Anti Counterfeit Newsletter - Pharmacy Education

Olga Kruszyńska  Fifth Year Pharmacy Student at Medical University of Lodz, in Poland  Member of Educational Section and Editorial Board at Polish Pharmaceutical Students’ Association (PPSA) Counterfeit drugs – myth or reality? The current state of falsified medicine in Poland.

The phenomenon of counterfeit medicine entering the legal supply chain is steadily increasing. More and more medicinal products are now being falsified and it occurs in many countries worldwide.

Counterfeit drugs may contain no active ingredient, the wrong active ingredient or the wrong amount of the correct active ingredient. The use of these drugs poses therapeutic failure and can put patients’ lives at risk.

Is the location of Poland significant in illicit trade?

If we take Europe into account, the prevalence of falsified medicine is much higher in the eastern part of this continent. Poland is located in Central Europe and the World Health Organization (WHO) claims that it is classified as a country at high risk of counterfeit medicinal products because of its close proximity to former Soviet bloc countries.

They are known for their easy access to falsified drugs, resulting in expansion by illegal distribution channels into the Polish market and further to other European Union countries.

The scale of the phenomenon World Health Organization (WHO) present data that even every hundredth drug can be classified as a counterfeit drug in Poland and Polish consumers spend about 100 million zlotys per year on falsified medicines. It’s noteworthy that according to the statements of the Main Pharmaceutical Inspectorate, the phenomenon of medicine falsification in the legal supply chain does not exist in Poland. The problem is mainly related to the illicit supply chain and the most frequently falsified medication especially including potency drugs, contraceptives, psychotropic drugs and anabolic steroids. They are available practically everywhere but the particularly hazardous place to purchase them constitutes the Internet. Online stores which pretend to be legal pharmacies are on the agenda.

Are Polish healthcare workers and laypeople aware of this growing problem?

It’s worth paying attention to academic studies conducted in Poland that have been published. The studies present, that physicians and nurses working in hospitals in Poland are more aware of counterfeit medicines than laypeople and more often notice the presence of drugs from unknown sources. However, in spite of this, many healthcare professionals don’t know the procedure for reporting falsified drugs and don’t inform their patients of potential risk connected with counterfeit medicine intake. All this creates the need to promote knowledge about the threat of the presence of falsified drugs among patients. However, it is also necessary to provide procedures both in community pharmacies and healthcare institutions in case of suspicious medicine.

Strategies to combat or prevent drug counterfeiting The Main Pharmaceutical Inspectorate and other agencies responsible for drug policy realization have taken numerous measures to minimize the potential harm resulting from the presence of counterfeit drugs, such as educational campaigns and legislative initiatives. Part of them will be further explored below. The crucial information about the detrimental effect of falsified drugs are published on the Main Pharmaceutical Inspectorate’s website. They are presented in a graphic form (posters and leaflets), e.g. one of them contains a poisonous snake, a meaningful slogan: “Falsified Drugs Kill” and other key information. The warning about this phenomenon, definitions, examples of counterfeit drugs are also presented on the Ministry of Health’s website or the National Medicines Institute’s website. Due to increasing the counterfeit products trade, Minister of Health appointed Team for Falsification and Illegal Trade of Medicinal Products and Other Falsified Products Meeting the Criteria for Medicinal Products. Its tasks mainly include preventing the manufacture and distribution of counterfeit medicinal products, implementing activities related to dissemination of information about falsified drugs and organizing educational campaigns.

Furthermore, as regards legislative changes, from 2019, the Falsified Medicines Directive (FMD) has been implemented in the EU. Polish community and hospital pharmacies, wholesalers and all parts involved in drug distribution must comply with these regulations. The FMD introduced the duty to assign a Unique Identifier (UI) and Anti-Tampering Device (ATD) to each individual pack of a drug linked to the individual production data.

One of the aims of the directive is to create a European database system through which entities supplying medicines to patients will verify the authenticity of medical products before dispensing them.

What pharmacists can do?

Counterfeiting of medicinal products poses a significant challenge to public health. The harmonization of rules and procedures is one of the most important steps to minimize the risks associated with falsified medicine. But it’s equally essential to educate healthcare professionals and also patients. Pharmacists can play a significant role in this issue.

