We hope you have been keeping well and safe during what has been a challenging time for everyone, particularly for those of you who provide front line pharmacy and healthcare services.

Services During Covid
At PharmaConsult, throughout the height of the Covid pandemic we continued to offer remote consultancy services. While still working remotely where possible, since early July  we have been back in pharmacy, healthcare, training and legal environments, providing our onsite services in a Covid safe manner. Please don’t hesitate to call or email for information on any of our services.

1. Pharmacy SOPs
At PharmaConsult we are continually updating our SOPs to ensure they reflect the current pharmacy environment. For example, our current SOP sets include updated influenza vaccine SOPs for this year's flu season.

In recognition of the challenges facing community pharmacies due to Covid, we are offering the following discounts on SOPs purchased before the 30th September 2020:

• 15% off our SOP Sets
• 10% off all other SOPs

These offers are in addition to the significant price reductions available when purchasing multiple SOPs, multiple SOP sets or SOPs for multiple pharmacies. Further SOP details are available in the SOP section.

2. Onsite and Remote Services:
We currently have some dates in September and October available to provide remote or onsite pharmacy practice or regulatory consultancy services,. The services available include but are not limited to:

• Auditing (detailed quality improvement audits or audits based on routine PSI inspections)
  
• Quality Improvement Services (risk, error and complaint management; bespoke SOPs)
• Regulatory Assistance (inspection; registration; fitness to practice; general queries)
• Service Review and Development (care homes; vaccination; health screening; bespoke services)
• Quality Improvement and Regulatory Training
• Assistance with Pharmacy Practice and Regulatory Queries

3. Expert Witness/Legal Services:
PharmaConsult provides services to pharmacies, other healthcare providers and their solicitors. Our services include:

• Assisting solicitors and their clients with fitness to practice or court proceedings
• Preparation of expert witness and/or audit reports for legal proceedings
• Providing evidence at court or fitness to practice proceedings
• Our areas of expertise include pharmacy practice, medicines, medicines and pharmacy legislation and pharmacy regulation

4. European Automated Dose Dispensing Association (EAADD):
PharmaConsult are currently working with a number of European pharmacies who provide automated dose dispensing services to establish a European Automated Dose Dispensing Association (automated monitored dosage systems). One of the main goals will be to provide a platform for sharing ideas, knowledge, experience and research across Europe. If you provide or are thinking of providing these services and this association is potentially of interest don't hesitate to get in contact.

Further information on our core services is available on our services pages.
Don't hesitate to contact us  if you have any queries about our services.

 PharmaConsult at Pharmacy Show :
 PharmaConsult will have a stand at the    Pharmacy Show at the Aviva this Sunday and  Monday (14th and 15th April). Come and visit us to say hello. You can also avail of our competitive show prices and enter our competition for free consultancy. We look forward to seeing you there. 😊

PharmaConsult Services :
PharmaConsult's professional services support and enable pharmacists to optimise patient care, develop services, reduce risks and meet regulatory compliance standards in a cost effective and efficient manner.

Our Core Services Include:

• SOP Services: Template and Bespoke. Individual SOPs and full pharmacy sets
• Compliance and practice advice and updates (subscription service available)
• Audits (standard, detailed, bespoke and specific- new opening, vaccination)
• Error management review services
• Regulatory training service and associated regulatory booklet
• Assistance with PSI inspection, fitness to practice and registration interactions
• Quality management system services
• Pharmacy practice review and development services
• Residential care home services
• Pharmacy assessment system reviews
• HSE interaction services
• CPD requirement assistance services
• Project management services
• Expert witness and related services

The advice subscription service and regulatory booklet are available to purchase from our online store.

Further detail on each of these services is available by clicking on the service you’re interested in or by contacting us.

PharmaConsult at UD Show :
PharmaConsult will have a stand at the United Drug Show at the Aviva this Sunday and Monday (15th and 16th April). If you are at the show come visit us and say hello 😊

Caroline will also be attending the IPU conference at the end of April and looks forward to meeting colleagues and clients at what will no doubt be a fun and informative weekend.

