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Pre-reg/BNF/MEP 2019 > 01 BNF Preface > Flashcards

01 BNF Preface Flashcards

1
Q

What is multimorbidity?

A

The presence of two or more long-term health conditions in a patient.

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2
Q

What is multimorbidity associated with?

A
  • Reduced quality of life
  • Higher mortality
  • Higher rates of adverse drug reactions
  • Greater use of health service
  • Higher treatment burden (due to polypharmacy or multiple appointments)
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3
Q

What is deprescribing?

A

Deprescribing is the process of discontinuing or reducing the dose of medicines with the aim of managing polypharmacy and improving outcomes. Should be supervised by a healthcare professional.

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4
Q

What does deprescribing require?

A

Deprescribing requires careful counselling and shared decision-making with patients and is considered part of routine clinical care.

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5
Q

List the factors contributing to poor compliance with prescribed medicines: (9)

A
  • prescription not collected or dispensed
  • purpose of medicine not clear
  • perceived lack of efficacy
  • real or perceived side effects
  • patient’s perception of risk and severity of S/E differs from that of prescriber
  • unclear administration directions
  • physical difficulty in taking meds
  • unattractive formulation (taste)
  • complicated regimen
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6
Q

What is concordance?

A

The prescriber and patient should agree on the health outcomes that the patient desires and on the strategy for achieving them.

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7
Q

List ways of improving adherence: (4)

A
  • explaining rationale and S/E of treatment
  • reinforcement of dr’s instructions by pharmacist
  • advising patient of possibility of alternative treatments
  • simplifying drug regimen e.g combination products
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8
Q

What are biological medicines?

A

Biological medicines are medicines made by/derived from a biological source using biotechnology processes e.g recombinant DNA technology.

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9
Q

Why is variation present in biological medicines?

A

The size and complexity of biological medicines as well as their method of production may result in a degree of of natural variability in molecules of the same active, particularly in different batches of the medicine. This variation is maintained within strict acceptable limits.

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10
Q

Give 2 examples of biological medicines and how they are prescribed:

A

(1) Insulin
(2) Monoclonal antibodies

Biological medicines must be prescribed by brand names.

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11
Q

What is a biosimilar medicine?

A

A biosimilar medicine is a biological medicine that is highly similar and clinically equivalent (in quality, safety & efficacy) to an existing biological medicine that has been authorised in the EU (originator/reference medicine).

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12
Q

What is the difference between biological and its biosimilar medicine and when can it be authorised?

A

The active substance of a biosimilar is similar, but not identical, to its originator.
Once a patent for a biological medicine has expired, a biosimilar medicine may be authorised by the EMA.

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13
Q

What is the difference between a biosimilar and a generic medicine?

A

Biosimilars and generics should not be considered the same thing.
Generic medicines contain a simpler molecular structure that is IDENTICAL to the originator medicine.

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14
Q

Are biosimilars considered to be therapeutically equivalent to originators?

A

Yes, within their authorised indications. Biosimilars are usually licensed to all indications of originators, depending on evidence submitted to EMA.

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15
Q

What is the safety monitoring associated with biosimilar medicines?

A

Biosimilar medications have black triangle status at the time of initial authorisation. Report ADR using yellow card scheme. For all biological medicines, state batch number and brand name on ADR report.

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16
Q

List a few drugs available as biosimilar medicines: (14)

A
  1. Adalimumab
  2. Bevacizumab
  3. Enoxaparin sodium
  4. Epoeitin Alfa
  5. Epoeitin zeta
  6. Etanercept
  7. Filgrastim
  8. Follitropin alfa
  9. Infliximab
  10. Insulin glargine
  11. Insulin lispro
  12. Rituximab
  13. Somatropin
  14. Teriparatide
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17
Q

What is an unlicensed medicine and when is it necessary?

A

An unlicensed medicine is a medicine used outside the terms of their UK license or which have no license in the UK.

Unlicensed use of a medicine may be necessary when clinical need cannot be met by existing licensed medicines.

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18
Q

What is ‘off-label’ use of a medicine?

A

When a medicine is used or administered via a route outside of the licensed indication of the product.

