This article follows on from a previous IPU Review article, “PCRS: What to expect when they’re inspecting” (DAC Beachcroft, December 2023/January 2024 issue, available to IPU members at ipu.ie/ipu-review > Article Archive). The previous article focused on the right of the HSE PCRS to inspect a pharmacy under the HSE Community Pharmacy Contractor Agreement and how best to prepare for an inspection.

Do Not Substitute

The Health (Pricing and Supply of Medical Goods) Act 2013 provides the legislative basis for interchangeable lists and the use of ‘Do Not Substitute’. It says that, “When a branded interchangeable medicinal product is prescribed for a patient and the prescriber is satisfied that the medicinal product should, for clinical reasons, be exempted from substitution . . . the prescriber shall write, legibly and by hand, ‘do not substitute’ on the prescription beside the name of the medicinal product.”

With the introduction of Healthmail in 2020, HSE PCRS Circular 016/20 outlines that ‘Do Not Substitute’ can be computer generated on the prescription rather than in the prescriber’s own handwriting.

If ‘Do Not Substitute’ is not written or typed on the prescription but the patient wishes to take the branded medicinal product, the patient is liable to pay the difference (or part thereof), between the reference price and the reimbursement price if the brand has a higher reimbursement price than the reference price. This also applies even if the pharmacy only has a higher priced brand in stock because all cheaper referenced-priced versions are in short supply.

This can often lead to difficult conversations with patients and, as with other community drug scheme restrictions, it is the pharmacy that shoulders the burden of enforcing the HSE’s rules for the community drug schemes. Where a patient takes issue with being required to pay a co-payment, we recommend they contact the HSE on 01 240 8787 or PCRS Complaints on 0818 224 478 and pcrs.complaints@hse.ie.

However, any deviation from this legislative process for ‘Do Not Substitute’ is deemed an invalid claim by the PCRS. Failure to adhere strictly to this requirement is the subject of a number of ongoing claims investigations by the PCRS.

The IPU Guide to Generic Substitution and Reference Pricing is available to assist you in the process (see ipu.ie > Contract > Reference Pricing and Generic Substitution).

Correctly coding products

Product substitutions

Dealing with product shortages can cause challenges but it is important to be cognisant of record-keeping requirements. If a substitution must be made, the product actually dispensed must be recorded.

Exempt Medicinal Products (EMPs)

In some cases, an Exempt Medicinal Product (EMP), sometimes referred to as an unlicenced medicines (ULM), is supplied because there is no suitable licenced alternative. Again, it is imperative that the product actually dispensed, is recorded.

HSE PCRS Circular 012/23 outlines the protocol for supply of EMPs under Community Drug Schemes. Where medicines are on the HSE EMP List (which are assigned administrative codes), pharmacies can dispense and claim for the products electronically using the administrative codes specified, submitting them in the normal manner with the monthly claims.

However, if an EMP does not have an administrative code, then it cannot be claimed for under the GMS Scheme. It can only be claimed under the Community Drug Schemes using either the Discretionary Hardship Arrangement for GMS patients, or DPS exception 777xx codes, both of which need prior authorisation from the HSE PCRS before dispensing. It would be better to have confirmation through email of this authorisation but if it is taken over the phone, we recommend recording the details of the authorisation should any reimbursement issues arise. We recommend detailing who gave the authorisation, and the date and time of the call. A Phone Log is available on our website for this purpose (see ipu.ie > Contract > Claiming Procedures).

Parallel Imports (PI)

A parallel imported medicine is a medicine which is authorised in another EU/EEA Member State and in Ireland and which is imported from that Member State into Ireland and placed on the market here by a company other than the original marketing authorisation holder or its appointed agent/wholesaler. Parallel importing from outside the EU/EEA is not permitted.

Importers of Parallel Imported (PI) products must apply to the HSE Products Committee for approval in the normal way for a specific GMS number for each specific parallel imported product. When approved, the PI or DPR product is included on the HSE PCRS List of Reimbursable Items with a new code number to distinguish it from the originator product.

Claims must be coded correctly to ensure the correct reimbursement price is calculated and paid to the pharmacy. It is vital that you and your pharmacy dispensing teams understand these reimbursement criteria and code for the actual product dispensed. If the product does not have a GMS code, you cannot supply it on the community drug schemes.

The IPU Q&A on Parallel Imports is available on our website to assist you in dealing with parallel imports (see ipu.ie > Contract > Claiming Procedures > IPU Support Documents).

