Pharmacists and the new accreditation standards
In this article, you will learn:
- how new accreditation standards are changing the role of the pharmacist in hospitals and strengthening their involvement in the treatment process
- What are a pharmacist’s responsibilities regarding the supervision of pharmacotherapy and its periodic review?
- what role a pharmacist plays in the organisation of medicines management, storage and the safe use of medicinal products
- how a pharmacist contributes to the development of the hospital formulary and the principles of rational pharmacotherapy
- What tasks relate to the documentation, preparation and administration of medicines, and the safety of pharmacotherapy?
- what role does a pharmacist play in staff training and education in the field of pharmacotherapy?
- in which other areas covered by accreditation standards can a pharmacist be involved – including nutritional therapy, infection prevention, patient care and quality improvement
About this publication
Abstract
The new accreditation standards, announced by the Minister of Health on 6 September 2024, significantly expand the role of pharmacists within the healthcare system and raise their standing within the hospital hierarchy. Their responsibilities include overseeing the safety and efficacy of pharmacotherapy, the rational use of medicines, participation in clinical processes, and the education of staff and patients. As a result, the pharmacist becomes a key expert in the quality of care, and their knowledge and expertise have a tangible impact on improving patient safety and the effectiveness of pharmacotherapy.
Keywords
accreditation standards, safe pharmacotherapy, medicines management
Introduction
Pursuant to Article 22(5) of the Act of 16 June 2023 on the quality of healthcare and patient safety, the Minister of Health announced on 6 September 2024 the accreditation standards for medical activities in the category of 24-hour and inpatient hospital healthcare services [1].
In light of the new accreditation standards, pharmacists are becoming not only suppliers of medicines, but above all experts in the field of medicinal products and key members of the therapeutic team, responsible for overseeing pharmacotherapy and shaping medicines policy. Modern pharmacotherapy plays a key role in ensuring the safety and effectiveness of treatment for patients.
What challenges and responsibilities do pharmacists face in the context of the new regulations?
Challenges
Monitoring of drug therapy
As a member of the hospital’s designated therapeutic team, the pharmacist oversees the safety and effectiveness of the pharmacotherapy administered, which should be administered as rationally as possible, ensuring positive therapeutic outcomes and aimed at avoiding adverse drug reactions. This task may be carried out by the pharmacist prospectively – during the patient’s hospitalisation – as well as retrospectively – through the analysis of medical records, either from the hospital pharmacy or whilst working on the ward.
Standard FA 1 (The hospital oversees the pharmacotherapy provided) introduces an obligation to carry out periodic assessments of the pharmacotherapy provided in hospital wards. At least once a quarter, a review of at least ten randomly selected medical records must be carried out, analysing the appropriateness of medication use, the frequency of polypharmacy, monitoring of pharmacological coercion, and combinations of medicines used concurrently that are characterised by a high risk of adverse side effects [1]. This assessment should be concluded with findings and recommendations presented to and discussed with the staff of the relevant ward.
Such an assessment makes it possible to determine the quality of the therapeutic process, identify recurring errors in pharmacotherapy, reduce the likelihood of incorrectly prescribed medication, and cut costs. It forms part of the prevention of adverse events and actions, enables the implementation of systemic solutions and quality improvement projects in the field of pharmacotherapy, and provides valuable material for in-house training.
The standard also highlights the need to monitor the concentrations of medicines for which monitoring is indicated (e.g. antibiotics, immunosuppressants, cytostatic drugs, cardiac medicines, anti-epileptic drugs, etc.). This duty should also be carried out primarily by the pharmacist – in accordance with Section 4(16) of the Act of 10 December 2020 on the profession of pharmacist, the professional duties of a pharmacist include the management of drug concentration-monitored therapy [2].
Medicines management
The hospital should have clear guidelines governing the management of medicinal products. At the hospital pharmacy level, the pharmacist should be involved in determining which medicines are routinely available and which are subject to restrictions on use, and why (e.g. restricted antimicrobials / medicines dispensed only upon specific request / medicines available exclusively to the Head of Department or a doctor of a specific specialism / medicines under the national medicines programme, etc.). This requires not only an understanding of clinical needs, but also the ability to forecast demand, plan stock levels and monitor storage conditions.