They can not only inform patients about possible health hazards, but also warn them against purchasing medicine from unknown sources.

This will perhaps increase the awareness of drugs falsification among the general public, enhance patients’ safety and reduce costs of medical care.

Olga Kruszyńska

References Merks P, Swieczkowski D, Byliniak M, Drozd M, Krupa K, Jaguszewski M, Brindley DA, Naughton BD. The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists. Eur J Hosp Pharm. 2018; 25(1): 10–15. doi: 10.1136/ejhpharm-2016-000970 Binkowska-Bury M, Wolan M, Januszewicz P, Mazur A, Fijałek ZE. What Polish hospital healthcare workers and lay persons know about counterfeit medicine products? Cent Eur J Public Health. 2012;20(4):276-81.

Binkowska-Bury M, Januszewicz P, Wolan M, Sobolewski M, Krauze M, Fijałek ZE. Counterfeit medicines in Poland: opinions of primary healthcare physicians, nurses and lay persons. J Clin Nurs. 2013; 22(3–4): 559–568. doi: 10.1111/j.1365-2702.2012.04166.x. http://www.rynekzdrowia.pl/Farmacja/ Ziolka-z-internetu-zarazily-go-zoltaczka,9854,6.html https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products https://www.gov.pl/web/zdrowie/sfalszowane-produkty-lecznicze https://www.gov.pl/web/gif/informacje-ogolne https://iws.gov.pl/wp-content/uploads/2020/03/IWS_M%C5%82ynarek-M._Zjawiska-patologiczne-na-rynku farmaceutycznym.pdf?fbclid=IwAR1U1zIJyhm1YyWYZNKuag99fjZAvMy9hBh5Czcf82DKRsCjdU_RtQbdGUg https://www.nil.gov.pl/lekisfalszowane/ file:///C:/Users/Admin/Downloads/download-_file=File_Farmacja+Polska_2019_11_04_OG_Leki_sfalszowane_n.pdf.pdf https://scienceinpoland.pap.pl/en/news/news%2C28780%2Cexpert-counterfeit-drugs-kill-1-million-people-each-year.html

Qatar Pharmacy Undergraduate Society Fatima Nazar Pharmacy Student

Hiba Mohammed Pharmacy Student

For a period of consecutive 18 years, the pharmaceutical security institute (PSI) has collected a wealth of data regarding incidents that involved counterfeiting, illegal diversion and theft ("Incident Trends", 2021). Counterfeiting of drugs in this context is defined as the process of making a false replica of a medical product. These falsified drugs rob individuals of their finances in exchange of a medicine that may risk their lives (Agbozo, 2020). The latest report made by the PSI was made in 2019 in which 5,081 pharmaceutical crime incidents were reported and of these were 844 counterfeiting incidents that involved either police raids or customs seizures ("Incident Trends", 2021). The question of how Qatar may be affected by such an issue arises from the characteristics of the country itself. Qatar is a small country located in Western Asia and occupying the Arabian Peninsula and with a population of 2.6 million, 88% of which is accounted for by expats. Qatar’s geographical location leaves it vulnerable to incidents of counterfeiting as it neighbours countries such as the UAE whose open economy creates a pathway for counterfeit drugs (Alfadl, Ibrahim, Maraghi & Mohammad, 2018).

Therefore, the issue of counterfeiting in terms of the current states of affairs, the healthcare system’s and public’s awareness, actions taken by the government and case studies must be explored.

hat is the current state of counterfeit drugs and what are the current laws in Qatar?

There has been no officially published reports on the scale of counterfeit drugs distribution in the Qatari state. As mentioned previously, Qatar’s shared border with the UAE leaves it vulnerable since the UAE has an open economy depending mainly on trade, which in turn opens a pathway to counterfeits entry. This notion is supported by the literature as it is estimated that the value of the counterfeit drugs market is $1.02 billion a year in the UAE. Moreover, over 245,000 fake items had been confiscated and destroyed by raids conducted by Dubai’s Department of Economic Development.

