Tuesday, June 19, 2012

Counterfeit Drugs 6: Online Drugs, US FDA and G8 on Fighting Fake Drugs

Counterfeit drugs are dangerous. A patient taking it may develop new diseases as the original illness is not cured and may have evolved into something more serious inside the patient's body.

Here are four recent articles in BusinessWorld by Reiner Gloor on the subject. Reiner comes from the federation of mostly innovator and multinational pharma companies, PHAP. So he knows this subject through and through. The four papers are:

1. Medicines online, June 15, 2012
2. What's in a fake drug, June 01, 2012
3. G8 commits to fight global counterfeiting, May 25, 2012
4. Keeping safe from counterfeit drugs, February 23, 2012



(1) Medicines online 

June 15, 2012

Medicine Cabinet -- Reiner W. Gloor


In the Philippines, a global research marketing group disclosed that one in three Filipinos have access to the internet. The 2011 Nielsen report further said that five in 10 survey respondents have high-speed internet connections at home while others frequent caf├ęs or use their mobile phones to surf the Web.

The rapid growth of internet penetration in the country is expected to result in huge benefits. However, a recent global meeting of world leaders called for the need to put up barriers to threats that could adversely affect a user’s health, among others. The so-called Camp David Declaration of the Group of Eight Nations recently pledged to protect public health and consumer safety by committing to exchange information on rogue internet pharmacy sites that sell counterfeit medical products. The Declaration came ahead of World Anit-Counterfeiting Day on June 7 that also focused on pharmaceutical counterfeiting.

On May 29, the US Food and Drug Administration (FDA) warned consumers and healthcare professionals about a counterfeit version of a medicine used for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. The fake version of the controlled substance is being sold on the internet.

The FDA reported that preliminary lab tests showed that the counterfeit version of the 30 mg tablets contained the wrong active ingredients. The genuine drug contains four active ingredients. The fake medicine was found to have tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain. The physical look of the fake product purchased from the internet is a giveaway. It did not come in its original package, the color and shape of the pils were irregular, and there were no markings on the tablets. There were also misspellings on the package such as “Singel” instead of “Single” and “Aspartrte” instead of “Aspartate.”

Developed countries have established a system of regulating legitimate online pharmacy sites. But even with safeguards, counterfeit medicines continue to be a threat to those who purchase drugs online.

Some copycat medicines sold on the internet fit the World Health Organization (WHO) description of “spurious, falsely labeled, falsified and counterfeit” medicines. Their ingredients are too strong or weak, have dangerous ingredients, are expired, and are not manufactured using safe standards. If taken by a patient these could have dire health consequences.

Furthermore, fake pharmacy sites sell medicines that are not appropriate for one’s condition while other sites place personal credit information at risk.

Fortunately, there are ways of establishing the legitimacy of online pharmacies.
The first is its ownership. Legitimate sites display the web owner on every major page with a link to the home page. The “About Us” page is helpful in determining who runs the site. A “Contact Us” page with the physical address of a company also helps.

The so-called generic top level domains will also be useful in knowing ownership. Sites that end in “.gov” are run by a government while a “.edu” is run by a university or educational institution. A non-profit group maintains a “.org” while a “.int” means it is run by international organizations. A site ending in “.net” or “.com” is often a commercial site.

Remember, too, that the country of origin is not a guarantee that the medicines are genuine. Despite strong regulatory measures, some of the counterfeiters either actually operate in these countries or make it appear that they are legitimate business establishments in these countries.

Licensed online pharmacies are also strict about requiring a doctor’s prescription. And, as dicussed in our previous columns, online pharmacies that offer unbelievably low prices are too good to be true.

A site that promises quick, dramatic, miraculous results, a cure-all medication that relies on a “secret ingredient” is spurious, said the FDA. It added that one should avoid sites that make use of sensational writing or those that use technical jargon.

Meanwhile, websites that offer health information must cite sources, medical facts and figures with references. Opinions published on the website must be set apart from information that is evidence-based.

It is also important that sites are current and updated regularly. Broken links are a sign that that site may not be updated.

It will also be useful to visit the “Privacy Statement” of a website that either tracks past visitors or asks for personal information. The page must be able to explain what the site will do and will not do with the information a user will be providing. It will be wise not to divulge any personal information or sign up for a subscription if one does not fully understand the terms and conditions.

As for e-mail messages, a careful evaluation of the message’s origin and purpose will be important. The desire to promote a product may influence the accuracy of health information. (For more information on purchasing medicines online, visit www.fda.gov.)

