1.Why has the HSE implemented reimbursement restrictions regarding the number of Blood Glucose Test Strips for patients with Type 2 Diabetes Mellitus?

The HSE advises that the changes are based on recommendations from a review carried out by the Medicines Management Programme (MMP) of international evidence, best practice guidelines and national usage with regard to the self-monitoring of blood glucose for patients with non-insulin dependent diabetes. The HSE believes that this initiative will reduce the unnecessary consumption of test strips and ensure continued supply for those who need test strips to help manage their diabetes.

2. Who do the reimbursement restrictions apply to?

The restrictions apply only to patients being treated for type 2 diabetes mellitus. There will be no limit for patients with this condition that are being treated with insulin.

3. Are there any exceptions?

The restrictions do not apply to patients suffering from type 1 diabetes or patients with Type 2 diabetes Mellitus that have received Insulin in the last twelve months.

4. What are the reimbursement restrictions that are being implemented?

The reimbursement restrictions differ in their application depending on how the patient’s type 2 diabetes mellitus is managed:

• Patients whose type 2 diabetes mellitus is being managed with insulin
  There will be no reimbursement limit for patients treated with insulin, either on a continuous or sporadic basis within the last twelve months.

•  Patients whose type 2 diabetes mellitus is being managed through diet alone:
  The patient will be reimbursed for two boxes of test strips per annum. i.e 100 test strips/annum.

• Patients whose type 2 diabetes mellitus is being managed through the use of sulphonylurea or meglitinide drugs?
  Patient will be reimbursed for two boxes of test strips per month i.e. 1,200 test strips/annum.

• Patients whose type 2 diabetes mellitus is managed through the use of oral hypoglycaemic drugs other than sulphonylurea or meglitinide drugs?
  Patient will be reimbursed for one box of test strips per month i.e 600 test strips/annum.

5.Is there a list of medicines referred to in the circular? Eg, sulphonylurea or meglitinide drugs?

Yes, the HSE PCRS included with Circular 30/16 a complete list of products for persons with type 2 diabetes that sets out how much reimbursement support applies at an individual product level for the medicinal products referred to in the Circular.

6. For patients that manage their diabetes through diet alone, can they receive their annual allowance of two boxes of test strips per annum (100 test strips/annum) in one dispensing?

No, one pack should be provided every six months.

7. Does the restriction apply to boxes or strips?

The vast majority of strips are in boxes of 50 strips, however the system operates on strip numbers rather than packs.

8. How will I keep a tally of strips dispensed in accordance with the limits?

The IPU has been in contact with System Vendors and their respective customer services departments will provide guidance to members on how to manage the new requirement.

9. What happens to the reimbursement limits if the prescriber changes the manner in which the patient is being managed?

Claims for the dispensing of blood glucose test strips will be validated on a monthly basis. If the treating doctor decides to manage the patient in a different way, leading to a change in the reimbursement limits for testing strips for that patient, the MMP recommendations apply to that specific treatment regimen.

10. What steps has the HSE taken to ensure that prescribers are aware of these limits at the point of prescribing?

The HSE has also sent a circular to GPs making them aware of the reimbursement restrictions. They have also been informed of the facility to request additional reimbursement supports for patients through the GP application suite.

11. If a patient requires additional strips, will they be reimbursed?

Where enhanced blood glucose monitoring may be required, supplemental reimbursement support can be requested by the patient’s GP via an online application system. We have been advised that this will facilitate immediate reimbursement support for additional test strips under the community drugs schemes.

12. How will I know if the prescriber has registered the patient to receive greater support?

The patient’s full eligibility will be listed on the Pharmacy Application Suite. The Application Suite is available online at www.pcrs.ie – Online Services. Pharmacists, through the enhanced visibility system available to them, can establish whether the patient had been notified to the HSE as requiring extra reimbursement support. Eligibility confirmation will only be available through the enhanced visibility system. (Circular 3/15 pertains).

13. How will I know if a patient has previously had a box of test strips dispensed at another pharmacy?

The threshold will operate on an individual pharmacy basis.

14. Do the restrictions only apply to the Long Term Illness Scheme?

No, the restrictions also apply to the General Medical Services Scheme and Drugs Payment Scheme.

15. Do the restrictions apply to patients with Gestational Diabetes?

The restrictions apply depending on the Scheme:

Drug Payment Scheme (DPS):

Subject to the usual rules applicable to DPS patients, the dispensing threshold for test-strips for patients with type 2 diabetes mellitus do not apply to DPS patients with type 2 diabetes mellitus/ gestational diabetes that are of childbearing age (being between 15 and 50 years old). DPS patients with gestational diabetes/ type 2 diabetes mellitus will therefore not have to be registered to avail of additional support by their GP.

General Medical Service Scheme (GMS):

Where women with gestational diabetes hold current GMS eligibility, their physician must register them using the online process for them to be identifiable to the HSE as persons with full access to diabetic strips without any threshold arising.

