FDA, FTC Act To Remove HCG Weight Loss Products From Market

FDA News Release

The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) today issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss.

Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and found in the urine of pregnant women. HCG is FDA-approved as an injectable prescription drug for the treatment of some cases of female infertility and other medical conditions.

The letters warn the companies that they are violating federal law by selling drugs that have not been approved, and by making unsupported claims for the substances. There are no FDA-approved HCG drug products for weight loss.

The joint action is the first step in keeping the unproven and potentially unsafe products from being marketed online and in retail outlets as oral drops, pellets, and sprays.

The labeling for the “homeopathic” HCG products states that each product should be taken in conjunction with a very low calorie diet. There is no substantial evidence HCG increases weight loss beyond that resulting from the recommended caloric restriction. Consumers on a very low calorie diet are at increased risk for side effects including gallstone formation, electrolyte imbalance, and heart arrhythmias.

“These HCG products marketed over-the-counter are unproven to help with weight loss and are potentially dangerous even if taken as directed,” said Ilisa Bernstein, acting director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “And a very low calorie diet should only be used under proper medical supervision.”

“Deceptive advertising about weight loss products is one of the most prevalent types of fraud,” said David Vladeck, director of the FTC’s Bureau of Consumer Protection. “Any advertiser who makes health claims about a product is required by federal law to back them up with competent and reliable scientific evidence, so consumers have the accurate information they need to make good decisions.”

According to the Warning Letters, the companies have 15 days to notify the FDA of the steps they have taken to correct the violations cited. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution.

Consumers and health care professionals are encouraged to report adverse events (side effects) that may be related to the use of these products to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.

Sell Yourself

By DWIGHT NYBERG | President | MPA

In the early 1970’s, my Dad’s prescription volume was one-third of today’s volume, and he made twice the profit! That’s the new math I never understood.

The President’s call for zero copay on prescriptions for our Tricare patients is a prime example of not understanding healthcare. The lower copay for prescriptions should be available at the pharmacies that provide one-on-one or face-to-face consultation, patient education, drug therapy modification and/or product selection. The remaining pharmacies are mandated to charge copays.

It’s a proven fact that medication therapy management and patient education are both proactive methods of: Improving healthcare outcomes and quality of life. What an example of managing healthcare expenses! The same pharmacists who are hurt by this are already dispensing a larger percent of generic drugs. This helps the health care system save more money.

Could you do 20 or 30 MTM’s or patient education sessions each day, at $100 to $150 per session?

Remember, you’re the expert, you’re the best, you’re selling yourself.

Take a moment, estimate the dollar savings you could create each day, week, month, and year.

An easy $200 to $300 a day, $1,000 to $1,500 a week, $20,000 to $30,000 a month … you continue and use your estimate. Are you worth more than $150 per session?

Now, think about the diabetic, the asthma patient, the potential fall patient who’s lifestyle and quality of life you helped improve.

You’re the drug expert, you’re selling yourself !!!

Afraid the future will leave you behind? Then help create the future!

Participate with the Missouri Pharmacy Association as we challenge, change, and develop the future of Pharmacy.

An opportunity for all pharmacists!

Sell yourself, SELL YOURSELF!!!

International Pharmaceutical Experience

By KK VOUTHY | UMKC | 2013 Pharm.D. Candidate

On September 7 three UMKC School of Pharmacy students traveled to Mexico City to present a poster at the International Society for Pharmacoeconomics Outcomes Research third Latin America Conference. The poster the students submitted, with guidance from faculty members, was titled Describing Trends and Determinants of Non-opioid Analgesic Prescribing Chronic Non-Cancer Pain in the U.S. Outpatient Settings.

The poster was a finalist for the best poster in the Health Care Use & Policy Studies – Disease Management category. The presentation was open for conference attendees to attend and speak with presenters regarding their findings. UMKC students had an opportunity to meet with researchers from various countries including Argentina, Mexico, Brazil, Colombia, Canada, and  the United Kingdom.

“Most of the presentations were not in English, but they had translators you can listen to. There was definitely a language barrier since most people spoke Portuguese or Spanish,” says Fikru.

In between poster presentations, fourth year students Bithia Fikru, Walter Agbor, and KK Vouthy attended various educational lectures about health technology assessment, costs of healthcare, pharmacoeconomics of various disease state management strategies and issues facing Latin American health.

“It was an eye opener to see how advanced the United States utilization of health care technology to make cost effective decisions compared to a Latin American countries , they are in the process development stage,” says Vouthy.

Before they left, the three students experienced Mexico City by taking a self-guided tour of the central portion of Mexico City. They tasted well-cooked –piping-hot street tacos, freshly made tortillas, roasted corn on a stick, and drank from a young coconut with a straw.

They also had a chance to Salsa in the park, every Friday night and all day Saturday people gather around at the park and dance. Instructors, experienced and un-experienced dancers come together to practice and enjoy dancing.

“The people are very warm and affectionate; you can see that everywhere you go. The culture is very romantic,” says Agbor.

On their last day, students were amazed at how committed to health the city was to promote bike riding. Large portions of the historic center of Mexico City were closed to traffic, the weekly event was called Muévete en Bici or Move by Bike. Throughout the area there were bike stations for people to check out bicycles called Ecobicic. Their hotel was centrally located in the historic area; the students had an opportunity to get their morning work, walking many blocks to find a taxi to the airport. The trip was a success; they worked with the University and SOP student services office to ensure a safe trip.

