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Pharmacy Pre-reg > MEP 2019 > Flashcards

MEP 2019 Flashcards

1
Q

Who can administer CDs to patients?

A

Doctor, dentist, pharmacist IP or nurse IP
Supplementary prescriber
Person acting in accordance with directions of a prescriber

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2
Q

What are the legal requirements for a CD requisition form?

A 
Signature of the recipient 
Name of the recipient 
Address of recipient 
Profession or occupation 
Total quantity of drug
Purpose of the requisition
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3
Q

What 2 pieces of important information on a instalment prescription direction is stated?

A

Amount of medicine per instalment

Interval between each time the medicine can be supplied

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4
Q

How many standards are listed in the Standards of pharmacy professionals? State them

A

9

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

What are GSL medicines and where can they be sold?

A

General Sales list medicines

Can be sold in registered pharmacies and other retail outlets (including vending machines).

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6
Q

What are PO medicines and give an example

A

Pharmacy only medicines
Used by manufacturers to describe a product that is licensed as a GSL but the manufacturer wishes to restrict sale/supply through pharmacies only.

E.g. 30 sachet pack of Fybogel

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7
Q

Can GSL medicines be sold without the Responsible Pharmacist signed in?

A

No, pharmacist must be signed in as the RP.

But can be sold if the Pharmacist is physically absent for a limited period of time while still signed in as RP.

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8
Q

What are P medicines?

A

Pharmacy medicines

Sold from a registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist.

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9
Q

What are the legal restrictions on the selling of pseudoephedrine and ephedrine products without a prescription?

A

It’s unlawful to supply a product or combination of products that contain more than 720mg of pseudoephedrine OR 180mg of ephedrine at any time without a prescription.

It’s unlawful to sell or supply any pseudoephedrine product at the same time as an ephedrine product without a prescription.

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10
Q

If there are suspicions during requests for pseudoephedrine/ephedrine, who can I report to?

A

Local GPhC inspector
Local CD liaison police officer
Accountable officer

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11
Q

What is levonorgestrel 1.5mg licensed for?

A

EHC for women aged 16 and over within 72 hours of unprotected intercourse.

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12
Q

What is ulipristal licensed for?

A

EHC within 120 hours (5 days) for unprotected intercourse.

Not contraindicated to patient under 16 but pharmacist must consider various factors such as sexual content, safegrauding etc.

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13
Q

What are the advice of advanced supply of oral EHC?

A

Pharmacist can provide an advanced supply to a patient requesting it .

Patient should be assessed to ensure that they are competent and the medicine is appropriate.

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14
Q

Can you supply EHC to the patient’s representative?

A

Yes. If you are satisfied it is a genuine request and the treatment is clinically appropriate for the patient.

Telephone the patient to assess suitability of the oral emergency contraceptive if their representative cannot provide you with the necessary information to determine whether the request is appropriate and genuine.

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15
Q

What is the OTC restriction of paracetamol and aspirin?

A

Not more than 100 non effervescent tablets or capsules can be sold to one person at any one time.

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16
Q

What are the legal limits on the quantities of OTC effervescent tablets, powders, granules, liquids

A

No legal limits.

Use professional judgment

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17
Q

What are the controls and warnings on OTC medicines containing codeine or dihydrocodeine?

A

Indications: short term treatment for acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone.

Pack size: no more than 32 dose units. This includes effervescent formulations. More than 32 is POM.

One pack should be sold at one time.

‘Can cause addiction. For 3 days use only’ should be stated clearly on the box.

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18
Q

When medicines for coughs and colds are seen as unsuitable children under 6 years? How about age 6-12?

A

Antitussives: dextromethorphan, pholcodine

Expectorants: Guaifenesin, Ipecacuanha

Nasal decongestants: Ephedrine, oxymetazoline, phenylephrine, pseudoephedrine, xylometazoline.

Antihistamines: chlorphenamine, diphenhydramine, prometazine

Age 6-12 years: medicines are fine as second line best practice advice. No more than 5 day use.

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19
Q

What are the best practices for treating children with a cough/ or cold?

