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