SOP 11 Preparation of medication into Monitored Dosage Systems (MDS)
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SOP 11 Preparation of
medication into Monitored
Dosage Systems (MDS)
Document Reference SOP 11
Date of first issue April 2013
Version 6
Review Date June 2019
Next Review Date June 2021 or sooner if required e.g. change in
legislation, serious incident
Prepared by Paula Murphy MPSI Superintendent Pharmacist
Yvonne Griffin MPSI
Approved by (Supervising Pharmacist)
Pharmacy to which this SOP relates
Date of Implementation in this Pharmacy
Roles to which this SOP relates Pharmacists
Pharmacy Assistants
Pharmacy Interns/APPEL Students
Pharmacy Technicians and Trainee Pharmacy
Technicians
1
Contents
1 Introduction .......................................................................................................................................................... 3
1.1 Context ......................................................................................................................................................... 3
1.2 Purpose ......................................................................................................................................................... 3
1.3 Scope ............................................................................................................................................................ 3
1.4 Staff training ................................................................................................................................................. 4
2 Procedure ............................................................................................................................................................. 4
2.1 Patient Assessment ...................................................................................................................................... 4
2.2 Patient consultation ..................................................................................................................................... 4
2.2.1 Patient consent ..................................................................................................................................... 4
2.3 Planning for MDS .......................................................................................................................................... 5
2.3.1 MPS script scheduler. ........................................................................................................................... 5
2.3.2 Promotion of an MDS service ............................................................................................................... 5
2.3.3 Pharmacy facilities and resourcing ....................................................................................................... 5
2.3.4 Equipment ............................................................................................................................................ 5
2.4 What not to store in MDS packaging: stability of medicines stored outside their original packaging ........ 6
2.5 Dispensing MDS prescriptions ...................................................................................................................... 7
2.5.1 Allcare MDS Patient Medication Record Form ..................................................................................... 7
2.5.2 Labelling the MDS pack ........................................................................................................................ 8
2.5.3 Assembling the MDS prescription items for packing............................................................................ 8
2.5.4 Filling the MDS trays ............................................................................................................................. 8
2.5.5 Accuracy checking of the MDS ............................................................................................................. 9
2.5.6 MDS checking errors and near misses .................................................................................................. 9
2.5.7 The final check ...................................................................................................................................... 9
2.6 Storage and disposal of MDS ......................................................................................................................10
2.7 Transfer of MDS to patient .........................................................................................................................10
2.8 Patient counselling .....................................................................................................................................11
2.8.1 Information supplied to patients ........................................................................................................11
2.9 Claiming for reimbursement for PCRS for MDS and phased prescriptions ...............................................12
2.9.1 Phased fees ........................................................................................................................................12
3 References ..........................................................................................................................................................13
4 SOP Revision History ...........................................................................................................................................13
SOP 11 Appendix One: Patient Assessment for Medicines Compliance Support and MDS .......................................14
SOP 11 Appendix Two: Allcare MDS Patient Medication Record Form .....................................................................17
SOP 11 Appendix Three Allcare Phasing Dispensing Prescription Collection Form V2 ..............................................18
2
1 Introduction
1.1 Context
Monitored Dosage Systems (MDS) refers to any process whereby medicinal products are removed from their
original package into a box, blister or pouch system which indicates the days of the week and/or times of the day
medicinal products should be taken.
MDS dispensing must only be supplied where it will support the safe and appropriate medication use by the
patient and facilitate adherence to the patient’s medication regime. While the system can very beneficial to some
patients and/or their carers, introduction of MDS can introduce inherent and additional risks which must be
managed carefully for both the patient and the pharmacist.
1.2 Purpose
• Adherence to this SOP ensures that in Allcare pharmacies, medication prepared via MDS will be supplied
safely and appropriately to all patients while adhering to the legislation and guidelines that govern this
supply.
• This SOP covers:
• Assessment of patient suitability
• Planning for and preparation of MDS
• Dispensing of MDS
• Suitability of medication for use in MDS
• Patient counselling and supply
• Claiming and reimbursement for MDS and phased dispensing
• Documentation and record-keeping
• This SOP must be used in conjunction with all relevant SOPs and guidance including:
• SOP 9 Emergency Supply and Loan prescriptions
• SOP14 Prescription Processing
• SOP 13 Managing Pharmacy Errors and Near Misses
• SOP 15 Management of CDs
• SOP 19 Sourcing, Storage and Disposal of Medicinal Products
• SOP 43 Allcare Pharmacy Prescription Texting Service
• PSI Pharmacy Practice Guidance (Current version)
• Regulation 9 of the Regulation of Retail Pharmacy Businesses Regulations (S.I. No. 488 of 2008)
• MPS Nursing Home Plus User Manual (where relevant)
1.3 Scope
• This SOP covers every aspect of the dispensing of MDS to the final supply to patient or representative and
submission of claim for payment for MDS to PCRS.
