Commission On Human Medicines Research Articles

OP98 Improving Patient Involvement In Health Technology Assessments: Is It Enough To Train Just The Patients?

IntroductionPatient involvement is a core principle of the National Institute for Health and Care Excellence (NICE) and we continually strive to improve patient involvement in health technology assessments (HTAs) of medicines. We iteratively surveyed and reviewed how patient involvement can be improved with patient organizations, patient experts, NICE HTA decision-making committees, and staff. We re-examined feedback that we collect on an ongoing basis, as well as one-off evaluations, to check how we can improve patient involvement.Improvements ranged from support for and how we work with patient stakeholders to training the various stakeholders who take part in the HTA process to build up a comprehensive and evolving training package and stimulate a cycle of continually improving patient involvement.MethodsWe reviewed the outcomes and recommendations from the following larger projects:•Review of public involvement across NICE 2015;•Improving meaningful patient involvement in HTAs 2019;•Improving patient expert involvement in committee meetings 2019; and•The value of patient expert input 2022.Feedback from monthly surveys of patient experts and organizations was also reviewed.ResultsThe results included recommendations about:•Changing the culture so that patient involvement at NICE is everybody’s business;•The key role of the committee chair in including patient experts;•The importance of committee culture and behavior in including and valuing patient input;•The need for a greater understanding of how NICE technical teams can best support and obtain the most meaningful evidence from patients; and•What additional support and training patient organizations and experts want from NICE’s public involvement team.ConclusionsWe concluded that not only patients need training, but also everybody included in the NICE medicines HTA process. Over time we have gradually added to our training portfolio for patient organizations and experts as well as NICE staff and independent committees. We now run patient involvement as part of the induction program for all staff, technical staff, medicines committee chairs, and NICE committees and lay members.We also provide monthly training for patient organizations and patient experts.

A Service Evaluation of the Implementation of E-sign for Homecare Prescriptions in Secondary Care

Abstract Introduction Homecare Medicine Services allow patients with chronic conditions, reliant on specialist medicines prescribed by secondary care, to manage their symptoms at home rather than requiring regular attendance to a hospital for treatment1. The Royal Cornwall Hospital NHS Trust (RCHT) manages over 3000 patients on homecare services across a range of specialties. Traditional homecare processes required prescriptions to be printed on paper at the hospital, signed by hand by a prescriber and then securely couriered to the homecare provider for processing. The secondary care Electronic Prescription Service (EPS) is coming but in the interim a solution was commissioned by the National Homecare Medicines Committee to improve processes, reduce administrative burden, and improve the timeliness of prescriptions for direct patient benefit. The product selected was E-sign (E-Sign (UK) Ltd) which allows prescriptions, as PDF files, to be signed with an advanced electronic signature and tracked through a managed workflow compliant with applicable legislation2. Working collaboratively with Sciensus we introduced E-sign in March 2022. In the last year we have processed approximately 3500 prescriptions via this process. We sought to evaluate E-sign prior to wider adoption within the Trust. Aim To evaluate the acceptability, benefits or drawbacks of the new E-sign process for prescribers and patients. Methods In January 2022 (pre- implementation) we audited 100 homecare prescriptions recording the time between prescribing on our electronic prescribing system (ePMA) and collection by the Sciensus courier. Post-implementation data was gathered by comparing the time of prescribing on ePMA and time of release to Sciensus on the E-sign workflow for 142 prescriptions in May 2023. Data was analysed in Microsoft Excel and a T-test was used to test significance. A short survey was sent to all prescriber and pharmacist users of the E-sign system (12) to evaluate the speed, flexibility and ease of use of the system. As this project falls under the definition of a service evaluation, according to UK NHS Research Ethics Committees, formal ethical approval was not required, it was registered with the Trust’s clinical audit database. Results There was a statistically significant (p < 0.05) decrease in the average time taken for prescription transmission, from 200 hours pre-implementation to 25 hours post-implementation. All respondents to the survey (N=8) agreed it was easier to use than the manual system and would recommend it to colleagues. Most (75%) felt the system was faster and more flexible than the paper system. 50% believed it improved the service to patients. All respondents would recommend the system to their colleagues. Discussion/Conclusion The E-sign system has brought benefits to prescribers and ultimately patients. Prescriptions are now transferred significantly more quickly to homecare providers, and the risk of lost prescriptions is removed. E-sign has allowed for service transformation; we now have prescribers who work entirely remotely using E-sign. Future developments will include collaborating with additional homecare providers, including a new patient workflow, and migrating to EPS when available. Study limitations were due to the sample size of prescribers available for survey.