PharmaConsult Services and Website Update:
We are delighted to announce that we have updated our website, in particular the service sections. The updates increase the clarity of our current services and provide information on a number of new services. Don’t hesitate to contact us if there is a service or product you would like further information on.

Our new Services include:

• Compliance and practice advice and information subscription service
• Expanded SOP service, including the availability of individual SOPs and SOP sets
• Error management review service
• Regulatory training service and associated regulatory booklet

The advice subscription service and regulatory booklet are available to purchase from our new online store.

We continue to offer our other core services, including:

• Audits (standard, detailed and specific)
• Pharmacy assessment system reviews
• Assistance with PSI inspection, fitness to practice and registration interactions and responses
• Expert witness and related services
• Quality management system services
• Pharmacy practice review and development services
• Residential care home services
• CPD requirement assistance services
• Training and project services

Further detail on each service is available by clicking on the service you’re interested in or by contacting us.

Regulatory and Practice Updates:

Storage of Pharmacy-Only Medicines: From this month the PSI expect pharmacy-only medicines to be stored in a part of the pharmacy premises that the public don’t have access to, in line with the regulatory requirements. Further information is available in my recent blog.

Automated Dose Dispensing Guidelines: The European Directorate for the Quality of Medicines (EDQM) recently issued Automated Dose Dispensing (ADD) Guidelines: ‘Best Practice for the ADD Process and the Associated Care of Patients’. Caroline is delighted to have chaired the group that developed these guidelines during her time at the PSI and subsequently consulted to the EDQM to ensure their completion. Further information on ADD is available in a previous PharmaConsult blog.

CPD: Practice and E-portfolio Review: The Irish Institute of Pharmacy’s (IIOP) first practice review process will take place shortly (April 21st and 22nd) and this year's e-portfolio review is underway. Information on these and other CPD updates are available in the IIOP’s most recent newsletter.

Garda Vetting: All employers are required to Garda Vet employees who work with children or vurnerable adults, including pharmacists, pharmaceutical assistants and any other relevant employees before 1st May. Details of the process are set out on the citizens information website. Further information is available from the IPU, who are acting as the umbrella organisation for pharmacies.

Food Intolerance Testing: The PSI and HPRA recently clarified that pharmacies should no longer be offering food intolerance testing services. Further information is available on the PSI website.

Benzodiazepines: The HSE's Medicines Management Programme has published useful resources for healthcare professionals and the public. For healthcare professionals they have developed prescribing tips and tools for benzodiazepines for the treatment of anxiety and insomnia.

PSI Superintendent Pharmacy Seminars: Caroline recently attended one of the PSI’s superintendent pharmacist workshops where the focus was on their new corporate strategy and how the PSI hope to move towards developing standards for pharmacies in combination with the profession.

Other Regulatory Updates: The PSI issued regulatory updates on various topics including the new General Data Protection Requirements (GDPR), Fitness to Practice updates and the risks associated with Topirimate use in pregnancy in its recent newsletter.

PharmaConsult offers regulatory compliance and practice review and development advice and services to pharmacists, pharmacy owners, chains and pharmacy and healthcare organisations throughout Ireland. We operate out of Dublin and have satellite bases in Tipperary and Sligo.
Our Services include:

• Vaccination Service Audits and Assistance
• New: Pharmacy Regulatory and Practice Update and Advice Service (Subscription)
• Pharmacy Assessment System Services
• Continuing Professional Development Assistance (E-portfolio etc.)
• General Pharmacy Audits (based on PSI Inspections)
• PSI Interaction/ Response Services (Inspection, Registration, Fitness to Practice)
• Practice Review and Development (Prescription Management, Care Homes etc.)
• Quality Management System Review (SOPs, Error Management etc.)

