wholesaler role in recalls - na.eventscloud.com
TRANSCRIPT
Wholesaler Role in Recalls
Rob Smyth, Quality Defects and Recalls
Wholesale Distribution Conference
11th November 2014
Expectations and Best Practices
Outside Scope
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Coordination of recalls by EMP supplier
ID & reporting of defects at wholesaler
Veterinary products
Wholesaler Involvement
Recall = Retrieval of batch(es) from market, subject of a quality
defect, other MA non-compliance or safety/efficacy issue
• 109 recalls on Irish market in 2013. Wholesale (WS) involvement in
most recalls at some level
Legal Basis
• SI538 (2007) – as per Schedule 2
- requirement to have a recall procedure
- carry out procedures as directed by the Board
• GDP Guide – responsibilities as per Chapter 6.5 - recalls
- documentation, record keeping, mock recalls
• Recalls are Risk-reducing activities
WS involvement = WS plays a part in helping to reduce that risk
Ineffective Recall – increased exposure = increased risk!
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Challenges posed by Recalls
• Recalls are unpredictable
• Lack of experience – how do you know how well-
equipped your facility is?
• Recalls can be resource and time-intensive
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Recalls can be
complex
1° and 2°
wholesale
involvement
Multiple
customers,
multiple products
Often no time to
prepare
How to overcome challenges
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Know the recall process
Know the supply chain
Know common problem areas & how to overcome
Have effective procedure(s)
in place
Carry out recall quickly and
effectively
prepared
The Recall Process
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Defect
Identification
Risk
Assessment
Recall
Decision
Y/N
Quarantine
*
Recall
Reconcile
Targeted
Defined distribution
listing
Exact list
• All WS and retail
customers known
List by date
• If no batch tracking,
cannot create lists by
batch – needs to be
from first date of
distribution
Where >1 WS
involved, MAH will
compile consolidated
list, from all WSs
Blanket
Unknown distribution
listing
• Not possible to
create consolidated
list in time
• Recall letter sent to
all retailers
• Return back through
wholesalers which
originally handled the
stock
* May happen at an earlier stage
Recall Activities at Wholesalers
• e.g. One batch of Product X recalled to retail / pharmacy
level, wide wholesale involvement, targeted approach
• Recall decision (MAH, HPRA, EMA)
Looks Simple, but there are pitfalls!
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Listings
• Customers of 1° & 2°
• Compiled by BN, by distribution date
Quarantine
• 1° & 2°
• Communication & confirmation
Recall
• Recall letter
• Return / uplift
• Reconcile stock
1. Distribution Listings
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A recall cannot occur until we know to whom to send recall communications
Incomplete Listings
- Customers not contacted to quarantine / return product
= potential unnecessary exposure to patients
Even 1 omission can cause large amounts of stock to be omitted
(e.g. 1 wholesaler had ~15 pharmacy customers holding 5-10
packs each. Could run into hundreds!
Delayed Listings
- Customers not contacted in timely manner
= potential exposure to patients for increased time period
- Significant in serious/urgent (i.e. patient level) recalls
Listings Issues - Causes and Solutions
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Causes Solutions
Incomplete Lists Delayed Lists Batch tracking to retail
-Exact lists (no wastage, less errors)
- Quick generation
Validation of Inventory Management System
- Quick generation of listings by batch
number or by date
Training / Familiarity – recall-related tasks
- Detail in recall SOP
Mock Recalls
- Generate lists for product x, batch Y
- Repeat. Can the time it takes be reduced?
- Collating lists
(manual or system
error)
- Application of
incorrect distribution
dates
- Failure to ID a
customer as a
wholesaler
Over-reliance on
manual work
- Merging lists
Resourcing &
Training
- Unfamiliarity =
mistakes / delays
Poor
communications
between 1° & 2° WS
/ between different
departments
2. Quarantine & Protection of Stock
Recalls can take time: weeks to months. As well as > exposure,
risk exists of (re)release of recall stock
- Additional work and knock-on effect – further delays
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Causes Solutions
Poor or no segregation of stock
- Storage next to saleable stock
- Automatic – batch subject to recall
not blocked on the IMS or it is
possible to override the block
Move QT’d stock to secure area
Recall labels / attach recall letter
Block batch(es) – restrict access to
unblocking or remove the option
Quarantine SOP / Recall SOP
-Standard locations checks for stock
-Standard communications
-Defined roles
Challenge the procedure – how
quickly can you get batch X
quarantined? Fully accounted for?
Failure to identify recall stock
-stock not labelled clearly
Failure to account for / locate stock
- e.g. Stock that has been picked
but not yet dispatched
Delays in passing on QT request, to
other relevant staff or wholesaler(s)
3. Recall Letters, Return / Uplift
Return / Uplift
The physical process of recalling the stock
Involvement can vary, i.e. A blanket recall involves all
pharmacies / retailers
= Potential multiple handovers of affected stock
More handovers = more risk!
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Recall letters• Standard instructions – incorporate into QT / recall procedure (e.g. Return
stock within 4 weeks of receipt of letter)
• Distribution to other WSs
- email/fax is acceptable, can be followed by hard copy
- only distribute to WSs which received affected stock (stop unaffected
retail customers being contacted).
Read instructions carefully!
3. Return / Uplift
Uplift from Retail
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Problem
• Stock is (quarantined) at
retailers but not
returned – risk of
redistribution
Causes
• Pharmacist / retailer
not aware that stock is
on premises
• Delivery van is not
aware that retailer is
on affected listing
• Uplift can take a long
time, for large recalls
where distribution is
widespread
Solutions
• Communication: all
drivers (blanket) or
some drivers
(targeted) made
aware, e.g. Copy of
recall letter
• Prompt by delivery
staff for stock held at
retailers
Putting it into Practice - The Recall SOP
Purpose: ‘to ensure the effective implementation of any recall from the market
of any such product, or batch thereof’ (SI538/2007)
Covered in SUR-G0019, Section 6.1
• 6.1.6 Describe system which identifies where batches distributed
• 6.1.7 Describe placing of goods in quarantine area (N.B. GDPs now require
separate area)
=Minimum Contents of the Recall Procedure
• Does your recall SOP actually contain the specific instructions to ensure this, if
followed? One error = ineffective
One way to measure is mock recalls. At least one per year required by GDPs
(challenge the recall procedure)
-Difficult to accurately reflect real-life situation, but can challenge some areas
(distribution, quarantine)
If your facility is involved (significantly) in a recall, can use that instead
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Putting it into Practice - The Recall SOP
Recall SOP should also be regularly updated – legislation & guidance
-but also after every real / mock recall, with improvements
Recall Log / Records
- Storing correspondence
- Storing ancillary forms, WIs to the recall process
- Recall communications
Review file to identify OFIs
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Design Challenge Improve
In ConclusionMAH is responsible for placing batch / product on the market
WS shares responsibility in removing it successfully
Successful recall minimises risk to patients
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• Recall
SOP
• Mock
recalls
• Defined
roles
• Systems,
processes
Identify all
customers
Quarantine
and Secure
Locate and
Uplift
Return and
reconcile