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"WHAT IF?" COMPLIANCE sCENARIOS
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A
sales rep with a pharmaceutical company is allocated ten samples
per doctor once every two weeks. A doctor he has a good relationship
with asks for more and the rep gives him 100 samples. To thank the
sales rep, the doctor gives him two tickets to Sunday's football game. Does this transaction require compliance consideration?
Read more and decide... |
After
a sales rep resigns, managers at a pharmaceutical manufacturer discover
that the rep had an additional storage unit containing samples that
would ultimately balance a previously erroneous reconciliation report.
The former sales rep wonders if a new report will be filed with the FDA
to let them know her inventory did in fact reconcile now that the
additional samples have been returned. Do you agree that at the end of this scenario, there is nothing to report to the FDA?
Read more and decide...
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A
pharmaceutical company uses the ABC Group to handle all of their sample
accountability. Once a month, ABC Group sends the pharma company sales
reps pre-printed forms for distributing samples to physicians.
When a new practitioner is sampled, it is recorded on a blank form and
the license is validated. Once valid, the practitioner information is
preprinted on the forms in the next shipment. If the new
practitioner is not on the pre-printed forms, it is expected that the
representative will know not to continue sampling. Does this scenario represent a compliant process?
Read more and decide...
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A
brand manager for a pharmaceutical company wants to avoid the expense
of a lot of returns on any un-sampled product when one of their drugs
goes off-patent at the end of the year. He instructs the field
representatives to give out all of their samples of this particular
product by the end of the year in the hopes that it will create some
brand loyalty once the generic is available. Are you comfortable with the decision in this scenario?
Read more and decide...
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During
a PDMA audit, a pharmaceutical company realizes that a sales rep made
an error on a disbursement, entering two (2) zeros after a disbursement
of one (1) unit, thus recording the disbursement as 100 sample units
instead of 1 sample unit. Since the company's electronic sales force
automation system does not allow adjustments to a sample disbursement,
the company corrects the transaction by entering a phantom shipment for
99 units to balance the rep's inventory. Do
you agree that this is an appropriate way to correct the error? If you
do, have you considered the impact of federal and state reporting laws?
Read more and decide...
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International Society for Medical Publication Professionals Poster
CIS' Jamie Kendall worked with Shire Development Inc. to produce a poster compiling guidance for publication leaders and teams to use for publication planning, processes and daily tactical operations.
The Ten Commandments of Sample Accountability (Sixth Edition)
Read this updated reference guide for building a PDMA-compliant sample accountability program.
The Ten Commandments of Federal & State Compliance & Reporting (Third Edition)
Read reference guide for building a compliant Federal & State reporting program.
GCP Compliance Checklists
Checklists
can be very effective in investigating compliance trends across sites,
or in identifying sites that may require the rigor of an audit. CIS has
developed two checklists, click on the links to download.
Checklist #1: GCP Compliance Checklist: Sponsor/CRO Systems
Checklist #2: GCP Compliance Checklist: Specific Clinical Trial
The TRICARE Final Rule was
enacted by the Department of Defense on March 17, 2009. Recent
challenges to the rule, which mandated that manufacturers refund
amounts in excess of the Federal Ceiling Price (FCP), led to a
surprising turn of events. Listen to this 10-minute podcast for background and recent changes to the TRICARE Final Rule.
The Pharma Compliance Blog,
created and run by Compliance Implementation Services, is a completely
free gathering place in which members of the pharmaceutical industry
can exchange information and discuss issues in a safe environment. The
site, www.pharmacomplianceblog.com,
features daily posts and articles, key industry terms and the most
recent pharmaceutical news. The blog also archives all previous posts
and relevant comments so that visitors can tour the site for key issues
related to their department and overall business.
PharmaComplianceExchange (PCX) The best source for critical compliance information – http://pharmacompliancexchange.com
The US Food and Drug Administration (FDA)
is responsible for protecting the public health by assuring the safety,
efficacy and security of human and veterinary drugs, biological
products, medical devices, our nation’s food supply, cosmetics and
products that emit radiation.
http://www.fda.gov
The International Conference on Harmonisation (ICH)
of Technical Requirements for Registration of Pharmaceuticals for Human
Use (ICH) is a unique project that brings together the regulatory
authorities of Europe, Japan and the United States and experts from the
pharmaceutical industry in the three regions to discuss scientific and
technical aspects of product registration. http://www.ich.org/cache/compo/276-254-1.html
The European Commission (formerly the Commission of the European Communities)
is the executive branch of the European Union. The body is responsible
for proposing legislation, implementing decisions, upholding the
Union's treaties and the general day-to-day running of the Union.
http://ec.europa.eu/index_en.htm
Centers for Medicare and Medicaid Services (CMS)
is an agency within the Department of Health and Human Services, is
responsible for administering the Medicare and Medicaid Programs. As
such, CMS issues rules and guidance pertaining to both Programs. For an
exhaustive listing of CMS information, please refer to this site:
www.cms.hhs.gov.
HHS-Office of Inspector General (OIG)
is responsible for investigating fraud, waste, and abuse among the
various Federal health care programs. The OIG has issued both
program-specific and general compliance-related regulations and
guidance. For an exhaustive listing of OIG information, please refer to
this site:
www.oig.hhs.gov.
HRSA Office of Pharmacy Affairs (OPA)
is an Office within the Health Resources and Services Administration,
an agency within the Department of Health and Human Services. The OPA
is responsible for administering the 340B Program, which provides
discounted drug pricing to certain statutorily defined entities. The
OPA works in conjunction with the Pharmacy Services Support Center
(PSSC) as well. All three organizations, including the Public Health
Service, have issued regulations and/or guidance pertaining to the 340B
Program. For an exhaustive listing of HRSA, OPA, and PSSC information,
please refer to these sites:
http://www.hrsa.gov/, http://www.hrsa.gov/opa/, http://pssc.aphanet.org/.
Department of Veterans Affairs (VA)
is responsible for overseeing and administering many different
veterans' benefits, only one of which pertains to drug pricing. The VA
has issued regulations and guidance pertaining to the VA drug pricing.
For an comprehensive listing of VA information, please refer to this
site:
http://www.va.gov/.
TRICARE Management Authority (TMA)
and the Department of Defense are responsible for administering
TRICARE, a program which is part of the CHAMPUS Program. Both
organizations have issued regulations and guidance pertaining to the
TRICARE Program. For an comprehensive listing TRICARE information,
please refer to the following sites:
http://www.tricare.mil/ and http://www.defenselink.mil/.
Listen to this industry attended teleconference to hear more about TRICARE.
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