Compliance Toolkit SOP Index N.B REMMBER TO PRINT AND INSERT PHARMACY & OWNER NAMES ON EACH SOP

Transcription

1 Compliance Toolkit SOP Index N.B REMMBER TO PRINT AND INSERT PHARMACY & OWNER NAMES ON EACH SOP 1. Introduction, Reviewing & Updating SOP s 2. SOP 1 : Good House Keeping 3. SOP 2 : Daily Routines & Working Hours 4. SOP 3 : Enquiry Or Complaint Procedures 5. SOP 4 : Pest, Rodent, Insects, etc Elimination Procedure 6. SOP 5 : Effective Stock Rotation 7. SOP 6 : Stocktaking 8. SOP 7 : Disposal or Removal Of Damaged or Expired Stock 9. SOP 8 : Obsolete & Unusable Products 10. SOP 9 : Special Storage & Handling Instructions 11. SOP 10 : Separation & Handling of Goods Returned From Patients 12. SOP 11 : Recall Of Medicine 13. SOP 12 : Delivery Of Medicine 14. SOP 13 : Receipt Of Stock 15. SOP 14 : Storage Of Medicine 16. SOP 15 : Procurement Of Medicine 17. SOP 16 : Handling Of Product Complaints 18. SOP 17 : Pre-Packing 19. SOP 18 : Procedure For A Locum/Relief Pharmacist 20. SOP 19 : Handling Of Schedule 5 & 6 Medicines 21. SOP 20 : Cold Chain Management & Refrigerator Power Failure

2 SOP S REVIEWED AND UPDATED REF NO: SOP 26 DISTRIBUTION: ALL STAFF TO ENSURE SOPS ARE REGULARLY REVIEWED AND UPDATED 1) GENERAL 1.1) All SOPS will be reviewed once a year, as per date on each SOP 1.2) The Responsible Pharmacist is responsible for maintaining and updating SOPS, with the input of the Shop Manager, Store Manager and any other essential staff members 1.3) If any changes need to be made to an SOP before the annual anniversary of the SOP, these need to be brought to the attention of the Shop Manager and/or Store Manager and the Responsible Pharmacist 1.4) SOPS will be updated by the Responsible Pharmacist if deemed necessary and productive 1.5) Once SOPS have been updated, it must be distributed amongst the relevant staff 1.6) Staff must legibly sign the back of the updated SOP, along with the date. 1.7) This updated SOP must be filed in the SOP file, stapled on top of the outdated SOP 1.8) The SOP file must be made available to all staff at all times

3 GOOD HOUSE KEEPING REF NO: SOP 1 DISTRIBUTION: ALL STAFF TO ENSURE REGULAR, SUPERVISED CLEANING PROCEDURE IN THE PHARMACY 1) GENERAL 1.1) Cleaning will be conducted by the cleaners and supervised by the manager 1.2) Supervised cleaning must be conducted daily 1.3) Cleaners must wear suitable clothing 1.4) Cleaning to follow the Cleaning Roster 1.5) All dustbins must be emptied before the end of each day 1.6) No eating or drinking on the shop floor 1.7) All computers and telephones are to be kept dust-free 1.8) Toilet facilities and all basins must be cleaned daily with suitable cleaning products 2) DISPENSARY 2.1) All working surfaces and floors in the dispensary must be cleaned every day 2.2) All dispensary shelves must be wiped or dusted at least once a week 2.3) After use, all dispensing equipment must be cleaned to ensure that no residue remains ie. Ointment slabs, measuring cylinders, scales, mortar and pestle 2.4) Pill counters and pill cutters should be wiped between uses to ensure no cross-contamination 2.5) All computers and telephones are to be kept dust-free 2.6) Expired stock must be removed for destruction (See SOP 7) 3) FRONT SHOP 3.1) All flooring is to be vacuumed or swept daily, and mopped with appropriate cleaning products once a week. 3.2) All shelving must be wiped or dusted at least once a week and kept in a tidy manner 3.3) Expired stock must be removed for destruction (see SOP 7) 4) STAFF ROOM/KITCHEN AREA 4.1) All crockery and utensils must be cleaned and put away before the end of the day 4.2) Staff refrigerator must be cleaned out once a week and defrosted and cleaned once a month NAME OF PHARMACY OWNER DATE: 9 th September 2017 REVIEW DATE: 9 th September 2018