• This SOP applies to all dispensary staff in the pharmacy.
• It is the ultimate responsibility of the supervising pharmacist to ensure that all staff are
appropriately trained, and the SOP is implemented.
• It is also the responsibility of the supervising pharmacist to ensure this SOP reflects the day-to-
day practice in their pharmacy.
• All pharmacists are expected to exercise their professional judgement when needed.
3
1.4 Staff training
All staff in the pharmacy who may be involved in the preparation, dispensing and supply of MDS and phased
prescriptions (including pharmacists, pharmaceutical assistants, technicians, trainee technicians, interns, and
APPEL students) should be trained on this SOP.
2 Procedure
2.1 Patient Assessment
• The use of original packs of medicines supported by appropriate pharmaceutical care and counselling is
the preferred option in dispensing medication.
• To support patient independence, patients who can safely administer their medicines should be
encouraged to do so through counselling.
• It is recognised however, that packaging of medicine into MDS packs may be a safer alterative for some
patients or their carers to help comply with their medication regime and support safe and beneficial
medication use.
• A risk benefit analysis should first be undertaken with the patient engagement if possible, to establish the
need for MDS. This should examine and reinforce the advantages and disadvantages of supplying
medicinal products in an MDS.
• A sample of a Patient Assessment for MDS is available in Appendix One.
• Supply of an MDS can proceed when the pharmacist, healthcare team and patient/carer have concluded
that it is in the best interest of assuring the patient’s pharmaceutical care needs. It must be apparent that
the patient understands how MDS works, that it will improve compliance, and will be cost effective and
risk neutral to the patient. This decision and date of commencement should be documented on the
patient’s PMR.
• The pharmacist should consult with patient/carer as to the correct times of taking medication in advance
of supply. Where the medication can be taken at any time, pharmacists should ascertain from the patient,
when they prefer to take their medicines so that the MDS can be used most effectively.
• Note: MDS dispensing may be unsuitable for certain patients e.g.: patients whose medication regimen is
subject to frequent changes or periodic reassessment.
2.2 Patient consultation
• If after assessment of the patient, the pharmacist decides that MDS would be beneficial, the patient
should have their details recorded during a consultation in the pharmacy consultation room.
• The detail of their medication and dosage times should be discussed so that the pharmacist is aware the
usual times the patient takes their medications and ensures that these times are appropriate for the
medication concerned.
• Any medications that are not suitable for MDS packing should be identified to the patient at this point.
• The Allcare MDS Patient Medication Record form can be completed by the patient or carer to ensure we
dispense medications into the appropriate time compartments in each MDS.
• The completed form should be kept on file with the patient’s prescription or scanned onto MPS.
• Any discrepancies between this form and what the prescription indicates should be discussed with the
patient’s GP as per SOP 14 Prescription Processing.
2.2.1 Patient consent
• Pharmacists should obtain consent for their medication to be prepared into an MDS pack. This should be
recorded on the Allcare Prescription Services Form and scanned to the patient’s PMR if an MPS scanner is
available. (Otherwise hard copy kept on patient’s file or in patient service folder for reference for 2 years
from date of last supply).
42.3 Planning for MDS
2.3.1 MPS script scheduler.
• MPS script scheduler allows you to list patients who have repeat prescriptions or have had phases in the
past and anticipate when their next repeat or phase is due.
• This information can be compiled into a calendar whereby reminders can be created to contact patients
and prepare their medication for collection.
• The MPS script scheduler can be used in conjunction with the Allcare Prescription Texting Service. MDS
and phased patients should always be offered this service. See SOP 43 Allcare Pharmacy Prescription
Texting Service for instructions on how to implement this service.
2.3.2 Promotion of an MDS service
• Sample demonstration packs can be displayed in the pharmacy to illustrate to customers how an MDS
pack appears and works.
• The pack must be labelled as a sample, must not contain any medicinal products and should not be on
display in an area accessible by or in direct line of vision of children.
