This strengthened restriction in the UK comes following a MHRA review into the effectiveness of existing measures to reduce the risk of long-term and irreversible effects associated with fluroquinolone use, e.g. tendon rupture, QT prolongation, neuropathy, psychiatric symptoms. The review considered all available evidence, including data from a 2023 UK-based study and adverse event reports from patients and health care professionals. The review found no change to fluoroquinolone prescribing habits after restrictions were introduced in 2019, e.g. fluoroquinolones were still being prescribed for mild to moderate or self-limiting infections, or for non-bacterial conditions. There was also evidence found of disabling or long-term adverse effects associated with fluoroquinolone use, e.g. tendon damage.

If a fluoroquinolone antibiotic is needed, ensure patients are informed of the potential risks, and advise them on symptoms and signs that warrant seeking medical attention. A patient information sheet, developed by the MHRA is available here.

In the September, 2023 edition of Prescriber Update, Medsafe reminded prescribers of the potential for fluoroquinolones to, in rare cases, be associated with disabling, prolonged and potentially irreversible adverse effects. This was also reported in Bulletin 83. Prescribers should report adverse reactions to the Centre for Adverse Reactions Monitoring (CARM).

Pharmac has released a proposal to widen access to the varicella zoster virus vaccine (shingles; Shingrix). Vaccination with Shingrix requires two doses, given six months apart, and is currently funded for people aged 65 years. It is proposed that from 1^st July, 2024, eligibility will be widened to include people aged ≥ 18 years who are immunocompromised with any of the following:

• Pre- or post-haematopoietic stem cell transplant
• Solid organ transplant
• Haematological malignancy
• Poorly controlled HIV infection
• Planned or receiving disease modifying anti-rheumatic drugs (DMARDs) for polymyalgia rheumatica, systemic lupus erythematosus or rheumatoid arthritis
• End stage kidney disease (CKD 4 or 5)
• Primary immunodeficiency

Pharmac has released a proposal to fund a triple medicine inhaler (ICS/LAMA/LABA) for patients with moderate to severe COPD from 1^st May, 2024. Having the option of this novel funded triple combination treatment (fluticasone furoate with umeclidinium and vilanterol [Trelegy Ellipta]) would mean that patients only need to use one inhaler to achieve ICS/LABA/LAMA combination treatment (instead of two or three), which may improve treatment adherence. This benefit was highlighted in a 2023 report from the Global Initiative for Chronic Obstructive Lung Disease (GOLD).

For further information on the management of COPD in primary care, see: https://bpac.org.nz/2020/copd.aspx. The bpac^nz COPD prescribing tool is also available here.

Pharmac has announced that from 1^st March, 2024, it is removing the requirement for annual renewal of Special Authority numbers for patients taking sacubitril with valsartan (Entresto), an angiotensin receptor-neprilysin inhibitor (ARNI), for heart failure. This medicine is recommended for patients with ongoing symptomatic HFrEF despite optimised standard treatment (N.B. Some recent international guidelines, e.g. the 2022 AHA/ACC/HFSA (US) heart failure guidelines, consider that an ARNI, ACE inhibitor or ARB are all now equal first-line options).

Sacubitril with valsartan is funded with Special Authority approval for patients who have NYHA class II – IV symptoms and who are receiving concomitant optimal standard chronic heart failure treatments. The criteria also state that patients should have either a confirmed LVEF < 35%, or if echocardiography is not practically possible, the medicine can be initiated if the clinician believes they are “likely to benefit from treatment”.

For information on the management of heart failure in primary care, see: https://bpac.org.nz/2022/heart-failure.aspx. A clinical audit on optimising treatment in patients with heart failure is also available here.

There is a supply issue affecting stock of the 20 mg and 40 mg omeprazole capsules. The 10 mg capsules and powder for liquid suspension are currently unaffected by the stock issue. Pharmac has advised that stat dispensing will be temporarily removed for all three omeprazole capsule presentations from 1^st March, 2024, and switched to monthly to maintain continuity of supply until new stock arrives (currently expected April, 2024). Once the supply issue has resolved, stat dispensing will resume.

Dispensing of oestradiol valerate (Progynova) 1 mg tablets will temporarily switch to monthly from 1^st March, 2024, due to a supply issue. Stat dispensing is expected to resume from 1^st June, 2024, when stock becomes available. Supply of the 2 mg oestradiol valerate tablets is currently unaffected.

For further information on menopausal hormone therapy formulations, see: https://bpac.org.nz/2019/mht.aspx

The funded brand of bisoprolol fumarate is changing from Bisoprolol Mylan or Viatris to Ipca-Bisoprolol. Ipca-Bisoprolol has been listed on the Pharmaceutical Schedule and funded since 1^st November, 2023. Patients must be switched to the new brand by 1^st April, 2024, when Bisoprolol Mylan and Viatris will no longer be funded.

If bisoprolol is prescribed generically, prescribers do not need to change anything as pharmacists will dispense the newly funded brand when new prescriptions are presented. Patients taking bisoprolol tablets should be advised that their brand is changing, and that the tablet shape, colour and packaging will look different, but be reassured that there has been no change to the active ingredient. A patient information leaflet about the brand change is available here.

