Transcript Slide 1

Standard Operating Procedures
(SOP) for ARV Drug Management
at Health Facilities
HIV Care and ART: A Course for
Pharmacists
Learning Objectives
 Describe the forms for recording ARV drug
transactions
 Identify the procedures for recording and filing
confidential patient information
 Illustrate mechanisms for avoiding wastage and
establishing efficient inventory systems
 Determine methods of tracing patients to ensure
and support ART adherence
 Describe methods of compiling and preparing
monthly pharmacy ART activity reports
2
What are Standard
Operating Procedures?
 SOP are a written specification of what should
be done and when, where, and by whom
 Documentation of the procedures for each activity a
pharmacist performs
 What is the purpose of SOP?
 Ensures that operations are carried out correctly and
always in the same manner
3
Benefits of SOP
 Helps assure quality of service and the
achievement of good practices at all times
 Enables pharmacists to delegate responsibilities
 Avoids confusions over who does what (role
clarification)
 Source of advise and guidance for staff
 Serves as tool for training new staff member
 Contributes to the audit process
4
SOP/DMIS for ARV Drugs
Management in Ethiopia
 Assessment findings from different regions
indicated poor overall pharmaceuticals
management at health facilities:
 Non-uniform procedures between health facilities
 Non-standardized DMIS formats for recording drug
transactions
 Irregular and non-uniform reporting system
 Poor mechanisms for inventory tracking and stock
monitoring
5
SOP/DMIS in Ethiopia (2)
 SOP for ARV Drug Management was developed
to meet the needs identified in the assessment
 The new ARV Drug MIS is:





Simple and user friendly
Built on existing systems whenever possible
Avoids duplication of information
Captures only relevant information
Generates powerful information for decision-making
purposes
6
ARV Drug Management
Information System at Health
Facilities:
DMIS Formats and Main
Procedures
Instructions
 When entering data write neatly and legibly
 Do not delete entries. If a mistake is made, cross
the mistake out with one line and put your initials
next to it
 E.g. Outpatient pharmacy Inpatient pharmacy
BM
 Follow the rows strictly to avoid confusion
 All information required in a form should be
completed
 If the form is to be completed by multiple people,
complete your portion thoroughly
8
Instructions (2)
 After recording all the necessary data into a
form, file it properly as described in the manual*
 Confidential forms should be kept in a secure
place
 Ensure an adequate supply of all forms, at all
times
* Standard Operating Procedures for ARV Drugs
Management at Health Facilities, Forms and
Guidelines, DACA and MSH/RPM Plus, 2004.
9
Ordering and Receiving Form
(ARV/ORF-04)
 Definition:
 Ordering and Receiving Form is a serially numbered
triplicate form which is used for ordering, supplying
and receiving ARV drugs
 Purpose:
• To order and receive ARV drugs from suppliers and the
main store within health facilities
10
11
Ordering and Receiving Form (2)
 Rationale:
 Different health facilities use different ordering and
receiving forms
• Government health facilities under MOH use
Model 22 and Model 19 for issuing and receiving
• Other Government health facilities (e.g. Police
Hospital) use their own legally approved forms
(Models)
• Standardized and uniform system is required
 Ordering and Receiving Form is designed to
standardize procedures for ordering and receiving
ARV drugs
12
Ordering and Receiving Form (3)
 Advantages:
 The names of the drugs are pre-printed
• The requesting, supplying and receiving parties will
only need to enter the figures
 The request, supply and receipt information are all
summarized into one single sheet
• Provides an overview of what has happened with one
glance
13
Ordering and Receiving Form (4)
 Completing Form:
 Items Ordered section - to be filled by the requesting
party
 Items Supplied section - to be filled by the supplying
party
 Items Received section - to be filled by the receiving
party
 The Delivery Mode refers to how the supply is
delivered
• Completed as either delivered or collected
14
Ordering and Receiving Form (5)
 Filing Form
 The form is prepared in three copies and therefore a
copy of the form is to be filed by:
• Main store manager of the health facility
• Supplier or receiver
• Supplier - for transactions outside the health facility
• Receiver - for transactions within the health facility
• Accounting section
15
ARV Drugs and Patient
Information Sheet (ARV/PIS-04)
 Definition:
 A single copy form that is used to record and track HIV patientdrug related information
 Purpose:
 Serves as a data base for each patient receiving ARV drugs
• Contains socio-demographic, clinical, medication and other
related information
