Statement 3.6

“When the reconstitution or mixing of medicines takes place in a patient care area, a hospital pharmacist should approve written procedures that ensure staff involved in these procedures are appropriately trained”

Among healthcare professionals the hos- pital pharmacist is in the best position, because of their expertise in formulation, to advise on reconstitution or mixing of medicines. It is critical that any healthcare professional undertaking these tasks is competent.

What does it mean for patients? Not all injectable preparations can be prepared by the pharmacy. In such cases, hospital pharmacists have the competency to define safe procedures to be used by other healthcare professionals to avoid patient harm.

What does it mean for healthcare professionals? Not all injectable preparations can be prepared by the pharmacy. In such cases, hospital pharmacists should support other healthcare professionals, nurses and doctors by describing feasible procedures for safe and preparation and administration.

What does it mean for Hospital Pharmacists? Where it is not feasible for the hospital pharmacy to prepare such medicines e.g. they do not have aseptic facilities, then hospital pharmacists should be involved in ensuring there are appropriate policies and protocols in place for preparation to be undertaken safely at ward level. Only reconstitution considered low risk should be prepared at ward level. In addition the staff preparing the medicines should have received training and be competent to undertake reconstitution.

Statement 3.5

“Hazardous medicines should be prepared under appropriate conditions to minimise the risk of contaminating the product and exposing hospital personnel, patients and the environment to harm”

To achieve this there will need to be a multidisciplinary risk assessment of the hazardous medicines to determine where and how it is best pre- pared.

What does it mean for patients? Hazardous medicines such as cytotoxics, radiopharmaceuticals and gene therapy need special handling. Hospital pharmacists have the facilities and the skills to produce safe preparations.

What does it mean for healthcare professionals? Hazardous medicines such as cytotoxics, radiopharmaceuticals and gene therapy can harm healthcare professionals if prepared on the ward. Hospital pharmacists have the facilities and the skills to produce safe preparations and thus reduce the risk of such harm.

What does it mean for Hospital Pharmacists? Centralised cytotoxic preparation using safe technique and appropriate technology should be implemented in every hospital handling such drugs.

Hospital pharmacists should ensure that policies are in place to prohibit the preparation of cytotoxic drugs at ward level, including when they are clinically needed in emergency situations.

The Hospital Universitario Clinico San Carlos is SILCC Host providing training on this Statement. Please learn more about the SILCC programme here.

Statement 3.4

“Hospital pharmacists must ensure that an appropriate system for quality control, quality assurance and traceability is in place for pharmacy prepared and compounded medicines.”

What does it mean for patients? In case of adverse events a patient has the right to receive all information necessary to check whether the event was unavoidable and not due to ineffective treatment. Thus a tracking system is necessary to assure the information flow.

What does it mean for healthcare professionals? In case of adverse events, doctors or nurses should have the possibility to examine the manufacturing records to see whether the produced medicines fulfilled all quality requirements. This is only possible if the pharmacy implements an appropriate tracking system

What does it mean for Hospital Pharmacists? In case of adverse events the pharmacy has to demonstrate that all quality requirements were fulfilled in the production of the medicine of interest.

Hospital pharmacists should:

  • Define written procedures for all 
individual preparations
  • Record all individual 
preparations in a database
  • Create a tracking system

 

The Hospital Universitario Clinico San Carlos is SILCC Host providing training on this Statement. Please learn more about the SILCC programme here.

Statement 3.3

“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.

Statement 3.2

“Medicines that require manufacture or compounding must be produced by a hospital pharmacy, or outsourced under the responsibility of the hospital pharmacist.”

What does it mean for patients? Not all medicines that patients need are commercially available. Pharmacists are the only healthcare professionals who have the professional education and facilities to prepare safe medicinal products for individual patients or small populations.

What does it mean for healthcare professionals? Not all medicines that patients need are commercially available. Pharmacists are the only healthcare professionals educated in producing safe medicines for individual patients or small population and should do so if required. Healthcare professionals can be assured of the quality and safety of these medicines produced

What does it mean for Hospital Pharmacists? Hospital pharmacies should have the facilities or arrangements in place for the production of medicines for individual or small patient populations, when not commercially available. The hospital pharmacist should be aware of compounding and production practices within the hospital and should attempt to conduct this activity within the hospital pharmacy in the interest of quality and patient safety

Statement 3.1

“Before pharmacy manufacture or preparation of a medicine, the hospital pharmacist should ascertain whether there is a suitable commercially available pharmaceutical equivalent, and if necessary, discuss the rationale for this decision with the relevant stakeholders.”

What does it mean for patients? Individual preparations can improve the outcome of patients. If there is a perceived benefit for a particular patient/patient group, a discussion between the prescriber and the pharmacy should take place, especially if there is a commercially available suitable pharmaceutical equivalent.

All patients should be informed about the risk/benefit assessment for their treatment.

What does it mean for healthcare professionals? The decision on whether an individual preparation may improve the patient’s outcome is a complex one and doctors and pharmacists should therefore make a joint assessment of the risk/benefit balance considering all aspects (therapeutic, pharmaceutical, environmental and personal).

The professionals involved in patient care should jointly assume responsibility in this assessment for determining the added value of a pharmacy preparation.

What does it mean for Hospital Pharmacists? Pharmacy preparations are not advisable if a suitable pharmaceutical equivalent with a marketing authorisation is available. Before preparation the pharmacist should verify whether a pharmaceutical equivalent is available, taking into account pharmaceutical form and the strength.

Hospital pharmacists should develop together with doctors and other healthcare professionals’ criteria for the risk/benefit assessment.

These criteria may consider:

  • The individual situation of the 
patient
  • The availability of a validated 
formula
  • The availability of ingredients of 
pharmaceutical quality
  • The equipment necessary for 
safe preparation (e.g. clean 
rooms)
  • The experience and skill of 
personnel