2. Management of Medicines and Pharmaceutical Supplies for use in the prevention and treatment of Pre-eclampsia and Eclampsia
Grace Adeya, SPS/MSH
February 23, 2011

3. Why Consider Medicine and Pharmaceutical Supplies Management Issues?
Uterotonics Supply Management Cycle
Why Consider Medicine and Pharmaceutical Supplies Management Issues?
Effective management of PE/E helps ensure that medicines and supplies are on hand for immediate administration.
Effective management requires careful product selection, procurement, storage, distribution, and use.
PE/E medicines are in many countries part of the national pharmaceutical supply system
Subject to the same structural, financial and human resource constraints as all products that rely on this supply system
The pharmaceutical management cycle summarizes these requirements

4. Pharmaceutical Management Cycle
Uterotonics Supply Management Cycle
Pharmaceutical Management Cycle
I will summarize key elements to consider when thinking about the management of the medicines and supplies for the management of PE/E and other obstetric conditions using the the pharm management cycle and drawing on some examples from a couple of assessment we have done in DRC and in Mali

5. Uterotonics Supply Management Cycle
Selection
Build consensus on protocol for PE/E with committee of experts and consult best practices
Use the following selection criteria
At what level of health system? Who will use them?
Types of medicines? First-line medicine?
Cost
Safety and efficacy
Quality and stability (storage conditions)
Availability for procurement
Registered for use in country?
Include selected PE/E in national essential medicines list (EML) and standard treatment guidelines (STGs)
First element for consideration is selection – which was the subject of discussion during some of the sessions yesterday. Th
The committee of experts should be composed of experienced clinicians, including OB/GYN specialists, midwives, pharmacists, policy makers from MoH, community representatives etc. This committee should consult international and regional reference materials for best practices.
This committee should draft a proposal of what should be included in STGs and protocol of how to manage PPH, such as AMTSL.
The committee needs to take into consideration all of the criteria listed here; many of them are interrelated. With respect to the first bullet, the committee should decide which uterotonics should be/need to be available at each level of the health system; this also depends on the skills and human resources available in the country at each level. Along these lines, the number of medicines required needs to be considered. Is the same medicine appropriate for each level, or do different levels require different medicines? How will the number of medicines affect the cost of implementing AMTSL at the different levels? The budget available might influence the uterotonic selected.
A review of some countries showed that although uterotonics are available, they are not included in the national STGs and EMLs; the implication is that they are not purchased with national funds.

6. Selection: Who is making the purchasing decisions at the health facility level?
DRC (N = 30)
Mali (N=100)
Background of personnel managing medicines at health facility level
7 % pharmacy technicians
80% Nurses
18% - pharmacists
3% - pharmacy technicians
4.8% - matron/nurse/midwife
22% - no training
Percentage of respondents trained in the management of uterotonic / PE/E medicines
27%
21%
Proportion of Facilities with a copy of the NEML 0%
45%
Percentage of respondents who know MgSO4 is in the NEML
41%
28%
Percentage of respondents who know Oxytocin is in the NEML
90%
65%
Percentage of respondents who know Calcium Gluconate is in the NEML
14% 2%
Percentage of respondents who know Diazepam is in the NEML
37.3%
15%
Having the an up to date NEML is only the first step; those who have to make the purchasing / procurement decisions at the health facilities or peripheral level stores need to be know that the desired products are on the EML
Table summarizes some of the findings from the assessments.
Note variability in the qualifications of those who manage medicines. This is not an unusual occurrence and it has been my experience that there is no consistency across countries on who is selected to perform this role
Mali: 10% of Respondents had only primary level education; only 30% had above secondary education.
It is clear that there is a real difference in the awareness of oxytocin vs the awareness of products for PE/E

