The health institution of the Pharmacy of Montenegro, Montefarm, announced today that it does not have the space for the planned galenic laboratory.
Yesterday, the news announced that two years since the sector for the galenic laboratory in Montefarma has been in existence, that institution has not produced a single drug, and the date of the start of production is not even in sight.
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"A drug factory and a galenic laboratory are not one and the same. Galenic laboratories produce galenic drugs/preparations that are necessary for a smaller number of patients, they are made in smaller batches, with a shorter shelf life. Precisely in the spirit of preserving tradition and quality, when all medicines were "manually" made, which is what our pharmacies have been known for for decades, we came up with the idea of reuniting this type of production in one place. Preparations will be standardized, they will be made on the basis of a single prescription, we would have greater control and availability of them ", the Montefarma press release points out.
From that institution, they added that it was planned that at the beginning the production would be carried out only for the needs of pharmacies, and later all health centers and hospitals.
"At all times, they would be supplied with galenic preparations in sufficient quantities, which, especially during the COVID pandemic, proved to be one of the pressing problems that must be solved in the long term for the benefit of the entire public health and our citizens," Montefarm said.
They said that according to the Regulation, in the drafting of which they participated, it is a fact that it is necessary to provide space, equipment and staff to start galenic production.
"For the planned galenic laboratory, the space must be between 600-700m², a ground-floor building, which Montefarm does not have in its composition, and it is necessary to either rent it or build it. We have already tried to find an adequate place and space, but the offered options do not suit for now by what the Rulebook itself dictates," Montefarma said in a statement.
They stated that then the space needs to be adjusted, considerable resources should be invested in order to meet all standards, including: lighting, temperature maintenance, air humidity and ventilation due to direct or indirect harmful effects during the production process itself, etc., smooth flow of materials, personnel and products , connections to the communal infrastructure, arrangement of rooms without risks and the possibility of replacing or mixing starting materials, intermediate and semi-products and finished galenic medicines, special conditions of the so-called sterile rooms, etc.
"For all of the above, funds are needed, with a note that such a space must be leased and until the opening itself, rent must be paid for a minimum of eight months before even the most basic production begins, which is approx. 100.000,00 euros per year. After the space is technically equipped according to by all standards, the procurement of extremely expensive equipment based on the specification, according to our information, also requires time where the delivery terms are 8-12 months from the conclusion of the contract," Montefarm said.
According to them, a special and extremely important problem is staff, especially when it comes to graduated pharmacists - specialists in the field of pharmaceutical technology and specialists in the field of testing and quality control of medicines, of which four executors are necessary according to the current systematization.
"Given that we do not have the aforementioned specialists, whose training and qualification require three years, and if Montefarm were to provide funds, there is no guarantee that they will stay and work in our galenic laboratory after their return, especially since they are absolutely shortage of staff in Montenegro. If we were to decide to offer a job to specialists from the region, until our pharmacists acquire the necessary title, it is necessary to allocate quite large funds for their engagement. For this reason, for now, there is only one experienced pharmacist in the Galenic Laboratory Sector, who has the task of preparing all of the above and there are no other employees," they stated from Montefarm.
From that institution, they said that, as they clarified in earlier addresses, the idea of opening a galenic laboratory is at least seven to eight years old.
"We hope that from this clarification of ours it is now clear to the layman that the process of opening a galenic laboratory, which would solve the long-term problem of the lack of galenic drugs in the public health system, is not at all simple, starting with space, equipment and the most important professional staff. Finally, we thank ND Vijesti for raising such an important issue. We believe that the intention was to bring this project to the public to help Montefarm to finally start galenic production, and not to provide the competition with as much information as possible," Montefarm's announcement concludes.
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