There is an ongoing supply issue affecting stock of salbutamol 5 mg/2.5 mL (2 mg/mL) and 2.5 mg/2.5 mL (1 mg/mL) nebuliser solutions (Asthalin). Resupply of the 2 mg/mL presentation is expected in March, 2024; no date has been announced yet for resupply of the 1 mg/mL nebuliser solution. Nebulisers are now used infrequently in primary care, and are usually reserved for people with severe asthma who do not respond to inhaled treatments.

An alternative brand of the 2 mg/mL presentation (Cipla; Section 29) has been listed on the Pharmaceutical Schedule since 1^st February, 2024, and a limited amount of stock has now been released to wholesalers. Pharmac advise that the Cipla brand is a 30 pack (not 20 like Asthalin) and order quantities should be adjusted accordingly as stock is limited.

From 1^st March, 2024, an alternative brand of the 1 mg/mL presentation will be listed on the Pharmaceutical Schedule (Teva-Salbutamol Sterinebs; Section 29). N.B. Ventolin Nebules (Australia, Section 29; Section 29) and Salbutamol Nebuliser Solution (Accord; Section 29) have been listed on the Pharmaceutical Schedule since September, 2023, as alternative brands of the 1 mg/mL presentation, however, are currently out of stock.

For further information of management in asthma in primary care, see: https://bpac.org.nz/2020/asthma-children.aspx and https://bpac.org.nz/2020/asthma.aspx

There is a supply issue affecting stock of mesalazine 800 mg tablets (Ascol), used in the treatment of ulcerative colitis and other inflammatory bowel conditions. The 400 mg tablet and other presentations of mesalazine are currently unaffected. Stock is expected to be limited until July, 2024. Patients can be prescribed the 400 mg strength of mesalazine (Ascol) and advised to take two tablets to achieve the required dose. The supplier is also looking into the possibility of sourcing an alternative product.

There is an ongoing supply issue affecting stock of olsalazine 250 mg and 500 mg tablets (Dipentum), also used in the treatment of ulcerative colitis. An alternative brand of 500 mg tablets (Atnahs Olsalazine; Section 29) was listed on the Pharmaceutical Schedule, however, this product is now out of stock and re-supply is not expected until April, 2024. Pharmac is advising prescribers to consider alternative funded treatments where possible, e.g. mesalazine (in stock formulations).

For further information on the management of inflammatory bowel disease, see: https://bpac.org.nz/2021/ibd.aspx

• This nested case-control study was conducted in the United Kingdom using the Clinical Practice Research Datalink (CPRD) GOLD dataset. Eligible cases were people aged 16 years or over with a diagnosis of incident bipolar disorder (Type I and II) between January, 2010, and July, 2017, (n = 2,366). Each case was matched by sex, age and registered general practice with up to 20 controls who did not have a recorded diagnosis of bipolar disorder (n = 47,138). Approximately 60% of participants were female and the median age at diagnosis of bipolar disorder was 40 years.
• A list of potential health events that may precede a diagnosis of bipolar disorder were complied with input from clinical experts and members of a “lived experience” advisory panel. These included a diverse range of potential variables relating to pre-existing psychiatric conditions/behaviours, patterns of psychotropic medicine prescribing as well as health service use or interactions.
• People diagnosed with bipolar disorder were more likely to have been previously diagnosed with depression or depressive symptoms, personality disorders, anxiety disorders and schizophrenia (and related disorders) compared to controls without a recorded bipolar disorder diagnosis
  • The strength of this association increased closer to the time of bipolar disorder diagnosis, e.g. the odds ratio for bipolar disorder was 8.5 (confidence interval; CI: 7.8 – 9.3) if depression was diagnosed one to three years before index date, but this increased to 13.2 (CI: 12.0 – 14.6) if diagnosis was made within one year (of bipolar disorder diagnosis)
  • The association was identifiable up to ten years before a bipolar diagnosis for certain preceding health events, e.g. recorded depression or depressive symptoms
• Compared to the control group, a history of mood swings, self-harm and suicidal ideation, anger or aggression and sleep disturbances were all more common in people who were later diagnosed with bipolar disorder
  • Of note, people with bipolar disorder were eight times more likely to have self-harmed and or experienced suicidal ideation in the two years before diagnosis of bipolar disorder
• Antidepressants, antipsychotics and mood stabilisers were more commonly prescribed in people later diagnosed with bipolar disorder, compared to the control group. Also, people diagnosed with bipolar disorder were far more likely to be prescribed three or more psychotropic medicines in the same year, compared to those without a bipolar diagnosis over the same period.
• People with undiagnosed bipolar disorder are more likely to attend multiple general practice consultations within one year while also repeatedly missing scheduled appointments. In this study, people later diagnosed with bipolar disorder had a median of eight general practice consultations per year within three to five years of a bipolar disorder diagnosis, compared to four consultations for people in the control group. During the same period, people with undiagnosed bipolar disorder are four times more likely to have missed six or more appointments in the same year.
• Limitations in this study mainly concern the nature and accuracy of patient health records. Misclassification of Read codes, minor differences in coding choices and the use of the free text feature (e.g. writing a note on a patient’s family history of mental health conditions instead of using a Read code) can reduce the accuracy of patient records and introduce bias to the study results.