 
Vaccination Service Audits and Assistance:
PharmaConsult offers a pharmacy vaccination audit and review service, which can be provided as a standalone service or alongside a standard audit.  As you are probably aware the PSI are currently inspecting vaccination services (PSI Newsletter 14/12/17). If you would like an audit to review your vaccination service and ensure it complies with requirements, PharmaConsult would be delighted to assist you. Caroline is ideally placed to review vaccination services as she was the primary author of the PSI vaccination guidelines and she inspected many pharmacies vaccination services during her time at the PSI. Due to her knowledge of the area she can answer your queries or provide assistance with any aspect of a vaccination service. If you have any questions or would like to avail of this service please call or email Caroline: 087-4198376, caroline@pharmaconsult.ie

New: Advice Subscription Service for Pharmacists and Pharmacy Owners/ Chains:
PharmaConsult are now offering a pharmacy regulatory and practice update and advice subscription service. The annual service includes six written updates on regulatory and practice issues a year exclusively for signed up members and three half hour consultations (advice/ information via a combination of phone and/or email) on topics and at a time suitable to the subscriber. Subscribers also have access to the service within defined short timelines. Modifications to this service are available on request. Pricing is competitive for this new service, particularly if you sign up before the end of January 2018. Members can also avail of our other services at more competitive rates. If you want to sign up or think you might be interested in this service, please contact us for further information: Caroline: 087-4198376, caroline@pharmaconsult.ie. Further information on this service will also be included on our website in the coming weeks.

PSI Pharmacy Assessment System:
PharmaConsult continue to supply PSI pharmacy assessment system assistance services to pharmacies. Pharmacies should have almost two cycles of the assessment system completed and will shortly receive the documents for the third cycle from the PSI (PSI Newsletter 14/12/17). Caroline, who was involved in the development of the system while at the PSI, is available to assist you with your assessment system needs. She can review completion of your assessment system to date, assist you with completing new or partially completed sections and ensure you are using the system to both effectively drive continuous improvement in your pharmacy and meet PSI expectations. Further information on these services is available on our assessment system page. If you have any questions or would like to avail of this service please call or email Caroline: 087-4198376, caroline@pharmaconsult.ie

CPD: Irish Institute of Pharmacy E-portfolio Review:
PharmaConsult continue to supply CPD E-portfolio review services to pharmacies. For the almost 1300 pharmacists who have been selected for e-portfolio review, you are no doubt aware you can start submitting your e-portfolios from January 8th (IIOP Newsletter 14/12/17) and will want to ensure your e-portfolio extracts meet the requirements. Caroline is aware of the e-portfolio requirements and is happy you assist you by reviewing your cycles, assisting with developing further cycles or with understanding the process. If you have any questions or would like to avail of this service please call or email Caroline: 087-4198376, caroline@pharmaconsult.ie

Information on our other core servcies are set out in the services pages.

Storage of Pharmacy Only Non-Prescription Medicines

The PSI recently announced that they would be expecting pharmacy's to demonstrate compliance with the 2016 legislation on the storage of pharmacy only medicines by April 2018: PSI Regulatory Notice 1/2017: Storage of Pharmacy Only Medicines in a Retail Pharmacy Business. This blog aims to help pharmacists carry out a review of the storage of these medicines.

The PSI notice follows an update to the legislation in 2016. The Regulation of Retail Pharmacy Businesses Regulations 2008 (S.I. No. 488 of 2008) was amended by S.I. No. 80 of 2016 and Regulation 5(1)(ea) was inserted. Under this regulation the pharmacy owner and the superintendent pharmacist is required to ensure that pharmacy-only medicines “are stored in a part of the premises to which the public does not have access”. In practical terms this means  pharmacists should review the shelves in the public pharmacy area and any pharmacy only medicines should be relocated behind the medicines counter or to another appropriate area of the pharmacy that the public don’t have access to. To ensure a thorough review, any medicines located beside or adjacent to the medicines counter should also be included. Essentially if pharmacy only medicines are stored in any area of the pharmacy where a member of the public could pick them off the shelf they should be moved to an area the public don’t have direct/physical access to.

If you are not sure of the classification of a medicine, it can be checked via the ‘Find a Medicine’ section of the HPRA website www.hpra.ie. As the regulator of medicines their information takes precedence over information on the status of medicines from other sources. If the listing for a medicine on the HPRA website states it is a ‘product not subject to medical prescription’ and is ‘supplied through pharmacies only’ the product is a pharmacy only medicine and is required to be stored in a part of the premises to which the public does not have access.  

