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IPSF NEWSLETTERAn-Counterfeit Drug Campaign

Internat ional Pharmaceut ical Students Federat ion

Issue N91

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IPSF

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Internat ional Pharmaceut ica l Students Federat ion

Anti-Counterfeit Drug Campaign

IssueN9

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ChrisneCoo

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An-Counterfeit

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Coordinator2010-11

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ipsf.org

IPSF Public Health EdionAn-Counterfeit Drug Campaign Newsleer

Summary

2Ghana:FighngCounterfeitDrugs in the Country

4Qatar to issue lawagainst counterfeitdrugs

5Bouderbala: 60%of imports arecounterfeit

5Manufacturersasked to reducedrug prices to ght

counterfeits

6The Possible Dangers

of Buying Medicinesover the Internet:

Are we aware?

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IPSFNEWSLETTER

Coordinators Leer:

Hello IPSFers!

Welcome back to the world of combang counterfeit drugs.In this newsleer, we have news arcles on steps Ghana andQatar are taking towards eliminang counterfeit drugs in theirrespecve countries, along with a call for pharmaceucalcompanies to lower prices on real drugs. We also have a shortreport on how prevalent counterfeit medicines are in Algiers(wow!), and we close up the newsleer with informaon abouthow to buy medicaons over the internet, which includespossible signs of counterfeit medicaons being sold.

This last arcle is an excellent one to read and share theinformaon with your paents if they menon looking onlineto buy cheaper medicaons, so if you only have a minute tospare for reading, that is the one I denitely recommend toread. However, I have found all this news interesng, so I hopeyou do too.

This is the last newsleer of the year for our current ACDCteam, and I would like to say a special thanks to my team forall their hard work: thank you so very much for all your support

and eorts over this past year!

We will be having an ACDC workshop this year at the 57 th WorldCongress in Hat Yai, Thailand, so be sure to stop by to learnmore about how you can combat counterfeit medicaons andkeep your paents safe. See you there!

Sincerely,

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Ghana: FighngCounterfeitDrugs in the Country

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IPSFNEWSLETTER

The doctor prescribes an unnamed medicaon tomanage your pain. It comes in awless packaging...almost. In this true account as relayed bymulnaonal Pzer, the color has been clinchedwith oor polish and lead-containing paint whilebrick dust has been improvised as an adhesive. Totop it, boric acid, known for its deleterious eectson the kidney is a constuent!

Welcome to the world of counterfeit drugs, themost protable industry in the world of organizedcrime. As it turns out, with limited technologicaland human resource capacity, porous bordersand sub opmal mul country collaboraon

between security agencies, regulatory bodies andprofessional unions, West Africa is hardly in poleposion in the ght against counterfeit drugs. Itis perhaps to remedy this that nine West Africancountries and other key stakeholders gathered inDakar in the rst quarter of 2011 under the aegisof internaonal pharmaceucal Pzer, to as it were,create synergy of eort.

Since 2004, Pzer alone has discovered 65 millioncounterfeited drugs in addion to the discovery of

acve pharmaceucal ingredients to manufactureanother 68 million drugs. In addion, Viagra is byfar the most frequently counterfeited drug. Anmalarials have not been spared with dire implicaonsfor Africa where according to the World Malariareport 2010, 78% of cases worldwide and 91% ofdeaths worldwide from malaria were in Africa.Also, a study done in 2008 in six African countriesincluding Ghana revealed 35% of an malarials tobe sub standard. Nigerias (full name) NAFDAC for

example states unequivocally that anmalarials andanbiocs are the most frequently counterfeiteddrugs and have formed the focus of their eortswhile deploying cung edge technology liketruscan.

The Ghana team that assembled included ocialsfrom the Criminal Invesgaons Division, CustomsDivision, Food and Drugs Board and professionalbodies including the Ghana Medical Associaon andthe Pharmaceucal Society of Ghana.

New dimensions in counterfeit trade

The counterfeing world seems to have assumednew dimensions both in West Africa and elsewhere;clients purchasing drugs using the internet, linkageswith the narcoc trade and money laundering.Perhaps in equal measure, those ghng thismenace have responded through the deploymentof new technologies like the truscan and mobiletelephony services. Of course, and there was thenot so small maer delivered though a lively debateof some manufacturers themselves introducingsub standard drugs unto the market aer securingapproval to produce drugs of the highest quality. Ofcourse this was hotly contested!

