E-DRUG: SIAPS Program releases new bedaquiline roll-out info graphic (2)
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Congrats Team SIAPS on your strong work including development of
pharmacovigilance systems with the roll-out of new TB medicines in 5
countries!
Per the 2016 WHO Global TB report
<http://goo.gl/i0xObh>
card, 70 countries have started using bedaquiline by the end of 2015; and 30 have started using delaminid by the end of 2015.
Do we know how the safe use of the new TB drugs are monitored in these 70 countries?
I notice that Pakistan (a country where no functional pharmacovigilance system exists) is among the countries listed where both these drugs have been used/is being used as part of expanded access, compassionate use or under normal programmatic
conditions.
Do we know if there has been any pharmacovigilance
strengthening activities such as training for the staff of the national PV
center (if one exists) and/or the National TB program conducted in all
these countries.
I am concerned since the use of new TB drugs in countries
without adequate training and capacity building in pharmacovigilance can
lead to irrational use; and over the counter availability of antibiotics in
general and the new TB drugs in particular can lead to development of
resistance and resistance anywhere is resistance everywhere.
Rizwan
Syed Rizwanuddin Ahmad, MD, MPH, FISPE, FCP
Pharmacovigilance & Regulatory System Strengthening Consultant
Ex-Consultant/Safety Reviewer, U.S. FDA (1998-2013)
Associate Professor (adjunct), Rutgers School of Public Health, NJ, USA
Assistant Professor (adjunct), Georgetown University School of Medicine,
Washington, DC, USA
www.drugsafetyconsultant.com
Syed Ahmad <drugsafetyconsultant@gmail.com>