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Articles from September 2009

The dangers of internet drugs?

“GPs have alwaysknown that medication bought from the internet is a potential minefield andrecent studies are showing just how risky it is…The medication might be impureand have a higher dosage than expected, and the risk of side effects, overdoseand/or interaction with other medication is worrying.” Read this week’sScrubbing Up on BBC News online, where thechairman of the Royal Collegeof GPs, Professor Steve Field, says the only way for anyone to safely buydrugs via the internet is to talk to their GP or pharmacist first. (BBCNews, 9 September 2009)

Drug export warning to NHS trusts

NHS hospital trusts in England have been warned against any attempt to cash in by exporting medicines intended for NHS patients.The Health Service Journal reports some trusts have considered taking advantage of the weak pound to make a profit. But the government’s chief pharmaceutical officer Dr Keith Ridge has written to all NHS trusts, calling the practice irresponsible. Dr Ridge warned it could threaten the quality of patient care. He said it was particularly irresponsible to export pharmaceuticals at a time when the supply chain was threatened by the swine flu pandemic. The low value of the pound means drugs could be bought in sterling, then sold on in countries where prices are higher. Read the full story on BBC News online. (BBC News, 1 September 2009).

US Senate leader guarantees action on Rx imports

US Senate Majority Leader Harry Reid has pledged that the Senate will, before year-end, look at plans to allow Americans to re-import US-approved prescription drugs, whether or not they come up in the health care reform debate.

The Pharmaceutical Research and Manufacturers of America (PhRMA), which has always strongly opposed allowing drug re-imports, has welcomed the delay on the vote. “We should not pursue policies that could expose Americans to substandard drug products and potentially weaken the FDA by crippling the agency’s ability to fulfill its mission in protecting public health and safety,” says PhRMA.

– The bill to allow re-imports – the Pharmaceutical Market Access and Drug Safety Act – was introduced by the three Senators and others in March this year. They point out that the Congressional Budget Office (CBO) has estimated that passage would save US consumers $50 billion over the next decade, including more than $10 billion in federal government savings, and add that would not only “bring consumers immediate relief” but would “ultimately force the pharmaceutical industry to lower drug prices in the United States.” Read the full story on Pharma Times online. (PharmaTimes, 23 September 2009).

Internet Search Engines Promote Illegal Online Pharmacies

The Partnership for Safe Medicines speaks out against dangerous ads for illicit online pharmacies

The Partnership for Safe Medicines, a group of organizations and individuals dedicated to protecting consumers from counterfeit medicines, issued the following statement regarding recent reports released by LegitScript, an online pharmacy verification service, and KnujOn, an Internet compliance company, which found that 80 to 90 percent of search engine-sponsored advertisements of online drug pharmacies violate federal and state laws, including selling substandard or counterfeit drugs to unsuspecting consumers.

“Rogue online pharmacies continue to profit from the sale of counterfeit drugs,” said Marv Shepherd, Ph.D., PSM president and director of the Center for Pharmacoeconomic Studies at the University of Texas at Austin’s College of Pharmacy. “What’s even more alarming is that Internet search engines are in no way held accountable for hosting and profiting off the illegal online pharmacies who distribute substandard and counterfeit drugs. How long will our policymakers allow search engines to knowingly facilitate the illegal importation and distribution of unsafe medicines?”

Internet search engines claim to protect consumers by verifying the legitimacy of an online drug advertiser using PharmacyChecker.com’s services. However, LegitScript and KnujOn’s latest report revealed that this Web site does not rigorously inspect online pharmacies for quality of product and safety. In fact, the report’s researchers were able to purchase prescriptions from an Internet pharmacy approved by PharmacyChecker.com without a prescription and many of the Web sites claiming to be based in Canada actually shipped drugs originating in India, Singapore or Barbados.  Read the full story on PR Wire online. (PR Wire, 20 September 2009).

Drug Companies Struggling to Improve Supply Chain to Battle Counterfeiting,

Safety Concerns as global complexity increases risks for pharma and life sciences organizations, track and trace growing in importance to ensure more agile, secure supply chains, IBM study concludes By Editorial Staff

The study surveyed executives at pharmaceutical, biotechnology, medical device and consumer health care industry companies who are responsible for planning, logistics, procurement and coordination throughout the life of a drug or medical device. More than 50 percent of executives polled for the study said their companies fail to respond quickly enough to pandemics and other emergencies because of lapses in their supply chain. Companies must work to improve their ability to keep wholesalers, hospitals and pharmacies stocked with the products they need to meet patient demand, the study concludes.

Tracking every step of how drugs are manufactured and distributed are key priorities for more than 70 percent of companies. And while the industry is far ahead of most others when it comes to supply chain planning with suppliers, the study indicates the industry falls far behind on collaborating with customers on demand planning, forecasting and replenishment. These are all critical steps to rapidly responding with new vaccines in the event of pandemics, and to ensure that demand does not outstrip supply, IBM writes. Read the full story on SDC Exec (SDC Exec, 19 September 2009).

£35,000 of unlicensed medicine found in car boot

More than £35,000 of unlicensed erectile dysfunction medicine was seized in Sutton Coldfield yesterday as part of a covert investigation undertaken by the Medicines and Healthcare products Regulatory Agency (MHRA).

A 60-year-old man was arrested for possession with intent to supply the medicines which included Kamagra, Savitra and Apcalis, all unlicensed Indian products. The man was taken to Sutton Coldfield police station for questioning on the extent of his illicit online pharmaceutical business.
Tattered cardboard boxes and dirty plastic bags full of the drugs were found jammed in the boot of his vehicle.

