Challenges in Cold Chain Management Universal Immunization Program (UIP) and Supplementary Immunization Activities (SIA)Dr Pritu DhalariaDirector Immunization PATH
Evolution of UIP1978 - Expanded Program of immunization (EPI)1983 - TT immunization of Pregnant Women1985 - Universal Immunization Program (UIP) For 6 VPDs1990 -Vitamin A Supplementation was added; UIP and ORT universalized in all districts1992- CSSM1997- RCH-12000- Immunization Strengthening Project (2000-03)2005- NRHM and RCH II
UIP - An Overview• Largest public health interventions, largest in the world• Target 27 million infants and 30 million pregnant women every year• Against the 6 Vaccine Preventable Diseases (VPD) (Tuberculosis, Polio, Diphtheria, Tetanus, Pertussis, & Measles)• Since 2006, Hepatitis B and Japanese Encephalitis vaccines introduced in selected districts and states• India is close eradicating Polio transmission• Measles second opportunity is being introduced – SIAs / RI• Introduction of the Pentavalent vaccine in the UIP may also be on the cards
SIAs in Recent Times• Pulse Polio (Polio SIAs) under Polio Eradication Initiative• Japanese Encephalitis (JE) Vaccination Program• Measles SIAs Maintaining Cold Chain remains one of the big challenge
Cold Chain - Definition The cold chain is a system of storing and transporting vaccines at recommended temperatures from the point of manufacture to the point of use - WHOhttp://www.who.int/countries/eth/areas/immunization/epi_logistics/en/index1.html
Cold Chain System• High coverage is important, but it is not enough!• Was potent vaccine administered safely and efficiently in a timely manner before exposure to disease?• All Vaccines lose potency on exposure to heat above +80 C• Some Vaccines lose potency when exposed to freezing temperatures• The damage is irreversible Colder is not necessarily better!!
Essential Elements of Cold ChainThe cold chain is the combination of people,equipment and established processes. processes.• PERSONNEL to organize and manage vaccine distribution.• EQUIPMENT for storage and transport of vaccine.• PROCEDURES to ensure that vaccines are stored and transported at appropriate temperature• MAINTENANCE OF EQUIPMENT• MONITORING
Cold Chain System Needs to be Robustto Support Various Newer Vaccines Current RI Vaccines for Potential New Vaccines SIAs Vaccines BCG Monovalent OPV1 Pentavalent1 VaccineOPV Monovalent OPV3 Pneumococcal VaccineMeasles Measles Rota Virus VaccineDPT JE, etc.Hepatitis BTetanus Toxoid1. Pentavalent includes Hib, diphtheria, pertussis, tetanus, Hep B Hib, pertussis,
Impact of New Vaccines on ColdChain (Pentavalent, MR, PCV & Rota) Pentavalent, Rota) 0 50 100 150 200 250 300 350 TV (BCG, DPT,TT,MSL,OPV) 45.6 TV – Traditional Vaccines Cold chain Space TV+ Penta 33.6 19.8 required per cm3 TV+ Penta+ MR 33.6 19.8 3.1 TV+Penta liquid+Pneumo(PFS) 33.6 19.8 197 TV = Traditional Vaccines TV +Penta liquid+Pneumo(2DV) 33.6 19.8 22 TV +Penta liquid+Rota Lyo with Diluent 33.6 19.8 222 TV +Penta liquid+Rota Liquid 33.6 19.8 255TV (bcg, dpt,opv, msl, tt) TV + Penta TV + Penta + MR Pneumo (PFS)Pneumo (2 dose vial) Pneumo Uniject Rota Lyo GSK with Diluent Rota Liquid MSD
Vaccine Stores in India Store Level Numbers Equipments Stock PurposeGMSDs 4 WIC, WIF & 3 Buffer & Supply for NE Concrete Cold months States, UTs , J& K RoomsState Vaccine Stores 39 WIC, WIF Buffer & Supply to Divisions/Districts 3Divisional Vaccine 123 WIC, WIF, DF months Buffer & Supply toStores (large), ILR (large) DistrictsDistrict Vaccine 618 DF (large), ILR 3 Buffer & Supply toStores (large) months BlocksCHC 4045 DF ( small) & ILR 1 Supply to Session SitesPHC 22394 (Small) month DFs are used for freezing of vaccines / Ice packs besides storage of OPV All RI vaccines are kept in ILR at PHC/CHC.Immunization Division, MOHFW, GoI.
Key Cold Chain Issues• Most cold chain rooms are old & substantial up gradation is required*• A large part of the cold chain equipment in the country is currently operating on obsolete CFC refrigerant (aging cold chain equipments)*• Cold chain management is poor in some places (including private practices), particularly for temperature recording and risk of freezing the freeze- sensitive vaccines**• Inadequacy of trained manpower with essential qualifications at every level *www.mohfw.nic.in/…/JS_AMP_Presentation_13Apr2010.ppt accessed on 11th Nov.2010 **www.mohfw.nic.in/nrhm/Presentations/Bhopal…/immunization.ppt accessed on 11th Nov.2010
Cold Chain Issues in FieldUntrained Manpower handling the cold chain• Cold chain handlers are often personnel who lack the capacity, skill and dedication, generally too old for field work/office work. Eg. LHVs, senior ANMs• Comprehensive and hands on training required• No alternate plan in case the designated Cold chain handler is on leave• Trained manpower often transferred and replaced• Medical officers often themselves lack knowledge on cold chain maintenance, difficult for them to supervise• Interpretation of VVM by field workers remains a big challenge
Cold Chain Issues in Field…Inadequate maintenance of cold chain equipment**• High cold chain sickness rate#• Long response time to breakdown of equipment• Not enough cold chain engineers / refrigerator mechanics in states and districts• Lack of adequate training• Lack of adequate equipments• Voltage fluctuation, equipments not attached to stabilizers, lack of proper wiring and earthing• Improper cleaning and defrosting of equipment#The proportion of cold chain equipment out of order at any point of time.
