HIV Care and ART: A Course for Pharmacists

HIV Care and ART: A Course for Pharmacists
Standard Operating Procedures (SOP) for ARV Drug Management at Health Facilities HIV Care and ART: A Course for Pharmacists This unit should take approximately 1 hour and 40 minutes to complete and half a day for the practicum session Step 1: Unit Introduction and Learning Objectives (Slide 2) – 5 minutes Step 2: Standard Operating Procedures for ARV Drug Management at Health Facilities - (Slides 3-58) – 1 hour and 30 minutes Step 3: Discussion of Key Points (Slides 59-60) – 5 minutes Step 4: Practicum (Slides 61-63) – half a day

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 Step 1: Unit Introduction and Learning Objectives (Slide 2) – 5 minutes

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 Step 2: Standard Operating Procedures for ARV Drug Management at Health Facilities - (Slides 3-58) – 1 hour and 30 minutes For all jobs and duties, relevant operating procedures should be available at the working station.

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

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 Good inventory management: Avoid losses due to unnecessary expiry, theft, etc. Avoids stock outs at all times—very critical with ARV drugs There is a need for an effective and efficient system to monitor every step in the process. Developing and implementing SOPs for pharmaceutical practices with special emphasis to ARV drugs management and use is required.

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

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

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.

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

Refer participants to Handout 15.1

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 Models and other legally approved forms shall be used as usual in parallel to the newly developed form.

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

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 How should it be completed? Ordering and Receiving Form has three main sections: Items Ordered, Items Supplied and Items Received. All these sections are to be completed by different persons as indicated in the form. The Items Ordered section is to be completed by the requesting section that could be: The outpatient/inpatient pharmacy (for transactions with in the health facility), or The main pharmacy (for transactions outside the health facility) The Items Supplied section is to be completed by the supplying section that could be: The main store (for transactions within the health facilities), or The supplier such as PHARMID, RHB, etc (for transactions outside the health facility) The Items Received section is to be filled by the receiving section that could be: The outpatient/inpatient pharmacy for receiving from the main store with in the health facility. The main store for receiving from the supplier such as PHARMID, RHB, etc.

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

ARV Drugs and Patient Information Sheet (ARV/PIS-04)
Definition: A single copy form that is used to record and track HIV patient-drug 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 drug-disease interactions, adherence, treatment failure, patterns of drug/regimen used, regimen switching, and other patient specific encounters

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 Until recently, there was no tradition of keeping patient information in the dispensing pharmacy at all health facilities in Ethiopia. The importance of such information becomes evident when one intends to follow up a patient on a particular drug treatment. So far pharmacists are little involved in following up treatment outcomes, development of ADRs, side effects or allergies, etc which are related to the medications. An involved pharmacist assists: Patients through providing easily accessible help and advice Physicians by reducing the number of patients visiting for minor problems

Completing Form: Filled by pharmacy personnel when dispensing ARV drugs Three major information sections Patient Clinical Drug Dispensing Patient information may be collected from the: Patient card, patient, or prescription Clinical information may be collected from the: Patient’s treatment card or passport, patient, or simple observations Drug dispensing information may be collected from the: Prescription paper, patient

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

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

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

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

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 Note: the patient should come at least 2 to 3 days earlier than the deadline for their next visit. Appointment should be scheduled accordingly in consultation with ART clinicians and nurses.

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 In the current system, a prescription registration book is used for this purpose. However, it does not satisfy the information requirements of MIS for ARV drugs, and few facilities use the registration book.

ARV Drug Dispensing Register currently used

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 Finished registers should be stored for future reference

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

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

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 All drug quantities are expressed in packs of medicines or bottles for liquid preparations. Make sure that the correct pack size is indicated in the reporting form and make appropriate adjustments, if necessary.

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

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

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 All drug quantities are expressed in packs of medicines or bottles for liquid preparations. Make sure that the correct pack size is indicated in the reporting form and make appropriate adjustments, if necessary. Dispensing pharmacies should provide total number of patients: Served at the facility, Transferred out to other facility, Stopped t/t by physician, Lost for follow up, Died Main store should supply: Quantity received last month, Stock on hand, Quantity on order, Quantity damaged or expired, Quantity short dated, Number of days out of stock last month

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

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

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 The success of ART depends greatly on adherence.

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

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

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

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

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

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

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

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

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 The extensive ARV Drugs Pharmacy Internal Monitoring Form can deter concerned authorities from identifying problem areas. Therefore the internal monitoring committee should be able to summarize the key deficiencies and problem areas that need the attention of higher authorities. The summary of the findings of the internal monitoring will then be presented at a meeting with the program managers so that remedial measures will be taken by these higher authorities.

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 Refer the manual: ‘Standard Operating Procedures for ARV Drugs Management at Health Facilities, Forms and Guidelines, DACA and MSH/RPM Plus, 2004’ for detailed explanation of each indicator.

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

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

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

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

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

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

Management Information System
Patient Treatment Card (Patient Passport) Prescription Patient ARV Drugs and Patient Information Sheet ARV Drugs Dispensing Register Monthly ARV Drugs Dispensing and Consumption Summary Monthly ARV Drugs Pharmacy Activity Report

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 Step 3: Discussion of Key Points (Slides 59-60) – 5 minutes

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

Practicum Step 4: Practicum (Slides 61-63) – half a day
The trainer is expected to prepare the following before conducting the training. Prescription: Prepare at least 10 sample prescriptions. The prescriptions should be complete and can be a hypothetical prescription or copied from already existing prescriptions at health facilities. The prescription should include all components of the clinical information as an additional note so that trainees would exercise entering such types of information into the ARV Drugs and Patient Information Sheet. The prescription should include all types of possible encounters in real settings. At least one of the prescriptions should be for a refill case so that trainees could be aware of recording information in to the ARV Drugs and Patient Information Sheet for refill patients. ARV Drugs and Patient Information Sheet The number of ARV Drugs and Patient Information Sheets should correspond with the number of patients (not with the number of prescriptions). When grouping participants, the number of each group should be in such a way that one participant would fill at least 2 ARV Drugs and Patient Information Sheet. ARV Drugs Dispensing Register Prepare at least one copy of ARV Drugs Dispensing Register per group (preferably one extra) ARV Drugs Dispensing and Consumption Summary ARV Drugs Monthly Pharmacy Activity Report Prepare at least one copy of ARV Drugs Monthly Pharmacy Activity Report per group (preferably one extra) Ordering and Receiving Form Prepare on Ordering and Receiving Form into which is entered hypothetical (real) data ordered and received at the beginning of the month and which trainees would consider the data as their beginning stock/beginning balance. Instruct participants to generate a monthly report.

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 Important: This exercise takes half a day The trainer is expected to prepare the items described above beforehand. Group participants into convenient size Distribute the above items and inform participants what has been distributed to them Ask members of each group to check that they have received all the items listed above Instruct trainees to generate a monthly report

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 To the trainer: Describe them briefly how the trainees should go about executing each activities Instruct each group to produce a monthly report making sure that all steps has been followed Discuss the results of the monthly report The results of each group should be compared with the results of the trainer (that has been worked out beforehand) Discrepancies should be thoroughly discussed and errors should be identified if any. At the end of the practical session, a group debrief should be conducted, going over the monthly reports that participants have generated. Ask participants if they have any final question regarding any of the forms, the monthly report, and this unit.

HIV Care and ART: A Course for Pharmacists

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