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

Qualitydefects@hpra.ie

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