phpm assessment tool

8/3/2019 PHPM Assessment Tool

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[insert name of Principal Recipient]

[insert proposal title]

[insert country][insert component]

Pharmaceutical and Health Product

Management (PHPM)Assessment Tool

INTERNAL USE AND CONFIDENTIALThe information in these documents is confidentialand is not subject to public disclosure pursuant to

the Global Fund Documents Policy.

This report is prepared for the Global Fund by:[insert name of LFA]

[insert name of LFA lead assessor][insert date]


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Introduction

Pharmaceutical and Health Product Management (PHPM) are cornerstone activities of mostGlobal Fund grant recipients. The availability of Global Fund resources provides unprecedentedopportunities to procure, store and distribute significant volumes of health products used in thefight against AIDS, tuberculosis and malaria. However, there are also significant risks involved;not only could scarce resources be wasted, poor quality products may potentially cause severedamage to the health and well-being of those affected by the diseases.

Purpose

This tool allows for a focused assessment of systems and structures to be used for the effectivemanagement of pharmaceuticals and other health products within public health interventionsfinanced by the Global Fund. The purpose of the assessment is to determine whether (1) theprocurement and supply management plan of a nominated Principal Recipient (PR) adheres tothe Global Funds policies, (2) the nominated PR has the capacity to implement the plan. Based

on the findings of the assessment, the LFA will provide recommendations to the Global Fund asto whether a nominated PR has the capacity to implement its proposed procurement and supplymanagement plan or, which next steps should be taken before it may do so.

Application

This tool is a checklist that reviews the various activities related to Pharmaceutical and HealthProduct Management to be used during grant implementation. It is to be used in order tocomplete Part VI of the Principal Recipient assessment report. The completed tool should not besubmitted to the Global Fund. Please note that all questions included in this checklist should beconsidered when completing Section VI of the PR assessment report. Please ensure that any

additional relevant issues that may arise during the assessment should also be addressed in thePR Assessment report

Mandatory standard background reading

Guide to Global Funds Policies on Procurement and Supply Management. Geneva,Switzerland,

November 2006. Available at:

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http://www.theglobalfund.org/pdf/guidelines/pp_guidelines_procurement_supplymanagement_en.pdf

The Global Funds Procurement and Supply Management Assessment Tool 3
http://www.theglobalfund.org/pdf/guidelines/pp_guidelines_procurement_supplymanagement_en.pdf%20http://www.theglobalfund.org/pdf/guidelines/pp_guidelines_procurement_supplymanagement_en.pdf%20http://www.theglobalfund.org/pdf/guidelines/pp_guidelines_procurement_supplymanagement_en.pdf%20http://www.theglobalfund.org/pdf/guidelines/pp_guidelines_procurement_supplymanagement_en.pdf%20


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Interagency guidelines on operational principles for good pharmaceutical procurement.1999 (available at: http://www.who.int/3by5/en/who-edm-par-99-5.pdf)

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http://www.who.int/3by5/en/who-edm-par-99-5.pdfhttp://www.who.int/3by5/en/who-edm-par-99-5.pdf


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Sources and prices of selected medicines and diagnostics for people living with HIV/AIDS,June 2005 (available at:http://www.unicef.org/supply/files/sourcesandprices2005.pdf )

Untangling the Web of Price Reduction, 10th edition. Mdecins Sans Frontires. July 2007.



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(available at:http://www.msf.or.jp/pressroom/img_press_report/pdf/Untangling_10th_edition_July2007.pdf)

Drug patents under the spotlight, sharing practical knowledge about pharmaceuticalpatents. MSF, May

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http://www.msf.or.jp/pressroom/img_press_report/pdf/Untangling_10th_edition_July2007.pdfhttp://www.msf.or.jp/pressroom/img_press_report/pdf/Untangling_10th_edition_July2007.pdfhttp://www.msf.or.jp/pressroom/img_press_report/pdf/Untangling_10th_edition_July2007.pdfhttp://www.msf.or.jp/pressroom/img_press_report/pdf/Untangling_10th_edition_July2007.pdf


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2003. (available at: http://www.accessmed-msf.org/documents/patents_2003.pdf) Determining the patent status of essential medicines in developing countries. Health

economics and drugs.Geneva, World Health Organization, 2004. EDM series No.17 (WHO/EDM/PAR/2004.6)

Fact Sheet: Pharmaceutical Patents, Obligations and Exceptions. Geneva, World TradeOrganization,

http://www.accessmed-msf.org/documents/patents_2003.pdfhttp://www.accessmed-msf.org/documents/patents_2003.pdf


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Sept 2006 (http://www.wto.org/english/tratop_e/trips_e/factsheet_pharm00_e.htm accessed1 August2007).

