JCI Tracer FAQs PDF

JCI Tracer FAQs 17 Jun 2022 A) Pharmacy Premises 1 What are the restrictions for food Food/drinks to be consumed/stored only in designated pantry area (please know where) away from drug preparation areas. consumption/storage in the pharmacy? Food/drink...

JCI Tracer FAQs 17 Jun 2022 A) Pharmacy Premises 1 What are the restrictions for food Food/drinks to be consumed/stored only in designated pantry area (please know where) away from drug preparation areas. consumption/storage in the pharmacy? Food/drinks cannot be stored in the refrigerators. 2 How do you clean the Clean twice daily with liquid detergent & water & allow to dry. dispensing/retail counters? How often do you clean them? 3 How often do you clean the Floors are cleaned daily. dispensing area and medication Dispensing counter is cleaned twice daily storage shelves? Storage shelves are regularly cleaned (at least weekly in pharmacy & monthly in store) 4 Are there pest control measures in Appointed pest control vendor will inspect the pharmacy premise at least once every month. place? Vendors supplying stock are generally GDP-certified. 5 How do you provide privacy for We have a counselling room which provides privacy for the counselling session patients who require counselling? 6 Who has access to the pharmacy? The pharmacy is generally a restricted area where only pharmacy staff can access. Others e.g. delivery personnel must be accompanied by the pharmacy staff. 7 Show me the security systems Staff should be able to state the system specific to the pharmacy concerned: available in the pharmacy to deter e.g. Alarm system/CCTV/security mirrors/grills/locks. a break-in Physical barriers e.g. doors, barriers. 8 Who is authorised to hold the For pharmacies that are still using physical keys to open and lock the pharmacy pharmacy keys? Staff should be able to say which (limited) pharmacy staff hold the keys (Note that a pharmacist should be present at opening and closing of the pharmacy). Limited to 4 sets of keys. For pharmacies that no longer use physical keys to open and lock the pharmacy We no longer use physical keys to access our pharmacy. Staff could access the pharmacy using their access card. (Note that a pharmacist should be present at opening and closing of the pharmacy). 9 Is the drug picking & dispensing Pharmacy store as well as picking and dispensing areas are air-conditioned 24/7 for all the pharmacies. area air-conditioned 24/7? 10a What are the requirements for use The requirements are: of the flammables cabinet? Do not exceed its maximum storage capacity for flammable products Do not place anything on top of the cabinet Where possible, observe a 1 metre external clearance around the flammable cabinet, except behind the cabinet if backed by a wall. Ensure that the cabinet doors are not blocked Do not put outer carton boxes inside the flammables cabinet 10b How do you know whether the The maximum storage capacity (in litres) is stated on the flammable cabinet. The total volume of fluids stored within the maximum storage capacity of the cabinet should not exceed the maximum volume allowed. Eg. For our Justrite flammable cabinet, the total volume of fluids flammables cabinet has been stored within should not exceed its capacity of 114 litres. exceeded? 10c What are the products kept in the (Refer to Storage Conditions for SHP Drugs list in :\Documentation For Pharmacy Staff Reference\Forms & flammables cabinet? Documents\Documents) 10d How do you decide which products We keep products that are labelled as “flammable”, “combustible” or the like, in the flammables cabinet. are to be kept in the flammables cabinet? B) Pharmacy Equipment 1a Do you keep an equipment list? If Yes, we have a consolidated equipment list of all medical equipment in our polyclinic, and it includes medical equipment in yes, what is the purpose of this our pharmacy e.g. pharmaceutical fridges. This list is overseen/managed by our nurse manager. The purpose of this list? consolidated equipment list is to allow our Polyclinic Management team to keep track of the locations of medical equipment in our polyclinic, the equipment specifications as well as their maintenance/inspection dates and schedules. Whenever there is update to any medical equipment in our pharmacy, our pharmacy manager will liaise with the nurse manager to update this consolidated equipment list. Note: If pharmacy staff is asked to show the location of the polyclinic consolidated equipment list, he/she should refer the query to the CPM in-charge who should know where it is kept. 1b What are the medical equipment Equipments involved are the pharmaceutical fridge, domestic fridge, electric water pot, hot air oven, and electronic kept in the pharmacy that require weighing balance for weighing children. maintenance checks, and how Pharmaceutical fridge: 6 monthly preventive maintenance checks. frequent are the checks? Domestic fridge, electric water pot and hot air oven: regular functional checks and annual electrical safety checks conducted by Pharmacy staff. Electronic weighing balance for weighing children: annual calibration and equipment safety checks by the vendors. (Note: Pharmacy does not keep electronic weighing balance for counting tablets and capsules) 2 Who services your pharmaceutical Staff should be able to state the name of the servicing company & service frequency. (Staff to refer to equipment log / fridge and how often is the maintenance contract / tag attached to the equipment) servicing? 3 Who will ensure that the medical The pharmacy manager or a staff he/she designates will monitor the next service due date by regularly checking the equipment is maintained as maintenance tag or consolidated equipment list & ensure that the vendor services it before the due date. After the medical scheduled? How is it tracked? equipment has been serviced or when there is an update in the period of servicing, our pharmacy manager will liaise with the nurse manager to update the consolidated equipment list of our polyclinic. Page 1 of 37 30-04-24 4 How do you deal with defective Label all defective equipment and contact technical support personnel as soon as possible for repair/replacement. equipment? 5 What are the recommended Fridge: 2 oC to 8 oC. storage temperatures for the Freezer: < - 20 oC. pharmaceutical refrigerator? How Twice-daily temperature checking and recordings of both the 24-hour monitoring chart and maximum-minimum do you monitor the temperature thermometer. within? 6 What are the apparatus kept in Tablet counter, stainless steel tray and metal spoon. the pharmacy for preparing drugs to be dispensed or pre-packs? 7 What are the teaching aids If PT is asked this question, to reply that medication counselling is done by the pharmacists. Hence, this question should be available for patient counselling? answered by a pharmacist (Where applicable) Demo sets of inhaler /spacer / BP monitor / glucometer Patient information leaflets (online: http://infopedia/SHP/WS/Pages/Clinic%20resources/Patient%20Education%20Materials/Medication%20Information%20Le aflets.aspx ) (Note: pharmacists to be able to show documentation of medication counselling done). Page 2 of 37 30-04-24 8a What is the hot-air oven used for Drying dropper bottles for olive oil ear drops, after they have been washed. and how do you ensure that the Regular functional checks are conducted i.e. the oven does not have any visible defects and the bottles/droppers are oven is kept in good working thoroughly dried on removal. Annual electrical safety checks are performed annually by the Pharmacist/Pharmacy condition? Supervisor) Supplier is called in the event of equipment malfunction 8b Why is there no preventive Regular functional checks are sufficient as the hot air oven is only used for drying glass bottles maintenance for the hot air oven? 8c How you know the hot air oven is The oven functions as expected during use and the olive oil eardrop bottles/droppers are observed, after drying, to be dry in good working condition? upon visual inspection 9 How do you clean the interior of The interior of the hot air oven is cleaned with a damp cloth (water only) once a month. the hot air oven and how often do you do it? 10 How do you know that the The temperatures of the pharmaceutical fridge is being monitored twice daily and any abnormal trending of the fridge’s pharmaceutical fridge is working? temperature, which may be suggestive of malfunctioning of the fridge, can be picked up during such monitoring. The fridge is regularly cleaned and our vendor will perform a 6 monthly preventive maintenance checks and calibration to ensure that the fridge remains in good functioning order. (In addition to the above, the freezer is also regularly defrosted for pharmaceutical fridge that comes with the freezer compartment.) 11 How do you know that the The temperature of the domestic fridge is kept within the normal temperature range of 2 to 8 oC as monitored by a min-max domestic fridge is working? thermometer. A designated pharmacy staff will monitor the temperature of the domestic fridge twice daily using a min-max thermometer, any deviation from the normal temperature range will be immediately reported to pharmacist who will investigate the problem. 12 How often would you defrost the We will conduct defrosting of the pharmaceutical fridge freezer on a 6 monthly basis, or earlier if frost built-up is observed. pharmaceutical fridge freezer? 