A
  • most will resolve within 5-7 days.
  • drink plenty of fluids.
  • for fever and pain: paracetamol or Ibu. Don’t give both at the same time in children below 5 years.
  • nasal congestion: saline nasal drops, vapour rubs, decongestants, steam inhalation.

for cough: warm, clear fluids or warm honey and lemon aged 1 and above.
glycerol or simple linctus.

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20
Q

What is the age restriction of OTC codeine linctus for dry coughs in children?

A

should not be used in children below 18.

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21
Q

what are reclassified medicines? list examples

A

Medicines switched from POM to P.

  • Amorolfine 5% nail lacquer
  • Chlorampenicol eye drops/ointment.
  • Levenorgestrel and Ulipristal (EHC)
  • Omeprazole and Pantoprazole.
  • Orlistat
  • Sumatriptan
  • Sildenafil
  • Tamsulosin
  • Tranexamic acid
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22
Q

What are the legal prescription requirements?

A
  1. Signature: signed by ink by appropriate prescriber. Advanced e-signature can be used to authorise an e-prescription.
  2. Address of prescriber
  3. Date
  4. Type of prescriber

5 & 6. Name and address of patient.

  1. Age of patient is under 12 years.
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23
Q

Is it allowed to accept carbon copies of an NHS script?

A

Yes, as long as it is signed in ink.

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24
Q

How many times can a repeatable prescription be dispensed if a number is not stated?

A

Dispensed Twice (REPEAT ONCE)

If for oral contraceptive: Dispensed 6 times (REPEAT 5 TIMES)

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25
Q

Can CD be repeated?

A

Sch 2 and 3 CD CANNOT be repeated.

Sch 4 and 5 are repeatable.

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26
Q

when should the first dispensing of a repeatable script be made?

A

Within 6 months.

there is no legal time limit for the remaining repeats.

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27
Q

when should the first dispensing of a repeatable script be made for sch 4 CD?

A

Within 28 days.

there is no legal time limit for the remaining repeats.

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28
Q

Can repeat prescription be dispensed in other pharmacies?

A

Yes,

the repeat will be retained in the pharmacy.

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29
Q

What is the advice on the validity of owings on prescriptions?

A

Any owned medicines should be supplied within the validity of the prescription.

POM, P, GSL and sch 5 CD: 6 months from appropriate date.

Sch 2, 3 and 4 CD: 28 days from appropriate date.

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30
Q

list some EEA countries

A 
Austria 
Belgium
Croatia, Cyprus, Czech republic
Denmark
Estonia, Finland, France 
Germany, Greece
Hungary, Iceland, Ireland, Italy
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden.
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31
Q

Are prescriptions & repeatable scripts issued by an appropriate presciber from EEA or Switzerland recognised in the UK?

A

Yes,

Emergency supplies are also permitted.

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32
Q

what are the prescription requirements from EEA or Switzerland?

A
  • Patient’s details: full name, DOB
  • Prescriber details and signature: inclduing qualifcations, e-mail address, telephone or fax number, work number.
  • prescribed medicine details: brand name where appropriate.
  • date of issue.
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33
Q

which medicines are not available on a EEA prescription?

A

Sch 1, 2 and 3 CDs and medicinal products without a MA valid in the UK cannot be dispensed.

consider referral to an appropriate UK prescriber if needed.

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34
Q

Is a faxed prescription legal?

A

No, because it is not written in ink and has not been signed in ink by a prescriber.
However based on the pharmacist’s informed decision.

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35
Q

Would you accept a faxed prescription for a sch 2/3 CD drug?

A

No!

Against the law, can be prosecuted as a criminal offence.

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36
Q

What can dentist legally prescribe, in general?

A

Any POM legally, however the GDC advises dentist to prescribe within the areas of competence and medicines that have uses in dentistry.

For dental NHS prescribing: restricted to the dental prescriber’s formulary.

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37
Q

Can a EEA prescriber and patient request an emergency supply?

A

Legally yes, follow usual processes. This includes Sch 4 and 5 CD.

Must receive the prescription from the EEA prescriber within 72 hours.

Sch 1-3 CDs including phenobarbital cannot be requested and supplied.

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38
Q

What can the pharmacist suggest to a patient from EEA if an emergency supply is deemed to be inappropriate, or script is not legally valid etc?

A

Refer patient to UK based prescriber.

