substandard and falsified products

Question 1

what is a substandard product

Answer 1

Substandard medicines fail to meet their quality standards or specifications, or both.

Question 2

what is a falsified one

Answer 2

Falsified medicines are medical products that deliberately or fraudulently misrepresent their identity, composition or source.

Question 2

substandard vs unlicensed vs falsified

Answer 2

https://www.notion.so/health-public-health-and-promotion-etc-1de00bb3982d802b8265d6835ef8a306?pvs=4#1e900bb3982d80e7b18bc5d43a97e84c

Question 3

• how much money worth of fmps have been seized

Answer 3

Over £11 million worth

Question 4

Value of the illegal market for FMPs is ~ to be worth?

Answer 4

$200 billion (10-15% of the global pharmaceutical market)

Question 5

why are FMPs the perfect crime

Answer 5

(high profit, low detection, low fines) funds other criminal activities

Question 6

Why was the COVID-19 pandemic called a “parallel pandemic” in the context of SFMPs?

Answer 6

It triggered a global surge in falsified and substandard products like fake medicines, masks, and test kits, due to high demand and panic.

Question 7

what falsified products were identified and where

Answer 7

• Falsified masks, vaccines, testing kits, “coronasprays” also reported in India, Bangladesh, Pakistan, UAE,etc.
• Falsified chloroquine products identified in 300 hospitals & pharmacies across DRC, Cameroon, Niger, Uganda.

Question 8

why is stockpiling so bad

Answer 8

• Stockpiling worsens drug shortages & pushes patients towards unofficial channels.

Question 9

what was the increase in cybercrime

Answer 9

5x
- Rise in online medicines purchases due to physical distancing requirements

Question 10

FDA’s Operation Quack Hack

• what was this

Answer 10

A campaign targetingfraudulent COVID-19 cures, such asMiracle Mineral Solution( fraudulent chlorine dioxide equivalent to industrial bleach), with legal and online enforcement.

• FDA has sent hundreds of abuse complaints to domain name registrars and internet marketplaces.

Question 11

what is DEG (diethylene glycol) i

Answer 11

a toxic contaminant found inchildren’s cough syrups

Question 12

what happened due to DEG poisoning

Answer 12

→Gambia (Oct 2022)
→ Indonesia (Nov 2022)
→ Uzbekistan (Jan 2023)

causing300+ deathsin Gambia, Indonesia, and Uzbekistan.

Question 13

• What are the health risks of DEG poisoning?

Answer 13

leads to acute kidney failure

Question 14

How are falsified medicines detected and reported?

Answer 14

Throughregulatory surveillance, hospital/pharmacy reports, and alerts from bodies like theWHO and FDA.

Question 15

wha are SFMPs?

Answer 15

These aregenuine productsthatfail to meet quality standards

Question 16

why do they fail to meet quality standards

Answer 16

• Poor manufacturing practices (e.g., contamination, incorrect ingredients or dosages)
• Inadequate storage/transport (heat, moisture damage)
• Supply chain failures or human error

Question 17

• What role do national regulators play with substandard medicines?

Answer 17

They have authority to investigate and take action against negligent or unethical manufacturers

Question 18

• Why can’t regulators take similar action against falsified medicines

Answer 18

Falsified medicines often listfake or unknown manufacturers, so the real source can’t be identified.

Question 19

What do regulators do when a falsified medicine is identified?

Answer 19

confirm that the producer is unknown and turn the case over to law enforcement.

Question 20

Why are falsified medicines difficult to prosecute?

Answer 20

Crime and corruption. Difficult to prosecute as often there is little evidence tying falsified drug in the market to the culprit.

Question 21

drivers of SF products

Answer 21

1. globalised supply chain
2. all countries vulnerable
3. misinformation pandemic
4. online verification

Question 22

costs of medical products

Answer 22

1. loss of confidence in healthcare
2. lost income
3. lack of social mobility
4. increased poverty
5. waisted resources

Question 23

How can poor-quality medicines contribute to antimicrobial resistance (AMR)?

Answer 23

They expose pathogens tosub-therapeutic doses, allowingresistant organismsto survive and multiply.

Question 24

What is a major disease where poor-quality drugs have worsened resistance?

Answer 24

Poor-quality drugs have contributed to the rise of drug-resistant tuberculosis.

Question 25

What type of bacterial infection is emerging as drug-resistant in several regions?

Answer 25

Drug-resistant staphylococcus infections are an emerging problem,

Question 26

what regions

Answer 26

especially in India, Latin America, sub-Saharan Africa.

Question 27

- How has antimalarial resistance emerged as a global threat

Answer 27

Resistance to **artemisinin-based therapies** is undermining malaria control efforts worldwide.

Question 28

how do we check for falsified medical product

Answer 28

- Examine the packaging for condition, spelling mistakes or grammatical errors; - Check the manufacture and expiry dates and ensure any details on the outer packaging match the dates shown on the inner packaging; - Ensure the medicine looks correct, is not discoloured, degraded or has an unusual smell; - Discuss with your patient where they are purchasing products e.g., online; - Report suspicious medical products to the National Medicines Regulatory Authority

Question 29

Why are some falsified medical products hard to detect?

Answer 29

Because they can be visually identical to genuine medicines, making them difficult to spot without careful inspection.

Question 30

Why are illegal internet pharmacies dangerous for patients?

Answer 30

They often sell unauthorised or counterfeit medicines with no assurance of safety, storage, or efficacy.

Question 31

What are the risks of medicine from illegal online pharmacies?

Answer 31

The medicine may be inappropriate, fake, contaminated, or interact harmfully with other drugs.

Question 32

How can illegal online pharmacies compromise patient safety and privacy?What technological threat is linked with spam emails advertising online medicines?

Answer 32

They may misuse personal or payment data and install spyware through spam emails.

Question 33

What technological threat is linked with spam emails advertising online medicines?

Answer 33

These emails can contain malicious software that compromises your computer and privacy.

Question 34

What is the simplest method to begin detecting falsified medicines?

Answer 34

Visual Inspection of product & packaging

Question 35

what physical properties are tested

Answer 35

reflectance & refractive index

Question 36

what chemical tests are used

Answer 36

colorimetry, disintegration, dissolution, chromatography

Question 37

what spectroscopy techniques

Answer 37

mass spectrometry

Question 38

What is FT-IR spectroscopy used for in counterfeit detection?

Answer 38

To analyse both medicine composition and detect falsified packaging using infrared absorption.

Question 39

how?

Answer 39

Some manufacturers label their packaging to take advantage of the fact that only inks that absorb in the infrared range will be visible under infrared radiation.