U.S. PDMA Compliance - LRN · 4.1 PDMA TRAINING Rationale Training is one of the most critical components of any prescription drug sample distribution and accountability program

1. PURPOSE

The purpose of this policy is to establish an overall compliance program for the distribution, auditing, monitoring and reporting of UCB prescription drug samples in the U.S.

Rationale

The Prescription Drug Marketing Act (PDMA) was enacted to ensure that prescription drug products purchased by and distributed to consumers would be safe and effective and to avoid an unacceptable risk that counterfeit, adulterated, misbranded, sub-potent, or expired drugs would be provided to the American public. Incorporated into the U.S. Food, Drug and Cosmetic Act, a variety of “prohibited acts” are proscribed [21 U.S.C. 331(t)], as well as the penalties for these offenses [21 U.S.C.333 (a) & (b)]. Additionally, the Food and Drug Administration (FDA) has issued regulations implementing the sample-distribution portions of the PDMA in part 203 of Title 21 of the Code of Federal Regulations.

The PDMA, its implementing regulations, and state laws and regulations govern the distribution of prescription drug samples by:

1. Banning the sale of, purchase of, or trade (including the offer to sell, purchase, or trade) of drug samples and drug coupons that may be redeemed for sample drugs; and

2. Mandating storage, handling, and record-keeping requirements for drug samples.

In addition to regulatory concerns, a well structured sample program can reduce incentives and opportunities for product diversion and adulteration, while maximizing the benefits of providing samples to practitioners.

2. SCOPE

This policy applies to all UCB Inc. (UCB) employees, who facilitate or monitor the virtualdistribution of prescription drug samples for UCB as well as to all third party vendors who handle or otherwise distribute prescription drug samples for UCB.

3. ABBREVIATIONS AND DEFINITIONS

To the extent that these definitions differ from those contained in the UCB Glossary, these definitions will take precedence for the purpose of this policy / procedure.

3.1 AbbreviationsPDMA The Prescription Drug Marketing Act

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ation purposes only. Policy gov-000391 5.0 Effective 08-Dec-2014

U.S. PDMA Compliance

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3.2 DefinitionsLicensed Practitioner As defined by the Food & Drug Administration

21CRF§203.3(r): Any person licensed or authorized by State law to prescribe drugs.

Virtual Sample Distribution Samples which are not physically distributed by UCB employees, but delivered by authorized third party vendors, usually pursuant to voucher redemption.

4. POLICY

UCB must establish and maintain a compliance program relative to the distribution of prescription drug samples. The program must include the establishment and maintenance of administrative systems and processes to include at minimum the following key provisions:

Training

Sample Distribution Security and Compliance Auditing Systems, which may include auditing of UCB field employees by personnel independent of the sales force if needed.

Sample Distribution, including methodology for reconciliation of requests and receipts, identifying patterns of non-response (and the manufacturer’s or distributor’s response when such patterns are found).

Third Party Vendors

Sample Monitoring

Electronic Signatures/Records

Document Retention

Licensed Practitioner Validation

Investigation & Notification to Regulatory Authorities, including identifying any significant loss of drug samples and notifying FDA of the loss, and monitoring any loss or theft of drug samples.

Sample Distribution Plans


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4.1 PDMA TRAINING

Rationale

Training is one of the most critical components of any prescription drug sample distribution and accountability program. Proper training helps ensure compliance with laws governing the distribution of prescription drug samples and establishes the conduct expected of employees.

UCB will provide training to effectively communicate the company’s internal policies and procedures for sample distribution and to communicate specific regulatory requirements for the distribution of prescription drug samples as set forth in State and Federal regulations (i.e. PDMA; current Good Manufacturing Practices [cGMP] and Controlled Substances Act).

Applicable new employees in the home office and the field will receive initial training and tenured employees will receive periodic refresher training on PDMA policies. In addition, UCB will regularly review procedures as needed and identify additional areas of training.

4.2 COMPLIANCE AUDITS AND COMPLIANCE MONITORING

Rationale

An integral part of an effective compliance program is the use of audits, monitoring, and risk evaluation techniques to ensure compliance with existing regulations, standards, regulatory commitments, and internal policies and procedures, identify problem areas, and assist in the prevention and correction of potential problems. Regulatory agencies expect that each pharmaceutical company will have an auditing system in place to assess the effectiveness of its quality management system.

UCB will establish and maintain compliance auditing and monitoring systems to include sample distribution vendors in accordance with applicable regulations, standards and laws.

