As a provider in a heavily regulated industry, you're no stranger to compliance and risk assessment in your business. But have you revisited your risk management efforts lately?
There are numerous risks that apply specifically to compounding pharmacies and home infusion providers. These risks range from the broader regulatory environment to the individual patient level. With all the uncertainty surrounding implementation and compliance with revisions to the United States Pharmacopeia (USP) compounding chapters, it's easy to focus on the overall industry risks. But you should not neglect the risks associated with providing home infusion services to individual patients day in and day out.
Meeting the unique challenges of the home care environment
Even as home infusion therapies are becoming more widely used than ever before, the complex effects of home administration on patient safety aren't always clear. Simply put, infusion pumps are complex devices that coexist with untrained patients and caregivers in the home environment. Even with trained infusion providers visiting regularly, the potential for device errors and malfunctions is significant.
A 2018 study that reviewed over 600 home infusion incident reports to the United Kingdom's national reporting service during a 10-year period found that a majority of these incidents were due to equipment failures.1 These errors most commonly resulted in under-dosing.
The authors identified seven key opportunities to help home infusion providers prevent, detect and correct infusion errors in the home setting:
1. Proper device setup
2. Routine use of devices during nursing visits
3. Educating the patient and family members on using the device, such as how to give bolus doses or the importance of avoiding dropping or bumping it
4. Detecting device failures during a nursing home visit
5. Reviewing sources of evidence, such as device memory and patient reports
6. Failure diagnosis, whether on the part of the home health nurse or via technical support
7. The importance of sharing what was learned from each incident with colleagues to prevent similar errors in the future, or to diagnose and correct them more quickly
Focus on minimizing home infusion risks
In considering your own home infusion patient population, focus on three key techniques for improving safety and performance:
- Employee training. Without the traditional safety review periods of in-hospital care, such as nursing shift handoffs or transfers, it's critical for home health providers to know the best practices for home infusion. What's more, you will want your employees to feel comfortable in calling for backup to double-check any policies or procedures when unsure
- Sophisticated troubleshooting. Encourage your home health providers to diagnose as well as correct device errors to the best of their abilities. The tendency is often to simply replace a device or restart it to run again without understanding what caused the problem, which could simply delay the patient's full treatment or an accurate diagnosis of the equipment problem. Selecting robust service plans and remote support can minimize interruptions to patient care
- Proactive maintenance. Making sure that your devices receive recommended servicing at the appropriate intervals is the best way to reduce the number of home infusion errors that your pharmacy must correct
Fine-tune your risk management planning
Dispensing errors and drug contamination are the biggest risks for the home infusion and compounding pharmacy businesses, but great providers seek to manage other risks, too. A well-crafted risk management plan can support business performance and, ultimately, patient outcomes.
Give your risk management plan a check-up to make sure there are no obvious risk management lapses. While the specifics of creating a sound risk management plan vary by industry, the underlying principles remain fairly constant. Try the following methodical approach to planning.
Assess the major risks to your home infusion or compounding pharmacy business
You can't protect against risks you don't know about or don't understand. Review aspects of your business processes and ask trusted colleagues and staff members for their thoughts, too. How would you answer these questions?
- What new or forthcoming legal or compliance issues are affecting the business or will be in the near future?
- Could this risk affect other parts of the business? (If yes, be sure to include these related risks)
- What events or regulatory issues have created business challenges in the past?
Mitigate risk by refining you processes
During this stage, you move from assessment to action by taking concrete steps to lessen or manage the risks you previously identified. Consider these questions:
- Does our plan prioritize the risks with the greatest potential to harm our patients or the business?
- Do staff members understand and follow the plan?
Monitor your pharmacy's risk performance
Once a plan is in place, you'll need to keep tabs on how well your pharmacy is managing risk not just at some arbitrary check-in point, but on a consistent basis. Continuous monitoring is essential in highly regulated businesses like home infusion services. Questions to ask yourself include:
- How do we keep employees engaged in helping monitor risk?
- How can we empower colleagues to identify risk incidents and bring them to our attention?
- Do we need to move a previously assessed minor risk up the priority scale to ensure it receives adequate attention?
Review & report your risk management performance
Go beyond basic reporting to cultivate the mindset that documenting and analyzing your risk management in pharmacy services presents important opportunities to share your risk performance with the team. The most positive outcome when sharing these data is that this will help to keep your team engaged in mitigating risks. In so doing, these questions may lead you to helpful further refinements:
- Are we capturing the best metrics to present our risk management performance accurately?
- How can team members stay informed about risk management performance but not overwhelmed by data? How often should team members receive risk performance updates? Monthly? Quarterly?
Minimizing risk in the home infusion business requires constant effort and vigilance. But once you create a robust risk management planning and review cycle that takes the challenges and safety of home infusion and compounding practices into account, you can achieve continuous improvement. By investing wisely in employee training and device technical support and maintenance services, your business will be well on its way to smoothing out the variables that exist in the home infusion process.