[e-drug] Expiry date versus batch number administration

E-DRUG: Expiry date versus batch number administration
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Dear e-druggers,

First Expiry First Out (FEFO) requires accurate recording of the expiry
dates of all incoming and outgoing goods. This can be managed through
pharmaceutical stock control software or simply by maintaining separate
paper Bin cards for each expiry of a product.

Such an "expiry date level"-administration can also be used to execute a
product recall. If we were informed that product X with batch number
BO-165/2 and expiry date 31 Jan 2011 has a suspected quality problem and
needs to be recalled, we would
- look up in computer or Bin card whether we have any remaining products of
that expiry-date.
- If this is the case, check manually in our warehouse whether it is from
that particular batch.
- If our records show that the product has already been distributed, look up which clients received it
- convey to them an urgent message to check their inventory and return any
remaining stock with expiry date 31 Jan 2011 and batch BO-165/2.

Since we had been recording expiry dates rather than batch-numbers, some
clients may be contacted unnecessarily as they had been supplied with
another, non-faulty batch (e.g.BO-165/3) with the same expiry date.
Regardless of this minor imperfection, the system is effective and
efficient.

Yet there is increasing desire by international organizations, donor
agencies and regulatory authorities to insist that all stock transactions be recorded on a more detailed Batch-level. I consider this an overkill with tremendous and undesired practical consequences. For example:

1. Batch-level control is very labour intensive. Expiry dates are fairly easy to read, interpret and copy to computer or Bin card. Whether it is written as 01/31/11, 31-Jan-11 or 31012011, we easily grasp its meaning. Batch numbers are more difficult to locate, read, handle and remember. This difference will be experienced every time a product is handled: at receipt, as the goods are located in the warehouse, during stock counting, during picking, during release etc.
   
2. Batch level administration poses a greater risk for errors and mix-ups. Can we really trust that there has been no mix up between BO-165/2 and BO 165/3? Has no stock been erroneously entered as B0-165/2, 80-165/2. B0-16512?
   
3. Proper batch level control requires more storage space. Products with the same expiry but different batches need to be stored on distinct shelf locations to avoid accidental mix-up.

Advocates of Batch-level control refer to official documents like WHO's GOOD DISTRIBUTION PRACTICES (GDP) FOR PHARMACEUTICAL PRODUCTS (working draft: www.who.int/medicines/services/expertcommittees/pharmprep/QAS_068Rev2_GDPdraft.pdf)which states that:

10.5 Records for the dispatch of pharmaceutical products should be prepared
and should include at least the following information:

- date of dispatch;
- name and address of the entity responsible for the transportation
- name, address and status of the addressee (e.g. retail pharmacy,
hospital, community clinic);
- a description of the products including, e.g. name, dosage form and strength (if applicable);
- quantity of the products, i.e. number of containers and quantity per container;
- assigned batch number and expiry date;
- applicable transport and storage conditions; and
- a unique number to allow identification of the delivery order.

10.6 Records of dispatch should contain enough information to enable
traceability of the pharmaceutical product. Such records should facilitate
the recall of a batch of a product as necessary.

Many medical stores struggle to comply with this demand but then some policy makers even wish to take this approach further: Whilst designing a national distribution plan for a large developing country (over 100 million
population), the authorities (backed by a local WHO representative) insisted that we design forms and mechanisms to ensure that batch numbers be administrated all the way through the supply chain, including the final
dispensing at the village level...

Especially for in-country staff, it is near impossible to argue with such
requests. The issue is often "solved" by everybody pretending that batch
level control is in place whilst knowing it actually is not. The Emperor has new clothes!

I would like to use this forum to ask: Is it justified to demand that
zillions (!) of warehouse transactions per year be administrated at Batch
level, while the sporadic product recalls can be handled satisfactorily by
keeping track of the expiry-dates?

Ron Wehrens

--
Ron Wehrens, MSc MBA Pharmacist
Phasuma Consultancy & Training
P.O. Box 36083,
1020 MB Amsterdam
The Netherlands
Tel + 31 (0)35 6550599
Mob +31 (0)6 4629 3590
Skype: ron.wehrens
r.wehrens@phasuma.com
www.phasuma.com

E-DRUG: Expiry date versus batch number administration (2)
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Dear friends,

Strange discussion where is a mix up of long term quality standards
development and short term stock management are put altogether in a
cooking bin to explain us that with a modern software you can manage
standards and norms in Europe but not in the Africa or other so called
developing country. Or even further : may be we even don't need them
here : it is so much work!!!

First of all a bar code system is nothing less or more than a taylor
made product identification. You can buy via Internet a (simple)
software to develop an in-house appropriate bar code system. You can
also ask the supplier of your stock management software to integrate a
bar code modul into the existing system. In both cases the medical store
has to develop a formula for the data he wants to get out of its bar
code. It is not only used in the food industry but it is used for almost
all industralised products world wide, your ID card, driving licences,
air ticket, etc. products from developing countries include. One of the
sectors which is underperforming in this field is the pharmaceutical
sector. You don't need to wait a solution of you supplier, you can
develop it yourself.

If you develop your formula you can already put expiry date,
batchnumber, product code, etc into the bar code. But this is not an
obligation since behind the barcode exists a file (bin card or other)
that contains the information you need for item management. There is no
reason to go for lower performance as actual technology allows you. The
enourmous decrease in ICT prices makes ICT much more accessable than 10
or 15 years ago. Indeed at reception of goods at central level there
will be an increase of workload (barcode development, printing labels,
put labels on products). At storage and delivery level this will
decrease errors and accelarate picking since staff can check with a
pencil or mobil warehouse reader the bar code and counter check it with
the information on the picking list or - in more advanced systems - the
code reader has the picking list information and checks it himselves.
Receiving partners at intermediate or district level can use the same
bar code as developed at central level. Indeed this requires better
trained staff but read the GDP guidelines and you will notice that
permanent training of staff is one of the standards for GDP approval.

Why using only one of the two quality indicators of pharmaceuticals
(batchnumber or expiry date). If using only one indicator is the
international standard : why is the pharmacutical industry (and food
industry among others) using and printing the two indicators? Why do
tender documents require both informations? We require these
informations of our suppliers and don't use them later in the flow
management! You need both indicators for higher quality standards.
Indeed more workload but the quality is in the detail and not in global
systems. Modern software includes both possibilities to create at the
computerized bin card the batch number and the expiry date. In more
advanced software you can block batchs at input in the bin cards and
block at a prefixed final supply date eg six months before expiry date.
If you need to recall a product you can find and print out in less than
two minutes all customers of a certain product and start procedures to
block this goods at the destination that uses the same bar code system.
Indeed recall do not occur so many times these days but that is the
output of improving standards over the last twenty years as supported by
organisations as the WHO, national governments, medical stores and
other partners involved. GDP is not a filed document but a permanent
action of all involved production, supply and staff levels. Quality
standards is not something coming from outside by international
organisations but is part of the ethics and responsability of our field
to protect the final user of the product.

Bar code is not the only solutions for flow management but can assist to
develop more efficient and better performing systems. National or
regional medical stores handling hundreds of thousands if not millions
of items a year and this at receiving - warehousing - supply levels need
high tech solutions to improve output of there services.

Chiel Lijdsman
Drug supply management consultant.
chiellijdsman@gmail.com