November 2017 Newsletter
 
Webinar-Thursday, December 14, 2017 - 12 noon-1:00 pm
Clinical Case: Dual Calcium Channel Blockade for the Treatment of Hypertension 
 
 
AdrianStephens,PharmD
PGY2AmbulatoryCarePharmacyResident
GradyHealthSystem
 
Objectives: 

Recall current treatment options in the management of resistant hypertension

Evaluate the mechanisms and potential synergistic activity of nondihydropyridine (Non-DHP) and dihydropyridine (DHP), calcium channel blockers (CCBs)

  Identify patient populations which may benefit from dual CCB therapy
 
Georg ia  Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharm acy Education (ACPE) as a provider of continuing pharmacy education. This program is approved for 1 hour (0.1 CEUs) of continuing pharmacy education credit.  Proof of participat ion will be posted to your NABP CPE profile within 4 to 6 weeks to 
participants who have successfully completed the post-test.   Participants must participate in the entire presentation and complete the course evaluation to receive continuing pharmacy education credit.  UAN  # 0228-0000-17-144-L01-P; 0228-0000-17-144-L01-T



This is a member service of GSHP.  There is no charge for members to attend.   Dues must be current to receive CE credit.
Non-members will be charged $20.

Non-member registration:  Email
sglass@gshp.org
Call for Committee Volunteers


GSHP invites you to serve as a member of one our committees during the 2018 year.  


 

GSHP's mission is to help our members become better practitioners.  We work towards fulfilling our mission every year through education of our members via district meetings, statewide meetings, newsletters, and our website; fostering professional standards; educating the public about the role of health system pharmacists; monitoring legislative issues that affect pharmacy; and by promoting health system pharmacy as a career path for future pharmacists.  The majority of our Society's work is done by member volunteers working through our committees.  You can play a vital role by serving on one of our committees.  


 

What will you get out of it?  It looks good on your resume.  You will meet and get to know many of the current and future pharmacy leaders in Georgia, make new friends, and maybe make a good impression on a future employer.  Also, you will have the professional satisfaction of helping shape and advance health system pharmacy in Georgia.  

What is your commitment?  It can be as little as giving your input during our upcoming
Committee Day on Saturday, January 6, 2018 and participating in conference calls, to taking on other assignments depending on your interests and time.   


 

The following is a description of the functions of each committee.  If you are interested in serving on a committee for GSHP, please click on the link below:  

https://www.surveymonkey.com/r/2018gshpcommittee

 

If you were a member of a committee last year, please also click on the link and confirm your participation for this year.  

Committees will meet on Saturday, January 6, 2018 from 9am to 12 noon at Eagles Landing Country Club in Stockbridge, (directions).  If you cannot attend  Committee Day, you can still serve on a committee.  The Committee Chair will contact you regarding upcoming meetings or other opportunities to participate. 


 

COMMITTEE FUNCTIONS AND CHARGES: 


 

COMMUNICATIONS COUNCIL: The Communications Council and Editorial Board is responsible for the direction, development, and quality control of all GSHP publications, including the GSHP web site. 


 

EDUCATIONAL AFFAIRS: The Educational Affairs Committee is responsible for planning, coordinating, and evaluating educational content of the 3 statewide GSHP meetings.   


 

LEGISLATIVE AFFAIRS: The Legislative Committee is responsible for informing the GSHP membership and Board of Directors of important legislation and regulations and how they will impact pharmacy practice in organized health care settings in Georgia. 


 

ORGANIZATIONAL AFFAIRS: The Organizational Affairs Committee reviews and analyzes the GSHP organization and make recommendations to increase its effectiveness. It also serves as a liaison between GSHP and other professional organizations. 


 

PROFESSIONAL AFFAIRS: The Professional Affairs Committee provides recommendations to the Board of Directors on policies and actions to be taken by GSHP on issues of professional practice.  


 

PUBLIC RELATIONS: The Public Relations Committee provides the public with information and awareness of GSHP's mission and values through a variety of forums and media. GSHP's publics include, but are not limited to: patients/consumers and their families, industry, other healthcare professionals, organized healthcare executives, academia, pharmacists, technicians and other pharmacy support staff, and other pharmacy professional organizations.  

