IPSF NEWSLETTERAnti-Counterfeit Drug Campaign

Internat ional Pharmaceut ica l Students ’ Federat ion

Issue N°91

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Internat ional Pharmaceut ica l Students ’ Federat ion

Anti-Counterfeit Drug Campaign

Issue N

°91

Christine Cooper

Anti-Counterfeit Drug Campaign

Coordinator 2010-11

counterfeit@ipsf.org

IPSF Public Health EditionAnti-Counterfeit Drug Campaign Newsletter

Summary

2Ghana: FightingCounterfeit Drugs in the Country

4 Qatar to issue law against counterfeit drugs

5Bouderbala: 60% of imports are counterfeit

5 Manufacturers asked to reduce drug prices to fight

counterfeits

6The Possible Dangers of Buying Medicines over the Internet:

Are we aware?

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Coordinator’s Letter:

Hello IPSFers!

Welcome back to the world of combating counterfeit drugs. In this newsletter, we have news articles on steps Ghana and Qatar are taking towards eliminating counterfeit drugs in their respective countries, along with a call for pharmaceutical companies to lower prices on real drugs. We also have a short report on how prevalent counterfeit medicines are in Algiers (wow!), and we close up the newsletter with information about how to buy medications over the internet, which includes possible signs of counterfeit medications being sold.

This last article is an excellent one to read and share the information with your patients if they mention looking online to buy cheaper medications, so if you only have a minute to spare for reading, that is the one I definitely recommend to read. However, I have found all this news interesting, so I hope you do too.

This is the last newsletter of the year for our current ACDC team, and I would like to say a special thanks to my team for all their hard work: thank you so very much for all your support and efforts over this past year!

We will be having an ACDC workshop this year at the 57th World Congress in Hat Yai, Thailand, so be sure to stop by to learn more about how you can combat counterfeit medications and keep your patients safe. See you there!

Sincerely,

Ghana: FightingCounterfeitDrugs in the Country

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The doctor prescribes an unnamed medication to manage your pain. It comes in flawless packaging ...almost. In this true account as relayed by multinational Pfizer, the color has been clinched with floor polish and lead-containing paint while brick dust has been improvised as an adhesive. To top it, boric acid, known for its deleterious effects on the kidney is a constituent!

Welcome to the world of counterfeit drugs, the most profitable industry in the world of organized crime. As it turns out, with limited technological and human resource capacity, porous borders and sub optimal multi country collaboration between security agencies, regulatory bodies and professional unions, West Africa is hardly in pole position in the fight against counterfeit drugs. It is perhaps to remedy this that nine West African countries and other key stakeholders gathered in Dakar in the first quarter of 2011 under the aegis of international pharmaceutical Pfizer, to as it were, create synergy of effort.

Since 2004, Pfizer alone has discovered 65 million counterfeited drugs in addition to the discovery of active pharmaceutical ingredients to manufacture another 68 million drugs. In addition, Viagra is by far the most frequently counterfeited drug. Anti malarials have not been spared with dire implications for Africa where according to the World Malaria report 2010, 78% of cases worldwide and 91% of deaths worldwide from malaria were in Africa. Also, a study done in 2008 in six African countries including Ghana revealed 35% of anti malarials to be sub standard. Nigeria’s (full name) NAFDAC for example states unequivocally that antimalarials and antibiotics are the most frequently counterfeited drugs and have formed the focus of their efforts while deploying “cutting edge technology” like truscan.

The Ghana team that assembled included officials from the Criminal Investigations Division, Customs Division, Food and Drugs Board and professional bodies including the Ghana Medical Association and the Pharmaceutical Society of Ghana.

New dimensions in counterfeit trade

The counterfeiting world seems to have assumed new dimensions both in West Africa and elsewhere; clients purchasing drugs using the internet, linkages with the narcotic trade and money laundering. Perhaps in equal measure, those fighting this menace have responded through the deployment of new technologies like the truscan and mobile telephony services. Of course, and there was the not so small matter delivered though a lively debate of some manufacturers themselves introducing sub standard drugs unto the market after securing approval to produce drugs of the highest quality. Of course this was hotly contested!

With some countries citing a weak legal regime,

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Ghana’s challenge seemed to be more a question of enforcement and the application of deterrent sanctions following convictions in court. The Food and Drug Board’s Thomas Amedzro lamented individuals caught red handed dealing in counterfeits and yet hardly being slapped with the maximum 500 penalty units or the 600 GH ¢. In one instance, after working extra hard to secure convictions, the convict was jailed for one week and then released which was a big demotivator to the anti counterfeit fight not to mention sending all the wrong signals to patrons of the thriving illegal trade.

