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OTC medicines

Updates

Vaginal estradiol tablets switched

Estradiol 10 microgram vaginal tablets were reclassified as a P medicine (brand name Gina and the same strength as POM Vagifem tablets). Community pharmacists now have the opportunity to recommend treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women aged 50 years and above, who have not had a period for at least 12 months.

The initial dose is one vaginal tablet used daily for two weeks followed by a maintenance dose of one tablet twice a week, leaving three or four days between each dose. New users are asked to return to the pharmacy at seven weeks to check that their symptoms have not worsened and that there are no new symptoms before another pack of vaginal tablets can be supplied.

A pharmacy checklist has been produced that sets out suggested questions for the three potential scenarios in which a woman might be having a consultation with a pharmacist:

  • Women who have never previously used Gina (first visit to the pharmacy)
  • Women who are returning to the pharmacy for their second visit (seven weeks) or first three-monthly visit
  • Women who are returning for their ongoing three-monthly visits.

A pharmacy guide and checklist can be found here. See also PM learning resources. 

St John's Wort

Updated NICE guidance for depression states that, although there is evidence that St John’s Wort may be of benefit in less severe depression, health professionals should not prescribe or advise its use by people with depression because of:

  • Uncertainty about appropriate doses
  • Persistence of effect
  • Variation in the nature of preparations
  • Potential serious interactions with other drugs (including hormonal contraceptives, anticoagulants and anticonvulsants).

E-cigarettes for smoking cessation

NICE published its updated guideline ‘Tobacco: preventing uptake, promoting quitting and treating dependence (NG209)’, in August 2022. There is still no e-cigarette containing nicotine that has licensed approval and NICE concluded that although “there is not enough evidence to know whether there are long-term harms from e‑cigarette use, [their use] is likely to be substantially less harmful than smoking”. 

NICE says the following options, when combined with behavioural support, are more likely to result in successfully stopping smoking:

  • Varenicline (offered in line with NICE’s technology appraisal guidance on varenicline for smoking cessation)
  • Combination of short- and long-acting NRT
  • Nicotine-containing e‑cigarettes.

Since varenicline (Champix) remains unavailable with no date as to when supplies may come back on stream, only two of NICE’s three first-line options can be offered to smokers wishing to quit.

A Government-commissioned report on nicotine vaping published in September 2022 concluded that although vaping is not risk-free, its risks are only a fraction of those from smoking. However, “findings of higher absolute exposure to toxicants from vaping, compared with not using any nicotine products, reinforce the need to discourage people who have never smoked from taking up vaping (or smoking),” says the report. 

Cuts to Government bodies responsible for overseeing vaping products are concerning, say the authors. Vaping and smoking among 11-18-year-olds increased in 2022, with nicotine vaping almost doubling compared with the previous year.

Reflection exercise

Think about the consultations you have had with women who have requested Gina. What three learning points would you include when briefing a new member of your team? 

Drug safety updates: MHRA

In June 2022, the MHRA advised that decreased vitamin B12 levels, or vitamin B12 deficiency, is now considered to be a common side-effect in patients on metformin treatment, especially those receiving a higher dose or longer treatment duration and in those with existing risk factors. 

Checking vitamin B12 serum levels was recommended in patients being treated with metformin who have symptoms or findings suggestive of vitamin B12 deficiency (e.g. patients presenting with megaloblastic anaemia or new-onset neuropathy). Consideration of periodic monitoring for patients with risk factors for vitamin B12 deficiency was also suggested.

In May 2022, all Accupro (quinapril hydrochloride) tablets were recalled as a precautionary measure due to the observation of levels of N-nitroso-quinapril (an impurity) above the acceptable daily intake level. Currently no information is available regarding when Accupro will be available again.

Based on the available data, there is no immediate risk to patients who have been taking this medication. Patients undergoing treatment should be advised not to discontinue Accupro without consulting with their prescriber, as there are potential risks associated with suddenly stopping treatment for blood pressure or heart failure.

The MHRA reminded health professionals that amiodarone has been associated with serious and potentially life-threatening side-effects, particularly of the lung, liver and thyroid gland, and that patients should be supervised and reviewed regularly during treatment.

Lung problems may have slow onset but then progress rapidly. A patient card is available for all patients who take amiodarone and includes information on the most serious and potentially life-threatening side-effects (and their symptoms) as well as reminding patients of the potential for drug-drug interactions.

Reflection exercise

How will the recently updated NICE guidance and Government-commissioned report on evidence relating to e-cigarettes impact on your practice when advising smokers on quitting? List three key points for discussion with your team.

Medication in pregnancy

Continued vigilance needed with valproate dispensing

Patient groups have reported examples of females not always given safety information when sodium valproate is being dispensed. Children born to women who take valproate during pregnancy are at significant risk of birth defects and other developmental disorders.  

In October the GPhC issued a reminder that pharmacists should:

  • Provide a valproate patient card every time the drug is dispensed
  • Make sure a copy of the patient information leaflet is provided
  • Remind the woman about the risks in pregnancy, the need for highly effective contraception and the need for annual specialist review
  • Ensure the patient has received a valproate patient guide
  • If valproate is dispensed in a white box, add a warning to the box and make sure that the patient label is not placed over any warning labels or warning stickers.

In addition, pharmacists should:

  • Ensure the pharmacy has a system to flag people who are at risk to make sure they are provided with the right information
  • Make sure people at risk have a pregnancy prevention plan in place and that they understand the risks, and refer to local contraceptive services if appropriate
  • Refer women who have not had a review within the last 12 months to their GP or specialist and know who to contact if their circumstances change
  • Record referrals and information provided on the patient medication record.

Pregabalin (Lyrica)

A new study has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Patients should continue to use effective contraception during treatment and avoid use in pregnancy unless clearly necessary. 

An observational study of more than 2,700 pregnancies exposed to pregabalin has shown use in the first trimester to be associated with a slightly increased risk of major congenital malformations compared with exposure to no antiepileptic drugs, or to lamotrigine or duloxetine.