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19
Q

(Excipients)

When can a branded oral liquid preparation be described as ‘sugar-free’?

A 
Liquid products that do not contain:
• fructose
• glucose
• sucrose
Preparations containing these can also be described as sugar-free as they do not cause dental caries (non-cariogenic):
• hydrogenated glucose syrup
• mannitol
• maltitol
• sorbitol
• xylitol
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20
Q

What excipients are marked in the BNF? (6)

A
  • Aspartame
  • Gluten
  • Sulfites
  • Tartrazine
  • Arachis (peanut oil)
  • Sesame oil
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21
Q

Which excipients for injections are indicated in the BNF and why?

A

Presence of benzyl alcohol and polyoxyl castor oil in injections is indicated.
Benzyl alcohol has been associated with a fatal toxic syndrome in preterm neonates.
Polyoxyl castor oils (used as vehicles in IV injections) have been associated with severe anaphylactoid reactions.

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22
Q

Which excipient in oral & parenteral injection is indicated in the BNF and why?

A

Propylene glycol can cause adverse effects if elimination is impaired.
E.g. in renal failure, in neonates and young children, in slow metabolisers of the substance.
Propylene glycol may interact with disulfiram and metronidazole.

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23
Q

Is lactose content in medicines a problem for most lactose-intolerant patients?

A

The lactose content in most medicines is too small to cause problems in most lactose-intolerant patients.
But in severe lactose intolerance: lactose content should be determined before prescribing.
Amount of lactose varies according to manufacturer, product, formulation and strength.

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24
Q

(Extemporaneous preparation)

When should a product be dispensed extemporaneously?

A

Only when no product with a marketing authorisation is available.

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25
Q

What does ‘freshly prepared’ mean in the BP?

A

The BP direction that a preparation must be ‘freshly prepared’ indicates that it must be made not more than 24 hours before it is issued for use.

26
Q

What does ‘recently prepared’ mean in the BP?

A

The direction that a product should be ‘recently prepared’ indicates that deterioration is likely if the preparation is stored for longer than 4 weeks at 15-25 oC.

27
Q

(Drugs and Driving)

What law came into force on 2nd March 2015 that affects drugs and driving?

A

A new offence of driving or attempting to drive with certain specified controlled drugs in excess of specified limits.
It applies to 2 groups of drugs:
(1) commonly abused drugs e.g amfetamines, cocaine, cannabis, ketamine
(2) drugs used for medical reasons e.g opioids, benzodiazepines - apomorphine hcl
Anyone found to have any of the drugs above specified levels in their blood will be guilty of an offence whether their driving was impaired or not. This includes drugs related to those included in he offence e.g selegiline hcl

28
Q

What should patients carry with them for a ‘medical defence’ against the law?

A

Legislation provides a statutory ‘medical defence’ for patients taking drugs for medical reasons in accordance with instructions IF their driving was NOT impaired. Is an offence if driving is impaired.
Patients should be advised to continue taking medicines as prescribed. When driving, they should carry evidence e.g PIL/repeat prescription that drug was prescribed/sold for medical or dental condition.

29
Q

(Labelling)

List 6 things that are legally required to appear on a medicine label and 1 that is good practice (RPS):

A
  1. Name of the patient
  2. Name and address of pharmacy
  3. Date of dispensing
  4. Name of medicine
  5. Directions for use of medicine
  6. Precautions for use of medicine

Good practice but not legal requirement:

  1. The words ‘Keep our of sight and reach of children’
  2. ‘Use this medicine only on your skin’ where applicable
30
Q

What are the legal requirements surrounding prescriptions by EEA and Swiss prescribers?

A

EEA and Swiss prescribers are not allowed to prescribe CD schedule 1,2,3 or for drugs without a UK Marketing authorisation.
Prescriptions should be in indelible ink, dated, name of patient, address of prescriber, prescriber’s particulars incl whether doctor, Dentist and signed.

31
Q

What is a patient group direction (PGD)?

A

A PGD is a written direction relating to the supply and administration of a licensed POM by certain classes of healthcare professionals. The direction is signed by a doctor and a pharmacist.