Weak research capacity

Another challenge that became apparent in the Ghanaian context and indeed in the presentations of many others is the research capacity or lack thereof some of these agencies fighting counterfeits. There appears to be very little or no data to inform policy makers and managers as to whether the fight is being won or lost and what impact if any current interventions are making in ensuring that people indeed are increasingly having access to safe and efficacious medication. In fact in some statistics quoted by the Pharmaceutical Security International, the paucity of information from Africa on reported seizures and hence the unreliability of data for decision making and strategic planning couldn’t be clearer. In Ghana for example, it is crucial for relevant agencies to begin to collect data and where data is available, to begin to analyze same to enable questions like the prevalence of counterfeit levels in our country to be determined plus the percentages of the most commonly counterfeited drugs etc

Again, in Nigeria and Ghana especially, there might be the need to reorient the mandate of some of our Customs agencies. When governments strongly positions the Customs Division of CEPS as a revenue agency with defined revenue targets while downplaying its regulatory role, it reinforces t he weakened capacity of an otherwise strong anti-counterfeit ally through an unintended weakening

of their regulatory role. It is time to begin to pay more attention to building the regulatory role capacity.

Public education

It is noteworthy that Ghana’s Food and Drugs Board following its recent proactiveness in the area of enforcement has decided to embark on a massive public education exercise. This should be comprehensive, focusing not just on the ways of combating counterfeits medications but on the harmful effects of the drugs on the man on the street who must be aided with basic street wise tools in detecting features of counterfeit medication. In addition, better collaboration ought to be built among all stakeholders including key ones like doctors, pharmacists who remain key in procuring medications for health institutions and dispensing same to clients etc. The public must know that every counterfeit detected is one life saved. They must know how a woman ordered a drug online and died the next day with fifteen times the normal aluminum levels being detected in her liver.

SMS technology

Use of text messaging services and portable devices like the truscan which require little/no technical expertise can ensure massive utilization at the ports, among providers, pharmaceutical companies etc in addition to the usual impromptu checks of undetermined effectiveness. Nigeria for example reports the existence and their use of a program that enables a text message to be sent to a code with a prompt reply confirming the genuineness or otherwise of a particular product.

Given intelligence indications of an observed shift of some barons from narcotics trade into counterfeit manufacturing, spurred by enviable profit margins and reduced security vigilance, now is a good time to join up our efforts at all levels.

Reference:Sodzi-Tettey S. Ghana: Fighting counterfeit drugs in the country. The Chronicle. 13 Jun 11. Accessed on 15 Jun 2011.Available at http://allafrica.com/stories/201106150102.html.

Qatar to issuelaw against counterfeit drugs

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Manama: Qatar’s Supreme Council of Health’s Pharmacy and Drug Control Department (PDCD) has issued a new draft law to combat and criminalise the sale of counterfeit drugs in the country.

Dr. Aisha Ebrahim Al Ansari, PDCD director, claimed once passed into law, it will be the first in Qatar and in the Middle East, Qatari daily Gulf Times said on Tuesday.

The draft law is currently being reviewed and will later be adopted and submitted to higher authorities for approval.

The counterfeit medicines problem is an issue all over the world related to the manufacturers’ complex distribution networks, she said.

According to the official, determining the size and extent of the problem of counterfeit medicines could be difficult for several reasons.

“The risks of taking counterfeit medicines are that they may not contain complete active ingredients being used by pharmaceutical companies or they may contain a lot of these active ingredients

or wrong ones. It is also unhealthy and often manufactured in sites other than the licensed and registered, and is manufactured using equipment below health standards. All these constitute a clear threat to life,” she said.

The fight against counterfeit drugs required the co-operation of all parties concerned including the supervisory authorities of health and pharmaceutical companies, legal authorities, rights groups, consumer and legislative bodies, with increased awareness in the media and the different ways on the threat posed by counterfeit medicines on patient’s health and their safety, she said.

Al Ansari called on international drug companies to reduce prices globally and stressed that it was the best policy to combat counterfeiting of medicines.

“It is important for drug manufacturers to provide original medicines at affordable prices so that patients will not go for counterfeit medicines being sold at cheap prices,” she said.

Reference:Toumi H. Qatar to issue law against counterfeit drugs. Gulf News. 14 Jun 2011. Accessed on 15 Jun 2011.Available at http://gulfnews.com/news/gulf/qatar/qatar-to-issue-law-against-counterfeit-drugs-1.821470.

