TABLE 1.
Group and characteristic | Comments (references) |
---|---|
Substandard antimicrobials | |
Reduced concn of AIa | Quantification of the AI content of an antimicrobial agent shows that the concn of the AI is lower than the claimed content declared on the packaging |
Poor manufacturing or transportation, decomposition, and poor storage conditions (2, 34, 35) and dilution of drugs with other chemicals (25, 26, 27) may lead to low concn of the AI | |
In a recent report of published prevalence studies regarding substandard/counterfeit antimicrobials, 14/15 (93%) studies reported this problem (59) | |
Reduced stability (dissolution failure) and bioavailability | Solubility or release of AI is not within the specified time range due to reduced stability of the drug, and this leads to reduced bioavailability of the antibiotic (59) |
Most of the limited no. of studies that have assessed the stability of antimicrobials had suboptimal design (29–33, 35, 36) | |
Antibiotics such as ampicillin (34), but not others such as penicillins and tetracyclines (7, 35), may degrade with high temperatures and humidity (30) | |
Reduced bioavailability may lead to suboptimal activity of antimicrobials (36); examples include antibacterials such as co-trimoxazole (38), tetracyclines (37), and metronidazole (38) and antiparasitic agents such as chloroquine (39), mefloquine (40), and pyrimethamine (41–43) | |
In a recent report of published prevalence studies regarding substandard/counterfeit antimicrobials, 5/15 (33%) studies reported this problem (59) | |
Impurities/unknown ingredient | Substandard wt of a tablet or capsule (59) |
Altered odor due to diluted AI or harmful additives | |
Inactive or harmful ingredients, impurities, or contamination such as mold | |
In a recent report of published prevalence studies regarding substandard/counterfeit antimicrobials, 2/15 (13%) studies reported this problem (59) | |
Counterfeit antimicrobials | |
Absence of pharmaceutical AI | Quantification of the AI content of an antimicrobial agent shows that the AI as declared on the packaging is absent (59) |
Antibiotics may contain no AI (9, 44, 48, 49) | |
The AI is replaced by cheap substances, such as flour in oral presentations and water in drinkable or injectable presentations (15, 17) | |
In a recent report of published prevalence studies regarding substandard/counterfeit antimicrobials, 7/15 (47%) studies reported this problem (59) | |
Reduced amt of AI | The antimicrobial may be considered counterfeit when the substandard amt of the AI is included deliberately in the drug (59) |
Increased amt of AI | The concn of the AI may be higher than the amt reported in the packaging (59) |
In a recent report of published prevalence studies regarding substandard/counterfeit antimicrobials, 6/15 (40%) studies reported this problem (59) | |
Altered chemical content/wrong ingredient | Detection of AI in the drug that is not declared on the packaging (59) |
Examples of wrong ingredients include erythromycin (45), flour, starch, or powder (26, 45–47), and tap water (9, 44, 48, 49) | |
These products may contain toxic chemical impurities (15, 17) | |
In a recent report of published prevalence studies regarding substandard/counterfeit antimicrobials, 4/15 (27%) studies reported this problem (59) | |
Impurities/unknown ingredient | Extraneous contaminants that should not be present in a drug (if done deliberately and not the result of poor manufacturing) (59) |
In a recent report of published prevalence studies regarding substandard/counterfeit antimicrobials, 2/15 (13%) studies reported this problem (59) | |
Inappropriate packaging | Packaging has incorrect labeling information about a drug origin or authenticity, and the color, size of pills, and bar codes are often similar to those for the original drug (25) |
False representation of identity is commonly used, by copying the packaging of another marketed product; the brand name may be modified to try to escape laws on infringing intellectual property | |
They are generally undisguisable in their outward packaging | |
In developing countries, many of the purchased drugs without packaging were counterfeit (57) | |
Antimicrobials with false packaging and labeling include penicillins (24), co-trimoxazole (50), tetracyclines (1, 51–54), chloramphenicol (1), quinolones (51), aminoglycosides (55, 56), and antimalarials (40, 57, 60). | |
Very few studies performed packaging analysis of the samples collected (40, 58, 59) | |
Mass uniformity test failure | The wt of a tablet or capsule is not within the avg range specified (if done deliberately and not the result of poor manufacturing) (59) |
AI, active ingredient.