This article published in the Irish Pharmacist is based on an interview with PharmaConsult’s Owner and Lead Consultant, Caroline Hogg MPSI. 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 or email PharmaConsult directly at 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.