13a What is Uninterrupted Power All SHP pharmacies except SHP – SK Pharmacy Supply (UPS) and Central Alarm Monitoring System (CAM) which is Vaccines are thermolabiles and we risk losing our costly vaccines during power outage. We have installed UPS/CAM to our connected to the COVID COVID pharmaceutical fridge to better manage such incidents. UPS kicks in during power outage and provides 3 hour pharmaceutical fridge? power supply. CAM is triggered when temperature of pharmaceutical fridge escalates to above 8oC. Ademco will alert SMM who would subsequently inform relevant staff to salvage the vaccines. NB: SHP - SK has not yet implemented UPS/CAM 13b How long can the backup The backup generator can provide power for 3 hours. generator sustain for? 14 What is the monitoring system for All Pharmacy pharmaceutical fridges, except COVID pharmaceutical vaccine fridge, are connected to BMS (Building fridge when there is a Management System) in Eunos. When there is a power failure or temperature excursion > 8 degree for over 15 min, an SMS temperature excursion? alert will be sent to SHP facilities staff. The SHP facilities staff will alert the clinic executive will inform the relevant domain. [SHP-Eunos Pharmacy only] COVID pharmaceutical fridge is connected to uninterrupted power supply (UPS) and Central Alarm Monitoring System (CAM) which provides 3 hours of power supply. C) Procurement & Listing of Drugs 1a What is the optimal stock-holding Clinic pharmacy holds about 0.5 month of stocks while the whole SHP holds about 1 month of stocks. level for pharmacy stocks and how Stock levels are closely monitored based on constant monitoring of consumption patterns, professional knowledge of does pharmacy ensure the prescribing trends, and stock balances as well as drug usage patterns of the polyclinic by the clinic pharmacy managers with continuity of supply to SHP the help of PPIM reports. Procurement is undertaken in a timely manner to ensure continuity of stocks. patients? There is a constant feedback loop between the clinic pharmacy managers and Pharmacy Admin to ensure continuity of supply 1b How does your clinic patient Our pharmacy dispenses drugs prescribed by our clinic doctors to patients who visit the clinic, and hence the clinic patient profile relate to the procurement profile may affect the drug consumption and usage patterns as well as prescribing trends in the polyclinic, which are being of drugs in your pharmacy? monitored for drug procurement purposes. 2 How does pharmacy deal with SHP does not keep any drug samples. drug samples for supply to patients? 3 How are drugs which are (i) Formulary Drugs (Standard or Non-Standard) prescribed but not available in the The Clinic Pharmacy Managers will assess the demand or need for the drug within the polyclinic and liaise with Pharmacy polyclinic pharmacy supplied to Administration to arrange for their procurement or deployment from other polyclinics which carry stocks. patients? (ii) Non-Formulary Standard Drugs (such a non-availability situation is highly unlikely to present under normal circumstances ) The Clinic Pharmacy Managers will assess the demand or need for the drug within the polyclinic and liaise with Pharmacy Administration to seek approval for the drug to be procured and to be added into SHP Formulary. Pharmacy Administration will surface the case to P&T Committee through pharmacy representatives for approval first before the drug is procured. (iii) Non-Formulary Non-Standard Drugs (For cash-paying patients) The patients can purchase their non-formulary non-standard drugs from external pharmacies. (For patients on public assistance schemes), an application to supply the non-formulary non-standard drug has to be put up by the attending doctor. Upon approval of application by the Polyclinic Director, the Clinic Pharmacy Managers will liaise with Pharmacy Administration to arrange for their procurement or deployment from other polyclinics which carry stocks. The process is similar for patients with eligible third party payers except that the attending doctor does not need to put up an application to supply the non-formulary non-standard drug. Page 3 of 37 30-04-24 4 (i) Who decides what drugs are to (i) P&T Committee will recommend to CGSC, which will approve for inclusion into SHP Drug Formulary. be included in SHP Drug Formulary and (ii) who decides whether to (ii) The Clinic Pharmacy Managers will assess the demand or need for the formulary drug within the polyclinic and liaise stock a formulary drug in a with Pharmacy Administration to arrange for their procurement or deployment from other polyclinics which carry stocks. particular polyclinic 5 What is your current stockholding Our current stockholding in pharmacy is approximately 3 weeks of stocks. in pharmacy and in your SHP shares the same warehouse (ALPS) with NHGP currently and we do not know ALPS’s stockholding for polyclinics warehouse? D) Vaccine Cold Chain 1 What is the definition for a “break Pharmaceutical fridge: both the min or max readings of the 24-hour monitoring chart and min-max thermometer are out of in Vaccine Cold Chain”? recommended temperature range (Note: the digital display of the fridge and the current temperature of the min-max thermometer main unit are NOT the points of reference for determining cold chain break) Domestic fridge: The min or max reading of the min-max thermometer is out of the recommended temperature range. Generally, 2°C to 8°C is recommended for the storage of vaccines in the refrigerator, and at -20°C or colder for storage of live oral polio vaccines (GSK) in the freezer. 2* What do you do if there is a break I will record the temperature of both the 24-hour monitoring chart and min-max thermometer on the temperature record in cold chain? form. I will check if the fridge doors are properly closed & whether the power to the fridge has been disconnected, & rectify these immediately if any. I will then seal off the fridge by putting up a sign to prevent other colleagues from taking drugs in the fridge out for use, and immediately inform my pharmacy manager. If the break in cold chain is confirmed by the pharmacy manager, the affected vaccines will be immediately quarantined and labelled “Do not use! Break in Cold Chain”. The affected vaccines will also be properly isolated from non-quarantined vaccines/thermolabiles so that they will not be inadvertently used/ issued for use. Head of Supplies & Logistics, Allied Health Department will be kept informed and he/ she will check with the vendor on the usability of the exposed vaccines. An incident report will also be put up. If the vaccines are usable, the pharmacist will seek approval from the polyclinic director to release the affected vaccines for use. Upon approval by the polyclinic director, the affected vaccines will be released for use. If the vaccines are not usable, pharmacist will immediately remove the affected vaccines from the pharmaceutical fridge and pack them into a box which is labelled with Condemnation Label i.e. “Do not use! Vaccines for condemnation”. Pharmacist will then follow up with condemnation of the affected vaccine. 3 When do you reset the min-max The temperature registered by the min-max thermometer should be checked twice daily to ascertain that the refrigerator thermometer? temperature is within the recommended range. If the temperature registered is out of the recommended range, a temperature excursion (out-of-range reading or readings) has been registered. In such a situation, the thermometer reading has to be recorded and the supervisor has to ascertain if there has been a break in cold chain for the affected refrigerator, before approval can be given to reset the thermometer If the temperature at time of check is within recommended range, the min-max thermometer should still be reset after each routine temperature recording so that the minimum and maximum temperatures recorded during each routine check will correspond to the period between the time of last reset to the time of routine check. 4a (To SPT) What would you look out Other than recording the temperature readings, I will check for any unusual temperature spikes that has occurred from the for when you read off the 24-hour time of the last record, and that the day stated on the temperature record form corresponds to that on the 24-hour monitoring chart? monitoring chart at the time of recording as evidence that the chart is moving/recording properly. I will then need to investigate further/report to my CPM if there are any unexplained fluctuations, temperature uptrending, or charting faults being detected. 