approved-ken-speidel-2016 ncpa - complimenting and ... · complementing and enhancing your...

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Complementing and Enhancing Your Comprehensive Pharmacy Services with an Innovative Compounding Practicesponsored by Medisca, Inc.

© LP3 Network Inc. 2016. All rights reserved.

Facilitator

Kenneth R. Speidel

BS Pharm, PharmD, RPh, FIACP, FACA

Senior Surveyor, Pharmacy Compounding Accreditation Board

Senior Consultant, Gates HealthCare Associates

Professor of Pharmacy Practice, University of Findlay

Consultant, MEDISCA Network Inc.

Consultant/Facilitator, LP3 Network Inc.

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Disclosure

Kenneth R. Speidel declare(s) no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.

Material presented during this CPE Activity reflects current literature on the subject and is presented without commercial bias, prejudice or influence.

Any personal opinions on the part of the presenter will be notably specified.


Content Disclaimer

Due to the very nature of compoundingpharmacy practice, content may addresstherapeutic options that may or may not beapproved by Governmental regulatory bodies ormedical associations.

Participants of this Activity should verify allinformation and data before advocating anytherapies described in this educational activity.

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The material presented is Copyright © 2016, LP3 Network Inc.

DISCLAIMER: The information contained in this program, which may include treatment modalities,diagnostic and therapeutic information, and instructions related to regulatory guidelines and currentstandards of practice for pharmacy compounding, is FOR EDUCATIONAL PURPOSES ONLY andshould not be taken as a treatment regimen, product indication, suggested treatment modality, orsuggested standard of practice. NOTE TO MEDICAL OR ALLIED HEALTH PROFESSIONAL: Anytreatments, therapies, or standards of practice must be fully investigated and prescribed by a dulylicensed medical practitioner in accordance with accepted professional standards and compendia. Anyregulatory or practice standard must be fully investigated by a licensed pharmacist in accordance withaccepted professional practice standards and compendia. The opinions and views expressed in thispresentation are those of the presenter only, and do not necessarily represent the views of LP3Network Inc.

Copyright and disclaimer


Learning Objectives

• Provide an update on the current state of the compounding sector.

• Consider specific strategic organizational changes in response to the potential changes targeting compounding pharmacy.

• Identify areas within pharmacy operations that result in a duplication of resources and activities.

• Highlight opportunities to collaborate initiatives to reduce costs while improving services.

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1 2 3

Compounding

• State of the Industry• Reasons for Compounding • What’s Driving the Growth

Intersections of TP & CP

• Parallel Universes• Business Image• Quality Assurance/QI• SOPs / Policies• Regulatory Compliance• Accreditation/Certification• Training /Competency• Academic Relationships• Marketing Activities• Patient Care Initiatives• Sales Initiatives

Synergistic Opportunities

• Clinical (MTM)• Collaborative Practices• Pain Management• Dermatological• Pediatrics• Geriatrics• HRT• Veterinary Services• Windows of

Opportunity

Outline


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February 23, 2015

CBS News aired a story about unethical marketing and billing of compounded pain creams.

The report exposed a telemarketing scheme:

• Get physicians to write prescriptions for patients who mentioned they were experiencing pain.

• The company would bill extremely high amounts of money to the patient’s insurance company and ship the medication.

• They often did not charge the co-pay to the patient.

Compounded Pain Creams Make Headlines For Unethical Marketing/Billing Scheme


• ….Justice Department to make $40 million available for victims of deadly meningitis outbreak…Post Nation

• June 2016 …HHS OIG Data Brief • Part D Spending onOpioids and Substantial Growth in Compounded DrugsRaise Concerns

• July 7, 2016…High Importance! FDA issued two draft guidance documents describing how the FDA would implement provisions of federal law that restrict compounding human drug products that are essentially copies of commercially available or approved drug products.

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July 20, 2016

• Citing Unnecessary Risks, FDA Proposes New Restrictions on Certain Compounded Drugs

Jul 25, 2016

• To avoid shortages, FDA allows imports from 8 drug plants banned for quality shortfalls

August 29, 2016

• China Drug Sales to the U.S. Grow Despite Safety Concerns at Home Chinese drugs and pharmaceutical ingredients jumped 3 percent to $56 billion last year. Yet even as China’s drug industry has grown in global stature, so have questions about the safety of its products

Aug 31, 2016 • FDA finds China manufacturing plant full of holes, chipped paint,

and insects.