 

STUDENT and RESIDENTS COMMITTEE: The Student and Residents Committee provides input to GSHP on how to get students interested in health-system pharmacy practice and how to get them interested and involved in GSHP.   


 

Make a commitment to get involved with a GSHP Committee.

 

 
GSHP Leadership Profile
Rondell Jaggers, PharmD

What is your current leadership position in GSHP?
 
Co-chair, Legislative Affairs Committee.  I'm also a Past President (2006-2007).
 
What benefits do you see in being active in a professional association such as GSHP?  
 
My involvement with state affiliates dates back to 1988 when I was elected as a board member to the Kentucky Society of Hospital Pharmacists.  I was just a few years out of my PharmD program at UK and in my first formal management role as pharmacy coordinator in a 300 bed community hospital.  The benefits of being involved were the same then as they are now:
 
  • Networking with friends and colleagues in other health systems and exchanging information on common initiatives and concerns, e.g. new drugs, pharmacy operations, pharmacy regulations, technology, advancing services, workforce needs, student and resident needs, etc.
  • Leadership development - Serving in leadership roles in professional associations such as GSHP helped me develop better organizational abilities and to improve my own leadership skills.  Also, having a leadership role at the state level often becomes a doorway to involvement with The American Society of Health System Pharmacists (ASHP).  ASHP has always provided various leadership development opportunities (workshops, symposia, Presidential Retreats, etc.).  Some of those early programs and opportunities were instrumental in me learning to run a meeting better; to become more comfortable doing formal presentations; learning to work with the other officers and board members to accomplish the organization's goals and provide value to our membership which by the way was a skill that hopefully translated well back into the organizations where I worked.
  • Last but certainly not least (and maybe most importantly), I think being active with professional associations exposed me to the seemingly limitless opportunities we have as pharmacists.  It helped me be around others, often leaders in the profession, who were able to help me develop personally and professionally.  Their experience, insights, vision, and lessons learned - that they willingly shared with me - helped make me a better pharmacist and hopefully a better manager and leader.       
What initially motivated you to get involved in GSHP?
 
While I was already motivated to become involved, I believe it was in January 2001 while I was working at Northside Hospital in Atlanta that our Director of Pharmacy (Mitch Wood) and my Manager (Judy Gardner) came to my desk one morning and basically said "GSHP's Committee Day is Saturday morning at Mercer.  We'll expect to see you there at 8:00".... Really, true story.  Up until then I had attended a couple of meetings and was looking for a chance to become involved and thanks to a nudge from my bosses I jumped in.  I left that annual committee day as Chair of the newly formed Student and Resident Affairs Committee.  I'm very grateful to Mitch and Judy for that nudge.  They didn't have to push too hard.
 
Where did you go to pharmacy school?
 
University of Kentucky... Is it basketball season yet?
 
Where have you trained or worked?  
 
After receiving my degree from UK, I had positions as a pharmacist, Director of Pharmacy and Pharmacy Coordinator in three small to medium sized community hospitals in Kentucky.  In 1992 to I moved to Gainesville, Florida to complete an Administrative Residency in Hospital Pharmacy at Shands at The University of Florida.  From there I moved to Northern Virginia and was an assistant director at Inova Farifax Hospital.  In 1999 my wife and I moved to Atlanta.   In Atlanta, I have worked as a pharmacist at Emory University Hospital, Clinical Pharmacist and Manager at Northside Hospital and since 2006 I have been at Grady Health System (GHS).   
 
Describe your current area of practice and practice setting:
 
I'm currently Executive Director of Pharmacy and Medical Nutrition Therapy at Grady.  I'm responsible for all GHS pharmacy operations and clinical services to our acute care facility (>28,000 discharges annually), our emergency department (> 145,000 visits annually), The Georgia Cancer Center for Excellence, and our primary care and specialty clinics. 
 
In addition to our inpatient pharmacy operations we have 13 outpatient prescription pharmacies and fill over 800,000 prescriptions annually.  Over 50% of our outpatient prescriptions are for un-insured or underinsured patients who pay $5 or less per prescription. 
 