7. Uterotonics Supply Management Cycle
Procurement
Quantity needed
Cost
Quality: packaging, cold chain
Shelf life
Supplier performance
Management information system (MIS) to monitor consumption
Medical Supplies e.g. BP machines
Once the required products are on the STG and EML, the next step is their procurement
Appropriate quantification is crucial for the PE/E medicines given the multiple indications of the antihypertensives and anticonvulsants. Quantification of MgSO4 is also challenging given that in many situations we are trying to introduce the product or scale up its current use.
The correct quantities are obtainable only with reliable, accurate data. Incorrect quantities lead to stock-outs and wastage.
It is essential that every health care provider contributes to maintaining available information accurate: for example, when the drugs are used, it is important to register this use.
Each set of data will provide different levels of accuracy, so it is important to consider several and evaluate before deciding on the quantity to be purchased.
Some useful tools for this purpose are available. Quantimed is a tool for quantification; inventory tracking tool helps to generate accurate information.
Supply data: stock cards; patient medication records
When considering the costs of the products to procure, hidden costs need to be considered. Hidden costs may be related to early expiry and disintegration of drugs, air freight for late delivery, inaccurate packing, losses due to poor packaging.
It is important to remember that quality has a cost and adds value to the medicine.
Packaging needs to withstand the challenges of transport (waterproof, opaque, insulation).
Procurement contract should include requirement for minimum shelf life of two to three years when received in country.
Supplier performance should be considered; for example, a supplier’s past performance, references or possible WHO prequalification.
MIS: inventory tracking systems essential for future procurement.

8. Procurement: Staff knowledge and use of essential data for quantification of requirements
DRC (N = 30)
Mali (N=100)
Knowledge of the stock on hand
70%
58%
Knowledge of the quantity dispensed per day
53% 5%
Knowledge of the facility’s consumption for one month
47% 4%
Knowledge of when and how the medicines were used
33% 7%
Ability to use the recorded data for retrospective analysis
10%
During the assessments, we tried to evaluate the knowledge of the respondents on the recording and use of data that is essential for quantification
The results from the mali assessment clearly demonstrate the inability of the staff to maintain and utilise the data they have to estimate their medicine requirements effectively. This without doubt will have real implications on the availability of the products and points to a real need for a review of the basic educational requirements of the staff, and capacity building on pharmaceutical management.

9. Uterotonics Supply Management Cycle
The Procurement Cycle
The key points that we will address are determining quantities and reconciling needs and funds.

10. Selection: Cost and Product versatility issues
Year
Product Name
 2007
 2008
 2009
Average
Diazepam 5 mg/ml (general anticonvulsant/antiepileptic; generalized anxiety; pre-operative)
Average of Supplier (US$) $ $
Average of Buyer (US$) $ $
Magnesium Sulfate 500 mg/ml (PE/E anticonvulsant ) $ $
Additional Thoughts:
Diazepam: Will continue to be available at the health facilities – mulitple indications; cheaper; familiarity
MgSO4: single use; costlier; unfamiliar;
Source: MSH International Drug Price Indicator Guide

11. Distribution and Inventory Management
Uterotonics Supply Management Cycle
Distribution and Inventory Management
Effects of heat and light
Cold chain equipment and transportation
Cold box or packs
Refrigerators
Excursion?
Inventory monitoring system
Stock cards and registers
Distribution network and transportation
Vertical vs. Integrated (How do PE/E products fit into overall supply system?)
Delivery kit system?
Non-facility locations
Key challenge: Systemic Resource based related to buildings, equipment, transportation
These may be some of the more entrenched gaps and interventions are primarily long-term.

