Counterfeit medicines and fraud Flashcards
What are SSFFC medicines?
Substandard, Spurious, Falsely labelled, Falsified and Counterfeit medicines are designed to appear identical to genuine medicines but will fail to treat the disease/condition. They are intentionally mislabeled with respect to their identity or source.
They can be entirely fake or contain incorrect ingredients, insufficient quantities of ingredients or a range of harmful substances such as lead road paint, brick dust, floor polish and boric acid.
Counterfeit medicines are often produced in unsanitary conditions, are not inspected by regulatory authorities, and so it is impossible to know what ingredients they contain.
What are some issues with counterfeit medicines?
Counterfeit antibiotics may not treat infections properly, contributing to antibiotic resistance
Counterfeit cancer treatments may not only be ineffective but could worsen the patient’s condition – can slow down the immune system activity throughout the body, leading to other infections or diseases
Fake painkillers and narcotics can lead to overdose or withdrawal symptoms which cause significant health risks
Fake lifestyle drugs (e.g. Viagra or weight loss medication) can be laced with harmful or non-medicinal substances
Counterfeit vitamins/supplements can contain no active ingredients, or ingredients that are not disclosed
What are some causes and contributing factors to the existence of counterfeit medicines?
Weak regulatory frameworks – regulatory agencies in developing countries may lack resources, infrastructure and authority to adequately monitor drug manufacturing and distribution
High demand – encourages counterfeits to exploit the need for essential medicines especially in developing countries. Some patients may turn to cheaper alternatives
Internet and online pharmacies
Lack of consumer awareness – low awareness of the dangers of counterfeit medicines can lead to consumers unknowingly purchasing them. Lower prices can contribute to this motivation
Inadequate enforcement – lack of robust law enforcement and international collaboration allows counterfeiters to operate more easily. They are often smuggled or distributed through illegal channels
How do serialisation and track-and-trace technologies prevent fraud?
Use of unique serial numbers, QR codes or other tracking mechanisms on packaging ensures authenticity. Allows drugs to be tracked through the supply chain
RFID (radio frequency identification) and blockchain technologies are being explored for supply chain monitoring
How do anti-counterfeiting labels prevent fraud?
Some pharmaceutical companies employ holograms, barcodes or watermarks on drug packaging to help identify counterfeit products
How do testing and quality devices prevent fraud?
Portable devices or rapid diagnostic tests can check the authenticity of medicines at sale or administration. For example, handheld spectroscopy devices can analyze the chemical composition of the drug
How do public awareness campaigns prevent fraud?
Education of dangers of counterfeit medicines
Includes how to identify legitimate pharmacies, recognize signs drugs are fake, and understand the risk of buying from unregulated sources
How does international collaboration prevent fraud?
Global efforts include cooperation among governments, international health organisation and the private sector
WHO, WCO and INTERPOL play crucial roles in this
Helps low- and middle-income countries who have limited regulatory capacity and gaps in supply chain security, through technical assistance, training and providing resources
How do regulatory measures prevent fraud?
Strengthening pharmaceutical regulations, improving inspection systems and enforcing stricter penalties for counterfeiting drug offenses
USA have introduced the DSCSA (drug supply chain security act) which requires tracking and tracing throughout the distribution chain
Good manufacturing practice ensures adherence to guidelines, which improve safety, efficacy and quality of products
Regulatory bodies should require regular inspections and audits of drug manufacturing facilities