With some countries cing a weak legal regime,

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IPSFNEWSLETTER

Ghanas challenge seemed to be more a quesonof enforcement and the applicaon of deterrent

sancons following convicons in court. The Foodand Drug Boards Thomas Amedzro lamentedindividuals caught red handed dealing in counterfeitsand yet hardly being slapped with the maximum500 penalty units or the 600 GH . In one instance,aer working extra hard to secure convicons, theconvict was jailed for one week and then releasedwhich was a big demovator to the an counterfeitght not to menon sending all the wrong signals topatrons of the thriving illegal trade.

Weak research capacity

Another challenge that became apparent in theGhanaian context and indeed in the presentaons ofmany others is the research capacity or lack thereofsome of these agencies ghng counterfeits. Thereappears to be very lile or no data to inform policymakers and managers as to whether the ght isbeing won or lost and what impact if any currentintervenons are making in ensuring that peopleindeed are increasingly having access to safe andecacious medicaon. In fact in some stascsquoted by the Pharmaceucal Security Internaonal,the paucity of informaon from Africa on reportedseizures and hence the unreliability of data fordecision making and strategic planning couldntbe clearer. In Ghana for example, it is crucial forrelevant agencies to begin to collect data and wheredata is available, to begin to analyze same to enable

quesons like the prevalence of counterfeit levels inour country to be determined plus the percentagesof the most commonly counterfeited drugs etc

Again, in Nigeria and Ghana especially, there mightbe the need to reorient the mandate of someof our Customs agencies. When governmentsstrongly posions the Customs Division of CEPSas a revenue agency with dened revenue targetswhile downplaying its regulatory role, it reinforces the weakened capacity of an otherwise strong an-

counterfeit ally through an unintended weakening

of their regulatory role. It is me to begin to paymore aenon to building the regulatory role

capacity.

Public educaon

It is noteworthy that Ghanas Food and DrugsBoard following its recent proacveness in thearea of enforcement has decided to embark ona massive public educaon exercise. This shouldbe comprehensive, focusing not just on the ways

of combang counterfeits medicaons but on theharmful eects of the drugs on the man on the streetwho must be aided with basic street wise tools indetecng features of counterfeit medicaon. Inaddion, beer collaboraon ought to be builtamong all stakeholders including key ones likedoctors, pharmacists who remain key in procuringmedicaons for health instuons and dispensingsame to clients etc. The public must know thatevery counterfeit detected is one life saved. Theymust know how a woman ordered a drug onlineand died the next day with een mes the normalaluminum levels being detected in her liver.

SMS technology

Use of text messaging services and portable deviceslike the truscan which require lile/no technicalexperse can ensure massive ulizaon at theports, among providers, pharmaceucal companies

etc in addion to the usual impromptu checks ofundetermined eecveness. Nigeria for examplereports the existence and their use of a programthat enables a text message to be sent to a codewith a prompt reply conrming the genuineness orotherwise of a parcular product.

Given intelligence indicaons of an observed shi ofsome barons from narcocs trade into counterfeitmanufacturing, spurred by enviable prot marginsand reduced security vigilance, now is a good me

to join up our eorts at all levels.

Reference:

Sodzi-Teey S. Ghana: Fighng counterfeit drugs in the country. The Chronicle. 13 Jun 11. Accessed on 15 Jun 2011.

Available at hp://allafrica.com/stories/201106150102.html.

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Qatar to issuelaw against counterfeit drugs

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IPSFNEWSLETTER

Manama: Qatars Supreme Council of HealthsPharmacy and Drug Control Department (PDCD) hasissued a new dra law to combat and criminalisethe sale of counterfeit drugs in the country.

Dr. Aisha Ebrahim Al Ansari, PDCD director, claimedonce passed into law, it will be the rst in Qatar andin the Middle East, Qatari daily Gulf Times said onTuesday.

The dra law is currently being reviewed and willlater be adopted and submied to higher authoriesfor approval.

The counterfeit medicines problem is an issueall over the world related to the manufacturers

complex distribuon networks, she said.According to the ocial, determining the size andextent of the problem of counterfeit medicinescould be dicult for several reasons.

The risks of taking counterfeit medicines are thatthey may not contain complete acve ingredientsbeing used by pharmaceucal companies orthey may contain a lot of these acve ingredients

or wrong ones. It is also unhealthy and oenmanufactured in sites other than the licensed andregistered, and is manufactured using equipmentbelow health standards. All these constute a clearthreat to life, she said.

