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A study on the
reconstitution of
botulinum toxin type A:
normal saline versus
bacteriostatic saline
02 February 2023 CLINICAL Rachel Goddard

02 February 2023 Volume 12 · Issue 1

Sections References

Abstract

Background:

This is a quantitative study on the

reconstitution of botulinum toxin type A,
whether medical aesthetics nurses use
normal saline or bacteriostatic saline to
reconstitute and what wider factors in<uence
this clinical decision. Medical aesthetics
nurses have not previously participated in this
area of research. The existing research uses
doctors as participants and excludes nurses.
Ultimately, the decision lies with the
prescriber, but there is a notable gap in
knowledge and a need to explore the preferred
practice of medical aesthetics nurses.

Methods:

An anonymous online survey was conducted

with participants who were medical aesthetics
nurses, based in the UK and members of the
British Association of Cosmetic Nurses. The
survey tool was used to gather data on
whether medical aesthetics nurses
reconstitute botulinum toxin type A with
preserved or normal saline.

Results:

93.2% of participants used bacteriostatic

saline to reconstitute botulinum toxin type A.
Some 88.6% of participants were nurse
independent prescribers, while 45.4% of
participants had a minimum of 10 years'
experience in medical aesthetics. All
participants were trained by either a nurse or
doctor.

Conclusions:

Medical aesthetics nurses are highly educated

and motivated independent nurses. They have
enterprising skillsets and it is highly unusual
to Rnd nurses with established private
practices outside the specialism of medical
aesthetics. Botulinum toxin type A treatments
are one of the core treatments in any patient-
centred, independent practice and are very
much results driven. Sustaining high levels of
patient satisfaction is an essential part of
medical aesthetics nursing.

The specialist area of medical aesthetics

originates from aesthetic surgery, which is a
branch of plastic surgery (Campion, 2012). There
has been a rise in the number of registered nurses
practising medical aesthetics (Di-Scala, 2017), and
it is the largest area of growth within personal care
and wellness (Advertising Standards Agency,
2018). However, statistics show that medical
aesthetics treatments are still relatively new in
comparison to cosmetic surgery procedures.

The British Association of Aesthetic Plastic

Surgeons (BAAPS) (2014) reported that the
number of patients undergoing cosmetic surgery
had declined by 9%. In 2017, a further audit
identiRed a decrease of 7.9% from 2016 Rgures for
the number of men and women undergoing
cosmetic surgical procedures (Cooke, 2018).

Botulinum toxin

The International Society of Aesthetic Plastic

Surgery (ISAPS) stated that, in 2019, botulinum
toxin remained the most popular non-surgical
treatment across the globe. There was an increase
of 7.6% in non-surgical procedures compared to
the previous year (ISAPS, 2020). In the USA,
surgeons reported that 1 712 994 botulinum toxin
treatments were performed in 2019 (The Aesthetic
Society, 2019).

In the UK, botulinum toxin type A medicines are

licensed for several different medical indications,
including blepharospasm, cervical dystonia,
paediatric upper limb spasticity, axillary
hyperhidrosis, bladder dysfunction and chronic
migraine (British National Formulary, 2020). In
medical aesthetics, botulinum toxin type A brands
are licensed for the treatment of the glabella lines,
periorbital lines and horizontal forehead lines in
patients between the ages of 18 and 65 years
(Electronic Medicines Compendium (EMC),
2020a).

Reconstitution of botulinum toxin

All botulinum toxin type A brands require

reconstitution into an injectable solution for
injection. At the time of the study there were three
licensed brands in the UK, produced by Merz,
Allergan and Galderma. All three pharmaceutical
companies advise that their products should be
reconstituted with sterile, unpreserved sodium
chloride 0.9%. This information is readily available
in each brand's summary of product
characteristics (SPC).

The Global Aesthetics Consensus accepts that

many clinicians prefer to use bacteriostatic saline
off-label to reconstitute botulinum toxin (Signorini
et al, 2016). It is unknown how many medical
aesthetics nurses choose to reconstitute with
bacteriostatic saline, but it appears to be a
considerable number (Turner Traill et al, 2012).
However, it is unclear as to why, given that this is
an off-label use of a prescription-only medicine.

