BSWH Technician Continuing Education 2016

Part 2: Pharmacy Law - Controlled Substance Security & Drug Supply

Chain Security Act (DSCSA) Contact Hours: 1.5

Objectives

• List some strategies regarding safe narcotics handling

• Explain the goals of the Drug Supply Chain Security Act (DSCSA)

• Review the reporting requirements for trading partners and manufacturers of the DSCSA

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Securing Controlled Substances

• The hospital pharmacy is entrusted with securing controlled substances (CS)

– This is a weighty responsibility on not only the pharmacist-in-charge, but all pharmacy staff

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Securing Controlled Substances

• Personnel – First step to diversion prevention is employee

screening • Baylor Scott & White hospitals perform background

checks when hiring pharmacy staff, and the Texas State Board of Pharmacy performs regular criminal background checks of registered pharmacists and technicians. Ensuring a trustworthy staff is indeed the first critical step in preventing drug diversion.

• Employees must hold themselves and their co-workers to high standards and are required to report CS security concerns to their manager

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Securing Controlled Substances • Physical Controls

– Establishing effective physical security controls in the pharmacy is required

• This is especially important in pharmacies that are not staffed 24/7

– Controlled substances are kept behind a locked door or cabinet commonly called “the vault”

– Controlled substances cabinets are commonly password protected in hospital pharmacy

– Security cameras are also used throughout the hospital – Staff must keep the physical controls in place – not prop

open doors, store CS outside a designated secure area, or share their passwords

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Securing Controlled Substances • Operational Controls

– Standard Operating Procedures (SOP)- written instruction or guidelines documenting how to perform an activity or process

– Establishing strong controls within SOPs for handling and processing CS, and assuring these SOPs are understood and followed by staff are critical for diversion prevention

– These safeguards must cover “every level of handling” - ordering and receiving functions, storage, counting, distributing to the floor, and the return of expired products

– Although CII’s carry the biggest risk for diversion, CIII, CIV, and CV CS should have certain controls in place

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Securing Controlled Substances

• One hallmark of strong CS controls is a “division of duties”

– These functions should be divided between two different people

• For example, the person ordering a supply of CS should not be the person who receives that order

• Even the pharmacist-in-charge should not routinely perform both functions

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Securing Controlled Substances

• Access Controls = Limiting access to CS – In hospital pharmacies with a limited number of

staff, all employees may play a role in handling CS, so limiting access to some employees may not be feasible

– In pharmacies with a larger staff, there may be the opportunity to restrict the number of employees with access

– Employees who might normally have access to CS storage locations when on duty should not be allowed access when “off the clock”

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DRUG SUPPLY CHAIN SECURITY ACT (DSCSA)

A sub-section of the DRUG QUALITY

AND SECURITY ACT (DQSA)

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DRUG QUALITY AND SECURITY ACT

• Signed into law on November 27, 2013, the Federal Drug Quality and Security Act (DQSA) is a significant move toward stronger drug quality and safety laws to ensure patient safety.

– The DQSA’s focus is to modify the Federal Food, Drug, and Cosmetic Act to grant the FDA more authority to regulate and monitor the manufacturing of compounded drugs

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DRUG SUPPLY CHAIN SECURITY ACT

• There is a specific sub-section of the Drug Quality and Security Act called the “Drug Supply Chain Security Act” (DSCSA)

– The DSCSA enhances the security of the drug supply chain

– It also protects consumers from exposure to drug products that may be:

• Counterfeit, diverted, or stolen

• Intentionally adulterated

• Subject of a fraudulent transaction

• Otherwise unfit for distribution (due to expiration or inappropriate storage conditions)

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• The DSCSA applies to transactions or changes in ownership of product (finished dosage form) performed by authorized trading partners. Certain prescription drugs will be traced as they move through the U.S. pharmaceutical distribution supply chain

• The result is improved detection and removal of potentially dangerous drugs from the supply chain

• When fully implemented, the system will provide the following:

enable verification of the legitimacy of the drug product identifier down to the package level

enhance detection and notification of an illegitimate product

improve efficiency for recalls

DRUG SUPPLY CHAIN SECURITY ACT

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Why is this law necessary?

• In 2012, a massive criminal drug diversion and relabeling scheme placed unknown numbers of consumer at risk and cost New York state’s Medicaid program more than $500 million

• The drugs were purchased on the street, then illegally sold back into

distribution • The drugs eventually reached pharmacies and were dispensed to

unsuspecting patients • Patients were exposed to medicines that may have been contaminated,

mislabeled, or expired

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Why is this law necessary?

• In 2009, a truck transporting over 120,000 vials of insulin was stolen

• The temperature-sensitive insulin was illegally sold back into the supply chain through wholesalers

• Retail pharmacies in Texas, Georgia, and Kentucky unknowingly received and dispensed the insulin

• Because the insulin was stored incorrectly, diabetic patients who

received the stolen product reported health complications

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DRUG SUPPLY CHAIN SECURITY ACT aka “Track and Trace” Goals

• Every drug in the supply chain (from the original manufacturer to the end distributor), will be tracked, so that in event of a problem, it is a path that can be traced

• “Critical steps are outlined in the DSCSA to build an “interoperable” system by November 27, 2023 and improve detection and removal of potentially harmful product from the pharmaceutical distribution supply chain.”