Cold Chain Issues in Field…Poor Monitoring of the Cold Chain• Slackness in the field regarding cold chain maintenance by ANM and MPW male• Poor supervision, monitoring, contingency plan• Condemned equipment not disposed off timely• Shortage of accessories like thermometers, stabilizers, equipment stands, freeze tag, etc.• Inadequate recording and documentation – Power cuts / generator running / defrosting not documented in log books – Temperature charting not done meticulously /regularlyThere is a saying “if it is not documented , it never happened!”
Challenges related to SIAs• Immunizing large population at one go• Bulk requirement of vaccine and logistics causing sudden and excessive burden on cold chain system• Extra pressure on overburdened health personnel• Reduction of focus due to other health programs• Intensive planning and training for campaign• Communication challenges• Extra funding• Waste disposal and safe injection practices
Cold Chain Space for SIAs:(Stress for Cold Chain System)Cold Chain faces stress during SIAs on following issues: • Needs to suddenly accommodate large volume • Storing the RI vaccine poses a big challenge • Requirement for Ice pack freezing increases • Transportation to session sites poses a big challenge, especially in absence of adequate number of cold boxes / vaccine carriers. • Vaccine delivery system is often inadequate, unreliable and no proper plan for AVD (Alternate Vaccine Delivery System)
Shortage of EquipmentsRefrigerators and freezers nottimely repaired
Transport challenges Large Volumes to transport Insufficient cool boxes for vaccine transportationLoose vials take lessspace, but stockmanagements becomesimpossible
Vial Protection and ArrangementsVials not put in plastic bag; exposed to contaminated meltwater from icepacks.
Vial Protection and Arrangements… mOPV 1 tOPVPresence of all 3 types of OPV at Planning units long after completion of SIA rounds Stage 3 vaccine Return all monovalent OPV to DHQ after the round. mOPV 3
Vaccine DeliveryVaccine carrier lying in area Vaccine left in carrier after5 days after SIA completed the activity
Key Steps for Improvement in ColdChain Performance during SIAs• To increase available cold chain space as per new requirement• Effective utilisation of available cold chain space• Assess Cold chain space requirement for storage of vaccine and diluents• Assess Cold chain space requirement for freezing and storage of Ice packs
Cold Chain System Assessment(Corrective Measures)• Vaccine arrival procedures• Stock management• Vaccine storage temperatures• Effective vaccine delivery• Cold storage capacity• Correct diluents use for freeze dried vaccines• Buildings, cold chain equipment and transport• Effective Vaccine Vial Monitor (VVM) use• Maintenance of cold chain equipment and• Vaccine wastage control
Planning of Cold chain Space• High expertise is needed on micro planning of cold chain• Extra space for the diluents also needs to be taken into account• Calculation of dry Cold chain storage space is imperative for storing syringes, hub cutter, etc.• Vaccines need to be supplied for vaccines in multiple cycles e.g State -Division, Districts- Blocks – like :50% (Before Activity): 25% (End of 1st Week): 25% (End of 2nd Week of Campaign).• Use of WIF /DF for storage of OPV/Measles vaccine only during campaigns/Catch up.
Planning of Cold chain Space…• Proper Icepack freezing plan (ensuring enough space is available for it)• Use of Cold Box for storage of vaccine and storing freeze icepacks during campaign• Storage of diluents in the Cold Box with conditioned Ice Packs 24 hrs before immunization• Use cold chain space of near by PHC and District vaccine stores• Identification of Ice factory with prior mutual agreement for storage of vaccine with clear space / Ice pack frezing
Dealing with Shortage and repair ofequipments• Identify all repairable equipment• Repair of equipment and proper maintenance• Making spare parts available : local procurement• Install and use of WIC/WIFs on a priority basis before campaign.• Installation of all new ILRs , DFs and Solar equipment on war footing• Expansion of cold chain points beyond Block PHCs• Quick assessment and Planning for installation
Vaccine Delivery System• Transportation of the vaccines to the site incase the extra vaccine is required• Availability of adequate vehicles and manpower for supplying vaccines, ice packs or diluents where ever there is shortage of supplies.• Need for proper management/ tracking of the unused vials which are returned from the Immunization sessions• Contingency plan needs to be such that there is a prompt supply of any deficit of the stock in terms of vaccines or the ice-packs.
Cold Chain System in Campaign• Use of generators for continuous power supply of all the electrical equipment• Training of cold chain handlers after needs assessment• Proper record keeping for temperature maintenance and vaccine distribution• Proper recording and reporting• Effective monitoring and supervision
Summary• Effective utilization of cold chain space• Regular assessment of cold chain systems to take corrective measures• Identify repairable equipment and ensure proper maintenance• It is essential to use generators for ensuring continuous supply of power• Comprehensive training of cold chain handlers is mandatoryAnd lastly to develop and implement an effective monitoring and supervisory plan to ensure smooth functioning of the cold chain system
Thank YouDr Pritu Dhalaria, MBBS, DCM, MD.Director Immunization [India]Project Director• Japanese Encephalitis• SCLTI Madhya Pradesh• RI Project in Mumbai SlumsPATH, Indiaemail@example.com/je