Health and Social Care Bill

Memorandum submitted by PharmaTrust UK Limited (HS 90)

1. Summary and Conclusions 

We would request that, in considering the draft bill, attention is paid to single integrated commissioning arrangement for medicines in order to reflect the following:

1. The need to quickly adapt to the further integration of care and shift of services between traditional providers. Thus a single integrated approach to commissioning of medicines management is required that doesn’t create arbitrary barriers between primary, specialist and hospital services.

2. A strategy led and integrated approach to how clinical services are commissioned through the National Commissioning Board and local commissioning consortia to ensure an integrated approach focused on patient need.

3. Commissioning and payment systems that reward and encourage desired behaviours to enable integrated medicines management. The focus should be on professional activities that are aligned to reducing errors and incorporate requirements for a pharmacist to interact with and counsel the patient (or carer/representative) in all cases when new medicines are dispensed regardless of location, rather than the current focus on payment for premises and dispensing processes.

4. Flexible approaches to pharmacist supervision and intervention that harness the use of modern technology and innovation. Thus allowing consistent and direct pharmacist involvement in all scripts regardless of the location and time of day without requiring actual physical presence.

The MedCentre provides the technology that enables delivery of higher quality pharmacy services, by ensuring personal one-on-one counselling and care from a pharmacist, with fewer errors and in a more accessible and ubiquitous manner. This model is exciting and disruptive and could revolutionise the delivery of safer and more accessible urgent care and related pharmacy services. It enables the Government’s legislative goals in that it puts patients first and at the centre of care. The PharmaTrust system improves efficiency and has enormous potential to improve health outcomes. Yet, the biggest risks to achieving these goals in terms of the delivery of pharmacy services (and elsewhere in the health care system) are the potential for vested interests to block such innovation and the potential for legislation and regulation to not be aligned to the goals of an integrated system.

We respectfully recommend that:

1. Government include key stakeholders, from all sectors, in the ongoing process to define an integrated and flexible commissioning process capable of driving and aligning the strategic imperatives and that these participants also include non-traditional suppliers such as PharmaTrust UK Ltd.

2. Proposed structures and models are flexible enough to anticipate the future integration of PharmaTrust type approaches to increase efficiency, better management of medicines and truly put the patient at the centre of care.

3. Legislation and regulation is drafted in a manner that encourages strategic imperatives to be addressed and enables new and innovative models of care using the latest technology enablers as opposed to; protecting the status quo, presenting barriers to innovation or becoming quickly outdated.

Effective Medicines Management can help relieve the disease burden and save patients and the NHS untold hardship and cost burdens. Medicine errors, non-adherence and other failures have been identified as major challenges to the system that add dramatically to unnecessary admission and readmission rates and cause unacceptable levels of morbidity and mortality. This Bill is an opportunity to address some of the structural and alignment problems that are seen as major contributors to the problem.

2. Introduction to PharmaTrust UK Ltd 

In response to the Health and Social Care Bill 2011 and the request for submissions and comments, PharmaTrust UK Ltd respectfully submits the following input and asks that it be taken into consideration as legislation is refined and further developed.

PharmaTrust UK Ltd is an organisation that enables the provision of enhanced pharmacy services through its patented technology (MedCentreTM and MedHome TM) that has the potential to make pharmacists and medicines available wherever and whenever patients require them. The PharmaTrust technology was originally developed and validated in Ontario, Canada where MedCentres have been operational since 2008. The MedCentre enhances the availability and reach of pharmacists so that they can truly be the most accessible frontline health care professional.

The MedCentre is a complete pharmacist controlled, point-of-care medicines dispensing system. It can stock and dispense over 2000 different medications. The MedCentres are under the direct supervision of a pharmacist who can intervene in real time at any point in the process. It ensures 24-hour access to medicines anywhere without the costs of traditional "bricks and mortar" pharmacies through the pairing of pharmacist expertise and innovative technology. The PharmaTrust system will significantly improve the management of medicines by enabling immediate access to medicines and pharmaceutical advice at point of care.

