Equitable access to quality generic medicines for patients with NCD in Tumkur, India: A health systems research Intervention plan document Maya Annie Elias, Manoj K Pati, Praveen Aivalli, Bhanuprakash, Mune Gowda, and NS Prashanth (with inputs from Bart Criel, , N Devadasan & Sadhana SM)
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for people with non-communicable diseases (diabetes and hypertension) in
Tumkur district. It is designed as a quasi-experimental study using a cluster-randomized control trial design. An intervention at taluka-level will beimplemented and its effectswill be studied through a baseline-endline survey
care.Lancet372:940–994.doi:10.1016/S0140-6736(08)61404-X9Puoane, T. R., Tsolekile, L., & Sanders, D.(2013). A case study of community-level intervention for non-
communicable diseases in khayelitsha , Cape Town Empowerment of Women and Girls. Institute of
DevelopmentStudies,UniversityoftheWesternCape.
10Hirimuthugoda, L. K., Wathudura, S. P. K., Edirimanna, H., Vithanage, T. K., & de Silva, P. A. (2013).
Experimental design: impact of an intervention to improve clinic attendance of patients with non-
communicable diseases through telephone follow-up. The Lancet, 381, S63. doi:10.1016/S0140-6736(13)61317-3
11Saleem, F., Hassali, M. a, Shafie, A. a, Ul Haq, N., Farooqui, M., Aljadhay, H., & Ahmad, F. U. D. (2013).
Pharmacist intervention in improving hypertension-related knowledge, treatment medication adherence
and health-related quality of life: a non-clinical randomized controlled trial. Health expectations : aninternationaljournalofpublicparticipationinhealthcareandhealthpolicy.doi:10.1111/hex.1210112Bonita,R.,Magnusson,R.,Bovet,P.,Zhao,D.,Malta,D.C.,Geneau,R.,Beaglehole,R.(2013).Countryactions
talukaschosenfortheATMstudy.Selectionofstudytalukas-RapidhealthsystemassessmentTumkur has 10 talukas16and they vary widely in terms of socio-economicdevelopment indicators. The state government-appointed committee for
addressing regional disparities in development categorized talukas across thestate basedon varioushealth, literacy, socio-economic, political, and economic
indices. In Tumkur, only the headquarter taluka (Tumkur)was categorised as
relatively developed. The other nine were classified as being “backward” to
“most backward”. Considering that the intervention is dependent on several
healthsystemfactorsfor it tosucceed, itwasnecessarytoassess ifall(orhow
many) of the 10 talukas have the necessary conditions to implement theproposed interventions (health services and community mechanisms
17van Olmen, J., Marchal, B., Damme, W. Van, Kegels, G., & Hill, P. S. (2012). Health systems frameworks in their political context: framing divergent agendas. BMC Public Health. http://doi.org/10.1186/1471-2458-12-774
Wedevised indicators for the various components of the talukahealth system
and based on this assessment, the talukaswhere the necessary health system
talukas were dropped). We chose three talukas randomly from among theremainingseven.ThetalukasareKoratagere,SiraandTuruvekere(asshowninfigure1). In these three talukas,PHCswillberandomlyallocated tooneof thethree armsof the intervention (A,B andC).Abrief socio-demographicprofile,
healthanddevelopmentindicatorsofthethreetalukasareshownintable1.Theintervention packages will be implemented in A and B, while C will be the
Formation and meetings of NCD groups at Subcentres
Training and supervision /support to ANMs/ASHAs
Reinforce PHC to enhance Access to generic medicine towards NCD.
Technical support to PHC MOs
Health Day at PHC
Meeting with ARS Members
Purchase & prioritization of medicines at PHCs
Strengthening of existing community participation platforms
Table2:InputsandactivitiesplannedunderPackageA
Inputs Activity Expectedoutcome
Source/finalise
awareness
material
Compile awarenessmaterial (pamphlets, posters, street play themesand wall-painting templates) in Kannada (local language) from allsources.Awarenessmaterial shall focuson(1) lifestylemodification forNCD,(2) need for long-term follow-up and medication for NCD, and (3)availabilityoffreegenericmedicinesforNCDatlocalPHCsObtain feedback from health workers on their utility for awarenessactivitiesatPHCandvillagelevelDisseminatematerialamonghealthworkers,ARSandVHSCs
Improved awareness among people about NCDtreatmentandprimary/secondarypreventionIncreased utilization of PHCs for treatment forNCDIncreased pressure on PHC for stocking andprovidingmedicinesforNCD
Workshops for
PHC health
workers (ANMs,
Anganwadi
workers and
Orientationtohealthworkerson:(1) lifestyle modification for NCD, (2) need for long-term follow-upandmedicationforNCD,and(3)availabilityoffreegenericmedicinesforNCDatlocalPHCs
ASHAs20) How to impart information about diabetes and hypertension tocommunitymembersusingtheawarenessmaterialHowtoorganizepatientsandformpatientgroupsInvolving ARS and VHSC members in improving utilization of PHCservices
Improved coverage of patients with NCD asmeasured by increased proportion of NCDpatientswithinthePHC’sdesignatedpopulation,whoseekandreceiveregulartreatmentforNCDatselectedPHCs
Formation of NCD
patientgroups
Support to theANMs in selectedPHCs toorganiseNCDpatientsandinformabouttheimportanceofregulartreatmentandtheadvantagesofgenericmedicinesNCD patient groups work with the ARS and VHCs to ensureavailabilityofgenericdrugsforNCDsatPHC.