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39
Q

What are the legal requirements when labelling medicinal products?

A 
Name of patient 
Name and address of supplying pharmacy
Date of dispensing 
Name of medicine 
Directions for use
Precautions relating to the use of the medicine

Rps also recommends the following:
‘Keep out of reach and sight of children’
‘Use this medicine only on your skin’ when applicable

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40
Q

What ways can medicines by supplied and sold without a prescription?

A
  • Patient group directions (PGDs)
  • Patient specific directions
  • Emergency supplies
  • pandemic exemptions
  • optometrist or podiatrist signed orders for patients
  • supply of salbutamol inhalers to schools
  • supply of naloxane by individual providing recognised drug treatment services.
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41
Q

What is a patient group direction?

A

PGD is a written direction that allows the supply and/or admin of a specified medicine by a named authorised health professionals, to a well defined group of patients needed treatment for a specific condition.

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42
Q

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

A
  • request is made by an appropriate prescriber
  • pharmacist is satisfied that a prescription can’t be provided immediately.
  • prescription will be provided within 72 hours
  • NOT FOR Sch 1-3 CDs, EXCEPT phenobarbital.
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43
Q

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

A
  • interview with the pharmacist and patient
  • Pharmacist is satisfied that there is an immediate need for the POM.
  • the dispensing label must have ‘emergency supply’ stated.
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44
Q

What is the maximum quantity that can be given for an emergency supply for a POM?

A

30 days

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45
Q

What is the maximum quantity that can be given for an emergency supply for sch 4 or 5 CD?

A

5 days

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46
Q

can you make an emergency supply when the surgery is still open?

A

Yes.

To avoid delay in treatment and potentially cause harm.

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47
Q

If can emergency supply requested by a patient is refused what advice can be given?

A

They can obtain a script from an NHS walk in centre, referral to a doctor or A&E department.

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48
Q

Can optometrist or podiatrist write prescriptions for the patients?

A

No, unless they are qualified as an independent or supplementary prescribers.

But they can supply certain POMs directly to patients with a signed order.

Optometrist who have undertaken additional training by the GOC are called ‘ADDITIONAL SUPPLY OPTOMETRIST’

They can issue signed orders for an extended range of medicines.

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49
Q

What should the pharmacist do when they have supplied medicine against a signed order?

A

Ensure the medicine is labelled appropriately.
PIL is included
Appropriate records are made on the POM register

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50
Q

What are the requirements of a signed order?

A

Not a prescription so it does not have to meet prescription requirements.

Should include:

  • date (because signed orders are not defined in legislation, there is no legal time limit but pharmacists would need to use professional judgement on clinical appropriateness)
  • The optometrist’s name, address and GOC number
  • The name and address of the patient (if applicable)
  • The name of the drug, quantity, pharmaceutical form and strength
  • Labelling directions
  • An original signature of the optometrist.
  • Label the dispensed product and provide a patient information leaflet (GOOD PRACTICE)

A record of the transaction should also be made in the POM register.

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51
Q

What can registered optometrist request in a signed order?

A

Eye drops that contain not more than 0.5% chloramphenicol
Eye ointments that contain not more than 1% chloramphenicol

(NOT FOR PARENTERAL ADMIN)

Medicines containing:

  • cyclopentolate hydrochloride
  • fusidic acid
  • tropicamid
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52
Q

What can additional supply optometrist request via a signed order?

A

additional supply optometrists
not for parenteral administration

Acetylcysteine
Atropine sulphate
Azelastine hydrochloride
Dicofenac sodium
Emedastine
Homotropine hydrobromide
Ketotifen
Levocabastine
Lodoxamide
Nedocromil sodium
Olopatadine
Pilocarpine hydrochloride
Pilocarpine nitrate
Polymyxin B/bacitracin
Polymyxin B/trimethoprim
Sodium cromoglycate
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53
Q

What are the requirements for a podiatrist signed order?

A

MUST be:

  • Signed by a podiatrist
  • certain list of Medicines requested

Also recommended:

  • Date the order was written
  • Podiatrist details
  • Patient details
  • Purpose of order
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54
Q

What can podiatrist request via a signed order with the appropriate annotation (Prescription Only Medicines – sale/supply)?