To generate a list of pharmacy only medicines from the HPRA website a ‘Find a Medicine’ advanced search can be undertaken. When undertaking the search ensure you tick the dispensing status as ‘product not subject to medical prescription’ and supply status as ‘supply through pharmacies only’. This will generate webpages listing pharmacy only medicines.

What medicines could you be missing? Examples of the more common pharmacy only medicines found on front of pharmacy shelves during PharmaConsult audits include Nizoral shampoo, Daktarin cream and powder, various NSAID gels, Difflam products and Pharmaton products.

If you would like assistance or further information on this or any other regulatory issue don’t hesitate to contact us at info@pharmaconsult.ie or caroline@pharamconsult.ie.

Management of Pharmacy Only Medicines

The PSI recently issued draft guidelines on the management of non-prescription medicines, which are currently undergoing a public consultation process. PSI Draft Guidelines on the Sale and Supply of Non-Prescription Medicinal Products from a Retail Pharmacy Business. Details of the consultation process are available on their website www.psi.ie.

The guideline addresses the legislative basis for supervision of the sale and supply of non-prescription medicines and the associated counselling of patients. The guidance has sections outlining the expectations in relation to pharmacist involvement in supplies, patient consultations in general and specific circumstances, the policy, procedure and staff training requirements and the management of internet supply.

Controlled Drugs Guidance

In October the PSI and Medical Council issued joint guidance entitled ‘Safe Prescribing and Dispensing of Controlled Drugs’. The guidance outlines the changes brought about by the Misuse of Drugs Regulations 2017, which came into effect in May this year. It sets out the legal provisions and requirements relating to prescribing and dispensing controlled drugs. The practical information on controlled drug classifications, prescription requirements and sample prescriptions are useful, particularly where they refer to the new requirements for benzodiazepine (schedule 4 part 1) prescriptions.

PharmaConsult Subscription Service 

From this month PharmaConsult will be offering a pharmacy regulatory and practice update and advice subscription service. The annual service will include six written updates on regulatory and practice issues a year exclusively for signed up members (similar to the above) and three half hour consultations (advice/ information via a combination of phone and/or email) on topics and at a time decided by the subscriber. Subscribers will also have access to the service within defined short timelines. Modifications to this service are available on request. Pricing is competitive for this new service, particularly if you sign up before the end of the year. Members can also avail of our other services at more competitive rates. If you want to sign up or think you might be interested in this service, please contact us for further information: info@pharmaconsult.ie,  caroline@pharmaconsult.ie or 087 4198376.

Further information on this service will be included on our website and circulated to contacts in the coming weeks.

Please also note that PharmaConsult onsite services are offered from bases in Dublin, Tipperary or Sligo.

If you would like to be added to the email blog circulation list please email us at info@pharmaconsult.ie

Caroline Hogg MPSI, Owner and Lead Consultant PharmaConsult

Having worked with several pharmacies since establishing   PharmaConsult to review and upgrade their quality systems and having recently completed the Irish Institute of Pharmacy’s (IIOP) Quality Improvement course, I thought quality in pharmacy would be an interesting topic to provide some information on. I’ve drawn on my recent experiences from PharmaConsult along with the experience I gained when in regulatory and community practice.  I found the IIOP course particularly useful as it helped me refocus on how different tools could be used to improve quality, particularly in relation to high risk medicines.

The Importance of Quality in Pharmacy Practice:

As you will be aware, there has been an increased focus on quality in pharmacy in recent years and particularly on having an effective quality management system (QMS) in place. This helps ensure the safe delivery of pharmacy services at a standard that meets patients’ needs and expectations. A robust QMS not only benefits patients by ensuring a consistent standard of care but also minimises the chances of negative reputational or regulatory consequences for pharmacists.

Important Elements of Quality Management Systems:

The important elements that underpin quality in pharmacy practice include:

• establishing a patient safety and continual improvement culture
• ensuring effective communication
• implementing risk assessment and reduction systems
• implementing effective error and near-miss management systems
• engaging effectively with patients and customers, including managing complaints
• having robust documented policies and procedures in place and ensuring such policies and procedures are implemented and followed
• ensuring adequate staff training occurs

The ongoing monitoring of processes and review of procedures, complaints and errors in order to continually improve patient services is a particularly important part of the process.

