Original Pack Dispensing (OPD) is an evolving practice in the pharmacy sector aimed at improving both efficiency and patient safety. Dispensing medications in their original manufacturer’s packaging rather than repackaging them into smaller quantities will also facilitate better stock control and adherence to FMD legislation.

 

Comparison with other countries

UK

Recent legislative changes in the UK in 2023 have given flexibility around the quantity prescribed versus quantity dispensed, and so has further facilitated the adoption of Original Pack Dispensing. The legislation allows pharmacists to dispense up to 10 per cent more, or 10 per cent less, than the quantity prescribed if it enables the medication to be supplied in its original packaging. For instance, if a prescription calls for 28 tablets, but the original pack contains 30 tablets, the pharmacist can dispense the full pack.

It also brought in new rules requiring pharmacists to dispense all licensed medicines containing valproate in the manufacturer’s original full pack.

Continental Europe

Most European countries (such as Belgium, Austria, Sweden, Italy, Portugal and France) original pack dispense all medications, both acute and chronic. As it is long-standing practice in these countries, they have various pack sizes of each medication to enable them to dispense an original pack that is close in size to that prescribed.

Ireland

The model of supply in original packs was clearly communicated to all our stakeholders in the IPU White Paper Key Enablers for a Sustainable Pharmacy Model.

Figure 1: Cut tablet strips

 

Benefits of original pack dispensing

Original pack dispensing (where appropriate) would have numerous benefits for patients and pharmacy teams including:

• Patient safety: It reduces the risk of picking and re-packaging errors when splitting packs;
• Tamper-proof seal: The tamper-proof seal will be intact to give reassurance to the patient that the box has not been tampered with;
• Medication integrity: The original container is designed to protect the medicine so dispensing in the original pack maintains the medication’s quality, integrity and shelf life;
• Patient Information Leaflet (PIL): a PIL is included in the box supplied to the patient;
• Traceability: It allows for better traceability of the medication batch in case of recalls or quality control issues;
• Consistency: If patients are dispensed medications in 28-day supplies, then they will always need to collect their medications on the same day at each dispensing (for example always Fridays);
• Efficiency gains: The pharmacy staff will spend less time looking for scissors, splitting packets of tablets and reshelving split packs, so will have more time for other tasks. This efficiency can lead to shorter wait times for patients and a more streamlined pharmacy operation;
• Waste reduction: There would be a reduction in waste from not having so many split boxes on the shelves;
• FMD: It would make it easier to comply with FMD requirements as it does not involve the use of split packs; and
• Accuracy checking: It will also potentially make the use of any new accuracy checking technology easier in the future.

 

Potential barriers to implementation

Some potential barriers to implementation would need to be considered:

• Patient perception: Patients might perceive that they are not receiving the exact amount of medication prescribed, which can affect their trust in the pharmacy. Clear communication and education are essential to mitigate this concern;
• Professional judgment: Pharmacists must use their professional judgment to determine when original pack dispensing is appropriate. This can add complexity to their decision-making process;
• Exclusions: Certain medications, such as controlled drugs or those requiring exact dosing, are not suitable for original pack dispensing. This limitation means that original pack dispensing cannot be universally applied to all medications;
• Consistency in quantity: Patients who are being supplied with various medicinal products which come in a mixture of 28-day and 30-day packs sizes may prefer consistency in the quantity supplied. However, where the patient safety benefits of original pack dispensing are clearly outlined to the patient, this perceived barrier may be overcome;
• Prescribers: Prescribers may be resistant to the change in policy as it might mean patients returning slightly earlier for their prescriptions, resulting in a slight increase in workload; and
• Cost: Private patients, as well as DPS and GMS patients below the maximum monthly threshold, may raise the issue of having to pay a 13^th dispensing fee in the year.

 

Regulatory and reimbursement considerations

PSI considerations

The PSI’s Good Dispensing Practice — High Tech Scheme states that High Tech medicines, where possible, should be dispensed in the manufacturer’s original pack.

PCRS considerations

The HSE Primary Care Eligibility and Reimbursement Service’s (PCRS) Information and Administrative Arrangements for Pharmacists states that; “Where the quantity of a preparation prescribed does not correspond with an original pack size and it is not feasible to supply the exact amount prescribed the pharmacist may, in the exercise of his professional judgement and bearing in mind the nature of the product and his statutory obligations, supply the original pack size nearest to the quantity ordered.”

Figure 3: Tamper-proof seal

Balancing supply

It is also important to discuss the options for a balancing supply of certain medications based on patient need. Where a 28-day supply of medication is routinely supplied to an individual or family under the community drug schemes, the HSE-PCRS allow for a balancing supply of medication (for example, a 13th dispensing of 28 days’ worth of medication in a 12-month period), where no co-payment applies. This is to ensure that no individual or family makes more than 12 payments in a calendar year. A printed calendar to show patients 13 dispensing’s over the year with 12 community drug scheme payments may provide reassurance to patients of how this would work in practice. Where any additional cost may rest with the patient, this should be clearly explained.

 

Standard pack sizes

The Association of the British Pharmaceutical Industry circulated advice to all its members in February 1986 that chronic treatment packs should contain treatment for 28 days, while short-term treatment packs should contain the quantity required to meet the manufacturer’s recommendations for a course of treatment. This would avoid the breaking of bulk to meet prescriptions.

In this year’s IPU AGM, a motion calling for a similar policy was passed which said:

“That this AGM calls on the Department of Health to implement a policy of a standard pack size for medications in Ireland. This will facilitate patient compliance and will reduce administrative workload in pharmacies and reduce risk within the dispensing process.”

A move to standard pack sizes would make the transition to original pack dispensing easier but is not something which has been implemented in Ireland to date. Given the current high level of medicine shortages, we would not want to insist on implementation of a measure that may impact medicine supply further.

