Published: 8th December, 2023
New article - Accelerated silicosis: diagnosis of an occupational disease
Accelerated silicosis is a progressive respiratory condition caused by exposure to respirable crystalline silica. Dry cutting artificial stone produces very high concentrations of ultrafine silica dust that is deposited in the lungs, causing inflammation and fibrosis. People can be exposed to silica dust from artificial stone for many years before they develop symptoms. Accelerated silicosis has recently emerged as a serious occupational health condition, mainly affecting people working with artificial stone benchtops. Increasing numbers of these workers will likely present in primary care with either a history of silica dust exposure or general health concerns.
The Accelerated Silicosis Assessment Pathway has been established to identify and assess those who have been exposed to silica dust while fabricating artificial stone. WorkSafe is encouraging workers to contact their primary care clinic for assessment. Once a diagnosis of accelerated silicosis has been made, there are no effective curative treatments; management is symptomatic and supportive. This highlights the importance of workplace safety and prevention strategies. Clinicians should be familiar with workplace safety recommendations that reduce silica exposure as these can guide discussions with people who may be at risk.
The full article can be accessed here
Navigating the last days of life: peer group discussion for general practice
We recently published a comprehensive resource aiming to educate and support primary healthcare professionals in caring for patients during the last days of life. This was developed with the support of Te Aho o Te Kahu, Cancer Control Agency, and contextualises information from the Ministry of Health, Manatū Hauora, “Te Ara Whakapiri: Principles and guidance for the last days of life” resources specifically for general practice.
As a continuation of this theme, we have now released a series of questions that can be used as discussion points for peer groups or self-reflection of practice. Is your practice regularly involved in caring for people during the last days of life? What symptoms do you find are the most complex to manage? How do you reduce the risk of unplanned hospital admissions?
View the peer group discussion here
Other recent resources from bpacnz
Oral anticoagulant selection in primary care:
Direct oral anticoagulants (DOACs) such as dabigatran and rivaroxaban are now established as the “go to” choice in primary care for prevention of thromboembolic events in patients at increased risk. DOACs have a superior clinical efficacy and numerous practical advantages, more rapid onset if action, fewer medicines and food interactions, compared with the conventional option, warfarin, however, oral anticoagulant selection should always be individualised. Warfarin is still sometimes required on a case-by-case basis in patients with specific co-morbidities or characteristics, e.g. mechanical heart valves, moderate-to-severe mitral stenosis or severe liver disease. Regardless of the option selected, ongoing management involves consideration of modifiable risk factors for bleeding, treatment adherence and monitoring for adverse effects.
Cough medicines: do they make a difference?:
Pharmacists and other staff working in community pharmacies are often tasked with guiding people who present with cough on appropriate management strategies. However, as there are a myriad of products available, with differing claims and extent of effectiveness, knowing which product(s) to recommend can sometimes be difficult.
Alert Communication update: sodium valproate use in males
In May, 2023, Medsafe issued an Alert Communication on the use of sodium valproate (Epilim) in “people who can father a child” based on evidence of a potential increased risk of neurodevelopmental disorders in children after paternal use of sodium valproate at the time of conception; this was covered in Bulletin 76. Medsafe has now updated the original Alert Communication with additional information that the potential increased risk of neurodevelopmental disorders in children is present following paternal use of sodium valproate up to three months before conception.
Males who take sodium valproate should be advised to use contraception during and for at least three months after stopping this medicine. They should also avoid donating sperm during this time period. Data sheets and consumer medicine information leaflets have been updated to reflect this; educational materials will be updated soon.
It takes approximately three months for new sperm to fully develop, but it is unknown if there are also potential risks to children conceived more than three months after the father stops taking sodium valproate. Males taking sodium valproate should be informed about this potential risk, and those who are planning parenthood soon may consider switching to an alternative treatment. This conversation should be revisited annually.
A letter for healthcare professionals from the manufacturer about this risk is available here.
N.B. These recommendations are based on evidence from a retrospective observational study in Denmark, Norway and Sweden. The results of this study have not been formally published at this stage. Read more about the study here. Medsafe discusses the results of the study here, along with updated figures after a second analysis of the data, as discussed in a European Medicines Agency review here.
The risk of adverse effects of antiepileptic medicines for females of reproductive age is already well documented, and precautions around effective contraception for females also apply. Read more here.
Latest edition of Prescriber Update released
The December edition of Prescriber Update has been published. Particular items of interest include:
A spotlight on dulaglutide adverse effects and safety considerations
The most common adverse effects associated with dulaglutide are gastrointestinal-related, including nausea, diarrhoea and vomiting. Serious adverse effects are rare but can still occur, e.g. acute pancreatitis, cholecystitis, hypoglycaemia, acute kidney injury secondary to dehydration. Hypoglycaemia risk is increased when dulaglutide is used with insulin or sulfonylureas; consider lower doses of these medicines if co-prescribing. Click here to read more. Also a reminder that dulaglutide should not be prescribed concurrently with vildagliptin.