Our clinical pharmacy programs include specialty services in critical care, drug information, internal medicine, infectious diseases, oncology, emergency medicine, and primary care.  We also provide a PGY1 Pharmacy Residency Program (5 positions) and have PGY2 programs in multiple specialties. 
 
What advice would you give to student pharmacists?
 
Your career, and for that manner personal life, will be a journey, not a sprint.  Be patient (BTW, I was not) and do not expect to accomplish all your career goals in the first five years after you finish your Doctor of Pharmacy. 
 
Most of you will complete pharmacy school in four years and if you pursue residency that will be another 1 to 2 year commitment.  If you're 24 to 26 years old when you complete your training, then you'll likely have 35 years (+ or -) of practice in front of you.  If you approach your new career at full throttle, it's analogous to trying to run a marathon at a sprint pace, i.e. the pace is sustainable for a while, but eventually you're going to hit a wall, so when you do hit the wall, be prepared to bounce back.  Sooner or later we all hit a wall that we didn't' see coming; how we bounce up from it is has a lot to do with sustained success. 
 
What pharmacy related issues keep you up at night?
 
New technologies, both drugs and information systems.  The rapidly increasing rate of advancement in technology and information systems is driving a pace of change that is stretching health systems' ability to implement and use them effectively.  This is not just a pharmacy phenomenon.  I think health care and pharmacy continue to be at an ever increasing risk of becoming "high tech and low touch".  Our patients need us to slow down, listen to their needs and help them take better care of themselves. 
 
Do you have any special interests or hobbies outside of work?
 
College basketball season is about to kick off, so I'll be following my Wildcats hopefully through March Madness.
 
What is your favorite place to vacation?
 
Nearby, Savannah
 
Faraway, Europe, e.g. Italy, Belgium,
 
What 3 adjectives would people use to best describe you?
 
It depends on who the people are.
 
A few people might use words like stubborn or hard headed. Alternatively I prefer to think of myself as determined.
 
I hope most others would say, diplomatic, reliable, encouraging, but I can think of a few people who excel at bringing out the grumpiness in me so they might use different words.  

Clinical Managers Call

Monthly Georgia Society of Health System Pharmacists invites all clinical leaders across the state to participate in a monthly conference call on current clinical pharmacy related topics affecting the practice of clinical pharmacy across the state.  Clinical Coordinators, Clinical Managers, Assistant Directors of Clinical Services or anyone else who serves in a formal or informal clinical leadership role is welcome to participate.  Calls are held at 3:00 PM the third Monday of every month. A call for agenda items will be sent out the week prior, and the final agenda will be sent out prior to the call.    

Clinical Articles

The Skinny on Weight Loss Drugs: Combination Options


Authors: Thomas 'Judd' Ott, Student Pharmacist Mercer University, Kendra Manigault, Pharm.D., BCPS, BCACP, CDE, Clinical Assistant Professor, Mercer University, Amy Grimsley, Pharm.D. BCOP, Pharmacy Residency Coordinator and Pharmacy Educator, Cheyenne Regional Medical Center


 

Introduction

In the previous article, we discussed the effects of obesity on comorbid conditions. In addition to the increased risk of comorbid conditions, obesity increases healthcare costs.  In 2008 an estimated annual health care cost of $147 was spent in the United States to treat obesity and comorbidities due to obesity.1 Finkelstein et al found obese individuals had medical costs $1,429 higher than individuals with normal weight in their study evaluating the costs of obesity across payers.1,2 Medications proven to increase weight loss and reduce weight regain can offer an opportunity to help combat obesity and potentially decrease medical spending by helping patients maintain a healthier body weight. The removal of weight loss drugs such as sibutramine, dexfenfluramine, and fenfluramine from the market for safety concerns led to few options for obesity management. The recent approval of newer medications for weight loss provides clinicians and patients with options to assist in achieving weight loss goals. Although several meta-analyses and reviews have compared available options, an updated review is needed to evaluate the newer therapeutic options. This third article of this three-part series will review combination weight loss medications available to treat obesity and offer a final conclusion on FDA approved weight loss medications role in weight loss management.