Long Term Illness Scheme (LTI):

Patients with gestational diabetes are not entitled to an LTI book on the basis that they have gestational diabetes. Where women hold current LTI eligibility for type 2 diabetes mellitus, their physician must register them using the online process for them to be identifiable to the HSE as persons with full access to diabetic strips without any threshold arising.

16. Has the HSE issued any support documentation?

Yes, the HSE issued a FAQs sheet for patients, a leaflet and Healthcare Professionals along with the findings of their study. You will find these here.

17. My patient doesn’t understand why I can’t supply the quantities of strips prescribed by the GP. Who should I direct them to with queries about the limits?

To assist with patient queries around the reimbursement limits on Glucose Test Strips, the HSE has set up a helpline within the National Medical Card Unit. The contact number is 1890 252 919; when the patient gets through they should press 1, 2, 3 or 4. It is open from 8am to 8pm, Monday to Friday. All agents will be able to deal with queries.

18. My question has not been answered, where can I get further information?

Further information is available at www.ipu.ie > HSE Contract > Medicines Information > Diabetes Test Strips or contact Linda linda.ahern@ipu.ie or Derek derek.reilly@ipu.ie  in the IPU Contract Unit on 01-4936401/01-4061557.

‘The information contained in this communication is correct to the knowledge of the Irish Pharmacy Union at the date of publication, being the 7 June 2016’.

1. Does Fampyra™ have a reimbursable code?

Yes: as of October 1^st, 2015 the reimbursement code for Fampyra™
10mg Prolonged Release Tabs x 56 is 32652.

2. Is Fampyra ™ now reimbursable for all patients with eligibility under
Community Drug Schemes?

No: conditional reimbursement applies under the General Medical Services
(GMS) and Long Term Illness (LTI) Schemes only. Approval is not required from the local health
office  for reimbursement of this product under the LTI Scheme.

3. What does ‘conditional reimbursement’ mean?

It means that reimbursement will only be approved for a patient where a
demonstration of clinical response based on objective criteria agreed with clinical experts is
recorded, and where that clinical response is shown to persist. This is referred to in the
Circular as the ‘responder protocol’. The protocol will continue to apply to the patient where
the clinical response continues based on objective measurements at six- month intervals.

4. Will the patient receive a letter of approval?

No: there is no paper application or approval process. The application and
approval must be carried out online. Pharmacists should therefore not accept approval letters as
evidence of eligibility.

5. How will the pharmacist know if a patient has been approved?

Pharmacists can check if a patient has been approved through the
eligibility confirmation web service or via the online PCRS Pharmacy Application Suite.

6. How do I access the online PCRS Pharmacy Application Suite?

The application suite can be accessed via www.pcrs.ie –> Online Services –> scroll down to
‘Services for Pharmacists only’. Please note the service is secured and is only available to
pharmacists who have a PCRS Security Certificates installed on that computer.

7. Will the patient be aware of the approval process?

Yes: as part of the application process, patients must sign a patient
consent form acknowledging that they understand the following:

• That they will initially receive Fampridine for a period of 4 weeks after which their
  response to treatment will be assessed by a walking test;
• That if they respond to Fampridine (as defined by a 20% or greater improvement in the
  walking test) reimbursement support will be provided by the HSE;
• That should they not respond as required to the treatment reimbursement support will not
  be provided by the HSE;
• That their neurologist has explained the process to them, they have had the chance to
  ask questions and have had the answers fully explained.

8. If a patient knows their application has been sent but they are not yet
approved on the system, will I be paid for dispensing?

No: reimbursement will only apply from the date of reimbursement approval.

9. Are prescribers aware of the approval process?

Yes: the HSE has written to the programme-approved prescribers explaining
the approval process and has asked them to forward responder details.

10. Can GPs apply for approval?

No: due to approval requirements the treatment must be initiated by a
hospital consultant.

11. Will all patients that apply be approved?

No: only patients who satisfy the responder protocol will be approved.

12. Will the patient be notified if approval is not received?

Yes: As the approval is completed online the prescriber will know at the
point of input whether reimbursement support is available or not as an answer is given in real
time. The prescriber can explain that to the patient at the time.

13. As patients are being reviewed at 6 monthly intervals, could they lose
their approval?

Yes, they could. Therefore the IPU recommends that pharmacists check each
patient’s approval for this medicinal product on an ongoing basis.

14. Further Information:

If you have further questions, please do not hesitate to contact Aoife
( aoife.garrigan@ipu.ie ) or Derek ( derek.reilly@ipu.ie ) in the Contract Unit on
01-4061557 / 01-4936401.

1. Who should restrict their movements and what does it mean?

You are advised to restrict your movements if you:

• Are a close contact of a confirmed case of coronavirus;
• Live with someone who has symptoms of coronavirus, but you feel well; or
• Arrive into Ireland from a country that is not on the COVID-19 green list— this list is reviewed regularly based on advice from officials, including public health experts, and will be updated if needed.