When science and evidence is not enough: challenging the recommendations from the Commission on Human Medicines Isotretinoin Expert Working Group.

The Commission on Human Medicines (CHM) Isotretinoin Expert Working Group recently released a report with several major recommendations. The authors scrutinized the evidence cited by the CHM and presented the case that their recommendations undermine evidence-based medicine and scientific thinking.

Do not do recommendations in different paediatric care settings

IntroductionThere are many initiatives aimed at eliminating health care interventions of limited utility in clinical practice. The Committee on Care Quality and Patient Safety of the Spanish Association of Pediatrics (AEP) has proposed the development of “DO NOT DO” recommendations (DNDRs) to establish a series of practices to be avoided in the care of paediatric patients in primary, emergency, inpatient and home-based care. Material and methodsThe project was carried out in 2 phases: a first phase in which possible DNDRs were proposed, and a second in which the final recommendations were established by consensus using the Delphi method. Recommendations were proposed and evaluated by members of the professional groups and paediatrics societies invited to participate in the project under the coordination of members of the Committee on Care Quality and Patient Safety. ResultsA total of 164 DNDRs were proposed by the Spanish Society of Neonatology, the Spanish Association of Primary Care Paediatrics, the Spanish Society of Paediatric Emergency Medicine, the Spanish Society of Internal Hospital Paediatrics and the Medicines Committee of the AEP and the Spanish Group of Paediatric Pharmacy of the Spanish Society of Hospital Pharmacy. The initial set was limited to 42 DNDRs, and the selection over successive rounds yielded a final set of 25 DNDRs, with 5 DNDRs for each paediatrics group or society. ConclusionsThis project allowed the selection and establishment by consensus of a series of recommendations to avoid unsafe, inefficient or low-value practices in different areas of paediatric care, which may contribute to improving the safety and quality of paediatric clinical practice.

Recomendaciones de no hacer en distintos ámbitos de la atención pediátrica

IntroductionThere are many initiatives aimed at eliminating health care interventions of limited utility in clinical practice. The Committee on Care Quality and Patient Safety of the Spanish Association of Pediatrics has proposed the development of «do not do» recommendations (DNDRs) to establish a series of practices to be avoided in the care of paediatric patients in primary, emergency, inpatient and home-based care. Material and methodsThe project was carried out in 2 phases: a first phase in which possible DNDRs were proposed, and a second in which the final recommendations were established by consensus using the Delphi method. Recommendations were proposed and evaluated by members of the professional groups and paediatrics societies invited to participate in the project under the coordination of members of the Committee on Care Quality and Patient Safety. ResultsA total of 164 DNDRs were proposed by the Spanish Society of Neonatology, the Spanish Association of Primary Care Paediatrics, the Spanish Society of Paediatric Emergency Medicine, the Spanish Society of Internal Hospital Paediatrics and the Medicines Committee of the Spanish Association of Pediatrics and the Spanish Group of Paediatric Pharmacy of the Spanish Society of Hospital Pharmacy. The initial set was limited to 42 DNDRs, and the selection over successive rounds yielded a final set of 25 DNDRs, with 5 DNDRs for each paediatrics group or society. ConclusionsThis project allowed the selection and establishment by consensus of a series of recommendations to avoid unsafe, inefficient or low-value practices in different areas of paediatric care, which may contribute to improving the safety and quality of paediatric clinical practice.