4 DAILY ROUTINE AND WORKING HOURS REF NO: SOP 2 DISTRIBUTION: ALL STAFF TO ENSURE PROPER PROCEDURES IN TERMS OF DAILY ROUTINE 1) WORKING HOURS 1.1) The pharmacy is open during the following hours: (Pharmacy manager to insert hours) Weekdays Saturdays Sundays Public Holidays 1.2) Staff Hours are set according to a schedule as set out by the manager. This schedule is subject to change, with coordination between the staff member and the manager. All leave is to be planned, with at least a month s notice. The manager is to be notified as soon as possible should there be any illness, accidents, emergencies or Family Responsibility requests 2) DAILY ROUTINE OPENING 2.1) Opening in to be done by the Key Holder on duty 2.2) Alarm to be switched off 2.3) All lights, computers, tills, air conditioners (if needed) to be switched on 2.4) Phone must be switched from Night service to Day service 2.5) Dispensary staff and Front shop staff must report to their stations 2.6) Cleaning is to commence as per SOP 1 3) DAILY ROUTINE - CLOSING 3.1) All computers to be shut-down 3.2) Phone to be switched from Day service to Night Service 3.3) Ensure all doors and windows are locked 3.4) All lights, computers, tills, air conditioners (if needed) to be switched off 3.5) Alarm must be set and the Key Holder to lock up

5 ENQUIRY OR COMPLAINT PROCEDURE REF NO: SOP 3 DISTRIBUTION: ALL STAFF TO ENSURE THAT ALL PATIENT / CUSTOMER ENQUIRIES OR COMPLAINTS ARE HANDLED APPROPRIATELY IN THE PHARMACY 1) GENERAL 1.1) All staff must be aware of all procedures when dealing with a customer complaint or enquiry. 1.2) Enquires and complaints will be handled by the appropriate staff concerned. 1.3) All details of the enquiry or complaint must be recorded in the Complaints/Enquiry book Customer s name, phone number, nature of complaint/enquiry. 1.4) The complaint/enquiry must be directed to the correct person to attend to and resolve. 1.5) The customer must be informed timeously of the outcome of the complaint/enquiry. 1.6) The outcome must be recorded in the Complaints/Enquiry book for future reference. 1.7) The Complaints/Enquiry book will be reviewed by the Responsible Pharmacist on a monthly basis, and may be subject to in-house training during the next staff meeting. 2) ENQUIRIES 2.1) All medicine/prescription enquiries must be directed to Dispensary staff 2.2) Front shop product availability enquiries must be directed to the person responsible for that particular product range, or to the pharmacy buyer 3) COMPLAINTS 3.1) Complaints must be directed to the Pharmacist in charge or the Manager immediately

6 PESTS (INSECTS, RODENTS, ETC) ELIMINATION REF NO: SOP 4 DISTRIBUTION: ALL STAFF TO AVOID CONTAMINATION AND DAMAGE OF STOCK DUE TO PESTS 1) GENERAL 1.1) Pharmacy must be sprayed and treated as per contract every three months through a suitable pest control company 1.2) All staff to be on alert for any signs of pest infestation, and should any be seen, it must be reported immediately to the Responsible Pharmacist or Manager, and the pest control company is to be notified 1.3) The pharmacy is to be kept clean and dusted as stated in SOP 1 1.4) No food is allowed in the dispensary, the front shop or in the storeroom at any time 1.5) No dirty dishes or utensils to be left in the kitchen overnight 1.6) Staff lockers to be checked once a month for evidence of pest infestation and appropriate action to be taken if such evidence is found.

7 EFFECTIVE STOCK ROTATION (FEEFO FIRST ENTRY, EXPIRY, FIRST OUT) REF NO: SOP 5 DISTRIBUTION: ALL STAFF TO MAINTAIN FEEFO FIRST ENTRY, EXPIRY, FIRST OUT AND TO REDUCE THE POSSIBLITY OF EXPIRED STOCK ON THE SHELVES 1) GENERAL 1.1) On receipt of stock, expiry dates must be checked, with any short-dated stock (i.e. 3 months or less) to be brought to the attention of the buyer. 1.2) All new stock must be packed on the shelf, with the newest stock at the back. However, if new stock arrives with a shorter expiry date than the stock already on the shelf, the product with the shortest expiry date must be packed in the front. 1.3) When packing out new stock, staff are to check dates of stock already on the shelves 1.4) Any stock that has less than 3 months until expiry date must be brought to the attention of the head of that department. 1.5) Any near-to-expiry date stock that can be returned to the Wholesaler for credit or exchange must be removed from the shelves and credit/exchange requested. 1.6) All expired drugs must be removed from the shelves and disposed of in the prescribed manner

