Article Category: Clinical Practice
Published Online: Nov 19, 2020
Page range: 129 - 135
DOI: https://doi.org/10.17225/jhp00162
Keywords
© 2020 Greta Mulders et al., published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.
An international survey of haemophilia nurses finds that, while opportunities exist to establish protocol-based best practice, their experience of switching patients’ treatment products is varied.
Haemophilia, a disorder of coagulation attributed to reduced levels of Factor VIII (haemophilia A) or Factor IX (haemophilia B) is treated by replacement of the missing factor in affected people either after a bleed (on-demand) or as prophylaxis to minimise bleeding events. The discovery of ‘antihaemophilic globulin’ in the twentieth century enabled the development of plasma-derived and later recombinant factor concentrates, facilitating home treatment, prophylaxis and self-infusion [1]. More recently, there have been significant changes in haemophilia management as new molecules have been developed, giving clinicians more choice in which treatments to use [2]. This growth in the choice of treatment products means that switching patients from one treatment product to another has become an increasingly important task for haemophilia nurses all over the world. As new treatments continue to be developed, so too the need to switch patients’ treatment products will continue. However, it is likely that the process will become more complex as a result of the differences between, for example, standard and extended half-life factor products, as well as various non-factor treatments.
Many countries around the world have national or regional tenders for factor concentrates, which are encouraged to ensure adequate supply and effective pricing [3]. Tendering is a formal procedure to purchase medications using competitive bidding, and although useful for cost containment, can lead to decreased competition in a given market and drug shortages can occur. In all cases, this can result in changes to treatment.
The literature on switching clotting factor products in people with haemophilia recommends that patients should be informed about their choices and the possible benefits and risks of switching; their management should be reviewed; the presence of inhibitors should be excluded; and patients should be followed up periodically after switching to assess individual pharmacokinetics [4,5,6,7]. However, the complexity and duration of the switching process suggests that a protocol would be a useful tool to ensure that patients’ needs are met.
Haemnet Horizons is a nursing research group within Haemnet (
Nurses, working as part of the wider multidisciplinary team, play a critical role in providing continuous high-quality care and excellent outcomes for patients. Informal conversations among the research group and with other specialist nurses suggest that activities related to switching patients’ treatment products require a significant amount of their time, and that nurses may not have sufficient time to fulfil responsibilities additional to the switching procedure when this is required.
The current study sought to explore nurses’ role in treatment switching procedures, including whether or not protocols are used to guide the switching process, among a cross section of haemophilia nurses from different countries
Pictured: Visual minutes by WovenInk from the Haemnet Horizons Meeting, London, 2018. The study reported here evolved from the recognition that, while good protocols are available in some HTCs, switching patients to another factor treatment product can be a complex process and there is a need for haemophilia nurses to support each other.
A non-validated questionnaire was devised by nurses attending the Haemnet Horizons meeting in London, UK, on 21 April 2018. The questionnaire comprised ten questions requiring short answers about how the process of switching treatment products was carried out, including the nurse's role in decision-making, informing/supporting patients, and the clinical process of switching and follow-up (see Appendix).
The questionnaire was distributed by a member of the Haemnet research team and the authors at the end of pre-congress nurses’ day at the World Federation of Hemophilia (WFH) Congress in Glasgow, Scotland, on 19 May 2018 and after sessions in the nursing track during the congress itself, from 20–24 May 2018. Nurses who agreed to complete the questionnaire either did so and returned it straight away, or returned their completed questionnaire to the research team via the ‘treatment room’ set up for the duration of the congress. In addition to completing the questionnaire, nurses provided basic information including hospital/HTC names, and had the option to submit any local switching protocols to the authors via email, if these were available and able to be shared.
The completed questionnaire data was entered into an excel spreadsheet and analysed for basic demographics (country, HTC, experience of switching), common themes and concepts.