A
  • Amorolfine hydrochloride cream where the maximum strength of 0.25% (w/w).
  • Amorolfine hydrochloride lacquer where the maximum strength of 5% (w/w)
  • Amoxicillin,
  • Co-Codamol,
  • Co-dydramol 10/500 tablets,
  • Codeine Phosphate,
  • Erythromycin,
  • Flucloxacillin,
  • Silver Sulfadiazine,
  • Tioconazole 28%
  • Topical hydrocortisone where the maximum strength of 1%
55
Q

Who can provide a signed order for salbutamol inhalers for schools? What should it state?

A

A written order signed by the principle or head teacher at the school.

It should state:
The name of the school for which the medicinal product is require.
The purpose
The total quantity required

Ideally, appropriate headed paper BUT NOT A LEGAL REQUIREMENT.

56
Q

How many inhalers can a school obtain?

A

Not specified in the legislation.
Depends on a variety of factors: the school size, number of children known to have asthma etc.

Schools can buy a small quantity of salbutamol inhalers, on an occasional basis.

57
Q

What records are kept for supplying inhalers to schools?

A

Signed orders needed to the retained for 2 years from the date of supply or an entry made in the POM Register.

Good practice to make record in POM and retain the signed order for audit purposes.

In the register:
Date the POM was supplied
Name, quantity, formulation and strength of POM supplied.
Name and address, trade, business or profession of the person medicine was supplied.
Purpose of supply.

58
Q

What is the requirements of the supply of naloxone without a prescription?

A

Staff engaged in lawful drug treatment services are allow to obtain naloxone from their wholesalers and make a direct supplies to patients.

59
Q

What is the recommended dose of naloxone for reversing acute opioid overdose?

A

Initially IM 400mcg, with a further 400mcg doses given incrementally every 2-3 minutes until the effect is noted and the ambulance arrives.

60
Q

What is isotretinoin used for and why is it part of the pregnancy prevention programme (PPP)?

A

Used orally to treat severe acne.

It has a high risk of causing serve and serious foetal malformations and can increase the risk of spontaneous abortion.

Therefore the PPP is in place to protect female patients at risk of pregnancy from becoming pregnancy while taking the med and for at least ONE MONTH after stopping treatment.

61
Q

Who can imitate the isotrentioin treatment?

A

Only initiated by or under the supervision of a consultant dermatologist and under the conditions of the PPP.

62
Q

How long is an isotretinoin script valid for?

What is the maximum quantity that can be supplied?

A

7 days, Ideally should be dispensed on the date of the prescription was written.

Max of 30 days supply. A quantity more than 30 days can only be dispensed if the patient is confirmed by the prescriber as not being part of the PPP.

63
Q

In accordance with the MHRA approved guidance, what should Pharmacist not accept with regards to isotretinoin?

A

Should not accept repeat prescriptions, free sample distribution or faxed prescriptions.

64
Q

What drugs are included in the pregnancy prevention programme?

A

Isotrentioin

Sodium valproate

65
Q

What is a biologic?

A

Medicine made from a variety of natural sources that may be human, animal or microorganism in origin.

E.g. vaccines, blood and blood products, somatic cells, DNA , human cells and tissue and therapeutic proteins.

The first or original biologic on the market is ‘’originator’’

66
Q

What is a bio similar?

A

Biologic medicine that is similar to an already licensed biologic medicine in terms of quality, safety and efficacy.

It’s licensed to treat the same diseases as the original innovator product.

A bio similar can only be marketed after the patent protecting the originator has expired.

67
Q

How will a biosimilar be prescribed?

A

By brand name, to avoid automatic substitution.

Recommended by MHRA.

68
Q

Give examples of Biologics and biosimilars:

A

Insulin glargine- Lantus- Abasaglar

Infliximab- Remicade- Inflecctra/Remsima

Epoetin Alfa- Eprex- Binocrit/Retacrit

69
Q

What are the regulations relating to drugs and driving??

A

Section 4 of the road traffic act 1988:

Offence of driving whilst impaired through drugs, regardless of whether or not the drug is being used legitimately.

70
Q

What is medical defence in relation to drugs and driving?

A

Protects patients that may test (+) for certain drugs as a result of taking meds in accordance with the advice from a HCP or PIL.