 

Sympathomimetic/Anticonvulsant combination


 

Phentermine hydrochloride and Topiramate (Qsymia®)

Combination phentermine and topiramate extended-release (ER) is approved under the brand name Qsymia® for weight management. As previously mentioned phentermine is a sympathomimetic amine that suppresses appetite through release of catecholamines in the hypothalamus.3 Topiramate, an antiepileptic drug (AED), has a mechanism of action for weight management that is not fully understood at this time. It is suggested that the weight loss mechanism could be contributed to a combination of effects on both appetite suppression and increasing satiety.4

Phentermine/topiramate is indicated for chronic weight management in patients with an initial BMI ≥ 30 kg/m2 or ≥27 kg/m2 accompanied with other risk factors (hypertension, dyslipidemia, and diabetes). It is available in capsules containing immediate-release phentermine and extended-release topiramate in four different combinations (phentermine mg/topiramate mg): 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg. It should be taken once daily in the morning without regard to food. The starting dose is 3.75 mg/23 mg and should be titrated to 7.5 mg/46 mg once daily after 14 days of therapy.  At the end of a 12-week period, the patient should be evaluated for ≥3% loss of baseline body weight. If the patient is not at goal, it is recommended to either discontinue the medication or increase the dose. The patient should be reevaluated 12 weeks after the dose increase, if the patients fails to achieve a ≥ 5% weight loss at the maximum dose, then discontinuation of therapy is recommended.4

Two selected studies evaluated phentermine/topiramate ER, the EQUIP study and the CONQUER study, both showed statistically significant results (P < 0.0001). 5,6 At the maximum recommended dosage of 15mg/92mg the EQUIP study showed an average decrease of 10.9% from baseline body weight compared to 1.6% decrease in the placebo group.5The CONQUER study showed an average of 10.2 kg decrease from baseline weight compared to an average of 1.4 kg lost in the placebo group.6  The CONQUER study reported an average 8.1 kg loss in baseline weight and 62% of patients lost > 5% of their body weight with the recommended dose of 7.5mg/46mg.6

The package insert for the combination product reported adverse reactions that occur in greater than 5% of patient populations include paraesthesia, dizziness, dysgeusia, insomnia, constipation and dry mouth. Patients should be monitored for suicidal ideation due to increased risk of suicidality associated with topiramate.4 Abrupt discontinuation of topiramate has been associated with an increased risk of seizures, therefore, patients should be titrated down when discontinuing therapy to reduce the risk of producing an event. Phentermine/topiramate has been shown to increase heart rate by as much as 20 beats per minute and should be monitored in all patients.4 Contraindications include pregnancy, glaucoma, hyperthyroidism, and use with or within 14 days of monoamine oxidase inhibitors. It should also be noted that use of the Risk Evaluation and Mitigation Strategy (REMS) program is mandatory due to risk of fetal toxicity.4,7


 

Opioid Antagonist/Antidepressant Combination


 

Naltrexone Hydrochloride and Bupropion Hydrochloride (Contrave®)

Naltrexone and bupropion, marketed as Contrave®, is approved for chronic weight management. This medication is a combination of an opioid antagonist (naltrexone) and an antidepressant (bupropion). Naltrexone/bupropion is thought to regulate food intake by effecting two separate areas of the brain: the appetite regulatory center of the hypothalamus and the mesolimbic dopamine circuit (reward system).8

Naltrexone/ bupropion is indicated in patients with initial BMI ≥ 30 kg/m2 or ≥27 kg/m2 accompanied with other risk factors (e.g. hypertension, diabetes, and dyslipidemia), to be used as an adjunct to diet and exercise.8 It is available as an ER tablet containing 8 mg of naltrexone and 90 mg of bupropion. The goal daily dosing is two tablets twice daily; titration should occur by using escalating dosage regime over a 4-week period. Patients should avoid taking the combination product with meals that are high in fat content due to a potential substantial increase in systemic distribution. Drug therapy should be discontinued if a 5% baseline weight loss has not been reached after 12 weeks.8

