Стрімкий розвиток фармацевтичної
галузі та розширення асортименту біотехнологічних
лікарських засобів (БТЛЗ) які потребують особливих
вимог до забезпечення якості, зберігання і
транспортування на протязі всього ланцюга: виробник
– дистриб'ютор – аптека – лікарський профілактичний
заклад (ЛПЗ) – пацієнт.
Нами була проаналізована діюча законодавча
база Міністерства охорони здоров’я України та
проведено дослідження з метою виявлення та аналізу
типових порушення в лікувально-профілактичних
установах і аптечних закладах.
The rapid development of the
pharmaceutical industry and the expansion of the range of
biotech drugs require special conditions to ensure the
quality, storage and transport through out the entire chain:
manufacturer - distributor - pharmacy - hospital - the
patient.We analyzed the current legislative frame work of
Ministry of Public Health of Ukraine and conducted a
study to identify and analyze of typical violations in the
medical and pharmaceutical institutions. The aim of the
investigation was to investigate and analyze inspection
acts under storage and transport of biological medical
products and identify major violations during the
performance requirements for storage and transportation
of drugs, level of awareness about medical products
which are requiring special storage requirement.
Methods: systemic, logistical, structural, marketing,
regulatory.
Results & discussion. According to the data presented in
the report «Assessing biosimilar uptake and competition
in European markets» of «IMS Health», sales of medical
products with biological nature - biological medicinal
products and biosymilyars is about 27% of total sales of
drugs in the EU. This segment of the pharmaceutical
market is characterized by faster growth compared to the
pharmaceutical marketas a whole. Thus, in 2012-2013
years sales of biological medical products in the EU
countries increased by 5.5% compared to 1.5% increase in
total sales of drugs. It is important that in Europe,
according to the 2013 preparations, the market share in
value terms, with eight to prepare biological products, the
term of patent protection that are either already expired or
will expireby 2020, and therefore they can be competitors
with biosymilars. In creasing the number of medications
on the market requires a careful approach of storing and
preserving the quality of distribution during throughout
the life of the medical products in the chain: manufacturer
- distributor - pharmacy - health caresetting - patient. The
percentage of major flaws in the system supply thermally
labile pharmaceutical products related to violation of
temperature regimes average 35 to 43%.
Conclusion. Assessing the overall state of the
organization, storage, transportation and complying with the requirements of "cold chain" for Ukraine should be
noted that, despite some progress in this area a lot of
works to be performed at all levels of health care are
needed.Necessary to improve practices in the training of
personnel, development of modern refrigeration
equipment and means of objective control, organization of
manufacturing andto provide all the equipment
manufacturing for enterprises, and public health
institutions and pharmacies. Need to review the functional
responsibilities of pharmaceutical workers in order to
strengthen the responsibility for dispensing of
biotechnological medical products.
