The German Pharmacy Operating Regulations contain a specific change to the quality management system (QMS) that is relevant to every community pharmacy.
1. Mandatory crisis preparedness in the QMS
Section 2a of the Pharmacy Operating Regulations is set to be supplemented by a sentence requiring the quality management system to include rules for pharmacy operations during crises, particularly short-term energy shortages.
What does this mean in practice?
In future, the QMS should contain documented procedures for:
- power failures
- IT failures
- internet outages
- failure of the pharmacy merchandise-management system
- telephone outages
- energy and heating shortages
- medicine shortages
- staff shortages
- disasters and other crisis situations
Useful SOPs every pharmacy should add
Power failure
- emergency lighting
- paper-based prescription acceptance
- manual documentation
- refrigerator and cold-chain management
- handling controlled medicines and safes
- checking emergency power arrangements
IT or internet failure
- offline work instructions
- alternative access to medicines and safety information
- paper forms
- backup arrangements
Supply crisis
- prioritising medicines that are essential to patient care
- substitution procedures
- communication routes to doctors and patients
Staff absence
- deputy arrangements
- minimum staffing
- prioritisation of tasks
2. Further QMS-related changes
Alongside crisis preparedness, other planned changes may affect work instructions and documentation.
Documentation and electronic signatures
For certain records, an advanced electronic signature is expected to be sufficient instead of a qualified electronic signature. This should make digital processes easier to operate.
Training and the use of support staff
The regulation envisages delegating selected activities to additionally trained staff. Training and supervision duties will therefore be required and must be described in the QMS.
Mail-order pharmacy
Documenting temperature monitoring during dispatch will become considerably more important. Breaches are intended to be expressly punishable as administrative offences, so mail-order pharmacies must strengthen their GDP and QMS processes.
Documentation duties
The Bundesrat has expressly requested sanctions for missing or incomplete records. Complete QMS documentation will therefore become even more important.
Recommended action for pharmacy managers
Pharmacies should add a dedicated “Crisis management and business continuity” chapter containing:
- a risk assessment
- a power-failure SOP
- an IT-failure SOP
- a communication plan
- emergency contacts
- a stock and refrigerated-goods plan
- a staff emergency plan
- an annual documented crisis exercise
This will help pharmacies prepare for the expected requirement and improve readiness for official inspections.