Compliance will follow the U.S. Affiliate External Audit Program standard operating procedure for conducting all PDMA related compliance audits. Monitoring tools will be developed on an as needed basis.

4.3 DRUG SAMPLE DISTRIBUTION

Rationale

It is the policy of UCB to comply with all applicable regulatory requirements, including the rules governing distribution of drug samples set forth in part 203 of Title 21 of the Code of Federal Regulations.

Regulations require that manufacturers and authorized distributors of prescription drug samples establish and maintain a system for tracking all locations and shipments of


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samples by quantity and lot number from the time the shipments leave the manufacturing facility until distribution to an authorized practitioner or other authorized recipient.

Drug samples and drug coupons cannot be offered for sale, purchase, or trade, or sold purchased, or traded under any circumstances. In addition, the sampling documentation must advise physicians that they may not charge a patient or bill a third party payor for UCB products provided as free samples. Free samples may not be provided on the condition, or with a mutual understanding that the health care practitioner will purchase or prescribe UCB products.

UCB may, from time to time, provide additional sample compliance guidance tailored to individual products. In general, and for all products, the following requirements apply:

a) Sample Distribution:

UCB employees do not currently provide prescription drug samples directly to Licensed Practitioners. All UCB products will be distributed by common carrier (e.g., Federal Express), as permitted by 21 C.F.R. §§ 203.30 and 203.31. UCB will ensure that a written request for the drug samples is received prior to delivery of a sample, and a receipt is received after delivery, as provided below.

Distribution of prescription drug samples to a requesting practitioner or other healthcare entity is permitted only in UCB sample programs managed by third party fulfillment programs sponsored by UCB.

For some products, UCB may institute caps to limit the number of samples a licensed practitioner may receive in a given timeframe.

b) Request Required

Before UCB will release prescription drug samples to a licensed practitioner, the practitioner must request the samples, in advance, in writing. The request form must include the practitioners name, street address (P.O. Box is not acceptable), professional designation, and signature; the requesting practitioner’s state license or authorization number; DEA registration number for controlled substance samples; the identity (i.e., proprietary or established name and strength) and quantity of products for which samples are requested; the name of the manufacturer; and the date of the request. Signatures by office staff or UCB employees on behalf of a licensed practitioner are not acceptable substitutions for a licensed practitioner’s signature when requesting the samples.

In the event of a written request by the practitioner for delivery of a sample to the pharmacy of a hospital or other health care entity, in addition to all of the information listed above, the request must also include the name and address of the pharmacy or other health care entity to which the drug is to be delivered. For controlled substance


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samples, the request must also include the DEA registration number for the facility, to which the sample is to be delivered.

UCB employees may process requests for prescription drug samples only from licensed practitioners located within the employees normal call region.

Requests may be transmitted to UCB electronically, provided that the method of transmission complies with the security requirements for electronic records set forth in Part 11 of Title 21 of the Code of Federal Regulations and this policy.

UCB will not distribute drug samples on the basis of open-ended or standing requests, but shall require separate written requests for each delivery of drug samples. An arrangement by which all licensed practitioner requests in writing that a specified number of drug samples be delivered over a period of not more than 6 months, with the actual delivery dates for parts of the order to be set by subsequent oral communication or electronic transmission (e.g., mail), is not considered to be a standing request.

c) Receipt Required

A written receipt is required for all samples delivered. For samples delivered to a requesting practitioner, or to the pharmacy of a hospital or other health care entity at the request of a licensed practitioner, by mail or a common carrier, a written receipt must be executed by either the requesting practitioner or by the person acknowledging delivery of the drug. When samples are delivered to a licensed practitioner, the receipt is required to contain the name, address, professional title, and signature of the practitioner or the practitioner’s designee who acknowledges delivery of the drug sample; the proprietary or established name and strength of the drug sample; the quantity of the drug sample delivered; and the date of the delivery.

When samples are delivered to the pharmacy of a hospital or other health care entity at the request of a licensed practitioner, the receipt is required to contain the name and address of the requesting licensed practitioner; the name and address of the hospital or health care entity pharmacy designated to receive the drug sample; the name, address, professional title, and signature of the person acknowledging delivery of the drug sample; the proprietary or established name and strength of the drug sample; the quantity of the drug sample delivered; and the date of the delivery.

Written receipts must be returned to UCB’s third party vendor after execution by the practitioner or designee. In accordance with current vendor contract on file, additional requests for samples will not be honored if sample receipts are not returned by the practitioner within the noted time period.