• Regulators• Boards of Pharmacy• DEA • OSHA• FDA

Who Regulates Compounding Pharmacies?

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Reactive

• Meningitis

• Ocular Injections

• Institutionally based

• Veterinary

Proactive

• Requires Quality Management/Assurance

• Premeditated standard compliance

• Standards are in place for a reason

Why has the role of the USP increased in compounding regulations?


• <795> Pharmaceutical Compounding – Non-sterile Preparations

• <797> Pharmaceutical Compounding – Sterile Preparations

• <1160> Pharmaceutical Calculations in Prescription Compounding

• <1163> Quality Assurance in Pharmaceutical Compounding

• <1176> Prescription Balances and Volumetric Apparatus

• <800> Hazardous Drugs – Handling in The Healthcare Setting

Application of the following:

• <51> Antimicrobial Effectiveness Testing

• <71> Sterility Tests

• <85> Bacterial Endotoxins Test

• Others

USP Standards

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• The demand for customized prescription medication is on the rise as drug manufacturers do not always meet the distinct requirements of each patient

• Specialty/compounding pharmacy significant growth• Compounding pharmacy a core competency • Improved/unique way to set a pharmacy apart• Identifies pharmacy as a part of the leading edge• Effective/unique patient follow-up (compliance et al.)• New markets continuing to open up

Where there is Change Opportunities


Opportunity Pharmaceutical Compounding

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History Tells Us…

That The CUSTOM in Compounding Has Always Been

The CUSTOMization of Drug Therapy

Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians to create customized medication solutions for patients and animals whose healthcare needs cannot be met by manufactured medications.

http://www.iacprx.org/default.asp - accessed 12/01/2014


Practitioners…

• Using Manufactured Products, are trying to match a patient to a product.

• Using Compounded Preparations, match a compounded formulation to a patient.

One Dose, One Delivery System DOES NOT FIT ALL

The compounding pharmacist that will differentiate themselves from others will believe in the ideology of matching a compounded preparation to the patient.

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Compounding pharmacists must have proven competence in:

Pharmaceutical Compounding: Individualized Patient Care

• pharmaceutics

• pharmacology

• pharmacogenomics

• formulations

• pharmaceutical chemistry

• medicinal chemistry

• physiology and pathophysiology

• microbiology

• non-sterile compounding & sterile compounding

The Role of the Compounding Pharmacist is the…

Individualization of Pharmacotherapy to Optimize Outcomes


Pharmacotherapeutic Customization

• Physiological Differences:– Skin– Mucus Membranes– Allergenicity

• Systemic Effects - Need for targeted treatment approach• Complex Symptom Presentation• Social/Environmental/Occupational Differences• Clinical Pharmaceutics• Pharmacodynamic Differences:

– Drug Class – Within the Same Class

• Pharmacogenomics

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Individualize Based on a Patient’s Genomic Composition: Pharmacogenomics

• Based on the individual’s human genome.

• Better selection of drugs:–Coffee anyone? Sorry, does it keep you up at

night?• CYP1A2

• Better selection of dose.

• Better selection of excipients.

• Compounding plays a major role!


• Clinical Pharmacy Practice

• Problem Solving Centers

• Difficult Cases are referred

• Off-label use potentials

• Broadened ability to provide pharm/care excellence

Compounding Pharmacy = A Patient-Centric Practice

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US Market:• 2003: approx 1% of all prescriptions are compounded = 30

million prescriptions = $1.5 billion- 2.3 % of dispensed prescriptions for independent

community pharmacies in Illinois, Missouri, Kansas, and Iowa

• 2016: approx 2-3% of all prescriptions are compounded = 110 million prescriptions = $5.5 billion

A look at the United Kingdom: • 2015: £ 74 million ($USD 99.4 million)

McPherson TB, Fontane PE, Jackson KD, Martin KS, Berry T, Chereson R, Bilger R. Prevalence of compounding in independent community pharmacy practice. J Am Pharm Assoc (2003) 2006 Sep‐Oct; 46(5):568‐573.Statement of Steven K. Galson, M.D., M.P.H., Acting Director, Center for Drug Evaluation and Research. U.S. Food and Drug Administration, Department of Health and Human Services, before the Senate Committee on Health, Education. Labor, and Pensions hearing on "Federal And State Role In Pharmacy Compounding And Reconstitution: Exploring The Right To Mix To Protect Patients." October 23, 2003. Food and Drug Administration. http://www.fda.gov/ola/2003/pharmacycompound1023.html.