Phased dispensing

Phased dispensing refers to the dispensing of a prescription in instalments where a patient/carer must make multiple trips to the pharmacy to collect the amount in instalments. There can be many reasons why a patient may have to have their prescription phased, as outlined by the PCRS:

1. At the request of a patient’s physician;
2. Due to the inherent nature of a medicinal product, i.e. product stability and shelf life;
3. Where a patient is commencing new drug therapy with a view to establishing patient tolerance and acceptability before continuing on a full treatment regime; or
4. In exceptional circumstances where the patient is incapable of safely and

effectively managing the medication regimen.

Phased dispensing fees are only remunerated under the GMS Scheme. Prior approval for phased dispensing is necessary for reimbursement of claims to be paid under reason one and four. Prior approval is not required under reason two and three, which are very occasional and specific in nature. Eligibility for phased dispensing approval can be confirmed on the PCRS Secure Scheme Checker (see sspcrs.ie).

Where the pharmacist claims for phasing under reason one, ‘phased dispensing’ or ‘dispense weekly’ must be written on the prescription each month unless the GP has made an application for the patient through the PCRS GP Application Suite for ongoing phased dispensing.

To claim a phased dispensing fee, all medicines must be dispensed on multiple supply occasions. The HSE does not reimburse for Monitored Dosage Systems (MDS) or blister packing. Phased dispensing fees are also not payable for patients in nursed supervised residential settings.

It is important for audit purposes that supporting documentation can be provided to the HSE on request or during inspections to substantiate such supply, to include the dates of each multiple supply occasion. The Phased Dispensing Collection Record Form template is available on our website and could be used for this purpose (see ipu.ie > Contract > Phased Dispensing). Records must be retained in the pharmacy for two years.

“It is important for audit purposes that supporting documentation can be provided to the HSE on request or during inspections to substantiate such supply, to include the dates of each multiple supply occasion.”  

GMS non-dispensing fee

A GMS non-dispensing fee is payable in circumstances in which the pharmacist in his/her professional judgement considers it to be in the patient’s interest not to dispense the medicine concerned. Pharmacists are required to make a note indicating the reason for non-dispensing. If the patient is no longer on the medication the GP should be contacted to draw attention to the redundant item.

The following reasons would not be acceptable for claiming a non-dispensing fee:

• The item is not available, i.e. stock shortage or product discontinuation situations;
• The item is delisted;
• The item is an owing to the patient or marked as ‘collect later’;
• Supply is not a contractually valid option, i.e. ONS on a GMS Repeat;
• Where it has been indicated that the patient is deceased;
• The item is not required by the Nursing Home;
• The supply frequency according to the Summary of Product Characteristics is such that monthly dispensing should not occur, for example, Prolia, Mirena, Nebido, Implanon, DepoProvera;
• Medicines that require prior approval by the HSE PCRS, and for which the patient has not been approved. For example, Entresto, CGM Sensors, Fampyra;
• The amount of blood glucose test strips dispensed to a patient has reached the maximum approved quantity and the Non-Dispensing Fee is requested to be paid for not dispensing above the threshold;
• The patient has purchased the product ‘over the counter’;
• The item has been claimed under another scheme, i.e. patient also has LTI eligibility; or
• A maximum quantity is specified and has been claimed in the same calendar month, for example medication for erectile dysfunction, Victoza.

Quantities

Quantities dispensed should correspond with the valid prescription while recognising that clause 4(2) of the HSE Community Pharmacy Contract Agreement allows for professional judgement:

“Where a prescription is issued in respect of a quantity of a medicine which does not conform to the amount in the pack presentation of the product which is available on the market, the pharmacist, in the exercise of his/her professional judgement and discretion, may supply the quantity in the nearest pack presentation provided that the quantity so supplied is not normally greater than one month’s supply for the patient concerned.”

The HSE PCRS can perform data analysis which highlights higher than average quantities or the dispensing quantities which are higher than those allowed for in the Summary of Product Characteristics (SPC). This analysis will indicate any patients who are receiving elevated supplies of medicines or medical devices.

The IPU recommends recording any clinical reason for dispensing higher than average quantities in the PMR and retaining a copy of the prescription to support the claim.

Support information

The IPU Contract Department is available to answer any queries you have concerning pharmacy claims and can be contacted on 01 493 6401 or via email at contract@ipu.ie. The IPU Claims Guide and the  IPU End of Month Pharmacy Guide are invaluable resources which can be accessed on our website at ipu.ie > Contract.

The HSE PCRS has a repository of all circulars pertaining to HSE PCRS Community Drug Schemes which can be found at pcrs.ie. Also, the HSE PCRS has a booklet entitled HSE Primary Care Eligibility and Reimbursement Service (PCRS): Information and Administrative Arrangements for Pharmacists, available on the Pharmacy Suite or from the PCRS website.

Checklist

The following checklist, with the support of PMR reports, can be used to audit your practice.