1. Management of the Tuberculosis Drug Supply Module 13 – March 2010

2. Project Partners Funded by the Health Resources and Services Administration (HRSA)

3. Module Overview  Determining appropriate quantities  Ensuring quality  Financing and procurement  Distributing and storing

4. Learning Objectives At the end of this presentation, participants will be able to:  Describe the basic principles of TB drug supply management  Identify areas in the drug supply management process that they can impact

5. Drug Supply  Management of TB medicines is critical to the success of a TB Program  Interruptions in drug supply can result in misuse, treatment default and the development of drug resistance  Nurses play an important role in ensuring an uninterrupted supply of TB drugs by monitoring stock supplies and advising those in charge of ordering of the TB medicine needs

6. Drug Supply (2)  Selection, distribution and management of the anti-TB drug supply is an important responsibility of the NTP  WHO and IUATLD recommend that use of fixed-dose combinations be restricted to combinations whose bioavailability has been demonstrated by laboratories that are independent from the manufacturers

7. Drug Quality  National TB control programs should ensure that anti-tuberculosis drugs are of good quality by making sure that the drugs: Are produced following the good manufacturing practices recommended by WHO Are imported with a PAHO/WHO certificate When bought by competitive tender, are ordered with the appropriate specifications Are stored properly following good storage practice and the first expiry, first out (FEFO) principle

8. Appropriate Quantity: Stock Control  Advantages of an effective stock control system include: Ensures efficient use of financial resources Prevents under-stocking and “stock outs” Prevents overstocking and wastage Prevents shortages in case of delays in delivery Keeps medicine stores going even when there are staff shortages Allows identification of security problems

9. Medicine Distribution & Supply  Keeping stock records up-to-date is important for real time assessment of available stock  Steps include the ordering, receiving and issuing of medications and related supplies (includes the removal of expired or damaged items from stock)

10. Ordering Principles  Order at regular intervals Know when orders are to be placed and get order in on time  Anticipate changes in demand Quantity is directly related to number of TB patients registered at the facility  Be systematic Perform a physical stock count Decide whether or not an item needs to be ordered Complete order for items under the minimum stock

11. Terminology  Order interval is the time between two orders  Minimum stock level is the level of an item that is twice what is generally used during an order interval  Maximum usage is the average consumption of an item during order cycle x. This number should be documented on the stock card

12. Terminology (2)  Lead time is the time it takes between the first step in the procurement process until the supplies arrive in the country’s central medical stores  Both minimum and maximum stock levels can change over time depending on consumption. For TB medications, these levels will change as the number of TB patients change

13. Calculating Minimum Stock Level Minimum lead time = 1 time per month Maximum Usage = 3 units per month Minimum Stock Level = 3 units X 2 X 1 = 6 units of isoniazid = 2 X Maximum lead time in months X Maximum Usage Minimum Stock Level Re-order when stock reaches minimum stock level Re-order when stock reaches minimum stock level

14. Receiving Supplies  When supplies are received, the following steps should be taken: Check that the number of items received matches the number of items ordered  Right item  Right unit size  Right quantity

15. Receiving Supplies (2)  Check that all boxes/containers are sealed and intact  Check medicine expiry dates  Document and report any problems noted

16. Storage of TB Medications  Good storage and management procedures are particularly important for medications Keep drugs safe – should be in a cabinet or room that can be locked/secured when not in use  Store high security/high value products in appropriate security zones Temperature, light, and humidity should be kept moderate in area where medications are stored No food, drink or smoking should be allowed in the storage area

17. Storage of TB Medications (2)  Place liquid products on the lower shelves or bottom of stacks  Separate damaged or expired products from the usable stock without delay and dispose of, using established disposal procedures  Arrange cartons so arrows point up and identification labels, expiry dates, and manufacturing dates are visible

18. Stock Records  Product name/description  Stock on hand/beginning stock balance  Receipts  Issues  Losses/adjustments  Closing/ending balance  Transaction reference (e.g., issue voucher number or name of supplier or recipient)

19. Distribution of Supplies  Each time supplies are issued/distributed, it should be recorded on the _________  Issuing supplies involves: Moving stock from shelf to dispensing areas, treatment rooms, outreach teams Ensuring medications issued to peripheral sites match the order sheet Removing stock of fast-moving items for pre- packaging Removing expired supplies or damaged items

20. Methods to Avoid Stock Wastage  FEFO Rule = First Expiry First Out  Clearly mark containers with close expiry dates (less than 12 months) and place at the front of the shelf  Return excess stock to hospital or medical stores as soon as you are aware of it

21. Summary  Ensuring a secure, uninterrupted drug supply is essential to an effective National TB Control Program  Staff at all levels can positively impact the national drug supply through: Appropriate use of TB medications Trouble-shooting supply problems Ensuring that guidelines for management of anti-TB drugs are fully implemented