• Allcare Health Service Leaflets providing advice on the service can be provided. Allcare Prescription
Services Leaflet (Uniphar code 771530), Allcare Medismart Leaflet (Uniphar code: 771525) and Allcare
Pharmacy Services Leaflet (Uniphar code: 771517) are available to order online from:
https://www.uniphar.ie
• Patients can be encouraged to trial the service where appropriate and can revert back to normal
dispensing if they feel it is not a positive benefit to them.
2.3.3 Pharmacy facilities and resourcing
• A specific area of the dispensary should be designated to prepare MDS packs. This area should be under
the direct supervision of the pharmacist and should reflect the volume of MDS that are being prepared.
• The layout should facilitate workflow in a logical sequence and should minimise the risk of interruptions
and errors occurring
• All MDS packs being prepared should be appropriately segregated, and only one patient should be
prepared at any given time in that area.
• The area should be routinely cleaned and kept tidy and clutter free.
• Adequate staff resources should be allocated to packing the MDS to ensure the process is completed
safely and a double check can be implemented.
• The supervising pharmacist must ensure that staff participating in MDS packing should be of the required
competency and be appropriately trained.
2.3.4 Equipment
• When choosing an MDS for the patient, the pharmacist should consider the suitability for both the patient
and the medicinal products it will store:
• Best practice advocates the use of tamper proof disposable systems that need to consider the following:
o Sealed blister pack systems provide some degree of barrier to water vapour and atmospheric
gases, but light protection will involve the use secondary packaging.
o Be capable of supporting the dosage frequency of the patient’s medication regimen
o Be easy to use for the patient: both patient dexterity and understanding of the system should be
ensured
o Provide a means of identifying each medicinal product dispensed in the MDS pack (i.e.: they must
be accompanied by a written description or photo)
o Provide clear visibility to the pharmacist checking the filled MDS before it is sealed and the
patient/carer using the MDS
o Be of appropriate size to safely and securely pack the medicinal products
• If a non-disposable system must be used (patient insistence/dexterity issues etc.), steps should be taken
to ensure it is clean and dry before use.
5• The Allcare preferred system is the Suremed System. This is available to order from:
Sam Mc Lernons packaging Phone: 01 4504121 Email: sales@sammclernon.ie
• The main benefits of this system are:
o Ease of checking due to clear components
o Ease of correction if an error is identified after the seal has been placed on the tray
o Each case contains trays, seals and inserts.
❖ Figure 1: Cl01-T Clear "Colour" 7 Day Pack (Pk 250)
❖ Figure 2: N55d Clear Duo Pack Twice Daily (Pk 100)
• All MDS materials must be stored in the dispensary or the pharmacy store room in a clean and hygienic
manner. It is not appropriate to store MDS materials in the bathroom/staff canteen/ area of pharmacy
which is not part of the registered premises
2.4 What not to store in MDS packaging: stability of medicines stored outside their original
packaging
• There is insufficient data published and no up to date authorative resource in Ireland on the stability of
products stored outside the manufacturers original packaging. Some useful online UK resources are
http://www.resourceclinical.com/stability-of-drugs-in-compliance-aids.html and
https://www.sps.nhs.uk/. If in doubt, contact the manufacturer as they are best placed to provide the
correct advice.
• Removing a medicine from the manufacturer’s original packaging can be considered as administering the
medication in an unlicensed form.
• Therefore, pharmacists must use the information available to them and ultimately their professional
judgment when deciding whether a product is suitable for MDS dispensing.
• As a general rule, the following should be excluded from MDS packs
Dispersible, effervescent, hygroscopic or uncoated tablets
Products that are unsuitable due to their storage requirements (e.g. light sensitive/refrigerated)
Non-tablet /non-Capsule formulations e.g. suppositories, liquids, powders, wafer formulations,
etc.
6 Drugs which may cause skin reactions / hypersensitivity reactions on prolonged contact e.g.
chlorpromazine
Products that may be potentially harmful to handle: e.g. cytotoxics.
Medicines that should only be taken “when required”
Those products whose dose is subject to frequent changes and dependent on test results (e.g.
warfarin)
Careful consideration should be given to medicinal products such as:
o Controlled drugs particularly in the event of a palliative patient where dose and strength may
be subject to rapid change to accommodate a patient’s condition.
o High tech medicines
o Exempt medicinal products
o Medicines which carry a greater risk of allergic reactions occurring (e.g. penicillins)
• Pharmacists should also consider potential risks when multiple medicines are repackaged within a single MDS
compartment such as:
o Interactions between medicinal products
o Medicinal products unsuitable for co-administration (e.g. antacids and tetracycline)
o Medicinal products with different methods of administration (e.g. chewable, buccal or sublingual)
o Medicinal products with specific administration instructions (e.g. those that should be taken 30 minutes
before the first food/beverage/medicinal product of the day)
o Expiry date of the medicines being packed and potential for use beyond that date. *
2.5 Dispensing MDS prescriptions
• MDS preparation and assembly should be carried out under the supervision of a pharmacist at all times.