Compounding Market Overview


• Increase in frequency of drug shortages in the US

• Currently, approximately 300 drugs in shortage

http://www.gao.gov/products/GAO‐14‐194

Manufacturer Drug Shortages

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• Increase in drug shortages• Increase in physician visits• Aging population• Growth and understanding of

Pharmacogenomics• Increase in number of prescriptions dispensed• Increase in the number of pets• Increased awareness of pharmaceutical

options among consumers • Rising demand for personalized medicine

Compounding Pharmacy Growth Drivers


1 2 3

Compounding






Opportunity

Outline

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Traditional Pharmacy Compounding Pharmacy

Universes

It’s Time We Intersect These Parallel Universes

Parallel Universes


Traditional Pharmacy Universe

• Pharmaceutical Care• BOP, DEA• Accreditation Requirements• Training Needs• University Affiliations• Patients with Pain• Pts. with Hormone Imbalances• Pediatric Patients• Geriatric Patients• Veterinary Prescriptions• Pts. with Dermatological Needs• Marketing Initiatives• Prescriber Relations

Compounding Pharmacy Universe

• Clinical Consultations• Regulatory Compliancy FDA• Accreditation Requirements• Quality Assurance Plans• Advanced training required• University Affiliations• Patients with Pain• Pts. with Hormone Imbalances• Pediatric Patients• Geriatric Patients• Veterinary Prescriptions• Pts. with Dermatological Needs• Marketing Initiatives• Prescriber relations

Looking at The Universes Through Your Telescope

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Intersections Traditional Community Pharmacy & Compounding Pharmacy Practices

• Market Image• QI/QA• Standard Operating Procedures• Regulatory Compliance• Certification / Accreditation• Training / Competency• Academia• Marketing• Patient Care• Sales


• Clinical Practice

• Problem Solver

• Educator

• Healthcare Provider

• Evidence-Based Practice

• Chemist

• Individualized Pharmacotherapeutics

Your Market Image Enhanced

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• Regulatory Requirement in many States. Accreditation Requirements.

• Assign a designated organizational QA associate

• Conduct joint projects (indicators)

• Trending Quality Related Events (QREs)

• Shipping/mailing temperature integrity tests

• Mock recall drills

• Hazardous chemical/drug training (USP/OSHA)

• Telephone waiting time

• Prescription pick-up rate

Intersecting Quality Assurance / Improvement Activities

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• Regulatory / Accreditation Requirement

• Many Community Pharmacies are naive to SOPs

• Reduces variability by conforming processes

• Critical SOP Intersections• Grievance/Complaints

• Training and Competency

• Recall

• Cleaning / Sanitizing

• Controlled Substance Management

Intersecting Standard Operating Procedures


• DEA Compliance Assessment

• OSHA and USP <800> safety assessments

• Board of Pharmacy Rules Gap Analysis

• EPA - Chemical Waste Disposal Management

• Local Municipalities

Intersecting Regulatory Activities

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The Increasing Importance of Pharmacy Accreditation

As competition grows among pharmacy service providers one thing has become evident:• pharmacy accreditation is no longer an option, it is now an obligation.

Not participating in accreditation may:• Decrease your competitive edge and compelling points of differentiation• Your Pharmacy may lose the ability to work with some major payers and

government entities who now require accreditation as a term of doing business

IntersectingAccreditation / Certification Activities


Select Pharmacy Accreditation/Certification Services

• ACHC (Accreditation Commission for Health Care)• PCAB (Pharmacy Compounding Accreditation Board)

• VPP (Verified Pharmacy Program)• CPPA (Center for Pharmacy Practice Accreditation) • URAC (Specialty Pharmacy Focus) • HQAA (Healthcare Quality Association on

Accreditation)• Joint Commission (Hospitals and other settings)• CHAP (Community Health Accreditation Partner)

Accreditation / Certification

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• Disease State Management

• Hazardous Drug Management

• Veterinary Pharmacy

• Hormone Therapies

• Pain Management

• Pediatrics

• Basic Compounding Competencies

Intersecting Training Competency Initiatives


• Market Image

• Several Clinical Settings to Offer

• Research Opportunities / Database Access

• IPPI (Introductory Pharmacy Practice Experience)