N.B. Dulaglutide is currently subject to supply shortages, and it is strongly recommended that it is conserved for patients already initiated on it, who are receiving benefit; see Bulletin 86.
Uterine bleeding with anticoagulants
As reported in Bulletin 58 and 71, abnormal uterine bleeding has been noted in some women taking oral anticoagulants. While this risk is low, patients should be informed that they may experience new or increased abnormal uterine bleeding with oral anticoagulant use, and should discuss this with their primary care clinician if it occurs. The bleeding may be caused by the oral anticoagulant, but it is important to investigate and exclude other possible underlying causes, e.g. fibroids, endometriosis or gynaecological cancer. Click here to read more.
Recent safety information updates for medicine data sheets
Several medicine data sheets have been recently updated with new safety information; for example: amoxicillin + clavulanic acid (drug-induced enterocolitis syndrome has been reported, mainly in children, interaction with methotrexate), estriol (may induce symptoms of hereditary and acquired angioedema; co-administration with hepatitis C combination regimens can significantly increase ALT levels), methotrexate (males should use contraception during treatment and for three months after) and tramadol (hypoglycaemia). Click here to read more.
MARC’s remarks: recommended medicine data sheet changes
Symmetrical drug-related intertriginous and flexural exanthema (SDRIFE)
SDRIFE is a type of medicine-induced erythematous rash involving the skin folds. It was originally referred to as “baboon syndrome” as it presents as a v-shaped rash in the gluteal or groin area, with additional involvement in other skin folds or flexural regions, e.g. armpit, behind the knee. It is most commonly caused by beta-lactam antibiotics (e.g. penicillins, cephalosporins - 50% of cases). This is a self-limiting reaction, without systemic symptoms (which is a key characteristic of SDRIFE, i.e. no systemic symptoms), and is expected to resolve when the medicine is stopped. Topical steroids may assist in clearing the rash more quickly. Re-exposure to a medicine that has caused SDRIFE usually results in recurrence of rash. Click here to read more.
View the full edition here
Medicines supply issues: ciprofloxacin, escitalopram, olanzapine depot injections, oxycodone
The following issues relating to medicine supply, of particular interest to primary care, have recently been announced. This information is also available in the New Zealand Formulary at the top of the individual monograph for any affected medicine and summarised here.
Ciprofloxacin brand discontinued
The currently funded brand of ciprofloxacin tablets, Cipflox, is being discontinued by the supplier, Viatris. At this stage, ciprofloxacin (Cipflox) 500 mg and 750 mg tablets are out of stock. The remaining supply of ciprofloxacin 250 mg tablets is limited and expected to run out at the end of December, 2023.
An alternative funded product, 500 mg ciprofloxacin (Ciprofloxacin – Torrent) has been listed on the Pharmaceutical Schedule but is not approved by Medsafe. It will need to be prescribed for supply under Section 29 of the Medicines Act 1981. Currently there are no alternative products available to replace the 250 mg and 750 mg ciprofloxacin tablets.
Escitalopram brand change
The funded brand of escitalopram is changing. Escitalopram Ethics will cease being funded from 1st April, 2024. Its replacement, Ipca-Escitalopram, has been listed and funded on the Pharmaceutical Schedule since 1st November, 2023. Patients should be advised that while the shape of the tablet and packaging are changing, the active ingredient remains the same.
A patient information leaflet about the escitalopram brand change is available here.
Olanzapine supply issue ongoing
There is an ongoing supply issue affecting stock of the olanzapine depot injection. There is limited stock still available, and, as reported in Bulletin 88, no new patients are to be initiated on olanzapine depot injections from 1st December, 2023. It is expected that stock availability will continue to be limited for the next six to nine months due to global manufacturing and supply constraints.
In situations where the prescriber believes olanzapine depot injections should be initiated for a patient with exceptional clinical circumstances, they can apply for a Named Patient Pharmaceutical Assessment (NPPA); note the deadlines for applications before the summer break.
Pharmac is also currently consulting on a proposal to fund an aripiprazole depot injection. Submissions on this proposal close today (8th December, 2023).
Oxycodone supply issue ongoing
There continues to be a supply issue affecting stock of oxycodone controlled-release tablets, as reported in Bulletin 85. Currently, 5 mg oxycodone (Sandoz) controlled-release tablets are out of stock, with resupply not expected until January, 2024. Stock of 10 mg and 20 mg oxycodone tablets has been resupplied.
Reminder: Patients should be instructed to swallow 10 mg oxycodone (Sandoz) controlled-release tablets whole. Cutting, crushing or chewing controlled-release tablets may increase the rate of absorption resulting in potentially harmful blood levels and adverse effects. Suitable alternative medicines include morphine modified-release capsules (m-Eslon SR) or oxycodone 5 mg/5 mL oral liquid.
