Originally posted on April 05, 2018
Updated August 2, 2021
While the COVID-19 pandemic has contributed to medication shortages, the FDA acknowledges that drug shortages can occur almost any time, due to factors such as manufacturing delays, quality issues, or discontinuations. In fact, the FDA now offers a Drug Shortages Mobile App to receive notifications within selected therapeutic categories.
As a result of pandemic-related shortages, some hospitals and health systems have opted to establish a combination of in-house and outsourced unit-dose drug repackaging to ensure supply availability and to keep costs in check. Regardless of which approach a facility chooses, cross-contamination remains a vitally important consideration for every hospital's unit-dose repackaging strategy.
Sources for cross-contamination
Failure to prevent cross-contamination during the medication repackaging process not only increases waste, but also decreases patient safety — a risk no one should be willing to make.
In the early 2000s, the FDA sought out advice from the pharmaceutical industry in order to develop an industry standard for assessing cross-contamination. This standard leaves it up to companies to run risk assessments in order to determine allowable exposure levels and to establish standards for cleaning equipment. The problem is that companies largely police themselves, leaving room for error. That's why it is imperative to understand how to avoid cross-contamination.
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.
The main reasons for pharmaceutical industry cross-contamination are typically attributed to:
- Human error, ranging from improper use of personal protective equipment (PPE) to unsanitary or direct contact with equipment, packaging, and products;
- Unsanitary or improperly cleaned, maintained, and operated equipment;
- Manufacturing facility imperfections, inadequate space between processing stations, or unclean conditions;
- Environmental factors including poorly circulated or unfiltered air, lack of ventilation, or improper storage temperatures or conditions;
- Improperly stored, handled, or mislabeled materials or packaging; and
- Inconsistent manufacturing, sterilization, labeling, and barcoding processes.
Pitfalls of cross-contamination
Medications repackaged without following aseptic technique, that are not processed in an FDA-approved facility or do not follow cGMP requirements can lead to additional challenges that can cause additional harm.
According to Pharmaceutical Processing World, contaminated products can have different effects on patients and may impact the drug's efficacy, trigger an allergic reaction in a patient or even alter the drug's intended dosage.
In turn, cross-contamination not only affects patient safety but can create a financial burden as well.
Weighing the options of in-house repackaging vs. outsourcing
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).
Safecor Health has 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 protection, 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 the 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.