[e-drug] Drug donations - will we ever learn?: Actions? (4)

E-DRUG: Drug donations - will we ever learn?: Actions? (4)
-------------------------------------------------

Eva Ombaka’s call to action for examining, discussing, and possibly
up-dating or revising the existing WHO Interagency Guidelines for Drug
Donation is most welcome. Unfortunately this is not the first time that
e-druggers have been invited to subject these very important guidelines
to critical examination – In July 2005 I used e-drug to express an
'urgent need' for a review of the interpretation and effectiveness of
the Interagency Guidelines.

I can only hope that the current call to action has more impact.

Clearly the present guidelines are still being ignored or misunderstood
by well-intentioned individuals and organisations. Without a serious
examination of the contents, and the ways in which they are interpreted
we can never know how we can work towards enhancing the effectiveness
and impact of the Guidelines.

I suspect that two factors may be significant:

1. The present Guidelines come without any indication of how they
should be interpreted. Almost all other forms of regulation (or
professional good practice guidelines) are accompanied by detailed
interpretation notes. The WHO Interagency Guidelines have no
accompanying material. Examples of very different interpretations are
too easy to find.

2. Individuals and organisations find it too easy to use the
Interagency Guidelines as a symbolic document. As long as they own a
copy, and repeatedly admit to compliance with the contents, they have
no need to read the guidelines carefully and critically.

(For e-druggers who remember the Peanuts cartoon strip - are people
using the Interagency Guidelines as though they are Linus’s Comfort
Blanket – as long as they own it and cite it, then they feel secure.)

Jim Russo of PQMD clearly supports Eva Ombaka’s call to action, but
could I gently remind him that my e-drug letter of July 6, 2005
included an example of 'inappropriate donation procedure' which was
drawn from major corporate donation programmes (no need to name the 3
corporations involved here). This was not offered as an example of
major companies ignoring the Interagency Guidelines, but included as an
example of critical variation of interpretation of the guidelines.

Count me in for a brainstorming e-mail group. Too many people have
become too comfortable with the Interagency Guidelines as they are. We
must not be afraid to challenge the present Guidelines and the way they
are used.

Dr Geoff Crumplin
(geoffrey.crumplin@ntlworld.com)

[Your affiliation would have been appreciated. moderator]

E-DRUG: Drug donations - will we ever learn?: Actions? (6)
---------------------------------------------

Geoffery Crumplin has identified some key issues regarding the use of the WHO Guidelines in justifying donations practices, many of which are not in compliance (w/ the Guidelines) despite representations of various role players otherwise.

That said, the donations community comprised of the pharma industry, NGOs involved in collecting and delivering (and in some cases administering donations), and beneficiaries have significantly improved donations practices over the last ten years. This is in large part due to increased dialogue and collaboration among the key players - donors, consolidators, implementing organizations and recipients, Jim Russo and the PQMD group foremost among them in the United States.

It may benefit this discussion and help to further understanding of the complex issues at play in the donations equation to examine the objectives of the WHO Guidelines along with the realities faced by the participants mentioned above (even though it may be stating the obvious to many). Some definitions: donor - the pharma company donating the drug; consolidator - the organization that appeals for and collects the donation (typically with limited presence in the recipient country); implementing organization - an organization that delivers and oversees the donation in-country (in limited cases they are the actual recipient/healthcare provider as well); recipient - the actual provider of healthcare services, the hospital, clinic, or healthcare professional administering the drug to the patient (the recipient is typically an indigenous organization with limited resources). To further confuse the matter, with the exception of the pharma donors, there are often overlapping roles played by the participants, and these roles may vary greatly from country to country.

I would offer that no major pharma company would consciously make a donation that was not in compliance with the WHO Guidelines. In a typical US-originated donations scheme, the pharma donors respond to appeals made by these other participants. For the most part, they are reliant upon these organizations' representations. Consolidators and implementing organizations in a rush to attract and utilize monetary donations following an emergency are compelled to respond. The WHO Guidelines can play a significant role in this response.

Many NGOs use the Guidelines as a credential (my organization included, even though our donations are purchased based upon the recipient's specific request) citing adherence to, compliance with, signatory of, etc. in their promotional materials. Frequently, organizations use such representations in their appeals for donations to pharmaceutical companies, in essence, as part of their sales pitch.

The intent of the Guidelines is to ensure that donations are made based upon the specific needs of the recipient healthcare organization, the entity actually administering the donated medicines. In the ideal, donations are "pulled" from the donations system - the good will of the pharma industry, consolidators, and implementing organizations - based upon specific needs and expressed (and documented) requests from recipients. All in all, this system is effective in supplying needed drugs to healthcare providers that otherwise would have fewer resources.

Complex humanitarian emergencies and large scale natural disasters greatly exacerbate the entirety of issues surrounding drug donations. The resulting outpouring of support, a significant portion of which comes from organizations inexperienced or with no experience in the responsible use of donations, inevitably overwhelms the WHO donations model. More importantly, the abilities of receiving countries to monitor and utilize donations (of all kinds) is quickly outstripped by the scale of the response. The vast quantities of unneeded donations following December's tsunami are only the latest example wherein donors, consolidators, and implementing organizations "pushed" donations into the system with little if any input from the actual recipients. Strained or nonexistent communications, damaged infrastructure, overtaxed transportation systems and personnel resources in the affected countries virtually assure inflow of unneeded donations, including drugs and medical supplies.

In such situations, I am not convinced that any measures can be implemented that would significantly reduce unneeded donations. Of course, the donations community can continue its efforts to educate donors, recipients and other role players. Such efforts could reduce to a limited extent bad donations that result from the rush to respond. The pharma industry can be encouraged to donate only to those organizations that have demonstrated capability in utilizing donations in compliance with the Guidelines. Ideally, donations would be made to those organizations that have full-time personnel in country working with the recipient healthcare providers (unfortunately there are too few organizations that provide such a comprehensive approach to utilization) and excluding organizations that only provide delivery or facilitation.

Allow me to suggest, however, that the donations community should be compelled to contribute to post-disaster remediation efforts and that this discussion focus on ideas that would further such efforts. The inclusion of such post-donation criteria in the Guidelines would ultimately benefit all parties and with continued education and diligence potentially reduce the amount of unneeded donations in the future.

Andrew Hannah
Bridge Foundation
drewhannah@msn.com

E-DRUG: Drug donations - will we ever learn?: Actions? (8)
--------------------------------------------

Dear e-druggers,

I think we are all mostly agreed that this is an important subject that
needs to be revisited, with a view to resolving or minimizing the practical
problems we face year in year out, crises in crisis out. As we do so,
however, it will be important to identify key players as follows: Donors,
Recipients and Intermediaries. The latter are often critical in this
process and yet, when breaches of the guidelines occur, it may be the donor
whose product lies on the bare floor, rotting away, who gets the bashing.
The recipients sometime say "yes", either in desperation or a lack of
understanding of the possible consequences of an unwanted donation. If
donors really mean to do good in an emergency, they should take part in
this debate and indeed have a preparedness plan in place for what to do and
how, in the event of an emergency. Unless these key players are working
together each time, the strength of the proverbial chain will always be the
weakest link.

Murtada M. Sesay
Technical Officer (Pharmaceuticals)
UNICEF Supply Division

Tel: +45 3527 3098
Mobile: +45 28 23 28 07
E-mail: msesay@unicef.org
Web: www.unicef.org/supply