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DH issues new estradiol patch SSP as HRT tablets also out of stock until June

The Department of Health and Social Care (DH) has issued a new serious shortage protocol (SSP) for a hormone replacement therapy (HRT) treatment.

The pharmacy negotiator today (March 28) announced that the DH has issued a new SSP for Progynova TS 100micrograms/24hours transdermal patches amid “significant ongoing disruption” to supply.

It comes after C+D revealed last month that the estradiol valerate HRT patch would be out of stock from the “end of February” due to a “production bottleneck”.

Read more: HRT patch out of stock from end of February due to ‘production bottleneck’

Under the SSP, pharmacists must supply one FemSeven 100 patch for every Progynova TS 100micrograms/24hours transdermal patch originally prescribed, the Pharmaceutical Services Negotiating Committee (PSNC) said.

The SSP - effective from today - is currently due to expire on June 9, although it may be “amended or revoked at any time”, it added.

Read more: Government admits HRT PPC will create additional 'costs' for pharmacies

However, the protocol does not allow pharmacists to supply for less than the number of days originally prescribed or to double up strengths, for example by supplying two 50 micrograms patches against a prescription for one 100 micrograms patch, PSNC said.

There are no SSPs in place for Progynova TS 50micrograms/24hours transdermal patches, which are “not affected by supply disruptions and should continue to be dispensed in accordance with the prescriptions”, it added.

Estradiol tablets out of stock

Alongside the SSP for Progynova TS patches - which contain estradiol valerate - HRT tablets containing estradiol will also be out of stock until late June.

PSNC said yesterday (March 27) that the DH has issued a medicine supply notification for Estradiol valerate/medroxyprogesterone acetate (Indivina ) 1mg/2.5mg tablets.

The tablets are “out of stock until [week commencing] June 26”, but “alternative continuous combined HRT containing estradiol 1mg but a different progestogen component remain available and will be able to support increased demand”, it added.

Read more: DH extends HRT SSPs and issues new protocol for paracetamol

Where alternatives are not suitable, pharmacists can source unlicensed supplies, although lead times “vary”, it said.

Specialist importer Mawdsley’s Unlicensed has confirmed it can source unlicensed Indivina 1mg/2.5mg tablets, although there “may be other companies that can also source supplies”, it added.

Other supply issues

Meanwhile, PSNC yesterday said that the DH had also issued medicine supply notifications for anticonvulsant primidone (Aspire Pharma) 50mg tablets and Acetazolamide (Diamox® SR) 250mg modified-release capsules.

The primidone tablets will be out of stock until the week commencing April 24, while the Acetazolamide capsules are out of stock until the “end of July”, it added.

The pharmacy negotiator said that the Teva brand of primidone 50mg tablets “remain available and will be able to support increased demand”.

Read more: HRT patches ‘out of stock’ as DH issues six medicine shortage notifications

However, it warned that since primidone is a category one anti-epileptic drug, “clinically relevant differences between different manufacturers’ products might occur, even when the pharmaceutical forms are the same and bioequivalence has been shown”. 

It recommended that patients “are maintained on a specific manufacturer’s product” but added that if this is not possible “as in the case of a shortage, patients should be monitored for worsening of symptoms or side effects after a switch”.

Read more: DH extends three serious shortage protocols for HRT products as two expire

Acetazolamide immediate release 250mg tablets “remain available and can support an uplift in demand” amid the shortage of the modified-release capsules, PSNC said.

“Limited supplies” of unlicensed imports of acetazolamide SR 250mg capsules have been sourced - with varying lead times - and “a number of” special manufacturers are able to produce acetazolamide oral suspension in various strengths, it added.

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