In 2021, the Department of Health and Social Care (DH) launched a consultation on original pack dispensing (OPD) and the supply of medicines containing epilepsy and bipolar disorder treatment sodium valproate.

Among its proposals to amend the Human Medicine Regulations 2012, the DH suggested that the supply of sodium valproate “must always be in whole packs in the original packaging” regardless of other reforms around OPD.

Read more: Pharmacists may have to supply sodium valproate in original pack

It also proposed giving pharmacists and staff under their supervision “flexibility to dispense more or less than the prescribed quantity” of a medication, within a 10% margin, so they can issue prescriptions in the manufacturer’s original packs.

However, this measure would not apply to controlled drugs and in cases where it would “negatively affect the patient’s clinical treatment regimen”, it stressed.

Now the DH and medicines watchdog the Medicines and Healthcare products Regulatory Agency (MHRA) have rubberstamped the plans.

 

“Overwhelming” support

 

In a consultation outcome update published on Sunday (March 19), the DH and MHRA said that “in light of the overall positive response, the government intends to progress the proposals for OPD and the whole-pack supply of medicines containing sodium valproate”.

This means that medicines containing sodium valproate will always be dispensed “to the nearest whole pack” – either rounded up or down – and must not be repackaged into plain dispensing packaging, it said.

Read more: Valproate chosen again as clinical audit focus for pharmacies in England

The consultation – which ran for six weeks from November 1 to December 13 2021 – garnered more than 80 responses, it added.

There was “significant support” for OPD flexibilities and “overwhelming” support for the introduction of mandatory whole-pack dispensing of medicines containing sodium valproate, the update said.

 

“Exemption” added

 

But it added that following responses around the impact on vulnerable patients, the government will “include an exemption to whole-pack dispensing of medicines containing sodium valproate on an individual patient basis” in certain circumstances.

These are when a risk assessment is in place that “refers to the need for different packaging” such as a monitored dosage system (MDS) and “processes are in place to ensure the supply of patient information leaflets”, it said.

Read more: ‘Clinical negligence claims against pharmacists ignoring sodium valproate guidance cannot be ruled out’

The proposals aim to “support increased patient safety by ensuring patients receive the necessary information that is included in the original manufacturer’s packaging about the safe and effective use of a product”, the DH and MHRA said.

They also aim to “support efficiencies for pharmacies” as they “free up pharmacists and their teams for other tasks such as providing clinical services to patients” instead of spending time splitting boxes, snipping blisters and repackaging medicines, they added.

Read more: GPhC: Dispensing sodium valproate without information leaflet 'unacceptable'

But responses to the consultation raised concerns that:

• OPD will cause an “adverse financial effect for contractors with up to five pharmacies who have no legal or financially viable access to automated dispensing”
• An increased use of OPD could lead to a “decrease in income” for individual community pharmacies due to issues around reimbursement, such as around container allowances
• “Discrepancies” in records between prescriptions and exact quantities dispensed could lead to patient confusion, “re-ordering issues later” and more emergency supplies needing to be provided by community pharmacies
• “Excess stock” in the hands of patients when they are dispensed more than prescribed would increase the risk of “medicine abuse or overdose”
• The need for more storage space could put “pressure” on pharmacies and they could be forced to create more medicines wastage
• Pharmacies will need to spend more time “explaining the process to patients and dealing with complaints”

The government stressed that pharmacists can use their clinical judgement as to whether to use the OPD flexibility – which is “enabling and not mandatory” – or supply the exact quantity prescribed.

 

Savings “limited and variable”

 

The government also admitted that overall time and cost savings for pharmacies “are likely to be limited and variable”.

It said that it “noted” comments on reimbursement, with concerns that pharmacy contractors should be reimbursed according to actual supply a “key theme throughout the responses”.

However, reimbursement arrangements are “yet to be determined” through negotiations, it added.

“The government also understands that pharmacies and GP practices may have to spend additional time with patients but has considered that this will level out over time,” it said.

 

“Transitional provision”

 

While the OPD amendments will come into immediate effect in Scotland once passed, they will not automatically apply in England, Northern Ireland and Wales, the update said.

However, amendments on the whole-pack dispensing of medicines containing sodium valproate will apply as soon they come into force, it added.

This “transitional provision” will “enable each administration time to agree with the appropriate community pharmacy representative body how the OPD arrangements will apply as part of NHS pharmaceutical service provision”, it said.

It comes as sodium valproate was again chosen as the clinical audit focus for community pharmacies in England for 2022/23, announced in November.