Saturday, 4 August 2018

Pharmaceutical counterfieting
A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/ or source. 
Counterfeiting of medicines can apply to both branded and generic products. Generally, counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with in correct quantities of activities ingredients or with fake packaging
 Counterfeit Medicines

Products marketed with intent to deceive

1– Counterfeit active/bulk ingredients
2– Counterfeit finished products
3– Unregulated diverted products
4– Counterfeit labeling
5– Mislabeled substances (e.g., generic anti-biotics)


Why are Medicines a Target?

  1. Fakes can be made relatively cheaply (at least as profitable as narcotics – lower risk).
  2. Many countries, especially in the developing world lack adequate regulation and enforcement
  3. Even in the industrialized countries, the risk of prosecution and penalties for counterfeiting are inadequate
  4. The way in which medicines reach the consumer is also different from other goods:  the end-user has little knowledge of the product – a ‘credence’ good

What is Particular to  Pharmaceutical Counterfeiting?

  1. Medicine counterfeiting is much more of a threat to public health than to company revenues
  2. Developing countries are the worst affected where regulatory structure is weaker and measurement and oversight is difficult; consumers in LDC’s often buy Rx drugs directly over the counter
  3. Non-branded generics are very widely counterfeited (e.g., ampicillin, paracetamol)
  4. Prices vary widely across the world, and parallel trade is widespread, allowing counterfeit medicines to enter the supply chain
  5. People will not knowingly buy a counterfeit drug, but consumer detection is extremely difficult: price is not an indicator in insured markets    
Current and Future Risks
  1. Treatment failure in malaria, TB and HIV/AIDS
  2. Growth of resistance to existing anti-infectives from use of sub-par treatments
  3. Spread of drug resistant pandemics, including HIV and influenza
  4. Use of illegal funds to finance further illegal manufacture of medicines and even terrorism
  5. Globalization of pharmaceutical production know-how drives counterfeiting: supply-driven
  6. Counterfeit drugs are increasingly showing up in OECD countries

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South Africans need to return 318,000 packets of potentially dangerous pills

The South African distributor of heart pills that may contain a potentially carcinogenic ingredient has confirmed that more than 318,000 packets of pills may be affected.
“Operationally, it is a difficult situation,” a representative of Pharma Dynamics, the distributor of the tablets in South Africa, told Business Insider South Africa.
The South African Health Products Regulatory Authority (SAHPRA) this week recalled Dynaval Co high blood pressure and heart pills, which may contain a controversial carcinogenic ingredient that was manufactured in China.
Dynaval Co 80/12.5 mg, 160/12.5 mg and 160/25 mg pills, which were manufactured by Zhejiang Huahai Pharmaceuticals, may contain the chemical NDMA.
NDMA is associated with liver damage and liver cancer in rats as part of laboratory tests, says dr Eric Decloedt, a clinical pharmacologist at the department of medicine of the University of Stellenbosch. “We extrapolate that it could hold the same risks for people.”
The affected pills contain the ingredient valsartan, but only tablets manufactured by Zhejiang may contain the NDMA. Dynaval 80 mg and 160 mg tablets are not affected.
The Dynaval Co pills were not available in the state health sector, but were in wide use among private patients, who used it for high blood pressure,  heart failure and as part of treatment after a heart attack.
According to Nicole Jennings, corporate communications manager of Pharma Dynamics, more than 318,000 packets of the pills are still in circulation. Anyone with a packet of Dynaval Co should urgently return the medicine to their pharmacy.
European authorities first announced a recall of the batch of medicines that was manufactured by Zhejiang earlier this month. It took a full three weeks for the local authorities to order its withdrawal in South Africa. 
"The responsibility of managing this matter and communicating this information to the public is shared by both SAHPRA and the manufacturers," a SAHPRA spokesperson told Business insider.
“Once SAHPRA was informed by Pharma Dynamics about the affected products, appropriate actions were undertaken in consultation with the manufacturer, to warn healthcare professionals and the public about this potential risk.”
She said that to date, SAHPRA has not identified other valsartan containing products that are affected.
At this stage reports around the impurity possibly causing cancer has not been verified by any health authority, said Jennings.  
“No definitive information has been received to indicate an immediate threat to patients as investigations are still underway."
People who have been using the medicine can get a refund from their pharmacies.
A Pharma Dynamics spokesperson warned that it is dangerous to just stop using the medication – they need to speak to a pharmacist or doctor first about a substitution. The company doesn’t have any immediate plans to foot these doctors’ bills, however.
Decloedt says other medicines containing losartan, candesartan or telmisartan – and pills that contain valsartan but not NDMA – could be prescribed.
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Wednesday, 1 August 2018

Regulatory intelligence

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