Invitation to participate in a survey about diagnostic pathways for lung cancer
Lung cancer is the leading cause of cancer-related death in New Zealand. Diagnosis often occurs late when people already have advanced disease, limiting the effectiveness of treatment. Early detection is therefore key to improving lung cancer survival outcomes.
A group of researchers from the University of Otago and the University of Waikato, including a medical oncologist and general practitioners, are undertaking a study to understand the regional differences in diagnostic pathways for people with suspected lung cancer. The group is aiming to identify challenges that primary care faces and determine what support is required to introduce a diagnostic method using liquid biopsy to assess circulating tumour DNA (ctDNA).
General practitioners and other primary care clinicians involved in lung cancer diagnosis are invited to take part in a survey about their clinical practice. The survey is expected to take approximately 15 minutes.
An information sheet for participants can be found here.
To take part in the survey, click here.
ACC Māori cultural competency guidance released
ACC has recently released updated guidance on cultural competency: Te Whānau Māori me ō mahi - Guidance on Māori Cultural Competencies for Providers. The original guideline (published in 2005) focused on cultural competency with the idea that increasing health professionals cultural knowledge and awareness would limit unconscious bias and promote effective communication with Māori, reducing health inequities. The new version was written with input from a range of Māori clinicians and other health professionals and builds upon the original guideline by incorporating cultural safety and anti-racism as further tools to reduce health inequities. It should support healthcare providers when applying Kawa Whakaruruhau; ACC’s Cultural safety and competency policy.
Key points include
- Power differences exist between healthcare providers and service users, i.e. patients. Cultural safety considers how these power differences, along with healthcare providers previous experiences and biases, may negatively influence health interactions and outcomes. Addressing these factors may help to develop health services Māori can relate to and feel comfortable using. “The word safety is deliberately chosen to give power to the consumer.”
- Anti-racism strategies (educating health professionals about how racism may be perpetuated in everyday interactions) aid cultural safety by giving health practitioners the knowledge and tools to identify and address situations or systems in healthcare that enable racism, e.g. invalidation or minimisation of concerns or offensive behaviours
- Reported barriers to effective healthcare for Māori include the availability of health services (e.g. location, timing), health service costs and cultural barriers that result in health services where Māori may feel uncomfortable or unsafe
- Collecting accurate ethnicity data should become an organisational priority. Access to high quality ethnicity data enables healthcare organisations to identify and address disparities between non-Māori and Māori.
- Tikanga Māori, or customs and protocols, may become more important to Māori during times of illness or injury and an understanding of this by the healthcare providers may aid communication, facilitating positive interactions and result in better health outcomes. Examples include:
- Whakawhanaungatanga – allow space and time during the initial consultation to build rapport between the primary care clinician and the patient and whānau. Rushing or ignoring this step may affect communication at a later stage.
- Healthcare professionals should make a point of introducing themselves and describe their role. Also, ask the patient or whānau if they have any cultural, spiritual or language needs and record these appropriately.
- Understand and respect the importance of names and correct pronunciation. If you are unsure, ask and make a record of the preferred name in the patient notes.
- Respect cultural beliefs (e.g. for Māori, the head is tapu, or sacred, so provide an explanation and seek permission before an examination of the head), allowing time for whānau to perform karakia or blessings (e.g. before a procedure or administration of a blood product)
Read the full document here
Further information about Kawa Whakaruruhau for ACC service providers is available here
NZF updates for December
Significant changes to the NZF in the December, 2023, release include:
- Breast-feeding advice has been updated for moxifloxacin
- Information regarding prescribing and supply restrictions have been added to the dosing regimen for CNS stimulants/ADHD medicines such as dexamfetamine and methylphenidate
- An alert and information regarding the change in brand of morphine oral liquid has been added to the morphine salts monograph
You can read about all the changes in the December release here. Also read about any significant changes to the NZF for Children (NZFC), here.
Paper of the Week: Low-dose amitriptyline for IBS
Irritable bowel syndrome (IBS) is a common gastrointestinal condition that can significantly reduce a person’s quality of life. Recommended treatments are dietary changes, lifestyle advice, e.g. stress reduction, and in some cases, probiotics, soluble fibre, antispasmodics, laxatives or antidiarrheals. However, for some people, these interventions are still not adequate for reducing IBS symptoms.
Some international guidelines, e.g. UK NICE guidelines, recommend the use of low-dose tricyclic antidepressants (TCAs) such as amitriptyline and nortriptyline as a second-line option for people with IBS. The mechanism of action for TCAs in this context is uncertain, but is thought to involve their neuromodulatory, analgesic and motility properties, rather than effects on mood. Despite evidence of benefit for TCAs in people with IBS, primary care practitioners may be hesitant to prescribe them based on their adverse effect profile and concerns surrounding anticholinergic burden.
