Guidance on the supply of Monitored Dosage Systems (MDS) by Community Pharmacies

Guidance on the supply of Monitored Dosage Systems (MDS) by Community Pharmacies Document Description Document Type Service Application Guidelines General Practitioners, Dudley Community Services (DCS) staff, contracted clinicians, Community Pharmacies. Version 3.0 Ratification date May 2018 Review date May 2021 Lead Author(s) Name Jag Sangha Position within the Organisation Pharmaceutical Adviser Community Pharmacy and Public Health Consultation Committee Date Dudley Local Pharmaceutical Committee (LPC) May 2018 Dudley CCG Prescribing Subcommittee May 2018 Presented for discussion, approval and ratification to Area Clinical Effectiveness Committee (ACE) May 2018 Change History Version Date Comments 0.1 October 2012 Original guideline produced by Judith Hesslewood (Pharmaceutical Adviser, Dudley PCT) in partnership with Dudley LPC 1

1.0 November 2012 Approved by Prescribing Subcommittee, NHS Dudley. 1.1 October 2015 Guidelines updated to reflect Equality Act 2010 legislation and contractual requirement with link to PSNC documentation. 2.0 November 2015 Approved by Prescribing Subcommittee, Dudley CCG and Dudley LPC. 2.1 April 2018 Minor update paragraph added Appropriate Claiming of Medicines for MDS. Approval by Prescribing Subcommittee, Dudley CCG and Dudley LPC. 3.0 May 2018 Ratification by ACE. Link with Care Quality Commission Essential Standards of Quality & Safety Regulation 10, Outcome 16 - Assessing and monitoring the quality of service provision. Regulation 13, Outcome 9 - Management of medicines. 2

Guidance on the supply of Monitored Dosage Systems (MDS) by Community Pharmacies Target Patient Group This document relates to the issue of monitored dosage systems (MDS) to patients living in their own homes. Context Appropriate use of MDS may allow individual patients to continue to self-administer medication. The provision of the Pivotel pill dispenser device as part of the local Dudley Metropolitan Borough Council scheme has its own assessment process and pharmacy standard operating procedure (SOP) and is initiated and managed by the directorate of Adult Social Services (Telecare department). Requests for MDS (trays, dossette boxes, Nomad, Venalink ) are currently coming from patients, carers, social services staff, community nurses and general practitioners (GP s). Recent legislation, the Equality Act 2010, which replaced The Disability Discrimination Act 1995, sets out a framework which requires providers of goods and services, not to discriminate against persons with a disability. The legislation does not require a provider to carry out an assessment under the Equality Act all that is required, is that the provider makes a reasonable adjustment, if this is what is needed in order to allow the person to access the service. Assessment for suitability should be discussed with the dispensing pharmacist and lines of communication agreed between all parties. In particular the patient must be in agreement with the arrangement and able to understand the purpose of and able to access the device. The use of MDS has become regarded as a panacea for medicines use and is often integrated into practice without giving due consideration to the alternatives available. Although MDS may be of value to help some patients with problems managing their medicines and maintaining independent healthy living, they are not the best intervention for all patients and many alternative interventions are available. The evidence-base indicates that MDS should not automatically be the intervention of choice for all patients. With the limited evidence base currently indicating a lack of patient benefit outcomes with the use of MCA, it is a recommendation of the Royal Pharmaceutical Society that the use of original calendar packs of medicines, supported by appropriate pharmaceutical care, should be the preferred intervention for the supply of medicines in the absence of a specific need for an MDS in all settings 1. The pharmacy contractual framework includes a sum of money towards the pharmacy contractor s compliance with the Equality Act 2010. This sum is not distributed specifically for any adjustments made, but is distributed on a flat rate basis, towards any adjustments that the pharmacy makes. 3

