Wholesaler Role in Recalls Rob Smyth, Quality Defects and Recalls Wholesale Distribution Conference 11 th November 2014 Expectations and Best Practices
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