Substandard and Counterfeit Medicines
Session 15: Substandard and Counterfeit Medicines
Total Session Time: 120minutes
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
20 minutes Presentation
2 Substandard and Counterfeit Medicines
Buzzing
30 minutes Presentation Differences between Substandard and
3
Brainstorming Counterfeit Medicines
35 minutes Presentation
Effect of Substandard and Counterfeit
4 Small Group
Medicines to the Public Health
Discussion
15 minutes Presentation Challenges in Preventing Counterfeit and
5
Substandard Medicines
6 10 minutes Presentation Key Points
7 05 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 objectives and clarify
ASK students if they have any questions before continuing.
STEP 2: Substandard and CounterfeitMedicines (20 minutes)
Activity: Buzzing (5 minutes)
ASK students to pair up and buzz on the following question for 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
respect to identity and /or source.(WHO)
o Their quality is unpredictable as they may count the wrong amount of active ingredients.
o In all cases counterfeit medicines are manufactured secretly with no possibility of
control.
o Counterfeiting occurs both with branded and generic products.
o It has been found that counterfeiters copy or imitate existing products but they also
manufacture products that are completely invented
o Counterfeit medicines represent an enormous public health challenge.
o Anyone, anywhere in the world, can come across medicines seemingly packaged in the
right way but which do not contain the correct ingredients and, in the worst – case-
scenario may be filled with highly toxic substances.
o In some countries, this is rare occurrence, but in others, it is an everyday reality.
international standards for quality, purity, strength, or packaging. ―And the amount of active
substance is lower or higher than as stated in standards for quality.
o Poor manufacturing practices,In some countries 10–20% of medicines fail laboratory
tests for quality, substandard products could result from poor manufacturing practices,
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unsuitable packaging, storage and distribution or when generic drugs are produced by
unregistered manufacturers. Not only potency but also dissolution rates of tablets and
capsules are a problem ,Unsuitable packaging, Storage and distribution
o When generic drugs are produced by unregistered manufacturers.
o Forms in which substandard and counterfeit occurs
Correct drug, correct ingredients not registered brand i.e. copies of original products
Wrong ingredients, but therapeutically active
No active ingredients
Toxic ingredients
Correct drug and quantities but fake packaging
Products with high level of impurities and contaminants
Incorrect quantities of Active Pharmaceutical Ingredient
STEP 3: Differences between Substandard and Counterfeit Medicines
(30mins)
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
to understand that they are different.
―spurious/falsely-labelled/falsified/counterfeit‖ medicines, are ―deliberately and
fraudulently mislabelled with respect to identity and/or source‖ (World Health Organization
2010).
health implications, counterfeits are not produced by licensed manufacturers.
active ingredient), this is not inherent in the definition of counterfeits.
medicines are distinct.
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enforcement, because manufacturers are known and licensed. Counterfeits, however, can be
produced in homes, small industries, and backyards, and are harder to regulate (International
Medical Products Anti-Counterfeiting Taskforce 2008).
of national pharmaceutical regulatory standards.
expiration date, medicines that have been compromised in shipping or storage, and
medicines that are missing active ingredients or contain the wrong ratio of active ingredients
(World Health Organization n.d.c).
(World Health Organization 2003). They may result from both inadvertent and deliberate
actions by a legitimate manufacturer.
The differences exist between counterfeit and substandard medicine aresummarized in the table
below;
SUBSTANDARD MEDICINES COUNTERFEIT MEDICINES
When substandard medicines are found, the With counterfeit drugs, the company that
company that made them is known. manufactured them is unknown.
Consequently, the authorities can work with the Authorities cannot remove the problem
company to remove the substandard medicine since the manufacturer is unknown
and correct the problem.
Have the key ingredients‘ but do Missing key ingredients
notspecifications
Have the correct active ingredients but may be May have the wrong active ingredients‘
below or above the stated standards
Are registered products Are unregistered products
Usually labelled Mis labelled
Also called out of specification, these are Medical products that are deliberately or
authorized medical product that fails to meet fraudulently misrepresent their identity
either their quality standard or their specification composition or source
or both
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STEP 4: Effect of Substandard and Counterfeit Medicines to the Public
Health (35 minutes)
Activity: Small Group Discussion ( 20 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 In public health
o In the health care system
o In industrial system
o Therapeutic failure;the regular use of substandard or counterfeit medicines can lead to
therapeutic failure or drug resistance; in some cases it can lead to death.For example:
During a meningitis epidemic in Niger in 1995, more than 50 000 people were
inoculated with fake vaccines, received as a gift from a country which thought they were
safe. The error resulted in 2500 deaths.
o Increase of mortality and morbidity;It is difficult to quantify the continental
morbidity and mortality toll of counterfeit or falsified medical products. There have
been no comprehensive studies to quantify its damage. Estimates put the total loss of life
to counterfeit pharmaceuticals between 500000 and 1 million people each year
(Kafchinski, 2009).
o In 1999, at least 30 people died in Cambodia after taking counterfeit antimalarials
prepared with sulphadoxine-pyrimethamine (an older, less effective ant malarial) which
were sold as Artusenate.
o Drug resistance (especially against antibiotics);Perhaps one of the most worrying
implications of the global boom in counterfeit medicines is the acceleration of new,
drug-resistant strains of viruses, parasites and bacteria. Counterfeit medicines for
infectious diseases containing too little or sub-therapeutic amounts of active ingredients
destroy the clinical efficacy of the genuine medicine by promoting drug resistant
pathogens.
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o Undermining public confidence in medicines;Patients who take counterfeits fail to get
better and lose faith in the effectiveness of modern medicine. In Asia where
complementary medicine is widespread, patients may turn instead to traditional or herbal
medicine. Counterfeit or falsified medicines may create the wrong impression that the
medicines themselves are ineffective and, thus, lead prescribers to unnecessarily opt for
others as their first line treatment
o Betraying the vulnerability of the pharmaceutical supply system;This is due to
interference of substandard and counterfeit in the supply chain
o Compromise credibility of national authorities;It causes devaluation of drug
authorities such TFDA
o Impact of cost;Counterfeit or falsified medicines may create the wrong impression that
the medicines themselves are ineffective and, thus, lead prescribers to unnecessarily opt
for others as their first line treatment which are of higher costs.
o Loss of facility‘s public trust
o Growth of Irrational prescribing
o Nosocomial infections exist, since drugs are not treating diseases.
o Ethical deviation to health practitioners
o Hospital underserviced concept arise Jeopardizing credibility of national authorities
o Take away incremental revenue from the pharmaceutical companies – the vast majority
of which would have gone straight to their bottom lines.
o Some country‘s regulations, insist companies responsibilities to counterfeit medicines,
including withdrawing product from the supply chain. This could result in loss of lot of
money to the respective company.
o Drug industry profile gone down, this could lead negative market environment
STEP 5: Challenges in Prevention of Counterfeit and Substandard Medicines
(10 minutes)
locally manufactured medicine in many developing countries cannot be guaranteed but lack
of regulation and enforcement poses challenge
substandard and standard medicines
is the quality e.g.; most parts of developing countries example Tanzania do not have this
equipments which makes it hard in preventing counterfeit/ sub-standards medicines
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prevent counterfeit and sub-standards medicines
STEP 6: Key Points (10 minutes)
respect to identity and /or source.(WHO)
that does not meet national or international standards for quality, purity, strength, or
packaging. ―And the amount of active substance is lower than as stated in standards for
quality.
counterfeit manufacturer is unknown
failure,drug resistance, costs and compromise of drug authorities.
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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