8 STOCK-TAKING REF NO: SOP 6 DISTRIBUTION: ALL STAFF TO ENSURE AN ACCURATE STOCK-TAKING SYSTEM 1) GENERAL 1.1) Staff will be notified at least 2 weeks in advance on the date and time for Stock-taking (Annual or otherwise) 1.2) Notices for customers and patients must be put up and staff must let customers know the shop will be closed 1.3) One week before stock-take, staff are to check for expired or expiring stock, and these must be removed from the shelves and dealt with accordingly. 2) ONE DAY BEFORE STOCK-TAKE 2.1) No more pre-packing of stock 2.2) All shelves to be straightened to assist with counting 2.3) In Dispensary, open packs to be combined if possible to make original packs, ensuring that stock with different expiry dates are not mixed in the same original pack. 2.4) Stock-sheets must be printed 2.5) Staff are to be divided into counting pairs 3) ON THE DAY OF STOCK-TAKE 3.1) Stock-sheets are to be handed out to counting pairs and a record of which pairs are responsible for which stock-sheets is to be kept 3.2) One staff member must count (and check expiry dates) and the other must record 3.3) Completed stock-sheets are to be returned to the stock-take controller, who must record them as returned 3.4) Auditors will check random sheets 4) AFTER STOCK-TAKE 4.1) Stock figures will be processed by the Admin staff, under the supervision of the auditors 4.2) Provisional figures will be checked by the Responsible Pharmacist, Store Manager and Accountant. 4.3) Any discrepancies are to be corrected

9 DISPOSAL OR REMOVAL OF S1-S6 EXPIRED, DAMAGED AND/OR CONTAMINATED STOCK AS REQUIRED IN REGULATION 27 OF ACT 101 OF 1965 REF NO: SOP 7 DISTRIBUTION: ALL STAFF TO ENSURE A SYSTEMATIC REMOVAL AND DISPOSAL OF UNUSABLE MEDICINE 1) GENERAL 1.1) All staff to check expiry dates on all medications when restocking shelves, as well as for damaged stock 1.2) Expired stock must be removed from the shelf immediately, and re-ordered if necessary 1.3) Damaged stock to be removed from the shelf 1.4) The Store Manager / Stock Controller must contact the relevant wholesaler and request credits or exchange for the returnable stock see Annexure A for list of wholesalers 1.5) All medication that is to be destroyed must be recorded on the Written off stock See Annexure B 1.6) Medicine for destruction is to be stored in the containers provided by the contracted medical waste company, which are to be kept in a designated area of the dispensary, away from all other medications. 1.7) All medicine for destruction must be written up on the Medicine for Destruction Form see Annexure C and attached to the Waste container. 1.8) Once ready for collection, the Waste company must be notified that their container is to be collected 2) ATTACHMENTS 2.1) Annexure A List of suppliers 2.2) Annexure B Written off stock list 2.3) Annexure C Medicine for Destruction form

10 SOP 7 ANNEXURE A LIST OF WHOLESALERS NAME CONTACT NUMBER CONTACT PERSON ADDRESS

11 SOP 7 ANNEXURE B WRITTEN OFF STOCK LIST DATE MEDICATION QUANTITY EXPIRY SUPPLIER REASON

12 SOP 7 ANNEXURE C MEDICINE FOR DESTRUCTION LIST DATE MEDICATION QUANTITY EXPIRY SUPPLIER REASON

13 OBSOLUTE OR UNUSABLE STOCK REF NO: SOP 8 DISTRIBUTION: ALL STAFF TO ENSURE REMOVAL OF UNUSABLE STOCK 1) GENERAL 1.1) All expired, damaged or discontinued stock is deemed as unusable stock 1.2) All unusable stock must be removed from the shelves as soon as possible 1.3) Expired stock that can be returned for credit or exchange must be given to the wholesaler Annexure A 1.4) All other expired or damaged stock must be destroyed as set out in SOP 7 1.5) Discontinued stock must be sold off or given away, and compensated by the Sales Representative of that particular product 1.6) Obsolete stock can also be written off or destroyed, with record of such stock on the Written off stock list Annexure B 1.7) All expired, damaged and discontinued stock to be kept away from saleable stock 2) ATTACHMENTS 2.1) Annexure A List of suppliers 2.2) Annexure B Written off stock list 2.3) Annexure C Medicine for Destruction form

