FDLI Canadian Conference: Health Canada's LASA Guidance and Naming Issues in US - Susan M. Proulx, PharmD President, Med-ERRS May 15, 2014
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FDLI Canadian Conference: Health Canada's LASA Guidance and Naming Issues in US Susan M. Proulx, PharmD President, Med-ERRS May 15, 2014 www.med-errs.com A subsidiary of the Institute for Safe Medication Practices (ISMP)
Overview of Presentation
• Overview of Med-ERRS
• History of Health Canada guidances
• Review of new guidance
• New and upcoming FDA guidances
• Comparison of Canada and US regulations related to
trademarks
Copyright Med-ERRS 2014 2
Med-ERRS
• Wholly-owned subsidiary of the Institute for Safe
Medication Practices (ISMP), incorporated in 1997
The relationship between ISMP and Med-ERRS gives us a unique
advantage, enabling us to apply our breadth and depth of safety
knowledge to the services we provide to our clients
• Independent company, professional staff of healthcare
practitioners
• Experts with over 50 years of combined experience in
medication safety and error prevention
Copyright Med-ERRS 2014 3
Med-ERRS
• Works in pre-marketing phase with the
pharmaceutical industry to evaluate product labeling,
packaging and nomenclature for safety
• Works in post-marketing phase to help monitor and
evaluate potential and actual medication errors that
have been reported
• We have worked with over 200 pharmaceutical and
healthcare companies over the past fifteen years
• The services we provide focus on reducing the risk
of medication error around the world to improve the
safety of the client’s product in the pre-marketing &
post-marketing phase
Copyright Med-ERRS 2014 4
History of Health Canada (HC) Draft Guidance:
“Review of Drug Brand Names”
• Current guidance became effective in January 2006
• Changes made to provide greater clarity to sponsors on
information requirements and enable greater consistency
within Health Canada
Internal Expert Panel
External Expert Panel – combining patient safety,
psycholinguistic and human factors expertise
Copyright Med-ERRS 2014 5
History of Health Canada (HC) Draft Guidance: “Review of Drug Brand Names” • Draft guidance released February 2013 • Industry consultation on draft guidance: February – May 2013 • Revised guidance released March 2014 • Expected to be posted June 2014, with effect taking place one year after posting (June 2015) Copyright Med-ERRS 2014 6
Revised Guidance • Scope: Prescription pharmaceuticals, biologics, radiopharmaceuticals, ethical drugs, drugs sold directly to health care practitioners (HCPs) intended for professional use • Purpose: Review of brand names to identify potential for a proposed name to be misleading and/or confused with another product authorized for use in Canada with the aim of preventing medication errors Copyright Med-ERRS 2014 7
Revised Guidance Changes
• Changes made on the basis of Industry consultation:
Removal of non-prescription drugs from scope
Removal of requirement for psycholinguistic testing
Ability to use any drug search engine (i.e., not exclusive to
POCA)
Lowering of similarity threshold to 50% and above (combined
scores)
Removal of requirement for patients to be involved in all
simulations and FMEA
Removal of requirement for all raw data with the exception of
the results from the search of the DPD and LNHPD.
Copyright Med-ERRS 2014 8General Overview of Guidance
• All brand names must be reviewed against criteria addressing
naming practices that HC considers misleading
• Some brand names will require look-alike/sound-alike (LASA)
assessments
• LASA brand name assessment is completed by the sponsor
Failure to provide a LA/SA brand name assessment may
result in sponsor not receiving a NOC or DIN
• Health Canada reviews the sponsor’s assessment; Health Canada
does not complete full LASA assessments
• HC may reject name considered likely to cause confusion with other
health products.
Sponsors have a right to appeal (Health Canada Guidance of
Industry : Reconsideration of Final Decisions Issued for
Human Drug Submissions”)
Copyright Med-ERRS 2014 92014 Revised Guidance: “Search, Simulate and Synthesize” Copyright Med-ERRS 2014 10
2014 Revised Guidance
Initial Brand Name Review: 14 Questions
• 14 questions to be answered by sponsor
• Sample questions 1-8:
Does name include or imply an ingredient not included in the
drug product?
Is name identical to an authorized product in Canada containing
a different medicinal ingredient?
Does name suggest an unsupported route of administration (i.e.,
AcetaminophenOral for a suppository product)?
• If affirmative reply to ANY of questions 1-8, HC will not initiate brand
name review and sponsor contacted to provide an alternate brand
name accompanied by LASA brand name assessment, if applicable.