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d) State License Validation/DEA Registration

UCB or other authorized distributors will provide a drug sample only to a requesting practitioner authorized under state law to prescribe the product. In addition, controlled substance samples will be provided only to requesting practitioners appropriately registered with the U.S. Drug Enforcement Administration. Prior to distributing samples, UCB will verify the status of these licenses, as set forth below in this policy.

e) Distribution to Mid-Level Practitioners

State law determines the authority granted to mid-level practitioners (i.e., nurse practitioners, physician assistants, etc.). Distribution of UCB prescription drug samples to mid-level practitioners will be permitted if distribution is authorized by and complies with state law and the mid-level practitioner is authorized by sate law to prescribe the drug to be sampled. If a mid-level practitioner is permitted to prescribe prescription drugs, but is prohibited by state law from receiving samples, that mid-level practitioner may not be sampled.

f) Distribution to Retail Pharmacies

Prescription drug samples or drug sample request forms may not be distributed to retail pharmacies.

g) Distribution to The Pharmacy of a Hospital or Other Health Care Entity

UCB prescription drug samples may not be distributed at sites other than the pharmacy of a hospital or other health care entity.

h) Distribution of Samples Based on Expiration Dates

Prescription drug samples distributed from an authorized distribution facility to a licensed practitioner should have no less than 3 months before product expiration.

Unless otherwise indicated by product labeling, the expiration day for a prescription drug sample will be the last day of the month indicated in the product’s expiration date. For example, the day a product with a labeled expiration date of 07/09 expires would be considered to be July 31.

In cases where there is a request to distribute samples to a licensed practitioner with less than a three (3) month expiration date, the requestor must have a deviation plan and provide the Quality Assurance Department with a temporary change control document noting the justification and any potential risks for the planned activity.


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i) Label Requirement:

UCB will include on the label of the sample unit and on the outside container or packaging of the sample unit, if any, an identifying lot or control number that will permit the tracking of the distribution of each drug sample unit. UCB will maintain for all samples distributed records of drug sample distribution containing lot or control numbers that are sufficient to permit the tracking of sample units to the point of the licensed practitioner.

Each sample unit shall bear a label that clearly denotes its status as a drug sample, e.g., “sample”, “not for sale,” “professional courtesy package.”

j) Sample Distribution Plan:

UCB will implement systems, processes, policies, and procedures relating to the development, implementation, and review of plans for the distribution of samples by UCB (Sample Distribution Plans). This will include a review of the bases upon, and circumstances under, which health care providers and health care institutions belonging to specified medical specialties or types of clinical practice may receive samples or vouchers for samples from UCB. The Policies and Procedures shall also require that UCB modify the Sample Distribution Plans as necessary to ensure that UCB is promoting its products in a manner that complies with all applicable Federal health care program and FDA requirements. UCB will take a product’s approved uses into account when determining whether licensed practitioners belonging to particular medical specialties or types of clinical practices may receive samples. UCB may not direct employees to provide samples to licensed practitioners who do not normally treat conditions or patients for which the drug is approved.

All sampling activities must be consistent with the relevant Sample Distribution Plan UCB has created in compliance with the Corporate Integrity Agreement.

4.4 THIRD PARTY VENDORS

Rationale

A manufacturer or authorized distributor of record that uses a fulfillment house, shipping or mailing service, other third party to distribute prescription drug samples, or which enters into a co-marketing agreement with another manufacturer or distributor to distribute drug samples or to meet any of the requirements of the Prescription Drug Marketing Act (PDMA) remains responsible for creating and maintaining all requests, receipts, forms, reports, and records required under PDMA.

a) Co-marketer/Sample Fulfillment House

Compliance will follow U.S. Affiliate External Audit Program procedure to evaluate entities identified as co-marketing companies distributing UCB product samples, or third party fulfillment houses that will store and distribute UCB prescription drug


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samples. Such procedures and processes will include monitoring of such entities to ensure compliance with requirements for sample distribution under PDMA and as applicable under the Controlled Substance Act, including creating and maintaining all required requests, receipts, forms reports, and records.

4.5 Documentation, Record Maintenance and Retention

All records, information and deliverables related to this procedure will be retained for a period of six (6) years or longer if required by applicable law, contract or regulatory requirement. Records related to this procedure will be maintained by the activity owner unless otherwise specifically directed by the Legal Department. For GxP records retention refer to Corporate SOP Global Archive Procedure for Critical Records.

Rationale

Documentation provides the proof that prescription drug sampling activities satisfy regulatory requirements. Adequate retention and archiving methods are essential in order to discourage retention of unnecessary or obsolete records, and to safeguard essential data and documents in the event of a major catastrophe and for review by regulatory authorities.