Based on projected requirements, the most appropriate methods of procuring medicines should be identified, along with the quantities of stock required in the pharmacy and on the wards (the so-called list of minimum stock levels necessary to ensure the basic functioning of a given organisational unit, medicines held in ward stores and available outside the hospital pharmacy’s opening hours, etc.), the methods for replenishing and storing them, as well as the rules for ordering and distribution [1]. Rational management should also take into account aspects relating to medical gases, which are classified as medicinal products (oxygen, nitrous oxide and mixtures thereof) or medical devices (e.g. carbon dioxide for cryotherapy or laparoscopic procedures).
The pharmacist shall lay down rules for the safe storage of medicinal products and medical devices in a manner that restricts unauthorised and unjustified access (particularly in the case of controlled substances), whilst at the same time ensuring that they can be used without undue delay and stored under temperature and humidity conditions that meet the quality requirements established for the medicinal product or medical device, including after first opening in the case of multi-dose packs (FA 4 Medicines are stored safely) [1].
High-concentration medicines, such as concentrated potassium chloride and others, the inadvertent use of which in undiluted form poses a particular risk to the patient’s health and life, should be clearly labelled, kept separate from other medicines and, where possible, replaced with medicines of lower concentration or stored in the hospital pharmacy [1]. It is good practice to label the packaging of medicines from List A (substances with very potent effects according to the 12th Edition of the Polish Pharmacopoeia) and concentrates dispensed to organisational units from the hospital pharmacy (e.g. using a coloured sticker bearing the symbol ‘A’ or ‘K’ ) and for the pharmacist to keep the list of these preparations constantly up to date. The hospital pharmacy should also ensure access to RTU (ready to use) and RTA (ready to administer) medicines, i.e. those requiring no further preparation before use [3].
Medicines requiring specific safety precautions (cytostatic agents, parenteral nutrition mixtures, compounded medicines) require the pharmacist to draw up and implement procedures for their preparation, labelling, transport and administration, taking into account the safety of both the patient and the staff preparing the medicine. If the applicable conditions for the preparation of medicines at the hospital’s pharmacy are not met, the hospital shall enter into a partnership with an external service provider (FA 5.1 The hospital shall ensure the conditions for the proper preparation and administration of medicines requiring special safety precautions) [1].
For patients who meet specific criteria and are undergoing cyclical intravenous chemotherapy, the hospital ensures, where possible, an optimal supply of the medicine through the use of vascular access ports supplied by the hospital pharmacy [1].
The verification of storage conditions for medicines and medical devices should be carried out by a pharmacist as part of their supervisory duties during regular, periodic inspections, carried out at least once a year and resulting in recommendations for the inspection of ward first-aid kits in all healthcare settings, including the post-anaesthesia care unit, the endoscopy suite, the interventional cardiology suite, etc. (FA 6 The hospital supervises the storage of medicines and medical devices) [1].
Pharmacists should also be involved in drawing up guidelines for the management of patients’ own medicines (FA 8) and unused medicines (FA 9) – those that have passed their expiry date; those that do not meet quality requirements, have been discontinued, have had their dosage adjusted, or are unused opioid analgesics [1].
Hospital Prescription Book
The hospital formulary (FA 2) is a compendium of the medication policy within a given organisation and the principles governing the rational management of medicines. The general section should include, amongst other things, information on:
- adding and removing medicines from the formulary,
- the use of medicines not listed in the formulary,
- the procurement of medicines on an emergency basis,
- the administration of medicines without a written prescription, in the case of nurses, midwives and paramedics
- the use of medicines for purposes other than those for which they are authorised (off-label),
The standards of pharmacotherapy adopted by the hospital – including antibiotic therapy, pain management (analgesia) and guidelines for the correct administration of medicines via enteral feeding tubes – which are often described in separate hospital-wide procedures, should also be co-developed by a pharmacist, as should information on equivalent drug doses (at least for statins, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers and benzodiazepines) [1].
A key component of the hospital formulary is the hospital medicines list (HML), in which medicines are categorised according to the classification system adopted by the hospital, e.g. the Anatomical Therapeutic Chemical (ATC) classification.
