Failure to prevent cross-contamination during the medication repackaging process not only increases waste, but it also decreases patient safety — a risk no one should be willing to make.
There are several steps you can put in place to avoid cross-contamination, including implementing current Good Manufacturing Practices (cGMP). Following cGMP guidelines is one of the best ways to prevent instances of product-to-product contamination, label/bar code mix-ups, process deviations and packaging errors, while assuring that repackaged drug products meet quality standards.
Recently, the biggest focus of cross-contamination prevention has been on hazardous drugs, but you should have cross-contamination prevention processes in place for all medications repackaged in a pharmacy environment (hazardous or not).
We’ve compiled a list of seven tips to help you get started on the best path to avoiding cross-contamination when repackaging medications.
1. Cleaning validation
You should always make sure you can validate your cleaning methods. Performing cleaning validation activities and keeping proper written procedures for decontaminating, cleaning and disinfecting any equipment used is imperative to avoid cross-contamination. Proper cleaning with a low-residue soap prevents cross-contamination, microbial buildup on equipment, bio-burden between drug products and ensures no residual cleaning agent is left on the equipment. Your cleaning validation process should be validated and documented by an outside lab. Something to keep in mind: If you have a high-speed packaging machine that uses a common chute in the packaging process, these types of machines present challenges as they can be difficult to clean and validate for cross-contamination.
Any equipment used should be cleaned, maintained and sanitized and/or sterilized appropriately to avoid any contamination. The condition of the equipment is important as a lack of a cleaning process and/or maintenance can lead to product residue inside the machine and compromise product quality. An equipment technician should maintain regular maintenance logs for each packaging machine, and packaging technicians should fully understand and be trained on the cleaning processes and maintain cleaning logs.
3. Quality control
Form a quality control unit to monitor and control all components, packaging material, labeling and drug products. The quality control unit should oversee the review of production records — before the product is put into inventory for dispensing or into the supply chain — to assure that no errors have occurred and, if they have, that they are fully investigated and resolved. You should have a root cause analysis process and document any corrective actions and process improvements.
It’s imperative to make sure that all employees are properly trained for the tasks they will be performing. Developing and implementing Standard Operating Procedures (SOPs) is the number one thing you can do to control quality and compliance. Make sure all appropriate employees are fully trained on your SOPs and that the information is easily accessible for review and re-training as needed.
5. Protective apparel
Employees should always wear the appropriate protective apparel to promote both medication safety and staff safety when repackaging. Proper protective apparel could include lab coats and gowns, masks, eye protections, gloves, hair and beard covers, and shoe covers. Your employees should always wear new gloves when they begin repackaging a new drug lot, and remove protective gowning before entering bathrooms or areas where food is consumed. Hazardous drug handling and repackaging may require additional protections and policies.
6. Employee health
Employees should practice good sanitation and health habits. Any employee with a health condition or open lesion that may have an adverse effect on drug products should be reported to a supervisor and excluded from direct contact with medications.
Any medication repackaging should be performed within a defined area of adequate size in an environment in which airborne particulates, contaminants and pollutants are kept within required limits. You can also help avoid cross-contamination by limiting entry of any unauthorized personnel, and continuously monitoring environmental conditions, including temperature and humidity.
Keeping accurate documentation of the repackaging methods, equipment and materials used in cleaning and maintenance operations will help avoid possible cross-contamination issues.
If you’re worried your institutional pharmacy doesn’t have the capability to repackage medications without a high risk of cross-contamination, it might be time to consider outsourcing your unit-dose repackaging. Working with an FDA-registered unit-dose packager that strictly follows cGMP guidelines — like Safecor Health — can not only reduce your in-house burden and costs of repackaging, but it can reduce the risk of any cross-contamination of your medications.
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