Anti-Counterfeit Drugs Campaign (ACDC) toolkit

Background It is very difficult to tell the differences between real and counterfeit medicines. Patients, doctors and other medical staff often assume medicines are what the label says they are and do not even suspect that there may be anything wrong. Not only it is hard to detect counterfeit products in most cases, but there is also a lack of public awareness about counterfeit medicines and their potentially serious adverse effects. As a consequence, medicines that do not work or cause unusual side-effects are rarely reported, since symptoms (including deaths) are usually attributed to the disease. Pharmacy students’ awareness about counterfeit drugs will definitely have an impact on population awareness on this issue. Therefore, IPSF encourages students to run and participate in Public Health Campaigns (PHC) about counterfeit drugs.

Campaign Materials Providing a communication toolkit to raise awareness of counterfeit medicines among health professionals, with tools and strategies for detecting counterfeits and informing colleagues and patients. Suggestions include

o General information and using fact sheets on the subject for health professionals, patients and public health advocates about counterfeit medical products

o Example: Did you know that…An estimated 36 million Americans purchased at least one prescription drug online without a prescription in 2010.13 More than 60 percent of medicines purchased online are fake or substandard.8 (It is advised to use local factsheets about your own country.)

o Campaign postcards, fliers, posters and brochures: o Example:

A medicine checklist poster for waiting rooms in hospitals and pharmacies. It may include the important factors we should pay attention to about a medicine. You can name it “Check your medication, Fake or Original”.

It is also advised to mention such materials for your brochures and during your campaign:

o How to identify a counterfeit medicine: o Examining the packaging for condition, spelling mistakes or grammatical errors o Checking the manufacturing and expiration dates and ensuring any details on the outer

packaging match the dates shown on the inner packaging o Ensuring the medicine looks correct, is not discoloured, degraded or has an unusual

smell o Discussing with your pharmacist or doctor as soon as possible if you suspect it is not

working properly or you have suffered an adverse reaction o Checklist for medicines purchased online:

Is it exactly the medicine ordered? Is it the correct dosage? Is the packaging in good condition, clean, with a patient information leaflet and

in the language in which it was advertised? Does the medicine look, feel and smell as it should? Are security seals intact with no signs of tampering? Does any customs declaration or postal label declare the contents as medicines? Does the batch number and expiration date on the primary internal packaging

match the batch number and expiry date on the secondary (external) packaging?

Because it is so easy to create a website, there are currently thousands of these illegitimate sites. The National Association of Boards of Pharmacy has reviewed more than 10,000 of them with truly frightening results. Only 3 percent of the sites appear to be in compliance with pharmacy laws and practice standards. See more information at: PhRMA Counterfeit Drugs

o Identify trusted websites for purchasing medication: you should be cautious of the following list which contains the characteristics of poorly trusted websites:

o Spam email advertising medicines o Lack of authenticity, no verification logo or certificate o Spelling mistakes and poor grammar on the packaging o Websites that do not display a physical address or landline o Websites offering prescription only medicines without a prescription o Suspiciously low priced products

Tool for Visual Inspection of Medicines: A checklist for visual inspection of medicines in order to identify suspicious products for further examination. This tool is suggested for healthcare professionals. FIP Visual Inspection

Raising awareness about counterfeit drug reporting systems (Regionally and Globally)

o Example: In 2013, the World Health Organization (WHO) launched a global surveillance and monitoring system to encourage Member States to report Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) incidents in a structured and systematic format to help develop a more accurate and validated assessment of the scope, scale and harm caused by this issue.

Providing a list of Frequently Asked Questions (FAQs) about counterfeit medicines

o What are SSFFC medical products? SSFFC are substandard, spurious, falsely labelled, falsified and counterfeit medical products. Counterfeit drugs are illegal copies of an original product. This can include products without active ingredients, with incorrect quantities of active ingredients, wrong ingredients, correct quantities of active ingredients but with fake packaging or high levels of impurities and contaminants.

o Which drugs are more probable to be counterfeit? In developing countries, the most disturbing issue is the common availability of counterfeit vaccines and medicines for the treatment of life-threatening conditions such as malaria, tuberculosis, and HIV/AIDS.4 Any kind of product can be and has been counterfeited including expensive lifestyle and anti-cancer medicines, antibiotics, medicines for hypertension and cholesterol-lowering drugs, hormones, steroids, and inexpensive generic versions of simple pain killers and even antihistamines.

o How can I identify a counterfeit drug? The most important thing about counterfeit medicines is that they are hardly recognizable. That is why it is highly suggested to buy medicines only from trusted pharmacies, drug stores and websites. For websites it is advised to pay attention to a list of security checks and since more that 60% of medicines purchased online are considered counterfeit. It is safer to purchase your drugs from a pharmacy.

o Is there an organization to contact if I suspect a medicine is counterfeit? If you bought the medicine from a pharmacy or drugstore, please inform your pharmacist immediately. In emergency cases (reports of life-threatening symptoms and sides effects using a counterfeit medication) you can contact the World Health Organization (WHO). The WHO surveillance and monitoring system receives reports from trained focal points in the National Drug Regulatory Authorities and international procurement agencies who, if necessary, will forward your report to the WHO. In emergencies please contact: rapidalert@who.int

o It is also advised to add your country ministry of health address in your campaign brochures so

that people can easily report counterfeit drugs. o Check out Lilly's Anti-counterfeit Products for more FAQs o See what our partners at FIP - Counterfeit Medicines have to say regarding this important topic.