Documentation relative to the handling and distribution of UCB prescription drug samples will be completed and maintained in accordance with the Prescription Drug Marketing Act (PDMA). Documentation created in accordance with Federal PDMA regulatory requirements will be maintained for a minimum of three (3) years after their creation. To comply with UCB’s current Corporate Integrity Agreement, documentation will be maintained for a period of six (6) years. Such documentation includes but may not be limited to the following:

Inventory/sample reconciliation records

Drug sample request forms

Records and reports of “significant loss” or records of the theft of prescription drug samples

District Manager “Sample Inventory” records;

Reports pertaining to investigations of sample handling and/or storage practices

Prescription drug sample storage locations records; and

Prescription drug sample delivery and receipt forms

a) Paper Documents

Documentation created on paper and maintained on paper or by photographic imaging (i.e., photocopies) will be retained in such a manner to resist tampering, revision,


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modification, fraud, unauthorized use, or alteration. Paper documents will be stored in an accessible and retrievable manner, and must be available to permit copying for purposes of review, analysis, verification, authentication, and reproduction by the person who executed the form or created the record, by the manufacturer or distributor, and by authorized personnel of FDA and other regulatory and law enforcement.

Documents shall be stored in such a manner so as to prevent loss of or damage. The risk factors that will be considered when assessing the storage arrangements include:

Potential for fire

Potential for water damage

Potential for theft or unauthorized access to documents

Accidental destruction/misfiling/retrieval and failure to return to proper storage location

b) Electronic Records & Signatures

Electronic records, electronic signatures and handwritten signatures executed to electronic records used to meet record and signature requirements of PDMA must satisfy the requirements of the Code of Federal Regulations, Title 21, Part 11 “Electronic Records; Electronic Signatures”. Combinations of paper records and electronic records, electronic records and handwritten signatures executed on paper, and paper records and electronic signatures or handwritten signatures executed to electronic records used to meet PDMA record and signature requirements must include a reasonably secure link between the paper-based and electronic components to ensure that the combined records and signatures are trustworthy and reliable and thesigner cannot readily repudiate the signed record as not genuine.

Documentation stored in electronic format will be available for printing to a hard copy format upon authorized request.

Documents stored in electronic form must be subject to the same level of control as those in hard copy form. Documents stored in electronic form must be held for the periods set forth above using a method that protects the data from loss, alteration or corruption and enables retrieval and reading of the record during the defined life of the document.

c) Validation

Computerized systems utilized for the creation and/or management of electronic records containing data required by the PDMA must be validated in accordance with UCB validation procedures.


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d) Terminated, or Reassigned Field Employees

In the event of a termination or transfer of a UCB field employee who may be in possession of PDMA documentation the following section will apply:

Terminated field employees will be instructed to return to UCB any confidential/proprietary materials (including PDMA-related documents) as noted in the Employee Self-Check Out.

Reassigned field employees will be instructed to transfer all UCB property (including PDMA-related documents) to another employee, manager or have the items shipped to UCB for filing as noted in the Employee Self-Check Out.

e) Availability of Documentation

Reports of the receipt, storage, distribution, return or destruction of prescription drug samples will be made available to an authorized agent of a State or Federal agency for review upon request or upon an agreed time frame between the agency and UCB.

Documentation maintained by UCB employees at third party or other off-site locations must be accessible within 48 hours (two business days) of the request.

4.6 PRACTITIONER VALIDATION

Rationale

The PDMA requires that manufacturers and authorized distributors of prescription drug samples must verify with the appropriate state authority that the practitioner requesting the prescription drug sample is licensed or authorized under state law to prescribe the product. State medical or prescribing licenses must be verified data or information provided by the appropriate state licensing board.

UCB prescription drug samples will be disbursed only to authorized licensed practitioners. Sample disbursement includes those samples delivered by common carrier pursuant to signed paper sample requests and UCB samples distributed by an authorized third party distributor. UCB must establish and maintain processes and procedures that will ensure the capture and maintenance of prescriber license validation status as part of the overall prescription drug sampling program. The overall process must ensure that the prescriber validation status is updated on at least an annual basis.

