PMID- 30053910
OWN - NLM
STAT- MEDLINE
DCOM- 20181219
LR  - 20190328
IS  - 1744-8603 (Electronic)
IS  - 1744-8603 (Linking)
VI  - 14
IP  - 1
DP  - 2018 Jul 27
TI  - A pharmacovigilance system for treatment access and medical donation programs: 
      The Max Foundation experience.
PG  - 76
LID - 10.1186/s12992-018-0391-4 [doi]
LID - 76
AB  - BACKGROUND: Cancer is a major burden of disease in low- and middle-income 
      countries (LMICs) yet financial barriers limit access to life-saving oncology 
      drugs. Medical donation and other drug access programs can help improve patient 
      access to essential medicines, such as quality assured oncology drugs in LMICs. 
      However, there are no published examples of the conduct of pharmacovigilance with 
      donated medical products intended for use in LMICs where pharmacovigilance is 
      weak. We describe a partnership between a pharmaceutical company and a 
      non-governmental organization as a case example that addresses the challenges in 
      performing pharmacovigilance with donated medicines in LMICs. The Max 
      Foundation's direct to patient model is designed to improve global access to 
      quality assured oncology drugs through access programs such as the Glivec(R) 
      (generic name: imatinib) International Patient Assistance Program (GIPAP). 
      RESULTS: Between 2013 and 2016, in the course of managing the GIPAP program, The 
      Max Foundation was made aware of 13,039 instances of adverse events (AEs). These 
      AEs were reported to The Max Foundation by physicians, patients, and caregivers. 
      The Max Foundation reported these AEs to Novartis through the AE reporting tool 
      within its Patient Assistance Tracking System (PATS). Physicians were the 
      reporters for 58% of the AEs while the remainder of the AEs were reported 
      directly by patients or caregivers. The overall rate of reported AEs remained 
      relatively steady for the years 2013 through 2016 at 92, 95, 86, and 97 AEs 
      reported per 1000 persons who received Glivec(R) per year, respectively. The vast 
      majority of adverse events (85%) were reported from countries where The Max 
      Foundation has a MaxStation, i.e., where The Max Foundation staff interact 
      directly with physicians and patients at clinics or over the phone. AE reporting 
      rates were consistently higher in all years studied from countries where The Max 
      Foundation has a MaxStation. While India accounted for the largest number of 
      reported adverse events in 2016 (1990), Bolivia had the highest rate of reported 
      adverse events at 484 AEs per 1000 patients. CONCLUSIONS: International patient 
      assistance programs that provide access to medicines can have an important role 
      in assisting pharmaceutical companies in fulfilling their pharmacovigilance 
      obligations. Adverse event information collected through PATS can potentially 
      contribute to the overall body of knowledge on the safety of medicinal products.
FAU - Novakowski, Ann Kim
AU  - Novakowski AK
AD  - The Max Foundation, 200 NW Pacific St, Suite 103, Seattle, WA, 98105, USA.
FAU - Garcia-Gonzalez, Pat
AU  - Garcia-Gonzalez P
AD  - The Max Foundation, 200 NW Pacific St, Suite 103, Seattle, WA, 98105, USA.
FAU - Wrigglesworth, Michael
AU  - Wrigglesworth M
AD  - The Max Foundation, 200 NW Pacific St, Suite 103, Seattle, WA, 98105, USA.
FAU - Stergachis, Andy
AU  - Stergachis A
AUID- ORCID: 0000-0003-0057-6627
AD  - Global Medicines Program, Schools of Pharmacy and Public Health, University of 
      Washington, BOX 357631, Seattle, WA, 98195-7631, USA. stergach@uw.edu.
LA  - eng
PT  - Journal Article
DEP - 20180727
PL  - England
TA  - Global Health
JT  - Globalization and health
JID - 101245734
RN  - 0 (Antineoplastic Agents)
RN  - 8A1O1M485B (Imatinib Mesylate)
SB  - IM
MH  - Antineoplastic Agents/*adverse effects/*supply & distribution
MH  - Developing Countries
MH  - Drug Industry
MH  - *Health Services Accessibility
MH  - Humans
MH  - Imatinib Mesylate/adverse effects/supply & distribution
MH  - Neoplasms/drug therapy
MH  - *Pharmacovigilance
MH  - Program Evaluation
PMC - PMC6062918
OTO - NOTNLM
OT  - Drug safety
OT  - Imatinib
OT  - Low- and middle-income countries
OT  - Medical donations
OT  - Patient assistance programs
OT  - Pharmacovigilance
COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: Not appplicable. CONSENT FOR 
      PUBLICATION: Not applicable. COMPETING INTERESTS: Ann Kim Novakowski, Pat 
      Garcia-Gonzalez, and Michael Wrigglesworth are employees of The Max Foundation. 
      PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional 
      claims in published maps and institutional affiliations.
EDAT- 2018/07/29 06:00
MHDA- 2018/12/20 06:00
PMCR- 2018/07/27
CRDT- 2018/07/29 06:00
PHST- 2018/02/05 00:00 [received]
PHST- 2018/06/29 00:00 [accepted]
PHST- 2018/07/29 06:00 [entrez]
PHST- 2018/07/29 06:00 [pubmed]
PHST- 2018/12/20 06:00 [medline]
PHST- 2018/07/27 00:00 [pmc-release]
AID - 10.1186/s12992-018-0391-4 [pii]
AID - 391 [pii]
AID - 10.1186/s12992-018-0391-4 [doi]
PST - epublish
SO  - Global Health. 2018 Jul 27;14(1):76. doi: 10.1186/s12992-018-0391-4.