4b (To SPT) How would you know if This would have been observed by the staff who reads off the 24-hour monitoring chart and min-max thermometer on the there has been a temperature next working morning (as part of twice-daily temperature recording). The staff would have also looked back at the readings spike/fluctuation that is out-of- recorded on the 24-hour monitoring chart over the weekend to ensure that there is no break in cold chain. range over the weekend? (For fridges with monthly Staff would have been alerted when reading off the min-max thermometer on the next working morning if there had been recording chart) The chart only a temperature excursion during the period since the last check. He/she would then have to investigate further, with the shows the readings for the past 10 possibility of removing the entire chart from the housing in order to check for spikes in temperatures recorded on the hours or so. How would you know monthly recording chart. if a spike has occurred before that? 4c (To SPT) What will you do if you I will compare the max temperatures registered by the min-max thermometer and the 24-hour monitoring chart to were to observe a temperature ascertain if there is a break in cold chain. spike/fluctuation (above 8°C) recorded on the 24-hour If the min-max thermometer's reading is shown to be within range (i.e. no break in cold chain), I will proceed to record the monitoring chart? reading resulting from the temperature spike/fluctuation and the approximate start time and duration of the spike in the temperature record form, with reason(s) (e.g. due to receiving or issuing of vaccines) indicated under the Remarks column. However, I will seal off the fridge by putting up a sign to prevent other colleagues from taking drugs in the fridge out for use, notify my supervisor immediately, and document the readings (as mentioned) in the temperature record form if I were to observe temperature irregularities (unexplained fluctuations or temperature uptrending) recorded on the 24-hour monitoring chart, so that he/she can investigate and take timely actions to relocate the thermolabile stocks if that is necessary. Page 4 of 37 30-04-24 4d Does it constitute a break in cold Fridge temperature digital display only shows temperature of a particular time. chain if both the fridge digital I will check the 24-hour monitoring chart to determine whether it is also out of range. If both the 24-hour monitoring chart temperature display and min-max and the min-max thermometer registered out-of-range temperature range, then we can confirm that there is a break in thermometer showed out-of- cold chain. range temperature? 4e How would you check and I would check the charting of the 24-hour monitoring chart over the weekend and also the min-max thermometer in the document, when you return to morning when I return to work following the weekend. After verifying that the temperature had stayed within the allowed after a week-end or public holiday, temperature range, I will document this check in the field “Sat pm to Mon am” under the column “Period Measured” of the that the pharmaceutical fridges’ ‘Temperature Record for Pharmaceutical Fridge’. temperature have been monitored over the weekend or public As for monitoring of fridge temperature over a public holiday, likewise, I would check the charting of the 24-hour holiday? monitoring chart over the affected period (corresponding to the public holiday) and also the min-max thermometer in the morning when I return to work following the public holiday. After verifying that the temperature had stayed within the allowed temperature range, I will document this check in the appropriate field “XXX pm to YYY am” under the column “Period Measured” of the ‘Temperature Record for Pharmaceutical Fridge’, depending on which day the public holiday falls. 5a Are the temperature readings that They should be reliable since there is quality assurance for the temperature monitoring devices from which the readings are you are recording on the temp taken, in the form of (1) preventive maintenance checks for the pharmaceutical fridges (past warranty period) and recording form reliable? calibration of the temperature chart recorders, on twice a year basis (2) certificate of calibration for the min-max thermometers. 5b The temperature record form has The form was modified in response to 2 incidents that had occurred, whereby the nurses did not realise that the 24-hour been modified (the first column monitoring chart had stopped moving and they went on to record the previous day's readings. With this new column, staff 'Day'has been added in). What is will need to record the day of the week that is corresponding to the latest temperature readings shown on the monitoring the reason for adding in this chart as an additional check that the chart is moving. In addition, the form (1 sheet per week) is supposed to be changed at column? the same time as the weekly monitoring chart, for easier cross-referencing. 6 Do you monitor the temperature Yes. The temperatures of the pharmaceutical fridges are continuously monitored by the 24 hour temperature chart and min- of the fridges during the weekends max thermometer (domestic fridge temperatures are continuously monitored via the min-max thermometer alone) during and after polyclinic operating weekends and after polyclinic operating hours. However, they will not be read on these days and only read the following hours? working day. If a cold chain break is detected on the first working day following the Sunday/ Public Holiday, we will respond accordingly based on SOP. 7 When will you change the 24 hour The 24 hour temperature chart is changed every Monday morning. If Monday happens to be a public holiday, the chart will temperature chart of the be changed on the Saturday before the public holiday instead. The chart will be changed again on Tuesday the following pharmaceutical fridges, if Monday week, and every Monday thereafter. happens to be a public holiday? 8 How often would you change the The rechargeable battery for the circular temperature recorder should be changed every 3 yearly, whilst the battery for the battery for the pharmaceutical rectangular monthly temperature recorder should be changed every 6 monthly by the technical support personnel. fridge temperature recorder? 9 How often would you change the Fisher Digital Min-Max Thermometer batteries for the digital min-max thermometers? The batteries for the digital min-max thermometer should be changed every 9 months, or immediately when the oC symbol on the LCD display screen start to flash, LCD display starts to fade, or the thermometer displays erratic temperature readings, whichever earlier. Note: 1. The date of the battery change and the next due date should be indicated on the main unit. 2. The next due date shall be calculated based on the above recommended period of battery change. 3. For Fisher min-max thermometer, the temperature range needs to be reset once the batteries are removed from the main display unit. 10 Do vendors include thermometers Our vendors delivering thermolabiles do not include thermometers in the cold boxes which they use to deliver thermolabile in cold boxes used to deliver items to our pharmacy. Instead, they use validated cold boxes to deliver thermolabile items to our pharmacy. thermolabile items to your pharmacies? At the point of receipt, instead of checking the temperature within the cold box with a thermometer, the receiving pharmacy staff should check that the validated cold box is secured/sealed with a Velcro strap and yellow strip. The fact that If not, how do you check that the the validated cold box is secured/sealed indicates that the thermolabile items within the cold box has been stored within thermolabile items have been the recommended temperature range before reaching our pharmacy. stored at within the recommended temperature range during Pharmacy’s vendors are certified by HSA to comply with Good Distribution Practices. This includes handling of thermolabile transport to your pharmacies? items. Under this certification scheme, Pharmacy’s vendors are subjected to audits from HSA on their cold chain handling process (where validation reports and their cold chain handling processes are reviewed). Page 5 of 37 30-04-24 11 During a power outage situation, If the power outage take place during polyclinic’s operating hours and it is reliably projected that the power can be restored how do you handle the vaccines within 2 hours, we will keep the refrigerator door closed as far as possible to maintain the interior temperature for as long that are stored in the pharmacy? as possible. I will open the refrigerator door only when absolutely necessary and work as quickly as possible. If it is projected that the power cannot be restored within 2 hours, or if the power outage takes place after polyclinic’s operating hours, and there is a danger of the vaccines being exposed to high temperature subsequently, we will pack the vaccines into cooler bags with adequate ice packs and arrange them to be transferred to the nearest functioning pharmaceutical fridges that can store them at optimal temperature temporarily. However, if it is not feasible for the vaccines to be transferred to another refrigerator within the polyclinic, my CPM would liaise with the CPM of the nearest SHP clinic with sufficient refrigerator capacity and arrange the transfer of the vaccines to that clinic. The handover of the vaccines to the receiving clinic staff will be documented on the List of Vaccines Sent to Alternative Site for Temporary Storage and in line with the SOP on maintenance of vaccine cold chain. Page 6 of 37 30-04-24 E) Pharmacy Inventory Management 1a How are the stocks arranged in the Stocks are arranged largely according to the therapeutic groups. picking area? 1b How are the stocks arranged in the BM, MP, OT & TP pharmacy store? The drugs are arranged primarily according to dosage form and secondarily by drug subsidy classification i.e. SDL vs NS vs Retail (where applicable). Within each subgroup, the drugs are arranged in alphabetical order. PR, SK There are 2 pharmacy stores. One store holds mainly the syrups, while the other holds mainly the tablets and capsules. The drugs are arranged primarily according to drug subsidy classification i.e. SDL vs NS vs Retail (where applicable). Within each subgroup, the drugs are arranged in alphabetical order. BD, PG The drugs are arranged primarily according to dosage form. Within each subgroup, the drugs are arranged largely according to alphabetical order. 