Building Relationships with Endocrinologists

Building Relationships with Endocrinologists Scott Isaacs, MD, FACP, FACE Medical Director, Atlanta Endocrine Associates International Seminar Houston, TX November 10 12, 2016 2016. All Rights Reserved. 1

What is an endocrinologist? M.D. or D.O. Medical endocrinologist: 3 years Internal Medicine, 2 3 years Endocrinology Fellowship Recertify every 10 years with American Board of Internal Medicine (unless Grandfathered) Reproductive endocrinologist: Background in obstetrics and gynecology. Focus primarily on reproductive medicine. 2016. All Rights Reserved. 2

What is an endocrinologist? Endocrinologists are trained to diagnose and treat hormone imbalances and problems by helping to restore the normal balance of hormones in your system. They take care of many conditions including: Diabetes Prediabetes Obesity Thyroid diseases Metabolic disorders Over or under production of hormones Menopause Osteoporosis Hypertension Cholesterol (lipid) disorders Infertility Lack of growth (short stature) Cancers of the endocrine glands http://www.hormone.org/public/endocrinologist.cfm 2016. All Rights Reserved. 3

Know Your Local Endocrinologists Some endocrinologists may not be in the yellow pages or have websites Local hospital physician referral phone or website Physician finder websites from AACE or Endocrine Society 2016. All Rights Reserved. 4

Major Endocrinology Organizations American Association of Clinical Endocrinologists (AACE) National and local Chapters American College of Endocrinology (ACE) The Endocrine Society (TES) American Thyroid Association (ATA) The Obesity Society (TOS) American Diabetes Association (ADA) National and local Chapters 2016. All Rights Reserved. 5

Secrets To Success Provide quality service Be good at what you do Seek new opportunities Get out there Submit outstanding proposals Close the deal Stay in touch (out of sight = out of mind) Phone calls, courtesy gifts, letters, office visits, lunch, etc. 2016. All Rights Reserved. 14

Networking Identify target endocrinologists Set personal goals and objectives specific to networking Identify things that might hold you back Effectively work the room at events Make a memorable impact when meeting someone Follow up timely and effectively 2016. All Rights Reserved. 15

Go Where the Endocrinologists are Local and regional medical meetings Local CME events Hospital CME events Think about how you can best befriend referral sources Conversation starters: Mention an endocrinologist you know. But I am so uncomfortable going there... 2016. All Rights Reserved. 16

Speaking Engagements, Teaching & Volunteering Identify target audiences State medical organizations Local medical organizations Local AACE Chapters Industry associations Business owner/ceo groups Be proactive, submit topic ideas, follow up Volunteer for national, state, or local organizations Teach what you are comfortable with Use the MEDIA... 2016. All Rights Reserved. 17

Articles & Publications Publishers are always in need of articles Write articles on timely topics that interest you Practice what you preach (i.e. discovery) Distribute articles electronically and get reprints Leverage articles into speaking engagements Create and disseminate publications to referral sources, clients and colleagues Distribute practice aids and/or other tools 2016. All Rights Reserved. 18

Online: Website, Social Networks, Blogs, Etc. Mobile friendly websites! Optimize your website for up to date communications, current news, new engagements, and image E Newsletters Social Networking: Facebook, Twitter, etc. Utilize a blog 2016. All Rights Reserved. 19

Mobile Friendly Websites How many pharmacists here have a mobile friendly website? (10 years ago, the question was how many have a website) How many plan to have one? How many people have had their mobile friendly website over a year? How many of those have updated it within the last year? 2016. All Rights Reserved. 20

Mobile Friendly Websites (cont d) How many people think it is important to update? Content is king : this helps Google list it Adding content / updating is easy Post an article you write Change the colors Provide a link to an article that affects endocrinologists 2016. All Rights Reserved. 21

Social Media Increasingly being used by endocrinologists Most organizations have social media outlets Many endocrinologists have personal Facebook pages Some endocrinologists have professional pages separate from personal pages Like endocrine Facebook pages to get the latest news on hot endocrine topics Suggest professional organization Facebook page or your to endocrinologists 2016. All Rights Reserved. 24

Thanks (how important is it?) One can pay back the loan of gold, but one dies forever in debt to those who are kind. ~ Malayan Proverb The only people with whom you should try to get even are those who have helped you. ~ John E. Southard Feeling gratitude and not expressing it is like wrapping a present and not giving it. ~ William Arthur Ward Silent gratitude isn't much use to anyone. ~ G.B. Stern 2016. All Rights Reserved. 32

