Denisa Canameti, Xhovana Kodra, gazeta “Shëndet+” (Click here for Albanian Version)
Hematology is a unique service for Albania. In this department at Mother Teresa University Hospital Center there are at least 300 new cases of patients suffering from malign diseases each year.
The systematic drugs’ absence which are smuggled or purchased by patients is the main problem for patients under treatment at the Hematology Service, because the Ministry of Health does not fulfill their needs although it is their legal right. We encountered many patients complaining about this problem and we have reported our findings to the relevant institutions.
Pharmacist Order blames state institutions saying that lack of medicines encourages smuggling, while the National Center of Drugs Control says it will make all relevant controls for drugs without stamp inside hospitals. At the other hand there is no answer from the Ministry of Health.
The patient: We buy the drugs ourselves
D.Z. is a patient recovered at the Hematology department who suffers from multiple myeloma. We asked her if the hospital guarantees necessary drugs she needs, and her answer was she buys all of them.
“We don’t have any drugs, we don’t have anything. We buy them out, but they are very expensive. Since they (the hospital) don’t have the main medicine “Velkad”, they give us cortisone which is for nothing. The cortisone raised my sugar level causing diabetes. I buy “Endoxan” which cost 1200 – 14000 Lekë each, until they will find us the main medicine. We are told that “Velkad” costs millions and is impossible to find it. I don’t think there is any other department in such a bad situation as this one”, says the woman.
Drugs without stamp: Ondansetron and Citozar medicaments without fiscal stamp at the Hematology Department
We found Ondansetron* and Citozari* medicament at the Hematology department, which were not purchased by the hospital pharmacy but patients themselves. Pictures show these drugs entered the hospital against the rules.
*Ondansetron is a medicine used to prevent nausea caused by cancer treatment drugs or postoperative nausea. You can find it out of hospital area, although on the package it is written “Only for hospital use”. This drug is frequently lacking at the Hematology department.
*Citozari can be used alone or with other drugs as a cure for different types of cancer. It is a chemotherapy drug which enables the slowdown of cancer cells or it stops them growing. This medicine which circulates at the Hematology service does not have the control stamp released by the Health Ministry, National Agency of Drugs and Medical Supplies.
When the Health Ministry does not supply, pharmacies do (smuggling drugs)
Health Minister Ilir Beqaj stated at a TV program he “should admit that in Albania, tumor diseases are still a battle to win from humankind and healthcare system”. In effect, the Ministry of Health has never been able to meet 100 % the hospitals demand for drugs, including cytostatics . The lack of this kind of drug is linked to lack of budget funds, because there is a gap between requests and capacity, as sources within Mother Teresa University Hospital Center state.
Diana Toma, president at the Pharmacist Order stated in an interview:
“I can guarantee that nobody wants to trade drugs without the security stamp because everybody knows what they risk. If you sell this kind of medicines, you will stay in SOS alert as long as your pharmacy is open. Do you find drugs without stamp? Yes, you do. Do you find them with stamp? No, you don’t. When these drugs are not supplied legally, it contributes the illegal activity”, said Toma.
According Toma, sanctions are not the solution. “Sanctions will only grow corruption. The bigger the sanction, the higher the scale of corruption. Being a citizen, if you have been diagnosed with a severe illness and you go to the pharmacy, do you think if the pharmacy is abiding the law or you just ask if it does have the drug you need to cure your disease? And the pharmacists are confronted everyday with people who have health problems.
Don’t misunderstand me. In this case, I don’t want to encourage drugs smuggling. I would want to urge state mechanisms to enable the supply of those drugs which are not registered, but are demanded from pharmaceutics”, said Toma. According to her there is a well achieved healthcare policy which aims to cure diseases with the most efficient and safest mechanisms.
“Is there any more precise, safer and effective mechanism that enabling this smuggled drug through an import license? The impasse is exactly this license. I’m not saying to freely give import licenses, but to issue them according to required standards. Furthermore unregistered drugs should pass through other stages. This would make patients happy but also would be an accomplished mission for pharmacists, and we would also have transparency of drugs which enter the Albanian market. Furthermore financial statements would be a benefit for the system. We would have financial statements in three components: the importer, the distributor within Albania and the last stage, the one who sell it to the patient, the pharmacy”.
The minister’s decree: All drugs in public healthcare institutions should have safety stamp
In July 2011, former Minister of Health Petrit Vasili issued a decree to “All drugs used in public healthcare institutions should have the safety stamp”. The decision made effective on July 25th 2011, aimed to decrease abuses, as in many cases hospital drugs were purchased in pharmacies.
The minister decree says:
“All drugs in the public healthcare system, apart from the safety stamp, must be sealed with the inscription “Hospital use-sale banned”.
