Category: Federal Forum Posters
Purpose: The purpose of this study was to find out the loose links between off-label use Food and Drug Administration (FDA) medication prescribing and utilization of anesthetic and analgesic medications also to identify adverse drug reaction associated between off-label anesthetics and analgesic with other therapy drug as off-label use of medicines creates uncertainty around liability and physicians may be less likely to report adverse events experienced by the patient or to receive inferior therapy.
Methods: The study was conducted in all wards at a tertiary care hospital in India. The newly admitted adult patient was randomly selected on daily basis and reviewed for the off-label usage. The patient demographics and all medically relevant information was noted in a predefined data collection form. The Micromedex, Medscape and references books were used as tools to review the prescription and case charts. All patients receiving off-label medication who were taking at least two drugs and had hospital stay of at least 48 hours considered as inclusive criteria. 1262 prescription reviewed in which 200 of them had off-label use.
The study involved 200 patients, of which 92 patients recruited were male and 108 were female patients. Adverse drug interactions occurred due to drug-drug interaction was recorded in an adverse drug reaction reporting form. For each adverse drug reaction, the following information were recorded: type of adverse event, seriousness, onset and resolution, severity, causality, action taken, and event outcome, and was analyzed using the following methods: causality assessment by WHO (world health organization) and Naranjo scales and severity by Hartwig scale. The data were stored confidentially and subjected to further analysis using appropriate software.
Results: During six month 1262 patient prescriptions were scrutinized, in which 200 prescriptions had off-label use. Major patients (n equals117; 58.5 percentage) received anesthetics followed by analgesics. fentanyl 20 (17 percentage) was highly prescribed anesthetic drug followed by adrenalin 17 (14.5 percentage), pethidine 16(14 percentage), and atracurium 12(10 percentage). The off-label indications were lidocaine: management of cancer pain; propofol: chronic migraine; ketamine: bronchospasm, opioid withdrawal; adrenalin: anaphylaxis, bradyarrhythmia, cardiac arrest, hyperkalemia, septic shock, local anesthesia; midazolam: refractory status epilepticus; atracurium: induction of neuromuscular blockade during mechanical ventilation; pethidine: cancer pain, chronic shivering; fentanyl: analgesia for a mechanically ventilated patient.
Among analgesics, tramadol was highly prescribed drug which was about 15 (18 percentage) followed by acetaminophen 13(15.7 percentage), and sulfasalazine 11(13.3 percentage).
The off-label indications were acetaminophen: migraine, osteoarthritis; Gabapentin: Restless legs syndrome; Sulfasalazine: Crohn disease; Codeine: migraine, management of cancer related pain; tramadol: intravenous tramadol controlled shivering during cesarean section under regional anesthesia; azathioprine: Crohn disease; diclofenac: fever, post-episiotomy pain; naproxen: menorrhagia, systemic lupus erythematosus;
Out of 200 prescriptions, Study shows resulting of 8 (4 percentage) ADRs due to drug interaction and drugs involved were adrenaline, lidocaine, atracurium, tramadol with propranolol, midazolam and clarithromycin, clindamycin and fluoxetine respectively.
Conclusion: The study showed that the quiet often the anesthetic and analgesics were indicated for off-label use.
fentanyl and adrenalin was highly prescribed anesthetics and tramadol and acetaminophen was highly prescribed analgesics off-label drugs. while comparing the prevalence of ADR adrenalin, lidocaine, atracurium, tramadol with propranolol, midazolam, clindamycin and fluoxetine respectively was identified which are associated with ADR.
There was 4 percentage incidence of adverse drug reactions which includes drugs adrenalin, lidocaine, atracurium, tramadol with propranolol, midazolam, clarithromycin, clindamycin and fluoxetine respectively causing bradycardia, respiratory depression, increased neuromuscular blockade, hypertension and hyperthermia respectively.
Kiana Hamed– Pharm.D. Intern, Karnataka college of pharmacy, BENGALURU, Karnataka, India