A. Procurement policies and systems

Yes, No,N/A

A.1Who among the PR staff is responsible for procurement under the Grant?

Comments: The procurement officer is responsible for procurement under the grant.The JD &CV of Procurement Officer NZ is attached along with JD and CV of SeniorExecutive Officer NZ who is in charge of all activities of procurement at NZ.

Does the above entity(ies) have a procurement procedure manual in adherence to theInteragency Guidelines on Operational Principles for Good Pharmaceutical Procurement? Ifyes, skip to question A.5

A.2

Review procurement procedures manual and identify its strengths and weaknesses.Please note if such a manual does not exist or if it does not correspond with theInteragency Guidelines on Operational Principles for Good PharmaceuticalProcurement.Comments: The Procurement Manuals of NZ are attached (Drugs Procurement & GeneralProcurement)

A.3 Is the actual procurement process competitive, efficient and transparent?Comments: As practiced by NZ the procurement process is competitive, efficient andtransparent. (Example: Comparison of 3 quotations on current market rates and alsotaking into consideration limited time frame in which the product/s need to beprocured and delivered in different cities. Comparison format attached)

A.4What is the anticipated duration of the procurement cycle (as applied under thisGrant) calculated in months from "product selection" until "arrival of goods"?Comments: The anticipated duration of procurement cycle is 1 month.

B. Intellectual Property Rights

B.1Is the country a Member of the World Trade Organization (WTO)?

Comments: Yes the country is a member of WTO since 1995

B.2 If yes, is the country least developed according to its submissions to the WTO?Comments:

B.3

Does the country have a patent law that allows for the patenting of pharmaceutical

products? Is the country a member of a regional organization administering a patentsystem that includes pharmaceuticals?

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http://www.wto.org/english/tratop_e/trips_e/factsheet_pharm00_e.htmhttp://www.wto.org/english/tratop_e/trips_e/factsheet_pharm00_e.htm


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Comments: Quality Assurance of pharmaceuticals to be procured by PR-1 is for primarycare of clients (e.g. cough, fever, headache, pain killers, infections, wounds dressingetc). These medicines are available in local market. The Quality Assurance of thesemedicines will be done by PR procurement department and Medical Officer of NZ withthe supervision from NZ Management Team at the time of selecting product and vendor.The Quality Control of these medicines will be done by Procurement Officer of PR-1with the support from SRs and through M&E department as well. Goods received notewill be confirmation of good quality product received at Coc site. It will also be done byM&E through field visits and randomly asking clients about the services provided tothem by SRs

Single and limited-source pharmaceutical products

C.6Is the PR familiar with the Global Fund QA policy and does the PR have the capacityto implement the QA policy?

Comments: Yes.

Multi-source pharmaceutical products

C.7Are the multi-source products procured under the Grant subjected to and incompliance with NDRA requirements (e.g. registration)?

N/A

Comments:

Quality control

C.8Does the party responsible for QA/QC systematically draw random samples of allpharmaceutical batches?

N/A

Comments: To my understanding this question is related to pharmaceutical batches forHIV & AIDS related pharmaceuticals, However NZ has a history of requesting theircenters in different cities to send random samples of pharmaceuticals received by

vendor to NZ head office so it can be made sure that the procured pharmaceuticalscomply with standards as described by NZ and agreed with supplier at the time ofproduct selection and placing order.

C.9

Are samples regularly tested by a qualified laboratory (e.g. accepted forcollaboration with WHO pre-qualification project; accredited in accordance withISO17025; AND/OR accepted by a stringent authority)?