• APPI (Advanced Pharmacy Practice Experience)

• Research Opportunities

Intersecting Associations with Academia

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• Captive patient and prescriber audience • FTE and Mkt expense savings

(Economies of Scale) • Larger offering• Diverse Prescriber Field• “One Stop Shop”• Fax blasts, bag stuffers, on-site

opportunities.• Co-Travelers

Intersecting Marketing Initiatives


• MTM (Medication Therapy Management)

• Familiarity and Convenience

• Collaborative Practice Agreements

• Compliance

• Counseling

Intersecting Patient Care Activities

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Compounding Pharmacy + Community Pharmacy A Patient-Centric Approach

The Advantages of providing your patients with individualized/tailored medications


• Complimentary Sales • Services

• Nutritionist• Herbalist• Health Coach• Naturopathic practitioner

• Products• Supplements (Quality Proven)

• HRT selenium, melatonin, adrenal support, thyroid support, metabolic support

• Pain Management magnesium glycinate, alpha-lipoic acid• Pediatrics liquid supplements, specialty AA’s,

additive/preservative free, dosing devices • Payer Contracts• Health System Preferred Provider Agreements

Intersecting Sales Initiatives

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1 2 3

Compounding






Opportunity

Outline


• Medication Therapy Management (MTM)• Endocrine Imbalances• Pain Management

• Collaborative Practice Agreements (CPA’s)• Niche Market Intersection

• Pediatrics• Geriatrics• Hormone therapy• Pain management therapy• Veterinary


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Medication therapy management (MTM) is medical care provided by pharmacists whose aim is to optimize drug therapy and improve therapeutic outcomes for patients.

MTM 5 core components: • a medication therapy review (MTR), • a personal medication record (PMR), • medication-related action plan (MAP), • pharmacist intervention and/or referral, • documentation and follow

Medication Therapy Management (MTM)


Diabetes is a predominant diagnosis responsive to MTM• Multiple endocrinopathies

• Thyroid• Adrenal• Gonadal

• Pain Management• Diabetic neuropathy is the most common complication of

diabetes mellitus (DM), affecting as many as 50% of patients with type 1 and type 2 DM

• Nutritional Deficiencies • Supplements• Lifestyle• Health Coach

MTM (continued)

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Diabetes is a predominant diagnosis responsive to MTM• Intersection Opportunities

• Hormone Consultation and Therapies (adrenal, thyroid, gonadal)• Pain Consultation and Therapies (topical, dorsal horn, systemic)

• Intersecting pathophysiology with pharmacology using a multi-modal tx• Decrease systemic side effects• Decrease opioid use• Maintaining income

• Increasing peripheral circulation• Supplements (Must Prove Quality)

• Alpha-lipoic acid• Magnesium glycinate• Vanadium• Vitamin D3

• Chromium

MTM + Clinical Consultations + Compounds + Supplements = $ Revenue

MTM (continued)


Treat the Pain, Know The Pathophysiology

DIABETIC PERIPHERAL NEUROPATHY: PATHOPHYSIOLOGICAL PATHWAYS KNOWN OR HYPOTHESIZED

1

Degenerative small nerve fiber neuropathy leads to: formation of neuromas on differentiated axon, hyper-excitability of peripheral nerve terminals, loss of sensation and dysfunctional signaling perceived as uncontrollable itching.

2

Insulin deficiency results in less insulin-like growth factor (IGF) which protects mitochondrial function during hyperglycemia, and damages neuronal cells.

3 Constant signaling leads to central excitation through normal channels.

4Hyperglycemia in spinal column, through increased flux in aldose reductase and induction of COX-2 and prostaglandin release, leads to central inflammation.

5Cross talk connections between neurons overwhelms the descending noxious inhibitory control system.