Further information about the Equality Act 2010 and 28 day prescribing is available on the Pharmaceutical Services Negotiating Committee (PSNC) website at http://psnc.org.uk/contractit/pharmacy-regulation/dda/the-equality-act-2010-28-day-prescribing/ Medication Issues Non-adherence with medication has considerable health, economic and social implications 2. Several factors have been implicated in non-adherence, hence the difficulty in addressing the issue. NICE guidance 2 has identified patient s medicines adherence issues that include: Difficulty accessing medication from packaging due to manipulation problems Sight impairment Difficulty reading labelled directions, warnings / distinguishing between medicines Difficulty accessing medication from packaging Confusion / forgetfulness Complexity of treatment regimen Some of these issues can be resolved using provision of MDS, resulting in improved adherence to prescribed medication. Initial Steps When a patient, carer or healthcare professional contacts the pharmacy requesting that medication requires to be packed into an MDS Before making a supply in MDS, it is essential that the pharmacist satisfies himself that the patient has a disability and the patient will be able to use the MDS safely. A person is regarded as being disabled, if they have a physical or mental impairment which has a substantial adverse effect on that person s ability to carry out day to day activities. The impairment must be either long term (that is, has lasted more than 12 months) or is expected to last more than 12 months or for the rest of the person s life (for example multiple sclerosis). MDS is just one of the modifications that could be made large print labels, reminder charts and easy opening non-child-resistant containers are other examples. If a person is disabled, the provider of services must consider whether a feature of the way in which the service is provided means that the disabled person would not be able to access the service, whereas a non disabled person would. The provider of the service must then consider whether any adjustment could be made, which would have the result of overcoming the obstacles to accessing the service. The provider will be in breach 4

of the legislation if there is a reasonable adjustment available which the provider chooses not to make, causing the person to be unable to access the service. The legislation does not require a provider to carry out an assessment under the Equality Act. All that is required is that the provider makes a reasonable adjustment, if this is what is needed in order to allow the person to access the service. Whichever adjustment is made to assist patients with a disability, it is essential that the pharmacist satisfies himself that the patient is able to understand and be able to benefit from the adjustment, without introducing additional risks. To support pharmacy contractors to decide on the appropriateness of a reasonable adjustment under the legislation, the Primary Care Commissioning Community Interest Company (PCC) website provides access to a resource toolkit which is available at http://www.pcccic.org.uk/article/disability-discrimination-act-resource-kit In circumstances where it is considered that a reasonable adjustment has not been made by the pharmacy contractor resulting in the patient not being able to take their medication. In the first instance, contact should be made with the pharmacy contractor to confirm the reasons for this decision and to resolve at a local level. If this is unsuccessful and where the community pharmacy provider may potentially be in breach of the legislation (i.e. there is a reasonable adjustment available which he/she chooses not to make), then the NHS England Area Team (commissioner) should be notified on england.medsreporting@nhs.net Under what circumstances might a 7-day prescription be appropriate? Where the prescriber s clinical decision is that: Flexibility is required to change the medication at short notice. The patient s medicine needs are unstable and liable to change. There may be risk to the patient or others from having too much medicine in the home. Weekly provision of MDS is required to support medicines optimisation. Appropriate Use of Weekly Prescriptions There is no fundamental link between dispensing in an MDS and the period of treatment covered by a prescription. A prescription for 28 says supply might be supplied in an MDS, and a prescription for seven days might be supplied in the original manufacturer s carton. There will be occasions when weekly prescriptions (or even daily) are the best way to deal with a situation. For example, where a prescriber has concerns over patient safety such as potential overdose or suicide risk, prescribing for some substance misuse patients, or where frequent dose 5

changes occur. In all other cases, where a 28-day prescription for MDS is presented, the medication can be dispensed at one dispensing using either four 7-day trays or one 28-day tray. If seven day prescriptions have been requested and are provided by a practice, then the pharmacy should be dispensing the MDS at seven-day intervals (and ensuring collection or delivery weekly if part of the collection delivery service). There is also an expectation by the CCG that the pharmacy has arrangements in place to monitor medication adherence by patients supplied a MDS (such as viewing/collecting the previous weekly MDS to identify any concerns promptly requiring communication to the patients GP). Prescribers should be aware that where a change is made to therapy mid-pack, pharmacists are not contractually obliged under their NHS terms of service to re-use or re-package existing MDS packs and will require a whole set of new prescriptions to generate the updated MDS packs. This should be taken into account when deciding whether 7 or 28-day prescriptions are most appropriate for the patient concerned. The NHS Pharmacy Terms of Service do not impose a requirement to dispense into compliance aids or to dispense in instalments (other than instalment prescriptions for the treatment of substance misuse clients). Therefore, a prescription ordering 28 days treatment should be dispensed on one occasion as the NHS requires the medicine to be dispensed on the one occasion, for one dispensing fee. It is for the pharmacy contractor to decide whether it is appropriate to dispense into MDS and this decision is not influenced by the period of treatment. Appropriate Claiming of Medicines for MDS It is the view of the Pharmaceutical Public Health Team that medicines should only be claimed for by contractors once the dispensing process is complete. To that end, the dispensing process under the NHS Terms of Service requires that the medicines have been supplied to the patient and are no longer in possession of the pharmacy contractor (includes delivery driver). Medicine(s) that have been placed into a MDS (whether sealed or not by pharmacy teams) ahead of scheduled supply to the patient must not be claimed for if in the period between dispensing the MDS and supply, the prescriber requests a change resulting in dispensed medicines requiring removal from the MDS before supply has occurred. These medicines cannot be claimed for within the NHS Terms of Service because the pre-packed MDS has not left the pharmacy premises and therefore the dispensing process remains incomplete. If community pharmacy teams in the course of their business choose to dispense medicines into MDS in advance of patient supply to manage their workload then they accept a risk that medicine changes may result in stock loss if medicines are required to be removed ahead of actual supply to the patient at the request of the prescriber. Stock loss may occur if the responsible pharmacist considers that the stability of re-using medicine already decanted from its primary packaging is unacceptable or inappropriate. 6