Comments: The pharmaceuticals procured under GF grant by PR-1 will be used forPrimary care of clients. These pharmaceuticals are approved by NDRA and are availablein local market for purchase by general public. The medical stores and suppliers obtainlicense from government after proper verification and meeting the requirements as set

out by government, However to my understanding the above mentioned testing isrequired for product procured related to HIV/AIDS.

D. Product Selection

D.1Who/which department is responsible for product selection under the Grant?

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Comments: Procurement Officer / Procurement department will be responsible forselection of products in consultation with NZ Senior Management Staff, Medical staff andrelevant center Managers and also based on prior experience. NZ management staff, NZdoctors, Managers and procurement department staff are well experienced to select,negotiate, arrange and manage the product selection process.

D.2Is the nominated PR aware of Global Fund policy regarding product selection and howdoes the nominated PR (intend to) adhere to this policy?

Comments:

E. Management Information Systems

E.1Does the PR have an adequate Management Information System(s) to keep track ofstock levels and consumption data of health products to be procured under thisgrant? (Please describe the system in place)

Comments: The track of consumption for health products (namely syringes, condoms,avil, sunny plast and spirit swabs) are all available through the software currently usedby NZ. (Hard copy of Data sample from software attached) The consumption of healthproducts can be calculated if and when required on daily, weekly, monthly or annuallybasis which ever the case may be.The stocks of health products can be verified at any given day through stock registers asthey are properly recorded on daily basis at all centers. Also when ever new demand isgenerated it is required by procurement department that copy of stock register showingupdated current balance and quantity required for next period to be mentioned indemand form so consumption and stock balance can be calculated and also to confirmthat the forecast is properly done.For this purpose the daily demand form, service delivery form, daily report andcumulative monthly report are also used. (the different form are attached)

E.2Is the system in place adequate to provide reliable, complete and regular reports tocentral level to enable appropriate revision of quantities to be ordered?

Comments: Yes the system is reliable and reports are generated regularly(e.g. dailyreports , weekly reports and monthly reports) so that consumption and stock balance canbe calculated at any day. This data is also a major factory for procurement departmentin deciding the revision of quantities to be ordered for next period if and when required.As the data gives the information regarding use per day, per week and per month it isreliable and is very useful in deciding consumption on daily, weekly and monthly basis.(Software print out, daily report & monthly report format attached)

F. Forecasting

F.1Who/which department is responsible for forecasting (including forecasting of bufferstocks) under the Grant?Comments: Procurement Officer with supervision by Senior Executive Officer, Doctor andM&E department is responsible for forecasting based on targeted population as shown inthe plan. (see forecasting and distribution plan attached for health products) Practicallyevery NZ center has at least 1 (one) Medical Officer who generates demand for nextmonth keeping in mind last month consumption. The demand is forwarded to HeadOffice for procurement. The demand generated is forwarded to Senior Medical Officer

for scrutiny by procurement officer if required and after verifying the demand is sentback to Head Office as final list for procurement. (Please see attached monthly demandform format.



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F.2How were forecasts developed for required quantities of health products under thisGrant?

a)Consumption method, using quantities of drugs distributed and dispensed topatients? : NZ uses this method as it is the most reliable source of data and this iscalculated by looking at the mobile van medical register for daily service delivery.

b)Morbidity method, using population, case detection rate, and patient segmentation?

c) Other method?

Comments: The forecasts are developed keeping in mind the number of clients to beserved in each quarter under GF for Yr1 & Yr2. (Please see attached Annex A-1)

F.3 How are forecasts validated?Comments: This is done by regularly checking service delivery reports generated ondaily basis forwarded to M&E and management section to keep a track record ofconsumption of all products forecasted.

F.4 Are adequate volumes of buffer stocks planned at relevant levels?Comments: According to NZ current practice when the stock of health products andpharmaceuticals reaches a point of request indicator (RI) new demands by centers are

generated. The RI is identified by keeping in mind the time required for next delivery bysupplier. This is also explained in procurement manual. The request indicator is based ondaily consumption or monthly consumption and new demand should be generated whenRI is reached so that the remaining days are treated as buffer stock till next supply ismade. (Please see example in procurement manual)

F.5 How is forecasting data managed (e.g. use of Information Systems)?Comments: All forecasting for centers and demands by centers are maintained oncomputers as soft copies and also in form of hard copies for future reference and forcomparison to decide if forecasting needs to be revised.