The MedCentre benefits to patients and the NHS are as follows:

1. Immediate access to prescription medicines at the point-of–care for all patients

2. 24-hour pharmacies anywhere without the barriers of time, distance, or costs

3. Pharmacists relieved of routine dispensing tasks to focus on patient counselling and clinical tasks

4. Specialty or foreign language pharmaceutical advice available to all, wherever and whenever required

5. Guaranteed full counselling of all patients by a pharmacist at the time of dispensing and as a routine follow up

6. Reduced errors and untoward events through contraindications, compliance etc.

7. Consequential reduction in emergency hospital admissions

8. Potential for new models for reimbursement for dispensing that get away from facility and script based reimbursement.

3. Our Interest in the Health and Social Care  Bill

We recognise Pharmatrust has a legitimate commercial interest in how this legislation is framed. However the pace of change and innovation is accelerating and the MedCentre is just one example of a rapidly increasing myriad of new enabling technologies for which the NHS Act will need the flexibility to respond and adapt to if patient benefit is to be fully maximised.

We also recognise that the UK has been slow among developed countries to embrace the strategic opportunities to enable the shift in the locus of care from inpatient to ambulatory settings that modern technology facilitates in the management of complex diseases.

We firmly believe in the principle that any new legislation should be enabling and not prescriptive so it can adapt to the future unknown innovations that will be rapidly upon us. Without such flexibility we risk the possibility of the new Act being obsolete before it is on the statute book resulting in legislation and regulation being the barrier to innovation rather than the enabler.

The effectiveness of prescribed medicines is dependent on a number of factors involving the clinician, the pharmacist and the patient. The optimisation of these is a major challenge in developing effective medicine management systems. The potential negative factors are:

· The wrong medicine is prescribed

· The patient fails to have his or her prescription filled

· There are errors in the dispensing process

· The patient fails to adhere to the required regime

· The desired clinical outcome is not achieved

Recently, a study conducted by Professor Nick Barber (Garfield, Barber, Willson, Walley. BMC Medicine 2009) and other similar studies have indicated a minimum of 60% of prescriptions fail to deliver their maximum potential benefit (see below). Thus any innovation that addresses the causes of these failures will:

· Contribute to the improvement in patient outcomes

· Reduce the frequency of untoward events that lead to complications

· Avoid unnecessary hospital admissions/readmissions.

· Reduce the cost of waste and unused medicines

PharmaTrust believes its approach will help reduce these failures by ensuring all patients receive immediate access to their medicines and guaranteed patient communication with, and access to, a pharmacist at the time of dispensing and subsequently.

Contribution by Type to Ineffectiveness of Prescribed Medicines

In section 4 below, we outline our concerns and the suggested approach to making the legislation more enabling. In section 5 we have addressed specific amendments to the current and proposed legislation that we believe should be considered by the Bill drafting committee. Our brief conclusions are in section 6. A specific example of how such changes will enable the more effective management of medicines in the proposed Urgent Care Centres is attached, as an addendum, in section 7.

4. Key Issues to be addressed by the  Legislation

We believe that the causes of some of these failures identified above are the behaviours and incentives that the current bifurcated structures and reimbursement systems encourage. Our submission is intended to address some of the fundamental issues that the new Health and Social Care Bill and related legislation should address to facilitate a more integrated approach to medicines management, how it is reimbursed and how new integrated strategic innovation can be encouraged.

The most critical needs are that the new legislation will:

1. Ensure a single integrated approach to commissioning of medicines is established in such a way that funding and incentives will drive behaviours that are aligned with the patient’s and the system’s best interests. We have examples, at present, where cost shifting causes patient delays in access to their medicines and robust pharmaceutical advice. The consequence is that some prescriptions remain unfilled and the lack of immediate and ongoing access to robust pharmaceutical advice contributes to the high level of potential errors or adherence issues identified above.

