This time for original pack dispensing?
Currently, contractors must supply the exact quantity of medicine prescribed, unless certain exceptions apply. This means that pharmacy staff still split original manufacturer packs to dispense the prescribed quantity, often resulting in the patient information leaflet (PIL) being left out.
The proposed changes would give pharmacists the flexibility to dispense up to 10 per cent more or less than the prescribed quantity, if that meant supplying the manufacturer’s original packs – except where this would negatively affect the patient’s clinical treatment regimen. In that case, the responsible pharmacist can make a judgement about what is appropriate, to provide a full course of antibiotics, or to ensure people do not take medication for longer than the course.
From a patient perspective, OPD will make it easier for pharmacies to provide the PIL. Patients are also less likely to receive split calendar packs where the days of the week are marked, making it easier to see whether a medicine has been taken that day. But what could the change mean for manufacturers, wholesalers, pharmacists and pharmacy workflow?
The consultation document says it is not clear whether the changes will cause a significant increase or decrease in total medicines dispensed, or in the quantity of medicines patients can access compared to what has been prescribed for them.
The DHSC estimates that around 75 per cent of prescription items are already prescribed in quantities that align with available pack sizes (April 2021), and not all of the remaining 25 per cent will be suitable for the flexibility to be applied. However, the DHSC acknowledges that allowing community pharmacies to dispense medicines in original packs could lead to changes in purchasing patterns that would have a knock-on effect in terms of demand for particular pack sizes from manufacturers. OPD would also mean a reduction in the use of boxes, reducing the carbon footprint of the medicines supply process.
For patients, the positives are obvious
Martin Sawer, executive director of the Healthcare Distribution Association (HDA UK), says his organisation and its members support the proposals. “OPD is something the HDA has been promoting for some years,” he says. “It will help make things more efficient in the supply chain and automation-wise. However, NHS prescribing systems must be aligned to make sure doctors can prescribe what’s in the packs in the first place.”
Pharmacists, too, agree with the Government that OPD will help them become more efficient and free time up for other tasks such as providing clinical services to patients. “Splitting 28s/30s packs is such dead time for pharmacy teams,” says Gareth Hughes, independent prescriber and superintendent at Sheppards Pharmacy, South Wales. “As we move to providing more clinical services, the dispensing process must be as efficient as possible – this will help.”
Mimi Lau is chief operating officer and superintendent pharmacist at Mr Pickford’s Pharmacy, an independent group operating 21 pharmacies across Leicestershire and Northamptonshire. Calling the consultation “long overdue”, she says the benefits for pharmacists and patients are intertwined.
“For our teams, benefits include improved efficiency and time saved with respect to the dispensing process,” she says. “For patients, the positives are obvious: every patient gets a PIL with each pack, and assurance that packs are have not been ‘tampered’ with. Many packs are also calendar packs, thus supporting medicines adherence as patients can clearly see what days medicines have been taken or not. Furthermore, the 10 per cent flexibility to over/under supply empowers the pharmacist to do the right thing for patients on a case-by-case basis.”
The larger groups are also in favour. A LloydsPharmacy spokesperson said the company has long called for changes to the way medicines are dispensed, and welcomes any changes that simplify the dispensing process. But, they stressed: “It is vital that all the benefits of efficiency gains remain within the community pharmacy network, and there is no parallel loss of income.”
A Numark spokesperson said: “Any developments that seek to enable further efficiency are welcome.” But added: “It would be helpful if manufacturers were to produce common pack sizes linked to either normal treatment duration (as with antibiotics) or period of treatment guidance (i.e. 28 days) as this would further assist pharmacy teams.”
While the policy intention covers NHS and private prescriptions, the proposed OPD amendments would be enabling and not mandatory, and the Government would also place a transitional provision in the Human Medicines Regulations 2012 so that the flexibility does not automatically apply in pharmaceutical services in England, Northern Ireland and Wales. This, it says, will enable these administrations to consider how they want to implement it within their respective NHS services. This is not an issue for Scotland, where OPD has been in place for more than 20 years. “It is normal practice, which works well without any issues,” says Clare Morrison, RPS director for Scotland, “benefitting patients since medicines are supplied in complete patient packs, and pharmacy teams who don’t have to spend time snipping.”
OPD and automation
The Government is further showing commitment to supporting efficiencies in community pharmacy by pursuing legislative change to enable all pharmacies to use hub and spoke dispensing models. OPD means more prescriptions can be assembled using an automated process. A public consultation on hub and spoke is imminent, with a Government caveat that if OPD is not enabled, the potential efficiencies of hub and spoke dispensing will be curtailed.
“We believe this consultation is a necessary pre-requisite to further improving efficiency of automated centralised dispensing, so we are fully supportive,” says Ms Lau. “We are further ahead than some pharmacies in that we have already transformed our pharmacy workflow by operating a hub and spoke model for our branches. This transformation has been critical to release pharmacy team time at the spokes to deliver patient centred services, which we do very well and which is the future.”
Paul O’Hanlon, managing director of pharmacy workflow and automation supplier Centred Solutions, has no concerns that OPD will create hurdles for automation. “If anything it would facilitate it,” he says, “although it is important to standardise packs on 28 days or sub units of 28, rather than 30.”
Indeed, it’s not too much of a stretch to see how OPD plus automation could be transformative for pharmacy workflow. “The most significant impact would be that more repeat dispensing volume could be dispensed by pharmacy automation solutions, which would be transformative for pharmacy workflow,” says Mr O’Hanlon. “Reducing the time pharmacists spend on dispensing in particular means they can focus on patients with the greatest needs and have a real impact on clinical care. Pharmacists are highly skilled clinicians who should be utilising what they’ve studied and been trained to do. They should not be constrained to a dispensary or perceived as only the distributors of medication.”
OPD changes would not apply to Controlled Drugs, and the Government has stressed that sodium valproate must always be supplied in original packaging (regardless of the conditions it ends up setting around OPD) to ensure a PIL is provided each time – a move welcomed by patient groups.
Sodium valproate poses significant risks to a developing baby: the chance of it causing a birth defect is up to 10 per cent, while up to 40 per cent of babies go on to have problems with development and learning. The Government’s proposal is that where a sodium valproate prescription is not for a quantity in an original pack size, the nearest number of whole packs will be supplied (up or down), so that the patient receives only complete packs.
The MHRA worked with the DHSC to produce the OPD consultation document with, says Alison Cave, the MHRA’s chief safety officer, the specific aim of supporting “increased patient safety for females of child bearing age who have been prescribed a medicine containing sodium valproate … to ensure that without exception this group receives the warnings and information in the manufacturer’s packaging.”
Patient groups have also, unsurprisingly, welcomed the proposals. “We know that despite previous measures, some women with epilepsy were still not receiving patient information leaflets as part of their sodium valproate prescriptions,” says Daniel Jennings, senior policy and campaigns officer at Epilepsy Action. “So we hope these measures will help ensure that the necessary safety information is routinely included.”
Ley Sander, medical director at the Epilepsy Society and professor of neurology at UCL, says: “Almost half of babies born to women taking valproate have a physical or neurodevelopmental disability, so it is absolutely critical that sodium valproate is dispensed in its original packaging and contains all the safety warnings. When valproate is dispensed, there should always be a conversation to ensure that the woman is aware of the risks. This is the ideal time for the pharmacist to explain any differences between the amount prescribed and the amount dispensed and, where necessary, the need for a timely repeat prescription.”
The Original pack dispensing and supply of medicines containing sodium valproate consultation closed on 13 December 2021. Details and updates here
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