Impending Inventory Impact: Your pharmacy and requirements under the - - PDF document

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Impending Inventory Impact:

Your pharmacy and requirements under the Drug Supply Chain Security Act

NCPA Annual Convention 2019 Kala Shankle, J.D. Lisa Schwartz, Pharm.D.

NCPA

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Disclosure

There are no relevant financial relationships with ACCME- defined commercial interests for anyone who was in control

• f the content of the activity.

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Pharmacist and Technician Learning Objectives

At the conclusion of this program, you will be able to:

• Describe current and future requirements under the DSCSA

for community pharmacies

• Discuss processes for identifying and investigating suspect

product

• Discuss practices that help your community pharmacy

comply with the DSCSA

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History

• Prescription Drug Marketing Act (PDMA) – 1988

§ Outdated - didn’t address today’s counterfeit circumstances, technologies, business conditions (i.e.. interstate distribution)

• Pedigree laws: California’s “e-pedigree”

§ Real-time, interoperable tracking system § Scanners, too much data, super expensive (estimated $100k per individual pharmacy in the first year)

• Enter the Drug Quality and Security Act (2013)

§ Title I: Compounding § Title II: The Drug Supply Chain Security Act (DSCSA)

• DSCSA preempts state pedigree laws

§ Stop talking about pedigree laws… 5

Goals

• FDA, Center for Drug Evaluation and Research
• Implement an interoperable, electronic tracing of products at the

package level by 2023:

§ Facilitate electronic exchange of transaction information for each sale of prescription drugs § Use product identifiers to verify product at the package level § Support prompt response to suspect and illegitimate products when found § Improve efficiency of recalls

• Establish national standards for licensure for wholesale distributors

and third-party logistics providers

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What’s covered under the law?

• Products: Prescription drug in finished dosage form for administration

to a patient without further manufacturing (such as capsules, tablets, lyophilized products before reconstitution)

• Not products: OTC, medical devices, API, or drugs indicated for animal

use

• Blood and blood components intended for transfusion
• Radioactive drugs and radioactive biologics
• Imaging drugs
• Intravenous products
• Medical gases
• Homeopathic drugs
• Compounded drugs

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What actions do pharmacies have to take with these products?

• Transaction = occurs when a product changes ownership
• Traceability requirements apply to transactions
• Traceability requirements:

§ Transaction information (TI): Includes the name of the product; strength and dosage form; NDC; container size; name and address of the seller and the purchaser; and other DSCSA specified information § Transaction history (TH): Paper or electronic statement that includes the transaction information for each prior transaction back to the manufacturer § Transaction statement (TS): Paper or electronic attestation by the entity transferring ownership of the product that it is authorized under the Act; received the product from an authorized party; and other DSCSA specified information 8

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Exclusions

• Specific patient need: Transfer of a product from one pharmacy to

another (regardless of whether the two pharmacies are affiliated in any way) to fill a prescription for an identified patient.

• Office use: Distribution of minimal quantities of products by a licensed

retail pharmacy to a licensed practitioner for office use

• Mergers: Distribution of a product pursuant to a sale or merger of a

pharmacy or wholesaler

• Combo products: Distribution of combination products (device +

drug/device/biologic)

• Emergencies: Distribution for emergency medical reasons

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Specific Patient Need

• Specific patient need: Transfer of a product from one pharmacy to

another (regardless of whether the two pharmacies are affiliated in any way) to fill a prescription for an identified patient

• If a transaction falls into this category, no product tracing requirements
• Otherwise, pharmacy may need to register as a wholesale distributor
• FDA guidance:
• August 2017: Identifying Trading Partners Under the Drug Supply Chain Security

Act, Guidance for Industry

• March 2018: Standardization of Data and Documentation Practices for Product

Tracing Guidance for Industry 10

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Who can you trade product with? Aka who’s an “authorized trading partner?”