As the Nielsen report said, e-commerce in the country is still in its infancy. On the other hand, the continued growth in internet use opens huge potentials for online trade. Purchasing medicines online would add to the ease and convenience of patients. However, patients must be careful when getting them online.

For more information, consult your doctor or you may log on to www.phap.org.ph orwww.phapcares.org.ph. Join us on www.facebook.com/people/Pharma-Phap/. e-mail the author atreiner.gloor@gmail.com.




(2) What’s in a fake drug


June 1, 2012

Medicine Cabinet -- Reiner W. Gloor


 http://www.bworldonline.com/weekender/content.php?id=52693




Some say that the wrong ingredients make the right dish. This may be true in some cases but in medicines, the wrong ingredients often have dire consequences on health.
Medicines are composed of so-called active ingredients, which, according to the US Food and Drug Administration (FDA), provide pharmacological activity or direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

If a product does not contain the correct ingredients or if it has wrong ingredients, is without active ingredients, or with insufficient active ingredients, it is considered counterfeit by the World Health Organization (WHO).

In its recent meeting, the G8 sounded the alarm against the global counterfeiting of pharmaceutical products. And it has legitimate reasons for doing so. Early this year, two men were arrested in the US for selling counterfeit medicines through their multiple online sites. They pleaded guilty to illegally selling bulk prescription drugs to US buyers, including more than 9,000 drug shipments. Following laboratory results, the fake medicines were found to contain insufficient active ingredients.

Halfway around the world in 2011, about 11 people also pleaded guilty to producing and selling fake cancer medication in Shanghai, China. A drug test report disclosed that the fake cancer drug contained contaminated saline with excessive bacteria endotoxin that caused eye infections in 61 people.  Dozens of children were also believed to have died in Nigeria in 2008 after they were given a supposedly baby teething medicine which was found to have contained a solvent common in antifreeze.

The Partnership for Safe Medicines (PSM) observed that laboratory tests confirmed the presence of several unwanted ingredients in counterfeit medicines. Among these are heavy metals such as mercury, lead, cadmium, arsenic, chrome, uranium, strontium, selenium and aluminum which are carcinogenic or toxic to the central nervous system, kidneys, liver, skin, bones or teeth.

In 2006, a woman from Canada who thought she had flu purchased a medicine from what she did not know was a fake online pharmacy. She died of cardiac arrhythmia caused by metal toxicity from her counterfeit medication.

The PSM, likewise, noted that fake medicines were found to have actual poisons such as rat poison, boric acid, antifreeze, Polychlorinated biphenyls (PCBs) and benzopyrenes. Boric acid and antifreeze cause kidney damage and failure while PCBs may cause breast, uterine and cervical cancer and can lead to developmental defects. Benzopyrenes, on the other hand, are carcinogenic.

Common household items such as floor wax, brick dust, sheet rock, house paint, road paint, paint thinner have also been mixed in counterfeit drugs.

According to the PSM, floor wax gives a nice sheen to resemble an enteric coating, brick dust and paints fake the proper color of pills, and sheet rock can be made into pills.

Interpol reported that in Ecuador, boric acid was found as an ingredient in fake medication while sheet rock and rat poison were ingredients in Columbia. Methamphetamine was also found in fake medication in Hungary, and commercial-grade wall paint was used to color fake pills in Montreal. Antifreeze was also found in cough syrups and other common drugs, resulting in the deaths of hundreds of adults and children in Panama, Haiti, Nigeria and Guanzhou.

Substitute ingredients that have not been approved by regulators for medicinal use have also been found in counterfeit medicines. These substitutes are cheaper but have been rejected or are untested for use in people, with potentially dangerous side effects and contraindications.

Medications with no active ingredients or insufficient quantities of active ingredients can also harm patients by not providing any therapeutic effect for a disease. Cases showed that counterfeit medicines with little or no drugs in them had adverse impacts on cancer and asthmatic patients. (For more information, go to
www.safemedicine.org.)

The use of what the WHO calls spurious, falsely labeled, falsified and counterfeit medicines (SFFC) can result in treatment failure, even death.

In the coming days, the public could expect the implementation of strategies against global counterfeiting following the G8 Camp David Declaration branding fake medicines a threat to public health. 



Pharmaceutical companies have stepped up surveillance systems to ensure the quality, efficacy and safety of medicines. The public can also help by being vigilant and by reporting counterfeiting incidents.
One may report to FDA at 807-8275 or the multi-stakeholder alliance Safe Medicines Network at 1-800-10-FAKEMED.