• Through improved detection and removal from the drug supply chain, U.S. consumers will be protected from compromised or counterfeit drugs. U.S. consumers can rely on receiving safe, effective, and high-quality medications

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Ultimate Goal

• Identify each individual prescription drug package in a way that will enable rapid and accurate verification of the legitimacy of the products

• When suspect products are identified in the supply chain, immediate notification of hospitals, health care professionals, and patients can occur

• This is an important tool in the fight against counterfeit drugs

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Definitions

• Trading partners – manufacturers, re-packagers, wholesale distributors, or dispensers

• Suspect product – product for which there is reason

to believe that it is potentially counterfeit, diverted, or stolen; is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans; is potentially the subject of a fraudulent transaction; or appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans

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Definitions

• Illegitimate product – product for which credible evidence shows that it is counterfeit, diverted, or stolen; is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans; is the subject of a fraudulent transaction; or appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans

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Definitions

• Transaction History (TH) – The term “transaction history” means a statement, in paper or electronic form, including the

transaction information for each prior transaction going back to the manufacturer of the product • Transaction Information (TI)

– The term “transaction information” means the: (A) Proprietary or established name or names of the product; (B) Strength and dosage form of the product; (C) National Drug Code number of the product; (D) Container size; (E) Number of containers; (F) Lot number of the product; (G) Date of the transaction; (H) Date of the shipment, if more than 24 hours after the date of the transaction; (I) Business name and address of the person from whom ownership is being transferred; and (J) Business name and address of the person to whom ownership is being transferred

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Definitions

• Transaction Statement (TS) – The “transaction statement” is a statement, in paper or electronic

form, that the entity transferring ownership in a transaction: • (A) Is authorized as required under the Drug Supply Chain Security Act; • (B) Received the product from a person that is authorized as required

under the Drug Supply Chain Security Act; • (C) Received transaction information and a transaction statement from

the prior owner of the product, as required under section 582; • (D) Did not knowingly ship a suspect or illegitimate product; • (E) Had systems and processes in place to comply with verification

requirements under section 582; • (F) Did not knowingly provide false transaction information; and • (G) Did not knowingly alter the transaction history

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DRUG SUPPLY CHAIN SECURITY ACT Timeline

TH- Transaction History; TI-Transaction Information TS- Transaction Statement 20

Why pharmacy participation matters

• Because pharmacies are the last stop in the distribution supply chain before medicines reach patients, their participation is an essential component of the new DSCSA

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Who is affected?

• The following groups must provide product and transaction information with each sale and notify the FDA and other stakeholders of identified illegitimate products:

o Manufacturers

o Repackagers

o Wholesale distributors

o Dispensers o Dispenser is defined as “A retail pharmacy, hospital pharmacy, a group of chain pharmacies under

common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor; and does not include a person who dispenses only product to be used in animals in accordance with section 512(a)(5)”

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What changes will pharmacies see?

• JANUARY 01, 2015 – Manufacturers, wholesale distributors and repackagers were

required to meet the initial tracing and verification regulations of the DSCSA

– Pharmacies now receive a “transaction history” document with each drug shipment listing every company that previously owned the drugs. In addition, a transaction statement accompanies the shipment attesting to the legitimacy of the drugs. This will assist pharmacies in verifying the purchased medications came from authorized suppliers

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What changes will pharmacies see?

January 1, 2015 (continued) • Dispensers must be able to receive the following lot-level

compliance data for every item purchased: – Transaction History (TH) – Transaction Information (TI) – Transaction Statement (TS)

• These 3 information pieces are referred to as “T3” compliance

documentation

• Additional requirements maybe necessary depending on pharmacy operating procedures

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BREAKING NEWS: Timeline Changes and Allowances

The requirements described in the next slides carry a JULY 2015 implementation date, but the FDA started enforcing the track-and-trace requirement on March 1, 2016 to allow more time for implementation.

• The FDA will exercise enforcement discretion for dispensers to allow additional time to perfect their compliance.

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What changes will pharmacies see?

• JULY 01, 2015 – Tracing and verification regulations for dispenser in effect. Pharmacies must maintain the

entire chain of custody information, both incoming and outgoing, to enable tracing of all products

• Step 1 – Receive LOT LEVEL COMPLIANCE DATA (T3) for all purchases

• Step 2 – Verify T3 compliance data

– Dispensers should verify the T3 compliance data against the product shipped by suppliers

– Any product determined to be suspect or questionable to be quarantined

– One of the known issues is that the new law will generate a tremendous amount of data. The FDA will allow paper transactions at the onset, but eventually the paper trail will be phased out and digital storage of all data will be required

– NOTE: The FDA exercises enforcement discretion for dispensers to allow additional time to perfect their compliance. The FDA started enforcing the track-and-trace requirement on March 1, 2016

