Dangerous drugs on the market

The SCOOP investigation showed that even approved products from some of the most famous European pharmaceutical companies are traded on the black market with no government controls. Many of those medicines are counterfeit and sold to unsuspecting consumers.

By Zaklina Hadzi-Zafirova and Xhelal Neziri

Suzana S. from Gostivar was stunned when she realized that the colic syrup she had bought for her baby at the local pharmacy was actually expired and had been sold illegally. The 33-year old mother simply wanted to help her child with abdominal pain that had kept him from sleeping at night. After seeing the expiration date, she immediately tried to find information on the bottle to see who produced the drug and where it came from, but the syrup had no band, which is required by law of all legal medicines.

Unfortunately, Susan’s situation is not unusual. Medicines of of dubious origin and incomplete packaging can be purchased in across Macedonia. Sometimes they are sold illegally in pharmacies that buy expired or banned products from neighboring countries. Other times the medicines are sold in green markets where they are stored at extremely high or low temperatures – furthering lessening the drugs’ effectiveness and potentially making people’s health even worse.

The State Drug Bureau and Ministry of Health claim that regular inspections are carried out and that no drugs of dubious quality or counterfeit drugs have been recorded on the Macedonian market. They point to what they call a practice of regular inspections as proof that they know everything that is sold in the country. However, an investigation by SCOOP has shown the opposite.

Repackaging

Macedonia, as do most countries, has a list of drugs approved for sale in the country – any medicine not listed cannot be sold legally. Still, many non-approved products routinely are sold to the public. But the SCOOP investigation showed that even approved products from some of the most famous European pharmaceutical companies are traded on the black market with no government controls.

Many of those medicines are counterfeit and sold to unsuspecting consumers. They are of lesser quality and often contain substances that can actually harm people in need of medicines. In other cases, the drugs are expired or purchased illegal in other countries to avoid state taxes.

In an interview, one black market trader explained how he operates.

“Almost every month I travel to Germany and other European places to order goods. We buy drugs that are approaching their expiration date and we sell them in Macedonia and other countries in the region,’’ said the man. SCOOP reporters also bought several types of counterfeit drugs from him.

Getting the man to talk was difficult as he was afraid to meet with reporters or to reveal his identity. During our negotiations with him we had talked at least five times and he always changed the location for the meeting.

After lengthy telephone convictions we agreed to meet him in a restaurant in Gostivar, a town in Northwest Macedonia.

He slowly began to tell us about the whole scheme.

He said drugs with a shelf life of 3 to 6 months are distributed in pharmacies in Kosovo and Macedonia, while those with a shelf life of less are stored in separate rooms. In some printing houses counterfeit packages are manufactured to change the expiration date as a way of fooling unsuspecting consumers and expand the shelf life. Instructions in local language are sometimes added to the packages.

After repackaging, these drugs are put into circulation in the region.

Also, according to him, the presence of drugs without official stamps from Macedonian pharmaceutical companies is the result of smuggling done to avoid paying taxes. For example, drugs for export mainly in Kosovo are illegally shipped over the border to Macedonia, where the price is at least 20-percent cheaper than the same drugs with a Macedonian band.

“We found a way to get it in. Sometimes on horses, sometimes loaded via illegal border crossings,’’ said the man who smuggles counterfeit medicine.

Magic pills

The greatest profit is made from so called “magic pills,’’ including Viagra, which are designed to improve male potency. Viagra – sometimes counterfeit, and sometimes smuggled illegally -- usually enters Macedonia through illegal border crossings, loaded on horses.

“Often villagers do not know what they transport. They do this because they have no other opportunities to work,’’ said the drug smuggler.

According to experts, in Macedonia and the countries in the region, only a small number of people with erectile dysfunction refer to the family doctor to seek help. Thus they do not have a prescription to legally buy the “magic pill”, which would cost about €40 a package.

The fact that potency pills are popular on the illegal market is not only about avoiding the doctor, but also because the prices are lower. A packet of Viagra on the black market costs about €20, while rival potency drugs Kamagra and Levitra cost about €10 per package.

Doctors warn about potentially fatal consequences if these drugs are used without a doctor’s supervision, especially for people with heart troubles. But their sale on the black market is rapidly expanding.

