10/18/19 1 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 2 1
10/18/19 Disclosure There are no relevant financial relationships with ACCME- defined commercial interests for anyone who was in control of the content of the activity. 3 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 4 2
10/18/19 History • Prescription Drug Marketing Act (PDMA) – 1988 § Outdated - didn’t address today’s counterfeit circumstances, technologies, business conditions (i.e..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 6 3
10/18/19 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 7 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 4
10/18/19 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 9 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 5
10/18/19 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) 12 6
10/18/19 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 13 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 14 7
10/18/19 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 15 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 outer/inner container, missing or wrong package insert, damaged or broken seal, open package, different product name than FDA approved version 16 8
10/18/19 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 17 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 18 9
10/18/19 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:” o Not a wholesaler requirement, web-portal o Access vs. storage o Dispensers must keep certain DSCSA specified records for “not less than 6 years” § Information and verification requests: o Suspect and illegitimate product investigations o Dispensers have 2 business days to respond to FDA or other gov’t info requests 19 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 20 10
Recommend
More recommend