(3):G8 commits to fight global counterfeiting

May 25, 2012

Medicine Cabinet -- Reiner W. Gloor

http://www.bworldonline.com/weekender/content.php?id=52288


The Group of Eight Nations, composed of the world’s superpowers led by the United States and the United Kingdom, met early this week to discuss matters with political and economic significance.


Along with issues on nuclear disarmament, Europe’s debt crisis, global hunger, the transition in Arab countries, and climate change, the so-called G8 recognized counterfeit medicines as threat to public health.

World powers such as the US, UK, Germany, Japan, Italy, Canada and Russia issued the Camp David Declaration which highlighted, among others, the importance of intellectual property rights and the commitment to fight counterfeit medical products.

The Camp David Declaration in Maryland stated: “Given the importance of intellectual property rights (IPR) to stimulating job and economic growth, we affirm the significance of high standards for IPR protection and enforcement, including through international legal instruments and mutual assistance agreements, as well as through government procurement processes, private sector voluntary codes of best practices, and enhanced customs cooperation, while promoting the free flow of information.”
It added: “To protect public health and consumer safety, we also commit to exchange information on rogue Internet pharmacy sites in accordance with national law and share best practices on combating counterfeit medical products.”

In February, the Bureau of Customs announced that it seized two vans loaded with P400 million worth of fake items, including 130,000 cough medicine capsules. The said counterfeit items were confiscated at the Port of Manila and were said to have originated from China.

In the United States, the Food and Drug Authority alerted doctors and patients about the counterfeit version of a cancer medication and other non-approved injectable cancer treatments that were being sold to clinics and most likely administered to patients.

A report indicated that the fake cancer drug came from a Syrian broker to an Egyptian supplier before making its way through both legitimate and unauthorized wholesalers or distributors in Switzerland, Denmark and UK before reaching the US market.

The medicine trail showed that the intention of the counterfeiters was to deceive the patients and health care providers about the origin of the fake products. It also showed the determination of counterfeiters to avoid both local drug distribution laws and law enforcement in each of the countries.

Reports worldwide indicate the rise in counterfeiting activities. John P. Clark, Pfizer’s chief security officer and vice-president of global security, observed the same.

Clark said that there has been an increase in the number of countries where fake Pfizer medicines were found and confirmed. As of March this year, there were 105 countries in the list involving 60 of their medicines.

He added that there was a more dramatic increase in terms of the number of countries where fake medicines have breached legitimate supply chains such as pharmacies. Also as of March, they confirmed fake versions of 23 Pfizer medicines in 56 countries. (For more information, visit www.phrma.org.)
However, it must be noted that both innovator and generics medicines are being counterfeited.

The G8 also gave specific attention on the need for information exchange concerning “rogue Internet pharmacy sites.” The World Health Organization (WHO) estimates that more in than 50% of cases, medicines purchased from unlicensed Internet sites that conceal their physical address have been found to be counterfeit. The Partnership for Safe Medicines (PSM) said several of these uncertified online pharmacies are “large criminal organizations” that operate from countries with weak regulatory and enforcement systems.

Clark explained that this is because pharmaceutical counterfeiting is “low risk” with high profit potentials, attracting even those involved in illegal trafficking of narcotics and firearms.

The online pharmacy sites are being aggressively advertised via e-mail spam while some create convincing “trade names.” They also make promises of rock-bottom prices, quality, efficiency, fast delivery, and simple return policy.

The PSM warned that these counterfeit products usually contain lethal ingredients or no ingredients at all. Some victims, adult and children alike, have been sickened or have died from taking fake medicines that either poisoned them or failed to treat their conditions.

Aside from the threat to health and life, purchasing medicines from these illegal online drugstores also expose the patient’s personal information such as credit card details, address, and phone number.
Counterfeit medicines are a threat to public health. The pharmaceutical industry has established medicine surveillance systems to help keep the integrity of medicines. Some even have dedicated anti-counterfeiting teams composed of investigators, analysts and physical security experts.

While the G8 is taking a lead in the fight against fake drugs this year, patients also have a big role to play by knowing how to identify fake medicines and by reporting incidents of counterfeiting. The public may report the suspect medicine to the Food and Drug Administration at 807-8275 or the multi-stakeholder alliance Safe Medicines Network at 1-800-10-FAKEMED. They may also report to their doctor and the pharmaceutical company involved.




