The hospital pharmacist plays a key role in safe handling of products and devices, robotics, the use of biosimilars, dose-banding and cost-control of cytostatic therapy. Safety and efficiency are key drivers as discussed by the HPE Advisory Board
Paul PH LeBrun
Hospital Pharmacist and Clinical Pharmacologist,
Central Hospital Pharmacy,
The role of the Dutch hospital pharmacist in oncology therapy is very broad, with a focus on product and process aspects. An important task is, of course, the delivery of a safe product. Since the 1990s, The Netherlands has had a GMP-derived standard for the safe preparation (GMP-Hospital Pharmacy, Annex H4: Dispensing of hazardous materials and products). It has proved to be an adequate standard. From monitoring results, we know that interpretation of GMP rules in a less stringent set of rules is possible without jeopardising quality.
To date, cytostatics are reconstituted in every hospital pharmacy, with a fast service to the patient. However, due to high investments in premises and a quality system, centralisation of the process has been increasingly considered. Centralisation also opens the door to robotics which, to date, are only operational in few Dutch hospitals. An increase of automated preparation is expected in the near future.
Medication safety is paramount in oncology and therefore, the authorities issued a guideline in 2011 that detailed responsibilities of the doctor, the pharmacist and the nurse in order to prevent dose errors in prescription, preparation and administration. Among other measures, the preparation must be based on a complete prescription with patient data, including the therapeutic goal of the treatment. The actual therapy protocol also has to be available to the pharmacist.
Cost control is a key challenge, and hospital pharmacists play a key role. As a member of the oncology committee in most hospitals, the pharmacist can encourage the use of biosimilars. Sound product knowledge will support this role. Another challenge is to demonstrate added value of new therapies in practice, which can be done by initiating outcome measurements.
Clinical Pharmacist, Paediatric Haematology, Oncology and Stem
Pharmacy, Ghent University Hospital, Belgium
Over the past decade, the specialty of oncology pharmacy has expanded and gained knowledge and experience. Similar to the shift that occurred in oncology from a ‘disease-focused’ to a ‘patient-focused’ approach, so the pharmacists’ tasks have changed from ‘drug-oriented’ to more ‘patient-oriented’ services.
It is clear that due to the complexity of the drug therapy (conditioning regimens during stem cell transplantations, polypharmacy, drug–drug interactions, etc), cancer patients are a target population for pharmaceutical care. To optimise the knowledge and practice of pharmaceutical care and to reduce drug errors, it becomes necessary for pharmacists to specialise in-depth in topics such as chemotherapy (targeted therapy, oral anticancer drugs) and supportive care (for example, mucositis and emesis prophylaxis and treatment; nutritional support, pain management, infectious diseases) as these have become an integral part of anticancer therapy.
As oncology pharmacists are experts in the field of pharmacology, they are the right persons to help coordinate the continuity of pharmaceutical care for patients and to ensure optimal use of medications in various treatment settings. Acting in a multidisciplinary team, they are a valuable resource to physicians, nurses and other healthcare providers in providing education and information about chemotherapy agents. In addition, they facilitate optimal chemotherapy dosing and can assist in coordinating safe and timely administration of chemotherapy drugs and supportive therapies. Finally, they can be involved in the development of treatment guidelines to ensure optimal use of supportive care medications.
Oncology pharmacists can also play a key role in education of other members of the healthcare team on issues such as chemotherapeutic medications and their expected side effects and management, and to patients and family members or other people who want to know about cancer risk factor, prevention strategies and recommendations for screening and early detection.
Including an oncology pharmacist in the treatment team for cancer patients is an added value and might improve outcome for patients, and even reduce length of stay for complications or adverse events.
Martin J Hug
Director of Pharmacy
University Medical Centre,
The use of cytostatic or cytotoxic drugs as the therapeutic mainstay in the treatment of malignancies has increased dramatically over the past 50 years. The majority of such drugs are prepared individually for each patient, which results in a significant workload for the pharmacies filling the prescriptions for the respective therapies. Chemotherapies bear substantial risks for both the patient and the person preparing the drugs for administration. It is therefore not surprising that the German rules governing the operation of pharmacies (‘Apothekenbetriebsordnung’) have been reformed in the past couple of years to ensure maximal safety when parenteral solutions are prepared. Conditions similar to the standards set in the EU-GMP guidelines are nowadays mandatory for German pharmacies that perform aseptic preparations.