F.6 Are forecast presented based on reliable data and methods?Comments: All forecast are based on actual consumption and service delivery reports bycenters, However in GF grant PR-1 has made forecasts considering targets set for eachquarter for each SR.

F.7Are (and how are) forecasts of parallel procurement efforts appropriatelyharmonized with the procurement under this Grant?Comments:

G. Receipt and storage

G.1Who/which department is responsible for receipt and storage of procurementsunder the Grant?Comments: The PR office will carry out all activities of procurement and the procureditems will be delivered to SRs directly. The SRs will be responsible for receipt andstorage of procured items. It will be made sure that the Coc sites are adequatelyequiped and in accordance with good storage standards as described in NZ Manual.

G.2Is the storage capacity adequate and appropriate for the expected products? If not,describe plans to which plans exist to improve and/or expand storage capacity (with

a timetable).

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Comments: The store capacity is explained in procurement manual of NZ. As describedin manual all requirements as per GF standards will be met and SRs will also beeducated and trained regarding good storage practice. All standards required for goodstore capacity will be adhered to as also explained in NZ procurement manual. (Pleasesee NZ manual attached)

G.3Is sufficient and adequately trained staff available to handle the supplies procuredunder the Grant?

Comments: The items to be procured under GF fund are similar to what NZ has beenprocuring and keeping in mind the previous outcomes it is quite evident that NZ hassufficient and adequately trained staff available to handle the supplies procured underthe Grant. (JDs and CVs of concerned staff are attached for review)

G.4Is adequate storage equipment available at critical levels (e.g. pallet racks, trolleys,forklifts, refrigerators etc.) to handle products procured under the Grant?Comments: All equipment required to handle products procured under GF grant will beavailable and also that the equipment available is relevant to activities to be performed

to make sure that all products procured are handled and stored properly.

G.5 Are storage conditions (e.g. temperature, humidity, cleanliness) appropriate?Comments: Fridges will be available where items need to be stored in temperaturecontrolled environment (like medicines) proper racks will be installed, cleanliness willbe made sure. All points mentioned in NZ procurement manual regarding storageconditions will be made sure by regular visits and inspections and also by giving propertraining to relevant staff regarding proper storage conditions and proper guidance onhow to maintain a store which will be done through NZ procurement manual (seemanual attached)

G.6Which inventory control mechanism is used (e.g. bin cards, ledgers, computers) andis this system reliable?

Comments: Stock Registers and soft record on computers for inventory control aremaintained at all sites. (see copies of stock register attached)

G.7 Is a physical inventory check of all products carried out at least annually?Comments: Physical inventory check is done regularly. This is also done to confirmFEFO. Further to this inventory is done at three different levels. (1) When dailydemands are taken out for service delivery the store in charge after taking out dailydemand rechecks the inventory to make sure that it is in accordance with the physicalbalance available. (2) During visits from Head Office including but not limited toInternal Auditor the physical inventory of stocks is also checked and verified, this can

also be verified from Internal Audit department. (3) During Visit by funding authority /donor the visiting member is also shown and he/she checks the physical stock againstock registers and signs the stock registers as confirmation of verification. (see copiesof stock register attached)

G.8 What is the average stock turnover time?Comments: Since demands are generated on monthly basis considering monthly servicedelivery reports so all procurement for pharmaceutical and Health products are done onmonthly basis. So average stock turnover time is 1 month.In GF procurement will be done on quarterly basis so average stock turnover will be 3months.

G.9 Are adequate security measures in place to prevent theft of stored products?



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Comments: Security guards are hired at sites where store facilities are maintained.Addition to this it is made sure that the locks on doors are properly working. (see alsoprocurement manual security measures)

G.10 Does the PR have an insurance cover for the stock in case of damage or theft?Comments: Since the quantity of items being procured by NZ are for consumption within1 month therefore insurance cover for the stock procured is not done previously, but ifits compulsory requirement by GF it can be adopted where applicable.