(4) Keeping safe from counterfeit drugs

Posted on 05:53 PM, February 23, 2012

Medicine Cabinet -- By Reiner W. Gloor



The US Food and Drug Administration (FDA) recently issued an advisory to warn health care professionals and patients concerning a counterfeit version of cancer medication that may have been purchased and used by some medical practices in the United States.

The warning said that the counterfeit version of Avastin 400mg/16mL does not contain the drug’s active ingredient, bevacizumab, most likely resulting in patients not receiving the needed therapy. It also urges consumers to report adverse effects while taking the drug.

Last week, the FDA likewise issued letters to medical practices in the US that purchased unapproved cancer medicines from a foreign supplier. It has requested the medical practices to stop administering any remaining products as it cannot ensure the safety or efficacy of the unapproved products.

The letter added that it is “very concerned that these products may cause harm to patients because they are unsafe or ineffective.” It said that the products “may be from unknown sources, have unknown ingredients, and may not have been manufactured, transported or stored under proper conditions required by US law, regulations, and standards.”

In an issuance made in January, the FDA stated that it is aware of promotions and sales of unapproved medications direct-to-clinics in the US. These products include medications whose quality could be adversely affected if not stored or transported under specific temperatures.

The products from non-verified source are potentially unsafe and ineffective since they are unapproved, and therefore not manufactured according to standards. When purchased, patients are placed at risk for receiving medicines that have uncertain purity, storage, handling, identity and sourcing.

It reminded health care providers to obtain and use only approved pharmaceutical products from manufacturers or licensed wholesale distributors.

It urged providers to carefully inspect the product and packaging of pharmaceutical products. The US FDA specifically asked providers to be on alert if the packaging looks different; the labeling is not in English; the dosing recommendations are unfamiliar; or the dosage form or route of administration is different.

Furthermore, it also advised health care providers to “question whether a price sounds too good to be true.”

Finally, the issuance said that health care providers are expected to monitor and report should they receive multiple complaints about the same product, such as a new side effect or lack of therapeutic effect.

The recent US FDA safety alert reminds health care professionals and patients that counterfeit, adulterated or fraudulently obtained drugs remain an issue in the US and around the globe.

In fact, reports early this week disclosed that Customs confiscated P400 million worth of fake goods, including some 130,000 capsules of a known over-the-counter cough medicine from the port of Manila.

So, to help the public judge the safety of medicines, the Partnership for Safe Medicines has developed an eight-step checklist to ensure that the medicine they purchased has not been compromised.

First, patients are encouraged to request a sample medicine from the physician when first prescribed a medication to help establish a “baseline” of a product’s characteristics, including its appearance, taste, texture, reactions and packaging.

There is also a need for patients to compare the prescription medicine by taking pictures of the original manufacturer’s drug and all associated packaging. When comparing packaging, one must look for differences in paper, printing, color and fonts.

It is also important to take note of the prescription drug’s taste and any associated feelings once taken. It also means monitoring, or even keeping a diary, of any unusual body reaction to the medicine such as a stomachache or headache.

The next step is to evaluate whether or not the patient’s condition is improving, stabilizing or reverting to ill health. Counterfeit drugs may contain not enough, too much, or no active ingredient.

If the medications do not seem to be the same or if there’s an unusual outcome after taking the medication, one must immediately write down the symptoms and contact his doctor and pharmacist.

The public is also encouraged to report any concerns about the quality of the drugs purchased to the proper authorities or the pharmacy. When reporting, information such as how, where, and when the suspect medication was purchased will be helpful.

In the Philippines, the public may report by calling the FDA at 807-8275 or the Safe Medicines Network at 1-800-10-FAKEMED. They may also report to their doctor and the pharmaceutical company involved, or fill up Bantay Gamot Forms which are available at all FDA-registered drugstores.

Counterfeit drugs defraud consumers, deny patients of needed therapies, and can cause great harm. Both health care professionals and the patients will benefit if they make themselves aware of the risks of counterfeit drugs and follow the steps to avoid them.

For more information, consult your doctor or you may log on to www.phap.org.ph orwww.phapcares.org.ph. Join us on www.facebook.com/people/Pharma-Phap/. E-mail the author atreiner.gloor@gmail.com.
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See also:
Counterfeit Drugs 1: On the Growing Fake Drugs Worldwide, December 21, 2007
Counterfeit Drugs 2: IPN Report on Fake Drugs in Poor Countries, May 29, 2009
Counterfeit Drugs 3: The SCLD, RA 8203, June 04, 2009
Counterfeit Drugs 4: Drugs Can Kill, December 17, 2010

Counterfeit Drugs 5: Mongolia Case, December 22, 2010

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