Fwd: [Uganda's Coalition on AEMI] Release: UCAEM calls for urgent action by NDA, MoH to cease use of non film coated TDF+3TC--the 'bitter pill'

[uhspa uganda]

For immediate release:

-----
PRESS STATEMENT

People living with HIV Call for Urgent Action by Health Ministry to
Cease Use of “Unusable” Medicine
Risk of Chaos in HIV Treatment Undermines the Right to Health

For Immediate Release: September 2 2014
Contact for more information: Kenneth Mwehonge, HEPS Uganda and
Uganda Coalition for Access to Essential Medicines:: 0701182809
Margaret Happy, International Community of Women Living with HIV East
Africa: 0772695133

(Kampala) The Uganda Coalition for Access to Essential Medicine today
called on the Ministry of Health to heed the decision of the Uganda
National Drug Authority (NDA) and cease use of non film coated
tenofovir+lamivudine, a two drug combination used with a third
medicine, typically efavirenz or nivirapine. This two-drug combination
is notoriously bitter and was recalled by NDA in January 2014
following widespread complaints by people living with HIV and their
providers when it was being used in 2013.

However, the Ministry of Health has reintroduced this medicine despite
the recall order of the NDA, because of an apparent shortage of the
non-bitter version of the medicine, apparently caused by incompetent
procurement practices or errors in procurement.

“Based on the evidence from patient experience we gathered nationwide
when this bitter medicine was being used in 2013, people living with
HIV will more likely stop taking treatment than use this now-recalled
medicine,” said Margaret Happy of ICW East Africa. “This will cause
chaos and harm to the national response—people will be at increased
risk of development of drug resistance, or even disease progression if
they go without treatment, or try multiple times and fail to tolerate
this drug.”

“We understand that mistakes happen in the Ministry of Health, and we
sympathize,” said Mwehonge Kenneth of HEPS Uganda. “But our
communities should not have to pay with our health for the mistakes of
others. That is too high a price—instead this drug, which is now
illegal in Uganda—should be disposed of rapidly. It should have been
disposed of from the moment it was recalled.”

Activists pointed out that any cost savings the country might try to
gather from using this recalled product will be outstripped by the
cost of having to enroll people on second line treatment once their
first line treatment fails due to treatment interruptions.


“This strategy is unacceptable, and we are concerned it also might be
illegal. The Ministry of Health should take action now by sending out
a circular to all the service providers to stop dispensing the non-film
coated tenofovir+lamivudine.” The activists noted that emergency
procurements could be made of the acceptable, film-coated version of the
product.


ENDS

--
Asia Russell
Health GAP (Global Access Project)
email: as...@healthgap.org
tel: +256 776 574 729 (Uganda)
     +256 703 574 729 (Uganda)
     +1 267 475 2645 (US)
http://www.healthgap.org
skype: asia_ilse
twitter: @asia_ilse

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Kikonyogo Kivumbi
Executive Director, Uhspa-Uganda
Plot 2A, Gaddafi  Road,Nansana East, off Hoima Road, Kampala( Next to
Hippos Recreation Centre)
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[uhspa uganda]

NDA  immediatelyrecalls the bitter pill. Here is their statement:

17/SR/NDA/1/14

 

To       All Patient Rights Organizations

          

RE:     UNCOATED LAMIVUDINE / TENOFOVIR (300mg/300mg) AND TENOLAM (LAMIVUDINE / TENOFOVIR (300mg/300mg)

Reference is made to complaints received by NDA regarding the two types of uncoated tablets; Lamivudine / Tenofovir  (300mg/300mg) and TENOLAM (Lamivudine / Tenofovir  (300mg/300mg).

Your complaints indicate that the said drugs are reported to be bitter and this has consequently affected adherence to treatment, leading to patients abandoning their prescribed doses.

The mandate of NDA as a regulatory body is not only to ensure that the drugs on the market are safe, efficacious and of good quality, but also user friendly. Please be assured that the product in question is safe, efficacious and of good quality.

However,  because of the associated bitterness when they are ingested, patients taking the uncoated drugs are reported to have less adherence to it in comparison to the coated drug.

In line with its statutory mandate, NDA has therefore decided to recall the uncoated products from all health facilities and have them replaced with the coated one.

We wish to thank you and your team for alerting NDA and urge you to remain vigilant and report any suspicious product which may threaten the health of our population.

Attached also is a photo indicating the packaging of the two products for ease of identification.

Looking forward to further cooperation in this matter

 

Gordon K. Sematiko

EXECUTIVE SECRETARY/REGISTRAR

 

Copy to          :           Drug Information Department

                        :           Inspectorate Department

                        :           Drug Assessment and Registration Department

                        :           Head, Quality Management