6 Decrease in some of the descending inhibitory pathways.

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Know The Physiological Targets: Points of Interception

- - - - - - - - - - -- - - - - - - - - - -

- - - - - - - - - - -- - - - - - - - - - -

Stop action potentialBlock ion channel

Block action potential

Alter release of neurotransmitters

Facilitate or enhance

neurotransmitter reuptake

Act on receptor sites causing

same transmitter effect: Agonism

Block receptor site: Antagonism

Decrease activity of enzymes that destroy

neurotransmitters


• Medication Therapy Management• Endocrine Imbalances

• Pain Management

• Collaborative Practice Agreements (CPAs)

• Niche Market Intersection• Pediatrics

• Geriatrics

• Hormone therapy

• Pain management therapy

• Veterinary


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Collaborative practice agreements (CPAs) prescribers (generally physicians) authorize pharmacists to engage in specified activities such as adjusting and/or initiating drug therapy, to help patients achieve more effective and efficient drug therapy outcomes.• Authority for a CPA is generally incorporated in the state

pharmacy practice act.• Some boards of pharmacy have promulgated regulations

creating CPAs based on broad authorizing language.

Collaborative Practice Agreements


CPAs are commonly being used for:• immunizations, • emergency contraception, • asthma therapy management, • dyslipidemia therapy management, • warfarin anticoagulant therapy

management, • diabetic therapy management, • smoking cessation therapy, • flu/antiviral therapy.


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For pharmacists to participate effectively in CPAs, the following conditions should exist:

a collaborative practice agreement; o access to patients; o access to medical records; o a defined level of education, training, knowledge,

skills, and abilities; o documentation of clinical activities; o and payment for a pharmacist’s activities.



A clinical compounding practice can expand the opportunities to enhance and potentially expand CPA’s:

o Endocrine imbalances o Topical treatments for neuropathies o Dosage form adjustment in specific pt. populationso Modification of a delivery system in order to

improve outcomes and/or compliance.


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• Pain management

• Dermatology

• Pediatrics

• Geriatrics

• Hormone replacement therapy

• Veterinary

CommunityRX

CompoundingRX

Universes Intersect


• Pain management

• Dermatology

• Pediatrics

• Geriatrics


• Veterinary

Universes Intersect

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• At least 100 million adults have common chronic pain conditions (USA) & 18.9% of adults have chronic pain conditions (Canada)

• Healthcare providers wrote 259 million prescriptions for opioid pain medications (USA-2012)

• Over 420,000 emergency department visits were related to the misuse or abuse of narcotic pain relievers (USA-2011)

• Almost 2 million Americans abused or were dependent on prescription opioids (2014).

Institute of Medicine of the National Academies Report. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, 2011. The National Academies Press, Washington DC.http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm; http://www.cdc.gov/drugoverdose/data/overdose.htmlSchopflocher D, Taenzer P, Jovey R. The prevalence of chronic pain in Canada. Pain Research & Management : The Journal of the Canadian Pain Society. 2011;16(6):445‐450.

Pain Management – The Market


• Every day, over 1,000 people are treated in emergency departments for misusing prescription opioids (USA-2013)

• From 1999 to 2014, more than 165,000 persons died from overdose related to opioid pain medication (USA)

• Over the last decade, there has been an increase in opioid (narcotic) pain medication-related deaths in Canada and the USA.

Institute of Medicine of the National Academies Report. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, 2011. The National Academies Press, Washington DC.http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm; http://www.cdc.gov/drugoverdose/data/overdose.htmlSchopflocher D, Taenzer P, Jovey R. The prevalence of chronic pain in Canada. Pain Research & Management : The Journal of the Canadian Pain Society. 2011;16(6):445‐450.

Pain Management – The Market

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• Direct application to affected site

• Reduction in systemic effects

• Reduction in drug concentration in the blood

• Reduction in first pass metabolism

• Painless administration

Compounding for Pain Management -Advantages


• Ability to combine multiple drugs in one preparation

• Ability to choose desired base

• Increase patient compliance / convenience

• Ability to continually customize and modify based on a patient’s changing needs

• Avoidance of opioid and narcotic dependency

Compounding for Pain Management -Advantages

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• Improved Outcomes

• Decreased Side Effects

• Decreased Drug Interactions

• Decreased Opioid Use

• Decreased Medication Costs

• Multimodal Approach to Pain Treatment in 1 formulation

• Prescriber Loyalty

• Supplement Sales

• Payor Access

• Revenue $

Potential Intersection Opportunities Pain Management


• Pain management

• Dermatology

• Pediatrics

• Geriatrics


• Veterinary

Universes Intersect

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Most popular dermatological conditions benefiting from compounded preparations:

• Acne• Hair loss• Pruritus such as eczema and psoriasis• Calluses and warts• Corrective cosmetic• Topical fungus and rashes• Anti-aging

Dermatology


Cosmetics (Dermaceuticals)

• Many patients have multiple skin concerns and have difficulty finding a traditional, mass-market skin care product that meets their needs

• Customized to the patient’s needs by carefully selecting the right moisturizing agents, non-irritating bases and hypoallergenic products to treat your concerns based on your skin type

• Deliver active cosmetic boosters and a unique texture perfectly adapted to your skin’s needs

• Personalized and multi-functional solution

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• Individualized Dermatological Pharmacotherapy• Decreased Side Effects• Non-irritating bases and delivery system• Unique treatments without commercial product

• Topical B12

• Topical Estriol• Topical Hydroquinone

• Tailored Dermaceuticals (Cosmetics)• Private Label - your own line

• Prescriber Loyalty• Supplement Sales• Payor Access• Revenue $

Potential Intersection Opportunities Dermatology


• Pain management

• Dermatology

• Pediatrics

• Geriatrics


• Veterinary

Universes Intersect

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• Many Community Pharmacies are not comfortable compounding for kids – a simple suspension is sometimes not so simple

• Compounders are Formulation Experts • Reduce the risk of adverse drug events relating to

accidental overdoses for APIs with narrow therapeutic index

• Small amounts are desired or the dose required is not easily manipulated from the commercially available strength/dosage

Pediatrics


• Increase in compliance by masking the taste through the use of flavors.

• Compounders can give the child the option of choosing their flavor or even combining multiple flavors if desired

Pediatrics

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• Special populations, such as children with behavioral problems, diabetes, sensitivities or allergies in which symptoms can range from minor irritations to potentially causing anaphylactic shock.

• Additional Special Populations within:• Autism• Eosinophilic esophagitis• Resistant diaper rash

Pediatrics


• Compounders can make chewable tablets or liquids for patients that have difficulty swallowing a large tablet or capsule

• Child-friendly dosage forms include gummies, troches, lozenges, lollipops, oral liquid, suppositories

Pediatrics

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• Specializing in formulation expertise. Most community pharmacies are not equipped to formulate for children.• Lack of precise equipment (i.e., analytical balance, particle size

reduction/conformation)

• Flavoring experts• Unique treatments without the availability of commercial

products.• Prescriber Loyalty• Supplement Sales, dye free, preservative free, amino acid

supplements• Opens market to Pediatric Sports Medicine • Payor Access• Revenue $

Potential Intersection Opportunities Pediatrics


• Pain management

• Dermatology

• Pediatrics

• Geriatrics


• Veterinary

Universes Intersect

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• Growing number of senior citizens

• Represent 30% of the annually prescribed medications

Salom IL, Davis K. Prescribing for older patients: How to avoid toxic drug reactions. Geriatrics 1995;50:37‐44.

Geriatrics – The Market


• The concerns we have with pediatric patients are often shared with the elderly

• Difficulty swallowing tablets and capsules because of conditions such as dry mouth*

• The need to take numerous medications• Lower doses required• Easier administration• Combination of multiple drugs into one

preparation

Geriatrics - Advantages

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Common dosage forms :

• Oral liquids• Topical and/or transdermal creams• Ointments• Gels• Rapid Dissolving Tablets (RDT)• Sublingual sprays• Troches• Lozenges• Injections• Suppositories

Geriatrics


• Potentially reduce systemic side effects by using topical options • NSAIDs

• Topical Shingles Treatments

• Anal Fissures

• Unique treatments without the availability of commercial products

• Seminars and Events (Brown Bag, Used Rx Destruction)

• Supplement Sales specific to the seniors

• Assisted Living

• Revenue $

Potential Intersection Opportunities Geriatrics

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• Pain management

• Dermatology

• Pediatrics

• Geriatrics


• Veterinary

Universes Intersect


Pinkerton JV, Constantine GD. Menopausal Hormone Therapy (MHT) Usage: FDA‐Approved MHT Has Decreased While Compounded Non‐FDA Approved MHT Has Increased. Poster Board FRI‐124 Hyperandrogenic Disorders and Menopause. Presented at: The Endocrine Society Annual Meeting; March 5‐8,2015, San Diego.