32
Q

(Emergency supply)
The Human Medicines Regulations 2012 allows exemptions from Prescription Only requirements for emergency supply provided: (5)

A
  1. Pharmacist has interviewed pt and is satisfied there is
    i) immediate need
    ii) POM had previously been prescribed for pt
    iii) dose appropriate for pt
  2. No greater quantity supplied than 5 days for phenobarbital and CD 4/5, or 30 days treatment for other POMs.
    Smallest pack: insulin, cream, inhaler.
    Full cycle: oral contraceptives
    Smallest quantity for full course of treatment: Abx
  3. Entry to be made in prescription book stating date of supply, name, quantity, form and strength, name and address of pt and nature of emergency.
  4. Container to be labelled with date of supply, pt name, pharmacy name and address, name + quantity of Med, the words ‘Emergency supply’ and ‘keep out of reach of children’.
33
Q

When can you make an emergency supply at the request of a prescriber?

A
  1. Satisfied that prescriber cannot immediately furnish a RX due to emergency
  2. Prescriber will furnish Rx within 72 hours
  3. Medicine is supplied in accordance with prescriber’s directions
  4. Medicine not a CD 1,2,3 (for UK and EEA)
  5. Entry to be made in prescription book stating date of supply, name quantity and strength of med, name and address of prescriber, name and address of pt, date on Rx, amend this to state when Rx has arrived.
34
Q

What is the RPS guidelines on emergency supply? (2)

A
  1. Pharmacist should consider medical consequences of not supplying a medicine in an emergency.
  2. If the pharmacist is unable to make a supply of a medicine the pharmacist should advise patient on how to obtain medical care.
35
Q

(Controlled Drugs)

What does the Misuse of Drugs Act 1971 and 2001 do?

A

Prohibits certain activities in relation to CDs- their manufacture, supply and possession. Penalties applicable to offences involving the different drugs are graded broadly according to the harmfulness attributable to a drug when it is misused. There are 3 main classes: A, B, C

36
Q

Name 3 Class A Drugs:

A
  1. Cocaine
  2. Diamorphone Hydrochloride (heroin)
  3. Fentanyl
37
Q

Name 3 Class B Drugs:

A
  1. Sativex
  2. Codeine phosphate
  3. Pholcodeine
38
Q

Name 3 Class C Drugs:

A
  1. buprenorphine
  2. Tramadol
  3. Zolpidem/zopiclone
39
Q

What does Misuse of Drugs Regulations 2001 define?

A

Defines the classes of person who are authorised to supply and possess CDs while acting in professional capacity AND the conditions under which these activities can be carried out. In 2001 regulations, drugs are divided into 5 schedules, each specifying requirements governing import, export, production, supply, possession, prescribing and record-keeping.

40
Q

List 4 types of schedule 1 Drugs:

A

Schedule 1 includes drugs not used medicinally.
1. Hallucinogenic Drugs (LSD)
2. Ecstasy-type substances
3. Raw opium
4. Cannabis
Home office licence generally required for production, possession or supply. CD register.

41
Q

List 5 classes of schedule 2 drugs:

A

Schedule 2 includes:
1. Opiates e.g diamorphone hcl (heroin), morphine, methadone, oxycodone, pethidine
2. Major stimulants e.g amfetamines
3. Quinalbarbitone
4. Cocaine
5. Ketamine
CD2 Drugs subject to full CD requirements, safe custody (except quinalbarbitone) and CD register. Possession, supply and procurement is authorised for Pharmacists and other classes in 2001 regulations.

42
Q

Name 5 CD3 Drugs:

A
  1. Barbiturates (except secobarbital CD2)
  2. Buprenorphine
  3. Midazolam
  4. Temazepam
  5. Tramadol

Special prescription requirements, safe custody except for phenobarbital, midazolam, tramadol. No CD register but retain invoices for 2 years.

43
Q

Name drugs in the 2 different parts of Schedule 4 classification:

A

Schedule 4 Part I:
Benzodiazepines (except temazepam and midazolam CD3), non-benzodiazepine hypnotics (zolpidem and zopiclone)
Sativex

Part II:
Androgenic and anabolic steroids
HCG, somatotropin

No CD Rx requirements, no safe custody requirements. No register except for Sativex.