Additionally, Qatar’s second most significant neighbouring country, Saudi Arabia had stated that items confiscated at ports in 2014 were valued at $50 million and the number of these products surpassed 62 million items (Alfadl, Ibrahim, Maraghi & Mohammad, 2018). Qatar’s geographical location hence drives one to the logical conclusion that the problem of counterfeit drugs in the Qatari market would be present despite the lack of statistics and reports.

Is there a law in Qatar that addresses counterfeit medications?

Unfortunately, the Qatari law and the Drug Control Department do not directly address the presence and control of counterfeit drugs. However, Law No. 2 of 1999 with respect to Combating Fraud in Commercial Transactions states that individuals and organizations involved in committing fraud with the intention of selling or trading an item that is an agricultural crop, natural material or industrial product (including drugs) must be sanctioned. Additionally, it is stated that the same sanctions must be applied to people who sell these items while having the knowledge of their fraudulence (Combating Fraud in Commercial Transactions, 1999). Therefore, it can be indirectly drawn that counterfeit medications and the trade of these products would lead to such consequences.

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Are the healthcare system & public aware?

A cross-sectional study conducted in 2018 explored the awareness of the public and healthcare professionals, specifically community pharmacists, on counterfeit medications. The investigators of this study distributed a total of 109 questionnaires to community pharmacists and members of the public and obtained responses from a total of 167 the distributed questionnaires. Overall, there was no statistically significant difference between pharmacists and the public in terms of their perception of counterfeit drugs. When the questionnaireâ&#x20AC;&#x2122;s component questions were analyzed individually there was a statistically significant difference between pharmacists and members of the public, defined a p-value of <0.05, in terms of awareness towards counterfeit medicines, its societal consequences, the effect of price affordability and the effect of pressure exerted by relatives and friends on purchase intent of counterfeit medicines (Alfadl, Ibrahim, Maraghi & Mohammad, 2018). In other words, community pharmacists were more aware of the issues surrounding counterfeit drugs. A significant difference was that the public was also more likely to be influenced by family and friends than pharmacists were to purchase non-registered medicines.

Moreover, the study assessed the level of vulnerability of the study subjects using the questionnaireâ&#x20AC;&#x2122;s results and while there was no statistically significant difference between pharmacists and the lay individuals (p-value= 0.833), both groups were considered to be of moderate vulnerability to counterfeit medications. The study concluded that both pharmacists and the public had a low level of knowledge on counterfeit medications and that they were moderately vulnerable to these low-quality medications (Alfadl, Ibrahim, Maraghi & Mohammad, 2018).

How can the issue of counterfeit drugs be handled?

Many different kinds of technologies are utilized today to tackle the issue of counterfeit drugs. Some of these technologies used in Qatar: (Agaj, 2017) 1)

Radio Frequency Identification ( RFID)

Radio Frequency Identification ( RFID) is a cutting edge technology that allows the manufacturers and distributors to precisely track the drug products through the supply chain. Thereby, it creates an electronic record of the chain of custody from the point of manufacture to the point of dispensing. The technology thus, has made it easier for the authorities to ensure that the drugs are authentic.

How does RFID work? An individual drug package is equipped with a RFID tag which contains information about the drugâ&#x20AC;&#x2122;s point of manufacture. This information is hard to manipulate and proves the authenticity of the drugs. In practice, authorized drug ingredient manufacturers tag all their ingredients with RFID tags before distribution to the pharmaceutical companies 2)

Micro tagging

Micro tagging is another innovative technology, which has been developed with the purpose of identifying the characteristics of individual pills or tablets. In essence, microtags serve as non-visible edible bar-codes and can be utilized by the pharmaceutical companies to track their drug product on a batch basis.

How do micro tags work? The micro tag is made up of porous silicon dioxide particles, which have been electrochemically etched. The microtags contain a unique porous structure as a consequence of these particles, and the porous structure in turn creates a unique ID of the drug.

3) Nanoscale Encryption: Nanoscale encryption is another technology that has, in recent years, caught the eye of the pharmaceutical industry.

How does Nanoscale Encryption work? The encryption details are proprietary, but in essence an individual pill can be embossed with specific encrypted information or codes at the nanoscale. This can include a variety of encrypted information, for example information regarding the point of manufacturing, the delivery destination, the dosage and expiration date and other such information which would be utilized to identify and authenticate the medicines.