• Follow all relevant Allcare SOPs when dispensing the MDS prescription.
• The written prescriptions should be available in the pharmacy before the MDS are packed.
• All supplies of medicinal products in an MDS should reflect the instructions of the prescriber.
2.5.1 Allcare MDS Patient Medication Record Form
• The Allcare MDS Patient Medication Record form should be completed in full for every patient. A template is
supplied in Appendix Two.
• This allows the pharmacist performing the final check on the MDS to ensure the correct medications in the
correct quantity is dispensed into the appropriate time compartments in each MDS.
• This is a word document and must be amended each month to reflect accurately the patient’s prescription
and the medication being packed into the MDS.
Alternatively, MPS Nursing Home software can be used if available, provided the tablet descriptions are
populated accurately
• These forms can be saved securely to a dedicated folder on the pharmacy desktop.
*In the absence of applicable data and in order to support practice, RPS recommends a maximum interim expiry date of eight weeks for products in
sealed MCA. This pragmatic decision was taken to support pharmacists in their practice and was based on current practice rather than having any
scientific basis. However, it should be recognised that there may well be circumstances where an expiry date of less than eight weeks is used for a
product in a sealed MCA if this is recommended by the medicines manufacturer or indicated by published scientific studies. With regard to unsealed
MCA, it has been common practice since 1987 to store medicines in daily dose reminders for up to seven days. This seven day expiry date for unsealed
MCA is an arbitrary timescale which reflects what typically happens in practice as, in most cases, unsealed MCA have sufficient space for seven days
medication ( Source RPS April 2nd 2019 : Note: UK guidance in the absence of specific Irish guidance)
7• The copy corresponding to the monthly prescription can be scanned to patient’s file using the MPS scanner
where available or a hard copy placed in the patient file/stapled to the prescription copy.
• Tablet descriptions must be kept accurate and up to date to enable the patient/carer or medical staff to
identify the individual tablets in the MDS
As it is a substantial source of error and confusion, it is also of paramount importance to counsel
patients/carers of any change in appearance of tablets
• If all the medication labels do not fit onto one record form, use a second sheet stapled to the first. Please
clearly indicate how many sheets have been included in each weekly pack.
• Attach this form to each MDS pack with affixed labels (see 2.5.2)
2.5.2 Labelling the MDS pack
• Issue the labels from MPS, alerting the pharmacist (where applicable) to any messages on the PMR or any
cautions/interactions that flash up.
• Issue enough patient bag labels to affix to each individual MDS pack.
• Attach an additional label highlighting how many weeks correspond to the prescription e.g.: Week 1 of 2’,
‘Week 2 of 2’, etc.
• Along with regular legal requirements, labels should also include:
o Time taken
o Expiry date of medication if within the next six months
• A label must be generated for every item dispensed into the MDS and this label attached directly to the
Allcare MDS Patient Medication Record Form/MPS Nursing Home Template. Affix all cautionary and
advisory labels where omitted.
• Pharmacists should ensure that the font and labelling is clear, legible and of an appropriate size for an
individual patient’s circumstances.
Figure 3 Sample Label
2.5.3 Assembling the MDS prescription items for packing.
• Reading from the prescription, collect the stock items required in a basket.
• Ensure the correct drug, strength, from and quantity is selected.
• Check the expiry dates.
• Assemble items that cannot be blistered. These items should be double checked into the patient’s bag from
the prescription and a sticker placed on the bag highlighting that MDS packs are to be added.
• Label the collected items to be blister packed and get checked by a pharmacist before the tablets are packed
in the MDS.
2.5.4 Filling the MDS trays
• Gloves should be worn when MDS are being prepared for patients and tablets should be handled as little as
possible.
• Any equipment used in the preparation of MDS must be cleaned regularly.
• The preparation area must be kept clutter-free.
• Label each MDS pack with the patient bag label in advance of filling .
8• For each item to be blistered, remove the medicine from the stock container/box and place the required
quantity into each blister.
• The medication must be transferred directly from the original packaging into the MDS.