44
Q

Name 3 schedule 5 CDs:

A

Certain CD preparations e.g codeine, pholcodine and morphine which due to their Low strength are exempt from all CD requirements other than retention of invoices for 2 years.

45
Q

Prescription requirements for CD Drugs (2&3)

A
  1. Indelible
  2. Signed by prescriber *handwritten
  3. Date of signing
  4. Prescriber’s address
  5. Name and address of pt
  6. Dosage form, regardless of brand, strength (if more than one strength), each strength prescribed separately
  7. Liquids: total volume in ml in both words and figures. Dosage units: total numbers in words and figures rather than total quantity
  8. Dose clearly defined (not words and figures)
  9. The words ‘for dental treatment only’ if Dentist
46
Q

When can a pharmacist amend a CD prescription?

A

If it species total quantity only in word or in figures, or minor typographical errors. Provided that amendments are indelible and clearly attributable to pharmacist (name, date, GPhC number).

47
Q

What did the Department of Health strongly recommend maximum quantity with a CD to be?

A

For schedule 2, 3, 4: should not exceed 30 days. If longer, should document reason on patients notes.

48
Q

What is the length of validity for a CD Prescription?

A

For schedules 2, 3, 4: 28 days from the date stated (can be forward-dated). Schedule 5: 6 months.

49
Q

What are the requirements for instalment prescriptions for schedule 2 and 3 CDs?

A
  1. Must have an instalment direction including dose, instalment amount and interval between each time medicine can be supplied.
  2. Must be dispensed within 28 days of appropriate day (date of signing unless indicated day), Rx to be marked with date of each supply
  3. The instalment direction is a legal requirement and must be complied with but there is specific wording which allows some flexibility (Home Office)
50
Q

What are repeatable prescriptions?

A

Prescriptions which contain a direction that they can be dispensed more than once. Only for schedule 4 and 5 CDs.

51
Q

What are the extra requirements for a private CD?

A

Written on designated FP10CD forms, with prescriber’s identification number.
Prescriptions to be supplied by a pharmacist in hospital are exempt from requirements for private prescription.

52
Q

Is supervised consumption a legal requirement?

A

Under 2001 regulations supervised consumption is not a legal requirement. If supervised consumption is directed on the Rx, DoH recommends that any deviation from the prescriber’s intended method of supply should be documented with justification.

53
Q

What are the prescriber’s 3 main responsibilities when prescribing drugs likely to cause dependence or misuse?

A
  1. Avoid creating dependence by introducing drugs to patients without sufficient reason
  2. To see that patient does not gradually increase the dose of a drug, given for good medical reasons to the point where dependence becomes more likely (esp with hypnotics and anxiolytics)
  3. Avoid being used as source of supply by addicts
54
Q

(Travelling abroad)

Which schedule of drugs are not subject to import or export licensing?

A

Schedule 4 part II (CD Anab) and schedule 5

55
Q

For what schedule of drugs is a person required to have personal import/export license when travelling abroad?

A

Schedules 2, 3, 4 part I (CD Benz)

And also part II (CD Anab) if they are carrying more than 3 months supply or travelling for 3 months or more.

56
Q

What is required for importing schedule 1 CDs?

A

Home Office licence.

57
Q

What is necessary to include with an application for a licence?

A

Cover letter signed by prescribing doctor or drug worker confirming:

  1. Patients name and address
  2. Travel itinerary
  3. Names of prescribed CDs and total amounts to be carried
58
Q

What should you advise patients who are travelling for less than 3 months or carrying less than 3 months supply of CDs?

A

Do not require personal import/export licence but are advised to carry a cover letter signed by prescribing doctor or drug worker.

59
Q

When do medical prescribers need a licence issued by the Home Secretary to prescriber, administer or supply diamorphine (heroin), dipipanone and cocaine?

A

For the treatment of drug addiction.

Licence not needed for relieving pain from organic disease or injury.

60
Q

(Yellow Card Scheme) When to report adverse drug reactions (ADRs) using Yellow Card scheme?

A

He

Pre-reg/BNF/MEP 2019 (2 decks)

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