14 SOP 8 ANNEXURE A LIST OF WHOLESALERS NAME CONTACT NUMBER CONTACT PERSON ADDRESS

15 SOP 8 ANNEXURE B WRITTEN OFF STOCK LIST DATE MEDICATION QUANTITY EXPIRY SUPPLIER REASON

16 SOP 8 ANNEXURE C MEDICINE FOR DESTRUCTION LIST DATE MEDICATION QUANTITY EXPIRY SUPPLIER REASON

17 PRODUCT TYPES REQUIRING SPECIAL STORAGE OR HANDLING INSTRUCTIONS REF NO: SOP 9 DISTRIBUTION: PHARMACISTS, PHARMACIST S ASSISTANTS, INTERNS, STOREROOM MANAGER, TO ENSURE THAT THERMOLABILE PRODUCTS AND HAZARDOUS CHEMICALS ARE HANDLED AND STORED CORRECTLY 1) RECEIVING 1.1) Delivery must be received by the authorised person 1.2) When goods arrive, ensure that they have been transported correctly if you have any doubts, raise concerns immediately and contact the supplier for exchange 1.3) Check for damaged stock and expiry dates 1.4) Once checked against the invoice, the product must immediately be placed in the dispensary refrigerator. 2) STORAGE 2.1) Only medications to be stored in the Dispensary refrigerator 2.2) Only ice-packs to be stored in the freezer compartment not medicines 2.3) The fridge door is to be kept closed at all times only open when necessary 2.4) The temperature of the fridge must be maintained between 2 and 8 degrees Celsius 2.5) Take a reading from the thermometer twice a day morning and afternoon and record on the Temp Chart Annexure A that is fixed to the door of the fridge 2.6) An alarm must be installed to alert the pharmacist on duty should the fridge temperature drop of rise beyond the acceptable temperatures 2.7) Should there be a power failure, SOP 20 procedures should be followed 3) DISPENSING 3.1) When dispensing any of these items, patients must be informed on the storage conditions 3.2) The product must have a Keep Refrigerated sticker 3.3) The pharmacist must determine from the patient the travelling time to home to the fridge if there is going to be a delay, the product must be packaged with an ice-pack and wrapped appropriately 4) ATTACHMENTS 4.1) Annexure A Temperature Chart

18 SOP 9 - ANNEXURE A DATE AM PM DATE AM PM DATE AM PM

19 PHARMACY NAME: SEPERATION AND HANDLING OF GOODS RETURNED FROM PATIENTS REF NO: SOP 10 DISTRIBUTION: ALL STAFF TO ENSURE THAT ALL STAFF KNOW HOW TO DEAL WITH MEDICATIONS RETURNED BY PATIENTS 1) MEDICINES 1.1) Customers wanting to return medications must be referred to the pharmacist on duty 1.2) All medications returned by patients may not be re-dispensed for other patients 1.3) Returned medications must be stored separately from other medications in a clearly marked container, and must be disposed of as per SOP 7 2) OTHER PRODUCTS 2.1) Customers wanting to return front-shop items must be referred to the shop manager 2.2) If goods damaged or expired, the supplier must be notified, and replacement stock is to be requested 2.3) Goods to be collected by the supplier must be stored separately, so as not to be re-sold 2.4) Products to be destroyed must be stored and await destruction as per SOP 7

20 RECALL OF MEDICINE REF NO: SOP 12 DISTRIBUTION: ALL DISPENSARY STAFF AND STORE ROOM MANAGER TO ENSURE PROBLEMATIC BATCH MEDICINE IS RETURNED TO THE MANUFACTURER AND THE PUBLIC ARE PROTECTED 1) GENERAL 1.1) Once a Medicine Recall Notice is received, the Responsible Pharmacist must immediately check whether or not any of the recalled medications are in stock 1.2) The details of the recalled medication name, strength, batch number, etc must be given to the storeroom staff and receiving staff to ensure that any new stock does not come from that batch 1.3) Any recalled medication must be removed from the shelf 1.4) If any recalled medications have been received, dispensary staff must do an audit trail and confirm if any patients have received this stock 1.5) Contact these patients and explain the medicine recall, as well as any further action required, if needed 1.6) Replace recalled medications returned from patients if deemed safe and necessary 1.7) Any patient incidents to be recorded and the MCC and manufacturer must be made aware 1.8) All recalled stock must be returned to the supplier or manufacturer for credit or exchange