Due to the lower cost versus Viagra, Kamagra has has seen its sales increase recently. The dealers we met offered us Kamagra gel for 4 Euros or a pack of 10 tablets for 25 Euros.

Drugs on stalls

Reporters from SCOOP tried to purchase several types of medicines at local green markets. At one stall, we found a man who regularly sells sundries, and he explained he also sells medicines.

Our conversation went this way.

“Good afternoon! Do you have something to regulate high blood pressure?

“From the Bulgarian or...?,’’ the man replied.

“Let me see what you have...’’

“I have these. They are for high pressure…’’

During the conversation, the middle-aged salesman removed a strip of blood pressure drugs () from a canvas bag that hung under an umbrella he used as protection from the broiling sun and high temperatures. We asked him whether there were other medications, and he told us that we could also take "herbal" remedies for diabetes and inhalation drops for children, but we had to wait for them, because, as he explained, they should be ordered from Bulgaria, where he had received other medications that he offered to us.

He was careful with the answers, constantly looking around while talking. On his stall there were no drugs, only sundries. He said that most often his suppliers carried drugs for him from Bulgaria, so if we wanted , we could come back at a later time and order a specific medicine from him.

We searched for other drugs sold on other green markets. One particular part of the downtown area is very well known for “the Bulgarians,’’ who regularly come on Thursdays. When we visited the market the dealers were not in the usual place, but stallholders told us that they regularly came to one of the stalls and sold drugs they carried from Bulgaria. Even one of the taxi drivers confirmed it, saying that they were sometimes present on the sidewalks supposedly offering people various kinds of drugs.

Despite repeated instances of drugs sold on the streets, and the problems encountered by Susan, the mother who bought expired colic medicine at a pharmacy, government officials contacted for this story still insisted that no illegal trade of medicine exists in Macedonia.

However, public markets are not the only way to buy drugs at the black market for those who do not want to wait in long queues in pharmacies or at the family doctor for a prescription. Our reporters learned that specific drugs can be ordered via well-developed channels, through contact with people who smuggle them via neighboring countries.

The sale of drugs is controlled, institutions claim

The director of the Drug Bureau as well as the director of the National Pharmacology Center) official institutions argue that the sale of medicines is under strict control and that they have not seen or been informed that drugs are sold at green markets. On the contrary, the former director of the Bureau for Medicines, Ilco Zahariev, claimed they had found counterfeit drugs and that in his tenure some pharmacies had been closed upon the sale of such drugs. 

"Although regarded as a potency drug, most fakes are those for erectile dysfunction in men. It is a fact that such drugs are used in West Macedonia, including the drugs Viagra, Cialis and Levitra. We have found amazing fakes identical to the originals that cannot be seen with the naked eye.

“But our analytical procedure showed no general active ingredients. What will the effect be if you take the medication? There are no benefits, and some serious adverse reactions to patients’ health may appear,’’ Zahariev said.

But erectile drugs that don’t work are not nearly as dangerous as other medicines inspected by the Bureau of Medinces, he said. In Kosovo and Serbia, as well as in Macedonia, inspectors found counterfeit medicines used to treat the extremely dangerous condition of tetanus.

“Do you know what that means?,” Zahariev said. “If a patient who is exposed to the risk of tetanus received such a drug there will be no effect and he can get tetanus. Zahariev said the country has also seen a fake Italian drug Diclofenac enter from Kosovo, and fake nitroglycerin from Montenegro. Nitroglycerin is used to prevent heart attacks and counterfeit of that product would almost certainly mean death if someone was in an emergency situation. Zahariev said that counterfeiting medicines is a global process, with as many as 30-percent being counterfeited in underdeveloped countries and 10-percent in developed nations.

One of the largest recorded counterfeit medicine scandal in recent years occurred when $10 million worth of fake drugs from Russia were imported into France from the Netherlands. Worldwide, an estimated $80 billion dollars worth of fake drugs are marketed and sold to unsuspecting consumers each year. 

“And if you as a country do not protect yourself through fair and open procedures for registration, drug analysis and quality control certificates, then you have a problem", said Zahariev.

We asked him whether in Macedonia consumers could possibly buy drugs without knowing their origin. Zahariev denied, that was true saying that in the legal system it was not possible. He did admit that it it was possible to sell something "on the black."

