ASHP InterSections ASHP InterSections

November 18, 2019

ASHP Taking Steps to Address Drug Manufacturing Quality and National Security Risks

Filed under: From the CEO — jmilford @ 8:16 pm

Dear Colleagues,

Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

A recently released report from the U.S.-China Economic and Security Review Commission underscores the need to address our nation’s dependence on China for the manufacturing of pharmaceuticals and their active product ingredients (API). In particular, the report recommends that Congress hold hearings on the topic and pursue new quality oversight mechanisms for foreign-sourced drug products.

The report shines a light on some foreign manufacturing practices that may pose national security and public health risks. We have previously called for the Department of Health & Human Services and the Department of Homeland Security to conduct a risk assessment of national security threats associated with manufacturing and distribution of critical drugs, their APIs, and associated medical devices used for preparation or administration. Relying predominantly on other countries for necessary ingredients to manufacture crucial drugs, APIs, and devices required to safely prepare and administer drugs presents a potential threat to the stability of the U.S. drug supply. At present, more than 80% of API is produced in China and India – this leaves our supply chain vulnerable to disruption and puts API sourcing at risk.

To identify meaningful solutions, early next year ASHP will convene a summit in partnership with stakeholders and experts including government, medicine, nursing, hospitals, standards-setting bodies, manufacturers, supply chain and others to examine manufacturing quality and foreign sourcing of drug products and formulate recommendations to protect the safety and quality of the U.S. drug supply. This will build on our previous summits convened by ASHP, including the 2018 “Drug Shortages as a Matter of National Security: Improving the Resilience of the Nation’s Health Care Critical Infrastructure.” We will share more with you in the coming months as we continue to engage our partners and experts in this important area.

Please know that ASHP takes the long-term safety and quality of our nation’s pharmaceutical supply very seriously, and will allocate the necessary resources to lead efforts to help ensure that our patients have consistent access to a safe and effective supply of necessary medicines.

Thank you for being a member of ASHP and for everything that you do for your patients and our profession.





November 5, 2019

Namaste: ASHP Members are Pharmacists and Certified Yoga Instructors

Seena Haines, Pharm.D., FASHP, BCACP

SEENA HAINES, Pharm.D., FASHP, BCACP, has long embraced physical fitness. Throughout her career, the professor and chair of the Department of Pharmacy Practice at the University of Mississippi School of Pharmacy has lifted weights, taken kickboxing and spin classes, and attended boot camps. Even when she exercised twice a day, she sometimes felt overwhelmed and in need of something to help reduce stress.

About three years ago, a pharmacy colleague suggested she try yoga. Dr. Haines took advantage of an introductory special offered by a local yoga studio. Within a few sessions, she was hooked, going to class several times a week. She has since become an instructor who teaches yoga to residents and college students at the studio where she trained. She also teaches yoga at national conferences.

“I was completely amazed by the impact it had on my mindset and my stress levels,” she said. “It helped quiet what I call the ‘monkey mind’ and focus on the present moment. This was exactly the mind-body connection and stillness that I was searching for that I couldn’t find through other group conditioning activities.”

Yoga provides calm and balance
Dr. Haines is one of several ASHP members who have not only embraced yoga but have gone on to become certified yoga instructors. Kathryn Samai, Pharm.D., BCPS, is an emergency medicine clinical pharmacist at Sarasota Memorial Healthcare System in Florida. She is an instructor and enthusiast of Ashtanga yoga, a vigorous physical form of yoga that combines synchronizing breath with various postures.

She said the practice has helped her better interact with her colleagues. Yoga reminds her that everyone has stress and difficulties. She approaches each person with more compassion and a sense of shared connection. “As pharmacists, we deal in this very fast-paced workflow where you have to be extremely meticulous and extremely detail-oriented,” Dr. Samai said. “We interact with a lot of people who are upset, hurting, and stressed-out, whether it’s our co-workers or our patients.”

Hala Hijazi, Pharm.D.

She has discovered that yoga gives her more time because she operates in a different mindset. “It’s almost like you can slow things down even though the workflow is never going to slow down,” she said. “Yoga is the attainment of a calm and peaceful state of being.”

ASHP member and yoga instructor, Hala Hijazi, Pharm.D., agrees. She is a clinical staff pharmacist at King Faisal Specialist Hospital in Riyadh, Saudi Arabia. Dr. Hijazi found yoga as a teenager when her aunt suggested she try it to help manage the stress surrounding her ulcerative colitis.

Dr. Hijazi noted that practicing yoga helped her survive her pharmacy residency and today makes her feel more balanced in her life, work, and spirituality. A breathing technique called pranayama, also known as the life force, helps her get into a meditation state.

“I learned to slow down, be more patient, and focus more,” Dr. Hijazi said. “Now, when I have a few tasks to do, I don’t become stressed-out about them. I prioritize and take it task by task.”

Benefits of yoga
Published studies demonstrate many benefits to yoga, Dr. Haines noted, including lowered anxiety, depression, and risk for cardiovascular events. “I feel that practicing yoga is essential for success in preventing disease onset and severity,” she said. “It can provide dividends now and in the future as we continue to age.”

Yoga not only is good for flexibility and physical health but also can help people become more centered, added Dr. Samai. “When you start to do these physical postures, you lengthen your spine and [improve your] ability to bend and move. You find yourself becoming more patient, more compassionate, making a little more room for kindness,” she said.

Yoga for beginners
There are many ways for busy pharmacists and student pharmacists to incorporate yoga into their lives, said the interviewees. Ideally, try a class at a local studio or even online, Dr. Hijazi advised. Initially, she said, “just an hour a week was enough for me to feel like I was going to be ok.”

Kathryn Samai, Pharm.D., BCPS

Some hospitals or institutions host classes. In addition to her studio classes, Dr. Samai teaches 15-minute sessions of gentle yoga at her hospital a couple of times a month. These short sessions are focused on relieving stress and fatigue.

Dr. Samai advises individuals who are new to yoga to try different types. Some may seem too physical or too gentle, or have too much chanting for your taste, she said.

According to Dr. Haines, there are many styles of teaching, and it may take some time to find what works for you. Be patient with yourself as your body adjusts to some of the positions. Over time, you will see improvement, she added.

Dr. Hijazi explained that yoga doesn’t have to take up a lot of time. Take five minutes when you wake up, after work, or before you go to sleep, to turn your attention inward. Do some breathing techniques to slow down, or think of things for which you are grateful, noted Dr. Hijazi, who teaches classes at her home, a local studio, and online.

Dr. Samai sets alarms on her phone to remind her to repeat one of her mantras. Pharmacists can do something similar each time they do an automatic task, like washing hands or using sanitizer before entering a patient room. When a pediatric patient died in the ED recently, she took a few minutes for breathing as a transition before resuming work. “You don’t have to get yoga pants, you don’t need to drive somewhere or do something,” said Dr. Samai. “Those little moments of mindfulness are yoga.”

Remember that yoga is a life journey, not just a session where you go and work out, said Dr. Hijazi. “I would say to any pharmacist or health care practitioner, we should give ourselves time every week to find ourselves, and yoga helps us do that,” she added.


By Karen Blum


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