 Therefore used:
• As a major source of information about HIV patients at the
dispensary
• For follow-up of ADR, side effects, drug-drug and drugdisease interactions, adherence, treatment failure, patterns of
drug/regimen used, regimen switching, and other patient
specific encounters
16
17
ARV Drugs and Patient
Information Sheet (2)
 Rationale:
 Currently pharmacists are not responsible for
following and maintaining patient information on side
effects and treatment outcomes
 There is no system to assist a pharmacist in:
•
•
•
•
Contributing within the health care team
Assisting patients with drug related problems
Helping patients enhance adherence to treatment
Tracking patients who fail to collect refills
18
ARV Drugs and Patient
Information Sheet (3)
 Completing Form:
 Filled by pharmacy personnel when dispensing ARV
drugs
 Three major information sections
• Patient
• Clinical
• Drug Dispensing
19
ARV Drugs and Patient
Information Sheet (4)
 Patient Information:
 Date eligible: date patient was eligible to start ART
 PEP: patient receiving ARVs as post-exposure
prophylaxis
 Emergency: patient that is not client of the facility, but
given ARV drugs to avoid treatment interruptions
 Transfer in: patients who have been referred from
other health facilities
 PMTCT Plus: mothers and their close family members
who are preferentially eligible to receive ART in the
course of PMTCT
20
ARV Drugs and Patient
Information Sheet (5)
 Clinical Information:
 Current Status:
• On active treatment: taking their ARV drugs currently on a
regular basis
• Transfer out: have been referred to other health facilities
• Stopped by physician: stopped taking their regular ARV
drugs by order of physician
• Lost to follow-up: disappeared for unknown reason
 History of ADR or Side Effects:
• Date: date ADR or side effect was been observed
• Description: short description of the ADR or side effect
21
ARV Drugs and Patient
Information Sheet (6)
 Clinical Information (cont):
 Concomitant Diseases:
• Date: date disease started (onset of the disease)
• Description: short description of the disease
 Reason for Change in Regimen:
• Date: date regimen was changed
• Description: short description of the reason regimen
was changed
22
ARV Drugs and Patient
Information Sheet (7)
 Drug Dispensing Information
 Reason for visit:
• Start: patient beginning ARVs for the first time
• Refill: patient on ART and getting subsequent doses
• Switch: patient who is changing their previous regimen
for physician-approved reasons
 In/Out Patient (I/O): inpatient = ‘I’ outpatient = ‘O’
 Drug Name: abbreviated name of drug e.g. ZDV, 3TC
23
ARV Drugs and Patient
Information Sheet (8)
 Drug Dispensing Information (cont):
 INH Prophylaxis: patient taking isoniazid for TB
prophylaxis
 Cotrimox. Prophylaxis: patient taking cotrimoxazole
for prophylactic treatment
 Other Drugs: patient taking drugs other than ARVs
 Date of Next Visit: deadline for next patient visit
24
ARV Drugs Dispensing Register
(ARV/DDR-04)
 ARV Drugs Dispensing Register is a registry
book for compiling key patient data and
quantities of ARV drugs dispensed to these
patients
 Used for monitoring drug consumption and use
25
26
27
ARV Drugs Dispensing Register (2)
 Completing Form:
 Form may be completed by pharmacy assistant, data
clerk or any other trained personnel
 Personnel completing form must understand
confidentiality
 Should be completed immediately after dispensing, or
at the end of the day, if necessary
 Information obtained from the ARV Drugs and Patient
Information Sheet
28
Monthly ARV Drugs Dispensing and
Consumption Summary (ARV/MCS-04)
 Monthly ARV Drugs Dispensing and
Consumption Summary is a single copy form
kept at the pharmacy
 Main source of information for decision making
and reporting
 Information is drawn from the ARV Drugs
Dispensing Register
 Provides an overview of the development of
drug consumption and patient parameters over
time
29
30
Monthly ARV Drugs Dispensing and
Consumption Summary (2)
 Rationale:
 Records at the pharmacy are not usually used for
decision making purposes
 Individuals recording the information do not know
what to do with the data in the end
• Leads to recording fatigue and lack of motivation
 Ultimately, all the effort and time spent to record and
compile the data is wasted if not used
31
Monthly ARV Drugs Dispensing and
Consumption Summary (3)
 Completed monthly by the pharmacy personnel
in charge of dispensing
 Columns are identical to the ARV Drugs
Dispensing Register. Sums may be transferred
directly
 Should be filed with the ARV Drugs Dispensing
Register
32
Monthly ARV Drugs Pharmacy
Activity Report (ARV/MAR-04)
 Two page form for monthly reporting of
pharmacy activities related to ART
 Used for reporting to the concerned authority
•
•
•
•
•
Services provided
