TABLE 4.

Descriptions of Reports Submitted via the Smartphone Application in Indonesia and Subsequent Outcomes

Region	n	Report Type	Product	Product Type	Do You Suspect This Medical Product to be Substandard or Falsified?	Do You Suspect the Product May Have Caused an Adverse Reaction or Unexpected Lack of Efficacy?	Reporting Reason	Testing Results	Conclusion	BPOM Action	Reported to WHO
DKI Jakarta	1	Medicine	Cetirizine syrup	Antihistamine	Substandard	No	Leakage of bottle	No sample at facility but another product within the same batch was tested and was within specification	Substandard due to facility’s storage issues	Provided storage guidance	N/A
DKI Jakarta	1	Medicine	Paracetamol syrup	Analgesic	Substandard	No	Bottle half-filled with unclear liquid	No sample at facility but another product within the same batch was tested and was within specification	Substandard due to facility’s storage issues	Provided storage guidance	N/A
Jawa Tengah	1	Medicine	Fresofol 1% MCT/LCT (Propofol)	Anesthetic	Substandard	Yes	ADRs, less effective	Tested; within specification	Genuine	Input for inspection	N/A
Jawa Tengah	1	Medicine	Symbicort Turbuhaler (Bedesonide formoterol fumarate)	Corticosteroid	Falsified	No	Different labeling on primary and secondary packaging	No sample at facility but received manufacturer confirmation that the product was genuine	Genuine	Follow-up with manufacturer on availability of retained samples	N/A
Jawa Timur	1	Medicine	Regivell Spinal 0.5% Bupivacaine-Heavy	Anesthetic	Substandard	Yes	ADRs, less effective	No sample at facility but received manufacturer confirmation that the product was genuine	Genuine	N/A	N/A
Jawa Timur	1	Medicine	Regivell Spinal 0.5% Bupivacaine-Heavy (different batch than above)	Anesthetic	Substandard	Yes	ADRs, less effective	No sample at facility but received manufacturer confirmation that the product was genuine	Genuine	N/A	N/A
DI Yogyakarta	1	Medicine	Ranitidine injection	H2-blocker	Substandard	No	Empty ampule	Not tested due to sample unavailability; note another batch of this product was previously reported to BPOM	Substandard	Recall	No
DI Yogyakarta	1	Medicine	Dexamethasone tablets	Corticosteroid	Substandard	No	Half of primary packaging (strip) was empty	Not tested due to sample unavailability (disposed of by HCP)	No conclusion	Input for inspection	N/A
DI Yogyakarta	1	Medicine	Ifison tablets (prednisone)	Corticosteroid	Falsified	No	Contained 1,000 tablets in bottle	Tested; within specification	Genuine; note manufacturers given grace period to switch from 1,000- to 100-tablet containers	N/A	N/A
DI Yogyakarta	1	Medicine	Methyl prednisolone	Corticosteroid	Substandard	Yes	No tablet in 1 part of strip	Tested; within specification	Genuine	Input for inspection	N/A
DI Yogyakarta	1	Medicine	Fludara oral	Anti-cancer	Substandard	No	Different batch number and expiry date on primary and secondary packaging	No, cannot be sampled due to high cost	Genuine; note this product was permitted on a temporary basis	N/A	N/A
Jawa Barat	1	Medicine	Lincomycin Kapsul	Antibiotic	Substandard	No	Suspected leakage	Tested; within specification	Genuine	N/A	N/A
Jawa Barat	1	Other	Provital Plus	Health supplement	Substandard	No	Partially filled strip (missing tablet)	N/A; out of scope of pilot	N/A; out of scope of pilot	N/A	N/A
Jawa Barat	2	Other	Vossecal	Health supplement	Substandard	No (n=1) Yes (n=1)	1 broken tablet	N/A; out of scope of pilot	N/A; out of scope of pilot	N/A	N/A
Jawa Barat	1	Other	Hi-Bone Active	Health supplement	Substandard	No	2 tablets in same packaging	N/A; out of scope of pilot	N/A; out of scope of pilot	N/A	N/A
Banten	0

Abbreviations: ADR, adverse drug reaction; BPOM, Indonesia National Agency of Drug and Food Control; HCP, health care professional; LCT long chain triglycerides; MCT, medium chain triglycerides; N/A, not applicable; WHO, World Health Organization.