Are there any reported cases of Counterfeit Drugs in Qatar?

It was found according to a study published by the American Journal of Tropical Medicine and Hygiene, that 127 countries out of 196 total, had no reported cases of counterfeit drugs and Qatar was one of these countries (Mackey, T. K., Liang, B. A., York, P., & Kubic, T., 2015).

Additionally, there have been no reports of any fatalities from counterfeit drugs made in the Qatari media or from governmental institutions. In other words, one might expect that these reports and documents may be government classified.

References: Agaj, I. (2017). The Fight Against Counterfeit Pharmaceuticals: Innovative Technologies to the Rescue?.

Retrieved 21 January 2021, from https://www.tamimi.com/law-update-articles/the-fight-against-counterfeitpharmaceuticals-innovative-technologies-to-the-rescue/ Agbozo, P. (2020). Measures to tackle trafficking in falsified medical products. The Hague International Model United Nations Qatar. Retrieved from https://qatar.thimun.org/wp-content/uploads/2019/11/CCPCJ-Falsified-Medical-ProductsPrincess.pdf Alfadl, A., Ibrahim, M., Maraghi, F., & Mohammad, K. (2018). General Public and Community Pharmacists Perception on Counterfeit Medicines: A Preliminary Cross-sectional Study in Qatar. JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH. doi: 10.7860/jcdr/2018/28451.11136 Al-meezan. Combating Fraud in Commercial Transactions (1999). Doha, Qatar.

Incident Trends. (2021). Retrieved 21 January 2021, from https://www.psi-inc.org/incident-trends

Mackey, T. K., Liang, B. A., York, P., & Kubic, T. (2015). Counterfeit drug penetration into global legitimate medicine supply chains: a global assessment. The American journal of tropical medicine and hygiene, 92(6 Suppl), 59â&#x20AC;&#x201C;67. https://doi.org/10.4269/ajtmh.14-0389

Lebanese Pharmacy Students’ Association

Joulana Jaloul Pharmacy Education Chairperson

Nour Rehayem Pharmacy Student

Global Newsletter: Counterfeit Drugs in Lebanon What are counterfeit drugs?

- According to the FDA, counterfeit medicine is fake medicine which might turn out to be harmful for one’s health. CFM are usually illegal drugs that are sold at a generally lower price. The package might seem very similar to the original one but the composition of counterfeits is very different as it has no active ingredients but potentially harmful substances. It’s important for people to be aware of the possible signs of counterfeit drugs which include the following: o A package that looks different than the one they normally get o Patients experiencing new or unusual adverse effects upon administration o Unknown selling sources (internet sources and the like) o 3D hologram on the box

What is the current state of counterfeit drugs in Lebanon and are healthcare providers and the general public aware of this particular problem?

- The issue of counterfeit medications started in November 2012 when the involvement of several known persons were revealed, among whom was Minister M.F.â&#x20AC;&#x2122;s brother, A.L.F., who turned himself on Friday to the authorities at the Baabda Judicial palace.

- Though it began in November, this issue is not new since Lebanon has borne witness to a series of counterfeit drug-related scandals: -In 1998, Deputy I.S. revealed the entry of a large amount of counterfeit drugs to Lebanon and the file was closed when unknown assailants broke into the judicial palace and stole the file.

-In 2004, another scandal was revealed when medical products were withdrawn from the Lebanese markets and a resolution was ratified calling for suspending the use of these products since they are smuggled and lacking genuineness. As for the accused persons, their whereabouts remained unknown.

-Accordingly, in 2010 counterfeit and expired drugs were found in 7 pharmacies and 4 drug warehouses that were all closed upon an official decision. However, these institutions were reopened under a political cover.

- According to the Lebanese newspaper, Al-Akhbar, sources say “Merchants [who smuggled the medicine] did not use refrigerated transportation. They used metal containers where the internal temperature could reach 60C,” such high temperatures could affect delicate products such as pills or liquid medication. Former Lebanese Minister of Health Dr M.K. told Al Arabiya News: “Smuggling counterfeit drugs are part of organized crime - the drugs are smuggled through illegal border entries. Their origins cannot be traced easily, and to be marketed in certain areas where the control is poor (Palestinian refugee camps etc.),” he also added that: “There are large networks of smugglers that work together at many levels in order to secure the success of their crimes… Some have gone to extreme lengths to ensure that their counterfeit drugs have the same serial numbers as the original manufacturer’s (the numbers are acquired by unknown methods) in order to avoid getting caught.