71
Q

What are the specified drugs listed in the first group what would affect driving?

A 
Cannabis 
Ecstasy (MDMA)
Ketamine 
Methylamfetamine  (Selegiline is metabolised to this)
Cocaine 
LSD
Heroin/diamorphine metabolites
72
Q

What specified drugs are listed in the second group that would affect driving?

A 
Clonazepam 
Diazepam
Lorazepam
Oxazepam
Temazepam
Flunitrazepam
Methadone
Morphine
Amfetamine (Selegiline is metabolised to this)
73
Q

What should be included in the RP display notice?

A

Name of the RP
The GPhC number

The fact that the RP is in charge of the pharmacy at the time

74
Q

What is the Pharmacy record? What format can it be kept?

A

It’s Legal document

Can be kept in:
Writing, electronically, or in both forms

75
Q

The pharmacy record should ….

A

-be recorded accurately and reflect who the RP is at any given date and time (including any absences).
-an entry may be made remotely as long as the record complies with all the relevant and professional reqs.
-any alterations or amendments made for both paper-based and electronic pharmacy records need to identify when and by whom the amendment was made.
-

76
Q

What should be recorded in the pharmacy record?

A
  • Name of RP
  • Date and time at which the pharmacist became the RP and stopped being the RP.

-If you are absent from the premises:
The date and time the RP left the pharmacy premises
The time at which the RP returned back to the pharmacy premises

77
Q

How long should the pharmacy record be retained for?

A

5 YEARS

78
Q

How long can a RP be absent for during the pharmacy business?

A

Maximum of 2 hours

Between midnight and midnight.

79
Q

If the RP is absent, what should be put into place?

A
  • only be absent if the pharmacy can continue to run safely and effectively
  • remain contactable with the pharmacy staff, where this reasonably practical and be able to to return which promptness.
80
Q

What should be put in place if the RP cannot be contactable and return with reasonable promptness?

A

RP must arrange for another pharmacist to be contactable and available to provide advice.

This does not need to be another responsible pharmacist.

81
Q

What activities can ONLY take place with an RP and the supervising pharmacy physically present?

A
  • clinical and legal check of a prescription
  • sale/supply of pharmacy medicines
  • sale/supply of POM
  • supply of meds under the PGD
  • wholesale of meds
  • emergency supply of a med
82
Q

What activities can take place with an RP and the supervising pharmacy is not physically present?

A
  • generating a dispensing label
  • taking meds of the dispensary shelves
  • assembly of items (e.g. counting tablets)
  • labelling of containers with the dispensing label
  • accuracy checking
83
Q

What activities can take place with an RP in charge BUT DOES NOT REQUIRE supervision of a pharmacist?

A
  • sale of GSL meds

- processing waste stock medicines to patient returned meds (NOT CDs)

84
Q

What activities can take place WITHOUT a RP in charge but requires trained support staff?

A
  • ordering stock from pharmaceutical wholesalers
  • receiving stock from pharmaceutical wholesalers into the building (EXCLUDING CDs)
  • putting meds stock received from the wholesaler away onto the pharmacy shelves (EXCLUDING CDs)
  • date checking (excluding CDs)
  • cleaning the pharmacy
  • stocking pharmacy with consumables
  • responding to enquiries (about meds issues)
  • accessing the PMR
  • receiving scripts from EPS system or collecting from the surgery.
  • receiving patient returned meds (not CDs)
85
Q

What are the GPhC standards for pharmacy professionals?

How many are there?

A
  1. Provide person centred care
  2. Work in partnership with others
  3. Communicate effectively
  4. Maintain, develop and use their professional knowledge and skills
  5. Use professional judgement
  6. Behave in a professional manner
  7. Respect and maintain the person’s confidentiality and privacy
  8. Speak up when they have concerns or when things go wrong
  9. Demonstrate leadership
86
Q

Can pharmacist dispense veterinary prescriptions?

A

Yes

87
Q

What are the vet prescription requirements?