A machine learning approach to support triaging of primary versus secondary headache patients using complete blood count.

Headaches account for up to 4.5% of emergency department visits, where they present a significant diagnostic challenge. While primary headaches are benign, secondary headaches can be life-threatening. It is essential to rapidly differentiate between primary and secondary headaches as the latter require immediate diagnostic work-up. Current assessment relies on subjective measures; time constraints can result in overuse of diagnostic neuroimaging, prolonging diagnosis, and adding to economic burden. There is therefore an unmet need for a time- and cost-efficient, quantitative triaging tool to guide further diagnostic testing. Routine blood tests may provide important diagnostic and prognostic biomarkers indicating underlying headache causes. In this retrospective study (approved by the UK Medicines and Healthcare products Regulatory Agency Independent Scientific Advisory Committee for Clinical Practice Research Datalink (CPRD) research [20_000173]), UK CPRD real-world data from patients (n = 121,241) presenting with headache from 1993-2021 were used to generate a predictive model based on a machine learning (ML) approach for primary versus secondary headaches. A ML-based predictive model was constructed using two different methods (logistic regression and random forest) and the following predictors were evaluated: ten standard measurements of complete blood count (CBC) test, 19 ratios of the ten CBC test parameters, and patient demographic and clinical characteristics. The model's predictive performance was assessed using a set of cross-validated model performance metrics. The final predictive model showed modest predictive accuracy using the random forest method (balanced accuracy: 0.7405). The sensitivity, specificity, false negative rate (incorrect prediction of secondary headache as primary headache), and false positive rate (incorrect prediction of primary headache as secondary headache) were 58%, 90%, 10%, and 42%, respectively. The ML-based prediction model developed could provide a useful time- and cost-effective quantitative clinical tool to facilitate the triaging of patients presenting to the clinic with headache.

Codeine linctus would qualify for reclassification to a prescription-only medicine, minutes reveal

Codeine linctus meets one of the criteria for reclassification to a prescription-only medicine (POM), meeting minutes from the Commission on Human Medicines (CHM) have revealed. At a CHM meeting, held on 27 October 2022, the group was presented with an assessment of the benefits of codeine linctus in the treatment of dry cough and the […]

Pharmacist-led medication reviews for older care home residents: are we delivering person-centred care?

Abstract Introduction National policy and guidance in England has identified Pharmacists as having a pivotal role in medications optimisation for care home residents with complex polypharmacy. Guidance advocates a person-centred approach to the medication reviews.1 Despite this, studies looking at reviewing and stopping medication rarely include patients’ goals and pReferences regarding medication. There is no consensus regarding a definition for person-centred care or how this translates into practice. Multiple factors may influence the ability of a pharmacist-led care home medication review to include residents’ goals and pReferences, including the pharmacist; local context and resources supporting the review process, and the resident or their family. By exploring these factors, this research study aims to develop a deeper understanding of what person-centred care means in the context of medication reviews in the care home environment, and the barriers and enablers to achieving a person-centred approach. Aim This study aims to explore what person-centred care means in the context of pharmacist-led medication reviews for older care home residents, aged 65 years and above and to identify barriers and enablers to achieving a person-centred approach. Methods Virtual or telephone, semi-structured qualitative interviews were conducted with pharmacists working in care home roles in England (n=17). Participants were recruited via local and national care home pharmacist networks, and by snowball recruitment. Interviews were anonymised and audio transcribed verbatim before undertaking reflexive thematic analysis2, supported by NVivo software. Ethical approval was obtained from the University of Leicester Medicines and Biological Sciences Research Ethics Committee. Results What it means to be person-centred when conducting medication reviews within a care home environment for older residents was seen to be multifactorial, consisting of six key components; 1) focusing on quality of life; 2) understanding what matters to the resident and family regarding medication use; 3) being able to see the resident; 4) showing respect and compassion; 5) considering the resident’s identity, 6) optimising medicines. Four key themes were constructed that shaped the extent to which pharmacists reviews could be person-centred: 1) Trust, acceptance and understanding of the pharmacists’ role; 2) co-ordination and communication regarding care; 3) managing risks, 4) practical barriers. Discussion/Conclusion Guidance suggests that structured medication reviews should be person-centred, including the goals and pReferences of the patient and their understanding of medication.1 However, a standard model of how this should be applied to practice does not exist. In order to deliver person-centred care, there needs to be an understanding of what this means in context. By exploring how residents’ goals and pReferences form part of the pharmacist-led care home medication review, this research provides insight into what person-centred care means in context, identifies barriers and enablers to achieving a person-centred approach in the care home environment, and identifies suggestions for practice. This study describes the views of pharmacists and does not include the perspectives of patients or their carers. A further limitation of this research study was that it was undertaken during the pandemic, therefore some participants were only able to reflect on their experiences of virtual reviews.

