If you ask Albanians what they think about medication they will tell you two things: first, medication is continuously missing in hospitals, and oftentimes in pharmacies one cannot find the same medication one used when the cure started; and second, the medication is unsafe.
Why this perception? Let us investigate the reasons.
In Albania, the medication that is prescribed is either imported or produced inside the country. Imports mainly come from EU states; another portion comes from Turkey and few of them from outside Europe.
How does the government control imported medication?
Through the National Agency for Medication and its laboratory. But is the laboratory able to control every imported product, every batch, and every pill box that enters Albania, however modern and efficient it is? Certainly not. And the reason isn’t because the laboratory is lacking something, but because even abroad it doesn’t function like this; it is practically impossible to analyze each and every medicine that is imported.
Let us observe how the world works: it has been over twenty years that Europe uses a unified electronic system of medication control, from the producer, to the Agency of Medication that approves trade, from the distributor, pharmacist, and doctor, until it reaches the patient. This system is called “the pharmacovigilance system for medication.”
If the patient has an unexpected problem from taking certain medication, the patient, the pharmacist, or the family doctor issues an electronic report, but they can also send a manual report to the National Pharmacovigilance Center. The report is serious, professional, reasoned, and complete. Every report is processed immediately, the producer company is advised, and the medication is withdrawn from the market (or other precautions are taken).
Where does Albania stand regarding this issue?
Albania lingers between reasonable and unreasonable rumors about medication quality, doctors that fill out prescriptions with costly pills at the expense of the patient, and medication that in Europe has either been withdrawn or blocked, but information is lacking. But this isn’t the worst part.
A huge amount of money has been spent, with more to come, on a system for electronic prescriptions. The pharmacovigilance system that is used around the world, however, has been ignored. It is as we have built a highway that we have to later destroy because if we are to enter EU one day, the system of pharmacovigilance will be a requirement.
Let us investigate a bit further the safety of medication internally.
Companies that want to produce medication need a license of good production practices called GMP. Today, in the region, the biggest Macedonian producer holds a Romanian GMP, and the biggest Serbian producer holds a European GMP. Only Albania, Montenegro, and Kosovo allow local pharmaceutical production with a GMP issued by the local Ministry of Health.
Is the Ministry in a position to issue a pharmaceutical production license?
Our Ministry has a commission for issuing a pharmaceutical production license without a specialist or supervisor of production, while around the world, this job is carried out by the best specialists, with a long experience in pharmaceutical production.
Since 2009, the Italian Agency of Medication, AIFA, has approached Albania in order to train production supervisors through a mutual agreement, but from the looks of it, our ministers have considered it unnecessary.
So let us suppose for a minute that the best medication enters in Albania, how is it distributed?
Around the world it is compulsory that whoever distributes medication must sign a document that is called GDP (good distribution practice). Even here, in order to get a medication distribution license (a license for pharmaceutical warehouses), a self-declaration must be signed that the Technical Director knows and applies the GDP.
The question is, what kind of GDP? A GDP has never been designed within our legal system. Even though, according to the Medication Act from 2014, one should have been in place since the end of that year as a bylaw. In this case, a translated European GDP would have been sufficient. But it seems that it is not a priority issue.
So, the warehouses sign a fake statement, while they are free to transport medication with scooters, not even pizzerias use this mode of transportation any longer. But a law that prohibits this is not in place.
