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SBOM > Prescribing safety > Flashcards

Prescribing safety Flashcards

1
Q

Controlled drug schedule 1

A

Controlled drug licence

Have no recognised medicinal use and include cannabis, coca leaf, lysergic acid diethylamide (LSD) and mescaline.

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2
Q

Controlled drug schedule 2

A

Controlled drugs

Includes diamorphine (heroin), morphine, remifentanil, pethidine, secobarbital, glutethimide, amfetamine, and cocaine.

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3
Q

Controlled drug schedule 3

A

Includes a small number of minor stimulant drugs and other drugs which are less likely to be misused than the drugs in Schedule 2.

Examples are the barbiturates (except secobarbital, now Schedule 2), buprenorphine, diethylpropion, mazindol, meprobamate, midazolam, pentazocine, phentermine, and temazepam.

The government has now placed tramadol in Schedule 3 to the Misuse of Drugs

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4
Q

Controlled drug schedule 4

A

Exempt from safe custody requirements, with destruction requirements only applying to importers, exporters and manufacturers.

Specific CD prescription-writing requirements do not apply.

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5
Q

Controlled drug schedule 5

A

Includes preparations of certain controlled drugs
(e.g. codeine,pholcodeine, morphine) which are exempt from full control when present in medicinal products of low strengths, as their risk of misuse is reduced.

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6
Q

CD prescription should include the following…

A 
Patient’s name and address
Drug name and form
Strength
Dose
Total quantity in words and figures
Must be hand signed by prescriber
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7
Q

What is the general prescribing advice?

A 
Indelible ink/legible
Signature/Dated
Generic Prescribing*
No abbreviations
Changes- clear strikethrough
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8
Q

Which drug group has a wide variation of dose?

A

Opioids

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9
Q

Weekly prescribed drugs

A

Methotrexate, alendronate

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10
Q

Twice weekly prescribed drugs

A

HRT patches, fentanyl patches

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11
Q

Loading dose (IV/oral) drugs

A

Amiodarone, digoxin

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12
Q

Alternate daily dosing drugs

A

Metolazone (thiazide), furosemide

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13
Q

CYP450 inducers

A 
Carbamazepine (anti-epileptic)
Rifampicin (anti-TB)
Alcohol, chronic
Phenobarbitone (anti-epileptic)
Griseofulvin (antifungal)
Phenytoin (anti-epileptic)
Sulfonylureas (oral hypoglycaemics)
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14
Q

CYP450 inhibitors

A 
Sodium valproate (anti-epileptic)
Isonaizid (anti-TB)
Cimetidine (anti-histamine)
Ketoconazole (anti-fungal)
Fluconazole (anti-fungal)
Alcohol, binge
Ciprofloxacin (quinolone)
Erythromycin (macrolide)
Sulphonamides (antimicrobial)
.
Chloramphenicol (antimicrobial, misc)
Omeprazole (PPI)
Metronidazole (nitroimidazole)
Grapefruit juice
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15
Q

IV paracetamol (acetaminophen), key points…

A

Dose is dependant on the weight of the patient

Doses should always be prescribed in mg not ml.

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16
Q

What are the key sources of information when considering medication on admission?

A 
Patient
Recent HMR
GP printout
Relative/Carer
Nursing home/MARS
Community Pharmacist
Specialist Clinic
17
Q

What are the important things to be aware of when looking at medication on admission?

A 
Out of date information
Recent changes, partners medication
Insulin’s
Anticonvulsants
Hepatic and renal impairment
Substance misuse e.g. alcohol, methadone
18
Q

Adverse drug reaction

A

An unwanted or harmful reaction experienced following the administration of a drug or a combination of drugs, and is suspected to be related to the drug

19
Q

Black triangle drugs

A

New medications, report ALL suspected ADRs

20
Q

Examples of serious suspected ADRs

A

Fatal
Life threatening
Involves or prolongs inpatient hospitalisation
Involves persistent or significant disability or incapacity
Congenital abnormality
Medically significant

21
Q

Drug interaction

A

Occurs when the effects of one drug are changed by the presence of another drug, food, drink, or an environmental chemical agent.

An interaction may alter the effectiveness or toxicity of the drug

22
Q

Therapeutic index

A

a ratio between the toxic and therapeutic doses of medications

23
Q

Which situations is therapeutic drug monitoring (TDM) useful?

A

1) Drugs used to maintain the absence of a condition

2) To avoid serious toxicity

24
Q

Examples of drugs with narrow therapeutic range

A 
Vancomycin
Gentamicin
Phenytoin
Digoxin
Lithium
Aminoglycosides
25
Q

Type A reaction

A 
Usually pharmacological mechanism
Predictable
Dose dependant
Reversible- on reducing dose or withdrawing drug
80% of ADRs
26
Q

Type B reaction

A 
Usually idiosyncratic or immunological
Not predictable
Unrelated to dose
Prolonged, permanent or fatal consequences if not identified early
20% of ADRs
27
Q

Pre-clinical toxicity testing: genetic

A

Genetic endpoints in bacteria (Ames test) and mammalian cells (chromosome abberations); screens for carcinogens

28
Q

Pre-clinical toxicity testing: acute

A

Usually single dose study

29
Q

Pre-clinical toxicity testing: short term

A

Repeated doses for 1‐2 weeks in 2 species; identifies the target organ (rodent and dog)

30
Q

Pre-clinical toxicity testing: sub-chronic

A

Repeated doses for 90 days in 2 species (rodent and dog); gives dose‐response relationship

31
Q

Pre-clinical toxicity testing: chronic

A

Repeated doses for 1‐2 yrs; used to investigate carcinogenicity

32
Q

Pre-clinical toxicity testing: reproduction

A

To investigate effects on fetal and neonatal development

33
Q

Phase 1 clinical trials

A

Define route & metabolic fate in normal volunteers (n<50). Initial dose: usually 1/20th or 1/50th of effective dose in animals. ADR monitored by clinical biochemistry etc.

34
Q

Phase 2 clinical trials

A

Define therapeutic profile and dose regimen. Dose‐ranging: some data at sub‐optimal doses.
Larger numbers studied (n<500); some may be patients.

35
Q

Phase 3 clinical trials

A

Determine clinical efficacy compared to placebo / comparator.
Longer duration and larger numbers (<5000) studied in multiple centres. Close monitoring of compliance, other drugs and ADR.

36
Q

‘Phase 4’ clinical trials (= post‐marketing surveillance)

A

Reflects real‐life clinical practice and patient compliance.
Very large numbers and more diverse patients treated.
ADRs are reported by practitioners.

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