Better awareness in the community leading toincreasedregistrationofnewpatientsDecreaseinstock-outofNCDdrugsatPHC
IEC at community
level
The health workers of the intervention PHCs will receive a foldercontaining-Informationleafletsaboutdiabetes&hypertension-InformationaboutthedesignatedNCDcheckupday- The PHC health day event held 1-3 times per year at the PHCwillalsoincludeactivitiesrelatedtoNCD,ledbyARSmembersandhealthworkers
Better awareness among community membersabouttheillnessandtreatmentIncreasedpatientregistrationatPHCSBettertreatmentadherenceDecreasedout-of-pocketexpenditure
Also the information about diabetes and hypertension will bedisplayedatprominentplacesinthePHCandlocalvillages
PackageB:HealthserviceoptimizationOne-thirdof thePHCs in thestudy talukaswouldreceive inputs foroptimizingtheirhealthservicesso thatNCDpatientscouldberegisteredat theirPHCandperiodicfollow-upcouldbestarted.Atpresent,PHCsarenotgearedtoprovidecontinuouscareforpeoplewithNCD.Forexample,mostPHCsinTumkurdonotusepatientorfamilycards.Theuseofpatientorfamilycardsisvitaltoensurecontinuous care for people with NCD. In addition, the use of simple clinicalprotocols for diagnosis and management of diabetes and hypertension atprimaryhealthcareareavailable,butrarelyfollowed.The logic of Package B is that merely the formation of patient groups andpressure on existing community participation platforms will be inadequate toimprovetheprovisionofgoodqualityNCDcareatthePHC.Thecommunitylevelactivitieswill increase thenumberofpatients seekingcare fromPHC,whereasthere is aneed toensure that thePHC is able toprovidegoodquality care forNCDs. PHCs that receive Package B PHCs shall also receive inputs to optimizetheirexistingoutpatientconsultationarrangementstoaccommodatethespecificneedsofensuringcontinuouscare forpeoplewithNCD(sufficientconsultationtime to allow for counseling on lifestyle issues, medicines as per establishedprinciplesofrationaltreatmentandregularfollow-upthroughpatient-heldcaserecords).Theinterventionassumptionscouldbesummarizedasfollows:
(1) PHCs in Tumkur are focused on care for acute episodes of infectiousdiseases;theyrequireinputstohelpmodifytheiroutpatientcareprocessforensuringcontinuouscareforNCD
(2) Improving access to medicines for NCD at PHCs requires support toimproveservice-deliveryarrangementsatthePHC,includingasystemofregistration of patients, implementation of patient-held treatmentrecords, increased consultation time for counseling on lifestylemodificationandinvolvementofhealthworkers(especiallypharmacists).
Theproposedinterventionlogic isdepictedin figure4.Healthworkerswillnotrespond uniformly to these inputs. Moreover, several local relationships anddynamics within the PHCs are likely to affect (and be affected by) theintervention inputs. However, we hope to be able to understand whichcommunityplatforms and/orPHCs respondpositively andhow their responseaffects(ordoesnot?)theNCDcareandaccesstomedicinesforNCDatthePHC.
Figure4:InterventionlogicofPackageB
State
District
Taluk
Inputs Processes Output Outcome
Training for MO Patient Cards Increased Patient Registration
Improved care for NCDs
Rational treatment and adherence to STG
Increased access to generic medicines
Reduction of OOP
Training for Pharmacists & Lab technician
Standard Treatment Guidelines(STG)
Improved indenting and stock
Better Compliance.
Advocacy and Partnership
Improved investigation and prompt test result
Training for ANMs Follow Up and Coordinate with NCD patient group.
Increased Consultation time.
NCDDay
Drug and Lifestyle modification awareness
Rational Prescription
Reduction of waiting time
Continuous patient flow and improved access for NCD care
TrainingwillfocusonNeedassessmentformedicinesIndentingformedicinesRecordkeepingatPHCsRole of pharmacists in providing advice to patients on medicines, side-effectsandcounsellingonnon-drugtreatmentforNCD.PharmacistswillbeencouragedtogiveprovidetheseinputstopatientswhiledisbursingthemedicinesatPHCs
In addition to activitiesunderPackageA, in thesePHCs, the focuswouldbe tohelpANMsandASHAswithfollow-upofNCDpatientsintheirareaandensuringthattheyvisitthePHCregularlyforfollow-upandmedicines.
- Better patient awareness on NCDsresultinginbetterpatientflow
- Better coordination between healthworkersandcommunity
Advocacy andcoordination
Coordination and advocacy at state, district and taluka levels with differentstakeholders to ensure supply of drugs to the PHCswhich ask for these drugseitherthroughroutinesupplychainorthroughdistricthealthactionplans(asaninnovation)orthroughprocurementfromlocalfunds(ARS)
- Monthly follow-up dates will be given to all patients. PHCs will beencouraged to designate a monthly NCD clinic day to ensure thatsufficientconsultationtimemaybegiven
- Pharmacistsparticipateinprovidinglifestylemodificationadviceaswellas clear and detailed instructions to all patients on how to takemedication (unlike short-term episodic medicines for infectiousdiseases)
- Increasedpatientregistration- Improved treatment compliance of
NCD patients due to patient-retainedrecords Improved utilization of PHCservicesforNCD