• Wholesale distributor: Has a valid license under state law or section 583, in

accordance with section 582(a)(6), and complying with the licensure reporting requirements under section 503(e)

• Third-party logistics provider: Having a valid license under state law or

section 584(a)(1), in accordance with section 582(a)(7), and complying with the licensure reporting requirements under section 584(b)

• Dispenser: Has a valid license under state law
• Check out the FDA’s database to check who is an ATP

§ https://www.accessdata.fda.gov/scripts/cder/wdd3plreporting/index.cfm § Also, look at your state’s licensing authority for updated list 11

What’s on the line?

• Failure to comply with a DSCSA requirement is a “prohibited

act”

• Commission of a prohibited act subjects a party to:

§ Injunction of unlawful activity § Seizure of goods § Civil and criminal fines and penalties (including jail)

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Phase I Requirements

• Product tracing: Phased approach requiring manufacturers, wholesale

distributors, dispensers and repackagers to pass, capture, and maintain certain information with respect to each transaction

• Trading partners must:
• Receive and capture TI/TH/TS
• Provide TI/TH/TS (as applicable…not when dispensing)

§ Standards for product tracing and data exchange (currently paper or electronic is ok) § FDA guidance:

§ November 2015: DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy Guidance for Industry (Revised) § March 2018: Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry

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Phase I Requirements (continued)

• Store 6 years of records (“maintain the transaction data”)

§ Third Party Agreement

• Respond to information request
• Look for suspect and illegitimate product at their pharmacies
• Return product to trading partner

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Phase I Requirements: Verification

• Pharmacists must institute a process to deal with suspect or

defective products

• Suspect Product: Dispenser has reason to believe:
• Potentially counterfeit, diverted, stolen
• Subject to fraudulent transaction
• Intentionally adulterated or appears otherwise unfit for

distribution such that would result in serious adverse health consequences or death to humans

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Verification (continued)

• Illegitimate product: Dispenser has credible evidence that shows:
• Product is counterfeit, diverted, stolen
• Subject of fraudulent transaction
• Intentionally adulterated or appears otherwise unfit for distribution such that

would result in serious adverse health consequences or death to humans

• FDA examples: Altered product, missing info on label, looks different

than product on shelf, no “Rx only” symbol, bubbling on the label, foreign language, lot numbers or expiration dates do not match the

• uter/inner container, missing or wrong package insert, damaged or

broken seal, open package, different product name than FDA approved version

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Verification (continued)

• Quarantine and investigate the product
• Investigation: Validate TI and TH, by 2020 must verify lot number

and product identifier

• Notification: If product is illegitimate, notify FDA and trading

partners within 24 hours

• FDA form 3911 (only for illegitimate product)
• Respond: Work with manufacturer to take steps to prevent product

from reaching patients

• Recordkeeping: Store investigation records for 6 years

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Verification (continued): FDA-3911

• Requirements:
• Dispensers and other trading

partners must notify FDA of illegitimate products within 24 hours of determination

• If product is determined to be

legitimate, then traders must notify FDA

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Can’t pharmacies just rely on their wholesalers?

• It depends…

§ If a dispenser enters into …an agreement [such as with a wholesaler] the dispenser must maintain a written agreement and shall not be relieved of the obligations…” § “Maintain the transaction data:”

• Not a wholesaler requirement, web-portal
• Access vs. storage
• Dispensers must keep certain DSCSA specified records for “not less than 6

years”

§ Information and verification requests:

• Suspect and illegitimate product investigations
• Dispensers have 2 business days to respond to FDA or other gov’t info

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FDA Enforcement of Phase I

• FDA sends warning letter to trading partner for violations of the track

and trace law, first of its kind

• The letter alleges that the distributor sent missing and wrong pills to

multiple pharmacies

• The shipments were originally supposed to be for opioids.
• This warning letter is an important milestone for the supply chain

because it serves as a warning to the industry that all U.S. trading partners, including pharmacies, should ensure they are adhering to their responsibilities under the DSCSA