To meet these requirements, the pharmacy staff has to invest a lot more time in clean-room maintenance, particle monitoring and documentation. But how can a hospital pharmacy fulfil the growing need for chemotherapies if the preparation of which is becoming more and more time consuming? Over the years hospital pharmacists have developed several strategies to cope with such problems. One approach is to utilise Computerised Physician Order Entry (CPOE) systems. If standardised chemotherapy protocols are developed and organised in tight collaboration with the hospital pharmacy, precious time can be saved because the pharmacy staff will receive the prescriptions electronically without the need for further interpretation. The production for scheduled therapies can be planned ahead as long as the pharmacist has full access to CPOE entries. Some systems have already been implemented successfully in a few hospitals across Germany, demonstrating a substantial decrease in medication errors and resulting in higher patient safety and less hassle for the pharmacy staff. Another means to increase efficiency in oncology therapy is the use of robots that replace some of the manual work technicians and pharmacists have to undertake. Until now, few hospital pharmacies have successfully implemented such systems into their daily routine. The substantial costs, the lack of customised interfaces to the common production software products and the need for sufficient space make these robots an exclusivity only few hospitals can afford. There is no doubt, however, that such machines will become more and more common in the near future if competition between the manufacturers results in a significant price drop.
Robots for cytotoxic compounding may be most efficient if used in batch production. As mentioned above, chemotherapy is mostly prescribed in a dose adjusted to the individual patient’s weight or body surface area. While the rationale for this dosing scheme is lacking support by many scientific studies, some hospitals have begun to implement the dose-banding concept into their clinical routine. Here, compounds with sufficient physical–chemical stability are prepared in batches at fixed doses suitable for the majority of patients. With this approach, both quality and efficiency of chemotherapy production can be increased dramatically. Time will tell whether introduction of dose-banded cytotoxic preparations will benefit oncology therapy. It is sure, however, that the hospital pharmacist will have a significant contribution to this process.
María José Tamés
Hospital Pharmacy Specialist, Assistant Manager Pharmacy Department, Onkologikoa Foundation,
San Sebastian, Spain
Hospital pharmacists can contribute to ensuring safety and efficiency in oncology therapy in an important way. Considering the different steps of the chemotherapy process, implementation of different actions will result in an increase of efficiency in the whole process.
- Prescription: nowadays CPOE (Computerized Physician Order Entry) is implemented as an essential tool for chemotherapy treatments. The oncology pharmacist is usually involved in the introduction and maintenance of the protocols in the software as well as in the design of clinical decision-support systems (CDSS) that will help oncologists to prescribe treatments. But there is another phase that nowadays takes great importance – the Evaluation and Selection of new drugs – due to the high costs associated with them. In Spain, the hospital pharmacist is participating in new national organisms created with this aim playing an important role in this new scenario.
- Validation: this is a competence exclusive of the pharmacist. To perform it in an efficient way is important in the implementation of electronic clinical records in the institution to enable pharmacist access to the patient clinical information.
Both steps of the process require an oncology clinical profile of the hospital pharmacist, helping him/her to interact with other stakeholders of the clinical team. More recently, new clinical areas such as pharmacogenetics and pharmacogenomics are being incorporated into the hospital pharmacist portfolio to provide support in optimising individualised pharmacotherapy.
- Preparation and dispensing: these are the most pharmaceutical phases of the process, but there is much less experience in implementing new technologies in order to gain safety and efficiency. This might be because there is a need for special technologies, such as gravimetry, barcode readers, robots, etc. But it is essential to address these states because the prescription and validation stages can be well developed, but if preparation is not considered, the provision of safe efficient treatments for our patients will not be achieved.
- Administration: this is the last step of the loop and where errors are most difficult to prevent. Most of the current literature refers to barcode systems as effective technologies to prevent medication errors. More recently, the implementation of smart pumps for the administration of chemotherapy will close the loop for a safe and efficient administration process.
The contribution of the hospital pharmacist to efficiency in oncology therapy comes mainly as a result of clinical training and his/her overall position in the chemotherapy loop, which brings the possibility to participate in the design and implementation of technology.
BSc PhD FPSNI
Head of Pharmacy and Medicines Management,
Northern Health and Social Care Trust,
The hospital pharmacist has a significant role to play in optimising oncology therapies from both a preparative and clinical medicines management perspective.
The British Oncology Pharmacy Association has produced a set of standards for clinical pharmacy verification of prescription for cancer medicines. This covers a range of key measures including ensuring that the regimens have been through the local approval processes, checking that the regimen is the intended therapies in the treatment plan, is appropriate for the patient’s diagnosis, medical history, performance status and chemotherapy history. In addition, there are the usually expected activities of clinical pharmacists with regard to interactions, allergies, timing of administration, laboratory values, renal and hepatic functions, etc. There should be pharmaceutical care plans for each patient that are available to all of the multidisciplinary team.
These tasks highlight the value of the oncology pharmacist. The right skill mix in terms of pharmacists and pharmacy technicians is another factor in terms of ensuring that there is maximum efficiency in this regard. In terms of minimising the resources associated with the products, oncology dose banding has proved useful. Dose banding rather than individualised dosing has resulted in significant benefits including the timely administration of outpatient chemotherapy, better workload management, and both reduced risk of error and drug wastage.
There is a need to continue to review the cost effectiveness of local versus regional preparation given the requirements associated with ensuring a high quality safe system as well as economies of scale, and also the use of automation where appropriate.
The advent of biosimilars will become an increasing factor and the use of a robust clinician-driven, evidence-based methodology regarding product selection and choice, such as STEPSelect, is very important.