Reported data for naltrexone/bupropion from one clinical trial showed the combination drug was able to produce a mean change in body weight of 6.1% compared to 1.3% in placebo groups, 48% of patients in the naltrexone/bupropion group were able to lose at least 5% of their initial body weight compared to 16% in the placebo group (P < 0.001).9 One other study showed a mean change in body weight of 9.3% compared to a change in the placebo groups of 5.1%, with 66.4% of the treatment group losing at least 5% of their initial body weight compared to 42.5% in the placebo group (P < 0.001).9,10

Labeling for this combination product reports the common adverse reactions occurring at greater than 5% in patients include nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.8 There are two black boxed warnings associated with the combination, suicidal thinking/behavior and risk of neuropsychiatric effect (e.g. changes in mood, psychosis, paranoia). Of note, no suicides occurred during clinical trials and only 0.2% of patients reported suicidal ideation.8 Bupropion use also may increase risk for seizures. Caution should be used in patients that experience episodes, at risk for, or have a history of seizures. Consideration should also be given to patients that may be affected by an increase in opioid resulting in overdoses, increases in blood pressure and heart rates, hepatotoxicity, precipitation of mania, and angle-closure glaucoma.8


 

Discussion/Conclusion

Available weight loss medications provide prescribers with more options than ever to combat the growing issue of obesity. Most of the medications discussed require strict adherence to drug, diet and exercise regimens to be effective. For non-adherent patients, drugs with simply dosing regimens may be most appropriate. Additional patient specific parameters (e.g. willingness to administer an injection, comorbidities, etc,) should be reviewed prior to selecting pharmacotherapy. Of particular importance is the cost of the medications as weight loss drugs are not commonly covered by insurance. Patient-assistance programs or coupons may enable patients to afford medications but it may be challenging for patients to maintain weight loss goals if they are unable to continue therapy due to costs.

In conclusion, the weight loss medications discussed can provide patients with a 5% or greater sustained weight loss, a clinically significant number determined by the AHA/ACC/TOS obesity guideline, when used in conjunction with diet, exercise, and other behavioral/lifestyle modifications. Patients should be reminded that the first step to weight loss and a healthier lifestyle is an effective diet and exercise routine. Newer agents provide additional options for patients to obtain their weight loss goals. Providers should evaluate the risk versus benefit of weight loss medications when considering initiating these therapies.


 

 

1.         Obesity and Overweight for Professionals: Data and Statistics: Adult Obesity - DNPAO - CDC. http://www.cdc.gov/obesity/data/adult.html. Accessed May 24, 2015.

2.         Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff (Millwood). 2009;28(5):w822-w831.

3.         Phentermine HCl drug information. http://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=851b0ef4-c656-48f4-915f-6289cac3fde4&type=pdf&name=851b0ef4-c656-48f4-915f-6289cac3fde4. Accessed June 3, 2015.

4.         phentermine/topiramate - Qsymia drug information. http://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=40dd5602-53da-45ac-bb4b-15789aba40f9&type=pdf&name=40dd5602-53da-45ac-bb4b-15789aba40f9. Accessed June 3, 2015.

5.         Allison DB, Gadde KM, Garvey WT, et al. Controlled-Release Phentermine/Topiramate in Severely Obese Adults: A Randomized Controlled Trial (EQUIP). Obesity. 2012;20(2):330-342. doi:10.1038/oby.2011.330.

6.         Gadde KM, Allison DB, Ryan DH, et al. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. The Lancet. 2011;377(9774):1341-1352.

7.         Fujioka K. Safety and tolerability of medications approved for chronic weight management. Obesity. 2015;23:S7-S11. doi:10.1002/oby.21094.

8.         Naltrexone HCl/Bupropion - Contrave drug information. http://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=ed2da3a6-0614-4bea-8e82-962cbaae6428&type=pdf&name=ed2da3a6-0614-4bea-8e82-962cbaae6428. Accessed June 3, 2015.