2. Ensure that the structure and reimbursement systems are aligned to the goal of true integration of services. Examples currently exist where, on a single campus, an Accident and Emergency Department, an Urgent Care Centre and a GP Out-of-Hours service co-exist; each separately reimbursed, and managed and operating from physically remote locations with no common triage. This leads to patient confusion and duplication and doesn’t allow cost effective provision of medicine management services.

3. Recognise that the location of care is no longer an indication of the complexity of service (see schematic below). Secondary and Tertiary complex care is now delivered by specialists in home and ambulatory settings. The idea that all care delivered outside of hospitals is only delivered by GPs is no longer valid. To ensure provision for this trend there needs to be a single integrated approach to commissioning and funding of medicine management services. This should be aligned around the patient with the patient’s best interest driving all decisions and not be subject to an arbitrary split between GP and Specialist services.

4. Remove the protectionist and silo mentality. This has led to inappropriate lines being drawn between levels of care and the evident hostility that exists between primary and secondary care providers. These behaviours can, to some extent, be traced to the way that services have been independently organised and commissioned around care levels rather than patient need. It should be recognised that care can be led and integrated by specialists into the community or vice versa. Both approaches are appropriate and should be dependent on the circumstances and nature of the patient’s condition and his or her needs.

5. Enable the use of new technologies that allow innovative approaches to more effective medicines management. The ability of a pharmacist in a registered premises or designated call centre, to oversee and intervene in dispensing in a remote location is essential to harnessing the capability of providing more accessible and safer access to medicines and pharmaceutical advice. This can be achieved through "Hub and Spoke" models utilising the responsible pharmacist in an existing registered facility (hub) to supervise the MedCentres (spokes) or pharmacists in a purpose designed call centre with delegated responsibility.

Using our own innovative technology and remote services, the attached example (see Section 7 Addendum) demonstrates how the proposed new models for "Urgent Care Centres" addressed in the new Act can be developed. The model incorporates an integrated approach to medicines management to produce improved patients’ outcomes and at lower costs. However, it requires flexibility in its governance commissioning and reimbursement.

The issues identified above need to be addressed by the Committee in drafting the Bill’s approach to the structure and alignment of the commissioning functions. In addition, we have identified below in section 5, suggested issues and legislative concepts for the Bill and related legislation that would assist in removing some of the existing barriers to effective remote supervision and intervention. The suggested amendments ensure consistent medicine management support at the point-of-care and ensure patients can receive essential pharmacist support to address, heretofore mentioned, causes of failure or error.

5. Legislative Section

This part of PharmaTrust’s submission:

· Provides an overview of the current legislative framework relevant to the use of the PharmaTrust MedCentre, and similar technologies, in the United Kingdom; and

· Makes proposals for the amendment and clarification of the current legislative framework through the implementation of secondary legislation in connection with the Health and Social Care Bill.

1. Overview of relevant legislation

1.1 The starting point for an examination of the current legislative framework for the dispensing of medicines in the United Kingdom is the Medicines Act 1968 (as amended) (the "Act"). Part III of the Act contains provisions relating to the sale or supply of medicinal products. More specifically, section 52(1) of the Act provides that:

"…no person shall, in the course of a business carried on by him, sell by retail, offer or expose for sale by retail, or supply in circumstances corresponding to retail sale, any medicinal product which is not a medicinal product on a general sale list, unless –

(a) that person is, in respect of that business, a person lawfully conducting a retail pharmacy business;

(b) the product is sold, offered or exposed for sale, or supplied, on premises which are a registered pharmacy; and

(c) that person, or, if the transaction is carried out on his behalf by another person, then that other person, is, or acts under the supervision of, a pharmacist."

1.2 Put briefly, there are – on a generalised level - three conditions that must be fulfilled for the dispensing of a medicinal product in a manner that is lawful and that complies with the Act:

(i) the person dispensing must be lawfully operating a pharmacy;

(ii) the dispensing takes place on a premises that is a registered pharmacy; and

(iii) the dispensing must be carried out by, or under the supervision of, a pharmacist.