21 DELIVERY OF MEDICINE REF NO: SOP 12 DISTRIBUTION: ALL STAFF TO ENSURE THAT ALL MEDICINES ARE DELIVERED PROMPTLY AND THAT THE STOCK MAINTAINS ITS QUALITY DURING THE PROCESS 1) GENERAL 1.1) Deliveries take place between and Monday to Friday and between and on Saturday. There are no deliveries on a Sunday, nor on Public Holidays 1.2) All details must be recorded by the staff member taking the delivery i.e. Name of customer, delivery address, contact phone number, payment method, goods to be supplied, etc 1.3) Staff taking orders for delivery are not to promise delivery time, but to make a note and let the pharmacist or shop manager know so that they may liaise with the driver 1.4) If the order requires medications to be dispensed by the pharmacist, the order must be placed in dispensary in a container with the other front-shop items (if any ordered) with all details for the pharmacist Medical aid, patient s name and surname, etc 1.5) Dispensed medication for delivery must have clear and concise instructions on storage and dosage 1.6) Once the medication(s) have been dispensed, they must be sealed in a packet by the pharmacist, with the pharmacist generated script copy on the outside, and returned to the front shop staff for delivery. 1.7) If medications are to be refrigerated, a Refrigerate Item sticker must be put on the pharmacist generated copy, and the item must be kept in the fridge until the driver is ready for that particular delivery 1.8) If the order is urgent, and Urgent or Immediate Delivery sticker must be stuck on the outside of the parcel and left in the box for awaiting deliveries 1.9) If any other front shop items are to be added to the order, the staff member needs to collect all the items, and invoice accordingly i.e. COD, Account or Cape Consumers 1.10) Once packaged together, this parcel must be put in the box for awaiting deliveries. 1.11) Ensure that the correct delivery address is visible on the outside of the package, as well as the amount due 1.12) Any Schedule 6 items need to be collected from the pharmacist by the driver, and put immediately in the delivery vehicle under no circumstances can a Schedule 6 parcel be left unattended. 1.13) All Schedule 6 parcels must be written up in the marked Delivery of Schedule 6 parcels book, and the driver must get a signature and name on delivery these parcels cannot be left in a letterbox or on a door mat, and nor with young children 1.14) The driver must write up each parcel on the Delivery Sheet Annexure A 1.15) The delivery vehicle must be packed appropriately so as to minimise any damages during transport

22 1.16) Items requiring refrigeration must be packed in cool boxes with ice packs, and should be given priority on the delivery route 1.17) No parcels to be handed over without payment, unless otherwise arranged by the shop manager or responsible pharmacist 1.18) On return to the pharmacy, the driver must check for any urgent deliveries, which must be attended to, otherwise COD s must be paid at the till 1.19) Any queries or complaints with deliveries that the driver receives from the customers must be taken to the shop manager or responsible pharmacist immediately so that suitable action may be taken 2) ATTACHMENTS 2.1) Annexure A Delivery Sheet

23 SOP 12 ANNEXURE A DATE NAME ADDRESS TIME OUT TIME IN PAID

24 RECEIPT OF STOCK REF NO: SOP 13 DISTRIBUTION: ALL STAFF TO ENSURE PROPER STOCK MANAGEMENTS 1) GENERAL 1.1) All deliveries are to be received at the Stock Receiving Area, unless otherwise stated 1.2) Thermolabile medicines must be separated and checked first as per SOP 9 1.3) The pharmacist on duty must check Schedule 6 medicines against the invoice and sign for them and stored as per SOP ) All other medicines must be checked against the invoice and signed for by the Storeroom staff 1.5) Any discrepancies, damages or expired stock must be brought to the attention of the storeroom manger, the pharmacist on duty and the supplier. If any of this stock is required urgently for a script, arrangements must be made with the supplier for special delivery, and the customer should be alerted to the delay 1.6) Once stock has been checked against the invoice, it must be entered onto the computer system 1.7) Once stock is on the system, it can be packed out onto the shelves as soon as possible with expiry dates being checked again 1.8) SOP 5 and SOP 7 must be followed as stock is put out on the shelves 1.9) Excess stock may be stored in the designated Excess Stock area and must be regularly checked as to when it can be put out on the shelf