Of 91 nurses registered at the WFH Congress who were approached, 49 filled in and returned questionnaires. Four questionnaires (were excluded from the analysis: these included questionnaires completed by nurses from same HTC and containing the same information, and questionnaires where the responses were not legible. The remaining 45 questionnaires were unique returns. All respondents were from economically developed countries. The majority (27; 60%) were from Europe (Croatia, Denmark, Finland, Germany, Romania, Switzerland, the Netherlands, Ireland, Sweden, UK), and the remainder from Australia (1), Canada (5), New Zealand (4) and the US (9). The results are summarised in Table 1.
Summary of questionnaire responses
| Number of unique nurse responses (from individual centres) | 45 | UK | 10 | |
| USA | 9 | |||
| Netherlands | 6 | |||
| Canada | 5 | |||
| New Zealand | 4 | |||
| Ireland | 2 | |||
| Sweden | 2 | |||
| Australia, Croatia, Denmark, Finland, Germany, Romania, Switzerland | 1 each | |||
| Ever switched clotting factor product? | 45 | Yes | 43 | 95% |
| No | 2 | 5% | ||
| Reason(s) for switch (more than one answer possible) | 33* | Clinical need | 34 | |
| Funder/purchaser changed product | 30 | |||
| Patient request/preference | 21 | |||
| Was switch protocol-based? | 40* | Yes | 20 | 50% |
| No | 20 | 50% | ||
| If so, who wrote the protocol? | 24* | Haemophilia team | 15 | 62.5% |
| Nurse/nurse specialist | 4 | 16.5% | ||
| Doctors | 5 | 21% | ||
| Frequency of blood tests for pharmacokinetics before switch | 26* | Don’t know | 1 | 4% |
| No prior testing | 6 | 23% | ||
| Blood testing at least once | 18 | 69% | ||
| Depends on product | 1 | 4% | ||
| Frequency of blood tests for pharmacokinetics after switch** | 25* | None | 4 | 16% |
| Depends on product | 4 | 16% | ||
| Depends on clinical need | 1 | 4% | ||
| No/inappropriate response | 16 | 64% | ||
| Screen for inhibitors before switch? | 43* | Yes | 37 | 86% |
| No | 6 | 14% | ||
| Was patient association involved? | 43* | Yes | 11 | 26% |
| No | 27 | 63% | ||
| Not sure | 5 | 11% | ||
Missing data
Question was interpreted differently by respondents; see text for discussion
All respondents had been actively involved in the switching process in their respective countries, and most (43; 95.5%) had personal experience of switching individual patients’ clotting factor treatment. Thirty-three respondents provided reasons for switching, with the most common – reported by all – being clinical need. This was followed by national contracts or tender agreements (30; 91%), and patient request/choice (21; 64%).
Twenty respondents (50%) stated that their centre had a protocol to guide switching. Where a local protocol existed, the majority were co-written by the haemophilia clinical team and the remainder equally either by the haemophilia nurse or the medical team.
Twenty-six (58%) respondents provided information about blood testing for pharmacokinetics before switching, of whom most reported that at least one measurement was carried out. Around one quarter stated that testing was not performed. Forty-three respondents provided information about screening for inhibitors pre-switch, of whom six (14%) reported that inhibitor screening was not undertaken. Approaches to inhibitor testing after the switch were mostly unclear, although some stated this would depend on the product being switched from and to, as well as individual clinical need.
Twelve respondents stated they would share their local protocol/standard operating procedure with the Haemnet Horizons team, of whom six subsequently did (UK 2, Netherlands 2, Sweden 1, US 1). Of these, one was a practical guide to switching based on a tender; three dealt with switching from standard to extended half-life (EHL) products only; and two covered switching from plasma-derived factor to a recombinant product. One protocol provided comprehensive information in a step-by-step guide, detailing what to do when, and who should undertake various aspects of the switching process. Two protocols included patient questionnaires for nurses to assess their patients’ perspective on the procedure. Of the 43 respondents who provided information about the involvement of patient organisations, about one quarter stated that patient organisations were involved in the switching process in some way. One respondent stated that the patients’ association involvement was via a newsletter which explained to patients why their clotting factor product was being switched.