1.3 The requirements in the Act in relation to condition 1.2(i) above are set out in Part IV of the Act. More specifically, section 69(1) provides that the person dispensing must be a pharmacist, and that the conditions set out in section 70 of the Act must be fulfilled in relation to the retail pharmacy business. Section 70 states that a "responsible pharmacist" must be in charge of the business at the premises where the retail pharmacy business is carried on.

1.4 Section 72A of the Act provides that it is the duty of the responsible pharmacist to secure the safe and effective running of the pharmacy business at the relevant premises. It also states that a person may not be the responsible pharmacist in respect of more than one set of premises at the same time.

1.5 In relation to condition 1.2(ii), section 74 of the Act provides a definition of "registered pharmacy" as the "premises for the time being entered in the register". The register referred to in section 74 is maintained by the General Pharmaceutical Council.

1.6 Section 69(2) of the Act states that where: "a business which -…so far as concerns the retail sale of medicinal products, or the supply of such products in circumstances corresponding to retail sale, is or is to be carried on in one or more separate or distinct parts (but not the whole) of a building…each such part of that building shall be taken to be separate premises."

1.7 There is one further section of particular relevance in the Act: section 54 provides that "…no person shall sell, or offer or expose for sale, any medicinal product by means of an automatic machine unless it is a medicinal product in the automatic machines section of the general sales list."

2. Proposals for amendment of the current legislative framework

Mechanisms for amendment

2.1 The discussion and enactment of the Health and Social Care Bill represents an important opportunity for amendments to be made to the current legislative framework to more clearly enable the widespread use of remote dispensing technology in the United Kingdom. Furthermore, the groundwork for such amendments was laid by the Health Act 2006, which introduced sections 10(7A) – 10(7C) and sections 52(2) – 52(4) into the Act.

2.2 Section 10(7A) of the Act states that:

"The Ministers may make regulations prescribing conditions which must be complied with if a thing is to be considered for the purposes of [Section 10 of the Act] as done under the supervision of a pharmacist."

2.3 Section 52(2) and 52(3) of the Act provide that:

"(2) The Ministers may make regulations prescribing conditions which must be complied with if a transaction mentioned in [section 52(1)(c) of the Act] is to be considered for the purposes of [section 52 of the Act] as done under the supervision of a pharmacist.

(3) Conditions prescribed under subsection (2) may relate to supervision in the case where the pharmacist is not on the premises…"

2.4 There is, therefore, an opportunity for secondary legislation to be enacted in parallel with the Health and Social Care Bill to more clearly enable the widespread use of remote dispensing technology.

Suggested legislation

2.5 We have set out below the key points that PharmaTrust believes should be addressed in secondary legislation enacted pursuant to sections 10(7A) and 52(2) and (3) of the Act:

2.5.1 Pharmacist supervision by video and secure audio link is supervision by a pharmacist for the purposes of section 52 of the Act

2.5.2 A remote dispensing kiosk is an extension of a registered pharmacy

2.5.3 Responsible pharmacist: application to a pharmacy and related remote dispensing kiosks

2.5.4 Responsible pharmacist: appropriate delegation of operational responsibility

2.5.5 Responsible pharmacist notice requirements: application to a remote dispensing kiosk

2.5.6 A remote dispensing kiosk shall not be regarded as an "automatic machine" for the purposes of section 54 of the Act

2.5.7 Use of remote dispensing kiosks in the course of business of a hospital or health centre

* The absence of any required pharmacists involvement in the counselling of patients and the ability by a responsible pharmacist to intervene is inconsistent with the intent of the legislation. Remote supervision through video conferencing etc. addresses the logistic issues which precluded this requirement i n hospital and health centres. The patient’s interest would be better served if the requirements were consistent regardless of the location of dispensing.

6. Conclusions

We respectfully recommend that:

· Government include key stakeholders, from all sectors, in the ongoing process to define an integrated and flexible commissioning process capable of driving and aligning the strategic imperatives and that these participants also include non-traditional suppliers such as PharmaTrust UK Ltd.

· Proposed structures and models are flexible enough to anticipate the future integration of PharmaTrust type approaches to increase efficiency, better management of medicines and truly put the patient at the centre of care.