• NCPA Pharmacy Checklist on DSCSA available

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Phase II Requirements

• All about serialization: NDC, serial number, lot number, expiration date
• 2018: Manufacturers/repackagers must affix a product identifier to each individual

package and homogenous case

• 2019: Wholesale distributors must only accept products that contain the required

product identifier; and verify product identifier before redistributing returned products

• 2020: Dispensers must only accept products that contain the required product

identifier § And also can only buy/sell products that are serialized (unless grandfathered or

• therwise excluded)
• 2023: Unit level traceability

§ Excluded products, grandfathered, waiver or exempt

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Phase II: Serialization

• Dates everyone should know…
• Nov. 27, 2018: Serialized product now coming from manufacturers
• Nov. 27, 2019: Verification of saleable returns
• FDA enforcement discretion delays this to Nov. 27, 2019
• Nov. 27, 2020: Pharmacies can only accept serialized product
• A whole lot of misconceptions here

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What’s a DSCSA-compliant product identifier?

• Includes the product’s lot number,

expiration date, national drug code (or NDC), and a serial number

• The serial number is different for each

package or case

• This creates a unique identifier – human

and machine readable – to enable product tracing throughout the supply chain

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Phase II: Grandfathered Products

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Phase II Questions for Pharmacies to Ask

• Are you working on providing my pharmacy with tech to read a 2D

data matrix?

• Can the software integrate with other pharmacy software? Is there a

value-add beyond DSCSA compliance?

• Does this tech work in conjunction with all my wholesalers and other

systems that are holding my tracing information?

• Will this tech be updated as industry changes? Will this cost me more?
• What data standards does your technology solution support? Which

are not compatible?

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Phase II Questions for Pharmacies to Ask (continued)

• How will the technology vendor ensure my data is secure? What

happens if there is a breach? Is my data backed-up?

• Does the vendor have access to master data?
• What support services does the vendor provide to the pharmacy? Can

the vendor be reached 24/7? Via phone, email etc.?

• How are vendors identifying grandfathered product,

exempt/excepted/waived products?

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Takeaways: Pharmacies Should Know

• FDA’s small business study after 2023 implementation
• Do not wait to understand this law…
• Ask lots of questions of wholesalers and solutions providers

§ Get solid answers and be proactive

• If a pharmacy chooses to use a solutions provider, make sure

it’s not snake oil

• Pharmacies should have already implemented investigation

procedures

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Helpful Resources

• FDA’s “Utilize DSCSA requirements to protect your patients”

presentation:

§ https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyCh ainSecurity/DrugSupplyChainSecurityAct/ucm606945.htm

• FDA Guidances:

§ https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyCh ainSecurity/DrugSupplyChainSecurityAct/ucm424963.htm

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Use Cases

• Example on how to handle suspect product
• A pharmacy receives a package for a product with foreign text on the packaging.

What should the pharmacy do?

• Example on how to identify authorized trading partners
• A pharmacy receives a fax from Drug R Us offers great prices, but the pharmacy

has never traded with this wholesale distributor before. What steps should the pharmacy take before engaging in a business relationship with this wholesaler?

• Example on how to identify serialized product
• It is December 31, 2020. A pharmacy receives a shipment of product from a

wholesale distributor, but one of the packages in the shipment does not have a 2D barcode. What should the pharmacy do? 29

Impending Inventory Impact - Handout

• Pharmacies are required to retain DSCSA transaction data

elements and records of suspect and illegitimate product investigations for 6 years .

• Pharmacies should have already implemented

investigational procedures for suspect and illegitmate product investigations.

• Unless grandfathered or otherwise excluded, dispensers may
• nly buy/sell products that contain the required product

identifier as of (exact date) November 27th, 2020 .

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Kala Shankle, J.D.

Director, Policy and Regulatory Affairs kala.shankle@ncpanet.org 703-600-1179

Lisa Schwartz, PharmD

Senior Director, Professional Affairs lisa.shwartz@ncpanet.org 703-838-2684

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