2a How does pharmacy monitor the Pharmacy manager will monitor consumption reports and stock balance closely with the help of PPIM reports. expiry dates of pharmacy stocks Poor expiry dates are identified and highlighted by staff during weekly stock checks and annual stocktake. (including slow-moving items)? Minimum shelf life is stipulated in procurement contracts. Expiry dates are checked during receiving of stocks. Drugs with short expiry date will have the expiry date written on pink colour tag and adhered to the yellow medication bins to highlight to staff during picking. 2b How do you manage short expiry There are several strategies/practices adopted by SHP pharmacies to manage short-expiry medications drugs ? Designation of one senior staff to monitor expiry of medications. Timely identification of such medications for close monitoring. Such medications can be identified during weekly stock checks, during picking or topping up Tagging of storage trays containing medications with short expiry to alert all pharmacy staff Medications with shorter expiry dates are dispensed/supplied as soon as possible, in line with FEFO, with patients/users being reminded during dispensing to use up the dispensed/supplied medication before expiry Prior to that, efforts are taken to ensure that medication stocks in SHP pharmacies have good expiry dates include: Specification of minimum remaining shelf-lives when procuring medications Stringent checks of expiry dates of medication stocks at time of receipts – stocks with short expiry dates not meeting requirements specified in POs are rejected if stocks are not urgently required Minimum stocks are stocked in SHP pharmacies, in a balance between ensuring continuity of supplies and fresh stocks of medications When a new batch of medication with longer expiry arrives in the pharmacy , the shorter expiry ones are removed from the shelf and placed in a separate location to facilitate closer monitoring. In our context, short expiry refers to acute medications with < 2 months shelf life and chronic medications with < 6 months shelf life. If our supplier does not have stock of newer batch of medication, Staff would need to inform and obtain patient’s agreement before we dispense medication. For SHP pharmacies who practise the following, staff can mention this as an additional point: If short expiry items are picked, these are indicated on their medication labels to highlight to dispensing staff so that they can inform patients to take before expiry 3a How does the pharmacy ensure Pharmacy store is kept cool and dry by 24/7 air-conditioning (below 25 oC and relative humidity at or below 75%). Temp that drug stocks are stored at and humidity are tracked twice a day using a hygro-thermometer. optimal temperatures and Thermolabile Items requiring refrigeration are stored in the fridge or transported in insulated containers with ice-packs on humidity? all sides. 3b Is there a guideline for humidity In accordance with the ASEAN Guideline on Stability Study of Drug Products, the upper limit for Relative Humidity is 75%. control since humidity readings are recorded? 3c What steps are taken to ensure These drugs already come in appropriate moisture-resistant packaging by the manufacturer and they are kept at humidity proper storage of moisture- at or below 75% in the pharmacy store. sensitive stocks? 3d If this (refer to pharmacy store) We monitor the temperature (and humidity), using a thermohygrometer twice daily, at the start and end of the day. If the temperature is above 25oC say due air-conditioner is defective and temperature climbs above 25oC, the pharmacy manager will be alerted by the staff assigned to air-con breakdown, how are we to perform this twice daily monitoring, and will take timely action to call the maintenance company in to rectify the being alerted? problem. In fact, the pharmacy manager will be alerted even before the temperature climbs above 25oC, if any staff senses that the surrounding is warmer than usual, or the staff assigned to perform the monitoring notices an abnormal trend in the temperature. The pharmacy manager will thus take timely action to call the maintenance company in to rectify the problem. 3e Why does your pharmacy use Using temperature point readings is adequate for temperature monitoring of non-thermolabile medications kept In our point reading to monitor the pharmacy store. This approach was acceptable to the our national regulatory authority when they conducted periodic temperature of E-kit items kept in inspections of our pharmacy. your pharmacy store whereas the Nursing department of your As for our nursing colleagues, as they are already using min-max thermometers to monitor the storage temperatures of polyclinic monitors the min-max their thermolabile items (vaccines) and are familiar with the use of these instruments, they use the same type of temperatures of E-kit items in thermometer to monitor the storage temperatures of their e-kit chillers. their E-kit chillers? Page 7 of 37 30-04-24 3f What would you do if the relative Based on our tracking and trending of RH within the pharmacy store, we have been able to achieve maintenance of the RH humidity (RH) of the pharmacy at below the upper limit of 75%. store exceeds 75%? In the event that we encounter a RH reading of above 75%, we will take immediate measure to bring down the RH e.g. by adjusting the air-conditioner settings and/ or acquiring and using a dehumidifier. Temporary exposure to above RH of 75% will not significantly impact the stability of the stored pharmaceuticals as they usually come in protective moisture-resistant packages or even desiccants (in the case of loose tablets supplied in bottles). 4 What is the recommended The recommended temperature range is 2 to 8ºC because that is within the recommended temperature range for the drugs temperature range for this fridge? kept in the fridge. (referring to the domestic fridge) 5a What would be a break in cold When the max/min thermometer in the fridge shows any temperature out of the 2 to 8ºC range. chain for these items? (domestic fridge) 5b Will you dispose of the drugs when No, I will seal the fridge to prevent other colleagues from taking drugs in the fridge out for use, & immediately inform my there is a break in cold chain? pharmacy manager who will determine if each drug need to be disposed. (Note: these are thermolabiles other than vaccines e.g. insulins, eye drops) 5c (To the Pharmacist) What would I will check the maximum fridge temperature reached & check the insulin's product literature or other drug references for you do if there is a break in cold the recommended shelf life of the insulin at that temperature. If necessary, I will contact the product's agent or chain in the pharmaceutical/ manufacturer for the information. domestic fridge that stores the insulins? 5d Why are you using the domestic Insulin requires storage at the temperature between 2 to 8oC. It would be ideal to keep the insulins in the pharmaceutical fridge to store the insulins? fridge. But due to space constraints in the pharmaceutical fridge caused by increased storage space required for storing vaccines (due to increased range, volume and presentation of the vaccines), we have no choice but to store insulins in the domestic fridge for the time being. We will move the insulins to the pharmaceutical fridge at the earliest opportunity, when space permits. 5e Is it reliable to store the insulins in The temperature of the domestic fridge is monitored by the min-max thermometer and staff will check the temperature the domestic fridge? readings twice a day to ensure that the temperature in the domestic fridge is kept within the recommended storage temperature of the insulins. 6 How does the pharmacy dispose Drugs are segregated into a box marked as “Do not use. Drugs for condemnation”. expired or deteriorated drugs? CPM will raise condemnation form to seek polyclinic director’s approval. Drugs are condemned according to MOH’s Guidelines For The Disposal of Pharmaceutical Wastes in the presence of the NM/CE. 7a What are the drugs that should be Antibiotics, cytotoxics, vaccines disposed as biohazardous materials? 7b What is the process for such (Describe as stated in MOH’s Guidelines For The Disposal of Pharmaceutical Wastes) biohazard disposal? 7c How do you dispose of We will remove the tablets from the blister packaging or bottle, have the tablets crushed or wetted with water, and dispose condemned tablets if they are not into general waste bin. meant to be disposed into biohazard bins? 8 How does the pharmacy deal with CPM will report significant product defects to the vendor and arrange for stock replacements if necessary. defective stock? CPM will keep Pharmacy Admin informed. 