Characteristics of the patients served
Quantities and values of ARV drugs consumed
Current stock status
Constraints faced and supports needed, etc
33
34
Monthly ARV Drugs Pharmacy
Activity Report (2)
 Rationale:
 Every department in a health facility reports in some
way to higher authorities, though not regularly
 Poor quality reports will bias decisions
 Useful reports should include:
• Accurate information to help program managers/higher
authorities make appropriate decisions
• A feedback process that allows those receiving the
report to comment regularly
35
Monthly ARV Drugs Pharmacy
Activity Report (3)
 Should be completed monthly by the head of the
pharmacy department
 Information is collected from main, outpatient
and inpatient pharmacies
 Raw totals from the Monthly ARV Drugs Dispensing
and Consumption Summary
 Other information is available on the different forms
36
Monthly ARV Drugs Pharmacy
Activity Report (4)
 Completing the Form:
 PEP: Individuals taking ARV drugs for post exposure prophylaxis
 Drugs Issued for:
 Emergency:
• Patients who have forgotten their ARVs
 Return to supplier:
• Quantity of drugs returned to the supplier due to damage,
expiry, etc
 Transfer to other facilities:
• Quantity of drugs transferred to other health facilities
37
Monthly ARV Drugs Pharmacy
Activity Report (5)
 Completing the Form (cont):
 Date audited: Date auditing or internal monitoring was
done
 Supports needed: Supports pharmacy department
needs in order to improve service
 Filing the Form:
• One copy filed by head of the pharmacy department
• One copy sent to the higher bodies listed on the bottom
right position of the first page of the form
38
Patient Tracking Chart (ARV/PTC-04)
 Single copy chart used for tracing patients that
are not adhering to their refill dates
 Pharmacists can help patients adhere through
regularly following patient refill dates and
alerting them to take their refills on time
 Patients who fail to collect their drugs on time
are not adherent, and should be referred to the
ART team for adherence counseling
39
40
Patient Tracking Chart (2)
 Completed by the dispensing pharmacist
immediately after dispensing
 Patients are listed according to date of next visit
 Dispenser compares the patients who visited the
pharmacy to the list of patients who were
scheduled for a visit
 Patients who did not show up are traced in
collaboration with other ART team members
41
Expiry Date Tracking Chart
(ARV/ETC-04)
 Single copy sheet used for monitoring expiry
dates
 Helps pharmacist track endangered ARV drugs
in order to take appropriate action before
expiration
 Avoids unnecessary wastage of drugs, and
helps make all essential drugs available at all
times in adequate quantities
 Should be completed by store manager
immediately after receiving drugs from supplier
42
43
Expiry Date Tracking Chart (2)
 Completing the Form:
 Each product has space to list three different
batches/lots of drugs (if more than three, record those
that expire first)
 Quantity on hand at the end of the month can be
written in cells under the appropriate months
44
Expiry Date Tracking Chart (3)
 Completing the From (cont):
 Yellow stickers mark the expiry warning date and alert
the store manager
 Red stickers mark the actual month when each
batch/lot of drugs will expire
 Put the yellow sticker in the grid which corresponds to
6 months before the expiry date
 Put the red sticker on the date which the product
expires
45
Expiry Date Tracking Chart (4)
 Each month, enter the current stock level of
each batch/lot
 Stock levels show rate of use and determine
how much stock to return or exchange
 When the batch expires or is used up, erase the
entry and replace with the next batch to expire
46
Expiry Date Tracking Chart (5)
 If a drug expires after the three years covered in
the chart, record the drug in the chart, but do not
include stickers
 When updating the chart at the beginning of the
new year, if the drug is still in stock and expires
within the three years, add the stickers
accordingly
 To reduce the number of entries, make two
separate charts for liquid (e.g. syrups) and solid
(e.g. tablets/capsules) dosage forms
47
ARV Drugs Pharmacy Internal
Monitoring Form (ARV/IMF-04)
 An auditing form used for monitoring pharmacy
ART activities
 Auditing and monitoring allows early detection of
problems and deficiencies
 Monitoring activities using selective indicators
helps improve performance
 Many health facilities do not carry out auditing
on a regular basis
48
ARV Drugs Pharmacy Internal
Monitoring Form (2)
 Completing the Form
 Form should be completed monthly by a
committee assigned by the health facility
 Committee should be composed of ART team
members
 Internal monitoring committee should file form
and follow-up problem areas
49
ARV Drugs Pharmacy Internal Monitoring
Feedback Report (ARV/MFR-04)
