The Hospital Pharmacy is the part of the North Estonia Medical Centre that organizes general pharmacy operations to meet all of the Medical Centre’s needs. In its activity, the pharmacy observes legislation, other legal acts, the Medical Centre’s articles of association, the operational programme of the Medical Centre and the Hospital Pharmacy and the recognized standards for pharmacies.
- Supplying clinics with pharmacy resources
This activity encompasses many fields: procuring pharmaceuticals, pharmacoeconomic advice, pharmaceutical information etc.
Procurement of pharmaceuticals is primarily a logistical activity and is conducted through wholesalers with the respective licence. By law, most pharmaceutical goods are bought under public procurement.
Besides medicinal products, the hospital pharmacy also procures bandaging and wound care products, enteral nutrition and flammable disinfectants.
Pharmacoeconomic advice includes selection of pharmaceuticals based on qualitative and economic aspects, and preparing a list of hospital pharmaceuticals on this basis. In addition, the pharmacist takes part in preparing the hospital’s internal treatment guidelines.
The pharmaceutical information covers all topics related to pharmaceuticals, such as co-effects and adverse effects, administration through a tube, administration for patients with organ failure, as well as preparing various guidelines for administration of drugs and coordinating pharmaceutical recalls.
Aseptic preparation of pharmaceuticals
- Preparation of antineoplastic pharmaceuticals at the pharmacy
Preparation of antineoplastic pharmaceuticals refers to formulating a patient-based, ready to use solution or chemotherapy to be used for treating neoplastic growths. What the Hospital Pharmacy does is bring cytostatic medicines meant for parenteral use into application-ready form (such as injection, infusion, intrathecal and intra-arterial injections) as an individually customized dose. One aspect of preparation of cytostatic drugs is that it must occur in highly sterile conditions; another is that cytostatic drugs are hazardous substances. As cytostatic medicines have the property of potentially causing mutations in genetic code, they are to be considered potential carcinogens, mutagens and teratogens.
The Hiiu branch pharmacy of the Medical Centre pharmacies became the first in the Baltics to start providing a central chemotherapy drug formulation service, on 3 Match 2008. This was a major qualitative leap forward. The establishment of the centre ensures a high-quality, precise dose of medicine prepared in fully compliant conditions. It is also characterized by a safe work environment for employees and general environmental sustainability. Modernizing cytostatic waste handling operations was also important. Currently all pharmaceuticals are prepared at the fully up to date hospital pharmacy in the Mustamäe block.
In 2012, a total of 27,756 solutions were prepared at the central unit – about 6 percent more than in 2011. Besides the Chemotherapy and Haematology departments, solutions were also prepared for the Urology, Pulmonology, Rheumatology, Dermatovenerology and Dialysis/Nephrology departments. Preparation and handling of drugs for various clinical trials also continued. 2012. In 2012, we introduced the HIPEC procedure (Hyperthermic Intraperitoneal Chemotherapy) in the operating wing as well as ILL – isolated limb infusion – for treatment of tumours of soft tissues and other connective tissues. There were a total of six HIPEC procedures and one ILL procedure performed.
- Aseptic preparation of injection drugs
Based on the list of pharmaceuticals at the hospital, certain intravenous antibiotic drugs are issued to departments only upon order of a infectious diseases doctor. In 2011, we started preparing patient-based antibiotic solutions for the departments. Together with infectious diseases doctors and IT development department, a solution was developed allowing the infectious doctor’s permission to be given electronically, allowing the department to order the medicinal product prescribed by the infectious diseases specialist in a dilute form, one dose at a time (except for orally administered forms) and also set the time at which the patient needs the drug. Implementing this system also medicinal resources to be used in a more rational manner.
The Hospital Pharmacy also prepares antibiotics and epidural solutions for administration and makes casts from moulds.
On-demand preparation of medicines
Alongside injected drugs, we also prepare non-sterile medicinal products according to standardized recipes. On one hand, this includes topical salves, gels, suspensions and solutions, while it also includes internal medicinal forms, such as powders and capsules. The goal is always to prepare galenically stable medicines in the required form and which conform to the physician’s treatment plan.
Quality control ensures that the medicinal products are created and prepared based on the state of the art so that activities related to production and handling are clearly defined and follow good preparation practice, also ensuring that the medicinal products are issued only if the set procedures for preparation, verification and storage are followed and if the products have received consent for usage from a competent individual.
All of the substances used to prepare the medicines undergo organoleptic identification at the Hospital Pharmacy. Depending on the substance, various methods are used for qualitative analysis (chemical identification, melting point, refractive index and density measurement as well as IR spectrum measurement). The ethyl alcohol concentration (vol/vol %) is quantitatively determined using a density meter. The regulations listed in “European Pharmacopoeia 6” are used for identification of substances.
All of the products prepared at the Hospital Pharmacy undergo organoleptic identification. In addition, the conformity of purified water is verified, also with regard to the requirements of the European Pharmacopoeia.
The FTIR ATR spectrum database is seeing widespread use in identification of substances. Using a UV-V spectrophotometer, a chlorhexidine gluconate and potassium permanganate calibration graph began to be prepared to determine the concentration of these substances in solution. High pressure liquid chromatography (HPLC) work has begun to determine the stability and concentration of antibiotics and cancer-fighting drugs. Repeat experiments must be performed to refine the methodologies and render the conditions more suitable. We proceed from the methods of the European Pharmacopoeia.
Clinical drug studies
The procedures for performing clinical drug trials are set forth in a regulation of the Minister of Social Affairs. The North Estonia Medical Centre observes the rules on handling, preparation, accounting and reporting on clinical study drugs. Under these rules, the planning, execution and disclosure of findings must be in conformity with good clinical practice (GCP).
Before a study drug begins to be handled at the Hospital Pharmacy, paperwork must be prepared in which the conditions are agreed on and an agreement on provision of pharmacy service has to be concluded. The agreement is one part of the hospital agreement. The study’s dispensing chemist is responsible for the handling, accounting and reporting on study drugs.
Only dispensing chemists (7) or pharmacists (4) who have undergone GCP training and hold a corresponding certificate have the right to provide pharmacy service.
The path of the study drug must be documented. The study drugs are to be entered into a Hospital Pharmacy warehouse accounting programme similarly to other drugs. The study drugs are stored separately at the Hospital Pharmacy, in locked cabinets in a restricted access area or in locked cabinets in refrigerated storage.
The study drugs may also be prepared at the Hospital Pharmacy. The study sponsor sets forth the requirements for this purpose. Leftover study drugs are returned to the sponsor or Hospital Pharmacy, whichever was agreed previously.
Student internship centre
Every year, university students enrolled in pharmacy fields from the Tallinn Health Care College and the University of Tartu complete internships at the Hospital Pharmacy.
Our dispensing chemists take part in training nurses in courses with various topics and presentations, such as “Adverse effects of medicinal products and risks in regard to administration of drugs," "Safe handling of cytostatic drugs," Parenteral administration and of antibiotics and storage of injected solutions,” and others.