Service and Gratitude

By ANNE STEGEMAN | UMKC Class of 2013 | APhA-ASP Publicist | NCPA Public Relations

Remember that important oath we took as student pharmacists the first day of orientation and the night we received our white coats? Do you remember exactly what it says?

Pharmacist Oath

I promise to devote myself to a lifetime of service to others through the profession of pharmacy. In fulfilling this vow:

1. I will consider the welfare of humanity and relief of suffering my primary concerns.

2. I will apply my knowledge, experience, and skills to the best of my ability to assure optimal outcomes for my patients.

3. I will respect and protect all personal and health information entrusted to me.

4. I will accept the lifelong obligation to improve my professional knowledge and competence.

5. I will hold myself and my colleagues to the highest principles of our profession’s moral, ethical and legal conduct.

6. I will embrace and advocate changes that improve patient care.

7. I will utilize my knowledge, skills, experiences, and values to prepare the next generation of pharmacists.

8. I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.

Are you keeping your promise?

As student pharmacists we are very busy. We have a lot going on: school, student organizations and fraternities, family, friends, and let’s not forget that other thing … What’s it called again? Oh yeah, a job!

A wise friend once told me, “You’re blessed to be stressed.”

We sometimes feel frustrated with all our requirements and commitments but in reality we’re the lucky ones. We are so fortunate to be in the position we are, lucky for the opportunities presented to us, regardless of the degree of difficulty, just because we are in school, and pharmacy school at that. We’re lucky to gain the experiences we have available to us while in school and the support to keep us going all the while.

Many times we take it for granted how much we have at our fingertips … to be on campus with our class and the convenience to provide community service to patients in our town.

Weird to think of it that way, huh?

Meet Christina Stafford
Class of 2012

She joined the army reserves her senior year of high school as a way to help pay for college. She was deployed to Kosovo 2000-2001. Later that year, she was deployed again after 9/11 to fill in for those soldiers that were sent to Afghanistan.

In 2002, she took a leave after her mother was diagnosed with cancer but rejoined after receiving her acceptance letter to pharmacy school.

She was slated to go to Iraq a couple of years ago, but fortunately, her unit got pulled from that mission.

Current deployment- her unit is being sent to the Sinai Peninsula of Egypt to provide medical and logistical support to the soldiers there. They are part of MFO (Multinational Force and Observers), an independent international organization with peacekeeping responsibilities in the Sinai. She will be utilized part of the time as the pharmacy tech and will be called on for other pharmacy duties as needed. With the intense election scene in Egypt, her unit must still be proficient as combat soldiers. She is set to return sometime in August, 2012.

Feeling a little more lucky now? I challenge you to rededicate yourself to your promise of service this year. This is what you worked so hard for to be here today. Don’t forget it. So I encourage you to act with intention, serve with respect, and advocate for improvements.

Oh yeah, and the Gratitude part?

Don’t take these opportunities for granted. Not many are called to the position we are, so let’s make the most of it. And don’t forget to tell those serving us a big “Thank you!” even if it’s a simple smile.

Have you shown gratitude to those serving you in your pharmacy career path?

Whether it be a boss or mentor who wrote you letter of recommendations to apply and get accepted into school, maybe an upper classmen giving you advice on how to approach studying for a class, or maybe all the faculty and staff at school that have helped prepare you for your future.

A kind comment or small note can go a long way. Sometimes we get so consumed in taking care of our patients that we forget to take care of each other. One of these days, you will be the one serving pharmacy students and that small token of appreciation can light up your world… even far away in Egypt.

Thank you Christina Stafford for keeping the promise to devote yourself to the service of others. ϖ

UMKC Students Active all Semester Long

By KK VOUTHY | UMKC 2013 Pharm.D. Candidate

UMKC Student pharmacists jumped into action before the fall semester started in mid-August. The year began with a collaborative effort between the medical, dental , and nursing school for an event called “Lunch on the Lawn.” Students on the Health Sciences campus came together for an opportunity to learn about respective disciplines located on the Hospital Hill. Various organizations from the three schools had an opportunity to show case and recruit new members.

In October, student pharmacists from both campuses participated in the Script Your Future Campaign to spread awareness regarding the dangers of not taking medications properly. The APhA-ASP chapter published a public service announcement in the Kansas City Star newspaper about American Pharmacist month and promoting medication adherence.

Numerous activities helped launch the event in conjunction with the American Pharmacist Month Celebration on October 3. A reception was held for pharmacy faculty, staff, and students. UMKC and Columbia campuses both held multiple health fairs at the local farmer’s market to offer patient care screenings such as blood glucose testing and blood pressure measurements. Patients were also educated on medication compliance and proper drug disposal methods for unused, unwanted medications.

In the same month, students volunteered at the Kansas City CROP walk to distributed water for walkers. UMKC students educated over 300 walkers about medication compliance.

In November, fourth year student pharmacists assisted at the annual UMKC Healthy for Life Employee Health Fair. Student gave flu shots, took blood pressures, and performed blood glucose testing for faculty and staff. The experience gave students the opportunity to apply their class room knowledge to the real world.

Most recently, the national pharmacy leadership society, Phi Lambda Sigma teamed up with UMKC APhA-ASP to offer student pharmacists the opportunity to improve upon their interviewing skills and sharpen their curriculum vitae.

As the semester comes toward an end, students get a week break for Thanksgiving to catch up on family, work, and rest. When they return, it will be time for finals and preparation for the coming new year. Until the next time, on behalf of all student pharmacists at UMKC, we appreciate all the support from the Missouri Pharmacy community.