To claim for medicines that have not been supplied to the patient against an NHS prescription is considered fraudulent and should evidence come to light of such practice, this will be reported to the NHS Counter Fraud Authority for investigation. Pharmaceutical Public Health Team Position on MDS The Pharmaceutical Public Health Team does not promote routine use of MDS prepared by a community pharmacy because there are many disadvantages for both GP practices and community pharmacies: Complete re-dispensing may be needed if treatment is changed (involving wastage). Not all medicines can be packed in MDS, due to various stability problems. Liquid medicines, creams and those taken as required or as directed are not suitable for MDS. MDS is usually not as child resistant as original packaging. Accidental spillage from MDS by patients/carers often will not allow easy identification of medication and a re-supply of medication may be required. MDS preparation is very labour intensive for community pharmacy teams and there is no additional remuneration within the current community pharmacy contract (with NHS England) to account for this. Failure to communicate a treatment change to dispenser could result in a patient continuing to receive unintended treatment creating a risk of patient harm. MDS will not improve compliance in patients that intentionally do not want to take their medication. Deskilling of medication use by patients and carers. However, it is recognised that there is some limited evidence that MDS may be of value for some patients within the community (to maintain a healthy independent living) who have been assessed as having practical problems in managing their medicines 1. Each patient s needs must be assessed on an individual basis and any intervention must be tailored to the patient s specific requirements. Some potential benefits of MDS include 3 : Provide medicines storage that is easily accessible by patients (many MDS systems are manipulated such that they are easier to access than original packaging particularly for those with manual dexterity and/or visual impairment). Reduces complexity of adhering to a medication regime (polypharmacy) through preorganisation of medicines by the pharmacy into select compartments for both the specific time and specific day. Thus, patients do not have to select doses from multiple individual packaging. Minimize dose amount and timing errors since the medicine dose and timing is pre-set by the community pharmacy. Acts as a memory aid since patients can easily identify whether a medicine dose has been taken or not. 7

Whilst it would seem logical and intuitive that MDS supports medication adherence and thus medicines optimisation, the limited evidence that has been reported does not demonstrate any significant difference (for patient adherence to medicines) between a MDS and those not using an adherence aid 1,3. Additionally, whilst it is recognised that medication non-adherence has considerable health, economic and social implications 2, there is no evidence to support that a MDS has any impact on reducing any of these implications. Disadvantages of Weekly Prescriptions for General Practice Increased workload for practice if printing paper prescriptions (normally 4 prescriptions are prepared as a batch through Repeat Dispensing or standard repeat prescribing functionality). However, implementation of the Electronic Prescription Service (EPS) and the functionality of electronic repeat dispensing should facilitate reduction in practice workload and is the recommended mechanism of issue. Potential for error and confusion due to use of different treatment period /prescription printing protocols (especially in practices actively involved in repeat dispensing). Care Homes If care homes request MDS packs for their residents, this arrangement and any resulting financial issues should be discussed and agreed between the dispensing pharmacy and the care provider concerned. It is inappropriate to expect the GP practice to provide 7 day prescriptions in these circumstances unless a patient has medicine needs which have yet to be stabilised as discussed above. References 1. Improving Patient Outcomes The better use of multi-compartment compliance aids. Royal Pharmaceutical Society, July 2013. 2. NICE clinical guideline 76. Medicines adherence: Involving patients in decisions about prescribed medicines and supporting adherence. London: National Institute for Health and Clinical Excellence, January 2009. 3. Bhattacharya, D. Indications for Multi-compartment Compliance Aids (MCA) also known as Monitored Dosage Systems (MDS) provision. School of Chemical Sciences and Pharmacy. University of East Anglia, January 2005. 8