Bouderbala:60% of imports are counterfeit

Manufacturers asked to reduce drug prices to fight counterfeits

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Reference:Reference: Bouderbala: 60% of imports are counterfeit [in Algiers]. Ennahar Online. 14 Jun 2011. Accessed on 15 Jun 2011.Available at http://www.ennaharonline.com/en/economy/6814.html.

ALGIERS - Nearly 60% of imported products in Algeria for resale in the state are counterfeit, said Tuesday the Director General of Algerian Customs Mohamed Abdou Bouderbala.

Mr. Bouderbala has announced a tightening of legislation, has suggested a figure two to three million counterfeit products seized annually.

“Almost all cosmetics imported are counterfeit” as “all mobile devices that are not approved by the ARPT (Regulatory Authority of the phone market),” he told the APS.

He also cited the car parts, responsible for many road accidents regularly denounced by the authorities, appliances and kitchen appliances that cause home accidents, cigarettes but also drugs, sometimes fatal if not real.

Control services lack of modern means of expertise and have only 280 customs officers trained on certain brands to intercept c o u n t e r f e i t items,” he said.

Representatives of foreign brands sold in Algeria work with the inspection to the training of customs officers.

C o u n t e r f e i t products originate, in general, from China, UAE and South Korea.

GlaxoSmithKline has asked pharmaceuticals to reduce prices of essential drugs so as to be accessible and reduce counterfeits.

Addressing journalists in Kampala yesterday, Mr Patrick Adele, the commercial director GSK, East Africa said doctors, health insurance companies and pharmacists should fight counterfeits through making drugs more accessible.

He said: “As GlaxoSmithKline we are looking at reducing the prices of our essential drugs by 50 per cent to improve patient access to medicines.”

According to GSK East Africa managing director, Mr John Musunga, the company is shifting focus from a highly margin, low volume drive to a lower –high volume business model.

“The high prices of medicine have been a key barrier to business growth, and they are also a factor causing proliferation of counterfeit medicines.”

Some of the essential drugs that have had price reductions include Amoxil syrups, Bactroban ointment, Ventolin inhalers, Ventolin syrup and de-wormers.

Reference:Lyatuu J. Manufacturers asked to reduce drug prices to fight counterfeits. Daily Monitor. 16 June 2011.Accessed on 15 June 2011. Available at http://www.monitor.co.ug/Business/Commodities/-/688610/1181716/-/ch242r/-/.

The Possible Dangers of Buying Medicines over the Internet:

Are we aware?

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A counterfeit medication or a counterfeit drug is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body (e.g., absorption by the body), may contain ingredients that are not on the label (which may or may not be harmful), or may be supplied with inaccurate or fake packaging and labeling. Medicines which are deliberately mislabeled in order to deceive consumers—including mislabeled but otherwise genuine generic drugs—are counterfeit. Counterfeit drugs are related to Pharma Fraud.

As we know that medicines are sold over the internet are we aware that this might not be safe?

The Food and Drug Administration (FDA) wants to warn consumers about the possible dangers of buying medicines over the Internet. Some websites sell prescription and over-the-counter drugs that may not be safe to use and could put people’s health at risk.

So how can you protect yourself? FDA says that consumers should know how to recognize a legal Internet pharmacy and how to buy medicines online safely.

Don’t Be Deceived

Buying prescription and over-the-counter drugs on the Internet from a company you don’t know means you may not know exactly what you’re getting.

There are many websites that operate legally and offer convenience, privacy, and safeguards for purchasing medicines. But there are also many

“rogue websites” that offer to sell potentially dangerous drugs that have not been checked for safety or effectiveness. Though a rogue site may look professional and legitimate, it could actually be an illegal operation.

These rogue sites often sell unapproved drugs, drugs that contain the wrong active ingredient, drugs that may contain too much or too little of the active ingredient, or drugs that contain dangerous ingredients.

For example, FDA purchased and analyzed several products that were represented online as Tamiflu (oseltamivir). One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets. When analyzed by FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir.

FDA also became aware of a number of people who placed orders over the Internet for one of the following products:

• Ambien (zolpidem tartrate)

• Xanax (alprazolam)

• Lexapro (escitalopram oxalate)

• Ativan (lorazepam)

Instead of receiving the drug they ordered, several customers received products containing what was identified as foreign versions of Haldol (haloperidol), a powerful anti-psychotic drug. As a result, these customers needed emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms, and muscle stiffness—all problems that can occur with haloperidol.

