Building Relationships with Endocrinologists · Compounding Pharmacy 101 • Endocrinologists...

Building Relationships with Endocrinologists

Scott Isaacs, MD, FACP, FACEMedical Director, Atlanta Endocrine Associates

International SeminarHouston, 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.


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

glandshttp://www.hormone.org/Public/endocrinologist.cfm


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


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


The Endocrine Society

www.endocrine.org


AACE Physician Finder

www.aace.com


The Hormone Foundation

http://www.hormone.org


AACE Chapters Page

Upcoming local eventswww.aace.com


How to Find Local AACE Events


AACE Chapter Annual Meetings

Consider:Attending the annual meeting in your state or being an exhibitor.


AACE Physician Finder

Interest areas

AACE host website


Empower Website

http://empoweryourhealth.org/


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.


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


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...”


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...


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


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


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?


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


Blog About Interesting Topics in Your Field


…And Share it With Your Colleagues and Potential Referral Sources


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


Facebook


Twitter


YouTube


AACE on Facebook ‐ “The AACE”


Endocrine Society on Facebook ‐ “Endocrine Society”


Print Advertising

• Old dinosaur or still effective?• Yellow pages• Medical journals• Industry journals• Other…


Words of Wisdom

• News of good work travels fast• News of bad work travels faster• It’s expensive to keep a prescribing endocrinologist

• It’s more expensive to find a new one


“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


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


Combining Thanks and Marketing

• Send thank you cards• Birthday cards• Send holiday cards


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?


Endocrine Society Scientific StatementCompounded Bioidentical Hormones

* DOI: http://dx.doi.org/10.1210/jc.2016‐1271



• “…there is no rationale for the routine prescribing of unregulated, untested, and potentially harmful custom compounded bioidentical HTs.”


Rethinking the Use of Hormones to Ease Menopause Symptoms

* http://well.blogs.nytimes.com/2016/08/29/new‐research‐counters‐fears‐about‐menopause‐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 custom‐compounded multihormone mode of administration, combined with additional episodes of hormone testing using nontraditional body fluids.


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


Biest and Triest according toThe 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


Biest and Triest according toThe 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.”


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.


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



Thyroid Hormone Physiology

14:1 (T4:T3 Ratio) secreted from thyroid gland

4:1 (T4:T3 Ratio) in the circulationDesiccated thyroid products consist of 80% T4 and 20% T3 (4:1 ratio of T4 to T3).

14:1 is considered preferable it is the proportion produced by the normal human thyroid gland.

* 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.


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


hCG


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



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.


Organizations that Advise AgainstSalivary Testing

• American College of Obstetricians and Gynecologists

• North American Menopause Society

• The Endocrine Society


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.


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


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


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!


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.


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


Provide Creative Solutions• Troche • Capsule • Oil • Gel • Cream • Suspension • Tablet • Suppository • Pellet

• Aqueous solution • Powder • Lollipop • Foam • Inhalant • Injectable • Paste • Ointment • Food


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


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


Potential Areas to Market

• T3SR• Topical testosterone • Rectal suppositories for anti‐thyroid drugs• Diabetic wound care• Diagnostic agents• Meal replacements


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


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)


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)


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


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


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


Case: Hyperthyroidism

• What would you do?a. Change to oral methimazoleb. PTU suppositoryc. PTU suspension enemad. I131 ablatione. Thyroidectomy and thyroid hormone

replacement


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


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.


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.


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


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.


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


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


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


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


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.)


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?


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.


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


Scott Isaacs, MD, FACP, [email protected]


Building Relationships with Endocrinologists · Compounding Pharmacy 101 • Endocrinologists...

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