The ght against counterfeit drugs required theco-operaon of all pares concerned includingthe supervisory authories of health andpharmaceucal companies, legal authories, rightsgroups, consumer and legislave bodies, withincreased awareness in the media and the dierentways on the threat posed by counterfeit medicineson paents health and their safety, she said.

Al Ansari called on internaonal drug companies toreduce prices globally and stressed that it was thebest policy to combat counterfeing of medicines.

It is important for drug manufacturers to provideoriginal medicines at aordable prices so thatpaents will not go for counterfeit medicines beingsold 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 hp://gulfnews.com/news/gulf/qatar/qatar-to-issue-law-against-counterfeit-drugs-1.821470.

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Bouderbala:60% of imports are counterfeit

Manufacturers asked to reducedrug prices to ght counterfeits

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IPSFNEWSLETTER

Reference:

Reference: Bouderbala: 60% of imports are counterfeit [in Algiers]. Ennahar Online. 14 Jun 2011. Accessed on 15 Jun 2011.

Available at hp://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 ghtening oflegislaon, has suggested a gure two to threemillion counterfeit products seized annually.

Almost all cosmecs imported are counterfeit asall mobile devices that are not approved by theARPT (Regulatory Authority of the phone market),he told the APS.

He also cited the car parts, responsible for many roadaccidents regularly denounced by the authories,appliances and kitchen appliances that cause home

accidents, cigarees but also drugs, somemes fatalif not real.

Control services lack of modern means of experseand have only 280 customs ocers trained oncertain brandsto interceptc o u n t e r f e i titems, he said.

Representavesof foreign brandssold in Algeriawork with theinspecon tothe training ofcustoms ocers.

C o u n t e r f e i tproducts originate, in general, from China, UAE andSouth Korea.

GlaxoSmithKline has asked pharmaceucals toreduce prices of essenal drugs so as to be accessibleand reduce counterfeits.

Addressing journalists in Kampala yesterday, MrPatrick Adele, the commercial director GSK, EastAfrica said doctors, health insurance companiesand pharmacists should ght counterfeits throughmaking drugs more accessible.

He said: As GlaxoSmithKline we are looking at

reducing the prices of our essenal drugs by 50 percent to improve paent access to medicines.

According to GSK East Africa managing director, MrJohn Musunga, the company is shiing focus froma highly margin, low volume drive to a lower highvolume business model.

The high prices of medicine have been a key barrierto business growth, and they are also a factorcausing proliferaon of counterfeit medicines.

Some of the essenal drugs that have had pricereducons include Amoxil syrups, Bactroban

ointment, Ventolin inhalers, Ventolin syrup and de-wormers.

Reference:

Lyatuu J. Manufacturers asked to reduce drug prices to ght counterfeits. Daily Monitor. 16 June 2011.

Accessed on 15 June 2011. Available at hp://www.monitor.co.ug/Business/Commodies/-/688610/1181716/-/ch242r/-/.

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The Possible Dangers of Buying Medicines over the Internet:

Are we aware?

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IPSFNEWSLETTER

A counterfeit medicaon or a counterfeit drug isa medicaon or pharmaceucal product which isproduced and sold with the intent to decepvelyrepresent its origin, authencity or eecveness.

A counterfeit drug may contain inappropriatequanes of acve ingredients, or none, maybe improperly processed within the body (e.g.,absorpon by the body), may contain ingredientsthat are not on the label (which may or may notbe harmful), or may be supplied with inaccurateor fake packaging and labeling. Medicines whichare deliberately mislabeled in order to deceiveconsumersincluding mislabeled but otherwisegenuine generic drugsare counterfeit. Counterfeitdrugs are related to Pharma Fraud.

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

The Food and Drug Administraon (FDA) wantsto warn consumers about the possible dangers ofbuying medicines over the Internet. Some websitessell prescripon and over-the-counter drugs thatmay not be safe to use and could put peoples healthat risk.

So how can you protect yourself? FDA says that

consumers should know how to recognize a legalInternet pharmacy and how to buy medicines onlinesafely.

Dont Be Deceived

Buying prescripon and over-the-counter drugs onthe Internet from a company you dont know meansyou may not know exactly what youre geng.

There are many websites that operate legally andoer convenience, privacy, and safeguards forpurchasing medicines. But there are also many

rogue websites that oer to sell potenallydangerous drugs that have not been checked forsafety or eecveness. Though a rogue site maylook professional and legimate, it could actually be

an illegal operaon.These rogue sites oen sell unapproved drugs,drugs that contain the wrong acve ingredient,drugs that may contain too much or too lile of theacve ingredient, or drugs that contain dangerousingredients.