• Loose tablets stored in tablet vials, before packing in MDs must be labelled with the product name, strength,
date of removal from original packaging, batch number and expiry date.
• Stock containers used to assemble the prescription must be left for pharmacist to facilitate the accuracy
check.
• Check that each blister contains the correct medications.
• Take care with tablets and capsules with similar names, packaging and/or appearance.
• MDS should not be overfilled as overfull packs are difficult to check and may be prone to improper sealing as
a result of overfilling.
• Medicines should not be repackaged in their original strip or blister packs as there have been reports of
patient’s swallowing leading to gastric perforation or pelvic abscess.
2.5.5 Accuracy checking of the MDS
• The original prescription must always be used for the final MDS check.
• It is best practice to check the accuracy of the assembled item(s) using the Allcare MDS Patient Medication
Record Form/MPS NH template that contains accurate descriptions of the tablets contained within the MDS,
in conjunction with the original prescription.
• If an error is detected after sealing, the pack should be opened, the corrections made, and the medicines
repackaged into the MDS.
• The pharmacist performing the final accuracy check must sign and endorse the original prescription after the
accuracy check is complete.
• MDS should be sealed as soon as possible after preparation and checking by the pharmacist and care should
be taken that they are not left exposed to the environment for extended periods of time.
• In situations where an accuracy check is not possible immediately, the MDS should be left in a secure
designated area of the dispensary for accuracy checking by the pharmacist.
• Medicinal products should be stored in an MDS pack (and therefore out of the manufacturer’s original pack)
for as short a time as possible.
• If a patient’s medication changes midmonth or mid-cycle, pharmacists must dispose of previously dispensed
specific medicines and prepare a new MDS.
2.5.6 MDS checking errors and near misses
• MDS should always be viewed as a high risk activity in the pharmacy. Ensuring accurate dispensing is
paramount in preparing MDS for your patients as they will no longer be seeing tablet containers or packs
identifying what tablets they are taking.
• Pharmacists should only self-check prescriptions that they have dispensed, when there is no-one else
available. During these occasions, they should try and take a mental break and complete another task before
returning to complete the check.
• If the pharmacist becomes distracted during the accuracy check, start the accuracy check again.
• If an error is detected after sealing, the pack should be opened, the corrections made, and the medicines
repackaged into a new MDS. This should be recorded on Pharmapod as a “RECORD NEAR MISS”.
• All MDS errors that make it to patient’s/carers must be logged on Pharmapod as “RECORD INCIDENT”.
2.5.7 The final check
The final MDS check should incorporate the following elements:
9Check label against prescription: Check original packaging against prescription:
Patient name Drug name
Drug name,form,strength,quantity Dosage form and strength
Dosage instructions Expiry date
Check label and Allcare MDS Patient Medication
Record Form against medicine in MDS:
Drug name,form,strength,quantity
Dosage instructions
Check stability and suitability of product in MDS
Dosage Time
Tablet description
Check the integrity of MDS pack
All wells sealed securely? ( turn pack over and Check the products in MDS for any clinical
inspect/reinforce seal edges) requirements that might require additional
Outer label/Allcare MDS Patient Medication counselling for patient/carer
Record Form correct for patient eg. before or after food
Correct MDS dates
• When the pharmacist checking the final MDS pack is satisfied that each item is correct, the original
prescription should be fully endorsed.
• The above steps should be repeated for each MDS pack for a patient.
2.6 Storage and disposal of MDS
• Packed MDS awaiting collection should be stored in an appropriate area of the dispensary, protected
from heat and light until collected by the patient/carer.
• Where the MDS pack contains a schedule 2/3 controlled drug, the MDS must be stored in a controlled
drug safe until supplied to the patient in line with Safe Custody Regulations.
• The pharmacist should endeavour to ensure that there are suitable arrangements in place to mitigate the
risk of excess packs being available for collection at the same time by the patient or the patient having
excess packs at home which may cause further confusion.
• Medicinal products returned to the pharmacy unused and still sealed in the MDS pack must not be reused
or returned to stock. These medicinal products must be disposed of in the correct manner.
2.7 Transfer of MDS to patient
• Follow all relevant Allcare SOPs when handing out the MDS prescription.
10• Place the MDS pack(s) and additional items into a fully labelled bag, seal with a bag label, and store in the
appropriate area for collection.
o If the patient collects the medication weekly, a separate bag label with the collection date should
be used for each week’s supply.
o Fridge and CD lines must be retrieved in the fridge and CD safe respectively. Attach a “Pharmacist
Consultation Required” sticker to the bag with details to ensure these items are collected by the
patient and the pharmacist supervises this activity.
