Learning about our medicines from the people who take them

At Teva, patient safety is a shared responsibility. Our employees are accountable for reporting Adverse Events, special situations and other safety information about patients taking our products to Teva’s Global Patient Safety and Pharmacovigilance Unit. Our Local Safety Officers also follow adverse events to ensure the safety of Teva medicines and to improve patient experience.

Like all healthcare companies, Teva Pharmaceuticals receives adverse event (AE) reports about its medicines from patients, healthcare workers and its own employees. Any medicine, no matter how safe and effective, can sometimes cause side effects ranging from harmless to life threatening.

“An adverse event doesn’t mean the product is bad,” says Ken Piper, Senior Director, Pharmacovigilance. “It means Teva can discover even more about the safety profile of the product so we can better evaluate its risks versus its benefits. Known adverse event information is a way to help physicians make informed decisions on whether a patient should be prescribed a certain medicine or at a certain dose. Ensuring patient safety is our ultimate goal.”

AEs are also a paradox. People might think an AE means there’s something questionable about a medicine. Not necessarily. By gathering information and analyzing data around the questions an AE raises – the responsibility of a pharmaceutical company’s pharmacovigilance department – Teva has invaluable opportunities to
learn more about its products and, when necessary, take steps to make them safer.

While the main purpose of AEs is patient safety, occasionally, they provide insight that leads to new uses for existing medicines. For example, prostaglandin analogue treatment is used for increased eye pressure, also known as glaucoma. After months of therapy, patients noticed that there was increased eyelash growth. Eyelashes of the treated eye had increased in number, thickness, length, curvature and pigmentation, which are positive benefits and protect the eye from foreign particles. Further investigation confirmed that several prostaglandin medications had the same effect, and studies conducted have confirmed the unexpected beneficial effect of some of these medicines. This newly found effect is now being used for the development of medicinal treatments for the regrowth of eyelashes.

Once an AE is reported to a pharmaceutical company, the Local Safety Officers triage it by severity – was the reaction life threatening, such as a cardiac event or shortness of breath, or less severe, such as a rash or headache? The more severe or serious an AE is, the sooner pharmaceutical companies are required to report it to health authorities. The time requirements vary by country or region, but one thing’s for sure: Teva’s LSOs never take a rest.

Local Safety Officers: Creating personal connections for Teva

LSOs are on the front lines of patient safety at Teva. By training, many LSOs in Teva’s Global Patient Safety and Pharmacovigilance unit are pharmacists, nurses or scientists, and it is their responsibility to follow adverse event (AE) reports about the company’s medicines from the time they are received to when the file is closed.

While receiving, recording and submitting AEs involves many processes and timelines, for the LSOs, what matters most is how their work connects them with patients. It’s a major reason they are passionate about their jobs. Aysha Amman, once a practicing pharmacist and now an LSO who oversees AEs reported about Teva products marketed in the United States, says her commitment to patients is as strong as when she dispensed medicines.

“As an LSO, I am directly helping patients, too. Patients often contact us when they’re frustrated, fearful or unhappy about a medicine. They worry that their situation will not be taken seriously. I help them see the bigger picture – how AE reports on a product are examined for trends that could potentially lead to a product’s safety information being updated, which helps patients, doctors and pharmacists alike.”

One Friday afternoon, Alejandra Ramirez, the Teva LSO for Mexico, received an urgent call on her company mobile phone. “A hospital pharmacist noticed the batch numbers on a medication box and the medication bottle were different so she stopped dispensing the medication because she thought the numbers should be the same.” Now after business hours, Alejandra contacted a Teva Quality Assurance team member. He traced the product and determined that the different numbers were explainable and legitimate. Alejandra followed up with the hospital pharmacist, who was then able to dispense the medication to patients confident in its safety.

LSOs are not permitted to provide medical advice to patients, but by explaining how a medicine works or what its known side effects are, they can offer a dose of reassurance. Xenia Michail, Teva EU PV Sub-Cluster Manager and LSO for Greece and Malta, received an AE call from a woman concerned about her grandparents, whose casual gambling pastime was becoming an alarmingly frequent activity. “She was very upset. I asked her about any health conditions her grandparents had and any medicines they were taking,” recalls Xenia. “I learned that they both had Parkinson’s disease, and when I heard the name of the medicine they both took to help manage symptoms, it all clicked. One of the known side effects was increased obsessive behavior. That helped her understand a possible reason for her grandparents’ increased interest in gambling, and I encouraged
her to contact her grandparents’ physician.”

Patient safety is a partnership that connects the people who are taking medicines to the companies who manufacture and market those medicines, to the national authorities responsible for public health. All of us play an important role in ensuring the safe use of medicines and improving the lives of patients.

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Find out more

• Discover our winning formula for patient safety at Teva.
• Meet Sebastian Horn, Teva’s Head of Global Patient Safety and Pharmacovigilance.
• Learn how pharmacovigilance keeps patients safe by reading “A Journey into Patient Safety.”
• WouId you like to be a part of our team, helping to improve patients’ lives? Check out our Careers page!

This content represents the opinions of the contributors and does not necessarily reflect those of Teva Pharmaceuticals. All content is aspirational in nature, is intended for informational and educational purposes, and should not be considered for any product recommendations. Consult a qualified medical professional for diagnosis and before beginning or changing any treatment regimen.