SOPs for various activities in Community Pharmacy (as discussed in Theory and Practical)

OVERVIEW OF STANDARD OPERATING PROCEDURES (SOPs)

A standard Operating procedure is a document which describes the regularly recurring operations relevant to the quality of service being rendered. The purpose of an SOPs is to carry out the operations correctly and always in the same manner. It should be available at the place where the work is done. An SOPs is a compulsory instruction. All changes in the instructions must be documented and reported to the authorities who are the only ones to authenticate and approve such variations.

OBJECTIVES OF DEVELOPMENT OF SOPs

The development of Standard Operating Procedures (SOPs) serves several crucial objectives across various domains, including industries, healthcare, research, and more. Here are some of the key objectives:

1. Consistency: SOPs ensure consistency in operations and processes within an organization. By providing standardized procedures, SOPs help maintain uniformity in the execution of tasks, reducing errors and variations.
2. Quality Assurance: SOPs outline best practices and quality standards that must be followed to achieve desired outcomes. They help maintain and improve product or service quality by ensuring that all tasks are performed to specified standards.
3. Compliance: SOPs help organizations comply with regulatory requirements and industry standards. By documenting procedures and guidelines, SOPs ensure that operations are conducted in accordance with legal and regulatory frameworks, reducing the risk of non-compliance and potential penalties.
4. Training and Onboarding: SOPs serve as valuable training materials for new employees. They provide a structured guide for employees to learn about their roles, responsibilities, and the standard procedures they need to follow to perform their tasks effectively.
5. Risk Management: SOPs help identify and mitigate risks associated with various processes and operations. By outlining safety protocols, emergency procedures, and risk mitigation strategies, SOPs contribute to the overall risk management efforts of an organization.
6. Efficiency and Productivity: SOPs streamline workflows and eliminate redundant or unnecessary steps, thereby improving operational efficiency and productivity. By providing clear guidelines and expectations, SOPs enable employees to perform tasks more effectively and minimize wasted time and resources.
7. Continuous Improvement: SOPs serve as a reference point for evaluating existing processes and identifying areas for improvement. By regularly reviewing and updating SOPs based on feedback, new insights, and changing requirements, organizations can continuously optimize their operations and adapt to evolving circumstances.
8. Communication and Collaboration: SOPs facilitate effective communication and collaboration among team members by providing a common framework and understanding of how tasks and processes should be performed. They help align individuals and teams towards common goals and objectives.

Areas covered by this SOPs include

Standard Operating Procedures (SOPs) can cover a wide range of areas within an organization. The specific areas covered by SOPs may vary depending on the nature of the organization, its industry, and its operations. However, here are some common areas that are typically addressed by SOPs:

1. SOPs for Drug Lists
2. SOPs for Procurement of Medicines
3. SOPs for Receiving Drugs into Pharmacy
4. SOPs for Drug Storage
5. SOPs for Vaccine Storage
6. SOPs for Temperature Control
7. SOPs for Issue and Delivery of Drugs to Dispensary/Satellite
8. Pharmacies/Wards /Other Units
9. SOPs for Dispensing /UDDS
10. SOPs for Patients Counseling
11. SOPs for Counseling of Handicapped Patients
12. SOPs for Compounding of Medicines
13. SOPs for Procurement, Dispensing and Distribution of Narcotic Drugs and
    Poisons.
14. SOPs for Disposal of Expired Drugs
15. SOPs for Clinical Ward Round
16. SOPs for Training of Intern Pharmacists
17. SOPs for Continuing Education
18. SOPs for Drug Revolving Fund (DRF) Scheme
19. SOPs for Drug Information Service (DIS)/Drug Information Center (DIC).
20. SOPs for Dress Code
21. SOPs for Therapeutic Drug Monitoring(TDM)
22. SOPs for Screening Prescriptions
23. SOPs for Preparing a Drug Formulary.

SOPs FOR DRUG LISTS

1. Prepare an advocacy plan for the SOP
2. Write a proposal to management for setting up of drug and therapeutic committee in line with requirements prescribed by the National Drug Policy.
3. Identify different categories of drugs required by the health facility based on the national essential drug list (EDL) / National Standard Treatment Guideline (NSTGs).
4. Draw up list using generic and international non-proprietary name (INN) of the drug.
5. Obtain approval for the management of the facility
6. Circulate approved list to stake holders within the facility.
7. Ensure strict compliance to the use of the ELD.