For example, FDA purchased and analyzed severalproducts that were represented online as Tamiu(oseltamivir). One of the orders, which arrived

in an unmarked envelope with a postmark fromIndia, consisted of unlabeled, white tablets. Whenanalyzed by FDA, the tablets were found to containtalc and acetaminophen, but none of the acveingredient oseltamivir.

FDA also became aware of a number of peoplewho placed orders over the Internet for one of thefollowing products:

Ambien (zolpidem tartrate)

Xanax (alprazolam)

Lexapro (escitalopram oxalate)

Avan (lorazepam)

Instead of receiving the drug they ordered, severalcustomers received products containing what wasidened as foreign versions of Haldol (haloperidol),a powerful an-psychoc drug. As a result, thesecustomers needed emergency medical treatment

for symptoms such as diculty in breathing, musclespasms, and muscle snessall problems that canoccur with haloperidol.

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IPSFNEWSLETTEROther websites sell counterfeit drugs that may look

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

Signs of a trustworthy website

Its located in your country.

Its licensed by the state board of pharmacywhere the website is operang. A list of these

boards is available at the website of the NaonalAssociaon of Boards of Pharmacy.

It has a licensed pharmacist available toanswer your quesons.

It requires a prescripon for prescriponmedicines from your doctor or another health careprofessional who is licensed to prescribe medicines.

It provides contact informaon and allowsyou to talk to a person if you have problems orquesons.

Another way to check on a website is to lookfor the Naonal Associaon of Boards of Pharmacys(NABP) Veried Internet Pharmacy Pracce SitesSeal, also known as the VIPPS Seal.

This seal means that the Internet pharmacy issafe to use because it has met state licensurerequirements, as well as other NABP criteria. Visitthe VIPPS website to nd legimate pharmaciesthat 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 anotherdangerous product for your illness.

It doesnt provide a way to contact thewebsite by phone.

It oers prices that are dramacally lowerthan the compeon.

It may oer to sell prescripon drugs without

a prescriponthis is against the law! It may not protect your personal informaon.

Know Your Medicines

Before you get any new medicine for the rst me,talk to a health care professional such as your doctoror pharmacist about any special steps you need totake to ll your prescripon.

Any me you get a prescripon relled

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

check to see if it smells and tastes the samewhen you use it

alert your pharmacist or whoever is providingtreatment to anything that is dierent

Be aware that some drugs sold online

are too old, too strong, or too weak

arent FDA-approved

arent made using safe standards

arent safe to use with other medicines orproducts

arent labeled, stored, or shipped correctly

may be counterfeit

Counterfeit Drugs

Counterfeit drugs are fake or copycat products thatcan be dicult to idenfy.

The deliberate and fraudulent pracce ofcounterfeing can apply to both brand name andgeneric products, where the identy of the sourceis oen mislabeled in a way that suggests it is theauthenc approved product.

Counterfeit drugs may

be contaminated

not help the condion or disease themedicine is intended to treat

lead to dangerous side eects

contain the wrong acve ingredient

be made with the wrong amounts ofingredients

contain no acve ingredients at all or containtoo much of an acve ingredient

be packaged in phony packaging that looks

legimateFor example, counterfeit versions of the FDA-approved weight loss drug Xenical, which containsthe acve ingredient orlistat, recently were obtainedby three consumers from two dierent websites.

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IPSFNEWSLETTERLaboratory analysis showed that the capsules that

the consumers received contained the wrong acveingredient, sibutramine.

Sibutramine is the acve ingredient of a dierentmedicine called Meridia, a prescripon drug alsoapproved by FDA to help obese people lose weight

and maintain weight loss. In addion, sibutramineis classied as a controlled substance by the DrugEnforcement Administraon because of its potenalfor abuse and misuse.

Using medicine that contains an acve ingredientthat wasnt prescribed by your licensed health careprovider may be harmful.

FDA connues to proacvely protect consumersfrom counterfeit drugs. The agency is working withdrug manufacturers, wholesalers, and retailers toidenfy and prevent counterfeit drugs. FDA alsois exploring the use of modern technologies andother measures that will make it more dicult

for counterfeit drugs to get mixed up with, ordeliberately substuted for, safe and eecvemedicines.

For more informaon on this topic, visit FDAs Webpage 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 hp://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048396.htm.

For more informaon please visit on FDAs Consumer Updatespage, this features the latest on all FDA-regulated products.

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Internaonal Pharmaceucal Students Federaon

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