Figures & Tables
Tables
- TABLE 1.
Characteristics of Health Facilities in Pilot Study on Smartphone Application to Report Substandard or Falsified Medical Products
Tanzania, % (n=59) Indonesia, % (n=62) Location Urban 78 64 Rural 22 36 Sector Public 57 41 Private 41 56 Other/unknown 2 3 Type Hospital 76 85 Primary health care facility 24 15 - TABLE 2.
Reported Barriers to Reporting Substandard and Falsified Medical Products Among Health Care Professionals in Tanzania and Indonesia
Theme Subthemes Example Quotations, Tanzania Example Quotations, Indonesia Difficulties in identifying substandard or falsified products Difficulty identifying substandard and falsified products “Knowledge among the health workers on how to identify and report counterfeit drugs/medical products.” “To judge whether it is a fake/substandard drug or not is difficult.”
“Not knowing/not being able to distinguish/recognize real/fake drugs.”
“There is a fear that the report we make is wrong.”
Lack of general awareness/knowledge about substandard and falsified products “People are not knowledgeable on substandard and falsified medical products.” “If no one reports to us if there is a drug that is suspected to be fake/illegal.” Technical and logistical frustrations with current reporting systems Current reporting process is unwieldy “Complicated yellow form for filling substandard and falsified medical product.”
“The system we use is not user-friendly - it is time consuming.”
“There is no way to quickly report drugs.”
“Worry/fear the process becomes long/burdensome.”
“There is no easier way of reporting yet.”
Time/capacity constraints on reporting “Time limitations.”
“Short staff.”
“Dense work at the hospital.” No (prompt) feedback from national medicine regulatory authority after reporting “Lack of quick feedback mechanism after reporting.”
“Follow-up and feedback of reported cases was not easy. It reduces the morale of reporting.”
“Poor feedback from authority.”
“Fear that there is no follow-up from the parties concerned.” Health care professional and public do not know how to report “Health care provider doesn’t have the education on what to do.”
“Awareness of the public on how to report the resulted medical effect.”
“Do not know clearly the reporting process.” Fears of repercussions: personal safety and reputational risks Risks to personal security “Threaten to reporters.”
“No trust for privacy after reporting the matter.”
“I’m afraid of because of reporting this, the hospital could get into trouble and lose employment.”
“The reporter’s security guarantee.”
“As an informant, there are considerations that need to be taken regarding the reporting of the drug, in the sense that the reporter is not suspected of more than his role so that legal protection is needed for the reporter.”
Reputational risks Not applicable “When an incident occurs due to substandard or counterfeit drugs in my hospital, then it is reported, it will affect the public perception of my hospital even though the cause is unknown, so it is not reported.”
“Barrier/paradigm that hospitals become fake drug carriers.”
- TABLE 3.
Descriptions of Reports Submitted via the Smartphone Application in Tanzania and Subsequent Outcomes
Region n Report Type Product Product Type Product Suspected to Be Substandard or Falsified Product Suspected to Have Caused Adverse Reaction or Unexpected Lack of Efficacy Reporting Reason Testing Results Conclusion TMDA Action Reported to WHO Mbeya 6 Medicine Combiart Antimalarial Substandard No (n=5)
Yes (n=1)
N/A Passed Minilab by TLC but failed visual inspection - foreign marks on tablets and no manufacturing date on primary container Falsified Recall Yes Mbeya 1 Medical device NeoVac IV cannula Falsified Yes Not functioning properly Sterility failure Substandard Recall Yes Mbeya 1 Medical device Kit Kath IV cannula Falsified Yes Not functioning properly Sterility failure Substandard Recall Yes Dar es Salaam 1 Medical device CareStart Malaria Rapid diagnostic test Substandard Yes Errored/no results; using up to 5 rapid diagnostic test per patient N/A Substandard Recall Yes Dar es Salaam 3 Medicine Diclofenac Injection Analgesic Substandard Yes (n=2)
No (n=1)
N/A N/A Substandard Recall Yes Arusha 1 Medicine Adrenaline Broncho-dilator/cardiac stimulant Substandard Yes N/A N/A Unregistered Recall N/A Tabora 2 Medicine Metronidazole tablets Antibiotic/antibacterial/
antiprotozoal
Substandard Yes (n=1)
No (n=1)
N/A N/A Unregistered Recall N/A Mwanza 1 Medicine Tranexamic acid tablets (Tranacad) Antifibrinolytic Substandard Yes N/A Not tested due to no sample available No conclusion N/A N/A Mwanza 1 Medical device Sterile umbilical cord clamp Umbilical cord clamp Substandard Yes N/A Not tested due to no sample available No conclusion N/A N/A Mwanza 1 Medicine Coram 10 Antihypertensive Substandard Yes N/A N/A Genuine N/A N/A Arusha 1 Medicine D5 infusion injectable solution Hydrous dextrose Substandard Yes Leakage of product N/A Genuine N/A N/A Mtwara 1 Medicine LARTEM Antimalarial Substandard Yes ADRs N/A Genuine N/A N/A Abbreviations: ADR, adverse drug reaction; N/A, not applicable; TLC, thin-layer chromatography; TMDA, Tanzanian Medicines and Medical Devices Authority; WHO, World Health Organization.
- 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.
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