Both bacteriostatic saline and normal saline are

prescription-only medications (EMC, 2020b). When
bacteriostatic saline is used to reconstitute
botulinum toxin type A, this is classed as off-label
use, both in terms of the bacteriostatic saline use
and the reconstitution of the botulinum toxin type
A. Prescribing and administering off-label and
unlicensed medicines is recognised as an
acceptable practice if it is an appropriate option to
a licensed product and is beneRcial to the patient
(Nursing and Midwifery Council (NMC), 2018).

Treatment complications

Practitioners must be able to deal with any

treatment complications (Levy, 2012). Common
complications of botulinum toxin type A treatment
include bleeding, bruising, discomfort, erythema,
headaches and ptosis (EMC, 2020a). Other less
common complications can include facial
asymmetry, dysphagia, urticaria, dyspnoea and
anaphylaxis (EMC, 2020a). Side effects such as
pain, redness and localised swelling may occur
following the injection of sodium chloride or
bacteriostatic saline (WebMD, 2020). Medical
aesthetics nurses have a professional
responsibility and duty of care to recognise and
manage treatment complications (Di-Scala, 2015).

The research question

The research question focuses on the

reconstitution of botulinum toxin type A and asks
whether medical aesthetics nurses use
bacteriostatic saline (preserved sodium chloride
0.9% and benzyl alcohol 0.9%) or normal saline
(unpreserved sodium chloride 0.9%) for
reconstitution, and what factors in<uence this
decision.

It is thought that medical aesthetics nurses have

not previously taken part in this type of research
study. Turner Traill et al (2012) were the Rrst
nurses to discuss this subject and suggested that
a high percentage of medical aesthetics nurses
chose to use bacteriostatic saline to reconstitute
botulinum toxin type A. It is important to
understand the clinical decisions made by medical
aesthetics nurses, as they are accountable for all
aspects of their patient care, including patient
experiences and outcomes (Nibbelink, 2018).
Using evidence-based practice enables nurses to
use scientiRcally proven and critically appraised
evidence to support their clinical decisions (Majid,
2011). Training, prescribing choices and
experience will all in<uence clinical decisions, but
it is important to ensure that medical aesthetics
nurses are working autonomously and comply with
the NMC's Code of conduct (2018).

Nurse prescribers must follow the code of conduct

(NMC, 2018) and limit their prescribing to their
scope of practice (NMC, 2019). Since 2018, the
NMC has used the competency framework of the
Royal Pharmaceutical Society (RPS). Nurse
prescribers must ‘adhere to the RPS competency
framework as standards for safe and effective
practice to ensure patient safety’ (NMC, 2018).
The NMC (2018) states that a nurse prescriber
must be ‘satisRed that it would better serve the
patient's needs’ when deciding to prescribe off-
label. Rankin et al (2012) state that, ultimately, the
prescribing decision lies with the prescriber.
Autonomous practice requires the nurse to take
charge in clinical situations where they have
responsibility, which may include improving care
and patient satisfaction and reducing adverse
events.

There is diversity in the qualiRcations and levels of

competency of medical aesthetics nurses
(Greveson et al, 2013). As nurses with a full scope
of skillsets and working in private practice,
medical aesthetics nurses need to be fully
prepared when dealing with treatment
complications and adverse events (Fukada, 2018).

The purpose of this study is to answer the

research question and to understand the
in<uences on the clinical decisions made by
medical aesthetics nurses when reconstituting
botulinum toxin type A. This will incorporate
factors that may in<uence their clinical practice,
such as level of qualiRcation, location, workplace
setting, employment status, whether the
participants are independent prescribers,
frequency of training updates and attendance of
peer-to-peer British Association of Cosmetic
Nurses (BACN) regional group meetings. Other
in<uences, such as cost, patient comfort, peer
recommendations and level of training, will also be
discussed.

Reconstitution of botulinum toxin type A

and pain reduction upon injection

There appears to be a direct link between

reconstitution with bacteriostatic saline and pain
reduction when botulinum toxin type A is injected.
Alam et al (2002) conducted a double-blind
randomised controlled trial (RCT). The study found
that injection pain was reduced in 90% of patients
when preserved saline was used, and it had no
effect on ebcacy.