A
  • name, address, telephone number, qualification and signature of the prescriber.
  • for sch 2 and 3 CDs: RCVS reg number of the prescriber must also be added.
  • date of script
  • name and address of owner
  • identification and species of the animal
  • name of drug, quantity, dose and administration instructions (‘as directed’ is NOT ACCEPTABLE)
  • A statement highlighting ‘prescribed under the cascade’ etc.
  • if repeatable, the number of times the script can be repeated.
88
Q

What additional statement should be written on a CD vet prescription?

A

For sch 2 and 3 CDs:

‘The item has been prescribed for an animal or herd under the care of the veterinarian’

89
Q

How long should a vet prescription be retained in the pharmacy?

A

5 years

90
Q

How long should a human private CD prescription be kept for?

A

Not retained in the pharmacy. Must be submitted to the relevant NHS agency at the end of the month.

91
Q

What quantity for vet CDs prescriptions is considered good practice?

A

28 days worth of treatment.

92
Q

What quantity for human CD prescriptions can be prescribed?

A

Sch 2-4 CDs:

No more than 30 days.

93
Q

What additional prescriber information must be added to a human private CD prescription?

A

For sch 2 and 3:

Prescriber identification number must be included

94
Q

What is the veterinary cascade?

A

It’s an exemption within the veterinary medicines regulations allows the supply of medicines that are not licensed for animals.

95
Q

When supplying medicines under the veterinary cascade, what are the labelling requirements?

A 
Name of prescribing veterinary surgeon 
Name and address of the animal owner 
Name and address of the pharmacy 
Identification and species of the animal 
Date of supply 
Expiry date of the product 
Dosage instructions 
Drug
‘For animal use only’
‘Keep out of reach of children’
96
Q

What records are kept when a veterinary prescription med is supplied?

A

Name of the medicine
Date of the receipt or supply
Batch number
Quantity
Name and address of the supplier or recipient
-If there is a written prescription, record the name and address of the prescriber and keep a copy of the script.
-records can be kept electronically

97
Q

How long should records relating to veterinary medicines supply be kept for?

A

5 years

98
Q

What are the roles and responsibilities for a accountable officer?

A
  • oversight of the monitoring and auditing of the management, prescribing and use of CDs.
  • ensuring systems are in place for recording concerns and incidences involving CDs
  • the appointment of authorised witnesses for the destruction of CDs.
  • attendance of local intelligence network meetings.
99
Q

What are sch 2 CDs?

A

Includes opioids (e.g. diamorphine, morphine, methadone, oxycodone, pethidine). Major stimulants (amefamines), quinalbarbitone and ketamine.

100
Q

What are sch 3 CDs??

A

Minor stimulants and other drugs (buprenorphine, temazepam, tramadol, midazolam and phenobarbital)

101
Q

What are sch 4 part 1?

A

Most benzodiazepines, z-hypnotics and sativex

102
Q

What are sch 4 part 2 CDs?

A

Most anabolic and androgenic steroids,

clenbuterol (an adrenocoeptor stimulant) and growth hormones.

103
Q

What are sch 5 CDs?

A

Codeine, pholcodeine, and morphine oral solution

104
Q

What is needed in order to possess sch 1 CDs?

A

A home office license

105
Q

What are the exemptions can a pharmacist have when taking possession of sch 1 CDs?

A

2 exemptions:

  1. When possession is taken for the purpose of destruction.
  2. The purpose of handing over to a police officer.
106
Q

Can a requisition be made for sch 1, 2, 3 CDs?

A

Yes, but made through an approved form.

107
Q

What are the legal requirements for a CD requisition?

A 
Signature of the recipient 
Name and address of the recipient 
profession or occupation
Total quantity of the drug
Purpose of the requisition.
108
Q

How are CDs requisitions forms processed?

A
  • mark the requisition inedibly with the suppliers name and address (pharmacy), pharmacy staff must be clear.
  • Send the original requisition form to the relevant NHS agency.

-As good practice:
Pharmacy should retain a copy of the requisition for 2 years from the date of supply.

109
Q

What is oral isotrentioin used for?

A

To treat severe acne

110
Q

Why is isotrentioin a high risk drug during pregnancy?

A

Can cause foetal malformations

Can increase the risk of spontaneous abortions

111
Q

What is pregnancy prevention programme during isotrentioin (PPP)?

A

To protect female patients at risk of pregnancy from becoming pregnant while taking isotretinoin and at at least 1 MONTH after stopping therapy.

