What is a checklist for a pharmacy audit?
A checklist for pharmacy audits is a tool used by pharmacists to carry out regular internal audits. Pharmacies are obliged to meet certain standards in all their services in order to ensure the protection of customers.
The use of checklists for pharmacy audits helps pharmacists to check quality requirements and to optimise them where necessary. Regular inspections prevent costly cost refunds, save thousands of man-hours and contribute to compliance with health and safety standards. In addition, they help to be more relaxed about an external pharmacy audit by the pharmacist or public pharmacist.
This article covers the following topics:
What is important for a pharmacy audit checklist?
It is not necessary for pharmacy managers to carry out the self-inspection with checklist personally. Suitable employees from the specific area, for example pharmaceutical-commercial assistants (PKA) for merchandise management and pharmaceutical-technical assistants (PTA) for testing and manufacturing, can also be assigned. On the basis of the prepared reports on the actual state, the deficiencies found are then assessed depending on their impact on the quality of the service and necessary corrective measures are initiated.
However, the pharmacy manager together with his staff should define priorities before the pharmacy auditing and prepare a respective checklist to be worked through during the self-inspection. In the beginning, the pharmacy audits should be carried out at shorter intervals, which can be extended later. In critical areas that have shown defects, a self-inspection should be carried out more frequently in the pharmacy until these have been completely eliminated.
The internal audit checklist for pharmacy should cover the following 5 aspects and be able to answer the resulting questions:
Premises and facilities
- Have spatial changes been made since the last revision?
- Have the changes been notified to the competent authority?
- Are there enough places for individual consultations or hand sales tables available?
- Is the required requirement for a formulation fulfilled ?
- Are all professional certificates available?
- Are the areas of competence and work of the staff subdivided according to the legal requirements?
- Are duty and substitution schedules available?
- According to the deployment plans, is the permanent presence of a pharmacist ensured?
- Are the recommended and prescribed scientific aids available?
- Is the equipment for recipe production ready for operation?
- Are test devices for alternative test methods available and ready for operation ?
- Are devices requiring calibration (scales, water bath) calibrated regularly?
- Are the measuring instruments subject to legal metrology such as scales and thermometers calibrated?
- Are fire extinguishers available in sufficient numbers and TÜV-tested?
- Are source materials and primary packaging materials checked for identity with recognizable test certificates?
- Are only certified primary packaging materials purchased?
- Are the test certificates legitimate and have been issued by authorised persons or institutions?
- Are there test specifications available in the pharmacy?
- Are there manufacturing instructions for recipes and defects?
- The productions documented?
- Were the prescribed documentations carried out?
- Is the documentation up to date?
- Were the documentations signed by authorized persons?
- Is the storage and archiving of the documentation regulated?
- It been ensured that the retention periods are observed?
External inspectors investigate exactly which problems need to be resolved, especially with regard to pricing , regulations and the licensing and certification status of employees. Therefore, any checklist for the audit in the pharmacy should answer the questions listed. Any defects that occur should be corrected immediately by pharmacy management and staff.
Tips for preparing and avoiding an external pharmacy audit
A sensibly structured checklist for a pharmacy audit is the best prerequisite for external audits by public pharmacists and the pharmacy council. These are also carried out if there is no clear trigger. The auditors are obliged to carry out an inspection on a regular basis and report on it. Below are 7 tips for effective preparation and prevention of an external pharmacy audit by means of a self-inspection of the pharmacy:
- It should be clarified in advance what the scope of the external audit will be, to ensure that the necessary information is available and provided.
- Create a positive attitude towards external audits among the pharmacy staff and prepare the team for the audit.
- An agenda and timetable with practical examples: Nobody knows the pharmacy as well as its owners and employees.
- The necessary documentation such as policies and procedures, invoices and records (signature, controlled substances, etc.) should be available.
- These data records must never be changed. Negative findings should be checked before the auditors prepare their audit report.
- Regular, proactive self-revision in the pharmacy with checklists prevents the occurrence of common problems, such as calculation and spelling mistakes during the prescription process.
- After the audit is before the audit: All measures from the previous pharmacy auditing should be implemented by the next audit.
A checklist app for pharmacy auditing
Unannounced external audits by insurance companies and authorities can easily be prevented if new technology is used for the pharmacy’s own audit. Lumiform is a powerful inspection app that helps pharmacies identify defects and improve processes before the auditors arrive. This helps avoid costly chargebacks and criminal investigations.
Digitize checklists and internal processes with Lumiform:
- The flexible form construction kit helps you to convert any individual paper list into digital checklists within minutes.
- Generate real-time data via internal processes. This makes quality and security measurable and you can use the data to continuously optimize processes.
- Get an overview of everything that’s going on on site. Reports are created automatically – this saves the complete postprocessing.
- Save time by analyzing all data more easily and identifying areas that need your attention more quickly.
- The very simple operation offers no margin for error for inspectors on site. The app offers less complexity in documenting or filling out checklists than complicated paper or Excel lists.
- Depending on the application, tests are carried out about 30%-50% faster than strong tests.