Detection of Substandard and Counterfeit
Session 16: Detection of Substandard and Counterfeit
Medicines
Total Session Time: 120 minutes
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Resources Needed:
SESSION OVERVIEW
Activity/
Step Time Content
Method
1 05 minutes Presentation Introduction, Learning Tasks
30 minutes Presentation Methods for Detecting Substandard and
2
Buzzing Counterfeit Medicines
50 minutes Presentation and
Explanation on Methods for Detecting
3 Small Group
Substandard and Counterfeit
Discussion
20 minutes Presentation and Identification of Substandard and Counterfeit
4
Brainstorming by Consumers
5 10 minutes Presentation Key Points
6 5 minutes Presentation Evaluation
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SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing.
STEP 2: Methods for Detecting Substandard and Counterfeit Medicines (30
minutes)
Activity: Buzzing (5 minutes)
ASK students to pair up and buzz on the following question in 2 minutes
ALLOW few pairs to respond and let other pairs to add on points not mentioned
WRITE their response on the flip chart/board
CLARIFY and SUMMARIZE by using the content below
o Chromatographic Techniques, Thin-layer chromatographic (TLC) method
o HPLC, Gas Chromatography, Ion Chromatography, and Capillary Electrophoresis.
o Visual inspection
o Use of Cutting Edge Technologies ( example Truscan)
o Test-tube colour reactions
o Melting-point determination
which is formulated or made to appear to be better than it really is.
respect to identity and/or source or with fake packaging
of pharmaceutical dosage forms.
o To provide a simple and readily applicable method for verifying the identity of drug
substances, using a limited range of easily available reagents, when the labeling and
physical attributes give rise to doubt;
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o To provide a practicable means of confirming the identity of a drug when a well-
equipped laboratory facility is not available;
o To indicate if gross degradation has occurred in certain substances that are known to
decompose readily under adverse conditions.
impurities, the tests are not in any way intended to replace the requirements of international
pharmacopoeia or other pharmacopoeia monographs which give assurance of quality.
o There can be one or more manufacturer or even repackager who handles the drug before
it reaches the retailer.
o Counterfeit drugs are associated with the practice of diversion.
o Diversion is the sale of drugs outside the distribution channels for which they were
originally intended
o Diverted drugs can originate domestically-redirection of prescription drugs from other
legitimate sources (free samples for doctors or lower priced drugs for non- profit clinics
or Medicaid programs).
o Diverted drugs can originate from the foreign market (prescription drugs are donated or
a lower-priced product is diverted to a country where a higher price product is marketed.
o Counterfeit drugs enter the distribution system, because they are purchased outside the
normal distribution chain and without the usual regulatory safeguards.
STEP 3: Explanation on Methods for Detecting Substandard and Counterfeit
Medicines (50 minutes)
Activity: Small Group Discussion ( 30 minutes)
DIVIDE students into small manageable groups
ASK students to discuss on the following question
ALLOW students to discuss for 15 minutes
ALLOW few groups to present and the rest to add points not mentioned
CLARIFY and SUMMARIZE by using the contents below
o This method is used to identify and estimate the amount of the drug substance or the
presence of impurities in a drug sample. TLC method for identifying drug substances is
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based on selective affinity of test samples for the stationary or the mobile phase. TLC
procedures have been found to be suitable for testing drug products with insufficient
active ingredients and are chosen over WHO basic tests due to its specificity and
selectivity. This method is also subject to less interference by excipients.
o TLC is a planar chromatographic technique that is ideal for field drug testing
o In TLC comparisons, authentic samples travel the same distance on a TLC plate and
yield main spots of highly similar shapes, colours, intensities, and sizes as reference
standards.
o TLC is a qualitative and, when used with visual detection, semi-quantitative technique.
o The distance the sample travels is associated with its identity; the intensity of the spot
correlates with the amount of the drug present.
o High concentrations of impurities may be visible on a TLC plate as well.
o Many researchers use TLC to distinguish between authentic and falsified versions of
several medicines.
o TLC is an uncomplicated assay useful in developing countries because it yields
―versatile and robust‖ results at a low cost.
o This method involves a thorough examination of both the packaging system and dosage
forms before, during, and after purchase and even before administration. This method
serves as a lead to identifying fake products even in the absence of the knowledge of the
physical characteristics of a drug product
o Test-tube colour reaction is a WHO basic test which provides a simple and readily
available method for verifying the identity of pharmaceutical dosage forms when the
packaging system or physical attributes of the dosage form give rise to doubt. These
tests are carried out by mixing a calculated amount of the drug sample with reagents;
and observing the colour changes that may accompany the reaction. This method can
only identify a drug substance but cannot ascertain if they are in amounts other than
those declared.
o This is another way of verifying if a drug product is genuine or not. It involves
determining the melting range; that is, the span of temperature from the point at which
the drug sample first begin to melt to the temperature at which a given drug samples is
completely melted, as indicated by the disappearance of the solid. The acceptable
melting point is usually in the range ± 4 o C from the stated value, unless otherwise
stated.
o Advancement in technology has made product faking more sophisticated and
organized. This has led to the manufacturing of fake drugs that can hardly be
distinguished from the genuine drugs products by mere visual inspection or simple basic
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test. The use of analytical methods e.g., mass spectroscopy, High Performance Liquid
Chromatography (HPLC), etc., in identifying, separating or quantifying drug products
have greatly reduced the chances of obtaining a ―false positive‖ or a ―false negative‖
result of test drug samples under investigation.