How to Achieve Quality Improvement in your Pharmacy:

• Involve and engage with the pharmacy team (to develop a patient safety culture and ensure ‘buy-in’ to change)
• Critically review/ audit the current quality management system, including processes, documents, records and training methods
• Assess risks: Review relevant internal information, e.g. errors and near-misses, patient/ customer complaints, and external information, e.g. HPRA newsletters, PSI Fitness to practice learnings
• Develop an action plan to minimise risks. Establish the priorities for improvement, focusing on the core activities that affect patient care and quick wins first, e.g. management of the dispensing process and patient counselling, with a specific focus on ‘high- tech’ and high-risk medicines
• Utilise support tools, as appropriate throughout the process:
  • Regulatory and best practice documents
  • Assessment tools: e.g. risk register, SWOT analysis (strengths, weaknesses, threats, opportunities), ‘the five whys’
  • Quality improvement tools: e.g.  PDCA (plan, do, check, act), CAPA (corrective and preventative actions)
• Set SMART targets (specific, measurable, achievable, realistic and time based) and ensure follow through
• Establish a continuous quality improvement system, with regular ongoing reviews of systems, documentation and training

Further Information on Quality Management Systems:

The importance of robust QMS have been highlighted by the PSI, though its Pharmacy Assessment System and via the inspection process. Their requirements are supported and explained through their guidelines, advisory and fitness to practice learning documents, available on the PSI website (www.psi.ie). Other pharmacy organisations both national and international have also issued useful documents, e.g. several useful documents are available on the RPSGB website (www.rpharms.com).

Online and face to face pharmacy specific quality courses are provided by the Irish Institute of Pharmacy and such courses improve pharmacists’ knowledge and ability in this area. Other quality management system courses, e.g. on ISO QMS, are also available.  Engaging with other pharmacists who have implemented quality management systems nationally and internationally and learning from their experience is also helpful.

PharmaConsult provides quality review and improvement services, which assist pharmacists in assessing risks and reviewing their current or implementing a new quality system. This can occur either across the pharmacy or for specific pharmacy services, e.g. management of residential care homes. Bespoke tailored services are available and several standard support services and documents have been developed. Please don’t hesitate to contact us if you would like to discuss these services further (info@pharmaconsult.ie). 

Caroline Hogg MPSI, Owner and Lead Consultant PharmaConsult

We are sharing the article published in the April Issue of the Irish Pharmacist based on an interview with PharmaConsult’s Owner and Lead Consultant, Caroline Hogg. During the interview, Ms Hogg addressed the regulatory compliance and practice review and development issues affecting pharmacists today.
 
PharmaConsult: Preparation and Inspiration

In an era when the regulatory and business challenges for pharmacy continue to grow, ensuring compliance and reviewing and developing pharmacy services is essential.

As the role of pharmacists evolves to encompass greater responsibilities in healthcare provision, so too do the patient care and regulatory requirements on the profession. Anticipating patients’ healthcare and medicines needs is essential for pharmacies to thrive and services supporting pharmacists’ practice standards, knowledge and ability to comply with regulations are essential to meet these challenges.

Managing Director and Lead Consultant with PharmaConsult — a company offering regulatory compliance and practice review and development services to pharmacists throughout Ireland — Ms Caroline Hogg MPSI, told Irish Pharmacist (IP) how strategic preparation for inspections, risk reduction methods, upskilling staff and reviewing and expanding services is vital in a modern pharmacy in order to improve patient care, ensure best practice, as well as enhancing ‘bottom-line’ considerations.