SOPs FOR PROCUREMENT MEDICINES/ CONSUMABLES

1. Prepare an advocacy plan for the sop
2. Confirm the availability of funds
3. Match needs with available funds
4. Identify and verify the suppliers
5. Qualify suppliers
6. Choose method of procurement
7. Prepare an order form
8. Contact suppliers to quote the returns and complete the form
9. State the date of submission of the tender document
10. Organize public bid openings and record proceedings
11. Conduct evaluations
12. Submit recommendations to tender committee for approval of awards
13. Forward copies of award document to the store and finance departments
14. Facilitate the signing of contract agreements
15. Monitor suppliers performance and sanction defaulters
16. Receive and store drugs
17. Facilitate prompt payment to suppliers
18. Commence preparation for next procurement cycle
19. Provide the names and strength of each drug in the following order: Name (generic), strength and form, e.g.
20. Provide a column for the expiry date of drug
21. Provide a column for the price of each item and a column for the total price
22. Provide a space for the name of the company, giving relevant details such as address, telephone number, e-mail address, name of the contact person.

SOPs FOR RECEIVING DRUG ITEMS INTO A PHARMACY BULK STORE

Developing a Standard Operating Procedure (SOP) for receiving drug items into a pharmacy bulk store is critical to maintaining regulatory compliance, ensuring inventory accuracy, and safeguarding the quality and integrity of pharmaceutical products. Here’s an outline for such an SOP:

1. Pre-Receiving Preparation:
   • Ensure that the receiving area is clean, organized, and free from clutter.
   • Verify that the temperature and humidity levels in the receiving area are within acceptable ranges for storing pharmaceutical products.
   • Ensure that necessary receiving equipment (e.g., gloves, masks, labels, barcode scanners) are available and in good working condition.
2. Receiving Process:
   • Upon receipt of a shipment, the receiving personnel must inspect the packaging for any signs of damage, tampering, or contamination.
   • Match the received shipment with the accompanying packing slip or purchase order to verify the accuracy of the items received.
   • Use a barcode scanner or manual entry to record each received item into the inventory management system.
   • Check the expiration dates and lot numbers of each received item to ensure compliance with regulatory requirements.
   • If discrepancies are found between the shipment and the packing slip, notify the supplier and the Pharmacy Manager immediately.
3. Quality Assurance Check:
   • The Quality Assurance Officer conducts a visual inspection of the received drug items to ensure they meet quality standards.
   • Inspect packaging integrity, labeling accuracy, and overall condition of the drug items.
   • Randomly select samples for further testing or analysis if deemed necessary.
4. Storage and Documentation:
   • Store received drug items in designated storage areas according to their specific storage requirements (e.g., temperature-sensitive items).
   • Label shelves, bins, or containers with the name, strength, lot number, and expiration date of each drug item.
   • Maintain accurate and up-to-date records of received items, including quantity, lot numbers, expiration dates, and storage locations.
   • Document any discrepancies, damages, or deviations from the standard receiving process in the appropriate records and notify the Pharmacy Manager.
5. Cleanup and Post-Receiving Procedures:
   • Dispose of packaging materials and any damaged or expired drug items according to established waste disposal protocols.
   • Clean and sanitize the receiving area after each receiving session to prevent cross-contamination and ensure compliance with hygiene standards.

This SOPs provides a framework for establishing standardized procedures for receiving drug items into a pharmacy bulk store, ensuring regulatory compliance, inventory accuracy, and product quality control. Adjustments may be necessary based on the specific requirements and operational context of the pharmacy.

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SOPs For Drug Storage

Standard Operating Procedures (SOPs) for drug storage are crucial to maintaining the integrity, safety, and efficacy of pharmaceutical products within a pharmacy or healthcare facility. Here’s an outline for creating SOPs for drug storage:

1. Storage Environment:
   • Ensure that the storage area is clean, well-ventilated, and free from environmental hazards such as excessive heat, humidity, and light exposure.
   • Maintain appropriate temperature and humidity levels within the storage area as per the manufacturer’s recommendations and regulatory guidelines.
   • Regularly monitor temperature and humidity levels using calibrated monitoring devices and record the readings as per the frequency specified in the SOP.
2. Storage Conditions:
   • Segregate drugs based on their storage requirements (e.g., refrigerated, ambient, controlled substances) and store them accordingly.
   • Use designated storage shelves, cabinets, or containers for different categories of drugs to prevent cross-contamination and ensure organization.
   • Store drugs in their original packaging or containers to maintain product integrity and protect them from light, moisture, and other external factors.
   • Clearly label shelves, bins, or containers with the name, strength, lot number, and expiration date of each drug product.
3. Inventory Management:
   • Conduct regular inventory checks to monitor stock levels, expiration dates, and storage conditions of drugs.
   • Rotate stock using the first-in, first-out (FIFO) method to ensure that older inventory is used before newer stock.
   • Perform routine inspections of drug products for signs of damage, deterioration, or tampering and take appropriate action if discrepancies are detected.
   • Maintain accurate and up-to-date records of inventory transactions, including receipts, withdrawals, transfers, and returns.
4. Security and Access Control:
   • Restrict access to the drug storage area to authorized personnel only and implement appropriate security measures to prevent unauthorized entry or theft.
   • Keep all controlled substances securely locked and maintain strict adherence to regulatory requirements for handling and storing controlled substances.
   • Conduct regular audits and inspections of the drug storage area to ensure compliance with security protocols and regulatory standards.
5. Emergency Procedures:
   • Develop and document procedures for responding to emergencies such as power outages, equipment failures, or environmental disasters that may impact drug storage conditions.
   • Establish contingency plans for relocating drugs to alternative storage facilities or implementing temporary measures to maintain storage integrity during emergencies.