With monthly follow ups

112
Q

Who can initiate isotrentioin therapy?

A

Initiated by or under the supervision of a consultant dermatologist and under the conditions of the PPP.

113
Q

Who doesn’t need to be part of the PPP?

A
  • Female that cannot become pregnant e.g. hysterectomy

- Female that is not sexually active (AND will not be during the treatment)

114
Q

What is the prescription validity of isotrentioin?

What should be done if the prescription has expired?

A
  • Valid for 7 days
  • Preferably should be dispensed and supplied on the day the prescription was written.
  • After 7 days: EXPIRED- REFER patient to prescriber and reconfirmation of negative pregnancy test.
115
Q
  1. What is the maximum quantity of isotrentioin that can be supplied under the PPP?
  2. When can a larger quantity than the max recommended by supplied?
A
  • Maximum of 30 days supply.

- when the prescriber confirms the female is NOT part of the PPP

116
Q

Are isotrentioin prescriptions repeatable?

Can faxed prescriptions be dispensed?

A

No

117
Q

What is the only exception when isotrentioin can be supplied without a prescription?

A

A telephone request if an emergency supply at the request of the PPP specialist prescriber is made with confirmation of negative pregnancy test within the preceding 7 days.

118
Q

What are the counselling points of isotrentioin?

A
  • never share capsules with other people
  • return unused capsules to the pharmacy for disposal?
  • DON’T donate blood during and for 1 MONTH AFTER stopping therapy.
  • use sunscreen, lip balm and emollients during treatment, avoid UV exposure (including sunlight)
  • can cause dryness and thinning of the skin
  • avoid laser skin treatment, waxing, dermabrasion during treatment AND 6 MONTHS AFTER STOPPING THERAPY.
119
Q

How many methods of conception should be used?

A

At least one method but

Preferably 2 methods

120
Q

Are Progesterone only contraceptives effective?

A

No, not for the purposes of the PPP

121
Q

When would you refer a patient that is taking isotrentioin?

A
  • Pregnancy during and 1 MONTH after stopping- DISCONTINUE IMMEDIATELY and seek quick medical attention.
  • signs and symptoms of depression or worsening depression.
  • visual difficulties
122
Q

What materials support the PPP with valproate?

A
  • Patient card- to inform patients of the risks
  • patient guide- given to girls of all ages (or parents/carers)
  • guide for HCPs
  • Annual risk of acknowledgement form
123
Q

What is Annual risk of acknowledgement form for valproate?

A

Form to be signed at initiation and at treatment reviews at least every year.

Patient receives a copy, copy is kept in specialist notes, copy to sent to patient’s GP.

124
Q

What approx % of pregnancies leads to neurodevelopmental disorders?

A

30-40%

125
Q

What approx % of pregnancies leads to congenital malformation?

A

10%

126
Q

How should pharmacists ensure valproate meds be dispensed?

A
  • Ensure warning labels are clear on the carton or warning stickers are used.
  • dispense in whole packs when possible.
  • discuss with the patient about the risks in pregnancy
  • provide PIL.
127
Q

What should be done if a patient becomes pregnant during valproate therapy under the PPP?

A

REFER PATIENT TO THEIR PRESCRIBER IMMEDIATELY.

DO NOT STOP TAKING VALPROATE!

128
Q

How long are clinical audit records and patient surveys retained in the pharmacy for?

A

5 years

129
Q

How long is the CD register retained in the pharmacy for?

A
  • 2 years from that last day of entry

- BUT if it contains records of destruction of CDs (including patient returns and expired stock): keep for 7 YEARS.

130
Q

How long are CD requisitions, orders, delivery notes records etc retained in the pharmacy for?

A

2 years or 2 years from the date of last entry for the books.

131
Q

How long are superseded SOPS records retained in the pharmacy for?

A

15 YEARS

132
Q

How long are destruction of patient returns (NOT CDs) records retained in the pharmacy for?

A

6 months

133
Q

How long are PMRs retained in the pharmacy for?

A

10 YEARS AFTER THE DEATH OF A PATIENT

134
Q

How long are MUR records retained in the pharmacy for?

A

2 YEARS

Pharmacy Pre-reg (19 decks)

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