Thank Your Referring Physicians They have invested their credibility in you Their continued relationship with the patient may depend on how well you perform And thanking them makes them feel good 2016. All Rights Reserved. 33

What are barriers to building relationships with endocrinologists? Misperceptions about compounding pharmacies Not aware of compounding pharmacies Not aware of what compounding pharmacies can provide Concerns with certain products Prior bad experience with a compounding pharmacy Endocrine Society Guidelines Other barriers? 2016. All Rights Reserved. 35

Endocrine Society Scientific Statement Compounded Bioidentical Hormones there is no rationale for the routine prescribing of unregulated, untested, and potentially harmful custom compounded bioidentical HTs. 2016. All Rights Reserved. 37

Endocrine Society Scientific Statement Compounded Bioidentical Hormones Bioidentical hormones (literal definition): A hormone with the same molecular structure as a hormone that is endogenously produced and circulates in the bloodstream. Bioidentical hormones (marketing phrase): A customcompounded multihormone mode of administration, combined with additional episodes of hormone testing using nontraditional body fluids. 2016. All Rights Reserved. 39

Bioidentical Hormone Myths Naturally occurring hormones are superior to synthetic hormones Compounded formulations are better than FDA approved formulations Bioidentical hormones are safer than FDA approved formulations Combinations of hormones can mimic the circulating hormonal milieu of young adulthood and therefore prevent various ravages of aging Consumer is engaging in self advocacy by using bioidentical hormones 2016. All Rights Reserved. 40

Biest and Triest according to The Endocrine Society 3 circulating estrogens in women, estrone (E1), estradiol (E2) and estriol (E3) Differential biological potency (E2 > E1 > E3) In the presence of E2, E1 and E3 function as competitive inhibitors of E2 action, because they use the same receptor 2016. All Rights Reserved. 41

Biest and Triest according to The Endocrine Society (cont d) Much of the custom compounding literature interprets this to mean that E2, when administered alone, needs to be balanced with its natural antagonists, E1 and E3, in order to be truly physiologic This logic forms the basis for compounds such as Biest (E2 plus E3 in a 20/80 formulation) and Triest (E1 plus E2 plus E3 in a 10/10/80 formulation) There is no medical evidence to support this notion. 2016. All Rights Reserved. 42

Synthetic Thyroid Hormones are Bioidentical LT4 is structurally identical to the T4 molecules the human thyroid gland produces LT4 resolves hypothyroid symptoms in most patients LT4 is considered a form of bioidentical thyroid HT Synthetic LT3 is also bioidentical in structure * Nanette Santoro; Glenn D. Braunstein; Cherie L. Butts; Kathryn A. Martin; Michael McDermott; JoAnn V. Pinkerton; The Journal of Clinical Endocrinology & Metabolism 2016, 101, 1318 1343. 2016. All Rights Reserved. 43

The Argument Against T3 In humans, the thyroid gland functions mainly to produce a sufficient supply of the circulating prohormone T4 Deiodinases serve to provide appropriate intracellular T3 concentrations by regulating the conversion of local T4 to T3 in a highly tissue specific manner This ability of peripheral tissues, for the most part, to regulate T4 to T3 conversion, substantially weakens the rationale for individualized dosing of customized or compounded combinations of T4 and T3 * Nanette Santoro; Glenn D. Braunstein; Cherie L. Butts; Kathryn A. Martin; Michael McDermott; JoAnn V. Pinkerton; The Journal of Clinical Endocrinology & Metabolism 2016, 101, 1318 1343. 2016. All Rights Reserved. 44

Thyroid Hormone Physiology 14:1 is considered preferable it is the proportion produced by the normal human thyroid gland. 14:1 (T4:T3 Ratio) secreted from thyroid gland Desiccated thyroid products consist of 80% T4 and 20% T3 (4:1 ratio of T4 to T3). 4:1 (T4:T3 Ratio) in the circulation * Nanette Santoro; Glenn D. Braunstein; Cherie L. Butts; Kathryn A. Martin; Michael McDermott; JoAnn V. Pinkerton; The Journal of Clinical Endocrinology & Metabolism 2016, 101, 1318 1343. 2016. All Rights Reserved. 45

hcg * hcg, like lozenges and sprays, sold over the Internet and in some health food stores, are fraudulent and illegal if they claim weight loss powers. * http://www.nytimes.com/2011/03/08/nyregion/08hcg.html 2016. All Rights Reserved. 46