‘We support and enable pharmacists to optimise patient care, develop services and meet regulatory compliance standards in a cost effective and efficient manner.’ Ms Hogg told IP.  
‘We offer compliance services, including pre-inspection audits, based on PSI inspections, and more detailed audits. These audits minimise risk and improve compliance thereby reducing the likelihood of negative patient, reputational or regulatory consequences for pharmacies’ she explained. ‘It’s preferable for pharmacists to be prepared and to carry out external audits to prevent negative patient outcomes or interactions with the PSI than to suffer negative consequences due to an error or inspection issue, but when necessary we also assist pharmacists who have had a problematic inspection or a difficult fitness to practice interaction. Helping pharmacists to respond with confidence to the PSI, resolve highlighted issues and minimise the fears they have about the process is a core element of what we do.’

Ms Hogg also outlined PharmaConsult’s practice review and training services ‘These services optimise a pharmacy’s efficiency, patient safety and regulatory compliance. We work with pharmacists to improve their current set up by ensuring their services meet requirements and best practice. We also ensure new services are implemented in a compliant, effective manner.’ She added ‘I have reviewed many pharmacy services since establishing my company, including core services, such as prescription management, and extended services including, residential care home services.’

PharmaConsult’s services are diverse, Ms Hogg stated “I have also worked with pharmacies and locum providers either providing training on relevant topics or helping them develop their training. I also regularly work with pharmacies and pharmacy organisations on various projects where I can add value.”

PSI Inspections and Self-Assessment

One of the greatest sources of stress for a pharmacist is the anticipation of, and preparation for, an inspection: “This is especially true if a pharmacist is not sure what the inspector will be looking for.” she explains. ‘’Audits can help greatly in that respect.’’

Among the wide range of issues that may arise during an inspection, there are certain recurrent themes, Ms Hogg explained. “Management of prescriptions and controlled drugs certainly need to be in order. These are some of the core issues, but there are many issues that can arise and require the right preparation. Having a quality management system, which includes the effective management of errors and well developed and implemented procedures is essential.’ She added ‘while the core areas of prescriptions and controlled drugs will continue to form part of PSI inspections, there is a shift towards reviewing patient care issues, including ensuring prescription review and patient counselling is occurring for all medicine supplies.’

The PSI’s new self-assessment system is a tool developed to facilitate pharmacist’s reviewing their practice and identifying areas for improvement. It will be closely linked to the risk assessment of pharmacies by the PSI. Ms Hogg explained ‘The system is positive insofar as it is a move towards pharmacy self-review and away from traditional inspections. There is also an increased emphasis, within the system, on communication both within the pharmacy team and with patients, which I think is positive. However, it is a new tool and that presents challenges for pharmacists.’ She added that ‘My company’s assessment system services enable pharmacists optimise use of the system, which both improves the functioning of their pharmacy and helps minimise the frequency of future PSI inspections.’

CPD and Quality in Pharmacy

Ireland’s CPD system is also an area where PharmaConsult provides guidance. “This is an area where we can assist when pharmacists are not sure what is required” she said. “Pharmacists learn from the services we provide. For example, if I review a pharmacy’s SOPs, provide feedback and develop updated SOPs with the pharmacy, that is a form of CPD as pharmacists learn from the process. I also always help them to access further relevant information, including relevant guidelines. These types of learning can be reflected in a pharmacist’s portfolio. We can also assist in understanding the CPD system and meeting the requirements, because I gained an intimate knowledge of the system during my time at the PSI.”

Caroline acknowledges the challenges of engaging with CPD. ‘We are all busy so it can be hard to find time to engage in CPD. I think it’s important to look for learning opportunities in our everyday practice.  For example, I know about quality in pharmacy and I’m offering quality management services to clients so I identified the importance of engaging in further learning in the area to gain a different perspective and am currently participating in the Irish Institute of Pharmacy’s Quality Improvement Course.’

PharmaConsult’s standard quality improvement package reviews pharmacies resources, processes and procedures and advice is provided to ensure processes are safe, efficient, adequate and compliant. Caroline explained that the service also ‘‘addresses the management of dispensing errors and complaints and develops tailored documentation. As training staff is an essential element of quality, we usually also design and deliver a staff training package.’’
 