 A single copy form summarizing the key findings
obtained from the internal monitoring done immediately
after completion of internal monitoring activities
 Used for reporting to project managers in order to
facilitate remedial measures
 Should be completed by the monitoring committee by
identifying the key issues in the Internal Monitoring Form
 Filed with the Internal Monitoring Feedback Form
50
Key Indicators for Monitoring
 Adherence to standard prescribing and
dispensing guidelines






Eligibility of clients
Authorization of prescriptions
Patient adherence to treatment
Completeness of prescription writing
Recording in the ARV/PIS-04
Transfer of information from ARV/PIS-04 to
ARV/DDR-04
 Recording in the ARV/DDR-04
 Transfer of information from ARV/DDR to ARV/MCS
51
Key Indicators for Monitoring (2)
 Inventory management at the main and
outpatient pharmacy stores







Accuracy of bin card balances
Stock count discrepancy in the bin card
Agreement of records in the bin and stock cards
Adherence to correct arrangement of stock
Adherence to expiry date monitoring procedures
Stock count discrepancy in the stock movement card
Agreement of records in the bin and stock movement
cards
52
Key Indicators for Monitoring (3)
 Temperature control




To monitoring in the main store
To monitoring in the outpatient pharmacy
To monitoring of the refrigerator at the main store
To monitoring of the refrigerator at the out patient
pharmacy
53
Additional Forms
1. Receiving Discrepancy Reporting Form (ARV/RDR-04)
 Replaces Receiving and Inspection Report (RIR) currently in
place
 Used only in cases where discrepancies are encountered during
receiving
2. Stock Card and Bin Card
 To be used at the main store – familiar formats
3. Stock Movement Card
 Serves the same purpose as bin cards with additional
relevant/useful information
 Filled in single units at the end of each day
54
Additional Forms (2)
4. ARV Drug Dispensing Register for Post Exposure
Prophylaxis
 Used to record drugs issued for the purpose of post exposure
prophylaxis
 Expected to be placed in the inpatient pharmacy where there is
24 hour service
5. ARV Drug Dispensing Register for Emergency Supply
 Used to record drugs issued for the purpose of emergency
supplies
 Expected to be placed in the inpatient pharmacy where there is
24 hour service
55
Additional Forms (3)
6. Expiry and Damage Inventory Sheet
 Used for recording expired and damaged items until
they are disposed of
 Unusable items will be deleted from bin and stock
cards, and temporarily recorded on this sheet
7. Temperature Recording Chart
 Used for twice daily temperature monitoring at the
main store, outpatient dispensary and refrigerators
56
Additional Forms (4)
8. Prescription Paper
 The only legal prescription paper designed and
approved by DACA for prescribing ARV drugs
 Serially numbered and to be audited like the drug
itself
57
Management Information System
Prescriptio
n
Patient Treatment Card
(Patient Passport)
Patient
ARV Drugs and Patient Information Sheet
ARV Drugs Dispensing Register
Monthly ARV Drugs Dispensing
and Consumption Summary
Monthly ARV Drugs
Pharmacy Activity
Report
58
Key Points
 Recording information is required for different
management functions, including M&E
 Information is needed at every organizational
level, though the type and purpose of
information at each level may differ
 An effective DMIS is much more than just a
reporting system
 Supports the information needs of the pharmacist at
the service delivery point
 Can be used to communicate information to higher
levels
59
Key Points (2)
 Many types of ARV drug management problems
can be resolved through the use of an effective
DMIS
 A DMIS includes instruments and procedures for
recording client/patient profiles and other data
from routine activities
 All levels of the pharmaceutical management
system are interdependent when it comes to
collecting and using data
60
Practicum
Instructions to the Practical Session
 The materials distributed to each group include
the following items:
1. Prescriptions
2. ARV Drugs and Patient Information Sheet
3. ARV Drugs Dispensing Register
4. ARV Drugs Dispensing and Consumption Summary
5. ARV Drugs Monthly ARV Activity Reports
6. Ordering and Receiving Form (pre-filled)
 Each group is expected to produce a monthly
report
62
Instructions to the Practical Session (2)
 The practical section will incorporate the following key
activities covered during discussion on SOP/DMIS:
 Recording patient information into ARV Drugs and
Patient Information Sheet
 Transferring entries from ARV Drugs and Patient
Information Sheet into ARV Drugs Dispensing Register
 Transferring entries from ARV Drugs Dispensing
Register into Monthly ARV Drugs Dispensing and
Consumption Summary
 Preparing Pharmacy Monthly ARV Drugs Activity Report
63