12. Distribution: Storage Conditions
DRC
(N = 30)
Mali
(N=60)
Stock/storage location is secure (locked door, wire mesh on the windows, locked cabinets)
83%
87%
Storage location is visibly free of harmful insects and rodents
Products are arranged well on shelves or pallets
78%
92%
Products are arranged so that identification labels and expiration or manufacture dates are visible
67%
82%
Products are stored and organized according to expiration dates (FEFO)
85%
Boxes and products are in good condition
94%
Boxes and products are protected from water and moisture
80%
Products are protected from direct light and sun at all times
88%
The store has operational refrigerators
28%
43%
The temperature of the cold chain is recorded and monitored regularly 0% 7%
Temperatures of the cold chain are between 2°C and 8°C 3%
From the assessments: Except for the issues around cold chain management, which are more of a challenge for the storage of oxytocin and ergometrine, storage conditions were generally good.
This is not always the case in all countries

13. Uterotonics Supply Management Cycle
Use
Policy: Who is allowed to prescribe MgSO4?
Training in PE/E management: What skills are needed?
Service delivery protocols
Indications
Dose
Contraindications
Management of side effects
Skilled birth attendants
Client counseling
Adverse drug reaction monitoring
Injectables therefore limited ranks of those who can provide
Most countries limit use of MgSO4 to hospitals or higher level health centers, so at lower levels they are limited to diazepam or to referral without medicine. This evidently needs to change.
Use of MgSo4 should be included in preservice training, in-service training, and continuing education programs.
In many countries over half of deliveries occur outside of health facilities. How can the health system support them? And if thinking about community distribution, what impact on the type of products and formulations used? What about private sector health facilities
Adverse drug monitoring by health staff -

14. USE: Respondents Knowledge of Recommended Treatment
DRC (N = 30)
Mali (N=100)
Percentage of respondents who know Oxytocin is the recommended medicine for the practice of AMSTL
90%
56%
Percentage of respondents who know MgSO4 is the recommended medicine for the management of PE/E 8%
23%
Again highlighting the gap in knowledge and therefore use of MgSO4

15. USE: Product Availability
Medicines Available
DRC
(n = 18)
Mali
(n = 60)
Oxytocin 5 IU/ml ampoule -
46%
Oxytocin 10 IU/ml ampoule
78%
34%
Magnesium sulfate 4 g ampoule
11%
10%
Magnesium sulfate 2 g ampoule 9%
Calcium gluconate 10 mg ampoule
22%
15%
Diazepam 10mg inj
56%

16. Uterotonics Supply Management Cycle
Management Support
Standard Operating Procedures
Financing
Information management (MIS)
Human resources
Preservice education
Continuing education
In-service education
Monitoring and supervision
SOPs should be written for procurement, dispensing, and use of uterotonics. They should be part of the overall pharmaceutical management system.
Uterotonics should be included in EMLs and therefore budgeted for using national funds.
MIS does not necessarily have to be computerized. People who contribute data to the system should get feedback on how the information was used. MIS should be relevant to the information needs. (Don’t collect more information than you are really going to use!)
Program managers should visit and support pharmacy services.

17. Management Support: Advocacy for Maternal Health:
Maternal health issues should always be included among the health priorities.
Are maternal health program personnel at the table when decisions are being made on priorities for procurement
Forum for improved and regular communication between doctors, midwives and pharmacists e.g Drug and Therapeutics Committees
Improved selection, quantification and ordering of uterotonics
Clarification of roles and responsibilities of pharmacy, delivery room and recovery ward personnel

18. Policy and Legal Framework
Uterotonics Supply Management Cycle
Policy and Legal Framework
EML and STG
Registration issues
Importation
Centralized vs. decentralized; vertical vs. integrated programs
Financing mechanisms: cost recovery, cost sharing, insurance
Pharmacovigilance
PE/E service delivery protocols
Human resources: who is authorized to prescribe and dispense?
Most of these issues have already been discussed. In each step of the PM cycle, there are policy issues that need to be considered.
Drug Registration: New formulations or New suppliers required to register their product
MgS04 is a relatively cheap generic product – is it worth their while to go through the registration process?
Financing mechanisms – impact of cost recovery schemes where they pay for the financing of the health facility operations; what impact on the cost to the end-users of the products;

19. Thank you