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exactly like real FDA-approved medicines, but their quality and safety are unknown.

Signs of a trustworthy website

• It’s located in your country.

• It’s licensed by the state board of pharmacy where the website is operating. A list of these boards is available at the website of the National Association of Boards of Pharmacy.

• It has a licensed pharmacist available to answer your questions.

• It requires a prescription for prescription medicines from your doctor or another health care professional who is licensed to prescribe medicines.

• It provides contact information and allows you to talk to a person if you have problems or questions.

• Another way to check on a website is to look for the National Association of Boards of Pharmacy’s (NABP) Verified Internet Pharmacy Practice Sites™ Seal, also known as the VIPPS® Seal.

This seal means that the Internet pharmacy is safe to use because it has met state licensure requirements, as well as other NABP criteria. Visit the VIPPS website to find legitimate pharmacies that carry the VIPPS® seal.

Signs of an unsafe website

It sends you drugs with unknown quality or origin.

• It gives you the wrong drug or another dangerous product for your illness.

• It doesn’t provide a way to contact the website by phone.

• It offers prices that are dramatically lower than the competition.

• It may offer to sell prescription drugs without a prescription—this is against the law!

• It may not protect your personal information.

Know Your Medicines

Before you get any new medicine for the first time, talk to a health care professional such as your doctor or pharmacist about any special steps you need to take to fill your prescription.

Any time you get a prescription refilled

• check the physical appearance of the medicine (color, texture, shape, and packaging)

• check to see if it smells and tastes the same when you use it

• alert your pharmacist or whoever is providing treatment to anything that is different

Be aware that some drugs sold online

• are too old, too strong, or too weak

• aren’t FDA-approved

• aren’t made using safe standards

• aren’t safe to use with other medicines or products

• aren’t labeled, stored, or shipped correctly

• may be counterfeit

Counterfeit Drugs

Counterfeit drugs are fake or copycat products that can be difficult to identify.

The deliberate and fraudulent practice of counterfeiting can apply to both brand name and generic products, where the identity of the source is often mislabeled in a way that suggests it is the authentic approved product.

Counterfeit drugs may

• be contaminated

• not help the condition or disease the medicine is intended to treat

• lead to dangerous side effects

• contain the wrong active ingredient

• be made with the wrong amounts of ingredients

• contain no active ingredients at all or contain too much of an active ingredient

• be packaged in phony packaging that looks legitimate

For example, counterfeit versions of the FDA-approved weight loss drug Xenical, which contains the active ingredient orlistat, recently were obtained by three consumers from two different websites.

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Don’t buy from websites that offer to prescribe a drug for the first time without a physical

exam by your doctor or by answering an online questionnaire.

Laboratory analysis showed that the capsules that the consumers received contained the wrong active ingredient, sibutramine.

Sibutramine is the active ingredient of a different medicine called Meridia, a prescription drug also approved by FDA to help obese people lose weight and maintain weight loss. In addition, sibutramine is classified as a controlled substance by the Drug Enforcement Administration because of its potential for abuse and misuse.

Using medicine that contains an active ingredient that wasn’t prescribed by your licensed health care provider may be harmful.

FDA continues to proactively protect consumers from counterfeit drugs. The agency is working with drug manufacturers, wholesalers, and retailers to identify and prevent counterfeit drugs. FDA also is exploring the use of modern technologies and other measures that will make it more difficult for counterfeit drugs to get mixed up with, or deliberately substituted for, safe and effective medicines.

For more information on this topic, visit FDA’s Web page on Counterfeit Medicine.

How to Protect Yourself

Reference:Reference: The Possible Dangers of Buying Medicines over the Internet: Are we aware? FDA.gov. Accessed on 15 Jun 2011.Available at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048396.htm.

Check with your state board of pharmacy or the National Association of Boards of Pharmacy to see if an online pharmacy has a valid pharmacy license and meets

state quality standards.Make sure that the website will not sell your personal information, unless you

agree.

Look for privacy and security policies that

are easy to find and easy to understand.

Don’t give any personal information—such as a social security number, credit card information,

or medical or health history—unless you are

sure the website will keep your information safe and

private.

Don’t buy from websites that sell prescription drugs without a

prescription.

Only buy from state-licensed pharmacy websites.

Use legitimate websites that have a licensed pharmacist

to answer your question.

For more information please visit on FDA’s Consumer Updates page, this features the latest on all FDA-regulated products.

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