• Ensure any counselling notes are highlighted via the use of a “Pharmacist Consultation Required” sticker
on the patient’s bag and any paperwork that needs to be signed by the patient must also be included with
the bag.
2.8 Patient counselling
• Patients should receive comprehensive instructions and counselling, particularly when initiated on MDS
dispensing for the first time.
• The pharmacist should ensure at each supply that the patient has sufficient information and advice for
the proper use and storage of the MDS pack.
• Patients should be advised not to make any changes to their packs or rectify a pack spillage but to return
to the pharmacy if they need the pack changed.
• The counselling should include the following elements:
Storage of
medication,and
Clinical indication of Use and adherence to
particularly the need to
their MDS medication their PRN medications
keep out of reach and
sight of children
All other counselling as
How to use the MDS Identification of their set out by
pack medication in the MDS
Regulation 9 *
•
*Regulation 9 of the Regulation of Retail Pharmacy Businesses Regulations (S.I. No. 488 of 2008)
2.8.1 Information supplied to patients
• Patient’s and carers should be supplied with patient information leaflets (PIL) on each occasion for
medications repackaged into MDS packs and should always be able to identify the medication to which the
PIL relates.
• PIL’s can be printed from https://www.hpra.ie/.
112.9 Claiming for GMS reimbursement from PCRS for MDS and phased prescriptions
• When claiming payment, it is important to note that blister packing (MDS) and phased dispensing are two
separate processes:
• Phased Dispensing requires the patient to present to the pharmacy on multiple occasions in the month e.g.
each week for collection of medicines.
• Blister packing is where the medication is given in one visit and is packaged to indicate when medication
should be taken.
2.9.1 Phased fees
• Phased dispensing fees are only allowable on the GMS scheme, in certain narrow circumstances.
• The reasons previously agreed by the PCRS as appropriate for claiming phased dispensing fees are as follows:
o At the request of a patient's physician.
o Due to the inherent nature of a medicinal product: i.e. product stability and shelf life.
o Where a patient is commencing new drug therapy with a view to establishing patient tolerance and
acceptability before continuing on a full treatment regime.
o In exceptional circumstances where the patient is incapable of safely and effectively managing the
medication regimen.
Phasing fees must only be claimed when a patient (or their carer) attends the pharmacy on multiple supply
occasions within a claim month.
A phasing fee cannot be claimed in circumstances where a patient collects four MDS trays on one occasion.
• To satisfy the PCRS that prescriptions are collected on a weekly/fortnightly basis, Appendix Three
“Prescription Collection Form” must be signed by patient or their carer at each collection. This form must be
retained onsite in a hard copy in the pharmacy for 2 years for inspection by the PCRS. It can also be scanned
and saved to the patient’s file if an MPS scanner is available.
• Phasing fees are not claimable on DPS or LTI scripts.
• Phasing fees are not claimable for patients who are in nursing homes, or HSE Care homes.
• Phasing fees are not claimable for patients in other residential care settings were medication is collected on a
monthly basis.
• All pharmacy claims (Reason 2 to 4) for phased patients must be preapproved before a claim is made to the
PCRS using the PCRS online Pharmacy Suite:
Figure 4 Pharmacy Suite: online Phased Dispensing Application Process
• From 10th December 2018, prior approval for phased dispensing claims will be necessary for all newly
initiated phased dispensing patients for subsequent reimbursement to pharmacy. GP’s seeking phased
dispensing for their GMS patients (Reason 1) will be required to complete an application on the GP
Application Suite, before phased dispensing will be authorised.
• It is important to check that you are paid the correct fee that the pharmacy is entitled to by checking your
GMS Listing.
12• If it is not paid correctly, first establish whether you were actually entitled to claim phasing for this patient as
their status may have changed mid- month, and they may have moved into a nursing home without your
knowledge.
• If you are certain that you should have been paid a phasing fee, contact the PCRS to establish the reason for
non-payment of phasing and request a correction of payment.