• Sponsor can appeal refusal to initiate brand name review
Copyright Med-ERRS 2014 112014 Revised Guidance
Initial Brand Name Review: 14 Questions
• Affirmative reply to ANY of questions 9-14 will raise a concern that
proposed name could result in confusion, but HC will continue its review
if sponsor wishes
• Sponsor should supply HC with justification of why name is acceptable
• Sample questions 9-14:
Was the same/similar name used previously for a product no longer
available on the marked (i.e., discontinued)?
Has name been approved in another country for a product with a
different medicinal ingredient?
Copyright Med-ERRS 2014 12Revised Guidance “Search, Simulate and Synthesize” • If proposed name not refused following 14 question analysis, sponsor must conduct a three-step assessment of proposed drug name called: Search, Simulate and Synthesize • Testing of proposed brand names intended to assess likelihood of confusion between proposed name and product names authorized for use in Canada Copyright Med-ERRS 2014 13
Testing of Proposed Names for Look-Alike/
Sound-Alike Attributes
Step 1: SEARCH
• Search drug name and medication error databases to identify existing drug
names that may have potential for confusion with proposed brand that merit
further scrutiny during the final step, Synthesize
• Also, include medication error reports in published literature if proposed
name already in use in another country
• Submit proposed brand name to health product search engine and identify
any name with a similarity score equal to or greater than 50% using the
ALINE algorithm (objective criteria for orthographic, phonetic and combined
orthographic-phonetic similarity)
Any search engine can be used however, Health Canada will use
POCA (Phonetic and Orthographic Computer Analysis)
• Health Canada will complete a search of the DSTS
• All raw data from the database search(es) must be submitted to Health
Canada with the date of completion clearly identified
Copyright Med-ERRS 2014 14Testing of Proposed Names for Look-Alike/ Sound-Alike Attributes Step 2: Process Maps for SIMULATIONS • To create a context for planning and evaluating the simulations • Outline where and how the proposed brand named drug will be used, based on its indications and who in the medication use system will come into contact with the product • Prepared according to the most common use settings and circumstances (including the highest potential risk situations where applicable) • Where applicable, patients should be identified Copyright Med-ERRS 2014 15
Testing of Proposed Names for Look-Alike/ Sound-Alike Attributes (cont.) Step 2: Medication-use Simulations • To assess the confusability of a proposed name by inserting it into a variety of prescribing, transcribing, dispensing and administration scenarios and documenting the number and type of errors that occur • Involves healthcare professionals, ancillary staff and patients where applicable e.g. outpatient settings • At least 5 medication-use process simulations are required. These can be single replications of at least 5 scenarios, or multiple replications of single scenarios Copyright Med-ERRS 2014 16
Testing of Proposed Names for Look-Alike/ Sound-Alike Attributes Step 2: Medication-use Simulations (Cont.) • A minimum of 100 Canadian healthcare professionals must participate in the medication-use simulations unless a strong case can be made for a smaller number due to the specialized nature of the product and its intended users • Information gathered during the simulation studies is assessed in the last step of the name review process, Synthesize • Given the nature of how radiopharmaceuticals are managed and utilized, simulation exercises will not be required. Copyright Med-ERRS 2014 17
Testing of Proposed Names for Look-Alike Sound-Alike Attributes Step 3: SYNTHESIZE using Failure Mode and Effects Analysis (FMEA) • A rationale must be provided as to why any names generated during the database searches and simulations will be excluded from the FMEA, e.g., the name is of a disinfectant or veterinary product • Includes active practitioners in the field of use for the product whom handle/prescribe the drug • FMEA panel members will use the submitted medication-use process map(s) and seek to identify all potential things that can go wrong with a process or product • Includes comparisons of overlapping characteristics of the confusable drug names with the profile of the proposed product Copyright Med-ERRS 2014 18
Testing of Proposed Names for Look-Alike Sound-Alike Attributes Step 3: SYNTHESIZE (cont.) • Standard list of questions to be answered by panel members • Sponsors must prepare report summarizing all findings generated through 3 step analysis and submit to HC • HC renders decision to reject or approve name based on sponsor’s LA/SA brand name assessment Copyright Med-ERRS 2014 19
Brand Name Assessment Process
• An NOC/DIN can be issued under the drug’s common/proper name
If the brand name is the only outstanding issue, Health
Canada will move forward with the use of the proper/common
name and submission will be issued a NOC or DIN