 

Informing stakeholders

Informing the pharmacy team of the new policy

Staff should be trained on this practice change, and informed about the rationale for the change so that they can support patients. Locums should also be trained on the policy on starting their shift. Where a pharmacy chooses to move to a system of original pack dispensing it is recommended that this be done in a phased and planned manner and in agreement with the patient. This will allow time to adequately discuss the change with patients and answer any questions. It will also allow time to reflect on any feedback received from team members and patients, which can be used to inform any necessary change to the process.  

Informing local prescribers of the new policy

You may want to inform local prescribers of the new policy in case patients present for their prescriptions earlier than expected if they move from a 30-day prescription supply to a 28-day supply.  

Informing patients of the new policy

Pharmacists should educate patients about original pack dispensing, explaining why they might receive a slightly different quantity than prescribed and reassuring them about the safety and benefits of this practice. Clear communication helps prevent confusion and builds trust. Patients must be informed of the proposed change in practice well in advance of it occurring. This could take the form of:

• Visual aids:
  • A patient leaflet;
  • A patient information sheet;
  • A poster to display in the pharmacy; and
  • A calendar showing how 13 community drug scheme dispensing’s in a year might work.
• Talking to patients to raise awareness of the planned changes; and
• Sharing testimonials from other patients who have had positive experiences with original pack dispensing. Hearing from peers can help build trust and acceptance among patients.

  Figure 3: Tamper-proof seal

Informative material should be available to support patients in making an informed decision about moving to such a system. Give adequate time to having conversations with patients about the rationale, impacts and benefits of such a move, and allow patients time to ask questions. It might be beneficial to identify patients who previously insisted on 30-day or 31-day supplies of medication and for the pharmacist to take extra time to discuss the change in policy with them. It is important to listen to patients and respect their views about their health and medicines and to get their agreement to move to original pack dispensing. It may be the case that not all patients agree to move to the new system.

 

Implementing the policy

Regulatory compliance

Those in governance roles in pharmacies should ensure that the practice observed at the pharmacy is compliant with legislation, PSI guidance and HSE-PCRS reimbursement requirements.

 

Patient safety and clinical professional judgment

Pharmacists should use their professional judgment to determine if original pack dispensing is appropriate for each patient. This includes considering the patient’s ability to manage their medication, the potential impact on treatment outcomes, and ensuring that the slight variance in quantity does not negatively affect the patient’s clinical treatment.

 

Medications suitable for consideration for original pack dispensing

Pharmacists should make a professional determination as to the suitability of original pack dispensing on a case-by-case basis. In general, supply of medication for the treatment of a chronic condition is more suitable for original pack dispensing. The following types of medications could be considered for original pack dispensing:

• Medications for chronic conditions: Medications for the treatment of chronic conditions where the patient would generally be prescribed one month’s supply would be most suitable for consideration for original pack dispensing. If a medication was prescribed as a 30-day supply but dispensed as a 28-day supply to allow for dispensing in an original pack, then the difference between prescribed and dispensed quantities is less than 10 per cent. In the UK, this 10 per cent figure is the one they arrived at when they introduced legislation to support original pack dispensing and there it allows the pharmacist to dispense 10 per cent more, or 10 per cent less, than the prescribed amount. This slight variation is within safety limits, does not affect the overall treatment regimen and is not a significant difference from the intention of the prescriber;
• Valproate: The HPRA advises that valproate should be dispensed in the original package with the outer carton warning text and symbol, and that dispensing outside of original packaging (i.e. broken bulk dispensing) should be avoided; and
• Effect on quality: a medicine that cannot be dispensed in the quantity ordered without adversely affecting the medicine.

 

Medications not suitable for original pack dispensing

There will be situations where original pack dispensing is not appropriate. The following classes of medications would not be suitable for consideration for original pack dispensing:

• Acute medications: Dispensing the exact amount of dosage units prescribed is more appropriate for acute courses of treatment (such as with antibiotics and steroids);
• High-risk medications: Dispensing the quantity prescribed for high-risk medications (such as oral chemotherapy or cytotoxic drugs) is important for patient safety;
• Controlled drugs: For controlled drugs, the exact amount of dosage units as per the prescription must be dispensed;
• Drugs with potential for abuse: Where the risk of issuing more than the amount required by the patient outweigh the benefits of the original dispensing pack, for example products containing substances with potential for abuse; and
• Professional judgement: Cases where the pharmacist considers, in the exercise of their professional skill and judgement, that the supply of a different quantity to that ordered on the prescription may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber.

 

Record-keeping

Pharmacists should record any deviations from the prescribed quantity and ensure that all relevant information is communicated to the patient and documented in their records. This will allow for auditing of the records to see how the policy is being implemented and what is working well or not.

 

Feedback and learnings

Encourage patients and pharmacy team members to provide feedback on their experience with original pack dispensing. This can help the pharmacy understand patient concerns and foster a continued improvement behaviour within the pharmacy team.

 

Conclusion

Original pack dispensing represents a significant advancement in pharmacy practice, promoting patient safety and operational efficiency. By embracing this approach, pharmacies can enhance the quality of care they provide and contribute to better health outcomes.

IPU supporting materials

Supporting materials such as an Original Pack Dispensing policy document, a poster, a patient leaflet, a patient information sheet, a calendar showing an example of 13 dispensing’s in a year and a template letter to inform local prescribers are available under the SMART Pharmacy section of the IPU website, ipu.ie > SMART Pharmacy.

“We recently introduced original pack dispensing in all our stores and it has been a big success. From busier stores to quieter stores, there has been no significant feedback of resistance to the change.”      – Áine McCabe, McCabe’s Pharmacies  

References available on request