Salivary Testing Although physicians often prescribe compounded bioidentical HT based on salivary hormone testing, there is no scientific evidence that a correlation exists between a patient's symptoms and salivary hormones. Salivary hormone assays are not standardized, do not have independent quality control programs, and lack an accepted reference range. * Nanette Santoro; Glenn D. Braunstein; Cherie L. Butts; Kathryn A. Martin; Michael McDermott; JoAnn V. Pinkerton; The Journal of Clinical Endocrinology & Metabolism 2016, 101, 1318 1343. 2016. All Rights Reserved. 48

Salivary Testing The practice of using salivary hormones contradicts evidence based guidelines, which recommend that HT be individualized on the basis of symptoms (not hormone levels) for menopausal women using HT with estrogen and/or progestin, or androgen. Organizations advise against due to lack of rationale and therefore lead to unnecessary expense of treatment. 2016. All Rights Reserved. 49

AACE/ACE Position Statement on Physician Industry Relationships AACE and ACE are committed to preserving relationships, including those with industry and with government, that contribute to the fulfillment of their basic mission: to enhance physicians ability to provide the highest quality medical care to patients with endocrine disorders. 2016. All Rights Reserved. 51

Action Plan Identify endocrinologists Research physician background and areas of interest Identify partners, non physician providers, and staff Determine best way to contact (email, call, visit office, mailings, etc.) Contact individuals with a targeted message Cultivate referrals Thank your referral sources 2016. All Rights Reserved. 52

Office Lunches Often a way to have extended time with an office, the staff, and physicians Standard for pharmaceutical industry, so most endocrinologists have them in their offices Usually scheduled with office manager in person or on the phone 2016. All Rights Reserved. 53

Office Lunches Can bring low cost lunch Healthy lunches usually are preferred by the doctors, but not by the staff Bring lots of brochures, information, demos, etc. Bring as many staff as possible Follow up! 2016. All Rights Reserved. 54

Educating Endocrinologists: Compounding Pharmacy 101 Endocrinologists don t know much about compounding Many misperceptions and misunderstandings Explain the role of a compounding pharmacist and the mission of professional organizations Highlight your special training and certifications Bring articles, flyers, information, etc. 2016. All Rights Reserved. 55

Problem Solving Enhance physicians ability to provide the highest quality medical care to patients with endocrine disorders Creative solutions to problems Unique services Provide specialized products with a variety of routes of delivery Build confidence 2016. All Rights Reserved. 56

Give Confidence in Your Product Ensure a quality product Emphasize your credentials Display the PCCA name Product testing: Active ingredient potency Sterility Bacterial endotoxins Microbial detection 2016. All Rights Reserved. 58

Emphasize Potency Testing Analyze the active ingredients in preparations and measure their concentrations Use a reference standard Up to date instrumentations are the preferred methods for pharmaceutical analysis Provide copies of your Certificate of Analysis 2016. All Rights Reserved. 59

Thyroid Replacement Options Generic levothyroxine Branded levothyroxine Branded Desiccated Thyroid (Armour, etc.) Thyroid USP Compounded Internet thyroid products Thyrolar Branded Cytomel Generic liothyronine Compounded T3SR Compounded T4 +T3 2016. All Rights Reserved. 61

Sustained Release T3 Only available as a compounded product Natural T3 levels do not vary throughout the day Patients have better symptom relief when T3 levels are stable Patients have difficulty complying with BID or TID Emphasize T3SR quality and stability Emphasize E4M capsule technology (premium grade methylcellulose with a uniform particle size) 2016. All Rights Reserved. 62

Adverse Drug Experience on Thyroid Products Potency (both under and over) Stability Consistency in lot to lot bioavailability Variability with different excipients (color agents and fillers) 2016. All Rights Reserved. 63

How Endocrinologists are Prescribing Branded Thyroid Products Handwritten brand necessary, brand medically necessary, do not substitute Fighting for negative substitution list Rubber stamps: Unauthorized substitutions will be reported to the state pharmacy board. No phone ins Higher co pay 2016. All Rights Reserved. 64

The Generic Levothyroxine Guarantee A great way to get endocrinologists to send you their patient A written guarantee ensuring that your pharmacy will stock only one brand of generic levothyroxine and will not change brands without notifying the physician. Builds confidence in the endocrinologist s mind Makes a generic as good as branded product Endocrinologists will send patients to your pharmacy for this reason alone 2016. All Rights Reserved. 65