Some 15 patients participated in a double-blind

RCT that was conducted by Van Laborde et al
(2003). Patients were treated on one side of their
face with botulinum toxin that was reconstituted
with bacteriostatic saline. The other side was
treated with botulinum toxin reconstituted with
unpreserved saline. Some 87% of patients
reported less pain on the side that used
bacteriostatic saline. Although the study was
small, the Rndings support other research, which
suggests bacteriostatic saline has an analgesic
effect.

Van Labore et al (2003) also commented that

neither the investigators nor the participants
detected any difference in clinical effect between
the two sides. This suggestion adds to the
established knowledge that bacteriostatic saline
has no impact on the ebcacy of botulinum toxin.

Kwiat et al (2004) performed trials on 20 patients

who had previously received botulinum toxin type
A treatments. The patients underwent bilateral
injection of botulinum toxin type A, reconstituted
with either bacteriostatic or unpreserved saline.
The patients and researchers were blinded for the
trial. The clinical outcome was assessed using
verbal scales.

The study found that using bacteriostatic saline to

reconstitute the botulinum toxin type A made the
treatment less painful. The key beneRts of this
double-blind study are that it is considered to be
the most reliable type of study, minimising the
placebo effect and bias. These Rndings add to the
existing work carried out by previous researchers,
contributing further to the established
understanding of the analgesic effects of
bacteriostatic saline. It could be argued that the
study was only small and subjective to the
opinions of the patients and physicians. Pain
tolerance will vary from one patient to the next,
and the reliability of the verbal scale could be
questioned.

Carruthers et al (2004) published the Rrst global

consensus, recommending protocols for
botulinum toxin type A treatments. The members
of the consensus panel agreed that bacteriostatic
saline could be used to reconstitute botulinum
toxin type A (Carruthers et al, 2004). In a bilateral,
comparative prospective study, 100% of patients
reported less pain when bacteriostatic saline was
used instead of unpreserved saline. Some 20
patients who were injected with botulinum toxin
type A reconstituted with bacteriostatic saline
were asked to make a comparison with previous
injections using unpreserved saline. Reduced pain
with bacteriostatic saline was reported in 90% of
those patients.

In their consensus recommendations for

Bocouture, Kane et al (2010) reported that using
bacteriostatic saline to reconstitute botulinum
toxin type A did not alter the potency. It was also
reported that using bacteriostatic saline for
reconstitution made the botulinum toxin type A
injections less painful. Their comments conRrm
the existing thoughts that bacteriostatic saline
does not affect the ebcacy or longevity of
botulinum toxin type A and supports the research
that suggests bacteriostatic saline has an
analgesic effect.

Liu et al (2012) used an online survey to analyse

the practices of doctors who administered
botulinum toxin type A treatments and were
members of the American Society of Dermatologic
Surgery. Surveying members of an association
may be beneRcial, as it provides immediate access
to the membership. Some 77.9% of the doctors
chose to use bacteriostatic saline to reconstitute
botulinum toxin type A to reduce the pain
associated with injections (Liu et al, 2012). One
downfall of this study is that the survey only had a
32.2% response rate. According to Fincham
(2008), researchers should be achieving response
rates of approximately 60%. The low response rate
may impact the validity of the results, but it does
add to the other research discussed, which has
suggested the same.

Turner Traill et al (2012) recognised that it is

common practice among nurses and doctors to
use bacteriostatic saline off-license to reconstitute
botulinum toxin type A. They were the Rrst medical
aesthetic nurses to research bacteriostatic saline
and its use within medical aesthetics. Their work
discusses the Rnding of research involving
doctors, where the general consensus is that using
bacteriostatic saline for reconstitution reduces the
patient's pain. Turner Traill et al (2012) also
acknowledged the guidance from the Medicines
and Healthcare products Regulatory Agency
(MHRA) (2014), NMC (2018) and General Medical
Council (GMC) (2018) in their recognition that ‘the
prescribing and administration of off-label and
unlicensed medicines is accepted practice when it
is in the best interest of the patient’. Despite being
written in 2012, Turner Traill et al have a valid
discussion that can be applied to medical
aesthetics nursing today. As no further research
has been carried out by medical aesthetic nurses
since this article was written, it provides an
opportunity to expand upon their work, which is
often the case with research.

