MHRA Flashcards
MHRA: Risk of suicidal thoughts and behaviors (2008)
Small increase
ALL antiepileptics
Symptoms can occur 1 week after treatment
Counselling: report any mood changes, distressing thoughts, or feelings of self-harm or suicide
MHRA: Switching between different manufacturing products (2017)
Category 1 drugs = maintain on same product
Category 2 drugs = based on clinical judgement and patient consultation
Category 3 drugs = do not need to maintain on same product
*consider patients perceptions e.g. taste, confusion
*difficulties in co-morbidities e.g. autism, mental health, learning difficulties
MHRA: Gabapentin (Neurontin) risk of severe respiratory depression (2017)
Gabapentin is associated with a rare risk of severe respiratory depression even without co-admin opioids
Patients at higher risk: compromised respiratory fx, respiratory disease, neurological disease, elderly, renal impairment (renally cleared), co-admin use of CNS depressants (benzodiazepines, opioids, hypnotics, barbiturates, antipsychotics, lithium, antidepressants, alcohol, antiepileptics)
MHRA: Valproate medication (Epilim, Depakote) contraindicated in women of child-bearing ages unless Pregnancy Prevention Programme and only if no other alternatives. Contraindicated for patients with bipolar and only considered if no alternative (2018)
Sodium valproate / valproic acid = TERATOGENIC = congenital defects and neurological disorders
Consult GP immediately if pregnant / planning
Child-bearing ages under specialist supervision when alternative not effective
Pregnancy Prevention Programme = 7 day prescription validity, 30 day supply, use highly effective contraception, exclude pregnancy before starting
Pt fully aware of risk of use in pregnancy, sign RISK ACKNOWLEDGE FORM, see specialist at annual review
Highly effective contraception = IUD, sterilization, POP implant or x2 forms e.g. oral contraception + barrier / reg pregnancy testing
Provide PATIENT CARD
Dispense as whole pack (x30)
Ensure pt has received PATIENT GUIDE
Refer to GP if pt isn’t on effective contraception
Check pt has had annual review with specialist