25 PHARMACY NAME: REF NO: SOP 14 DISTRIBUTION: ALL STAFF STORAGE OF MEDICINE TO ENSURE THAT STANDARDS ARE UPHELD IN THE STORAGE OF MEDICINES TO MAINTAIN THEIR QUALITY AND EFFECTIVENESS 1) GENERAL 1.1) The storeroom is to be kept clean and free of dust see SOP 1 1.2) SOP 4 must be followed for effective Pest Control 1.3) No stock is to be stored on the floor and shelving is to be cleaned regularly as per SOP 1 1.4) The air conditioner must be serviced regularly, and a temperature at below 25 degrees must be maintained to reduce moisture content 1.5) No food is to be stored or eaten in the medicine storage area 1.6) Any spills must be cleaned immediately 1.7) All stock to be stored using FEEFO First entry, expiry, first out 1.8) The storeroom must be kept locked, with either the pharmacist on duty or the storeroom manager in charge of the key, to prevent any loss of stock due to theft 2) SCHEDULED MEDICINE 2.1) All scheduled medicine must be separated from other stock received, and given to dispensary staff 2.2) All Schedule 6 medicines are to be stored in a locked cupboard in dispensary 2.3) All thermolabile medicines are to be stored in a fridge between 2 and 8 degrees see SOP 8 2.4) All hazardous substances are to be kept away from other stock in a fume cupboard with a ventilation hole 2.5) Only Schedule 1 and Schedule 2 excess stock may be stored in the storeroom but in a special designated area. All other excess scheduled stock must be stored in a special designated area in the dispensary

26 PHARMACY NAME: REF NO: SOP 15 DISTRIBUTION: ALL STAFF PROCUREMENT OF MEDICINE TO ENSURE THAT PROCUREMENT OF SUPPLIES ARE FROM RELIABLE AND ETHICAL SOURCES 1) GENERAL 1.1) Stock may only be ordered from reputable suppliers see Annexure A for preferred wholesaler list get authorisation from responsible person before using a new supplier 1.2) Any urgent medication must be ordered from the wholesaler that would be able to deliver timeously, or who would be able to make the delivery a priority 1.3) The pharmacist on duty must place the order on the order system 1.4) Any out-of-stocks must be ordered with an alternative supplier 1.5) Schedule 6 order forms must be completed by the pharmacist and faxed or ed to the supplier 1.6) Any orders that Reps may want to place must be authorised by the pharmacist or the store manager 2) ATTACHEMENTS 2.1) Annexure A List of approved providers

27 SOP 15 ANNEXURE A LIST OF WHOLESALERS NAME CONTACT NUMBER CONTACT PERSON ADDRESS

28 HANDLING OF PRODUCT COMPLAINTS REF NO: SOP 16 DISTRIBUTION: ALL STAFF TO ENSURE PROPER MANAGEMENT OF PRODUCT COMPLAINT AND SAFETY OF PATIENTS ALWAYS 1) GENERAL 1.1) Listen carefully to the customer and remain objective do not admit liability 1.2) Remain calm and show concern for the customer also apologise for any inconvenience caused 1.3) Record all details of the product complaint in the Product Complaint book customer s name, address and telephone number; date of purchase; nature of complaint 1.4) If the customer would like a replacement of the product, the manager may do so 1.5) Any products returned to the pharmacy must be dealt with as per SOP 10 2) SCHEDULED MEDICINES 2.1) If the complaint is against a scheduled medication, the responsible pharmacist needs to be informed and involved 2.2) The pharmacist may replace the medication if it is deemed to be a problem with the original medication but the supplier must also be informed immediately and replacement stock arranged 2.3) If the complaint is related to an adverse effect, the pharmacist must alert the stockist, as well as the MCC 2.4) The customer must be informed of any outcome on all product complaints received