-In 2012, the counterfeit medicine issue was brought to light once again when forged documents related to medicine importations were exposed.

- According to a study conducted in 2017, by the School of Pharmacy and Biomolecular Sciences at the University of Brighton in the UK, the majority of the respondents (pharmacists) to the survey thought that pharmacists who sell CFM are both unprofessional and unethical. They further elaborated by stating that those same pharmacists carry such drugs in their pharmacies because they are considered a source of easy money and result in big profits and not because they are of acceptable quality. According to this same study, very few respondents thought that pharmacists that dispense CFM are actually clever and considered good business men/women

- According to this same study, there is no declared CFM definition in Lebanon which is why an agreement by the responsible authorities on a definition is crucial in identifying and labelling counterfeits.

- The knowledge Lebanese pharmacists had about counterfeits differed depending on their region of practice. Pharmacists in the Beqaa region for example, reported little or no knowledge, possibly due to lack of CFM awareness in this specific region.

- Another source clearly stated that counterfeit products are available throughout Lebanon but in certain regions to a higher extent such as the Beqaa Valley, Tripoli, Akkar, South Lebanon and the suburbs of Beirut.

- Also, the syndicate of hospitals introduced CFM, their risks and how to act upon such encounters in their specialized magazine in 2013 - Another campaign was launched in 2008 to counter fake drugs.

Brochures were distributed all over Beirut. The same organizers later worked with the local press and organized public symposiums to spread further awareness about some of the most common CFM including Viagra, Panadol, Xanax and many more.

- Another study was carried out by several professionals about the public and pharmacist perceptions about counterfeits in Lebanon in 2018. According to the respondents, the situation in Lebanon is serious and requires additional attention from both the Ministry of Public Health and the Order of Pharmacists.

- In 2013, the Ministry of Health launched the first Mobile Application to assist consumers in reporting suspicious cases of counterfeit (MOPH).

What actions are to be taken by the government and the responsible authorities to limit this issue?

- There is a need to establish strict control on medicine - Implement and enforce laws - Reactivate central or national laboratory which can test the quality and the safety of the both the imported and locally manufactured drugs.

- Create a counterfeit medicine reporting system - Develop continuous educational programs to raise awareness and reach bigger audiences. Itâ&#x20AC;&#x2122;s very important to spread awareness among consumers regarding counterfeit drugs. This can be done by setting awareness campaigns, physicians/pharmacists informing their patients, and the Ministry of Health playing an active role in enlightening the public about counterfeit drugs.

- Adopt of code of ethics for Pharmacists. The OPL should establish a code of ethics for pharmacists in which the roles and responsibilities of the pharmacists are clearly highlighted.

- Introduce whistleblowing. This concept is not part of the Lebanese culture but if implemented, it would give pharmacists the right to act against other pharmacists dispensing or dealing with CFM. - And educate the public on what to do if they encountered a counterfeit drug: inform the pharmacist and most preferably directly contact the Department of Inspection by Phone: 01-615749 or E-mail: inspection@moph.gov.lb

• Darya Salih Hussein • KPSA Pharmacy Education Chairperson • Fourth Year Pharmacy Student • University of Duhok in Kurdistan Region – College of Pharmacy Counterfeit Drugs In Kurdistan Region-Iraq

List of contents Tittle No. 1 2 2.1 2.2 2.3 3

Tittle Overview Discussion People Dissatisfaction Actions Against Those Drugs The Cases Are Taking Counterfeit Drugs Conclusion Main Sources

List of abbreviations

Abbreviation KRG

Full Word Kurdistan Regional Government

1.

Overview:

A counterfeit drug is pharmaceutical item which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. Not only take income from consumers, by having them pay for products that have little or no medical value, but they can also lead to unresolved health problems, and even death. Smugglers run these counterfeit drugs over the border and sell them in the country, who then, unfortunately, fails to assess if the drug is suitable. Those drugs play role in decreasing medicine access to patients because patients are aware of quality of medicines.