9.         Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomized, double-blind, placebo-controlled, phase 3 trial. https://d1niluoi1dd30v.cloudfront.net/01406736/S0140673610X61438/S0140673610608884/main.pdf?Expires=1433432434&Key-Pair-Id=APKAICLNFGBCWWYGVIZQ&response-content-disposition=attachment%3Bfilename%3D%22download.pdf%22&Signature=AirhveFbYAr06KfwcPbrzXH2AAl20U8N1ml0sh%7ESB4-1rC%7Ea%7ERlD-dUP77yjl4DxLwUmOQfqJYaDle3c72TYYz8CaOHGL1u-3L1td5NZ3u5OrVpMEkl1OOKZw7A1AsO%7ENITte0RXO3aPL%7EBAg5-QE1Cx%7E3fTCf%7EwvOFdJRPRycY_. Accessed June 4, 2015.

10.       Wadden TA, Foreyt JP, Foster GD, et al. Weight Loss With Naltrexone SR/Bupropion SR Combination Therapy as an Adjunct to Behavior Modification: The COR-BMOD Trial. Obesity. 2011;19(1):110-120. doi:10.1038/oby.2010.147. 

Dietary Supplements: Alternative Medicine or "Snake-Oil"?
Authors: Boram Jang, Pharm. D. Candidate Class of 2018, Miguel Zayas, Pharm. D. Candidate Class of 2018, and Maria Miller Thurston, Pharm.D., BCPS
 
Mercer University College of Pharmacy
Corresponding author:
Maria Miller Thurston, Pharm.D., BCPS
Email: thurston_mm@mercer.edu      
 
 
Background
Utilization of dietary supplements is a widespread self-care practice of many consumers in the United States (U.S.). During 2003-2006, over 50% of U.S. adult population admitted to taking at least one type of dietary supplement, which was estimated to be an approximately 10% increase from 1988-1994, according to National Health and Nutrition Examination Survey (NHANES).1 Among users of dietary supplements, approximately 40% reported that they used multivitamins/minerals, which were considered the most commonly used dietary supplements during 2003-2006, (e.g. calcium, folic acid, and vitamin D).1 Popularity has continued to increase in the last decade. In 2016, the Council for Responsible Nutrition (CRN) reported in their annual consumer survey on dietary supplements that 71% of U.S. adults take dietary supplements, with the five most popular supplements being multivitamins (75%), vitamin D (37%), vitamin C (34%), calcium (29%), and vitamin B/vitamin B complex (24%).2,3 Of the users of dietary supplements, 42% of them reasoned that they use dietary supplements "for overall health and wellness benefits" and 30% of them justified that they use them "for energy." Not only do U.S. adults believe in the health benefits of dietary supplements, but they also trust that dietary supplements are safe and effective; about 85% of U.S. adults and 96% of those who use dietary supplements express confidence regarding benefits of dietary supplements on health and express little to no concern regarding associated risks with some of the products.3
 
Rising confidence in the safety and effectiveness of dietary supplements may be related to the over 100 years of government efforts to build strong legislation to provide safe, effective, and quality products to consumers for protection of public health. Although the positive trend for utilization of dietary supplements can be correlated to America's rising interest in health, the Food and Drug Administration (FDA) warns consumers about potential risks of taking dietary supplements. So far, the Center for Drug Evaluation and Research (CDER) has reported 835 tainted products in the market over 7 years, and the list is expected to continue to increase as long as dangerous ingredients are detected in marketed products.4 Since the government has limited control on the process of manufacturing prior to marketing of the products, the government provides thorough regulations and policies encouraging safe practices by the companies before they market their products (e.g. good manufacturing practices [GMP] and the Dietary Supplement Health Education Act [DSHEA]). The government expects companies to comply with the standards before the products are placed in market. However, continued detection of dangerous substances in marketed products today consistently requires government interventions.
 
Important Legislations and Regulations
Modern regulation of the dietary supplement industry began with the DSHEA of 1994, which defined dietary supplements as "(A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in (A), (B), (C), (D), or (E)". In addition to defining dietary supplements, this act gave the FDA the authority to remove dietary supplement products from the market that are deemed unsafe. Prior to the passage of DSHEA, dietary supplements did not have a clear definition and were regulated in a similar manner to food products by the Kefauver-Harris Amendment (1962).5 Because of DSHEA, the FDA is able to regulate the safety and labeling of dietary supplements.
 