Some of the published studies demonstrate that

pain during injection can be reduced by
reconstituting with bacteriostatic saline (Kwiat et
al, 2004; Allen and Goldenberg, 2012). There are
several publications stating that bacteriostatic
saline has an anaesthetic quality (Carruthers et al,
1992, 2004).

Training of medical aesthetic nurses

Training in medical aesthetics procedures such as

dermal Rllers and botulinum toxin injections also
remains unregulated. Tan (2007) identiRed that
there was an international need for statutory
governance of aesthetic medicine. He commented
that, in many countries, procedures were only
marginally regulated.

Greveson (2013) wrote that, with a ‘lack of

regulation and standards for education, many
aesthetic nurses feel isolated and inadequately
prepared’. Medical aesthetics nursing is a highly
skilled specialism that needs to continue to
develop and evolve. Baker (2018) states that, to
establish and develop their role as a specialist
medical aesthetics nurse, nurses need to engage
with education and training opportunities. This
common theme highlights an area of medical
aesthetics nursing that needs to be addressed.

Guinan (2019) states that continuous professional

development is essential for safe clinical practice
and goes on to mention that attending
conferences ‘not only enhances practice but aids
in continuous professional development and post-
registration education’.

Holmberg et al (2019) used semi-structured

interviews in their qualitative study of 13 medical
aesthetics nurses, investigating the professional,
clinical and patient needs of participants. The
research found that all participants were
motivated to build professional networks and
‘create local medical and ethical guidelines until
more robust mandatory regulations are in place’.
Although the small sample may not represent all
attitudes, it does identify and discuss the need for
professional networking and education within
medical aesthetics.

Financial decisions

Collier (2018) advises that practitioners must

provide further evidence to support their clinical
decision-making. Collier concludes that the clinical
decisions around administering an aesthetic
treatment should never be based on Rnancial gain.
Prescribers should recognise factors that might
unduly in<uence prescribing.

For many years, those providing training courses in

medical aesthetics have not been assessed, and
the standard of education and experience has
varied greatly from one training academy to the
next. Franks (2016) suggested that ‘practitioners
should focus on the quality of teaching and
educational content, rather than how convenient
and cheap the courses are’. This appears to
support Collier's views on Rnancial decisions.

Methodology

A mono-quantitative approach was the most

suitable method for addressing the research
question, obtaining primary data by using a
systematic approach to obtain numerical data
(Quick and Hall, 2015).

The survey aimed to collect quantitative data that

was striving to avoid bias, while enabling the
researcher to access the participants' attitudes
and thoughts on the research question and wider
issues covered by the survey. An online
questionnaire in the form of a survey was used to
gather data.

» Nurses have a professional responsibility and

identity (NMC, 2018). This means doing things
correctly and being an advocate for patients, yet
many medical aesthetics nurses regularly
prescribe bacteriostatic saline off-license, which
goes against manufacturers' guidelines and the
summaries of product characteristics «

Sampling methods

The population of interest in this study are medical

aesthetic nurses. Although the exact number of
nurses specialising in medical aesthetics is
unknown, it is thought that 70% of medical
aesthetics treatments carried out in the UK are
administered by nurses. Convenience sampling, a
type of non-probability sampling was used. The
objective was to generalise the results of the study
to the general population.

A large sample size is important in quantitative

research, so the aim was to reach the largest
sample size possible. As the total population of
medical aesthetics nurses is unknown, the
decision was made to sample the membership of
the BACN. As the largest known organisation of
medical aesthetics nurses in the UK, with (at the
time of the study) 944 members, the aim was to
reach all members and obtain representation from
them.

Results and discussion

Descriptive and inferential statistics are used to

discuss the research data analysis and how the
analysis links back to the research question (Ali
and Bhaskar, 2016). Data visualisation provides a
graphical display of information, which is useful
for data analysis and in describing the research
Rndings (Pearson, 2010).

Highest level of nursing

qualiRcation
The highest level of nursing qualiRcation can be