Service Review and Expansion

With the expanding role of the Irish pharmacist comes new considerations in terms of regulation and the need for pharmacists to keep abreast of the changes. “PharmaConsult helps pharmacists to consider the opportunities these changes may present. Some recent changes include the ability to administer life-saving emergency medicines, the piloting of the HSE minor ailment scheme and various areas addressed in the PSI’s ‘Future Pharmacy Practice in Ireland’ report.’’ Caroline explained ‘‘If pharmacists are considering expanding into these or other areas we can help ensure this is done in an effective and compliant manner. We also provide expertise on working within the community— as the experts in medicine, pharmacists have a lot to offer in that regard.’’

Ms Hogg told IP “I have worked with various pharmacies reviewing their set up or preparing them for an expansion of their services. Expanding services can be challenging for pharmacists, particularly independent pharmacists who often don’t have access to as many resources.’’ She expanded ‘‘My work with pharmacists can involve reviewing an element of practice, for example a pharmacy’s medication management, or an extended service, for example, vaccinations — within the PSI I was the primary author who drafted their vaccination guidelines. I have also written or reviewed many other PSI documents so I can assist in diverse areas. Services I have reviewed since establishing PharmaConsult, include medicine delivery, veterinary and various hospital pharmacy services. While at the PSI, I chaired a European group that developed draft standards on Automated Dose Dispensing (ADD) so I also offer services around both ADD and more traditional dosage systems.’’

Residential care homes are where some of the most vulnerable patients in our communities reside. Because of this and the PSI and HIQAs focus on care home patients and medication management, this is an area Caroline feels all pharmacies should consider reviewing. Caroline explains ‘For those that provide medication services to nursing home patients, PharmaConsult can review a pharmacy’s specific set up, the care home and patient profiles and medication specific issues.’

Providing Assistance

Caroline has over sixteen years’ experience in regulatory and pharmacy practice settings and is passionate improving pharmacy standards and patient care. In PharmaConsult, she draws on the experience she gained as a practice development pharmacist, project manager and inspector during her six years with the PSI. She also draws on her experience of chairing and participating in national and international healthcare groups and Committees on behalf of the PSI. Before joining the PSI, Ms Hogg spent almost ten years between hospital and community pharmacy, in clinical, supervising and managerial roles, thus providing her with a comprehensive overview of all aspects of the profession.

Her company’s services enable pharmacists and pharmacy owners, to enhance patient safety and ensure compliance. Ms Hogg and PharmaConsult offer specific packages detailed on its website, as well as bespoke, tailored packages. Ms Hogg has also established a blog to update readers on pharmacy professional and regulatory developments.

Caroline concluded: “Preparing properly and investing in improving a pharmacy’s set up and services not only reduces stress, but also reduces the risk of something going wrong in day-to-day practice and the risk of damage to a pharmacist’s reputation and of course, most importantly, the risk of harm to their patients. If you look after your patients and place a reasonable amount of focus on compliance issues, that positively impacts your business, your reputation and standing, as well as putting you in a positive position with the PSI.”

To learn more about PharmaConsult’s services, Caroline’s experience or to view testimonials visit www.pharmaconsult.ie or email PharmaConsult directly at info@pharmaconsult.ie. Caroline would be happy to hear from pharmacists who have questions or would like to be added to the mailing list for PharmaConsult’s blog.

What is ADD: Automated dose dispensing is the dispensing, of one or more different medicinal products into an ADD container/pouch using an automated process. One container/pouch contains either one, some or all units of medicine an individual patient needs to take at a particular date and time. The medicinal products are usually removed from their (original) primary containers before they are dispensed via ADD; if the primary packaging container is a blister, this process is called “deblistering”. It is essentially the automated version of dispensing a monitored dosage system (MDS). Tosho machines are the most common ADD machines used in Ireland.
 
ADD in Ireland: While this practice is in it’s infancy in Ireland, a number of pharmacies use automated dose dispensing services on a small scale to dispense medication to their community and residential care home patients receiving their medication via MDS. A small number of specifically designed medium scale ADD services are also in operation.
 
ADD standards in Ireland: There are currently no specific ADD standards in place in Ireland. In the absence of legislative requirements, the PSI standards for ADD sites have been based on general pharmacy and medicine legislation and relevant PSI guideline requirements. Relevant international standards have also influenced the standards expected.
 
