Pharmacy Practice 2016/2017
PharmDr. Tünde Ambrus, Ph.D., Department of Applied Pharmacy, ambrust@vfu.cz
PHARMACEUTICAL INDUSTRY AND WHOLESALING
ORDERING AND STORAGE OF MEDICINAL PRODUCTS
Medicinal products in most European countries reach the patients by this classic distribution chain:
Manufacturer (producer) > Wholesaler (distributor) > Pharmacy > Patient
PHARMACEUTICAL INDUSTRY
The function of the industry (manufacturers) is mass producing of pharmaceutical products:
 medicinal products (for human or veterinary use)
 pharmaceutical substances
 medical devices
 laboratory and diagnostic kits, equipment, …
Good Manufacturing Practice (GMP)
The basic requirements of medicinal product quality are included in the European Pharmacopoeia.
Pharmaceutical industry – contact with wholesalers:
 business contact
 specialized information on medicinal products
Pharmaceutical industry – contact with pharmacies:
 specialized information on medicinal products, administrative information
 pharmaceutical/medical advertising
PHARMACEUTICAL DISTRIBUTION
Pharmaceutical distribution includes prewholesaling and wholesaling:
 Prewholesaling - manufacturer`s activity
 Wholesaling - wholesaler`s activity
There are 2 possible ways of distribution:
 Direct distribution
 Indirect distribution
Types of wholesalers – classification according to the distributed range of products
 Full-line wholesalers
 Short-line wholesalers
 Specialized wholesalers
Wholesaler`s obligations
The basic obligations of the holders of a wholesale dealing authorisation are defined by the directive of the
European Community 2001/83/EC.
The wholesalers should be:
 obtain their supplies of medicines only from a distributor or from a manufacturer
 supply medicines only to a distributor or who are authorised to supply medicines to the public
 keep records, for inspection purposes, giving for any transaction with medicines received or
dispatched
 comply with the principles and guidelines of Good Distribution Practice
Pharmacy Practice 2016/2017
PharmDr. Tünde Ambrus, Ph.D., Department of Applied Pharmacy, ambrust@vfu.cz
Good Distribution Practice (GDP)
 is a quality warranty system, which includes requirements for purchase, receiving, storage and
export of medicinal products
 regulates the division and movement of pharmaceutical products
PHARMACEUTICAL DISTRIBUTION IN THE CZECH REPUBLIC
Legislation
 Act on Pharmaceuticals No. 378/2007 Coll.
 Health Ministry Decree on Manufacture and Distribution of Pharmaceutical No. 229/2008 Coll.
Authorisation for wholesaling is issued by:
 in case of human medicinal products: State Institute for Drug Control (SÚKL)
 in case of veterinary medicinal products: Institute for State Control of Veterinary Biologicals and
Medicines (ÚSKVBL)
Distributed may be:
 authorised medicinal products
 non-authorised medicinal products – only in specific cases
Nationwide pharmaceutical full-line wholesalers:
 Alliance Healthcare, Via Pharma, Phoenix, Pharmos
 AVEL – Association of Full-line Wholesalers – national organization of the Czech full-line distributors
LOGISTICS IN PHARMACY
Ordering – possible forms:
 via internet – the most frequent form
 by phone
 in written form
- ordering is possible several times in a day
- wholesalers deliver products to pharmacies also several times
- number of wholesalers – pharmacy can choose
Receipt of the delivery
- confirmation of receipt – stamp and signature of the pharmacy on the copy of delivery list
- control of the delivery - according to the delivery list
 amounts of each medicines, exspiration, integrity of packages, price
Medicinal product storage in the pharmacy
- basic sources and rules (Decree on Good Pharmacy Practice, Pharmacopoeia, marketing authorisation)
- storage conditions
- system of storage – application forms / alphabetically / exspiration
- separate storage
 separately from human medicines: veterinary medicines, medical devices, other products
 separately, marked: after date of exspiration, defective packages, unusable medicines
Control activities
 storage conditions
 exspiration
 batches with quality defects
 documentation