"In the legal system no (illegal) drugs can get in through customs, if something is smuggled it can be sold on the black market, but if something like that is found at the pharmacy, the fine for the pharmacy is €25,000 to €50,000 and for the responsible person – the pharmacist, from €10,000 to €20,000. We have closed pharmacies on that basis."(As to the sale of illegal medinces at green markets, the ex-director of the Bureau comments:

"Green markets are something else. How it is now controlled I do not know, I have not been there for three months now. But when I was director, green markets were part of our control and we formed teams of five inspectors who inspected markets.’’

As an example, he said inspectors found people selling eye glasses that did not have proper corrective lenses, which can cause eye damange. He also noted that drugs become less effective when they are not stored properly, are left in sunlight or humidity, and are not properly controlled. All that makes buying from green markets and other black market operates far more dangerous for ordinary citizens.

Negative effects of drugs are monitored at the National Pharmacovigilance Center, at the Institute of Preclinical and Clinical Pharmacology with Toxicology. The director of the institution, Nikola Labachevski, says they regularly cooperate with family doctors about side effects of drugs. Labachevski recommends that citizens buy drugs only from pharmacies or healthcare facilities. Every purchase of medicine out of institutions may adversely affect health. However, he explains that even the best drugs can have adverse effects, which are considered normal.

"Adverse actions may be within what is usual for a drug because there is no drug without any side effects. Even the best quality medications have side effects. It should be asked whether some drugs that do not have any adverse effects have effects at all.’’

The quality of drugs at registration and marketing is tracked at the Institute of Public Health. Currently the Institute is checking drugs that were taken as samples within the great action for drugs control by the Ministry of Health.The laboratory of the Institute has received and tested a total of 168 medinces, but said that so far it has not found any of poor quality

Katerina Starkoska, a specialist in testing and drugs control by the Institute of Public Health explains which drugs are most often counterfeited:

"It is Viagra, sedatives, those products are usually brought in (from outside the country). Last year Viagra and sedatives were most submitted for testing. These drugs have the original manufacturer listed. We do not know where and who the real manufacturer is. It is stated on the package. We only inspect whether there is such an active substance and the quantity that is present in the drug. If it is fake you have half of the amount declared," emphasized Starkoska. She warns that counterfeits do not do provide any benefits for the patient, although consumers pay it as if it was a real drug.

To the question if there is a black market for drugs in Macedonia, the director of the Drug Bureau, Katerina Aleksoska says:

"In The Republic of Macedonia there are no counterfeit drugs marketed. The reason that in RM there are no counterfeit drugs found in circulation is the intensive control of inspectors from the Drug Bureau and controls of quality of medicines at random, good cooperation with Customs, the Post Office (packages are subject to inspection), as well as the excellent cooperation with drugs agencies from the neighboring countries", she said.

She claims that all drugs are strictly controlled, as well as those imported from abroad with regular and irregular controls by inspectors.

"Inspectors from the Bureau conduct regular inspection of the work in pharmacies, pursuant to the Law on drugs and medical devices and other regulations. For example, in the last extensive emergency control, performed in over 200 pharmacies in several towns in Macedonia, we found that the pharmacies comply with the regulations for storing, dispensing and prescribing prescription drugs. In the last crackdown inspectors from the Bureau randomly took more drugs from different batches directly from the shelves of pharmacies. The aim was to check the quality of the drug that is sold in pharmacies and compare with standards taken for examination by the respective manufacturer of the particular drug, or whether they coincide with the characteristics listed in the specification documents. The results showed that the quality of drugs for these generics was in accordance with the prescribed standards of quality and there is compliance between the qualities of the drug with the conditions of approval for marketing the drug", says Aleksoska.

Dismissing concerns that some drugs of dubious quality of reaching consumers, the director of the Bureau said that during the year all citizens and health professionals have the opportunity to report adverse effects, and that drugs are continually monitored by the Bureau through a special software program for continuous data monitoring.

"In the pharmacovigilance system 600 reports of adverse reactions are annually collected and evaluated, some of which result from spontaneous reporting, and others are registered in clinical trials", Aleksoska adds.

"The investigation is supported by CIN SCOOP MACEDONIA within the project Raising awareness about corruption though investigative report"

You can read the original article here: http://scoop.mk/investigations/208.html 

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