· Legislation and regulation is drafted in a manner that encourages strategic imperatives to be addressed and enables new and innovative models of care using the latest technology enablers as opposed to; protecting the status quo, presenting barriers to innovation or becoming quickly outdated.

Effective Medicines Management can help relieve the disease burden and save patients and the NHS untold hardship and cost burdens. Medicine errors, non-adherence and other failures have been identified as major challenges to the system that add dramatically to unnecessary admission and readmission rates and cause unacceptable levels of morbidity and mortality. This Bill is an opportunity to address some of the structural and alignment problems that are seen as major contributors to the problem.

7. Addendum  - A New Approach to Management of Medicines in Urgent Care Centres

Situation

The further development of Urgent Care Centres (UCCs) is seen by the Government as a means of improving access to care. These Centres will be part of an integrated offering either in a hospital, as an adjunct to the A&E dept., or as freestanding centres located in the community. In either case they will bring local GPs into a structured system of governance with clear accountability for managing the urgent care of defined populations and communities. The characteristics are as follows

· Resources for out-of-hours and urgent care will be concentrated into centres with sufficient critical mass.

· The intent is to reduce demand for or replace the ad hoc system of GP on-call.

· Where appropriate the centres will be integrated with existing A&E departments which already attract high volumes of "walking wounded and worried well".

· The larger centres could have volumes of >100,000 visits p.a.

· Funding will likely be a capitated budget for delivery of care and service.

· Budgets will cover the complete episode of care.

· Prescriptions could be in the form of internal hospital prescriptions. FP10 HPs or FP 10s.

· A variety of dispensing services with or without the intervention of a pharmacist are likely to be deployed.

Opportunity

PharmaTrust UK Ltd. has identified its purpose as "to facilitate accessible, affordable and error-free drug dispensing with the intention of reducing unnecessary hospital admissions and patient visits caused by medicine errors and non-compliance."

PharmaTrust’s MedCentre technology allows it to offer a more cost effective dispensing process immediately available, all hours, at the point of care, with improved patient counselling and compliance. It allows customisation of the formulary to the agreed care pathways and pharmacist involvement throughout the prescribing and dispensing process. Such integration can enable a model for urgent care that would offer improved outcomes to commissioners whilst sharing the risk and controlling the overall costs.

The UCCs are ideal venues to demonstrate the company’s capability to deliver on this vision. The new UCCs are potentially vulnerable in their ability to manage and control medicines costs. FP10s filled in the community will be charged to the NHS payment authority whereas FP10HPs and internal hospital prescriptions are charged back to the individual centre’s budget. This mixture of fee-for-service funding of prescriptions is not aligned to the effective management of prescribing or dispensing.

PharmaTrust has the opportunity to offer a new model by working in partnership with the centres’ clinicians. The offer would be to manage the medicines process and related costs within a capitated local pharmacy services contract (LPS). In conjunction with the management of the UCC and its clinicians, detailed patient pathways with prescribing guidelines and a formulary would be developed. It also has the opportunity to review a patient’s overall medicines regime and avoid potential long term consequences of inappropriate medicines management.

PharmaTrust has identified a number of partners with existing or proposed involvement in UCCs. PharmaTrust has also been in consultation with the Department of Health (DH) to ascertain their interest in new innovative models that may conflict with current reimbursement practices and possibly some aspects of regulation.

Legal advice has been obtained on models and reimbursement approaches that could be employed for the UCCs. It is important, initially, to create a business model that can operate within the allowed section 55 exceptions for Hospital and Health Centres under the Medicines Act.

An option that we believe would have attractions to government and remove the ambiguity and need for a NHS contract would be a Local Pharmacy Services (LPS) contract. This is a capitated or fixed price contract for full provision of medicine management services to a prescribed population or community. Thus the government’s liability is capped or based on a capitation model. This has the potential to align and integrate the interests of the clinicians as prescribers with the pharmacists responsible for the supply of medicines as dispensers. It would also shift focus to the overall better management of the patient’s medicines needs and profile.

March 2011