Health Advisory Council Newsletter | 2016 Q1 | Member Q and A
2016 | Q1 Newsletter | Q & A with Health Advisory Council Members
Leily Saadat-Lajevardi
Senior Manager, OTC Appropriate Use, Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Q. What is your role?
A. I manage our over-the-counter (OTC) medicine appropriate use efforts and initiatives. The mission of our group is to empower consumers to make the best choices for their OTC self-care by providing them with the necessary information and tools.
Q. Tell us about some of your current initiatives
A. We have several appropriate use initiatives, some that are internally led by Johnson & Johnson Consumer Inc. while others are led by external partners such as NCL. An example of an internal initiative that we launched in Q4 2015 is Every Label Every Time. This initiative is designed to educate consumers about the appropriate use of OTC medicines and the importance of reading and following all medication labels. The campaign highlights recent findings from a new survey of more than 2000 U.S. consumers such as the finding that only one in five consumers re-read the label of an OTC medicine they have used before.
An example of a current external initiative is the LifeSmarts program through our NCL partnership. Johnson & Johnson Consumer Inc. is a supporter of the development of the “Health and Safety” section of LifeSmarts U. As a healthcare company, we believe in the importance of educating future medicators and young adults about the responsible use of medicine.
Q. What is Johnson & Johnson Consumer Inc. doing to change the way people think about and approach healthcare?
A. Some consumers believe that OTC medicines are completely safe and can do no harm. OTCs are safe when used as directed, but if they are not used according to the label, they can cause harm. Our goal is to provide at-risk consumers with a “wake-up call” to choose and use OTCs appropriately so that they and their loved ones can get effective relief safely.
Q. What do you value about membership in NCL’s Health Advisory Council?
A. I value the exchange of ideas and dialogue between the Council members. In the future, I hope there will be more opportunities for partnering with Council members on appropriate use initiatives.
Q. Tell us about some of your partnerships.
A. Research shows that children begin to self-medicate around 11 years old. Unfortunately, when not equipped with the knowledge and information to make safe choices, adolescents may end up doing more harm than good. In 2014 alone, 140,000 cases of medicine exposures reported to poison centers involved children ages 6 to 19.
With this need in mind, Johnson & Johnson Consumer Inc. has supported the development of a free, evidence-based educational program for 5th and 6th graders, focused on medicine safety. The objective is to build a more responsible future medicating population and to build a healthy respect for all medicines, including OTCs, by teaching adolescents at an early age.
The program, “OTC Medicine Safety,” was developed and refined with the help of an expert panel, qualitative testing with teachers and students, and quantitative testing with over 1,200 students. In its fifth year, the program includes comprehensive resources for teachers, school nurses, community leaders, and parents – all of which play a critical role in helping tweens learn about responsible OTC medicine use and storage. All resources are completely free and available online.
Nelufar Mohajeri
Director, Global Stakeholder Engagement, U.S. Pharmacopeial Convention (USP)
Q. Tell us about your work at USP.
A. USP’s mission is to improve global health through the development of public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. For almost 200 years, USP has developed an extensive network of stakeholders and partners that engage with us to advance USP’s work of setting quality standards for medicines, foods and dietary supplements.
My work at USP focuses on how USP collaborates and engages with a diverse community of stakeholder organizations to impact the public health landscape in the U.S. and abroad. These stakeholders include academic institutions and associations, consumer organizations, governmental bodies, non-governmental bodies, manufacturers, trade associations and professional and scientific associations.
Our interactions with these stakeholders gain in complexity as we engage them in our functions at USP –developing quality standards, advocating for patient safety and safe medication use or promoting global public health, for example – and learn how to find the intersects in mission with these organizations and how to walk shoulder to shoulder as partners to advance policies, agendas, and activities.
Q. What do you love about your job?
A. I have been at USP more than seven years, and there are three distinct areas that fuel my passion for the organization. USP was founded by scientists and practitioners who were passionate about ensuring the quality of medicines for their patients. That passion continues today with a community of more than 1,000 experts who work closely with nearly 1,000 USP scientists and staff to ensure the quality and safety of medicines, dietary supplements and food ingredients in the U.S. and many other countries.
A second remarkable aspect of USP are programs that are little known to the public, but have tremendous impact on global health, such as the Promoting the Quality of Medicines program, a collaboration with the U.S. Agency for International Development (USAID) to build regulatory capacity in many countries. Through this program, USP is working with health authorities and collaborators worldwide to address supply chain issues as well as counterfeit and substandard medicines that plague so many nations.
Another little known program is the Dietary Supplements Verification program, which is a voluntary program for manufacturers of dietary supplements and dietary supplements ingredients to verify the quality of their products.
The third aspect of USP that inspires me is the diversity of staff. At USP, you will find staff representing many different nations. This diversity adds a unique nuance to the collaborative manner in which we work so that different perspectives inform our discussions, our work and our learnings.
Q. What is USP’s role in the public health sector?
A. Scientifically based, public quality standards, like those published in the U.S. Pharmacopeia-National Formulary (USP-NF), have helped ensure the quality and consistency of drugs and drug ingredients sold in the United States for almost two centuries.
Uniform public standards, such as USP’s, make it clear to everyone in industry and regulatory bodies what quality is expected of ingredients and products and what test methods are appropriate to determine whether that quality exists.
Although our standards are referenced in U.S. law, we are not part of government. Our standards are established by experts coming from diverse backgrounds – industry, regulatory agencies, academia and practitioner groups. USP’s experts and staff develop quality standards that provide a uniform point of reference for regulators, manufacturers and consumers.
Q. What public health initiatives is USP currently working on?
A. One example is the work we have developed on prescription container labeling. According to the Institute of Medicine (IOM), 77 million Americans have limited health literacy, and a majority of Americans have difficulty understanding and using health information and services. In 2007, USP started working on a standardized prescription container label with experts in patient safety, health literacy, pharmacy, medicine, human factors research and labeling technology. The goal of the standard (now called General Chapter <17>) was to organize labels in a patient-friendly way, using explicit language to describe dosages and intervals; improve readability with clear formatting; and address those with visual impairments and those with limited English comprehension.
At its 2012 annual meeting, the National Association of Boards of Pharmacy passed a resolution supporting state boards in requiring a standardized prescription container label. As with other healthcare quality standards, enforcement of General Chapter <17> is the decision of individual state boards of pharmacy, which may choose to adopt it into their regulations.
Another public health initiative USP has been engaged in for the past several years is promoting quality standards for dietary supplements. Approximately half of the American population consumes vitamins, minerals or other dietary supplements as part of their health regimen. Yet, because the regulations on dietary supplements are different than those for medicines (dietary supplements are regulated as foods), the quality and safety of these products is often put into question, with frequent reports of products connected to patient harm.
In 2001, USP started its USP Verified program for dietary supplements, which guarantees consumers of these products that what’s on their labels is inside the bottle; that the ingredients are present in the right potency and amount; that the products don’t contain harmful levels of contaminants; and that the products were made according to FDA and USP guidelines, using good manufacturing practices.
The program is voluntary for manufacturers, but we believe that choosing a product with the “USP Verified” Mark on the label provides consumers with an added assurance that the supplement recommended by their physician is of high quality.
Q. What do you value about USP’s participation in the Health Advisory Council?
A. USP’s engagement with the National Consumers League (NCL) and its Health Advisory Council is an important aspect of my work. NCL is a critical organization in the healthcare landscape because of its important work in representing consumer perspectives. Being at NCL’s table is important for USP because it gives us the opportunity to raise awareness of quality medicines, dietary supplements and food ingredients directly to patients and consumers.
