Statement 3.3

  • Section 3

"Before making a pharmacy preparation, the hospital pharmacist must undertake a risk assessment to determine the best practice quality requirements. These must consider premises, equipment, pharmaceutical knowledge and labelling."

What does it mean for patients? If the risk/benefit assessment is positive the pharmacist should decide about the necessary level of interventions necessary to optimize the quality of the produced medicine. Unambiguous and complete labelling is paramount to avoid any confusion, misinterpretation or administration error in the whole process. 

What does it mean for healthcare professionals? Doctors and nurses should rely on the pharmacist as the expert in deciding about the necessary level of interventions necessary to optimize the quality of the produced medicine. Unambiguous and complete labelling is paramount to avoid any confusion, misinterpretation or administration error in the whole process. 

What does it mean for Hospital Pharmacists? Patients have the right to get the best quality of medicines independently from industrial production or individual preparation.
Hospital pharmacists should guarantee that 

  • The facilities of the pharmacy are adequate 

  • The personnel is trained 

  • The production procedure is 
defined and validated 

  • The quality of all starting 
materials is appropriate 

  • The packaging material is appropriate and compatible to the product 

  • The labelling is unambiguous, complete and based on principle of f safe administration 

 

 

Premises, facilities and pharmaceutical knowledge should be appropriate for the preparation of the medicinal product and correct labelling should be assured through the whole process from production to administration. 

 

Resources

Preview Title Document
IMPLEMENTING A NATIONAL PORTFOLIO OF EXTEMPORANEOUS PHARMACEUTICAL PREPARATIONS USED IN DANISH HOSPITALS PDF icon Implementing a national portfolio of extemporaenours pharmaceutical preparations used in Danish hospitals.pdf
DEVELOPMENT OF NEW PRODUCTION WHEN NEITHER PACKAGING NOR SOME OF THE RAW MATERIALS CONFORM TO EUROPEAN STANDARDS PDF icon pc7160.pdf
HOW TO HANDLE ACTIVE AND PLACEBO DRUGS FOR A CLINICAL TRIAL IN THE PRODUCTION SYSTEM CATO IN ORDER TO SECURE THE BLIND AND TO ENSURE THE EXACT SAME PREPARATION OF ACTIVE AND PLACEBO PRODUCTS PDF icon pc7207.pdf
QUANTIFICATION OF WAITING TIME REDUCTION IN OUTPATIENT SETTING USING ASSISTED SYSTEMS IN AN AUTOMATED ONCOLOGY PHARMACY. PDF icon QUANTIFICATION OF WAITING TIME REDUCTION IN OUTPATIENT SETTING USING ASSISTED SYSTEMS IN AN AUTOMATED ONCOLOGY PHARMACY..pdf
OPTIMIZATION OF RISK MANAGEMENT OF DRUGS COLD CHAIN IN HOSPITAL BY FAILURE MODES, EFFECTS AND CRITICALITY ANALYSIS "FMECA" METHOD PDF icon OPTIMIZATION OF RISK MANAGEMENT OF DRUGS COLD CHAIN IN HOSPITAL BY FAILURE MODES, EFFECTS AND CRITICALITY ANALYSIS %22FMECA%22 METHOD.pdf
Resolution CM/Res(2016)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients PDF icon resource statement 3.3-compunding.pdf
EJHP: Legislation on the preparation of medicinal products in European pharmacies and the Council of Europe Resolution PDF icon resource statement 3.3.pdf
EAHP Survey results 2016/2017 (sections 1,3 and 4) PDF icon EAHP Survey Report 2016-17 .pdf
EAHP Survey Report 2015 PDF icon EAHP Survey report 2015.pdf
GPI:Implementing chemotherapy dose-banding using retrospective data analysis and exponential calculus PDF icon GPI 3.3-3.4.pdf

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