9 How is a product recall (Staff refer to Pharmacist.) conducted? a) We will determine the product involved, batch number(s) and level of recall based on the recall notification received. b) We will remove the affected stocks from storage areas and quarantine them with clear labelling to avoid accidental usage. c) The purchase orders/ delivery orders of the product involved will be traced to determine the date of receipt of the affected batches. d) If the recall is to retail level, we will count the affected quarantined stock quantity, report to Pharmacy Admin, and follow up as instructed by Pharmacy Admin e.g. return of affected stocks to vendor. We will also document the recall as per requirement stipulated in SOP. e) If the recall is to consumer level and patients’ details are traceable from pharmacy computer system, we will generate the list of patients dispensed with the affected drugs (inclusive of Pharmacy-only items or p-sales items) between the date of receipt and date of recall. We will contact the patients via phone, and if unsuccessful via letter, in accordance to SOP. When patients return the stocks to us, we will either provide an exchange or put up refund request as per the SHP Management-approved recall strategy. The documentation of the recall process will be carried out according to the requirements stipulated in the SOP. We will report to Pharmacy Admin and undertake follow up actions as instructed by them. The figure below helps to illustrate how 100% recall of all affected patients is achieved Page 8 of 37 30-04-24  f) If the recall is to consumer level and patients’ details are not traceable from pharmacy computer system e.g. GSL items, the consumers will learn about the product recall via mass media i.e. public notices put up by HSA &/or advertisements put up by the vendors involved. When the consumers returned the stocks to us, we will either provide an exchange or put up refund request as per the SHP Management-approved recall strategy. We will also report to Pharmacy Admin and undertake follow up actions as instructed by them. 10a During a product recall, when Product recall strategy is reviewed and approved by SHP Management. are staff required to personally In product recall, where the product defect may potentially be life-threatening, it will be critical deliver the patient alert to contact the patient as soon as possible. If patient is uncontactable vide phone (e.g. incorrect contact letter to the stated address number etc) , staff may then be required to deliver the patient alert to the patient's home. in patient's records? 10b How is the doctor kept informed The CPM will inform the Polyclinic Director of any recall, and the latter will then inform his/her doctor where necessary. of an ongoing product recall? The CPM will work closely with Pharmacy Administration to ensure continuity of supply of all affected drugs. Where necessary, the CPM will discuss with his/her Polyclinic Directors to draft a list of alternatives which can be prescribed in place of the affected drug, so as to facilitate communication to the doctors. 11 What do you check for when Before receiving deliveries of drugs by vendors, the invoices or delivery orders shall be checked against the original receiving stocks from vendors? purchase orders as well as the actual stocks to ensure that the items and quantities delivered are correct. The delivered stocks shall be checked for the following possible problems: a) Expired stocks or stocks with short expiry dates or expiry dates that are different from the expiry dates specified in the purchase orders. b) Damaged goods. c) Improper delivery conditions e.g. items that require refrigeration are not delivered in a cooler or suitable insulated container with ice packs. If any of the above problems are found, or the delivered stocks are unacceptable for any other valid reason, the stocks shall be rejected. 12 Describe your process of handling We do not keep controlled drugs in SHP. controlled drugs. 13a How do you identify the drug if Cut blister strips are stored in drug containers that are labelled with the drug name. The drug can also be identified by the you pick up one cut blister strip imprint, shape, size or colour of the tablet, or imprint or colour of its blister backing, by comparing with an uncut blister containing one tablet which does strip. not show the drug name? (e.g. levothyroxine 25mcg) 13b Some of the blisters have been cut Most medications stocked in SHP pharmacies are fast-moving. Hence, there is minimal risk of medications expiring before such that you cannot see the they are dispensed to patients. expiry date on the blister anymore. How do you ensure that Nonetheless, we do have measures, as follows, to minimize the chances of dispensing expired medications to patients: expired medications are not dispensed to patients? Pharmacy manager will monitor consumption reports and stock balance closely with the help of PPIM reports Poor expiry date identified and highlighted by staff during weekly stock checks and annual stocktake. Minimum shelf life is stipulated in procurement contracts. Expiry dates are checked during receiving of stocks. Drugs with short expiry date will have the expiry date written on pink colour tag and adhered to the yellow medication bins to highlight to staff during picking. 14 Why are there different pre-pack There is space constraint. The trays currently have partitioning and proper quantity labels for the different pack sizes in the sizes of medication in the same tray. yellow tray? Should they be separated so as to reduce the risk of incorrect picking? 15* Do you need to debox medications We will debox and discard cartons that are soiled or wet, cartons for flammable cabinet items, fridge items (to maximise from their shipping/delivery storage space and cooling to ambient fridge temperatures) and cartons from non HSA GDP-certified suppliers (usually cartons? suppliers of bottles, bags & some retail products). Shipping cartons (those with shipping labels) from HSA GDP-certified suppliers need not be deboxed as adequate pest control programme is a criteria for GDP certification. Deboxing these is neither practical nor a good utilisation of our limited resources, & may lead to higher risk of medication error. To mitigate the risk of pest infestation, SHP has engaged the services of pest control vendors. Page 9 of 37 30-04-24 16 Why are creams/ointments stored Cartons of solutions/mixtures are usually too heavy for staff to carry up and down. Therefore it would be more practical to on the top shelves and store the heavier items at the bottom shelves and lighter items at the top shelves. solutions/mixtures on the bottom shelves in your liquids store? 17 What is the expiry date of the ICM The expiry date of ICM Disov plaster remover is labelled on the bottle. Based on the advice of the manufacturer, ICM Disov Disov plaster remover and how plaster remover can be used up to the expiry date labelled. long after opening can it be used? 18 What is the storage temperature and shelf life for the multi-dose injectables (i.e. Testosterone Depo 1g/10ml inj, Cyanocobalamin 10mg/10ml inj, Streptomycin 5g inj) after opening? (Note: different shelf life when stored in Nursing Treatment Rooms) 19 How often do you change the Water for reconstitution of antibiotics is changed every working day (refer to date labelled on the container). water (referring to water for reconstitution of antibiotics)? 20 What is your procedure for For used E-kits, we will top up the used item(s) immediately when the nurse brings the E-kit to the pharmacy for replenishing emergency replenishment. For all emergency medications that are near expiry, the E room nurse is supposed to highlight to Pharmacy medications ? two months ahead of the expiry date so that replacements can take place in a timely manner. 21 If discrepancies between the The stock discrepancy will be investigated and documented. Stock discrepancies documented during stock checks from physical quantity and PPIM April to September will be reconciled in Oct after approval from management. quantity are discovered during weekly stock counts, what would As for stock discrepancies investigated and documented from Oct to the following March, stock reconciliation will be you do? performed following the annual 100% stocktake, after management’s approval. 22 What could have caused the The discrepancy could have arisen from the vendor end. Whilst pharmacy staff will check the quantity delivered at the discrepancy in the quantity of the point of receipt, it is not feasible for the staff to open up each individual box or bottle to count the tablets/capsules inside clonazepam? as there is insufficient time to do. However, any discrepancy in quantity will be detected during pre-packing or our monthly checks, and Pharmacy will then follow up with the vendor to rectify the matter. Note: Do not mention that the discrepancy in the quantity of the abusable drug is due to picking/ keying errors. 23 How do you ensure that the In our busy polyclinic environment, it is not feasible to open all delivered cartons at the time of delivery to count the quantity and contents within the delivered medications especially when the quantity we receive is huge. If the drugs are delivered in its original external carton is accurate when manufacturer’s carton, the quantity reflected on the carton is usually accurate. However, if we notice that the original you do not open up external manufacturer’s carton has been tampered with, we will check the contents of the carton. We have an understanding with carton for checking? ALPs and the drug vendors that we can report any discrepancies discovered after receipt of stocks (when we have more time to check), and they will make good any shortages. So far, vendors have accommodated our follow-up requests to make good shortages in medication delivery quantities. 24 How do you quarantine affected When there is a break in cold chain, the affected items will be labelled “Under Quarantine, Do Not Use” and segregated fridge items ? from unaffected items. Items on quarantine will be kept away till investigations are completed. 