From Cytokine Storm to Cytokine Breeze: Did Lessons Learned from Immunopathogenesis Improve Immunomodulatory Treatment of Moderate-to-Severe COVID-19?

Complex immune response to infection has been highlighted, more than ever, during the COVID-19 pandemic. This review explores the immunomodulatory treatment of moderate-to-severe forms of this viral sepsis in the context of specific immunopathogenesis. Our objective is to analyze in detail the existing strategies for the use of immunomodulators in COVID-19. Immunomodulating therapy is very challenging; there are still underpowered or, in other ways, insufficient studies with inconclusive or conflicting results regarding a rationale for adding a second immunomodulatory drug to dexamethasone. Bearing in mind that a “cytokine storm” is not present in the majority of COVID-19 patients, it is to be expected that the path to the adequate choice of a second immunomodulatory drug is paved with uncertainty. Anakinra, a recombinant human IL-1 receptor antagonist, is a good choice in this setting. Yet, the latest update of the COVID-19 Treatment Guidelines Panel (31 May 2022) claims that there is insufficient evidence to recommend either for or against the use of anakinra for the treatment of COVID-19. EMA’s human medicines committee recommended extending the indication of anakinra to include treatment of COVID-19 in adult patients only recently (17 December 2021). It is obvious that this is still a work in progress, with few ongoing clinical trials. With over 6 million deaths from COVID-19, this is the right time to speed up this process. Our conclusion is that, during the course of COVID-19, the immune response is changing from the early phase to the late phase in individual patients, so immunomodulating therapy should be guided by individual responses at different time points.

Abstract PO003: Combination therapy with Nivolumab/Bevacizumab is safe and effective in patients with recurrent hepatocellular carcinoma after liver transplant