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What changes will pharmacies see? JULY 01, 2015 (continued)

• Step 3 – Archive T3 compliance data – Dispensers are required to store the T3 data associated with every shipment for a period of

at least 6 years from the date of transaction

– Pharmacies must investigate any prescription drug in their possession that appears suspicious

• Any product appearing to be physically altered or missing required information such as the lot #, expiration date, or NDC #

– All trading partners must notify FDA, when it is determined that a product is a suspect of illegitimate product, not later than 24 hours after making the determination

• Records of the pharmacy’s investigation must be retained for six years (from the conclusion of the investigation)

– Notification must be given to the FDA for any product determined to be counterfeit, stolen, or otherwise illegitimate

• This information will support FDA investigations of supply chain breaches

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What changes will pharmacies see? JULY 01, 2015 (continued) Step 4 – Provide T3 compliance data for sales

– Dispensers must provide T3 documentation to another pharmacy or hospital if they are selling or loaning the product, and the ownership of that product changes hands

– A pharmacy is not required to provide T3 documentation:

– When dispensing a drug to an individual patient – When supplying a drug to another hospital or pharmacy to meet

an immediate individual patient need – When supplying a drug in an emergency – When supplying a drug between members of an affiliate

» Such as transfers between Baylor Scott & White facilities during a drug shortage

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What changes will pharmacies see?

JULY 01, 2015 (continued) • Step 5 – Retrieve & Respond to Request for

Information – If the FDA or appropriate federal or state official

issues a REQUEST FOR INFORMATION (RFI) related to a suspect product investigation or to facilitate a product recall, the dispenser in question must retrieve specific compliance data within two business days

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What changes will pharmacies see?

• JULY 01, 2015 (continued) • Step 6 – Respond to Verification Inquiries

– If the dispenser possesses a suspect product or if a request for verification is received from FDA, the product is quarantined and an investigation is conducted in coordination with trading partners that shall include validation of any applicable T3 compliance data

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What changes will pharmacies see?

• In 2017: – Manufacturers, followed by repackagers, will be required

to affix a unique product identifier to each drug package – A 2-dimensional (2D) bar code with a unique serial number

will be placed on each package of drug that contains the NDC, serial #, lot #, and expiration date

– Pharmacies may choose to check these numbers and verify the product’s authenticity before dispensing to patients, but they are not required to do so

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What changes will pharmacies see?

• In 2023: – Supply chain stakeholders and FDA will benefit from an electronic

interoperable system which facilitate efficient exchange of product and transaction information for prescriptions drugs at the individual package level

– Pharmacies and all other companies in the U.S. pharmaceutical distribution system must participate in a fully electronic traceability system utilizing the new serial numbers to identify and remove illegitimate drugs

– The specific parameters of the fully electronic system in 2023 are yet to be defined

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Requirements

– Trading partners • upon determining that a product in their

possession or control is illegitimate, should notify FDA and all immediate trading partners not later than 24 hours after making the determination

– Manufacturers • are additionally required to notify FDA and

immediate trading partners not later than 24 hours after the manufacturer determines or is notified by FDA or a trading partner that there is a high risk that the product is illegitimate

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Identification of suspect product

• Following are examples of scenarios that increase the risk of a suspect product entering the drug supply chain:

– Purchasing from a source new to the trading partner

– Receiving an unsolicited sales offer from an unknown source

– Purchasing on the Internet from an unknown source

– Product that is generally in high demand in the U.S. market

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Identification of suspect product (Continued…)

• Product that has a high sales volume or price in the United States

• Product that has been or is the subject of an illegitimate product notification under the DSCSA or other alert or announcement related to drug quality

• Appearance of a package or a container used for transport that seems suspicious

• Package that uses foreign terms, such as a different drug identification number rather than the National Drug Code (NDC)

• Package that is missing information, such as the lot number or other lot identification, or the expiration date

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How trading partners can identify suspect products • Be alert for offers of product for sale at a very low

price or one that is “too good to be true” • Closely examine the package and the transport

container for signs that it has been compromised, to see if product inserts are missing, for shipping addresses or postmarks indicating that the product came from a foreign entity

• Closely examine the label on the package for any missing information, altered product information, or misspelled words

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Notification of Illegitimate Product

– Access FDA’s webpage at http://www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm for notifications

– Follow instructions on the webpage for accessing FDA form 3911

– FDA form 3911 should be submitted by using the method provided in the form or on the webpage

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Summary The Drug Quality and Security Act (DQSA)

• Federal law enacted November 2013

The Drug Supply Chain Security Act (DSCSA) is a section of this law

• Requires database capable of providing: – verification of the legitimacy of the drug product identifier down

to the package level – enhanced detection and notification of an illegitimate product – improve efficiency for recalls

• Goal of immediate notification of hospitals, health care professionals, and patients, when suspect products are identified in the supply chain

• Full implementation by November 2023

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Please Complete Quiz Part 2: Pharmacy Law - Controlled Substance

Security & Drug Supply Chain Security Act (DSCSA)

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