Analysis of a Pharmacy Developed, Outpatient Lactation Consultant Initiated Domperidone Programme

Low breast milk supply is one of the most common reasons for discontinuing breastfeeding despite well-recognised benefits for both the mother and infant [1,2]. These benefits include preventing infection and necrotising enterocolitis, optimising nutrition and encouraging neurodevelopment in the infant [1,2]. Following inadequate response to first-line non-pharmacological measures, galactagogues may be trialled [3]. Domperidone has approval for use in Australia as an antiemetic and for the treatment of gastroparesis [4] and is used off-label to improve breast milk supply by increasing prolactin levels [5]. It is one of the most commonly utilised yet controversial pharmacological galactagogues due to the concerns regarding its potential for QTc interval prolongation [6,7,8,9,10].

There is low certainty evidence that the use of oral galactagogues in non-hospitalised term infants improves infant weight and milk volume, and this uncertainty of evidence affects both willingness to prescribe and public safety concerns [6,11,12,13]. Whilst there is little to no consensus on the exact regimen, most countries recommend a dose of 10–20 mg three times daily as per the EMPOWER trial for 14 days or longer [2,5, 10,11, 14,15,16,17,18,19]. Domperidone for lactation stimulation is well tolerated and has few contraindications [2,5,17,18,20]. In a 2016 Canadian study by Smolina et al., the incidence of arrhythmia hospitalisations linked to postpartum domperidone use was 21 in 22,532 women. However, all these women had a prior history of ventricular arrhythmias [21]. This suggests a role for electrocardiograms (ECGs) and/or physical exams in screening for cardiac abnormalities when commencing domperidone therapy but is not currently standard practice [10,11].

There are few studies that assess domperidone prescribing, access and stewardship. Haase et al. developed a clinical protocol to assist practitioners in determining the appropriateness of domperidone therapy for low breast milk supply [22]. This protocol included a checklist to determine precautions for commencing treatment and assess the need for referral to a senior physician. The Adelaide Mums and Babies Clinic uses a similar domperidone checklist [23]. Despite the existence of such clinical checklists, their use in facilitating and documenting patient screening, counselling and domperidone supply is vastly underutilised [12,24].

Mothers initially referred to LCs when experiencing low milk supply may be recommended domperidone. The mother must then seek a prescription from their general practitioner (GP) or specialist, who may be reluctant to prescribe domperidone due to unfamiliarity with the indication or the patient themselves [11]. This delay in accessing treatment and information from medical practitioners may discourage mothers and increase the likelihood of discontinuing breastfeeding altogether, [9] a consequence that could be avoided if appropriately trained LCs were involved in the domperidone supply. Currently, there are no studies or programmes reviewing domperidone supply for lactation stimulation by health professionals who do not normally have prescribing authority (such as LCs).

In the study site, as stated in the hospital clinical guideline,[3] the most important factors to increase milk production are the frequency of breastfeeding or milking and proper techniques, such as ensuring correct infant positioning and attachment, effective milk removal, unrestricted breastfeeding, avoiding long periods between feeds, offering both breasts and using gentle breast compression to encourage let down [3]. Domperidone may be considered following appropriate assessment and deemed an inadequate response to first-line non-pharmacological management according to the hospital guidelines [3]. In 2022, a SASA based on the Haase et al. protocol was implemented in the study hospital [22]. A SASA is a written direction that authorises a health practitioner to administer or supply medicine to any patient meeting the specified circumstances [25]. A SASA was put in place to allow clinical midwives certified as International Board-Certified Lactation Consultants (IBCLCs) at the Breastfeeding Centre within the study hospital to initiate and supply domperidone for patients deemed inadequate response from the first-line non-pharmacological management according to the hospital clinical guidelines [3]. The implementation of the SASA involved the preparation and endorsement of: (1) a hospital domperidone SASA with relevant guidelines such as dose, instruction, patient leaflet and supply quantity; (2) domperidone as a Galactagogue Checklist to assist in the assessment of the suitability of domperidone for the patient and to identify potential pre-existing medical conditions which require referral to the doctor; (3) a REDCap® database to document the supply of domperidone is documented. The SASA in place enables the IBCLCs to initiate and supply domperidone in a timely manner to breastfeeding mothers with lactation insufficiency.