Abstract Recurrent hepatocellular carcinoma (HCC-R) after Liver Transplant (LT) is difficult to manage and often characterized by relevant aggressiveness and extrahepatic localizations. Currently TKIs are the only therapeutic option, but results in term of overall survival (OS) and progression-free survival are disappointing. Immune checkpoint inhibitors in association with recombinant humanized monoclonal antibody to VEGF were to be proved effective in non-LT patients with metastatic hepatocellular carcinoma in determining tumor stabilization and improved survival. However, as in LT patients immunotherapy may increase the risk of acute liver rejection, such combination therapy has not been used so far. We designed a proof-of-concept study to analyze safety and efficacy of Nivolumab and Bevacizumab in LT patients as treatment for HCC-R after LT. Combination therapy received nominal authorization from the Provincial Medicines Commission. Candidate patients underwent routine blood test (hepatic, renal, and cardiac function), echocardiogram and a total body CT as baseline assessment. Patients with creatinine higher than 1.5 ULN or with ejection fraction lower than 45% were excluded. Five patients who experienced HCC-R 2 to 8 years after LT with pulmonary, lymph node, adrenal, bones, and hepatic localization and were either intolerant to TKIs or had had progression on TKIs, were included. All recurrent tumors and extra-hepatic localizations were characterized by high biologic aggressiveness. Patients received Nivolumab infusion every 14 days at a dose of 240 mg. Total body CT scan was performed every 8 weeks. When progression disease (PD) was detected at CT scan, Bevacizumab was added at a dose of 5 mg/kg every 14 days. One patient received a single Nivolumab infusion but was withdrawn because of rapid tumor progression, eventually followed by death. Another patient experienced moderate/severe rejection, which resolved with 1g/day Methylprednisolone e.v. for 3[EV1] days followed by Prednisone 50mg/day for 1 week then tapered and stopped. This patient was maintained on double therapy without residual problems. The 4 alive patients are still on double therapy after a mean period of treatment of 36±21 weeks. Disease stability with the combination of Nivolumab/Bevacizumab has been achieved in all patients at hepatic and all extra-hepatic HCC localization but bone, where 2/2 patients experienced progression. It should be underlined, however, that progression was very slow and mean survival of these two patients on combination therapy is 54±2 weeks. Combination therapy was very well tolerated, with few side effects throughout treatment period. These results indicate that the combination Nivolumab/Bevacizumab can be safely used in liver transplant patients. The risk of acute allograft rejection is minimal and manageable. Bone metastases remain an unsolved issue and need further alternative therapeutic approach. For patients with hepatic or other extra-hepatic localization, this combination obtained a relevant and protracted stabilization of disease. Citation Format: Lorenza Di Marco, Alessandra Pivetti, Nicola De Maria, Francesco Giuseppe Foschi, Dante Romagnoli, Federico Casari, Cristian Caporali, Paolo Magistri, Barbara Catellani, Fabrizio Di Benedetto, Erica Villa. Combination therapy with Nivolumab/Bevacizumab is safe and effective in patients with recurrent hepatocellular carcinoma after liver transplant [abstract]. In: Proceedings of the AACR Special Conference: Advances in the Pathogenesis and Molecular Therapies of Liver Cancer; 2022 May 5-8; Boston, MA. Philadelphia (PA): AACR; Clin Cancer Res 2022;28(17_Suppl):Abstract nr PO003.

Healthcare professionals to be ‘better monitored’ on new valproate safety measures

There will be “greater scrutiny” of the way sodium valproate is prescribed, following a safety review carried out by the Commission on Human Medicines (CHM). Under new safety measures that will be introduced “over the coming months”, the CHM has advised that no patient, male or female, under the age of 55 years should be […]

MHRA to consider evidence on transgenerational effects of sodium valproate

The Medicines and Healthcare products Regulatory Agency (MHRA) is reviewing data suggesting that genetic changes triggered by sodium valproate could be passed down through generations. As part of its safety review into the epilepsy drug, the MHRA has confirmed it has asked the Commission on Human Medicines (CHM) — an independent expert panel — to […]

Effectiveness and Controversy of Convalescent Plasma Therapy for Coronavirus Disease 2019 Patients.

Since the coronavirus disease 2019 (COVID-19) began to spread, it remains pandemic worldwide. The European Medicines Agency's human medicines committee and Food and Drug Administration have only granted a conditional marketing authorization for remdesivir to treat COVID-19. It is essential to apply other valuable treatments. Convalescent plasma (CP), donated by persons who have recovered from COVID-19, is the cellular component of blood that contains specific antibodies. Therefore, to determine the feasibility of CP for COVID-19, the effectiveness and controversy are discussed in depth here. It is suggested that CP plays a certain role in the treatment of COVID-19. As a treatment, it may have its own indications and contraindications, which need to be further discussed. Meanwhile, it is critical to establish a standard procedure for treatment from CP collection, preservation, transport, to transfusion, and conduct some large sample randomized controlled trials to confirm the transfusion dosage, appropriate time, frequency, and actively prevent adverse outcomes that may occur.

