Shortage Prevention and Mitigation Plans a Reality for Compliance

On June 18, 2024, the EMA issued templates for Shortage Prevention Plans (SPPs) and Mitigation Plans (SMPs). Marketing authorization holders (MAHs) in the European Union/European Economic Area are encouraged to create SPPs to minimize the risk of medicinal shortages. SPPs are already obligatory under Regulation 2022/123 for drugs listed in the list of critical medicines for that particular crisis, and the US has similar guidance.

Shortage Prevention Plans help to identify and manage potential risks in the supply chain and include information on the MAH, the supply and manufacturing chain, key data on stock, sales, consumption, and manufacturing, and an analysis of the history of supply issues. A SPP should be in place for each medicinal product marketed by the MAH. The minimum requirements for the SPP state that MAHs should analyze and evaluate weaknesses in the supply chain. The robustness of shortage prevention measures is to be evaluated. MAHs are obliged to assess the risks of supply interruptions for patients. A medicine shortage risk register should be developed to identify clinically significant products based on therapeutic use and availability of substitutes. Using available information, such as root cause analysis of shortages, the MAH must determine whether corrective and preventive actions or revalidation are needed nationally and internationally. Furthermore, MAHs should maintain minimum stock levels at national levels. Measures to prevent drug shortages should be reviewed regularly.

Shortage Mitigation Plans are designed to eliminate potential or actual drug shortages and minimize the impact on patients. The minimum requirements for the SMPs include procedures for dealing with shortages, from identification to resolution. These procedures should include measures to reduce the shortage’s impact, notification to regulatory authorities, and follow-up actions. MAHs should define roles, responsibilities, and escalation processes and maintain records of root causes and mitigation measures after resolving shortages.

Both should be readily available for submission upon request and can be subject to inspection during GMP and/or GDP inspections or inspections of MAHs. Thus, they should be living documents in the quality system together with the SMF, contamination control strategies, APQRs, and other similar apex documents.

Parental Leave

When I had my kids I was lucky to be able to take a week or two, and it certainly wasn’t easy coming back. As such I’m really invested in making sure my team gets the opportunity to have more breathing room around parental leave than I did. Here’s my checklist of activities.

Recommendation	Description
Plan early	As soon as you are notified of the upcoming leave, start discussing transition plans, coverage needs, and expectations.
Create a transition plan	Work with the employee to document key responsibilities, ongoing projects, contacts, and critical information.
Be supportive	Recognize this as an important life event and avoid making employees feel guilty about taking leave.
Maintain appropriate contact	Establish expectations upfront for communication during leave.
Plan for re-entry	Schedule a meeting before the employee returns to bring them up to speed on changes.
Be flexible upon return	Consider gradual return options and be open to flexible work arrangements.
Focus on outputs	Trust that the employee can still perform at a high level, even if their work style changes.
Provide mentoring support	Connect returning parents with other employees who have successfully navigated parental leave.
Review compensation fairly	Ensure taking leave doesn’t unfairly impact compensation or advancement opportunities.
Use leave as an opportunity	Identify ways to improve processes or develop other team members’ skills.
Communicate effectively	Be transparent about leave plans and delegate responsibilities clearly.
Trust and empower	Create growth opportunities for team members by delegating responsibilities.

Actions for Parental Leave

Thinking About the High Performers

I am blessed to have inherited a lot of high performers from my predecessor, who built and sustained a highly functioning team, often amid chaos.

I think about what that means to my team a lot. Being a bunch of high performers, they tend to get:

Stressful projects and goals: They often receive a lot of complex and risky projects and goals.
Meeting mania: Because my team is viewed as an essential part of the work (and they are) and can solve even the thorniest issues, their days are filled with back-to-back meetings.
Return-to-office pressure: Because they are “high profile,” my local team members are expected to work more from the plant, resulting in less flexibility. There are many good reasons for this, but that doesn’t make it more popular.

As I move through my 2nd quarter, here are the activities I am working to implement.

Establish a simple weekly team rhythm that drives intensity, not pressure. This is going to take a lot of effort with my peer teams. We need to build a rhythm where we know (to a much higher detail) the types of work we do. I want to move more to a model where we do prioritization on Monday, including defining projects, managing change controls, etc.; problem-solving midweek and a time we do a lot of execution (though frankly, that also happens on the weekend); and Friday is to review completed work, share feedback, and align on next steps. No matter what, we need to create a standardized calendar.

Measure the team’s motivation. As I get close to my 5-month mark, I will be asking the following questions:

What are teammates excited about working on in the second half of the year?
What might be causing them anxiety or pressure?
What habits does the team want to improve?
What are some specific ideas for improving those habits?
What did we do really well last quarter that we should maintain?

Continue to prioritize teaching. I will be scheduling a quarterly skill-check meeting with each of the team. During this conversation, I will help the individual reflect on their current skill goals and pick a new one if they don’t yet have any or have hit them all. We put a lot of work into this during my first quarter, and it is critical to continue to grow here.

Practice Joy. Practicing joy at work is important to maintaining a positive work environment and improving overall job satisfaction.

Cultivate gratitude: Start each day by acknowledging something you’re grateful for at work.
Celebrate small wins: Recognize and appreciate your accomplishments, no matter how small. This can boost your motivation and create a sense of progress.
Find purpose in your work: Connect your daily tasks to the larger goals of your organization or to your personal values. Understanding how your work contributes to a greater purpose can increase job satisfaction.
Find humor in daily situations: Look for opportunities to laugh and share light moments with your colleagues. Humor can help reduce stress and create a more positive work environment.
Practice self-care: Prioritize your physical and mental health by getting enough sleep, eating well, and exercising regularly. When you feel good, it’s easier to experience joy at work.