• If you have any queries, consult the Uniphar Retail Services Claims Processing Manual or contact the
Allcare/URS Dispensary Operations Coordinator/Claims Analyst
3 References
• HSE PCRS Phased Dispensing Circular 037/18
https://www.hse.ie/eng/staff/pcrs/circulars/gp/037-2018-gp-circular-phased-dispensing.pdf (accessed 2/4/19)
• IPU MDS Guidance https://ipu.ie/home/(accessed 2/4/19)
• NHS Specialist Pharmacy Services: Usage of Medicines in Compliance Aids ; https://www.sps.nhs.uk/articles/usage-of-medicines-in-
compliance-aids/ (accessed 2/4/19)
• PSI Draft Guidance for Pharmacists on the use of Monitored Dosage Systems (MDS)Draft Version September 2015
https://www.thepsi.ie/Libraries/Consultations/Draft_Guidance_for_Pharmacists_on_the_use_of_Monitored_Dosage_Systems_Sept1
5.sflb.ashx(accessed 2/4/19)
• Resource Clinical UK http://www.resourceclinical.com/stability-of-drugs-in-compliance-aids.html (accessed 2/4/19)
• Royal Pharmaceutical Society “Improving Patient Outcomes: The better use of multi-compartment compliance aids (July 2013)
https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Support/toolkit/rps-mca-july-2013.pdf (accessed
2/4/19)
• The Pharmaceutical Journal: How stable are medicines moved from original packs into compliance aids? The Pharmaceutical Journal
January 2016
https://www.pharmaceutical-journal.com/news-and-analysis/how-stable-are-medicines-moved-from-original-packs-into-compliance-
aids/10990832.article?firstPass=false (accessed 2/4/19)
4 SOP Revision History
• V2 July 2014 updated to include Script Scheduler
• V2 July 2014 updated to include claiming payment.
• V3 May 2016 updated to include;
o Medismart inserts
o Correct requirements for phased fee claim as per PCRS letter May 2016.
• V4 February 2017, internal review, no updates required.
• V5 May 2017 updated to include
• Approval process for new phased patients
• Phased Prescription Collection Form
• Version 6 April 2019 Required review and reformat: updated to include:
• Section 2.1 New: “The use of original packs of medicines supported by appropriate pharmaceutical care and counselling is
the preferred option in dispensing medication.”
• Section 2. New: Rationale for MDS based on NICE Clinical guideline 76 medication Adherence 2009
• Section 2.3.1 Script Scheduler Graphics removed
• Section 2.3.4 New “Sealed blister pack systems provide some degree of barrier to water vapour and atmospheric gases, but
light protection will involve the use secondary packaging.
• Section 2.3.4 Replacement of Eurodrug Nomad by “the Allcare preferred system is the Suremed System”.
• Section 2.4 New “There is insufficient data published and no up to date authorative resource in Ireland on the stability of
products stored outside the manufacturers original packaging. Some useful online UK resources are
http://www.resourceclinical.com/stability-of-drugs-in-compliance-aids.html and https://www.sps.nhs.uk/. If in doubt,
contact the manufacturer as they are best placed to provide the correct advice.
13• Section 2.4 New: “Controlled drugs particularly in the event of a palliative patient where dose and strength may be subject
to rapid change to accommodate a patient’s condition: “Interactions between medicinal products” and “Expiry date of the
medicines being packed and potential for use beyond that date.
• Section 2.5.1 New Section
• Section 2.5.2 New” this label attached directly to the Allcare MDS Patient Medication Record Form.”
• Section 2.5.3 New “Assemble items that cannot be blistered. These items should be double checked into the patients bag
from the prescription and a sticker placed on the bag highlighting that MDS packs are to be added.
• Section 2.5.4 New: “in advance of filling .” and “date of removal from original packaging. ”Medicines should not be
repackaged in their original strip or blister packs as there have been reports of patient’s swallowing leading to gastric
perforation or pelvic abscess.”
• Section 2. 5.5 New “If an error is detected after sealing, the pack should be opened, the corrections made, and the
medicines repackaged into a new MDS. .
• “The pharmacist performing the final accuracy check must sign and endorse the original prescription”
• Section 2.5.7 New Section
• Section 2.8 New Section
• Section 2.9 Increased emphasis on definition of MDS and Phased Dispensing
• Removal of Graphics
• Addition of GP approval information
• New Graphic of PCRS Pharmacy Suite and Phasing Portal
• New: Reference to “Uniphar Retail Services Claims Processing Manual or contact the Allcare/URS Dispensary Operations
Coordinator/Claims Analyst
SOP 11 Appendix One: Patient Assessment for Medicines Compliance Support and
MDS
Source IPU April 2019
This assessment tool should be used on each occasion that a request is made for a patient to have the
presentation of their medication adjusted. The most common example of this would be where a
pharmacist receives a request (from GP, patient, carer, other healthcare professional) to fill a monitored
dosage system (MDS) or other similar compliance box for a person although there are other examples of
adjustments to a person’s medication (e.g. supply of medicines in non-child resistant closures).