When helping to draw up the formulary, the pharmacist must take into account the specific nature of pharmacotherapy for patients admitted to a given healthcare facility – in particular newborns and children, pregnant and breastfeeding women, the elderly, and patients at risk of adverse drug reactions. The document should combine pharmacoeconomic considerations with the principles of good clinical practice. To this end, the START-STOPP criteria, the Beers’ criteria, the criteria for potentially inappropriate medication in geriatrics, the PRISCUS list, the PIMs list, STOPPFall, Hale’s categories of lactation risk, etc., may be helpful.
Documentation and guidelines on the preparation and administration of medicines
In accordance with the CMJ Communication on the procedure for providing access to medical records subject to assessment during accreditation reviews carried out from 1 May 2026, only medical records made available in electronic form will be subject to assessment [5].
The above rules also apply to the medical prescription form / medication prescription form. Accreditation standards (FA 3: Prescription of medicines is documented; FA 5: Medicines are administered in accordance with safety guidelines) precisely regulate the rules for documenting the prescription and administration of medicines. Each prescription must include, amongst other things, the prescriber’s details, the dose, the route of administration and, in the case of parenteral medicines, details of the solvent (name, volume) and the duration of the infusion [1]. The pharmacist should be involved in developing administration schedules for medicines and their mixtures within the hospital’s IT system, taking into account the principles of pharmacodynamics and pharmacokinetics.
The safe preparation and administration of medicines in hospital wards requires staff to have knowledge of: the action of the medicine and its side effects, synergistic effects, the distribution of the medicine in the body, symptoms of overdose, the manufacturer’s recommendations regarding the preparation and administration of the medicine, and how to proceed in the event of a life-threatening situation. Patient safety requires strict adherence to aseptic procedures, clear labelling of medicines and the immediate recording of their administration in medical records [1]. By developing procedures and training staff, the pharmacist minimises the risk of errors in this area.
Safety in pharmacotherapy
The hospital pharmacy is responsible for monitoring safety notices relating to medicinal products and medical devices (URPL, GIF), passing on information to wards and other organisational units within the hospital, and implementing measures in the event of products being withdrawn from the market and from use (FA 5 Medicines are administered in accordance with safety guidelines) [1].
Equally important is the recording and analysis of adverse reactions to medicinal products (FA 7: The hospital has implemented a procedure for dealing with adverse drug reactions). The obligation to report adverse drug reactions rests with all healthcare professionals, such as doctors, nurses, pharmacists and others. This obligation applies in particular to medicines subject to additional monitoring, identified by the black inverted triangle symbol appearing on the package leaflet and in the Summary of Product Characteristics ▼, a list of which may also be drawn up and kept up to date by a pharmacist.
Patients, their legal representatives and their de facto carers have the right to report adverse reactions to medicinal products both during and after their hospitalisation [6].
It is good practice for the register of reported adverse reactions to medicinal products to be maintained by the hospital pharmacy or a designated pharmacist. This is because medicinal products should be used as rationally as possible, thereby increasing the likelihood of achieving positive treatment outcomes and avoiding adverse reactions. An analysis of reports of adverse drug reactions carried out by a pharmacist can be used to draw up recommendations for measures to minimise the risk of such reactions occurring (e.g. by specifying the method of administration of a given medicine, the infusion rate, considering premedication prior to its use, etc.)
Training and education
The new standards require annual training in pharmacotherapy, tailored to the current needs and specific characteristics of individual wards, for all professional groups involved in the treatment process – doctors, nurses, midwives, pharmacists, paramedics and laboratory diagnosticians (FA 10: The hospital conducts training on pharmacotherapy) [1]. Regular training not only enables knowledge to be kept up to date, but above all helps to build a culture of safety in which the pharmacist becomes a key adviser and expert in the field of pharmacotherapy.