2.

Discussion:

A counterfeit drug is a global health risk, the practice of drug counterfeiting is unlikely to ever completely disappear. Globally, there were 1,510 total reports of Counterfeit Incidents from 1,799 different counterfeit medicine detections. Also in Kurdistan Region a large number of counterfeit medicines are seized and those people are arrested for alleged sales of the products. Drugs that claimed to treat cancer were being manufactured at a farm. The official explained that counterfeit medicines had been smuggled from different countries.

2.1 People Dissatisfaction Kurdistan Region citizens have recently been vocal about concerns over the lack of quality control and inflated medicine prices. People have welcomed the governmentâ&#x20AC;&#x2122;s new initiative to regulate the medicine market, purging it of smuggled or low-quality medication.

.2 Actions Against Those Drugs

2

In October 2018, the Kurdistan Regional Government (KRG) enforced new regulations on the regionâ&#x20AC;&#x2122;s pharmaceutical industry after sales of counterfeit drugs. The KRG established the drug control commission recently as the need for a body to supervise the import of food and medicine grew. It is told that one of the KRG cabinetâ&#x20AC;&#x2122;s agendas was to form a body that would oversee the import of said goods, as well as ensure quality and fair prices. Those smugglers are arrested who related to the case, noting that investigations are continuing to find out the source and distributors of those drugs. If there is a general law for importing counterfeit medicines or selling smuggled medication, they will be dealt with in accordance with the government laws.

2.3 The Cases Are Taking Counterfeit Drugs A film maker has produced a documentary highlighting the dangers of counterfeit medicine in the Middle East. In this case, counterfeit Avastin medicine blinded patients in 2013, and a number of the victims had their eyes taken out. Many of the victims remain terrified of receiving healthcare in the future. This is their story. A 57 years old woman with an infected eye taken out, she explains the traumatic experience: It was too painful and half of my head was aching with it, I felt like my nose, mouth, and teeth were falling off because of the pain. I once told them to cut off from my shoulder because it was too painful, at some nights I took painkillers three times but they were useless. I asked what the injection was? Was it poison? Cancer? What is it for? Another 60 years old man has also taken that injection too and he said: I lost my sight completely after about 24 hours and I could not see anything at all. I lost my appetite, my sleep, my rest, and peace.

It is admitted that the government was unable to test the medicine fully.

3.

Conclusion The practice of drug counterfeiting is unlikely to ever completely

disappear, it may be controlled if governments and all relevant parties combine forces to identify and disrupt the counterfeit chain. In considering measures against counterfeit drugs: The establishment of an adequate national drug regulatory system - an essential starting point.

The

system

should

include

licensing/authorization

of

pharmaceutical products. It should also cover licensing/authorization of manufacturing, importation and distribution practices and premises and adequate inspection arrangements.

Main Sources o Kurdistan 24.net o UKfilmreview.co.uk

Jordan Pharmaceutical Students’ Association • Rasha Alzyoud

• Jana Abu Toudeh

• 4th year pharmacy student

• 3rd year pharmacy student

• JPSA Professinal Development Local Coordinator Counterfeit drugs

WHO defines counterfeit drugs as being a product that is deliberately and fraudulently mislabelled with respect to source and/or identity.

They are manufactured using incorrect or harmful ingredients. These medicines are then packaged and labelled to look like the real thing.

Counterfeit medicines are unsafe because they may not work and could harm you.

Counterfeiting can apply to both generic and branded products.

Counterfeit drugs cause a serious problem that should not be taken lightly since it’s considered pharma fraud.

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It is not only illegal, but it is also a major public health concern. these drugs often contain the correct ingredients in incorrect quantities; however, they may also contain either a wrong API—which may even be toxic—or no active substance at all.

Treatment with ineffective counterfeit drugs such as antibiotics can lead to the emergence of resistant organisms and may have a deleterious effect on a wide section of the population. In extreme cases, counterfeit drugs may even cause death.

