To improve availability of cheaper medicaments, State Agency for Medicines (SAM) focussed, during the first half of 2013, on options to purchase medicaments at reference price or less in Estonian pharmacies. Availability of sub-reference and agreed price medicaments was checked at nearly 100 pharmacies, a quarter of which lacked one or numerous such medicines.
According to Inge Mäe, head of activity licences and inspections at SAM, the availability of cheaper drugs has improved, with majority of pharmacies utilising a system to ensure sales of reference and agreed priced medicaments.
Corresponding inspections were also carried out with medicines’ wholesale companies, a precept was issued to one wholesaler.
With wholesalers, omissions were also detected with quality systems. At occasions, medicaments had been issued to persons unauthorised to acquire medicine from wholesale companies. Errors were also detected in reports filed to SAM.
To ensure intended and rational consumption of medicaments, pharmacists are required to advise customers. Of the hundred-some pharmacies inspected, close to a fifth failed to provide advice on the level required – the main fault being failure to underline possible combined effects of medicaments purchased simultaneously.
Precepts for violations of medicine handling requirements were issued to ten licensed medicine handlers, and to three handlers without handling licences – two of which were representatives of marketing authorisation holders, one being an illegal handler.
For failure to adhere a precept issued by SAM, a penalty payment of €600 was applied to one pharmacy; a provider of veterinary services was fined with €1,200.
Wholesalers were fined for issuing medicines with date of expiry exceeded; providers of veterinary services being fined for use of medicines lacking marketing authorisations and exceeding expiry dates.
Medicines made in pharmacies were inspected on 134 occasions, close to three per cent not meeting requirements thereof. All such cases concerned solutions. According to SAM, the result is the most positive in past years.
As revealed by the six months’ report, problems persist with correct labelling of drugs prepared in pharmacies; many medicine labels lacking warnings concerning storage conditions, on occasions the expiry dates were faulty.
Regarding hazards in handling of cells, tissues and organs, eight complaints were filed to SAM, half of these having to do with microbial contamination of grafts removed from dead donors.
According to SAM biological preparations department head Tarmo Tiido, by the time the test results became evident, some grafts had already been applied to patients. However, no complications were detected with recipients. In the four cases whereupon this was not the case, hyperstimulation of ovaries developed with artificial insemination. All patients fully recovered.
37 cases of hazard were reported regarding blood handling. Of these, five related to serious side effects with recipients during or after blood transfusions, 11 cases having to do with positive results to bacterial seeding from blood products. The rest of hazardous cases related to positive blood tests regarding infectious agents such as hepatitis B and C, as well as HIV and syphilis, with serial donors.
Reference price
• In vase of various medicines with identical active substances on sale, reference price is calculated.
• A price agreement is entered with one or several marketing authorisation holders of a sub-reference-priced medicine, obligating them to guarantee the availability of that medicine for agreed price over a certain period of time.
• Both pharmacies and wholesalers are obligated to give priority to medicines with reference prices and price agreements.