Case: Hyperthyroidism 25 year old woman, 8 weeks pregnant Graves Disease, taking PTU No longer able to tolerate PTU due to bitter taste and morning sickness Increased nausea and vomiting Laboratory testing shows hyperthyroidism, other labs are normal 2016. All Rights Reserved. 66

Case: Hyperthyroidism What would you do? a. Change to oral methimazole b. PTU suppository c. PTU suspension enema d. I 131 ablation e. Thyroidectomy and thyroid hormone replacement 2016. All Rights Reserved. 67

Aplasia Cutis Rare birth defect associated with methimazole use in pregnancy Absence of a portion of skin on the scalp Generally a benign disorder Can be associated with other congenital abnormalities 2016. All Rights Reserved. 68

Rectal Administration of PTU Specially prepared suppositories for rectal administration Substantial absorption of PTU Serum levels of PTU were maintained within the high therapeutic range The patient improved clinically during this treatment Strongly supports the rectal administration of PTU in suppository form as an appropriate alternative route in any patient with thyrotoxicosis * Zweig, SB. Endocr Pract. 2006 Jan Feb;12(1):43 7. 2016. All Rights Reserved. 69

Rectal Administration of Methimazole Euthyroid volunteers Blood levels of methimazole were the same whether administered by the oral or rectal route Rectal administration of methimazole may be an alternative to treating hyperthyroid patients who are unable to tolerate oral * Nabil. J Clin Endocrinol Metab. 1982 Jan;54(1):180 1. 2016. All Rights Reserved. 70

Testosterone Therapy Male hypogonadism is common Many patients struggle with standard treatments Common complaints include: Too expensive Insurance doesn t cover or only covers a certain brand Even the generic gel is expensive Gel not potent enough Gel smells bad or is sticky Patch causes rash, falls off, or doesn t work Shots and pellets invasive, painful, unpredictable 2016. All Rights Reserved. 71

Topical Testosterone Therapy #1 problem is branded testosterone gel is expensive and difficult to prescribe due to insurance red tape! Compounded topical testosterone is safe and effective Many patients prefer compounded testosterone over other available treatments Emphasize safety, dose accuracy, and types of gels which can be customized to the patient Alcohol / carbopol gel 75% Absolute Ethanol and 25% PPG Proprietary gels Etc. 2016. All Rights Reserved. 72

Diagnostic Agents Various endocrine diagnostic agents are no longer available via traditional routes Most endocrinologists are open to the idea of compounding pharmacies to fill this need Many agents become temporarily unavailable Keep up to date with agent availability via AACE or Endocrine Society websites 2016. All Rights Reserved. 73

TRH Thyrotropin Releasing Hormone Diagnostic agent used to diagnose central hypogonadism TRH Stimulation Test protocols in all endocrinology text books No longer available through traditional methods Full dosing information in older PDRs 2016. All Rights Reserved. 74

GHRH Growth Hormone Releasing Hormone Also known as growth hormone releasing factor (GRF, GHRF) or somatocrinin Diagnostic agent used to diagnose growth hormone deficiency GHRH and GHRH Arginine Stimulation Test protocols in all endocrinology text books No longer available through traditional methods Full dosing information in older PDRs 2016. All Rights Reserved. 75

1 mcg Cosyntropin Standard dose of cosyntropin is 250 µg 1 µg dose has been shown to be more sensitive and may be the preferred dose Accurate dilution is not possible in most endocrinologist offices Most rely on hospital pharmacies for or just don t do the test 2016. All Rights Reserved. 76

Products to Offer Endocrinologists T3SR (emphasize dose precision and E4M technology) Testosterone gel (emphasize gel quality and price) Low dose naltrexone SR (emphasize tolerability) Diagnostic testing agents (emphasize availability) Custom compounding in general (PTU, etc.) 2016. All Rights Reserved. 77

Products NOT to Offer Endocrinologists hcg for weight loss Any type of estrogen or bhrt Topical metformin Topical glutathione Oxytocin troche T4/T3 combination tablets Thyroid USP Supplements Pain creams? 2016. All Rights Reserved. 78

Building Relationships Keep up to date with trends in the endocrine community Know the endocrinologist, the practice, the staff, and the areas of interest Determine the best method of communication. Take the first step, then follow up. 2016. All Rights Reserved. 79

Building Relationships Give ideas to demystify compounding, help patients and to solve problems Emphasize quality and new technologies Give confidence with PCCA membership, awards, certifications, product testing, etc. Have confidence and authority 2016. All Rights Reserved. 80