A counterfeit medicine could have: no active ingredient substandard ingredients undeclared ingredients illegal or dangerous ingredients incorrect dosage (too much, too little or variation in dose across tablets) contaminants from unhygienic manufacture.

The FDA estimates that counterfeits make up more than 10% of the global market, Jordan like many other countries has this problem; however its size is below the world average and has a smuggling problem of counterfeit drugs; however no accurate statistics appear to be available.

A study was conducted in Jordan to evaluate the status of the counterfeit pharmaceuticals in Jordan: Four types of pharmaceuticals were evaluated: 1. Lipitor (Atorvastatin-calcium) 2. Concor (bisoprolol fumarate) 3. Co-Diovan (Valsartan, hydrochlorothiazide) 4. Plavix (clopidogrel)

Were subjected to physical and chemical analysis. 173 samples of these four medicines were collected from the three most populated cities in the country, namely Amman (the capital of Jordan), Zarqa and Irbid. A sample of confiscated counterfeited medicines was obtained from the health authorities and tested utilising the HPLC and dissolution testing, in order t validate the reliability of the testing procedures.

Results of both chemical and physical analyses revealed that all samples were found to fall within the specification limits of United States Pharmacopoeia (USP) and no evidence was found of any counterfeit drug products in the samples examined. Since this study found no indication of a drug counterfeiting problem in Jordan, the researcher has concluded that there seemed to be two contributing factors to this result: ď&#x201A;ˇ first, the very effective legislative campaigns conducted by the health authoritiesâ&#x20AC;&#x2122; in Jordan against counterfeit trade through new public health and pharmacy law which has been launched in 2008. ď&#x201A;ˇ Second, the rigorous tough enforcement measures conducted by health and law enforcement agencies in the country.

Another study was conducted to evaluate the awareness of healthcare and the general public about the problem of counterfeit drugs:

Results showed that around 76% reported high awareness of drug counterfeiting problem and the current laws and regulations in Jordan and 54.8% perceived the regulations are extensive enough.

The majority (63%) of the respondents did not come across any case of counterfeiting themselves, while 37% had come across counterfeit cases and 50% of them had come across several cases.

About half (51%) of the respondents thought that drug counterfeiting is not a serious problem while 48.4% thought it is a very serious problem.

In addition to that, 54.8% thought that it is difficult to invade the Jordanian market with counterfeit drugs while 35.5% think that Jordan could be invaded easily.

Placebo tablets that devoid of any effective contents for the treatment of five main life-threatening diseases– namely, cardiac, diabetes, cholesterol, hypertension and inflammations, are scattered inside three warehouses sealed with red wax in the first case involving the manufacture of unlicensed drugs in Jordan.

The three warehouses, located in the Eastern suburbs of Amman, were closed down on July 25, 2007, after security officers, FDA inspectors, and officers of the anti-corruption department at the General Intelligence Department, seized thousands of tablets of counterfeit medications similar to the foreign-made ones.

The FDA estimates the value of smuggled and counterfeit medicines that were seized in Jordan during the year 2007 was around 10 JOD million; equalling 2% of the volume of the general consumption of imported medications which stood at 191 JD million in the same year.

This phenomenon has increased to the point where the FDA has closed down 56 pharmacies for periods not exceeding one month in the year 2007, compared to 10 in 2006, and only one pharmacy in 2004, for selling smuggled and counterfeit drugs.

Most of the smuggled and counterfeit medicines can be found at pharmacies all over Jordan, with the knowledge of the responsible pharmacist or his assistant– since they are both responsible for purchasing their stocks.

FDA Director General Prof. Mohammad Rawashdeh states that “These drugs get to the pharmacies through ruthless persons, who do not believe in the profession (pharmacy), and with the knowledge of both the buyer and seller”.

Though, the FDA sets the profit margin for each package at 22%. These legal transactions can be monitored through checking the name and batch number of each drug, as well as the price stamped by the Ministry of Health (MoH) and the Union of Pharmacists’.

For example, the FDA inspector can learn whether that drug is registered by entering the name of the drug into the website of the FDA. Official statistics released by the FDA do not reflect the true volume of the drugs seized in Jordan, nor do they reflect the volume of the smuggled and counterfeit drugs because they are based only on the seized goods Risking Patients’ Lives The WHO reports also show that 60% of smuggled and counterfeit medicines globally, include antibiotics used to treat inflammations– some 20% are tablets.