The development of European Standards: The European Directorate in the Quality of Medicines (EDQM), an organisation which provides policies and model approaches for the safe use of medicines in Europe, including guidelines on pharmaceutical care, have developed draft ADD guidelines. These guidelines were recently issued for public consultation on the EDQM website: Draft Guidelines.
 
The purpose of the guidelines is to harmonise the standards and approaches to ADD across Europe and to help ensure that this service is provided to a consistently high standard which ensures the safe supply of medicines to patients.
• EDQM’s work on this topic began with the identification of a need for guidance by the
Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and
Pharmaceutical Care (CDPPH/PC) in 2012.
• The document was then drafted by a Working Party of Experts in ADD and a workshop with stakeholders, interested parties and authorities took place in September 2015.
• The draft guideline document was finalised by CDPPH/PC in summer 2016 and released by the Steering Committee for public consultation at its meeting in September 2016. The public consultation closed in February 2017.
 
PharmaConsult’s lead consultant, Caroline Hogg MPSI, sat on the CDPPH/PC committee on behalf of the PSI and Department of Health from 2010 to 2015 and chaired the ADD working group which the developed the guidelines during this time. Her role included drafting the guideline development plan and the patient care elements of the guidelines and reviewing/ updating elements of the guidelines drafted by other expert working group participants. Caroline also presented the guidelines at committee meetings and chaired the workshop in September 2015.
 
Following the consultation, it is expected that the guidelines will be reviewed and updated by the relevant EDQM committees and in due course finalised, approved, published and disseminated.
 
Impact of the European Standards in Ireland: Subject to their approval by the necessary EDQM Committees, it is expected that relevant elements of the guidelines will be adopted in Ireland.
 
Information on ADD and the relevant Standards: Should you require information or advice on the guidelines or any elements of the standards relating to automated dose dispensing please don’t hesitate to contact us.

Welcome to PharmaConsult's First Blog

PharmaConsult: Who are we:
PharmaConsult offers expert regulatory compliance and practice review and development services to patient facing pharmacists and pharmacy and healthcare organisations throughout Ireland, primarily through our owner and lead pharmacist consultant, Caroline Hogg MPSI.
 
Caroline is passionate about pharmacy, particularly about improving standards and patient care and brings over 16 years regulatory and pharmacy practice experience to the business. Experience spans the PSI, community and hospital pharmacy, with PSI roles including practice development expert, project manager and inspector.
 
What can PharmaConsult do for you:
We support and enable pharmacists, pharmacy owners and healthcare providers to optimise patient care, develop pharmacy services and meet regulatory and compliance standards through training, audit, development and response services.
 
Our services are beneficial, if

• You find the PSI regulatory requirements challenging
• You have had a difficult inspection or interaction with regulators, or are you worried about having one
• You want advice on any regulatory or practice issues
• You would like to improve the quality systems in your pharmacy
• You want to review or expand your pharmacy’s services or improve patient safety

 
PharmaConsult provides:
Regulatory compliance/inspection services:

• Pre-Inspection Audits (Detailed Mock PSI Inspections)
• Assistance with the new PSI Pharmacy Assessment System
• Inspection or PSI Fitness to Practice Response Services

Practice Development and Training Services:

• Review of any Routine or Specialist Pharmacy Service
• Implementation or Review of Quality Systems (SOPs, Practices)
• Training for Pharmacists or Pharmacy Staff
• Project Management or Support

Tailored services are available
All services are professional, cost effective and confidential
 
Our compliance services minimise risk and improve regulatory compliance thereby reducing the likelihood of negative patient, reputational or regulatory consequences for your pharmacy.
Practice review, development and training services optimise the pharmacy’s efficiency, safety and regulatory compliance and can improve and expand pharmacy services for the benefit of both pharmacists and their patients.
 
Caroline will work closely with you to tailor any of PharmaConsult’s services to your pharmacy’s needs and is available for services ranging from one hour phone consultations to detailed project management.
 
Further information on our services, Caroline’s experience and client details and testimonials are available in the relevant sections of our website. Please don’t hesitate to call or email if you would like information on any of PharmaConsult’s services or if you have any questions.