E-DRUG: Pharmaceutical stock losses due to expiry?
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dear E-druggers,
The Supply Chain Management System (SCMS) has a about 1% loss of pharmaceutical stocks due to obsolesence.
We have heard that other organizations have losses up to 10%.
Have there been any publications concerning these losses?
with kind regards
Tom Layloff
Pharmaceutical consultant
tlayloff@aol.com
E-DRUG: Pharmaceutical stock losses due to expiry? (2)
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Hi,
Pharmaceutical losses is the most difficult issue to control especially in
developing countries. Many health institutions tend to develop adhoc
measures to "extend the shelf life" of stored products mostly for financial
reasons. But the very interesting question to ask is, when we talk of %
loss, what does this represent the cost of purchase value or the
quantitative/volume loss? Most of the reports refer to the finance, using
the cost at purchase of products. The subject has a great research potential which pharmacists and health care planners need to look into.
Qasim Al Riyami
Asst Dean for Training
College of Pharmacy and Nursing
University of Nizwa
P.O.Box 33 PC 616
Birkat Al Mouz; Nizwa
Oman
tel: + 968 2544 6273
email: karafuu@gmail.com & qasim@unizwa.edu.om
E-DRUG: Studies on drug stability
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[At the base of this message you will find a list of stability studies - There could be more available. Moderator]
Dear all
Is there any info available on drug stability and whether this can be
increased for use in resource poor settings. The DNDi Malaria treatment
is heat stable which is a strikingly important specific innovation
(aside from a single combination pill). I recall, but cannot find again,
a US Dept of Defense study on drug stability which found that there is a
large margin of safety for medicines.
Additionally, is there surveilance of suitability of drugs after they
have been expired?
Riaz
Riaz Tayob
Third World Network
riaz.tayob@gmail.com
Stability studies added
Accelerated stability studies of widely used pharmaceutical substances under simulated tropical conditions
WHO/PHARM/86.529
Accelerated stability studies of the drugs in pharmaceutical forms under simulated tropical conditions
WHO/PHARM/86.531
Inland stability study (Sudan). Pilot study 1989-1991
H.V. Hogerzeil, M. de Goeje, I.O. Abu Reid
WHO/DAP/91.4
WHO/UNICEF study on the stability of drugs during international transport
HV Hogerzeil, A Battersby, V Srdanovic, LV Hansen, O Boye, B Lindgren, NE Stjernstrom
WHO/DAP/91.1
Stability of essential drugs in tropical climates: Zimbabwe
WHO/DAP/94.16
Stability of injectable oxytocics in tropical climates.
Results of field surveys and simulation studies on ergometrine, methylergometrine, and oxytocin
WHO/DAP/93.6
Stability of oral oxytocics in tropical climates.
Results of simulation studies on oral ergometrine, oral methylergometrine, buccal oxytocin and buccal desamino-oxytocin WHO/DAP/94.13
Hogerzeil HV, Walker GJA, de Goeje MJ
Oxytocin more stable in tropical climates
BMJ volume 308 1 jan 1994
Hogerzeil Hans V, Godfrey JA Walker
Instability of (methyl)ergometrine in tropical climates: an overview. European Journal of Obstetrics and Gynecology and Reproductive Biology 69 (1996) 25-29
Hogerzeil HV, Battersby A, Stjernstrom NE
Stability of essential drugs during shipment to the tropics BMJ 1992;304:210-2
25 jan 1992
E-DRUG: Studies on drug stability (2)
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Hello all,
One small but important study which is not on the list is about the
instability of amoxicillin:
Naidoo, K. K., P. Nompuku, S. N. Mkalali, K. Shabangu, L. Nkabinde, and V.
Singh. 2006. Post-marketing stability surveillance: Amoxicillin. *South
African Family Practice* 48, no. 6: 14.
Also, is there somewhere these older WHO studies can be found? Are they
posted on the internet? (Most pre-date the internet!)
best wishes,
Susan D. Foster, PhD, MA
Director of Public Policy and Education
Alliance for the Prudent Use of Antibiotics (APUA)
75 Kneeland Street, 2nd floor
Boston, MA 02111 USA
T: +1 617 636 3961
F: +1 616 636 3999
www.apua.org
Susie Foster <susan.foster@tufts.edu>
[Thank you for that important study. The old studies mentioned in the previous message were found on the internet some time ago and downloaded. They had been scanned. The sites might have changed. Will follow up with WHO. Moderator]
E-DRUG: Studies on drug stability (3)
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Hi Riaz
The US Military and US FDA has a SHELF LIFE EXTENSION program called SLEP
(based on repeated testing of samples), to extend shelflife of critical medical
stockpiles stored under very tightly managed and controlled conditions, that are
stored at a limited number of locations. You can download infor paper
explaining processes used from SLEP website:
https://slep.dmsbfda.army.mil/portal/page/portal/SLEP_PAGE_GRP/SLEP_HOME_NEW
However it is important to note that this practice is not advisable when storage
conditions are less tightly controlled, as in many cases in developing
countries, and it would be inappropriate to extrapolate the data forund by US
FDA testing of these military stocks to other settings.
In very few cases it might be justifiable and cost-effective to use same
approach e.g. when large national stockpiles of tamiflu were about to expire in
post H1N1 pandemic period, then several countries considered extension of
shelf-life, based on laboratory testing of samples.
Unfortunately many national drug regulatory authority in low income countries
may not have the necssary technical capacity to conduct such tests and make
appropriate decisions on shelf life extension. Definetely such shelf life
expansion practice must never be applied to stocks distributed to
regionals/district stores and health facilities or pharmacies as storage
conditions may widely vary at these and quality of drugs may already been
affected by such different storage conditions .
It might sound a boring advice but putting resources (developing capacity) and
emphasis on correct quantification and supply management of essential medicines
to reduce risk of expiry is the most important way to ensure that valuable
medicines (procured with national and/or donor resources) do not get wasted due
to expiry.
all the best,
Klara
Dr. Klara Tisocki, B.Pharm., M.Sc., Ph.D.
Consultantsfor health anddevelopment bv
Sisalbaan 5E
2352 AZ Leiderdorp, The Netherlands
Tel:+31 71 7503240
Mobile: +31 643 536597
Fax: 31 71 5233592
Email:tisockik@chd-consultants.nl, ktisocki@yahoo.ie