Annual Number of Prescriptions

Market Value ($USD)

Commercial MHT market 36 million $3 billion – $4 billion

Custom compounded MHT market 26 – 36 million $1 billion – $2 billion

Most compounding pharmacists project a 5% to 25% growth in the compounding business over the next 2 years.

Hormone Replacement Therapy –The Market

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• Treatment has become more complex and all-encompassing

• HRT doesn’t only apply to women- Andropause

• Compounded Options afford prescribers and patients options.

• Core Health Consumers prefer compounded HRT.

Hormone Replacement Therapy


• Can provide the lowest effective dose without having to worry about the fixed dosing increments set by commercial products

• Provides hormones not commercially available.• Provide dosage forms of hormones not commercially

available, which delivers reported beneficial effects. • Provide unique and not commercially available delivery

systems in order to enhance clinical effects and decrease potential unwanted effects (RDTs, Troches, Pessaries, Topical, etc.)

• Minimize multiple medications being administered - multiple hormones can be combined into one preparation

• Increase patience compliance resulting in successful HRT

Hormone Replacement Therapy

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• Affords Physicians and Patients Options

• Individualization of Pharmacotherapy

• Clinical HRT Consults

• Unique treatments without commercial products• Estriol

• Intravaginal DHEA

• Transmucosal Delivery Systems

• Prescriber Loyalty

• Supplement Sales

• Payor Access

• Revenue $

Potential Intersection Opportunities HRT


• Pain management

• Dermatology

• Pediatrics

• Geriatrics


• Veterinary

Universes Inersect

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• Estimated 96 million Cats in US

• Estimated 80 million Dogs in the US

• Over 105 000 practicing veterinarians in USA

• Expected growth in number of pets

• By effectively handling a household pet prescription, you can obtain the pet owner’s business too

• Most Community Pharmacies Losing Market

• Community Pharmacists not Trained in Veterinary Pharmacy

www.avma.org/KB/Resources/Reports/Documents/Veterinarian‐Workforce‐Final‐Report.pdfwww.avma.org/KB/Resources/Statistics/Pages/Market‐research‐statistics‐US‐veterinarians.aspxwww.canadianveterinarians.net/documents/canada‐s‐pet‐wellness‐report2011www. ibisworld.com

Veterinary – The Market


Veterinary - Opportunities

• Domestic animals

• Food animals

• Exotic species

• Minor species

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• Fewer numbers of drugs available to veterinarians

• Species-specific requirements• Personnel safety when administering

medication to animals that is difficult to handle.• Transdermal Options, Paw Paste, Reverse

Gels, Ear Mites.

Veterinary - Advantages


Common dosage forms :• Oral pastes• Paw Paste• Chewable treats• Oral liquids• Topical Reverse Gels• Capsules• Injections• Topical or transdermal preparations• Powders (to be mixed with food)

Veterinary

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• Marketing Potential treating the whole family• Unique treatments without commercial product

• Paw Paste• Transdermal to pinna of ear• Reverse Gels

• Improving Vet Office Efficiencies• Improving Compounding Practices vs Vet Office• Animal Health Products Supplement Sales• Relationship with Law Enforcement• Revenue $

Potential Intersection OpportunitiesVet Pharmacy


1 2 3

Compounding






Opportunity

Outline

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• Consider this: avg pharmacy with 100 patients/day

• 5% (5 patients) requiring a compounded med

• The Average retail of compounded med = $901

• Annually = $117,450 addition to gross profit

• Compounding increases revenue, while offering options to your MD and patient base with targeted/personalized pharmaceutical care choices

1 http://lab.express‐scripts.com/lab/insights/drug‐options/closing‐the‐compounding‐loophole

Making Cents (₵) of it all …


Windows of Opportunity

Seeing through

the biggest windows

of them all.

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Windows of Opportunity

Patient Care

Business Development

Marketing

Regulatory / AccreditationParameters

PracticalImplementation


Make These Windows Become One

Quality Assurance – AccreditationRegulatory Compliancy – Certification

Marketing – Business ImageTraining – Competency – Academia

Clinical – Pt. Care – MTM – Collaborative PAsComplimentary Sales – Supplements – Services

“ What Obstructs Your View? Enlarge YOUR Window. See The 360° Panorama! Keep Your

Windows Clean”

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How Clean Are These Windows?


Questions???

What Opportunities Exist In Your Universe??

What Questions About The Universe Do You Have Today???

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