25 How do you ensure that the staff Only experienced and senior PTs are entrusted with stock receiving duties, particularly receiving of thermolabile items. receiving the thermolabile items These PTs must also have been assessed competent in receiving of stocks and in maintenance of cold chain for thermolabile put the receiving stocks in the items before being assigned such duties. fridge? There are guidelines/SOPs in place on how stocks of medications should be received as well as how cold chain should be Is it purely by human memory or is maintained for thermolabile items whilst in the pharmacy and up to when they are supplied/dispensed. These there any checks in place? guidelines/SOPs are regularly reviewed and updated, and serve to empower staff in performance of related duties, along with OJT and competency assessment. We have also been advised to concentrate whilst performing stock receiving and not to attempt to multitask, and to move on to other tasks e.g. dispensing duties only after we have completed our stock receiving duties, especially when receiving stocks of thermolabile items. F) Pre-packing of Medications 1 What is the purpose of pre- To improve efficiency of the dispensing process and reduce waiting time for patients packing medications? 2 How do you prevent errors from Pre-packing of one item shall be completed before commencing on the next and completed within the same day. occurring during the pre-packing Process is supervised by SPT who does reconciliation after pre-packing of each item is completed. 3 How do you ensure that the cut Issued bulk item for each pre-packing activity should be of the same batch i.e. there should not be mixed batches in a pre- blister strip in the pre-pack is of pack. Any loose quantities remaining after a pre-packing activity should be transferred to the dispensing area to be the same batch as the rest? dispensed out, i.e. remaining loose quantities should not be mixed with other batches of pre-packs. Page 10 of 37 30-04-24 4 What happens to the loose The loose quantities will be recalled together with the affected batches, as we will conduct a 100% recall of patients who quantities (those without batch & had been dispensed the affected drug between the date of receipt of the affected batches and the date of recall. expiry which have been channelled to the dispensing area) when there is a product recall? 5 How is the stainless steel tray for The stainless steel tray is washed and dried before and after each use. The hot air oven may be used to hasten drying pre-packing cleaned? before use (for those clinics with bigger ovens); otherwise the tray has to be air-dried in time for the next pre-packing activity. 6 (To packer) How do you ensure I will pack the number of tablets/ capsules according to the instruction from the designated senior Pharmacy staff. that the quantity of the drug in each Ziploc bag is correctly At the end of the prepacking, the information of the pre-packing work that I have done will be documented in the Pre- packed? packing forms. The designated senior Pharmacy staff will reconcile the quantities of the pre-packs before and after the prepacking. He/ she will check the documentation of the pre-packing process and check that the quantity of the pre-packs are correct by random sampling. 7 (To packer) How do you ensure I will pack one drug at a time and make sure that I have completed packing that drug before moving on to another one. that there is no mix-up of drugs during the packing process? 8 What information should labelled Containers of non-blister packed tablets/capsules and olive oil eardrops pre-packs are labelled with: on the containers of non-blister - Name of medication and quantity of the active ingredient packed tablets/capsules and olive - Batch number oil eardrops pre-packs? - Beyond use date Note: The above labelling requirements are required for pre-packed medications under the Health Products Act. 9 How do you derive at the beyond The beyond use date stated on the labels on the containers of non-blister packed tablets/capsules and olive oil eardrops pre- use date labelled on the packs will be the expiry date indicated on the original packaging i.e. manufacturer’s container, or 1 year from the date of containers of non-blister packed pre-pack, whichever is earlier. tablets/capsules and olive oil eardrops pre-packs? Page 11 of 37 30-04-24 G) Dispensing 1a What are the checks put in place The system of checks put in place at Pharmacy encompasses: at pharmacy to ensure that the right medication is dispensed to 1) Prescription Verification the right patient? - staff will check Rx for no omission of legally required information - staff will check Rx for appropriate dosage, therapeutic duplications and drug interactions - staff will check for special instructions from the prescriber, and any prescription ambiguities that require verification with the prescriber 2) Picking and Packing Medications - staff will employ the 3 step checking method (check labels against Rx before picking, check medications against labels before labelling, and check medications against Rx before signing off on the Rx) 3) Dispensing Medications - staff will check the packed medications against the labels, and labels against the Rx - staff will verify the patient's identity in accordance with SHP's 2-identifier policy - staff will check patient's allergy status - staff will counter check with patient the indications of the drugs, and clearly explain to the patient the prescribed dosage instructions and any precautions/special points to take note of. (Staff to refer to 'Essential Steps in Dispensing Prescriptions' reminders put up at the picking area) 1b How do you ensure the 5 Rights Right Patient (Right Patient, Right Drug, Right - 2 patient identifiers protocol (note: staff should be able to describe) Dose, Right Time, Right Route)? Right Drug - Routine check with patient for drug allergies, with verification against the allergies stated on the prescription. - Verify with patient the medication’s indication(s). - 3 step dispensing process to prevent errors. Right Dose & Route & Time - Refer to drug information references if unsure, especially for paediatric dosing. In addition, to check for: - Drug Interactions. - Therapeutic Duplication. - Special Prescriber Instructions. 2a How do you make sure that you I will verify the patient’s identity by checking 2 patient identifiers. I will ask the patient to show me his NRIC/appointment are serving the right patient? card & tell me his NRIC no., which I will then use for checking against the prescription. (Note: If this fails, to proceed to ask the other 4 identifiers in order of priority: Full Name DOB Address Telephone number Ask the patient to show or tell you. Do not read the identifier & ask patient to confirm). 2b If the patient does not have an I will ask for his name, and one other identifier (address or date of birth or telephone number) appointment card or IC with him & cannot remember his NRIC number, how do you verify his identity? 2c Why didn't you ask to see patient's I observed that the patient is not holding the appointment card in her hands & is carrying a big handbag. Sometimes appointment card (if auditor patients may take a while to search for the appointment card in their belongings & it is faster to ask verbally for the 2 notices that you asked the patient identifiers instead. to tell you her 2 identifiers (Or give other appropriate reasons. Do not say that appointment card is not necessary) instead) 3 Can you accept manual Only during systems downtime when electronic prescriptions cannot be generated. handwritten prescriptions from your polyclinic doctors at the outpatient pharmacy? 4a How do you ensure that the Tools/measures to ensure patients understand how to take their medications include: patient understands you? ·Label instructions ·Pictograms for illiterate patients. ·Speak to the patient in his/her own language. Otherwise get an interpreter (another staff). If necessary I can refer to the language proficiency list to check who among our staff can speak the patient's language. (To be able to show the hardcopy or softcopy list in SHP Intranet> Work Services>Docupedia> Clinical Services>List>Staff Language Proficiency List (SHP-CS- SLP-001) which includes all staff in the clinic) ·PILs ·Medication counselling - patient/caregiver should be able to teach back what has been taught to him/her Note to CPMs: Pls try not to mention writing down of patient’s instructions in their own language as this practice of manually writing label instructions is unsafe due to the risk of committing errors in writing down the instructions. However, in some situations, this may be unavoidable if requested by patients, in which case extreme care must be exercised by the staff concerned to avoid committing mistakes in the process. 4b How do you ensure that a deaf & Label instructions (& sign language if you are familiar), or counsel the caregiver if present mute patient understands you? 4c How do you ensure that a blind Counsel verbally, or counsel the caregiver if present patient understands you? 5 How do you know the patient Patients and/or caregivers should be able to explain/repeat/teach back/demonstrate what they have been taught. understood what you have taught them? Page 12 of 37 30-04-24 6 (To CPM) What kind of patient Medication review, medication counselling, use of medical equipment (eg. BP monitors, glucometers) and devices (eg. education do you provide? Inhalers). We will document the counselling conducted in SCM Clindoc (FAM Pt Education and Counselling) module. 6a (To CPM) What are the differences Medication review is a structured session where the main objective is to resolve medication-related issues e.g. issues which between medication review and affect the patient achieving his/her prescribed drug therapy goals. Hence doctors can send patients to Pharmacy for medication counselling? medication review if they feel that the patients may have medication-related issues e.g. when patients do not achieve therapeutic target despite adjustment of drug therapy. There are 2 criteria for referring patients to Pharmacy for medication review i.e. that patient has medication-related issues and/or on 5 or more chronic medications. On the other hand, medication counselling is a patient education session conducted by pharmacist when the patient faces an inadequate understanding of his/her existing medications. Hence, doctors can send their patients to Pharmacy for medication counselling if they want to empower their patients with better understanding of their prescribed medications. usually if a new medication has been prescribed to the patient. 