Off-label pediatric medicines in Spain

Since 2009, the use of off-label and unlicensed drugs has been regulated in Spain. In pediatrics, this exceptional use is more common than in other medical specialties. It varies from 10% to 90% of all prescriptions in children. This variability is due to differences in methodology, classification and sources of information used, and also to the different pediatrics subspecialties. In addition, the knowledge of several pediatricians on this issue is limited and more than half do not comply with the law, in many cases due to ignorance. However, the use of off-label and unlicensed drugs is legal and necessary. The Medicines Committee of the Spanish Association of Pediatrics (CM-AEP) considers that it is necessary to improve the existing information on medicines in the pediatric population. Therefore, the CM-AEP works out a document where suggestions and actions are proposed to achieve it, because children’s health deserves it.

Изучение стабильности биологически активных веществ в череды траве при хранении

This work presents the results of studying the content variability of polysaccharides, flavonoids, luteolin-O-7-glucoside and luteolin in Bur marigold herb for 24 months of storage in whole and cut form in two types of packaging – paper bags and parchment bags, packed in cardboard boxes. It was found that a change in the content by 5% of the initial content of the pharmacological marker recommended by the herbal medicines committee of the European Medical Agency, in Bur marigold herb, was observed for polysaccharides when it was stored in whole form in closed paper bags after 6 months, when it was stored in cut form months in closed parchment bags packed in cardboard boxes – after 9 months; for flavonoids, these periods were respectively 6 months and 3-6 months. In Bur marigold herb stored in whole form for 24 months in closed paper bags, the content of polysaccharides is 79.80-85.58%, flavonoids – 58.24-82.05%, luteolin-O-7-glucoside – 44.54-70.60% of the initial, luteolin – 57.14-61.02% of the value determined after 12 months of storage. In Bur marigold herb stored in cut form for 24 months in closed parchment bags packed in cardboard boxes, the content of polysaccharides is 74.60-85.00%, flavonoids – 55.87-77.98%, luteolin-O-7-glucoside – 51.56-65.08% of the initial, luteolin – 44.99-54.82% of the value determined after 12 months of storage. Thus, the preservation of flavonoids (total and individual components), the type of packaging used for storage, and Bur marigold herb size have a significant effect, these factors do not affect the variability of the polysaccharide content during storage.

Position Statement From The Spanish Association Of Paediatrics Medicines Committee Concerning The Use Of Alternative Medicine And Pseudo-Science In Children

Currently, there are some therapies that are being practiced without adjusting to the available scientific evidence. The terminology is confusing, encompassing terms such as "alternative medicine", "natural medicine", "complementary medicine", "pseudoscience" or "pseudo-therapies". The Medicines Committee of the Spanish Association of Paediatrics considers that no health professional should recommend treatments not supported by scientific evidence. Also, diagnostic and therapeutic actions should be always based on protocols and clinical practice guidelines. Health authorities and judicial system should regulate and regularize the use of alternative medicines in children, warning parents and prescribers of possible sanctions in those cases in which the clinical evolution is not satisfactory, as well responsibilities are required for the practice of traditional medicine, for health professionals who act without complying with the "lex artis ad hoc", and for the parents who do not fulfill their duties of custody and protection. In addition, it considers that, as already has happened, Professional Associations should also sanction, or at least reprobate or correct, those health professionals who, under a scientific recognition obtained by a university degree, promote the use of therapies far from the scientific method and current evidence, especially in those cases in which it is recommended to replace conventional treatment with pseudo-therapy, and in any case if said substitution leads to a clinical worsening that could have been avoided.

Position statement from the Spanish Association of Paediatrics Medicines Committee concerning the use of alternative medicine and pseudo-science in children

Currently, there are some therapies that are being practiced without adjusting to the available scientific evidence. The terminology is confusing, encompassing terms such as “alternative medicine”, “natural medicine”, “complementary medicine”, “pseudoscience” or “pseudo-therapies”. The Medicines Committee of the Spanish Association of Paediatrics considers that no health professional should recommend treatments not supported by scientific evidence. Also, diagnostic and therapeutic actions should be always based on protocols and clinical practice guidelines. Health authorities and judicial system should regulate and regularise the use of alternative medicines in children, warning parents and prescribers of possible sanctions in those cases in which the clinical evolution is not satisfactory, furthermore responsibilities are required for the practice of traditional medicine, for health professionals who act without complying with the “lex artis ad hoc”, and for the parents who do not fulfil their duties of custody and protection. In addition, it considers that, as already has happened, Professional Associations should also sanction, or at least reprobate or correct, those health professionals who, under a scientific recognition obtained by a university degree, promote the use of therapies far from the scientific method and current evidence, especially in those cases in which it is recommended to replace conventional treatment with pseudo-therapy, and in any case if said substitution leads to a clinical worsening that could have been avoided.