The FDA now requires companies to provide notification when new dietary ingredients (those that have not been marketed prior to October 15th, 1994) are being brought to market and to provide evidence of how the company determined that their new dietary ingredient was safe for human consumption.7 It should be noted that unlike drug products, dietary supplements do not undergo the same FDA approval process; however, the FDA may deny a company's request to bring a new dietary ingredient to market. The burden is currently placed on the FDA to prove that a dietary supplement product is unsafe before they may restrict the use of it or remove a product that is currently on the market.
 
The FDA requires dietary supplement companies to be clear and not mislead consumers in their labeling practices. Companies are prohibited from making claims that their product will "diagnose, cure, mitigate, treat, or prevent a disease" (claims that drug manufacturers may make).7 Companies may only make three types of claims about their products: health claims, nutrient content claims, or structure/function claims; however the FDA does not review these claims. Companies that do not follow these rules may be asked to correct their labeling or remove their product from the market. In a recent example of allegedly problematic marketing, on August 22, 2017, industry watchdog group Truth In Advertising (TINA), lobbied a complaint against a well known celebrity's company, Goop™, saying that many of their products made claims to treat, prevent, cure, or alleviate symptoms of various ailments.8 Cited in the press release were wearable stickers for anxiety and Vitamin D3 for cancer. It is also worth noting that even if a product is properly labeled without any misleading information, this does not guarantee the quality of a dietary supplement. Many products have recently been found to contain undisclosed, prescription ingredients. For example, On July 27, 2017 the FDA issued a statement concerning male enhancement supplements, "Man of Steel 1" and "Man of Steel 2". Both products were found to have the prescription drug Sildenafil in them, causing them to be classified as adulterated. The company ended up voluntarily recalling the adulterated lots of their product.
 
Safety and Efficacy
With the lack of definitive peer-reviewed studies to give us confidence in dietary supplements, patients and care providers alike may find it difficult to locate information regarding the quality, safety, and efficacy for specific dietary supplements. Thankfully, there are organizations independent of the FDA that will verify quality, for a price, and reputable websites that publish warnings regarding safety.
 
Should one wish to look up the latest products found to have serious problems associated with them, they can check out the FDA's MedWatch10 website or their list of tainted products marketed as dietary supplements9; links to both are provided in the references section of this article. On these websites one may find information on products such as the previously mentioned "Man of Steel 1" and "Man of Steel 2". Interestingly, a large portion of products found on the FDA's list of tainted products marketed as dietary supplements are "male enhancement" products that contain prescription drugs meant to treat erectile dysfunction.
 
With the FDA unable to verify the quality of nutritional supplements, some manufacturers have elected to undergo a voluntary review process in order to allow their products to "stand out." One may notice various "seals of approval" on the sides of nutritional supplements that may help to give some assurance of a product's quality, but it is important to know what these seals mean. No seal currently on the market is meant to test efficacy, but many may test for quality, purity, and other GMPs. For example, while the Good Housekeeping Institute's Seal of Approval may guarantee products to work as intended, the process of approval is not specifically defined for nutritional supplements. Labels like the TruLabel Program from ConsumerLab12 and the United States Pharmacopeia's (USP's) seal of approval13 may provide more reliability regarding their product by testing for product safety, identity, purity, disintegration, strength, as well as GMPs. For those products without a seal of approval, it is important to note that these programs are voluntary and are "fee for service," meaning that some companies may choose to forego testing in order to save on cost.
 
No matter how practitioners may feel about the dietary supplement industry, it is hard to deny that many of these products are essential in the care of our patients. Products containing essential vitamins and minerals can help provide needed nutrition for patients whose diet does not provide them. Knowing this, it is our job as pharmacists to be able to discern which of these products will legitimately help and which are "snake-oil."

Continuing reading the article  


Did you know that if you missed one of our monthly webinars, you can view them on the GSHP website?

Go to:  https://www.gshp.org/development_webinars.aspx 
     


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