G.11Is there a policy and practice of storing and issuing stock according to firstexpiry/first out inventory control procedures at all levels?Comments: On every fresh delivery by supplier item/s received are physically examinedand checked one by one for quality control and also for expiry date. This is also done tomake sure that the items received reconcile with the copy of purchase order. Also asexplained earlier in point G.7 this is also practiced after every 15 days to make surethat the items near to expiry are distributed first, this is also explained in NZprocurement manual for Drugs. (See procurement manual attached)

G.12What systems are in place to deal with expired products at either the nominated PRor sub-recipient sites?

Comments: As per previous practice the expired item/s are returned to supplier. Attime of receiving fresh supplies from supplier if an item is expired it will be handedover to the supplier for proper disposal of the item/s under good faith. Since there iscontinuous process of checking of all consumable items for expiry dates after every 15days if an items is about to reach its expiry the vendor is requested on during his visitfor delivery of supplies to change the near to expire items (This may happen when oneitems is not being used in field as much as it should be and the shelf life is about toexpire due to usage of that item, the vendor may be asked to replace that item withsome other item which is near to stock out or which is more in use).

H. Distribution

H.1 Have detailed distribution arrangements been described and agreed upon?Comments: Medicine distributors, Medical stores /suppliers which have adequatearrangements for delivery of pharmaceutical at various cities of the country have beencontacted. Distribution can also be carried out through local goods distribution serviceprovider as per previous practice.

H.2Is there a documented product distribution schedule for all (sub-) recipients (e.g.monthly, quarterly etc.)?

Comments: Yes a detailed product distribution plan for all products have beendocumented (this included Distribution schedule of syringes, condoms etc please seedistribution schedule attached)

H.3Are resources available for product distribution, including number and storagecapacity of vehicles as well as availability of petrol and drivers, sufficient for theapproved Global Fund proposals?

Comments: As practiced all items procured by NZ are ordered on monthly basis andthese quantities were manageable within the centers. The products procured weredelivered directly to NZ centers by selected suppliers and these products weredistributed to clients by these centers. Distribution of these products was done bymobile service delivery vans and through Out Reach Workers on motorbikes.

H.4

Is transportation outsourced at any level of the supply chain management system? If

yes, to whom is the responsibility outsourced and how effective has it been?

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Comments: As per previous practice the suppliers were contracted with the conditionthat they will supply procured products at NZ offices / sites. This has been veryeffective, cost efficient and also less time consuming.

H.5Describe the sources of significant delays to AIDS, TB and/or malaria productdistribution in the last 12 months (if any) and the actions taken since to prevent suchdelays in the future.

N/A

Comments:

H.6To ensure secured distribution of products, what additional security measures aretaken in distribution systems, e.g. insurance cover, locked cases or covered vehicles?

Comments: Since the services are provided to clients in field it is made sure that thevehicles are covered (in GF Suzuki Bolan will be used as same vehicle are used by NZwhich is already a covered vehicle) Services are also provided by Out Reach Workers onmotorbikes, to make sure that the items are securely delivered to clients on bikesspecial bags are procured by NZ to unsure safety of items carried by ORWs on bikes.

H.7What material accounting systems and processes are in place to ensure that theexact amount and type of products dispatched from the nominated PR site arereceived at the sub-recipient sites?Comments: Goods received note is required from all centers where procured items aredelivered. The Center in charge is required to complete the goods received note withquantities received for each item/s from supplier and center in charge is required tosend one copy to Head Office and one copy to supplier as receipt. This is done to makesure that the exact numbers of items procured are delivered at relevant center and it isalso required by accounts department for release of payment to supplier. This also helpsin QA/QC of the item/s procured and supplied by the supplier as each items is checkedone by one after verification of item/s Goods received note is forwarded.

H.8 Does the shelf life of products appear to be well-managed throughout the supplychain?Comments: Since NZ procured products that are to be consumed within 1-3 monthsduration so it is made sure that the shelf life is more than at least three months, andalso since the FEFO is followed and products inventory checked after every 15 days andalso forecast is validated every month it is made sure that the product is distributed andconsumed well before the shelf life expires.