“In the public healthcare system will be allowed drugs accompanied by the safety stamp and with price for the open pharmaceutical network if they carry the seal with the inscription “Hospital use-sale banned”. The ink used for sealing should be read and non removable.
NCDC: We will make the necessary controls
Asked about this issue, the National Center for Drugs Control stated:
“As for drugs purchased by patients without the National Agency of Drugs and Medical Supplies’ stamp, citizens must take into consideration the risk of their use, because these are uncontrolled drugs by the relevant authority. The National Agency of Drugs and Medical Supplies will practice relevant controls to make necessary verification and it is open to every report made by citizens or other secure source”.
Mother Teresa University Hospital Center: There is a bigger supply compared to 2013
Regarding the lack of “Velcade” medicament, Alvi Bajramaj, responsible of the Public Relations’ office at Mother Teresa University Hospital Center answered:
“During 2015, Mother Teresa University Hospital Center has spent 320 bottles of Velcade, compared to 19 bottles spent in 2013. The drug administration is achieved at the Hematology Service according to patients’ therapy”.
Smuggled cytostatics with lethal counter effects
One the main problems of smuggled cytostatics (apart their enormous high cost) is their quality. It is very necessary to transport cytostatics in a temperature of 2-8 degree Celsius and they should have proper conditions during transportation. The exposure and transportation of these drugs in high temperatures during summer not only decreases their quality and it cause ineffectiveness as a therapy, but also the drug might cause counter effects.
Every smuggled drug carries the risk of counterfeit, because either it does not contain active substance, or it carries a small quantity which makes the pharmacological effect insufficient to cure the disease. While in cases the drug contains a higher quantity of active substance it may cause a toxic effect.
Even if the product is original, when it smuggled still carries the risk of substance’ reduction due to inadequate conditions of storage or distribution causing more notable toxic effects (e.g.: The “Herceptine” can degrade if shaken during transportation).
MEDICRIME Convention- Council of Europe Convention on the counterfeiting of medical products considers smuggling drugs as a crime.
Regarding drugs’ storage and transportation conditions, the head of Pharmacist Order, Diana Toma, says it is very important to transport and storage this medicament at optimal conditions, in order to conserve its effectiveness. “Otherwise, the temperature change can destroy the drug’s structure not only making it ineffective, but also it may cause negative effects. Drugs are transported in refrigerated-trucks which monitor temperature every 15 minutes, printing all measurements and when it arrives we can control at which temperature the drug was kept during the whole road. If the temperature changes in the storage, the notifying alarm is activated”.
The control stamp released by the Agency is the only guarantee for the drug safety and quality.
Drugs’ controlling stamp
Nr.2, date 15.1.2013
On production, coding, stamp and delivery procedures, and monitoring drugs’ controlling stamps
1.3 The drugs’ controlling stamp enables the identification of the quantity ensures their authenticity in the users’ best interest and aims to enable drugs tracking in the whole country in order to identify their origin and legitimacy, as also it serves to eliminate illegal products as well as forged products production and trade.
2.6 “Drugs controlling stamp” is the stamp released by Republic of Albania, approved by the Authority and should seal all drugs produced in the country for the internal market, as also all imported drugs according to drugs’ law, the law for license’ contract approval as well as all secondary laws under their implementation.
The drugs’ controlling stamp must have these inscription elements: Health Ministry, National Center for Drugs Control, the drug’s name and form, its retail sales price (including VAT), and a two digit code to identify the authorized vendor, the producer and the authorized importer, evident serial number of reference as well as a barcode (SICPADATA Code) readable through SICPA mobile Reader.
2.7 “The drugs’ controlling double stamp” is the stamp of the Republic of Albania” approved by the Authority, which must be applied on all drugs produced in the country for the internal market, as also all imported drugs according to drugs’ law, the law for license’ contract approval as well as all secondary laws under their implementation.
The drugs’ controlling double stamp must contain in one of the remaining parts at the drug’ package these elements: Ministry of Health, National Center for Drugs Control, the drug’s name and form, its retail sales price (including VAT), and a two digit code to identify the authorized vendor, the producer and the authorized importer, evident serial number of reference as well as a barcode (SICPADATA Code) readable through SICPA mobile Reader.
The other part of the stamp which is ripped off and set on the doctor’s prescription must also have these elements: drug’s name and dosage, retail sales price (including VAT), a two digit code to identify the authorized vendor, the producer and the authorized importer and evident serial number of reference.
This story is within the project “Act now! Denounce corruption in health care system”, implemented by “Together for Life” organization and supported by US Embassy in Tirana. The opinions, findings and conclusions are of the author/s and do not represent necessarily those of US Department of State.