Not just the FA
The accreditation standards for healthcare providers introduced by the Minister of Health are changing the way patient care is organised and emphasise the importance of a team-based approach to treatment. The pharmacist is becoming an integral member of the treatment team, responsible for assessing the pharmacotherapy being administered, conducting medication reviews, participating in nutritional therapy and helping to develop clinical procedures. The new requirements clearly define the pharmacist’s role in the areas of assessing the patient’s health, the safety of pharmacotherapy and the quality of treatment.
| Accreditation standard | The role and duties of a pharmacist – examples (own work) |
| HEALTH ASSESSMENT | |
| OS 1.2: results of the subjective assessment | · a medical history regarding current medication, allergies and idiosyncrasies · medication reconciliation |
| OS 1.12: Regular assessment of members of the therapeutic team | · supervision of the patient’s medication· medication review |
| OS 1.15: Final recommendations | · recommendations regarding pharmacological treatment, including drug dosages and the duration of the recommended pharmacotherapy;· recommendations regarding lifestyle changes, e.g. giving up stimulants, taking up regular physical exercise, etc.;· education for the patient, their carers and loved ones;· raising therapeutic awareness and providing support in adhering to pharmacotherapy recommendations |
| NUTRITIONAL TREATMENT | |
| LŻ 1 Hospital oversees nutritional treatment | · member of the nutrition team |
| LŻ 2 The hospital provides nutritional therapies tailored to patients’ needs | · drawing up a list of medicines that must not be crushed or opened for administration via a feeding tube· specifying the method of administering medicines to patients receiving enteral nutrition· · ensuring that alternative forms of medicines (e.g. syrups, granules) are included in the hospital medicines list; · ensuring access to dedicated medical devices, e.g. enteral syringes |
| LŻ 3 The hospital monitors the outcomes and complications of nutritional therapies | · reporting, recording and analysing adverse reactions to infusion emulsions |
| LŻ 7 The hospital uses food for special medical purposes | · ensuring that the hospital pharmacy provides access to food for special medical purposes (FSMP) for in-patient care |
| PATIENT CARE | |
| OP 3 The hospital has implemented the clinical practice guidelines | · helping to draw up clinical procedures relating to pharmacotherapy in line with current medical knowledge, e.g. the use of an antidote in the event of active bleeding or in the event of paracetamol poisoning |
| OP 4 The hospital has implemented a procedure for the transfusion of blood and blood components. | · member of the Transfusion Committee (whole blood and plasma, or blood cells of human or animal origin, excluding industrially processed plasma; these are medicinal products authorised for marketing without the need for a marketing authorisation) |
| OP 5 The hospital has implemented measures to prevent venous thromboembolism. | · contributing to the development of clinical procedures for the pharmacological and mechanical prevention of venous thromboembolism· ensuring access to medical devices used in mechanical prophylaxis (cuffs for intermittent pneumatic compression of the lower limbs, graduated compression stockings) |
| OP 6 Pain assessment and management have been implemented at the hospital | · helping to draw up guidelines for the monitoring and treatment of post-operative and chronic pain in line with current medical knowledge, taking into account both aetiological and symptomatic treatment, the prevention of adverse effects associated with specific classes of medicines, and maximum doses |
| OP 7 The hospital has implemented guidelines for dealing with agitated patients. | · helping to draw up guidelines on the use of pharmacological coercion |
| OP 8 The hospital has implemented guidelines for the care of terminally ill patients | · drawing up guidelines for the administration of medication to terminally ill patients |
| OP 9 The hospital has introduced measures for the prevention and treatment of pressure ulcers | · ensuring the availability of a range of preventive anti-bedsore products and specialised dressing materials |
| OP 10: The hospital prevents falls | · assessment of the risk associated with current and planned pharmacotherapy in terms of its potential to increase the risk of falls (using the StoppFALL tool) |
| OP 11 The hospital provides health education for patients | · education tailored to the health needs of patients undergoing treatment and addressing the most common issues in pharmacotherapy, e.g. insulin therapy, the use of oral medicines in patients with a stoma, ‘New Medicine’ consultations, etc. |
| INFECTION PREVENTION AND CONTROL | |
| KZ 1.5 A procedure for dealing with occupational exposure has been implemented at the hospital | · access to safe medical equipment, e.g. plastic needle-free ampoules, safety needles or closed blood collection systems |