Also, small groups of original drugs smuggled from neighboring countries where they are less expensive than those sold locally, thus providing a larger profit margin for the pharmacist.

A physician, who preferred to remain anonymous recalls how he fell victim to a lady patient who sold him a heart drug for less than half the market price. He bought five packages at JD 25 each, against the market price of JD 70 for each pack of the original drug he bought from the pharmacy.“The patient told me the drugs belonged to her recently deceased mother, and she knew of no one who could benefit from buying them from her at less than the original cost,” the doctor said. “I believed her and bought the medicine, but she never returned to see me again.” A few days later, this doctor read the new reports of the seizure of a shipment of counterfeit heart drugs. He called his friend, who is the exclusive agent of the same medicine he had bought, and asked him to test it. Tests found out that it was totally ineffective.

Another case involved a lady in her forties suffering from high cholesterol, which had to have regular laboratory tests. A technician at the lab advised her to use a medication for her chronic disease, which he said he had obtained from a friend who had large quantities of American drugs and others from the MoH, and wanted to sell them at less than the market price in order to benefit both himself, and the buyer. The lady bought the package at JD 20, when it cost JD 50 in pharmacies. The next time, the technician raised the price to JD 25/package, but she still bought it to save money. “God’s protection saved me,” said the lady. She said the technician called to tell her that he suspected that the drug he had sold her was counterfeit. “I did not inform the authorities cause I did not want him to lose his job, as I believe he acted in good faith.”

Experiences Rania Jaber, secretary of a charitable organisation, recalled her experience with counterfeited antibiotics which she took for inflammations. “I did not benefit from it, so I visited my doctor again to get a prescription for another drug, after he assured me that the first drug I used was counterfeit, a mere placebo.”

Hamzah Ali, owner of a tile and marble factory, recalls his bitter experience with counterfeit drugs that he used after a stint deployment surgery following a heart attack. He did not improve much. He visited his doctor again and found out that he was taking useless capsules filled with starch which were imported from a neighboring country and sold at a local pharmacy.

“I began to suspect the pharmacist who used to tell me to return for picking up the drug in two days, as it was not available,” Ali said. “The last time I went there, I asked the pharmacist to give me a receipt with the name of the medicine and the price.

Then I lodged a complaint with the FDA, which followed up the matter with the pharmacist, sued him and closed down his pharmacy.”

“The drug was tested in the laboratory and proved ineffective, and on the basis of Ali’s complaint, we took the necessary measures against the pharmacist, his pharmacy was closed down and he was taken to court,” according to Head of inspection & monitoring at the FDA, ph. Tahseen Abbadi.

The joint efforts of authorities at country level in Jordan have been increased recently including making regular raids not only on pharmacies but also on beauty salons, increasing the number of inspectors and making new amendments on the law of circulating drug counterfeiting by increasing penalties, all these contribute to the drop of drug counterfeiting in Jordan recently.

However, it is suggested that the fight against drug counterfeiting is a shared responsibility between all parties to include; authorities, the industry, distributors and consumers and not the authorities’ responsibility only.

To achieve this goal an increase in awareness through campaigns is needed to target all concerned parties with special emphasis on the general public who presently have little knowledge on detecting counterfeit medicines.

References: 1. El-Dahiyat, Faris, and Louise Elizabeth Curley. "Pharmaceutical Policy in Jordan." Pharmaceutical Policy in Countries with Developing Healthcare Systems. Adis, Cham, 2017. 237-260 2. Mukhopadhyay, Rajendrani. "The hunt for counterfeit medicine." (2007): 2622-2627.

3. Dégardin, Klara, Yves Roggo, and Pierre Margot. "Understanding and fighting the medicine counterfeit market." Journal of pharmaceutical and biomedical analysis 87 (2014): 167-175 4. Abu Taleb, Yara, and Ra'eda Al Madadha. "Pharmacists' Awareness about Counterfeit Medications in Jordan." Journal of the Royal Medical Services 102.471 (2013): 1-14 5. Arab Reporters for Investigative Journalism (ARIJ), investigations section