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Counterfeit Drugs
Presenter-Dr. Amrita Parida
Moderator- Dr. K. L. Bairy
Protocol
Introduction
Current problem burden
Impact on public health
Factors promoting counterfeit drugs
Steps to combat counterfeiting of drugs
Conclusion
References
Definition
A counterfeit medicine is one which is
-deliberately and fraudulently mislabeled with
respect to identity and/or source and
-may include products with the correct
ingredients but fake packaging,
-with the wrong ingredients,
-without active ingredients or with insufficient
active ingredients
Also referred to as (Spurious/ Falsely
labelled/Falsified/ Counterfeit) SFFC medicines
Any kind of medicine can be and has been
counterfeited.
High consumption and expensive drugs-main
targets
Tablets and capsules most commonly
counterfeited.
Substandard medicines
Pharmaceutical products that fail to meet either
their quality standards and specifications, or
both.
-Poor manufacturing practices by the producer
-Good quality medicine is stored and distributed
under improper conditions.
A legitimate manufacturer produces a
substandard product intentionally-counterfeit
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Problem burden
Defining extent of problem is difficult.
Counterfeiting is greatest in regions where
regulatory and enforcement systems for
medicines are weak
Indian pharma industry- major producer of
counterfeit drugs
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Impact on public health
Counterfeit medicines are unsafe and ineffective
They endanger public health by increasing
resistance
Resources wasted on purchasing, inventory,
transport and dispensing with little or no effect
or even cause harm to the patient.
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Patients lose trust in health professionals
and health systems
Detrimental to reputation and financial standing
of original manufacturer
Recall of counterfeit drugs not possible.
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70,000 deaths every year
30 infants died in India due to paracetamol
syrup prepared with diethylene glycol (1998)
2500 deaths in Niger due to fake meningitis
vaccine (1995)
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Trail of deaths in Argentina
Veronica Diaz, 22 year old
2004-died after 7/10 injection treatment
May 2005, another woman died and a 22 year old
lady delivered a premature baby
To date, Argentina law doesnt consider
counterfeiting medicines a crime!!!!!
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Factors promoting counterfeit drugs
Easy money
Lack of legislation
Weak national DRA
Demand exceeding supply
Sophistication in clandestine drug manufacture
Lack of awareness
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Steps to combat counterfeit drugs
Transnational criminal network
IMPACT (International Medical Products Anti
counterfeiting Taskforce) in 2006
IMPACT with WHPA (World Health
Professional Alliance)
- Be Aware, Take Action toolkit
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Be Aware, Take Action Tool kit
1.
2.
3.
4.
5.
6.
Overview of the situation
Reporting Form
Visual Inspection Check list
Information leaflet for healthcare professionals
Patient information leaflet
Poster
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Visual assessment form
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Visual assessment tool
1. PACKAGING
1.1 Container and closure
1.2 Label
- trade name
- active ingredient name
- manufactures name and logo
- manufactures full address
- drug strength
- dosage form
- number of units per container
- batch number
- manufacturing and expiry date
1.3 Leaflet or package insert
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Visual assessment tool
2. PHYSICAL CHARACTERISTICS OF
TABLETS/CAPSULES
- Uniformity of shape, size, color, texture
- Markings
- Breaks, cracks and splits
- Embedded surface spots or contamination
- Presence of empty capsules
- Smell
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Reporting Form
Prescription/ non prescription
Stage of supply
Source of supply
Brand name
Active substance name, strength, dosage form,
package size, batch no, expiry date
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Reporting Form
Reason
How was it detected?
Measures taken
Source
Country of origin
Name of pharmacist with address
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Health professionals should
Be observant
Evaluate patients response to medicine
Acquire information about product
Where was the product procured?
Actively inform colleagues and patients
Remove any suspected medicines
Educate colleagues, patients and public
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Patients need to
Be aware that counterfeit medicines exist
Suspect any unnaturally low priced medicine
Be attentive to packaging and presentation of
medicines
Notice any unexpected reactions to the medicine
Purchase medicine from safe sources
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Internet purchase of medicines
Availability of medications without prescription
Being anonymous
Increasing range of possible treatments and easy
access to different drugs
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Authorities can help by
Supporting health professionals
Putting proper legislation in place
Financing secure health systems
Working with police and customs
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What to do if you suspect a medicine
to be counterfeit ?
Report to the appropriate authority
Keep samples of the suspected medicine or
medical products
Check current stock
Cease dispensing and secure suspect counterfeit
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Steps taken in India
CDSCO with DCGI as its head- central
regulatory body for enforcing standards of drugs
Drugs and cosmetics Act, 1940 (amended in
2008) and the drugs and cosmetics rule, 1945
Stringent penalties for the culprits
Scheme of monetary rewards for whistle blowers
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Technologies..
2D barcodes and scratch off labels
Quick Response (QR) codes
Certification system for pharmacists
Open source website- consumers and companies
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Conclusion
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References
WHO. IMPACT handbook (e-book). Switzerland: WHO Press, 2011. Available
from http://www.who.int/impact/en/index.html. Accessed February 20, 2012.
Report on country wide survey for spurious drug. CDSCO, Government of India.
2009. Available from http://cdsco.nic.in/REPORT_BOOK_13-7-10.pdf.
Accessed February 20, 2012
Golocorbin Kon S, Mikov M. Counterfeit drugs as a global threat to health. Med
Pregl. 2011;64(5-6):285-90.
Newton PN, Agyarko EK. The global threat of counterfeit drugs: Why industry
and governments must communicate the dangers. PLoS Med. 2005 April; 2(4):
e100.
Nsimba SE. Problems associated with substandard and counterfeit drugs in
developing countries: a review article on global implications of counterfeit drugs in
the era of antiretroviral (ARVs) drugs in a free market economy. East Afr J Public
Health.2008;5(3):205-10.
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Thank You.