SOPs For Storage of Vaccines

Standard Operating Procedures (SOPs) for the storage of vaccines are essential to maintaining their potency, efficacy, and safety. Here’s a comprehensive outline for developing SOPs for vaccine storage:

1. Storage Environment:
   • Designate a dedicated vaccine storage area that meets the recommended temperature and humidity requirements specified by vaccine manufacturers and regulatory agencies.
   • Ensure that the vaccine storage area is well-ventilated, clean, and free from environmental hazards such as direct sunlight, moisture, and temperature fluctuations.
   • Install calibrated temperature monitoring devices (e.g., digital data loggers) in the vaccine storage unit to continuously monitor and record temperature levels.
2. Temperature Monitoring:
   • Perform daily temperature checks using calibrated thermometers or digital data loggers to ensure that the storage temperature remains within the recommended range for each vaccine.
   • Record temperature readings at regular intervals and maintain accurate temperature logs as per regulatory requirements.
   • Take immediate corrective action if temperature excursions or deviations from the recommended range are detected, including notifying the Vaccine Coordinator and following established protocols for temperature troubleshooting.
3. Storage Practices:
   • Store vaccines in their original packaging or containers to maintain product integrity and protect them from light exposure, moisture, and contamination.
   • Arrange vaccines on designated shelves or storage units according to their storage requirements (e.g., refrigerated, frozen, ambient).
   • Rotate vaccine stock using the first-in, first-out (FIFO) method to ensure that vaccines with the earliest expiration dates are used first.
   • Regularly inspect vaccine vials or packages for signs of damage, leakage, or expiration and remove any compromised vaccines from inventory.
4. Inventory Management:
   • Maintain accurate and up-to-date records of vaccine inventory, including quantities received, lot numbers, expiration dates, and doses administered.
   • Conduct regular inventory audits and reconciliations to ensure that vaccine stock levels are accurately accounted for and discrepancies are promptly addressed.
   • Implement secure storage measures for vaccines, including access control, inventory tracking, and documentation of vaccine movements.
5. Emergency Procedures:
   • Develop and document procedures for responding to emergencies such as power outages, equipment failures, or natural disasters that may impact vaccine storage conditions.
   • Establish contingency plans for relocating vaccines to alternative storage facilities or implementing temporary measures to maintain storage integrity during emergencies.

SOPs For Temperature Control

Standard Operating Procedures (SOPs) for temperature control are essential for maintaining the quality, safety, and efficacy of temperature-sensitive products, including pharmaceuticals, vaccines, food items, and biological materials. Here’s a comprehensive outline for developing SOPs for temperature control:

Standard temperatures Chart: Here is a standard temperature chart outlining recommended temperature ranges for various purposes, including food storage, pharmaceuticals, vaccines, and laboratory samples:

1. Room temperature 15-30⁰C
2. Cool place below 15⁰C
3. Cold place below 8⁰C
4. Refrigerator 2-8⁰C
5. Freezer -20⁰C

It’s important to note that these are general temperature guidelines, and specific products or materials may have different temperature requirements. Always refer to manufacturer guidelines, regulatory requirements, or specific storage instructions for accurate temperature recommendations. Additionally, maintaining temperature logs and regularly monitoring storage conditions are essential practices to ensure compliance and product integrity.

Full Assignment Pdf : CLICK HERE

SOPs For Dispensing

Standard Operating Procedures (SOPs) for dispensing medications are critical to ensure accuracy, safety, and consistency in pharmaceutical practices. Here’s a generalized outline of SOPs for dispensing medications:

1. Prepare advocacy plan
2. Receive read and validate the prescription
3. Introduce yourself to the patient by saying “I am a pharmacist
4. Identify the prescribers intention for the patient
5. Confirm the ownership of the prescription in order to avoid dispensing to proxy
6. Find out if the medicine and/or other required items are available in the pharmacy
7. Cost the medicines prescribed
8. Inform patient of the cost implication of their medication (conduct with the physician for reviews if the need arises).
9. Direct the patient to make necessary payments and to present the appropriate receipt confirming payment of medicines/items dispensed.
10. Select the correct medicines /items in the pharmacy and read the label on the container (and/or package) before, during and after dispensing.
11. Write the label on each medicine, giving precise direction for use.
12. Put the medicine in the dispensing vial and place the label on the vial
13. Check the dispensed medicine and confirm that the medicine is what was prescribed
14. Hand the dispensed medicine to the patient or care giver/patient’s relation.
15. Counsel the patient giving details on how the medicine should be used
16. Give the patient a chance to ask questions and give the patient appropriate answers.
17. Say “thank you” to the patient before he leaves. This is to be done with a smile.
18. Keep all patient medication record.

