APPROVED-Ken-Speidel-2016 NCPA - Complimenting and ... · Complementing and Enhancing Your Comprehensive Pharmacy Services with an Innovative Compounding Practice sponsored by Medisca,
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9/28/2016
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Complementing and Enhancing Your Comprehensive Pharmacy Services with an Innovative Compounding Practicesponsored by Medisca, Inc.
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.
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.
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.
• ….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 FDA issued two draft guidance documents describing how the FDA would implement provisions of federal law that restrict compounding human drug products that are essentially copies of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.
• 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,
• 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
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.
• 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.
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.
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
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
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.
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.
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
• 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.
• 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.
• 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
• 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.
• 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
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
• 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 $