Drug and therapeutics committees in Nigeria: evaluation of scope and functionality

ABSTRACTIntroduction: Inappropriate use of medicines remains a problem, with consequences including increasing adverse drug reactions (ADRs) and prolonged hospitalizations. The Essential Medicines List and Drug and Therapeutics Committees (DTCs) are accepted initiatives to promote the rational use of medicines. However, little is known about DTC activities in Nigeria, the most populous African country.Areas covered: A cross-sectional questionnaire-based study was conducted among senior pharmacists, consultant physicians, and clinical pharmacologists in 12 leading tertiary health-care facilities across Nigeria.Expert commentary: Six (50%, 6/12) health-care facilities had existing DTCs with three (50%) having a subcommittee on antimicrobials. Seventy-five percent had infection control committees, with presence even in centers without DTCs. Chairpersons and secretaries of the DTCs were predominantly physicians (83.3%) and pharmacists (100%), respectively. Hospital formularies were available in five facilities with DTCs, while one facility without a DTC had an Essential Medicines Committee responsible for developing and updating the hospital formulary. The evaluation of ADRs was undertaken by pharmacovigilance units in nine facilities. Overall, DTCs were present in only half of the surveyed facilities and most were performing their statutory functions sub-optimally. The functioning of DTCs can be improved through government directives and mechanisms for continuous evaluation of activities.

PMS68 - HOSPITAL PHARMACY CENTRALIZED PROCESS FOR HOSPITAL-WIDE MANAGEMENT OF BIOSSIMILARS USE AND ITS EFFICIENCY

Efficient implementation of biosimilars policy at hospital level involves different internal and external stakeholders. This research aims to provide a detailed description and an efficiency assessment of the policy implemented by Centro Hospitalar e Universitário de Coimbra (CHUC) as a hospital pharmacy centralized, Fully Integrated Biosimilars utilization management System (FIBS). A mapping of the entire FIBS process was performed, from initial prescription to until dispensing and monitoring of biologics therapy. The step by step process and interdependencies between different stakeholders were implemented in Anylogic, a multi-paradigm simulation software. Efficiency assessment was performed by the extend of switching to or initiation of biosimilars by month, after policy implementation in October 2017 for etanercept, infliximab and rituximab. FIBS relies on prescription and dispensing by international non-proprietary name. Hospital Medicines and Therapeutic Committee (HMTC) recommends the initiation of or switching to (for patients with at least 12 months on same biologic brand) the option with the best economic value. Non-biosimilar utilization has to be clinically justified on a patient by patient basis by prescribing physicians. The latter decision needs to be validated by the Hospital board, HMTC and Hospital Pharmacy which acts as system gate keeper. Total traceability including biologic identification by tradename and batch number was fully demonstrated (100% of dispensed biologics) for the 602 patients analysed: rheumatic (36.2%), gastrointestinal (28.6%) and hematologic (20.4%) diseases. Utilization of biosimilars (54.6%) surpassed branded drugs (45.4%) after just 3 months of FIBS implementation. In May 2018 biosimilars quota were: etanercept (87.7%); infliximab (88.4%); rituximab (61.9%). Overall rapid biosimilar utilization was more related to switching to (70%) than initiation of biosimilars (30%) in naïve patients to biologics. The Fully Integrated Biosimilars utilization management System of CHUC demonstrate high levels of efficiency, integration and control over the utilization of biosimilars at hospital level.

Making prescribing a reality: the next steps in practice

Making prescribing a reality: the next steps in practice