
Q

When can use by and expiry date be used until

A

Use by - last day of previous month

Expiry date - last day of that month

147
Q

Pharmacies selling online must have what?

A

Registered with MHRA

Display common EU logo

148
Q

In terms of licensing for homeopathic products what does the MHRA require?

What about herbal products?

A

Quality and safety

Does not need to show efficacy

Herbal need to have full marketing authorisation showing all safety, quality and efficacy

or traditional herbal registration based upon safety, quality and evidence of traditional use

149
Q

You have professional, legal and moral duty to protect children from abuse and neglect.

what are some signs to look out for?

A

Physical abuse - unusual injuries, bruises, blaming on siblings etc

Neglect - poor growth and weight. hygiene, dirty and messy

Sexual abuse (children under 13 too young to consent to any sexual activity) anything with under 16 is also an offence but could be consensual

Parent/carer signs - delays seeking medical treatment

150
Q

What can you do if you suspect abuse/neglect?

A

Emergency - call police

Refer to social services and follow up

151
Q

You provide contraception or advice to a child under 16. can you tell their parents?

A

No - general duty of patient confidentiality still stands

consent needs to be sought before

but also judge case by case - can get advise without saying identifying info

152
Q

What about safeguarding vulnerable adults? what’s the process if you suspect something

A

Emergency - immediate action, call police etc

Consider consent
if pt has capacity - obtain consent to escalate

if they don’t give u consent - consider confidentiality - sufficient grounds to break to it

if they do give consent then refer to relevant service – social service etc and record this

if no capacity - take advice/check with GP then refer

153
Q

What are some brands of adrenaline? when might you need to administer it in an emergency?

A

Epipen, Emerade and Jext - these are pre-filled syringes

When giving vaccinations (The Green Book)

In emergency best to use anaphylaxis pack - containing ampoules and syringes

154
Q

How long should RP log book be kept for?

A

at least 5 years

155
Q

How long should destruction of pts CD record be kept for?

A

good practice - 7 years

156
Q

Where should private CD rx be sent to ?

A

NHSBSA - NHS business service authority

157
Q

How long should CD invoices be kept for?

A

6 years

158
Q

Can there be more than 1 RP and can they be in charge of more than 1 premises at any one time?

A

No
1 RP at a time
1 premises at a time

159
Q

What does being RP involve?

A
  1. Secure the safe and effective running of the pharmacy
  2. Display a notice - name & gphc number as well as stating RP is in charge of pharmacy at the time
  3. Complete the pharmacy record
  4. Establish, maintain and review pharmacy procedures
160
Q

What should be recorded in the pharmacy record for RP?

A
  1. Name
  2. Gphc number
  3. Date and time of start being RP
  4. Date & time of stopping RP
  5. If absent - date and time of leaving and returning
161
Q

How long should the pharmacy record be kept for ?

A

5 years

162
Q

How long can an RP absent for?

What must they ensure

A

2 hours from midnight to midnight even if RP changes

Fill in record as appropriate

Remain contactable - if not ask another pharmacist to be contactable

163
Q

What can be done in absence of RP? (5)

A
  1. Generating a dispensing label
  2. Taking medicines off shelves
  3. Assembly of item e.g. counting tabs
  4. Labelling
  5. Accuracy checking
164
Q

What can be done only if RP is present?

A
  1. Professional check - clinical and legal
  2. Sale/supply of P meds
  3. Sale/supply of POM (e.g. handing out to patients/delivery person etc.)
  4. Supply of med under PGD
  5. Wholesale of meds
  6. Emergency supply of medicine at request of a patient or healthcare professional
165
Q

What can happen with RP in charge but does not require supervision?

A
  1. Sale of GSL

2. Processing of waste stock medicines or patient returned meds excluding CDs

166
Q

What can be done without an RP in charge as long as staff trained?

A
  1. Ordering stock
  2. Receiving stock from wholesalers (exc. CDs)
  3. Putting stock away exc. CDs
  4. Date checking ex CD
  5. Stocking shop items
  6. Cleaning
  7. Responding to enquirires e.g. about medicine issues
  8. Accessing the PMR
  9. Receiving Rx from EPS, patients or collecting from surgery
  10. Processing Rx that have been dispensed e.g. on shelves etc
  11. Delivery person giving meds to patient
  12. Receiving pt returned meds (exc. CDs)
167
Q

What are the 9 GPhc standards?

A
  1. provide person-centred care
  2. work in partnership
  3. communicate effectively
  4. maintain, develop and use professional knowledge and skills
  5. use professional judgement
  6. behave in a professional manner
  7. respect and maintain persons confidentiality and privacy
  8. speak up when concerns
  9. demonstrate leadership
168
Q

Assessing capacity

To make an informed decision a person must be able to…?

A
  1. understand info given
  2. remember info given
  3. use and weigh up info provided
  4. communicate their decision to pharmacy professional by any means
169
Q

What should you do in the event of a dispensing error?

A

Root cause analysis - retrospective technique

  1. Establish if pt has taken any of meds
    if they have - were they harmed? give appropriate advice and contact GP
    if no harm - still contact GP
  2. Ask to inspect the incorrect medicine - if they don’t want to they can retain it until they hand it over to GPhc etc
  3. Apologise
  4. Make supply of correct medicine if appropriate
  5. Establish what the patient wants/expectations
  6. Talk to team/pharmacist
  7. Inform professional indemnity insurance provider

MEP (4 decks)

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