PMID- 31496527
OWN - NLM
STAT- MEDLINE
DCOM- 20200226
LR  - 20200309
IS  - 0971-5916 (Print)
IS  - 0971-5916 (Linking)
VI  - 149
IP  - 6
DP  - 2019 Jun
TI  - Prescription pattern & adverse drug reactions of prokinetics.
PG  - 748-754
LID - 10.4103/ijmr.IJMR_1039_17 [doi]
AB  - BACKGROUND & OBJECTIVES: Prokinetics are extensively prescribed leading to 
      several adverse events (AEs). The aim of this study was to assess the 
      prescription pattern in patients receiving prokinetics, and characteristics of 
      adverse drug reactions (ADRs) in an outpatient department set up in a tertiary 
      care hospital in western India. METHODS: Patients attending outpatient 
      departments of a tertiary care hospital and who had received prokinetic agent for 
      at least seven days over the last one month were enrolled. Causality assessment 
      of AEs was done and assessed for severity, preventability, seriousness and 
      predictability. RESULTS: A total of 304 patients [161 males (52.96%); 143 females 
      (47.04%)] were enrolled. Most prescriptions (299/304, 98%) included domperidone, 
      most commonly prescribed as fixed-dose combination (FDC) with pantoprazole 
      (274/304, 90%). Prokinetic dose was not mentioned in 251/304 (83%) prescriptions, 
      and 18/304 (6%) did not mention frequency. Of the 378 AEs reported from 179 
      patients (47.35%), 306 (81%) were mild, all non-serious; 272 (72%) not 
      preventable and 291 (77%) predictable in nature. Decreased appetite (n=31, 8.2%) 
      and fatigue (n=27,7.14%) were most commonly reported. Causality assessment by the 
      World Health Organization-Uppsala Monitoring Centre scale showed that 180 AEs 
      were related to suspected drug (17 probable and 163 possible ADRs). Significant 
      correlation was observed for AEs with increasing number of drugs per prescription 
      (Spearman's R=+0.8, P =0.05) and with increasing therapy duration (Spearman's 
      R=+1.00, P <0.001). INTERPRETATION & CONCLUSIONS: Our findings showed that 
      prokinetics were often prescribed as FDCs, with incomplete prescriptions. 
      Domperidone was found to be associated with multiple AEs. It is suggested that 
      regular prescription monitoring should be done in hospitals to encourage rational 
      use of drugs.
FAU - Biswas, Mansij
AU  - Biswas M
AD  - Department of Clinical Pharmacology, Seth Gordhandas Sunderdas Medical College & 
      King Edward Memorial Hospital, Mumbai, India.
FAU - Singh, Kritarth Naman Mithileshwar
AU  - Singh KNM
AD  - Department of Pharmacology & Therapeutics, Seth Gordhandas Sunderdas Medical 
      College & King Edward Memorial Hospital, Mumbai, India.
FAU - Shetty, Yashashri C
AU  - Shetty YC
AD  - Department of Pharmacology & Therapeutics, Seth Gordhandas Sunderdas Medical 
      College & King Edward Memorial Hospital, Mumbai, India.
FAU - Koli, Paresh G
AU  - Koli PG
AD  - Department of Pharmacology & Therapeutics, Seth Gordhandas Sunderdas Medical 
      College & King Edward Memorial Hospital, Mumbai, India.
FAU - Ingawale, Sushrut
AU  - Ingawale S
AD  - Seth Gordhandas Sunderdas Medical College & King Edward Memorial Hospital, 
      Mumbai, India.
FAU - Bhatia, Shobna J
AU  - Bhatia SJ
AD  - Department of Gastroenterology, Seth Gordhandas Sunderdas Medical College & King 
      Edward Memorial Hospital, Mumbai, India.
LA  - eng
PT  - Journal Article
PL  - India
TA  - Indian J Med Res
JT  - The Indian journal of medical research
JID - 0374701
RN  - 5587267Z69 (Domperidone)
RN  - D8TST4O562 (Pantoprazole)
SB  - IM
MH  - Adult
MH  - Domperidone/*adverse effects/therapeutic use
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/physiopathology
MH  - Female
MH  - Humans
MH  - India/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Pantoprazole/*adverse effects/therapeutic use
MH  - *Prescriptions
MH  - Prospective Studies
MH  - Tertiary Care Centers
PMC - PMC6755782
OTO - NOTNLM
OT  - Domperidone
OT  - gastric acid suppression
OT  - hypomotility
OT  - levosulpiride
OT  - prescription audit
OT  - proton pump inhibitor
COIS- None
EDAT- 2019/09/10 06:00
MHDA- 2020/02/27 06:00
PMCR- 2019/06/01
CRDT- 2019/09/10 06:00
PHST- 2019/09/10 06:00 [entrez]
PHST- 2019/09/10 06:00 [pubmed]
PHST- 2020/02/27 06:00 [medline]
PHST- 2019/06/01 00:00 [pmc-release]
AID - IndianJMedRes_2019_149_6_748_265951 [pii]
AID - IJMR-149-748 [pii]
AID - 10.4103/ijmr.IJMR_1039_17 [doi]
PST - ppublish
SO  - Indian J Med Res. 2019 Jun;149(6):748-754. doi: 10.4103/ijmr.IJMR_1039_17.