More facts on counterfeit drugs

o An estimated 700,000 deaths have been attributed to counterfeit drugs. o In 1995, during a meningitis epidemic in Niger, 2,500 people died after receiving a counterfeit

vaccine. o In 2008, 150 non-diabetic patients with severe hypoglycaemia were admitted to five public

hospitals in Singapore after taking counterfeit sexual enhancement drugs contaminated with glyburide, a medication used to treat type 2 diabetes. Seven patients remained comatose as a result of prolonged shortage of glucose in the brain, and four subsequently died.

o In 2010, a counterfeit version of Tamiflu was being sold online. This counterfeit drug was labelled as “generic” Tamiflu, but actually contained an ingredient that could cause life-threatening reactions to those allergic to penicillin.

o In 2011, contaminated IV fluid was suspected in the deaths of at least 12 pregnant women in India. The women fell critically ill after being given the fluid in the maternity ward; initial tests showed that the fluid was contaminated with bacteria and fungus.

o In 2012, The British Regulatory Agency discovered antimalarial agents with 14 times the quantity of active ingredient being used in Pakistan. These medicines are being blamed for the deaths of up to 112 patients.

o Counterfeit drugs are found everywhere in the world. India, the world’s largest manufacturer of generic drugs, may have as much as 12 percent to 25 percent of their supply contaminated with substandard and counterfeit medicines, and up to 40% of the drug supply in some African nations may contain counterfeits. An estimated 36 million Americans purchased at least one prescription drug online without a prescription in 2010.

o While many counterfeit drugs have been traced back to countries such as India or China, shutting down production there will not solve the counterfeit problem. It takes a concentrated effort of authorities and companies around the globe to reduce the number of counterfeit drugs reaching consumers.

o A website may be calling itself a “Canadian pharmacy” but it may actually obtain its medications from countries in Asia, South America, or Eastern Europe, where quality standards are generally considered more lax and counterfeit medications are widespread, permitting an opportunity for counterfeit medications to make their way into a prescription order.

o Additionally, prescription drugs imported from other countries are not FDA-approved and their safety and effectiveness cannot be ensured because they are outside the legal structure and regulatory resources provided by Congress.

o The opportunity to set up counterfeit operations appears greatest in those regions where regulatory and legal oversight is weakest.

o Sixty-two percent of medicines purchased online are fake or substandard. o The vast majority of online pharmacy websites do not require a valid prescription to sell a

medicine. Others issue an on-the-spot “prescription” after patients answer a simple questionnaire. This atmosphere provides the perfect haven for counterfeiters to sell illegitimate medicines.

o Counterfeiting is big business. Counterfeit drug sales generated an estimated $200 billion in illicit profits in 2011 alone.6 The counterfeit drug trade in Mexico is estimated to be valued at $650 million per year - equal to around 10 percent of total drug sales. Likewise, in Russia, it is estimated that counterfeits equal between five and 10 percent of the total market.

o In the United States, criminal penalties for counterfeiting prescription drugs are significantly lower than those for trafficking street drugs.

o In late January 2006, the United States Food and Drug Administration (FDA) issued an alert about

fraudulent flu remedies, including counterfeit oseltamivir (Tamiflu). o The Dutch Healthcare Inspectorate warned consumers in early 2006 not to buy Tamiflu through

the internet after counterfeit capsules were found in the Netherlands containing lactose, vitamin C, and no active substance. In the United Kingdom, officials seized 5000 packets of counterfeit Tamiflu in early 2006, estimated to be worth £500 000.

o A World Health Organization (WHO) survey of counterfeit medicine reports from 20 countries between January 1999 and October 2000 found that 60% of counterfeit medicine cases occurred in poor countries and 40% in industrialized countries.

o Peru’s Ministry of Health estimates that illegal sales of medicines account for 15-20% of the local market.

o A recent study in Lancet concluded that up to 40% of products labelled as containing artesunate (the most effective medicine to combat malaria) contain no active ingredients and therefore have no therapeutic benefits.

For more information, please visit the links below

o WHO GPHF Fact Sheet o WHO Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical product o PhRMA Counterfeit Drugs

Suggestions for workshops and events As counterfeit drugs is a specific issue related to pharmacists and pharmacy students, implementing special events and workshops to provide them with how to spot a counterfeit medicine can be beneficial and meanwhile recommended. Events can be wide lectures by university members about counterfeit drugs or small ones by students in order to raise awareness among pharmacy students about this growing concern.

Final point IPSF wishes you success in your ACDC campaign. Please let us know about your activities via detailed reports. Have in mind that public health messages won’t be effective and don’t lead to behavioural changes unless you include these four essential steps during the process:

Transfer an effective public health message

o Growing a global/national concern about the issue. Use factsheets to grow concern in your target population.

o Make the issue a personal concern. Tell your target that buying counterfeit medicine might happen to you. Also, be clever and use statistics.

o Give your target a solution for the issue. Tell him/her how he/she can distinguish counterfeit medicines from original ones.

o Ask your audience to take part in your activities. Give them a final task and ask them to tell their families and relatives about what they have learned from you about counterfeit medicines.

Thanks for your attention Shadi Izadi IPSF Medicine Awareness Coordinator 2015-2016