I. Rational drug use

Standard treatment guidelinesI.1

Are updated National Standard Treatment Guidelines available for relevant diseases?

Comments: Yes guidelines are available (STI & VCT see attached guidelines)

I.2Are available guidelines consistent with protocols specified in Global Fund proposals?If not, how will inconsistencies be resolved?Comments: National guidelines are used by NZ

I.3Are all guidelines supposed to be available at central, regional, district, and locallevels? If not, explain which guidelines are available at which level.Comments: Yes guidelines are available at all centers.

Adherence, resistance and adverse drug reactions

I.4

Are there appropriate mechanisms (including but not limited to fixed dosecombination drugs, once-a-day formulations, blister packs, peer education andsupport and in accordance with existing international guidelines) in place toencourage:

N/A



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a) Adherence to treatment? N/A

b) Monitor and contain resistance? N/A

c) Monitor adverse drug reactions? N/A

Comments:

J. Health products other than pharmaceuticals

J.1

Are non-durable products quality assured adhering to the same principles as forpharmaceuticals, namely from lists of 1) pre-qualified products, where they exist, or2) products accepted by stringent regulatory agencies or 3) products accepted bynational standards?

Comments: All non-durable products procured are under national standards.

J.2 For durable products(equipment), has the lowest possible price taken into accountthe Total Cost of Ownership (TCO), including the cost of reagents and otherconsumables as well as costs for user training, warranty, maintenance ?Comments: The lowest price for durable good have been taken into account and alsoconsidering prices of previous procurement of similar products. (See copies of currentmarket quotations attached)

J.3Has the nominated PR provided a plan for service and maintenance of durableproducts?Comments: NZ has a policy of signing of contracts with service providers or companieswho provide maintenance and carry out service of durable products for a fixed annuallypayment as agreed. NZ prefers that such a company should either have offices in all

cities where our sites exist otherwise service providers of relevant cities are contactedfor maintenance and to carry out service as and when required for a fixed annualcontract.

K. Management and Coordination (including of sub-recipients)

K.1Who/which department level is responsible for the overall management andcoordination of activities related to pharmaceutical and health product managementunder the Grant?Comments: Senior Program Manager & Procurement Officer of PR-1 is responsible for the

overall management and coordination of activities related to pharmaceutical and healthproducts management under this grant with the support from NZ management staff.Program Officer of each Coc site will also be responsible for overall management andcoordination.

K.2 Does this overall management and coordination capacity appear to be adequate?Comments: NZ has experience of providing services simultaneously in eight (8) cities ofPunjab and has done an excellent job in management and coordination of activitiesrelated to pharmaceutical and health product management.

K.3Are competent and adequate numbers of staff available to conduct and/or coordinatethe proposed PHPM activities under this grant?

Comments: Please see CVs attached

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K.4How does the nominated PR intend to direct, monitor (and where necessary, takecorrective action) and report on the PHPM activities conducted by sub-recipients toensure that the Global Funds policies are implemented and enforced?

Comments: SRs will be trained and educated about PHPM activities as per global fundpolicies and monitoring of PHPM activities of SRs will be done through visits by

procurement officer and also with the help of M&E department. Different types ofservice delivery forms developed by NZ will play major role in monitoring servicedelivery and management of pharmaceutical and health product. (please see forms)

K.5Does the nominated PR have adequate capacity to ensure sub-recipients compliancewith Global Funds procurement policies?

Comments:

K.6 Are plans in place to expand the availability of human resources where applicable?Comments:

K.7Have any PHPM activities been underestimated or overlooked in the budget/PSMplan?

Comments:

K.8Will patients/clients be charged for products procured under the Grant? If yes,explain in detail (in principle, this is against Global Fund policy).

Comments: All services provided by NZ are free cost and same will be practiced in GFfunded program.

K.9Is there a risk of overlap or duplication of health product provision by the GlobalFund and other donors? If yes, how is this risk mitigated?



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Comments:

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