| KZ 2.1. The hospital has implemented guidelines on the use of antimicrobial medicines | · contributing to and drawing up: – the hospital’s list of antimicrobial medicines, the procedure for ordering them and the rules for their use; – recommendations for the rational management of Class II and III antimicrobial medicines and medical devices, including guidelines for their prescription and distribution within the hospital; · providing advice on the selection, dosage and duration of treatment, taking into account patient-specific factors as well as the PK/PD profile of the antimicrobial agents used· guidelines for empirical and targeted treatment of infections, taking into account local data on the antimicrobial susceptibility phenotype of microorganisms; monitoring of antibiotic use · establishing a list of antimicrobial agents restricted to use in accordance with accepted guidelines, consistent with current medical knowledge in this field and the local epidemiological situation |
| KZ 2.2. Perioperative antibiotic prophylaxis has been implemented at the hospital. | · co-creation and development of: – a list and dosage schedules (timing, route, method of administration and number of doses) for antibiotics used in prophylaxis, taking into account the PK/PD profile of the prescribed antibiotics; – guidelines for the administration of additional doses of antibiotics; – a list of alternative antibiotics in cases of allergy to beta-lactam antibiotics; |
| KZ 3.2 An infection control programme has been implemented at the hospital | · monitoring the use of antibiotics |
| KZ 3.5 Data derived from infection monitoring are validated | · retrospective analyses of medical records · participation in the PPS HAI&AU study – ( Point Prevalence Survey of Healthcare-Associated Infections and Antimicrobial Use in Acute Care Hospitals) – a survey of the prevalence of healthcare-associated infections and the use of antibiotics in hospitals operating within the acute care system |
| IMPROVING THE QUALITY OF CARE AND PATIENT SAFETY | |
| PJ 1 The hospital runs programmes to improve the quality and safety of care | · developing and implementing quality improvement projects in the field of pharmacotherapy |
| PJ 2 Quality assessment is used to identify issues that require improvement. | |
| PJ 2.2 The hospital carries out quality improvement projects. | |
| PJ 4 The hospital analyses the reasons for patients’ prolonged stays. PJ 5 The hospital analyses unplanned, repeat admissions. PJ 6 Surgical wards analyse unplanned, repeat procedures. PJ 8 The hospital analyses the causes of patient deaths. PJ 8.1 The hospital analyses the causes of all in-hospital deaths | · analyses relating to pharmacotherapy |
| BP 1 The hospital has implemented a patient safety improvement system. BP 1.2 The hospital identifies adverse events that have affected a patient. BP 1.3 The hospital identifies adverse events that have not affected a patient. BP 1.4 The hospital carries out an analysis of actual and near-miss adverse events. BP 1.5 The hospital implements the recommendations from the RCA analysis to improve its operations. | · analysis of adverse events associated with pharmacotherapy· minimising the risks associated with pharmacotherapy and implementing effective corrective measures· identifying actual and potential drug-related problems (DRPs) using the PCNE classification |
Summary
The new accreditation standards significantly raise the profile of the pharmacist’s role within the healthcare system and clearly strengthen their role within healthcare organisations. The pharmacist is evolving from a role solely concerned with the distribution of medicines to becoming a central element of the system for ensuring the quality of pharmacotherapy. Responsibility for the supervision of pharmacotherapy, the rational management of medicines, participation in nutritional therapy, antibiotic policy and quality improvement schemes, the development of clinical procedures, safety control and the monitoring of adverse reactions, as well as the education of medical staff and patients, all contribute to making the pharmacist a key expert in the therapeutic process.
A pharmacist’s knowledge and expertise are essential for ensuring patient safety and that treatment complies with current medical standards, which has a tangible impact on improving the quality and safety of patient care.
Bibliography
- Announcement by the Minister of Health of 6 September 2024 on accreditation standards for healthcare activities in the category of 24-hour and inpatient hospital care.
- The Act of 10 December 2020 on the profession of pharmacist.
- Resolution CM/ResAP (2011) of the Committee of Ministers on requirements for the quality and safety of medicinal products prepared in pharmacies to meet patients’ specific needs.
- Regulation of the Minister of Health of 6 April 2020 on the types, scope and formats of medical records and the manner in which they are processed.
- Notice DAK.40.21.2025. to healthcare providers regarding the procedure for making medical records available for assessment during accreditation reviews carried out from 1 May 2026, CMJ Kraków, dated 12 May 2025.
- The Act of 6 November 2008 on patients’ rights and the Patients’ Rights Ombudsman.