o This involves the use of high technology devices to identify and semi-quantify active
ingredients present in drug products. These devices are portable, requiring small
amount of sample and gives immediate results on the identity of drug products in a
matter of minutes with the help of computerized control. Examples include Truscan
TruScan is an invention by the US military. It is a hand-held non-destructive point-
and-shoot sampling device that uses Rahrnan‘s spectroscopy for on-the-spot
detection of counterfeit medicines. This device is used to conduct field based
screening of drug products and can be used to verify broad range of chemical
compounds.
o The Mobile Authentication Service (MAS) is one of the methods for testing counterfeit
drugs that has given many cell phone users the power to detect fake drugs. It is the
world‘s first anti- counterfeiting device that uses the short message platform. This
method of identify fake drugs is very simple to apply, and generates immediate results
on the identity of drug products.
o The ―Black eye‖ is a bench-top device developed in Israel. It is a device which uses the
principle of active thermographs (Infra-Red technology) for the detection of fake drugs.
This device is very advantageous, in that, it is a non-destructive process. The Black Eye
has the capacity to screen multiple drug samples at the same time. In addition to
detecting if a drug product is genuine or not, the Black Eye can further give details of
the constituent ingredients in a pharmaceutical dosage form.
o This device has the ability to automatically track and trace regulated foods and
medicines from production to the consumer using electromagnetic fields, thus
preventing the forgery of sensitive documents.
o The Global Pharma Health Fund (GPHF) Minilab Test Kit
contained mobile laboratory that is used for speedy evaluation of drug products.
o GPHF-Minilab contains the essential lab wares, chemicals, and reference materials for
testing drug products in places where formal laboratory facilities are inaccessible.
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STEP 4: Identification of Substandard and Counterfeit by Consumers (20
minutes)
Activity:Brainstorming (5 minutes)
Ask students to brainstorm on the following question:
ALLOW few students to respond
WRITE their responses on the flip chart/ board
CLARIFY and SUMMARISE by using the content below
bodies to verify the identity of drug products. The following tips will serve as a guide to
purchasing genuine drug products.
o Visual inspection as stated by World Health Organization (WHO) (1999) still
remains the first step in identifying potential fake drug irrespective of the analytical
methods used. This is because such observation serves as a lead to identifying fake
products even in the absence of the knowledge of the physical characteristics of a
genuine drug product. You are expected to examine carefully both the package and
its content before purchase or use
o Visual inspection of the Package
Examine the package and check if it appears suspicious or different from what
you previously know.
Check if the security seal has been tampered with by looking for breaks or tears
in the sealing tape and seals.
Look for unusual fonts, font sizes, print colour, and spelling errors.
Check the legibility of the information on both the primary and secondary
packages.
Check if the batch number, expiry date and manufacturer‘s address on the
secondary package are the same with that on the primary package.
Check if the manufacturer‘s address is traceable, that is, if it contains the exact
location of the company and not just the country address.
Check if the registration number, TAN reg. number as the case is for products
marketed or sold in Tanzania) is properly printed or if it appears to be tampered
with.
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o Visual inspection of the Dosage form
At this stage, you are meant to
Check for differences in the physical appearance (colour uniformity, size, shape,
consistency etc.) of the drug. As stated by WHO, commonly encountered physical
defects that should be looked out for in tablets include:
Excessive powder and/or pieces of tablets at the bottom of the container (from
abraded, crushed or broken tablets);
Cracks or chips in the tablets, swelling, mottling, discoloration, fusion of tablets;
Appearance of crystal on the walls of the container or on the tablet.
Hardening or softening, cracking, swelling, mottling or discoloration of capsule shell
should also be looked out for.
Also check the organoleptic properties of the dosage form if you have been using the
medication.
o Source
The source of the drug also determines if you are buying a fake drug or not. Filling
your prescription in a reputable pharmacy greatly reduces your chances of buying
fake drugs while buying from illiterate and unqualified vendors who hawk drugs in
buses, motor parks and in the streets increases your chances of buying fake drugs.
o Price
This is another way of identifying fake product. If the price is far cheaper than what is
expected, then you have to think twice. However, this may not always be true
especially for some products (fake innovator/generic brands) which may be sold at
the same price as the genuine one.
o Unexpected side effect
Counterfeit drugs most of the time contains inert substances other than the
appropriate Active Pharmaceutical Ingredient (API).
They may also contain incorrect substances, improper dosage or hazardous
substances which do no elicit therapeutic effect.
Unusual side effects, allergic reactions, or a worsening of medical condition after
taking a medication may be a pointer to identifying a fake drug. The medication
should be stopped once any of the above is noticed.
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STEP 5: Key Points(10 minutes)
o Visual inspection
o Use of Cutting Edge Technologies
o Test-tube colour reactions
o Melting-point determination
impurities in a drug sample
contained mobile laboratory that is used for speedy evaluation of drug products
package and dosage form, source, price.
STEP 7: Evaluation (5 minutes)
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References
Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of
pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).
The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the
Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349
WHO Operational package for assessing, monitoring and evaluating country pharmaceutical
situations. (2015, November 20). Retrieved from
https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/
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