29 PRE-PACKING (INCLUDING QUALITY ASSURANCE PROCEDURES) (WHERE APPLICABLE) REF NO: SOP 17 DISTRIBUTION: DISPENSARY STAFF TO ENSURE THAT STANDARDS ARE UPHELD WITH ALL PRE- PACKING OF BULK MEDICATIONS 1) GENERAL 1.1) Bulk stock may be repacked into smaller pack sizes for sale 1.2) All repacking must be in accordance with terms provided in the Medicines Act, as well as MCC standards\ 1.3) Pre-packing can only be done by a pharmacist, or under strict supervision of a pharmacist, by a registered pharmacist assistant 1.4) All pre-packing must be done in a designated area, separate from the general dispensing area 1.5) All apparatus used for pill counting must be kept clean, and cleaned between different batches and products to avoid any cross-contaminations 1.6) Tablets must be manually counted measuring by volume is not allowed 1.7) Any product that is pre-packed must be recorded on the Pre-packed Product Record page (see Annexure A), and filed as per product and date in the Pre-Packed Product file 1.8) The labels for the Pre-packed product must be printed out as and when the Pre-packed Product Record page is completed, with a copy attached to the page, with the following information: 1.8.1) Approved name of medicine 1.8.2) Strength of product 1.8.3) Quantity or volume of medicine 1.8.4) Expiry date and batch number 1.8.5) Packaging date 1.8.6) Any additional information if necessary, e.g. storage conditions, warnings, etc 1.8.7) Directions for use 1.9) Any unused or damaged labels must be discarded 2) ATTACHMENTS 2.1) Annexure A Pre-packed Product Record

30 SOP 17 ANNEXURE A PRE-PACKING RECORD OF : NAME OF PRODUCT DATE STRENGTH DOSAGE MANUFACTURER EXPIRY DATE BATCH NUMBER LABEL

31 PROCEDURES FOR A LOCUM OR RELIEF PHARMACIST(S) (WHERE APPLICABLE) REF NO: SOP 18 DISTRIBUTION: RESPONSIBLE PHARMACIST, DISPENSARY STAFF TO ENSURE A SMOOTH HANDOVER TO A LOCUM PHARMACIST 1) GENERAL 1.1) The responsible pharmacist will maintain a list of suitably qualified locum pharmacists that may be called on should it be necessary 1.2) The locum pharmacists must be vetted and checked by the responsible pharmacist i.e. qualifications and registration with the Pharmacy Council 1.3) Should a locum pharmacist be required, the responsible pharmacist or shop manager must call and book a locum, confirming dates and times 1.4) The locum pharmacist must be made aware of all pharmacy procedures with the SOP file and with a brief introduction by the responsible pharmacist or the shop manager 2) INFORMATION FOR THE LOCUM PHARMACIST 2.1) All information must be made readily available to the locum pharmacist 2.2) As per 1.4, the SOP file must be made available, as well as other information 2.3) As well as SOPs, there must be staffing information in the file, including the following: The names, addresses, telephone numbers of key staff, as well as their In case of emergency contact person Working times of staff Any details of staff leave during the locum s shifts Any staff concessions Staff purchases 2.4) The file must also contain the following information with regards to the dispensary: Computer instructions Contracted Medical Aids Keys to the Schedule 6 cupboard Ordering systems and a list of preferred wholesalers 2.5) With regards to the rest of the pharmacy, information in the file must include: Instructions of use of alarm system, as well as contact details for security company Lights and air condition instructions Till operations and cash-up procedures List of service suppliers e.g. plumber, electrician, computer vendor Delivery service details

32 3) COMPLETION OF SHIFT(S) 3.1) Upon the completion of the locum pharmacist s shift(s), a complete handover must be done 3.2) The locum pharmacist must share any information regarding any unresolved problems or queries, as well as any difficulties experienced 3.3) Any staffing issues must also be mentioned