SOPs For Unit Dose Dispensing System (UDDS)

Standard Operating Procedures (SOPs) for a Unit Dose Dispensing System (UDDS) are essential to ensure the safe and efficient dispensing of medications in healthcare settings such as hospitals, long-term care facilities, and clinics. Here’s an outline of SOPs for a UDDS:

1. Prepare advocacy plan for the SOPs
2. Receive , read and validate prescription
3. Find out the prescriber’s intention for the patient
4. Find out whether the medicines (and / or other required items are available in the pharmacy)
5. Open the patient medication profile.
6. Cost the medicines
7. Direct the patient to make necessary payments and to present the appropriate receipt confirming payment of medicines/items dispensed.
8. Select the correct medicines /items in the pharmacy and read the
9. label on the container (and/or package) before, during and after dispensing.
10. Prepare the appropriate label which could contain the name, strength
11. and quantity of the medicine being dispensed. All necessary directions should comply with legal requirements (where applicable).
12. Include the expiry date for any product with limited shelf-life (where applicable).
13. Select the appropriate container and closure for dispensing medicines (where applicable). Plastic, amber dispensing vials for tablets and capsules are preferred.
14. Affix the written instructions (labels) on the container.
15. Ensure that all dispensed are put in patients respective cassettes and arranged in a trolley.
16. Deliver the trolley to the ward and give any necessary information to the nurses.
17. Initiate therapeutic drug monitoring (TDM) where necessary.
18. Document patients’ medication complaint(s) and discuss with the prescriber.
19. Reference must be made to the doctor’s prescription for every administration.
20. Pharmacist must be present at the ward to monitor the unit dose dispensing system (UDDS), improve in-patient dispensing and make the necessary therapeutic interventions.

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Note: The technical aspects of dispensing (such as counting tablets, pouring liquid and labeling containers) can properly be conducted by trained support staff under the supervision of a pharmacist. There is no alternative to the direct involvement of the pharmacist in the assessment of prescriptions and ensure that all necessary information is given to the patient or care-giver (i.e. patients’ relative) to achieve maximum therapeutic benefits.

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SOPs For Patient Counselling

Patient counseling should be carried out in a room or space dedicated for such purpose. Such a room should be adequately equipped.

1. Prepare advocacy plan for the SOPs
2. Welcome the patient with a warm smile
3. Ensure the patient is comfortably seated before facing you
4. Introduce yourself to the patient by saying’ I am a pharmacist……………….. I am here to talk to u about your medication’’.
5. Ensure the patients identity matches that written on absentee patient. Counsel the patient’s representative in the absence of the patient. (This should not be encouraged).
6. Confirm if the patient has been counseled by the doctor (prescriber) or any other staff member of the hospital. Note what the patient had been told.
7. Confirm if it’s the 1st time the patient is receiving the medication on prescription.
8. Show the patient what the prescribed drug looks like.
9. Tell the patient the name(s) of the drug(s) prescribed and explain in a simple language, how the drug works.
10. Inform the patient of the dosage requirement, route of administration, duration of drug therapy.
11. Provide the patient with any information on the onset of action.

SOPs For Screening Prescription

1. Prepare an Advocacy Programme for the SOP.
2. Ascertain that all the legal requirements for the prescription are met, including full name of the patient, age and sex date on which the prescription was written, name and strength of the drug written generically, quantity of drug to be supplied, directions for use, and full name and signature of the prescriber in his own handwriting.
3. As certain that all prescriptions for narcotic drugs are written on a separate prescription sheet.
4. Ensure that quantity of drugs in a prescription are properly written e.g 3g not 3.0g, 500mg not 0.5g, 100micrograms not 0.1mg, mi not cc or cm3.
5. Ensure that unapproved abbreviations are not used in writing prescriptions e.g. PCM for Paracetamol.
6. Ensure that the quantities for each drug to be supplied is clearly stated, e.g. 100 Tablets or that the dose and directions are clearly stated e.g. one tablet every 8 hours for 5 days.
7. Ensure that prescription written for animals contain all the necessary information, including the name of the owner and that it is clearly marked ‘’for animal use only’.
8. Screen all prescriptions for any incompatibility.
9. Ensure that all alterations on the prescription are signed by the prescriber.
10. Ensure that prescriptions written in duplicate are clearly labeled e.g. “Original”, “Duplicate”.