1 Pharmacy Regulatory Updates and an Introduction to Specialty Pharmacy Mark Atalla, PharmD.

1Pharmacy Regulatory Updates and an Introduction to Specialty Pharmacy

Mark Atalla, PharmD

2Disclosure

• I have no relevant financial relationships with commercial interests pertaining to the content presented in this program

3Objectives

• 3 Key Things to Walk Away With:– Understand what Specialty Pharmacy means– Understand Regulatory Landscape for Sterile Compounding– Discuss Pedigree and FDA Track and Trace Requirements

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Renal Specialty Pharmacy

Specialty Regulatory Tie-in

• Renal Therapy Management• Integrating care among clinics and patients to deliver health outcomes

• Focus on value added pharmacy services• Right dose, right time• Counseling• Adherence• Adverse events

Breakdown of the medicine value chain by stakeholder – IMS illustrative

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The Importance of Phosphate Management

*Urea Reduction RatioBlock GA et al. J Am Soc Nephrol 15: 2208-2218, 2004

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Renal Specialty Pharmacy

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Specific Goals of a Renal Specialty Pharmacy:• Create alignment with prescribers to improve medication compliance• Offer care and service to help our patients by providing convenient delivery

of medications in the most cost effective way• Be a valued resource to our staff to help improve patient outcomes

Breakdown of the medicine value chain by stakeholder – IMS illustrative

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Renal Specialty Pharmacy

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• How to get there:• Clinical pharmacists that review lab values, compliance, and engage

patients• Pharmacists with certification in ESRD and co-morbidities• Focus on execution, collaboration, and experience

Breakdown of the medicine value chain by stakeholder – IMS illustrative

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Specialty Pharmacy Overview

• Specialty Medications are:• CMS: medications that cost ≥$600 for a 30 day supply• Represent a limited number of drugs that are used by a small

proportion of beneficiaries • Have specific processing, handling, and administration requirements• May be a limited distribution network• Potential narrow, and narrowing, commercial networks

Alexion – Ultra-rare diseases

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Renal Specialty MedicationsIndication Medication Comments

Hyperphosphatemia Lanthanum carbonate (Fosrenol®)

Chewable or Powder

Hyperphosphatemia Sevelamer hydrochloride (Renagel®) -

Hyperphosphatemia Sucroferric oxyhydroxide (Velphoro®)

Chewable

Hyperphosphatemia Ferric citrate (Auryxia®) Potential increase in iron (ferritin)

Hyperphosphatemia Sevelamer carbonate (Renvela®)

Available in powder or tablet

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Renal Specialty MedicationsIndication Medication Comments

Anemia Darbepoetin alfa (Aranesp®)

Available in pre-filled syringes

Anemia Epoetin alfa(Epogen®)

Single and Multidose vials

Secondary hyperparathyroidism

Cinacalcet (Sensipar®)

Daily dosing – compliance is important

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Case Study

• ESRD patient with HIV • Common therapy for HIV is tenofovir (Viread)• Patient was taking Viread daily• Data and recommendations from manufacturer:

Intermittent hemodialysisTenofovir 300 mg PO every 7 days following routine dialysis; administer following completion of dialysis.

• Adverse reactions: hypertriglyceridemia, increased cholesterol, decreased bone mineral density, GI side effects

Key Take Away: Specialty pharmacies strive to deliver better outcomes through developing disease-state specific expertise

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Regulatory Environment

• Specialty pharmacies build expertise in specific disease states and the medications that affect those disease states

• The regulatory environment heavily governs pharmacy practice• State and Federal Regulations

• Three regulatory issues that affect practice and our patients:• CMS consent • Sterile Compounding• Pedigree and Track and Trace

Goal: Build awareness of the regulatory issues that impact pharmacy with leaders in ESRD care

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Patient Consent

• Automatic refills -> potential for waste• Patient complaints; consistent with decreasing fraud, waste, and

abuse• 2014 CMS – Part D sponsors to require pharmacies obtain patient

consent prior to each delivery • Goal: Decrease unintended waste, accumulation, costs

What does that mean for you or our patients?• Pharmacies must obtain patient consent prior to each delivery • Patients have a right to put a prescription on hold or refuse

treatment

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Sterile Compounding

• September 2012 – multistate outbreak of fungal meningitis• 751 patients affected in total, 25 in Florida (meningitis, stroke, spinal

infections)• 64 patients died, 7 in Florida

Previous Background• April 2002 – FDA issues Form 483 with findings• February 2003 – FDA issues Form 483 with findings

“…the potential for serious public health consequences if compounding practices are not improved…so long as a pharmacy’s operations fall within the scope of the practice of pharmacy, FDA will generally continue to defer to state authorities for regulatory oversight.”

• January 2007 – FDA Warning Letter• October 2012 – FDA Form 483

FDA New England Compounding Center: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/ucm325828.htm

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FDA Guidance

• 2013 - Drug Quality and Security Act and Compounding Quality Act • Establishes 503B outsourcing facilities• Drugs must be compounded in compliance with cGMP

• 2013/2014 -• Section 503A –Requirements for exemption for licensed pharmacists or

licensed physicians compounding small quantities• Section 503B – outsourcing facilities – must follow current good

manufacturing practices• “Inordinate amounts of compounded drug products interstate”

Positive changes and guidance from the FDA to help guide sterile compounding

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State of Florida

• 2007 - Standards of practice for compounding sterile preparations• 2013/2014 – New Standards of Practice

• Adoption of USP Standards • Sterile Compounding Permit Required – in- and out-of-state

• Pharmacy inspections – new inspectors; significantly different form • Consultant pharmacist: provide guidance for Class IIb permit (eg. immediate

use, beyond-use dating)

Key Take Away: Significant Federal and State changes require that all pharmacies that supply CSPs must be permitted by the State of Florida and

follow USP or cGMP guidelines for sterile compounding

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Pedigree

• Counterfeit medications: Less than 1% in the US (WHO; FDA)• Proactive FDA approach – as specialty items increase, greater economic

incentives for counterfeiting

FDA - Counterfeit Version of Botox Found in the United States. http://www.fda.gov/Drugs/DrugSafety/ucm443217.htm

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Pedigree

• 2013 - Drug Supply Chain Security Act – Track and trace• Goal is building an electronic, interoperable system over next 10 years• Trading partners (manufacturers, wholesale distributors, and re-

packagers) provide transaction documentation to dispensers• Transaction information, transaction history, and transaction

statements • Trading partners maintain for ≥ 6 years after transaction

Key Take Away: The pharmaceutical supply chain is becoming more regulated with eventual greater transparency and tracking of medications

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Conclusions

• Pharmacies should be seen as a partner that can offer value added services for the patients we all treat

• Specialty Pharmacy refers to the clinical and practical expertise needed to dispense the range of medications that fit specific criteria

• Significant Federal and State changes require that all pharmacies that supply CSPs must be permitted by the State of Florida and follow USP or cGMP guidelines for sterile compounding

• The pharmaceutical supply chain is becoming more regulated with Track and Trace.

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Thank you