33 HANDLING OF S5 AND S6 MEDICINES REF NO: SOP 19 DISTRIBUTION: ALL DISPENSARY STAFF TO ENSURE THAT SCHEDULE 5 AND 6 MEDICATIONS ARE HANDLED CORRECTLY 1) ORDERING AND RECEIVING 1.1) As per Regulation 28 of the Medicines and Related Substances Act 101 of 1965, the pharmacist must complete the Schedule 6 order form 1.2) The pharmacist s name and signature on the form must be legible, as well as his/her qualification and SAPC registration number 1.3) The order form must be faxed or scanned and ed to the supplier, and the original kept for delivery 1.4) On delivery, the order must be checked against the original order, signed for by the pharmacist if correct, and the original form must be given to the driver 2) STORAGE 2.1) Once signed for, the medication must immediately be entered in the Schedule 6 register by the pharmacist 2.2) If this cannot be done immediately, all paperwork and the sealed package must be stored in the Schedule 6 cupboard 2.3) The Schedule 6 cupboard is to be kept locked always, and the key held by the responsible pharmacist 3) DISPENSING 3.1) Only original prescriptions may be dispensed 3.2) Schedule 6 prescriptions must be dispensed by the pharmacist, and details of the prescription must be entered in the Schedule 6 register 3.3) In an emergency, a 48 hours supply of medication may be dispensed in accordance with Section 22A(6)(k) of the Medicines and Related Substances Act on condition that arrangements have been made to attain the original prescription within 72 hours 3.4) The original prescription must be filed in the Schedule 6 file, as per product and date order. This file must be stored in the Schedule 6 cupboard 3.5) A copy of the prescription must be filed in the general prescription file 4) CHECKING AND BALANCING 4.1) All Schedule 6 transactions for the day must be recorded in the Schedule 6 register by the end of the day 4.2) The responsible pharmacist must check the register against the computer printout at the end of the day considering all medications dispensed and medications received, as well as orders placed 4.3) As required by Regulation, the Schedule 6 register must be balanced quarterly

34 COLD CHAIN MANAGEMENT (INCLUDING PROCEDURES TO BE FOLLOWED IN THE EVENT OF A REFRIGERATOR POWER FAILURE) REF NO: SOP 20 DISTRIBUTION: ALL STAFF TO ENSURE THAT COLDCHAIN IS MAINTAINED THROUGHOUT THE DISTRIBUTION PROCESS, AS WELL AS IN THE EVENT OF FRIDGE FAILURE 1) DELIVERY TO CUSTOMER 1.1) Items must be kept in the fridge until the drivers is ready for delivery 1.2) All thermolabile items are to be packed in a cold box 1.3) Cold icepack must be packed in cold box, wrapped in plastic so as not to cause any water damage from condensation 1.4) Items must be packed protectively to avoid damage 1.5) The lid must be closed and sealed 1.6) Delivery of cold items must be priority and delivered first 2) DELIVERY OF VACCINES 2.1) Items must be kept in the fridge until the driver is ready for delivery 2.2) All vaccines are to be packed in a cold box 2.3) Solid icepack must be packed in cold box, wrapped in plastic so as not to cause any water damage from condensation 2.4) Pack Measles and Polio vaccines first, closer to the bottom and the icepack 2.5) Then BCG vaccines 2.6) Then DPT, DTP-hib, DT, TT, and HBV vaccines 2.7) Place a thermometer in the centre of the cold box 2.8) Close lid tightly and seal 3) FRIDGE FAILURE - ACCIDENTAL UNPLUGGING 3.1) Plug in immediately 3.2) Check the temperature on the thermometer 3.3) Note the date, time and temperature on the temperature chart 3.4) Do not open the fridge unnecessarily 3.5) Establish how long the fridge has been unplugged 3.6) The responsible pharmacist is to be informed of the incident, as well as the temperature reading and the current products in the fridge 3.7) The fridge must be serviced as soon as possible by a reputable technician, otherwise replaced

35 4) FRIDGE FAILURE MECHANICAL FAILURE 4.1) Check the fridge has not been accidently unplugged 4.2) Check the temperature on the thermometer 4.3) Note the date, time and temperature on the temperature chart 4.4) Report fridge failure to the responsible pharmacist 4.5) Pack all items in a cold box - as per SOP, points 1 and 2 and transfer all stock to the back-up fridge 4.6) Report to the responsible pharmacist a complete list of medication affected, as well as their batch numbers 5) FRIDGE FAILURE POWER FAILURE 5.1) Do not open the fridge unnecessarily 5.2) If the power failure persists, and the fridge shows signs of defrosting, remove stock and place in cold boxes or back-up fridge 5.3) Report to the responsible pharmacist a complete list of medication affected, as well as their batch numbers 6) FRIDGE MAINTENACE 6.1) The fridge must be cleaned and defrosted at least once a month 6.2) Whilst the fridge is being cleaned, all stock must be moved to cold boxes as per SOP, points 1 and 2 and if possible, moved to the back-fridge