If a sponsor does not wish to move forward with the use of the
proper/common name and all brand names are deemed
unacceptable, a Notice of Non-Compliance (NON) will be
issued
A sponsor may not sell the product under a name other than
the common/proper name without filing a supplemental
submission and obtaining an NOC or DIN for a different
product name
If a LASA assessment is not received (however is required),
the sponsor will be contacted. For Labelling only submissions
(requesting a name change), a screening deficiency notice will
be issued
Copyright Med-ERRS 2014 20Brand Name Assessment
Process (Cont’d)
Review Timelines
• For submissions that involve a review target of 180 days
or longer:
• Health Canada will complete an initial review within the first 90 days
of the submission being accepted for review
• A final abbreviated review will be conducted 30 days prior to
issuance of an NOC/DIN
• If the initial brand name is found to be unacceptable, a new brand
name and assessment must be submitted within the time requested
by Health Canada and at least 90 days prior to the review target date
• For submissions with a shorter review period than 180
days, one brand name review will be completed within
the submission review timeline
Copyright Med-ERRS 2014 21Brand Name Assessment
Process (Cont’d)
International
• If a LASA brand name assessment has been completed
in another jurisdiction, there may be a need for additional
assessment to reflect the Canadian context taking into
consideration:
• A difference in indication or other non-name attributes which
may render the name more likely to be confused in Canada
• The process maps as developed for the product. If the product
will be used in much to the same way, the outcome of the
simulations will be of relevance to making a decision about the
acceptability of a name in Canada
• Any issues that may arise due to the bilingual nature of the
Canadian healthcare environment
Copyright Med-ERRS 2014 22Newest FDA Guidances
• FDA is releasing a series of 3 draft guidances over the course of ~1
year
• Purpose: To help minimize risks contributing to medication errors in
the US Nomenclature Draft Guidance
Risk Assessment Draft • Anticipated: Summer 2014
Guidance • Will include best practices for the
development and testing of proposed
• Released: December 2012 proprietary names to minimize risks
• Recommendations to minimize risk associated with drug product
and improve drug product and nomenclature, such as proprietary
container closure design at earliest names that look or sound like the
stage in development name of another product
Package and Label Draft
Guidance
• Released: April 2013
• Recommendations for ensuring a
product’s container labels and carton
labeling are designed to promote safe
dispensing, administration, and use of
product
Copyright Med-ERRS 2014 23Comparisons of US and Canada Regulations
related to trademarks
Criteria US Canada
Number of names 1/1 1/1
submitted/approved
What to submit Proposed name plus Proposed name
(Mandatory/suggested) product characteristics plus brand name
assessment
(mandatory)
When to submit Can submit with IND or N/A
NDA
Additional names submitted? Y Y
Use of qualifiers/modifiers Case by case basis – May be acceptable
perform risk assessment if meets criteria
Testing methodology Not specified since Specified in
PDUFA IV concept guidance
paper (“search, simulate,
synthesize”)
Copyright Med-ERRS 2014 24Comparisons of US and Canada Regulations
related to trademarks
Criteria US Canada
Approval by other regulatory N/A Sponsor may
authorities submit
assessment that
was sent to other
regulatory
authorities
Reasons for rejection Confusability/ Confusability/
promotional issues misleading
Use of INN/USAN stems USAN stems not INN/USAN not
accepted in stem allowed in
position trademark in any
position
Use of revoked/withdrawn Generally not Raises “red flag”
names accepted
Language English English/French
Copyright Med-ERRS 2014 25What can sponsors do re: name creation?
More questions than answers
• More difficult today to get a global name with the increase in
rejections and increased scrutiny by regulatory authorities
A global trademark can decrease the risk of wrong drug being
dispensed to patient when traveling
• ROI: More time, money and effort for following the guidance (Health
Canada)
• If testing is done according to a guidance, then will we see an
increase in approvals?
• Should we develop/test more names?
• One report for all regulatory agencies? Probably not
• Should similar testing be performed in all countries where the name
will be filed?
Copyright Med-ERRS 2014 26What can sponsors do re: name creation?
More questions than answers
• Start name creation and initial testing earlier
Thank you!
Name bank?? (with preliminary name clearance)
Don’t develop names that would be attached to a particular
product
www.med-errs.com
Do safety testing even in countries without requirements
• Define a filing strategy of where to file first
Country with most rejections/largest market? (US)
Most comprehensive evaluation process? (Canada)
Most name approvals? (EMA)
Copyright Med-ERRS 2014 27You can also read