7 What are the educational methods Personal counselling, and/or provision of educational materials available to patients? 8 On what basis do you select the The education method should be consistent with the patient's and family's values and preferences. method to educate the patients and their family? 9 What teaching or educational Patient information leaflets (online: materials do you have? http://infopedia/SHP/WS/Pages/Clinic%20resources/Patient%20Education%20Materials/Medication%20Information%20Le aflets.aspx ), educational slides (eg. Anticoagulation & warfarin found in pharm shared drive) 10a Does the patient receive any Yes. When doctor specifies on the prescription the indication for a PRN medication, the indication will be typed or hand- written information on the written onto the medication label. appropriate use of PRN medications prescribed? 10b Do you intervene if the indication This is not always feasible as the doctors will be constantly interrupted if we were to do so. This can be avoided if the doctor is not stated for PRN medications had already specified the PRN indication(s) on the prescription. on the prescription? 11 What are the care processes in the The main role of Pharmacy is to ensure that medications are supplied correctly to the patients. pharmacy that may possibly pose risk to patients? (What are the risk There is a possibility of errors in processing prescriptions & dispensing. areas in Pharmacy?) What are you doing to reduce such risks? To prevent errors, there is a system of checks that are in place as per “Essential Steps in Dispensing Prescriptions” (staff can point to the Essential Steps In Dispensing Prescription which has been pasted on the wall). Checking of 5Rs (Right Patient, Right Drug, Right Dose, Right Time, Right Route ) also helps ensure that the correct drug is dispensed to the correct patient. For example, during entering prescriptions, I will clarify all ambiguities and do a final check on PPIM before “confirming” the order. During filling of prescriptions, I will check the labels against the prescription before picking, check drugs against labels before labelling and check drug against prescription before signing off on the prescription. During dispensing, I will do a thorough check i.e. check drugs against label and labels against prescription, call patient and verify their identity in accordance to SHP’s 2-identity policy. In addition, I will counter check with the patient indications of the drugs and will also check whether they have any known drug allergies. Further, the use of coloured labels for look-alike sound-alike (LASA) drugs and multiple strength drugs, HAM labels, and tall man lettering labelling system help to alert us to exercise more caution during the picking of the drugs. Placing of physically similar drugs as far apart as possible reduces the risk of picking errors. The rostering of staff duties i.e. keying, picking and dispensing helps to reduce risk of medication errors which may arise due to fatigue. 12a Do you know about care processes From actual incidents reported via incident reporting, we are updated by our manager on the care processes that pose risk that pose risk to patients? to patients. 12b How do you make use of these We will learn from these incidents (e.g. errors) & share with our staff how to take measures to prevent such incidents (e.g. data to improve care? errors). 13 What is the duration for storing 2 years (3 years for CDs) in a secured place. prescriptions? 14a How should pharmacy staff handle Interventions will be handled or screened by a pharmacist. Interventions will be performed in a timely manner. Staff will prescription interventions? either visit the doctor for rectification & obtain the amended prescription or call the doctor regarding prescription interventions using 3R Read Back Protocol to make the necessary amendments in the SCM e-prescribing module immediately. (Note: Staff should be able to describe how to perform 3Rs verification). Hardcopy Rx will be set aside while awaiting amendment of the Rx (with intervention notes written on it). The prescription shall be dispensed only after the corresponding amendments have been made in PPIM. (To note: Pharmacy staff will have to follow up to ensure that the amended hardcopy Rx (corresponding to the final dispensed orders in PPIM) is received by the end of the day, and attach it to the first Rx which had been earlier set aside). 14b Can you describe the 3Rs protocol Pharmacy staff shall Record details of interventions and verifications on the prescription (First R). The details of the as applied to Rx intervention over intervention shall be Read back to the prescriber (Second R) and confirmation shall be Received (Third R) by the pharmacy the phone? staff who performed the prescription intervention. Page 13 of 37 30-04-24 14c Do you dispense first if the doctor I will dispense after the necessary amendments have been made in the e-prescribing module and received into PPIM. I will has not provide the amended then follow up to ensure that the amended hardcopy Rx (corresponding to the final dispensed orders in PPIM) is received hardcopy prescription? by the end of the day, for reconciliation with the first Rx which has been set aside. 14d What if the doctor still fails to Will remind the doctor, or go to doctor's consultation room (myself or a colleague) to obtain the amended prescription. amend the prescription? 14e What if the doctor has left the Will approach a senior doctor (Clinic Director or Deputy Director preferably) for help in generating an amended clinic? prescription. 14f What does the staff do while The staff who made the intervention will place the prescription that is awaiting amendment in a designated tray/area (not waiting for the prescription to be to be mixed with other prescriptions). If necessary, he/she will inform the patient that there will be a delay in processing amended? his/her prescription. After receiving the amended prescription electronically or manually (HA sending amended hardcopy prescription should be instructed to pass it to staff at designated pharmacy counter, and not drop it into prescription box), he/she will follow-up to ensure that the correct medications are processed for dispensing as per normal procedures. 14g Does the pharmacy system alert It depends. you when the doctor has made an amendment to the prescription in For prescription amendments initiated by the doctor (without staff knowledge): the e-prescribing module? The pharmacy system will not alert me if the amendment had been made before the hardcopy Rx is received at the pharmacy and scanned into the pharmacy system. However, staff who are verifying the hardcopy prescription against PPIM should be able to detect the differences, if any. PPIM will also not alert me if the doctor makes the amendments after the prescription has been dispensed out to the patient. The doctor initiating the amendments should inform us of the intended changes, so that the wrong Rx is not processed/dispensed out. However, PPIM does have an additional check at the point of dispensing to alert the staff if amendments had been made by the doctor while the Rx is being processed. For prescription amendments initiated by pharmacy staff (i.e. as a result of pharmacy intervention): Pharmacy staff will contact the prescriber to make the necessary changes in the e-prescribing module, and obtain the amended hardcopy or check PPIM periodically to see if the amended orders have flowed in. Staff who made the intervention will need to acknowledge the amended orders in PPIM for processing before dispensing. There will be an alert/prompt to the staff at the point of dispensing if there are amendments made by the doctor which have not been acknowledged earlier on during the processing of the prescription. Once the prescription has been dispensed out in PPIM, pharmacy staff will not be alerted to any further amendments initiated by the doctor. 14h To PT: What would you do if you Depending on the complexity of the problem, either I, under the supervision of my pharmacist, or my pharmacist encounter a problem with the himself/herself will resolve the problem through undertaking prescription intervention in compliance with 3R/ Read Back prescription? Protocol. 14i What is the rationale of using 3R Mistakes can result from verbal messages which are misheard or misunderstood. This can result in miscommunication Read Back Protocol? between healthcare providers caring for a particular patient, which may affect quality care and/or patient safety. The 3R protocol used during prescription interventions (over the phone) helps to ensure that no miscommunication occurs between pharmacy staff and the prescriber/doctor, thereby ensuring that medication errors do not occur. 14j When do you perform a I will perform prescription interventions if I encounter any doubts concerning the prescriptions which requires clarification prescription intervention? with the prescriber to ensure delivery of safe and quality care to patients. Prescription interventions may be carried out in, but not limited to, the following scenarios. 