MHRA Head of Enforcement Mick Deats said this type of criminal activity was illegal under the Medicines Act and was enforceable with up to two years imprisonment and / or an unlimited fine.
“What we found yesterday were shockingly unhygienic conditions for the handling of medicines. Dirty plastic bags and shabby cardboard boxes of unlicensed medicines were rammed into the boot of a car as well as in and around the spare tyre.

Holy See Raises Alert over Fake Drugs Sold to Continent

As many as 50 percent of medicines sold in Africa could be fake, according to the president of the Vatican’s health care council.

Archbishop Zygmunt Zimowski, president of the Pontifical Council for Health Care Ministry, affirmed this at a conference of the International Federation of Catholic Pharmacists. The four-day meeting ended Monday in Poznan, Poland. It focused on ethics and awareness for pharmacists in the field of medicine security. The World Health Organization contends that in regions of Southeast Asia and Latin America, as many as 30 percent of medicines could be fake. “The manipulation and falsification of medicines,” the archbishop explained, “primarily affects children. Fake antibiotics and fake vaccinations cause grave harm for their health.”

“There are many deaths because of respiratory illnesses among African children, because they are treated with false antibiotics that don’t have an active ingredient, but which are sold at high prices,” he said. Citing Pope Benedict’s encyclical ‘Caritas in Veritate’, the archbishop affirmed that counterfeit medication is an ethical emergency in developing countries.

He invited Catholic pharmacists to “courageously denounce every form of falsification and counterfeiting of medicine, and oppose its distribution.” Read the full story on All Africa (All Africa, 15 September 2009).

New measures to curb fake drugs

Drugs sold in Kenya will bear a government symbol to curb counterfeits. However, the fight against the illicit multi-billion shilling drug trade was far from won, Medical Services minister Anyang’ Nyong’o said on Thursday.

The World Health Organisation said three years ago that nearly 25 per cent of pharmaceutical drugs sold in the developing world were fake.  And recent studies suggest a proliferation of fake drugs as the makers acquire more sophisticated equipment.

Speaking during a tour of pharmaceutical companies in Nairobi, Prof Nyong’o complained that the Kenya Medical Supplies Agency and Pharmacy and Poisons Board were failing to stop the entry of fake drugs. “We have to take drastic measures to safeguard the health of Kenyans. Soon, we will require that all drugs arriving on Kenyan soil and those made locally bear a government symbol,” he said. Read the full story on Nation (Nation, 11 September 2009).

Fake drugs facing the final frontier

Two researchers from the United Kingdom seem to believe so, after developing a quick low-cost system that uses the fruits of astronomical research. With counterfeit drugs a growing global problem – highlighted again at this week’s meeting of the International Pharmaceutical Federation in Turkey – Professor George Fraser and Professor Martin Gill from the University of Leicester combined their expertise of space physics and crime to design a system which can test a product in the field and does not require special measures to be taken by drug makers.

Shortlisted for a British innovation award, Spectral ID relies on detecting the differences between the characteristics of light reflected from printed packaging.

Trials so far have resulted in a 100 per cent success rate in identifying counterfeit products where the differences could not be detected by the untrained naked eye. Read the full story on Pharmacy News (Pharmacy News, 10 September 2009).

WHO to revive talks on fake drugs

The matter was taken out of WHO’s annual meet agenda early this year after protests.
Months after the member countries of the World Health Organization (WHO) failed to arrive at a consensus over the introduction of a new definition for “counterfeit medicines”, the multilateral agency has once again revived talks on the counterfeit issue.

The matter had to be taken out of WHO’s annual meet — the World Health Assembly (WHA) — agenda early this year due to protests from countries like India, which felt the proposed definition would harm seamless movement of genuine medicines between developing and least developed nations.

The main point of contention is known to be the way ‘substandard medicine’ will be described.

“A medicine which does not meet the quality standards is easy to be classified as a substandard medicine. But how do you classify a medicine that meets the quality standards but has been given marketing approval based on information that was deliberately false? This is the issue that needs to be tackled,” said an official. Read the full story on Business Standard (Business Standard, 4 September 2009)

Combating rogue internet pharmacy operations

One of the challenges for law enforcement in the 21st century is internet pharmaceutical drug traffickers operating in the United States. These online, legitimate looking and sounding pharmacies are peddling dangerous narcotics and other drugs, and in some cases counterfeit drugs that are ineffective for patients.

This DEA-led investigative effort is the first to target e-trafficking located solely within the United States. The alleged drug dealers who operated these rogue internet pharmacies received prescription orders for controlled substances over the Internet, which were then shipped to the doors of many US citizens — sometimes without any prescription needed. These alleged criminal pharmaceutical drug traffickers averaged more than $50,000 a day in profits from their illegal Internet based enterprise.

Those arrested included Johar Saran, of Arlington, TX; Gaston Blanchet and Gil Lozano, of Miami, FL; Ted Solomon, of Orlando, FL; and Steve Rosner, of Boca Raton, FL. These individuals are the alleged ringleaders of this multimillion dollar drug distribution network. Operation CYBERx is part of the DEA’s “Virtual Enforcement Initiative (VEI).” This new DEA cyber initiative acknowledges that criminals in the drug trade are embracing the use of state-or-the-art technology to peddle their narcotics and dangerous drugs into US communities, all with an air of respectability. Read the full story on The Examiner (Examiner, 1 September 2009).