People must be assessed to determine the support required to aid medication compliance. This form sets
out the person’s actual needs, risks and whether compliance support is required. This form can also be
used to determine if a reasonable adjustment is required from the pharmacist and/or the prescriber.
Patient Details
Name
Address
GMS/DPS/LTI No
GP & GP Practice
Patient Notes, allergies etc.
Assessor Details
Name of Pharmacist
a.m. lunch p.m. night
14Total number of medicines taken . . . . . .
Number of doses taken during the day
Does the person have problems / difficulties when?
taking their medicines?
Risk Level
Low Med High
Eyesight Unable to read labels?
Physical
Unable to distinguish between medicines by sight?
Manual Cannot manage blister packs?
dexterity and Cannot open or close child-resistant packaging?
coordination Has difficulty with a prescribed liquid medication?
Dosage form (e.g. tablet) is difficult to take?
Understanding Does not understand each medicine instruction?
Does not know which medicines are regular or PRN?
Does not know the reason for taking each medicine?
Mental
Complexity On medication with variable doses (e.g. warfarin)?
Taking many medicines with multiple doses in the day?
On medication with complex dose directions (e.g.
bisphosphonate)?
Risk Level
Low Med High
Mental
(cont.)
Remembering Is continuity of supply a problem?
to order Does this person forget to order?
Remembering
to take Does this person forget to take medication frequently?
If all boxes are ticked ‘Low’, it is unlikely that the patient requires additional compliance support.
Which adjustment might be appropriate?
This is a list of suggested adjustments to aid compliance problems. This list is not exhaustive.
Problem Solution Action Plan
Eyesight Enhance labelled instructions
• Increase font size
• Provide symbol-based label
• Braille labels
• Other (describe)
Manual dexterity and Assist with dexterity issues
coordination • Provide screw caps
• Provide wing lids
• Dispense blister packed tablets into
bottles
• Provide larger bottles and lids
• Provide halved or quartered tablets
• Provide oral syringe or measure
• Alternative formulation of same
medicine
15• Volumatic (for inhalers) or eye dropper
clamp
• Other (describe)
Understanding Enhance understanding
• Medicines Use Review
• Provide written information
• Rationalise medicines regime
Complexity Simplify medicines regime
• Medication review
Remembering to order Assist with ordering medicines
• Prescription collection service
• Repeat dispensing
• Reminder on calendar
Remembering to take Assist with taking medicines
• Rationalise medicines regime
• Reminder charts
Monitored Dosage Systems (MDS) – Please state reason for this supply
Summary of Assessment
Summary
It is my opinion that this person has/does not have (delete one) problems with taking their medicines
It is my opinion that this person would/would not (delete one) benefit from an adjustment to the presentation of
their medication
The recommended reasonable Provide Details
adjustment(s) for this person is:
Patient Signature (if applicable)
Pharmacist Signature
Date of Assessment
16SOP 11 Appendix Two: Allcare MDS Patient Medication Record Form
Patient Name Patient Address
D.O. B Doctor name and
address
Patient has Yes ❑ Date of
consented to No ❑ prescription
medication packed as
MDS:
MDS details updated Date of Update:
by:
(insert name of staff
member who
prepared this record)
Medication packed in MDS
Time of taking (insert further column for alternate times where appropriate)
Tablet Name, Form and Description (Colour, shape, scoring, Morning Afternoon Evening Night
Strength markings)
Medication not packed in MDS
Medication Name, Form and Strength Any specific prescriber instructions
Patient Notes and Comments including any allergies/impairments etc.
Checking Pharmacist Signature Date of final check
17SOP 11 Appendix Three Allcare Phasing Dispensing Prescription Collection
Form V2
Phased Reason (1-4):
Patient Name & Address
1. At request of prescriber
2. Product shelf-life
3. Establishing tolerance
(Affix dispensing bag label here) 4. Patient safety
Approval confirmed on PCRS Advanced Yes
Scheme Checker
No
________/_______
Expiry date of approval (month/year) or
Lifelong approval
If not patient,
relationship of person
Collected by Instalment (e.g. 1
collecting to patient Date of Collection
(signature) of 4, 2 of 28 etc.)
(e.g. carer, family
member)
1819
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