1. Omission of legally required information 2. Inappropriate dose, frequency and duration of therapy 3. Therapeutic duplication in patient’s drug regimen 4. Drug interactions 5. Unavailability of medicine prescribed 6. Any ambiguity or special instruction that requires verification with the prescriber 7. Hand-written amendments or instructions over the ordered medication on the prescription by the prescriber and they are not captured in SCM. (Note: Manual entry on the prescription may lead to potential medication errors as the next prescriber may not be aware of the amendment or instructions. In addition, this practice is discouraged as this may lead to unnecessary disruptions to both the prescriber and pharmacy staff.) 14k Does the pharmacy system alert For prescription amendments initiated by the doctor (without staff knowledge): you when the doctor has made an PPIM will not alert pharmacy staff if the amendment had been made before the hardcopy Rx is received at the pharmacy amendment to the prescription in and scanned into the pharmacy system. However, staff who is verifying the hardcopy prescription against PPIM should be the e-prescribing module? able to detect the differences, if any. PPIM will also not alert us if the doctor makes the amendments after the prescription has been dispensed out to the OR patient. The doctor initiating the amendments should inform us of the intended changes, so that the wrong Rx is not processed/ dispensed out. How do you know whether the However, PPIM does have an additional check at the point of dispensing to alert the dispensing staff if amendments had doctor has made an amendment been made by the doctor while the Rx is being processed. to the prescription in the e- prescribing module? For prescription amendments initiated by pharmacy staff (i.e. as a result of pharmacy intervention): We will know that the doctor has made amendment to the prescription in the e-prescribing module when we received the amended hardcopy Rx or when the amended orders have flowed in to PPIM when we perform periodic checks in the pharmacy system after the prescriber has been contacted to make the necessary changes in the e-prescribing module. Staff who made the intervention will need to acknowledge the amended orders in PPIM for processing before dispensing. If the amendments made by the doctor have not been acknowledged earlier on during the processing of the prescription, there will be an alert/ prompt in PPIM to alert the staff at the point of the dispensing. However, once the prescription has been dispensed out in PPIM, we will not be alerted to any further amendments initiated by the doctor. Page 14 of 37 30-04-24 14I With scriptless dispensing workflow, During the picking process, the picker needs to check picked medications and medication labels against the eRx (in PPIM) what do you check for when picking before releasing the basket of picked medications to the dispenser for dispensing. the medications to ensure medication safety? To facilitate checking of medications within zip-lock bags, staff have been advised/instructed to stick medication labels on the side of the bag printed with the pictogram. This will allow the dispenser to more easily check the picked medications through the transparent side of the zip-lock bag. 14J How does the pharmacy ensure that CPMs routinely conduct audits to check that the staff are adhering to the dispensing workflow. the dispensing workflow is adhered to by staff, including the checks. 14K When he/she is in the midst of Dispenser will be prompted in PPIM that there is amendment when he/she scans the QR code on the label or clicks processing a Rx, will the dispenser. know if the doctor had made amendments in the Rx after the patient had left the consultation room) ? 15a Do you consider prescriptions Yes. A near miss is an incident which was detected and harm, loss or damage was prevented, but if not detected could have intervened as near misses? How led to an adverse event. These include prescription errors that did not reach patient due to pharmacy intervention. do you define a near miss? 15b Do you monitor such prescribing Yes. Intervention details related to prescribing errors will be documented on the prescription, and subsequently keyed into near misses? If so, how? Prescription Intervention Management System (RIMS) in PPIM. Pharm Admin will send the collated data for all clinics on a monthly basis to Quality Management Dept for analysis, after which QMD will produce clinical quality indicators called Prescription Error, expressed as a percentage for each type of error & also the overall error rate. 15c Do you know whether your clinic The Prescription Errors will be displayed in a common area (please know where) for staff reference every month. The PMEs has improved in reducing such may also be shared with all staff in the clinic during clinic meetings. near misses? What happens if the Prescription If the Prescription Error indicator doesn’t meet target or is high compared with other clinics, our clinic will need to take steps to 15d Error indicator for your clinic doesn't identify the causes and address them accordingly. We could embark on a quality improvement (EPIC) project to do so. meet target? 16a Please show me how you are We document dispensing near misses [staff should be able to locate and show the near misses recording form if asked by monitoring near misses which may the auditor]. The clinic pharmacy manager will then submit the collated monthly near misses summary to Pharmacy occur during your dispensing Administration for onward submission to Quality Management (QM). Medication errors (including near misses) collated by process QM will then be submitted to the Ministry of Health (MOH) as required by MOH from January 2017 onwards. In addition, we correct the near miss once it is picked up via immediate communication to the relevant staff who will rectify and learn from that error. The clinic pharmacy managers will take note of the dispensing near misses committed for highlighting vigilance to the staff during staff meetings. Regular audits on the dispensing process are also carried out by the pharmacy manager or designated pharmacists to pick out areas of shortfall for rectification. 16b Do you report dispensing near Actual dispensing errors that reach the patient will be reported via incident reporting. Dispensing near misses are misses? documented and rectified immediately, and these may be highlighted to the Pharmacy Medication Safety Workgroup for solutioning so that more effective measures and system changes may be instituted to prevent error. 17a Does the pharmacy capture Actual dispensing errors that reach the patient will be reported using the SHP Incident Report (available at: dispensing errors and how are http://shpdocupedia/SHP/QM/FT/PublishedDocuments/SHP-QM-IR-T001_Incident%20Report%20Form_Rev%204.pdf) these errors documented? 17b What is the purpose of incident The purpose is for the affected parties to share and learn from the incident and, where necessary, work together to reporting? institute system changes to prevent further incidents from happening. 18a How would you define medication A medication error is any preventable event that may cause inappropriate medication use & jeopardise patient safety (e.g. error? prescription error) 18b Are medication errors confined to No. Medication errors also include errors arising from medication administration to patients by nurses & doctors (eg. prescribing & dispensing errors? vaccination) 18c Are medication errors confined to No. They include near misses too. actual errors that have happened? 18d (To PSA) Are you aware of I am not aware as my duties do not include the processing of prescriptions. pharmacy medication errors and PME indicators? 19a When can you interrupt a care Only when there is a time-sensitive safety or patient care issue (as per Framework for Patient Care SHP-CS--PC-F001) provider when he is with a Otherwise wait till the care provider finishes with the patient before approaching him/her. patient? 19b Can you give 2 examples of time- Medical emergency & prescription clarification with doctor for waiting patients sensitive safety or patient care issues? 20 What do you do with the findings The pharmacist will inform the staff of the findings & how to address the gaps. of the audit of the dispensing process? 21 Is there any process in the Patient can feedback on his experience of using his medications (eg. side effects, lack of efficacy) to the pharmacist during pharmacy where a patient can be medication review. The pharmacist can then give appropriate counselling if necessary to mitigate these problems or advise involved in improving his use of him to consult the doctor to review the use of the medication concerned. medications? Page 15 of 37 30-04-24 22a Do you use short-forms to I do use abbreviatons for some dosage forms. Eg. atenolol 50mg tab, where tab refers to tablet. document medications your patients are taking? Can you give me an example if you do? 22b How do you ensure that there will I use only abbreviations listed in the standardised SHP Abbreviations List. be no misinterpretion of the abbreviations you use? 22c Can you use an abbreviation for The abbreviations list can be assessed in our SHP Intranet. There is no approved abbreviation for chlorpheniramine, I will chlorpheniramine? How can you spell it in full. check? 23a Is paediatric medication dosing Doctor will prescribe based on weight if the child is a neonate (below 1 month), or if the medication has a narrow prescribed according to age or therapeutic index, or if the child is extremely overweight or underweight. In all other circumstances dosing will be weight?