BNF Misc Flashcards
What is a biological medicine? Give two examples
They are made by or derived from a biological source using biotechnology such as recombinant DNA technology. Size, complexity as well as the way they are produced by result in a degree of variability - this is acceptable within strict limits. E.g. Insulins & Monoclonal antibodies
TRUE OR FALSE Biological medicines must be prescribed by brand name. Brand must be specified on Rx. Can they be substituted at the point of dispensing? Applicable to biosimilar meds too
TRUE Brand name specific on Rx and no substitutions at the point of dispensing. Applicable to biosimilar meds too
What is a biosimilar medicine?
It’s a biological medicine which is highly similar and clinically equivalent to an existing biological medicine which has already been authorised by the EU. Active substance is similar but not identical. Once the patent runs out on the biological version - the biosimilar can be authorised by EMA. European Medicines Agency
Is a biosimilar the same thing as a generic medicine?
No because a biosimilar is similar not identical to the original. Whereas the generic is identical to original.
When biosimilar med has been given initial authorisation - what is it subject to? What should be recorded when reporting side effects?
Black triangle status Important to report suspected reactions using Yellow card scheme. Clearly include brand name and batch number.
Give some examples of biosimilar meds?
- Enoxaparin sodium 2. Epoetin alfa /zeta 3. Filgrastim 4. Infliximab 5. Insulin glargine/lispro
When should oral syringes be supplied? When should the 5ml spoon be used?
Supplied when oral liquid medicines are prescribed in doses OTHER THAN MULTIPLES OF 5ML. 5ml spoon us used for doses of 5ml/multiples of
Branded oral liquid preparations that do not contain 1. 2. 3. are described as ‘sugar-free’ in the BNF.
Preparations containing 4. 5. 6. 7. 8. are described as “sugar free” as evidence shows they do not cause ______.
- Fructose 2. Glucose 3. Sucrose
- Hydrogenated glucose syrup 5. Mannitol 6. Maltitol 7. Sorbitol 8. Xylitol Don’t cause dental caries.
Sugar free should be used whenever possible.
Benzyl alcohol present in some injections as a preservative has been associated with what?
Fatal toxic syndrome in preterm neonates. Should not be used.
Polyoxyl castor oil present in some injections as a vehicles is associated with ___?
Severe anaphylactoid reactions
Propylene glycol can cause adverse effects if its elimination is impaired. In which patients should be cautious? Which two medicines can it react with?
- Renal impairment 2. Neonates and Young children 3. Slow metabolism 1. Disulfiram 2. Metronidazole
Is lactulose in medicines an issue for lactulose intolerant patients?
Usually amount too small to cause problems. But if severe intolerance - amount of lactulose should be determined before prescribing.
Extemporaneous preparation - should be freshly made…what does this mean?
Must not be made more than 24 hours before it is issued.
If something has been recently prepared - what is the likely timeframe for deterioration ?
Deterioration is likely if stored for longer than about 4 weeks at 15-25 degrees.
What does water mean when it is used without qualification? When should it be used
Potable water freshly drawn direct from public supply and suitable for drinking OR Freshly boiled and cooled purified water. Latter should be used if the public supply is from storage tank or if potable water is unsuitable for a particular preparation.
The Misuse of Drugs Act 1971 has 3 classes of CDs which on the harmfulness attributable to a drug when misused.. Give examples of Class A drugs (13) When are class B substances classed as Class A?
- Alfentanil 2. Cocaine 3. Diamorphine hydrochloride (heroin) 4. 3,4 - methylenedioxymethamfetamine MDMA/Ecstasy 5. Fentanyl 6. Lysergide (LSD) 7. Morphine 8. Opium 9. Oxycodone hydrochloride 10. Pethidine hydrochloride 11. Phencyclidine 12. Remifentanil 13. Methadone hydrochloride class B when prepared for injection become class A