License validation will be required for all practitioners to whom samples are distributed, including mid-level practitioners such as Nurse Practitioners and Physician Assistants.

a) Controlled Substance License

Controlled substance samples will be disbursed only to practitioners currently licensed with the U.S. Drug Enforcement Administration to receive and prescribe the drug product. UCB must establish and maintain processes and procedures that will ensure


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the capture and maintenance of practitioner controlled substance license validation status as part of the overall program for sampling controlled drug samples.

b) One-Time Sample Rule

For sample distribution through delivery by common carrier, UCB will not provide for a one-time sample drop to practitioners.

4.7 NOTIFICATION TO REGULATORY AUTHORITIES

Rationale

Federal rules currently in place outline the investigation and reporting requirements with which a pharmaceutical company must comply if there is a significant loss or theft of a prescription drug sample, the suspected diversion of drug samples, or if there is suspected falsification of documents intended to record the distribution of prescription drug samples.

In addition to the federal requirements, some states have imposed their own requirements that differ from the federal rules. Pharmaceutical companies distributing drug product samples must be aware of these differences and assure that investigative and reporting systems not only meet federal requirements, but also specific requirements as imposed at the state level.

a) General

UCB must establish and maintain an investigation and reporting system that is compliant with federal requirements and those requirements imposed by individual states for the distribution of prescription drug samples. All UCB employees with responsibilities impacting the distribution of drug samples are responsible for the reporting of suspected or known acts of theft, loss, diversion or falsification to appropriate management and Compliance. Compliance is responsible for the investigation and reporting of the results of the investigations to the appropriate regulatory agencies.

b) Investigation and Reporting of Falsified Records or Product Diversion

If Compliance has reason to suspect that any person has falsified drug sample requests, receipts, or records, or is diverting drug samples, will notify the FDA in accordance with established Compliance procedures, within five (5) working days, and shall immediately initiate an investigation. UCB shall provide the FDA with a written report including the reason for, and results of the investigation, not later than 30 days after the investigation begins.

c) Investigation and Reporting of Significant Loss or Known Theft

Compliance will notify the FDA and applicable state authorities within five (5) days of becoming aware of a potential significant loss or known theft of prescription drug


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samples. Compliance will immediately initiate an investigation of the loss or theft and provide the FDA and applicable state authorities with a written report including the reason for, and result of the investigation not later than 30 days after the investigation began.

d) Conviction of a UCB Field Employee

Compliance, upon becoming aware of the conviction of an employee for a violation of the FD&C Act or any State law involving the sale, purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug sample, will notify the FDA within 30 days of becoming aware of the conviction.

e) Selection of Individual Responsible for Drug Sample Information

UCB shall inform FDA in writing within 30 days of selecting the individual responsible for responding to a request for information about drug samples of that individual’s name, business address, and telephone number.

5. REFERENCES sop-009342, Global Archive Procedure for Critical Records

6. DOCUMENT HISTORY

POL number SupersedesEffective

DateReason for revision

PC-POL-200 New Creation

q-000626 v1.0 PC-POL-200 15 Mar2007 Add Requirements for Controlled substances/New Policy Format and Numbering System

q-000626 v2.0 q-000626 v1.0 15 Mar2007 Migrated version into MIKADO

q-000626 v3.0 q-000626 v2.0 20 Dec 2009 Revised due to changing business needs. Merged into this policy:q-000628; q-000629; q-000632; q-000635; q-000636; q-000637; q-000638; q-00639

gov-000391 v4.0 q-000626 v3.0gov-000391 v3.0(number change

10 Oct 2011 Information under section 4.3(a) updated to include notice of sample request form limitations to HCPs and


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POL number SupersedesEffective

DateReason for revision

due to system upgrade)

DM allocations to sales reps. Movedinfo originally under “Abbreviations” section to “Definitions” Section.

gov-000391 v5.0 gov-000391 v4.0 03 Dec 2013 Removal of reference to annual inventory and reconciliation reports in Section 4;Removal of reference to sample request forms.Inclusion of planned deviations for sampling past 3 month expiration date.Update definition of a Licensed Practitioner.Removed reference to HCPs.Updated Termination/Reassignment Section.Changed sales representatives to “UCB employees” due to DMs now being able to obtain signature requests.


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DOCUMENT APPROVAL ELECTRONIC SIGNATURES

Signed by Meaning of Signature Server Date (dd-MMM-yyyy HH:mm:ss TZ)

DAVIS Clive Management Approval 22-Aug-2014 19:24:23 CEST

JONES Denise Author Approval 28-Aug-2014 14:16:28 CEST

COCHRAN Tyler Quality Approval 29-Aug-2014 16:19:40 CEST

NAEGELE Kimberly Legal Approval 10-Sep-2014 20:01:30 CEST


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