This study demonstrates remarkably similar experiences among 45 haemophilia nurses from different countries who have participated in switching patients from one haemophilia treatment product to another, most often due to clinical need, but also due to changes in funding/purchasing agreements and to facilitate patient choice. Patient choice was reported by nearly two thirds of those who gave reasons for switching products, although patients’ ability to choose their treatment may sometimes be impacted by other factors – for example, in countries with national tendering programmes that can demand frequent product switches at national (rather than individual patient) level [8]. Tendering programmes were initially undertaken with significant patient counselling, consenting and testing; however, more recently clinicians have been less concerned about inhibitor development and are therefore more relaxed about the process [9].
From our results, half of the respondents suggested that they had a centre-based protocol that was followed when switching products; however, very few protocols were made available for review. Importantly, half of respondents reported that they did not have a centre-based protocol for the switching process. The protocols that were provided were similar in that they recognised switching where there was choice (e.g. a new product to the market which enhanced patient care including choice) and those where there was no choice (such as a product no longer being commercially available), identification of which patients could switch and how the switch would take place (routine follow-up or more urgently), and the necessary follow-up to ensure safe and effective care. Key elements that should form the basis of any switching protocol include:
Providing information to the patient about the switch and receiving patient consent Undertaking blood testing and assessing quality of life and joint health prior to the switch Ensuring that the patient is supervised when administering the new product for the first time Undertaking blood testing and assessing quality of life and joint health post-switch.
There appeared to be no consensus on the testing for pharmacokinetics and/or inhibitor screening post-switching products. It is also unclear whether the inhibitor testing was part of routine practice or specifically associated with the switch. Twenty participants either did not answer this question or stated that no testing was done. This may be due to less clinician anxiety about inhibitor development post switching due to previous experience [8,9,10]. The recent WFH treatment guidelines suggest that there is no increased risk of inhibitor development following product switch, therefore inhibitor screening may be of a more academic than clinical interest [11].
During the most recent large-scale switching of factor products in the UK, prompted by a national tender (2018), template letters were used to inform people with haemophilia about the upcoming tender/switch and was reported as “enabling an easier process by nurses” [8]. These were developed following a meeting of experienced haemophilia nurse specialists and shared with nurses at HTCs around the UK. In a study of views of people with haemophilia and/or their caregivers about product switching, most reported that switching discussions happened with doctors and with their haemophilia multidisciplinary team [12]. Despite these discussions, however, most reported feeling that they had little influence on the decision to switch product.
Increasingly patients’ views should be included in shared decision-making around individual treatment choices [13], not least because their views and expectations may differ significantly from healthcare professionals [14,15,16]. Patients’ views bring added value to policymaking around tendering/switching experiences when expressed collectively through nongovernmental organisations such as national or regional patient organisations [17]. Respondents in the current study reported that patient associations were generally not involved in the switching process, but as advocates they perhaps have a greater role to play in ensuring that the patient voice is heard. Nurses also play a role in advocating for patients during the switching process, representing their views, the practicalities (dose/vial/infusion volumes, packaging, storage, etc.) and ensuring appropriate follow-up occurs.
Although the questionnaire was intended to capture data in a simple way, the responses we received raised further questions, many of which remain unanswered. The sharing of local protocols around switching may have helped to answer some of these questions, as well as helping to establish variations in the practice of switching in different countries; however, very few protocols were received by the research team. The combination of these factors is therefore a limitation of this research project.
The questions around pharmacokinetic sampling were interpreted differently by different respondents, indicating that they were perhaps not clear enough. This meant that it was not possible to consider variance in pharmacokinetic assessment at switch, and how this might relate to a general variance in practice across different countries.
As new and different products for the treatment of haemophilia become available, the need to guide patients through the switching process – whether as a results of clinical need, choice, or national tender – will continue to be a significant part of their care in which specialist haemophilia nurses play a key role. Almost all nurses who responded to this survey had direct experience of switching clotting factor products, but clinical practice in switching was variable and nurses reported different indications for switching, often driven by a tender process rather than by clinical need. Many nurses are switching treatments for patients without the support of a written protocol, whereas others are involved in writing and implementing protocols. Sharing protocols is a first step in helping to establish best practice and could be used, in the future, as a service evaluation or benchmark of centre/local/national or international care delivery and outcomes.