Monitored dosage systems (MDS) are one of the many tools pharmacists use to support patients with medication management. MDS are devices that enable the individual medicine doses to be organised according to the prescribed dose schedule.

Before facilitating this service to a patient, the pharmacist should assess the advantages and disadvantages of supplying the patient’s medication in MDS and the patient’s health and care needs. Engaging with patients and listening to their healthcare needs will support pharmacists with the initial risk-benefit assessment, and it is advised to ensure a shared decision-making process has taken place with the patient or their carer about the decision to use MDS. The pharmacist should also consider whether the medicine is pharmaceutically stable for repackaging.

If MDS is not appropriate for the patient, the pharmacist should be aware of other aids available that will support the patient with their medicine management and advise accordingly. This can include:

• Providing all the medication in 28-day calendar original packs dispensing;
• Electronic reminders;
• Reminder charts;
• Getting a career or a family member involved;
• Large font information sheets;
• Large font on pharmacy labels;
• Use of pictograms; and
• Reviewing the medicine and engaging with the prescriber with the purpose of deprescribing where appropriate.

Policies and procedures

The pharmacy should have strong policies and procedures in place to ensure that the supply of medicines to patients using a MDS is safe. These policies should include at least:

• Standard operating procedure (SOP) for the supply of medicines in MDS to patients:
  • The SOP should also refer to the risk assessment carried out for the patient and medicines involved in the patient’s treatment; assembling and checking of the MDS; storage of MDS; and counselling and handing out of the MDS to the patient or their career/representative. The SOP in place should accurately reflect the practice observed at the pharmacy;
• SOP on the cleaning of the repackaging area (MDS area);
• SOP on medicinal product waste management;
• SOP on the management of incidents;
• Error/incident log template;
• Risk assessment for the patient;
• Risk assessment of the medicines subject to repackage;
• Medicines Use Reviews (MUR) protocol;
• List of medicines that are not suitable for repackaging;
• Patient’s consent for the medication to be supplied in MDS;
• Patient’s medication record sheet; and
• Management of incidents (dispensing error log).

Starting a new patient

Once the pharmacist is satisfied that providing the patient’s treatment on an MDS is appropriate, the pharmacist should engage with the patient and/or carer and discuss the new arrangement. The pharmacist should ask the patient to sign a consent form that authorises the pharmacist to repack their medication to an MDS. The patient’s assessment should be reviewed when their treatment is modified and/or their health status or care needs change.

In addition to this, it is good practice for the pharmacist to develop a patient’s medication record sheet for each patient availing of this service. This document should contain:

• The patient’s contact details (including a telephone number);
• The patient’s GP and/or nurse;
• Patient’s medication;
• What time of the day the patient takes the medication prescribed;
• Frequency of collection (weekly, fortnight, monthly);
• Date of the last MDS collection:
• Who collected the MDS; and
• Additional pharmacist’s notes, for example, when MUR took place, and actions taken.

This document should reflect any changes in the patient’s medication, when they took place and which prescriber made the change (for example, change made in hospital or with GP). It is also good practice to maintain records of who prepared the MDS and who checked it.

This is a useful visual aid for the pharmacist to have when clinically assessing the patient’s MDS against a prescription.

Filling an MDS

The pharmacy should have a designated area for the preparation and checking of MDS. This area should be under the direct supervision of the pharmacist. If more than one MDS is being prepared for different patients at any given time, the work area should be appropriately segregated to minimise the potential for error.

Removing medicines from their original packaging increases the risk of incidents. Therefore, robust protocols and measures must be in place to safeguard the patient’s safety. Each medicine involved in the patient’s treatment should be assessed to ensure its safety in terms of repackaging. There will be occasions in which the repackaging will not be appropriate, for example:

• The tablet/capsule is too big for the MDS compartment;
• Effervescent/dispersible tablets;
• Buccal/Sublingual tablets;
• Cold chain medicines;
• Cytotoxic medicines;
• Tablets whose dose changes according to test results, for example, warfarin; and
• Tablets that require specific timing or need to be taken in a specific way, for example ‘as required (PRN)’.

Best practice is to use tamper-proof disposable MDS, as this reduces the risk of the medication being removed and/or placed in a different compartment, either deliberately or inadvertently. Once the medicines are repacked in the MDS, as this activity deviates from the medicine’s license, it could potentially affect the medicine’s expiry date. Therefore, the pharmacist must ensure that MDSs are filled, checked and sealed as soon as possible and close to the time the patient requires their medication.

Medicines should not be repackaged within a MDS in their original strip or blister packaging. There have been reports of people swallowing the medicine and its packaging resulting in severe harm and death.

Storing an MDS

The pharmacy should have assigned an area for the storage of MDS. Consideration should be given on how best to reduce the risk of storing in the same area, patients with similar names and/or addresses.

Those MDS that contain Schedule 2 or Schedule 3 controlled drug medicines must be stored in the Controlled Drug (CD) Safe until such time as the MDS is collected. Therefore, the pharmacist may need to assess the size of the CD safe present at the pharmacy to ensure that it is of a sufficient size to store the pharmacy CD medicines stock, in addition to the MDSs.

“It is advised to ensure a shared decisionmaking process has taken place with the patient or their carer about the decision to use MDS.”

Counselling patients

Pharmacists have a legal requirement to counsel patients on the medicines supplied. Patients supplied with MDS are vulnerable patients, and presenting their medicines outside their original packaging may pose an additional challenge as they might be unable to identify the medicine or what they are for.

When a patient is supplied medicines in MDS the pharmacist should explain to the patient and/or carer the layout of the MDS. Not all the MDSs look the same, however — they have similar characteristics in that they are multi-compartmental, divided into days of the week  (Monday to Sunday), and some of the compartments are also divided into various times of each day (morning, noon, midday, night).

It is important to outline to the patient the pharmacy labels attached to the MDS, which contain the dosage instructions. As good practice, there should be a pharmacy label supporting the identification of each medicine by indicating its shape, colour, size and score (if applicable). The batch number and expiry date of each drug packed in an MDS should be recorded. The patient should also receive the patient information leaflet (PIL) of each medicine contained in the MDS, at each supply.

Conclusion

The provision of MDS services is a common practice observed by many community pharmacies. Although this service might be a suitable option for polypharmacy patients, it may not always be the most appropriate choice for the patient and not always improve the patient’s treatment adherence. Engaging with patients and listening to their healthcare needs will support pharmacists with the initial risk-benefit assessment.

The IPU have resources available on our website to support you, should you consider providing this service at your pharmacy. For further information go to ipu.ie > SOPs and guidelines > Monitored Dosage System guidance, or contact