A 2023 study published in The Lancet examined the effect of low-dose amitriptyline on the symptoms of IBS in participants who did not respond to dietary changes and first-line treatment options. This research was specifically focused on the management of IBS symptoms in a primary care setting. The authors found that compared to placebo, participants given low-dose amitriptyline had greater improvements in IBS Severity Scoring System (IBS-SSS) scores and relief of IBS symptoms after six months. Rates of adverse effects were higher after three months for participants taking amitriptyline but comparable for both groups after six months. The lower doses required for TCAs in the context of IBS management may mean that a trial is worth considering for some patients.
Have you prescribed TCAs for patients with IBS? Do the results of this study change your threshold for considering TCAs as a second-line option for IBS?
- A randomised, double-blind, placebo-controlled study was conducted between October, 2019, and April, 2022, including 463 participants from 55 general practices in England
- Eligible participants were aged over 18 years with a primary diagnosis of IBS and had not responded to first-line treatments
- Females made up a larger portion of the participants (68%)
- The mean age of participants was 48.5 years
- Most participants had either diarrhoea predominant IBS (IBS-D) or mixed diarrhoea and constipation IBS (IBS-M) (> 80%), and a moderate to severe IBS-SSS score (> 85%)
- Participants were randomly assigned to receive either low-dose oral amitriptyline or placebo tablets for six months. Patients were initiated on one tablet (10 mg amitriptyline in the intervention group), once daily, at night. This dose was titrated up to a maximum of three tablets (30 mg amitriptyline in the intervention group), once daily, at night, over three weeks.
- Tolerability was assessed during weeks one and three and participants were permitted to modify their dose during the study period depending on treatment efficacy and adverse effects (as would be the case in primary care). A dose titration document was provided to allow patient self-management and there was access to on-call support nurses, if required. N.B. This resource could be adapted for people who take TCAs for other conditions.
- Treatment efficacy was measured using the IBS Severity Scoring System questionnaire after six months (the primary outcome). IBS-SSS score was also measured at 3 and 12 months.
- A subjective global assessment (SGA) was used to assess relief of IBS symptoms after six months (secondary outcome)
- Other secondary outcomes measured in this study include IBS-associated somatic symptoms, anxiety and depression scores and the participants ability to work and undertake daily activities
- A significant mean difference in IBS-SSS score was observed in the intervention group after three and six months versus placebo (–23; p=0·014 and –27; p=0·008)
- Participants who took amitriptyline were 70% more likely to report relief of IBS symptoms (based on SGA) after three months and 80% more likely after six months, compared to placebo
- Treatment adherence was similar for both groups after three months, but higher in the amitriptyline group after six months
- Discontinuation rates were 20% in the intervention group and 26% in the placebo group. Reasons for discontinuation included adverse effects (most common), perceived lack of benefit and loss to follow-up.
- There was a significantly higher rate of adverse effects after three months in the intervention group compared to the control group. However, this difference was not apparent after six months. Adverse effects in the intervention group were mainly related to amitriptyline’s anticholinergic activity, e.g. dry mouth (54%), drowsiness (53%), blurred vision (17%), constipation (56%) and difficulty with urination (22%). Very few adverse effects were considered severe (< 5%).
- No improvement in anxiety or depression scores was observed in the intervention group. This supports the hypothesis that the beneficial effects of TCAs for IBS symptoms do not involve the psychological mechanisms.
- Only a small number of people with constipation dominant IBS (IBS-C) were included in this study. Constipation is a recognised adverse effect associated with amitriptyline and this was stated on the information leaflet, therefore, people with IBS-C may have been hesitant to take part. Although the study was not powered to analyse the effect of amitriptyline on the individual IBS subtypes, there was no reported increase in serious adverse effects or study dropout in the IBS-C participant group, therefore, a trial of low-dose amitriptyline could be considered with caution in this group.
- In a recent podcast, the senior/corresponding author, who is a general practitioner, acknowledges concerns regarding anticholinergic burden with TCAs. She argues that the lower doses required for TCAs in the management of IBS (i.e. 10 – 30 mg) are much less likely to induce undesirable anticholinergic effects than the higher TCA doses used for other indications (e.g. up to 150 mg in depression).
In practice, nortriptyline may be better tolerated than amitriptyline, i.e. fewer anticholinergic effects, and may be an appropriate alternative treatment for patients with IBS.
Ford AC, Wright-Hughes A, Alderson SL, et al. Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment in primary care (ATLANTIS): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet 2023;402:1773–85. doi:10.1016/S0140-6736(23)01523-4
For further information on IBS in primary care, see: https://bpac.org.nz/BPJ/2014/February/ibs.aspx
This Bulletin is supported by the South Link Education Trust
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