This activity aimed to assess IBCLCs’ compliance with the domperidone SASA and guidelines, validate the appropriate use of the domperidone as a Galactogogue Checklist, assess the frequency and indication of referral to a medical practitioner and assess the satisfaction of IBCLCs with the domperidone SASA.

This is the first study and programme in Australia reviewing domperidone initiation and supply for lactation stimulation by the IBCLCs. This study evaluated and assessed compliance to and effectiveness of the SASA for IBCLC-initiated domperidone, the satisfaction of IBCLCs regarding the SASA use and the potential for IBCLC-initiated domperidone supply to be successfully established in other Australian tertiary healthcare settings.

Given the 4.56 out of 5 overall satisfaction rating and that most survey respondents strongly agreed with statements relating to the SASA structure and education, IBCLCs appeared highly satisfied with the SASA and its ability to supply domperidone directly to patients. Over half of the survey respondents strongly agreed that the domperidone as a Galactagogue Checklist aided in identifying the appropriateness of therapy and the need for referral. This suggests the checklist is sufficiently comprehensive and may be helpful in screening for the appropriateness of domperidone in other healthcare settings.

Two areas for improvement were identified regarding SASA compliance. Firstly, it was apparent that the checklist was not used with every screening of domperidone for low breast milk supply appointments, with only 55.6% of respondents answering “strongly agree” to using and completing the checklist with each domperidone screening. Multiple free-text comments indicated that IBCLCs were aware of the main contraindications for domperidone and omitted to complete the checklist if the patient did not clearly meet the criteria for supply. The checklist was, therefore, treated more as a final step prior to supplying domperidone rather than a tool to determine supply. As a result, the exact proportion of patients screened for domperidone to treat low breast milk supply is undeterminable and is likely underestimated due to non-reporting. Additionally, the frequency and most common reasons for referral (such as medical conditions and current medications) are likely not documented, as these would have been verbally discussed with the patient during the IBCLC-specific maternal assessments.

In reviewing potential reasons for lower compliance with the checklist, it was determined that the SASA does not explicitly direct that the checklist must be completed with every domperidone screening regardless of supply or non-supply. To increase the comprehensiveness of future audits, it is recommended that the SASA be updated with clearer instructions before checklist completion.

Secondly, a discrepancy between the REDCap® database reporting and physical checklists was identified. According to the database, 34% of patients were referred to GPs due to meeting the referral criteria. However, the physical checklists revealed that domperidone was supplied 100% of the time. Multiple survey comments stated that there was confusion regarding the wording of this statement on the REDCap® form, and this will be clarified. An additional education session where the updated change is publicly discussed would be helpful.

No adverse effects to domperidone or the need to cease therapy were reported. However, it was found that follow-up discussions regarding domperidone therapy were infrequently and/or vaguely documented. At least one survey respondent requested further information on how to approach weaning doses. Both IBCLCs and patients would benefit from clearly written instructions for weaning domperidone under the SASA, as seen in the Haase et al. protocol [23]. Several patient notes documented increases in milk volume exceeding 90mL, which is in line with current evidence [1, 14, 16,17,18]. However, this documentation was not uniform and outside the scope of this current audit as domperidone efficacy was not assessed.

Following this audit, the SASA and education package would be revised to include: (1) Clarification on the circumstances in which the domperidone as a Galactagogue Checklist should be completed (i.e. with every discussion of domperidone for lactation insufficiency); (2) Rewording of the statement on REDCap® from “criteria for referral” to “meets criteria for referral to senior physician” or similar to avoid staff confusion and encourage consistent reporting of referrals; (3) Standardised frameworks to document follow-up of domperidone therapy, including but not limited to weaning instructions, adverse effects and efficacy.

The system in place allows the IBCLCs to initiate and supply domperidone in a timely manner to breastfeeding mothers with lactation insufficiency. The support tools, including domperidone SASA, REDCap® documentation database and the checklist domperidone as a Galactagogue Checklist, can be greatly appreciated by the IBCLCs. Continued discussion with IBCLCs to refine and improve the SASA and associated education package will result in more consistent compliance. There is potential for the programme to be expanded to other sites with updates to the SASA requiring the use of the checklist with each screening and encouraging increased follow-up documentation of adverse effects, duration and weaning of domperidone therapy. Other health professionals may use this model of care to advance the scope of practice in other fields.