2. Who should self-isolate and what does it mean?

Self-isolation means staying indoors and completely avoiding contact with other people. This includes other people in your household, as much as possible. You will need to self-isolate:

• If you have symptoms of coronavirus;
• While you wait for a test appointment and your test results, if you have symptoms of coronavirus. If you are being tested as a close contact of a confirmed case of coronavirus and you don’t have any symptoms, you should restrict your movementsinstead; or
• If you have had a positive test result for coronavirus[1].

3. If someone tests positive for COVID-19 and is unable to work as they are required to self-isolate, what statutory entitlements are available, and how do they go about claiming them?

When someone tests positive and is required to self-isolate, they are entitled to claim Pandemic Sickness Payment Benefits. This arrangement does not require waiting time and allows the person to be paid from the date of claim. More information can be obtained at services.mywelfare.ie. The employer may only be required to pay if there is a sick pay scheme in the company which may require the employee to refund any social welfare received to the employer.

4. What statutory entitlements are in place for those who have been requested to restrict movements and due to their job profile are unable to work remotely?

Statutory entitlements are only applicable where a person has been required by a GP or the HSE to isolate. If a person is falls into category that requires them to restrict their movements, in those circumstances, they may be able to make a claim for the Pandemic Benefit to Social Welfare. However, this may not be applicable until they are requested to do so by GP/HSE/Public Health. The application process is the same as illness benefit. They will need to be medically certified by their GP or by an E-Cert. The benefit rate is €350 per week, for a maximum of two weeks.

5. If a child has been advised to self-isolate and their parent/guardian cannot work as they are required to be with them whilst the child is awaiting their test, what statutory entitlements would the parent /guardian have?

There are no specific entitlements provided by Social Welfare where someone is required to look after their children because they are awaiting a test. That person may be able to make a claim under Force Majeure provisions, but this is applicable only where there is a sickness or injury involved, so could only be claimed if the child is positive and the presence of the employee is essential. There is a maximum of three days payment in a twelve month period granted, where such arises it would not be unreasonable, if a parent is one of a couple, to expect an equal contribution from the other parent to the caring as well. The employer may be able to avail of the National Wage Subsidy Scheme for an employee who is looking after their child.

6. If a someone has travelled to a country not on the Green List and needs to restrict movements for 14 days, what statutory entitlements are available?

Where an employee is requesting the leave to go to a country not on the Green List the first consideration an employer must have is whether or not that leave can be granted, as that person would be missing not only for the leave period but also for the period of restricted movements. This may make it impractical for an employer to approve such leave. Where leave is approved, the employer should stipulate that the employee would not be paid for the restricted movement period. There is no obligation upon an employer to pay for this leave.

7. A member of staff has been requested to restrict movements due to being designated a close contact of another employee who has tested positive with COVID-19, what statutory entitlements are available?

An employer has an obligation under the protocols to ensure that the workplace is safe. Provided the employer has complied with all obligations and has done everything reasonably expected of them in relation to protecting employees, then this may not create a liability on the employer where an outbreak has occurred within the workplace. The employer will have to ensure employees are properly tested and take the necessary periods off and they may be entitled to benefits under the pandemic payments’ arrangements. Employers should regularly revisit all their procedures to ensure compliance and reinforce the protocols within the workplace amongst employees.

8. If a staff member is coughed upon during work by a member of the public, who is not wearing a mask, does the employer have a health and safety liability?

An employer has the responsibility to ensure all protocols are in place. This includes providing protective equipment to employees which would mean that if a member of the public coughs at an employee they should have the appropriate protective equipment to protect them from possible infection. In such circumstances, provided the employer has adequately provided appropriate protective equipment, any liability to that employer will be minimised.

9. If a staff member has a close contact who is considered vulnerable and does not wish to return to work, what obligations are there on the employer?

Under the Employment Equality Legislation an employer is not entitled to treat someone any less favourably than anybody else because of the fact that they might have a disability or because of their age. Often the case of vulnerable people is due to their age or because they are suffering from some sort of disability. Therefore, there is a risk that they are being treated less favourably on the basis that they are associated with or connected to another person who would fall within the definition of the nine protected grounds under the legislation. In this regard, an employer must review the circumstances surrounding the individual’s work. Where such a refusal has been made by the employee, and this would also apply to an employee who for personal reasons not related to someone else’s vulnerability doesn’t wish to return to work, we would suggest that the employee is reassured that the company is fully compliant with all protocols to protect people in the workplace. The employee should be encouraged to visit the workplace and see what steps have been put in place and allow them the opportunity to identify where they feel they may be at risk. The option of home working should also be a consideration. Where employers are satisfied that they have done everything possible to ensure the workplace is safe and have the necessary protocols to protect employees, then an employee should return to work. However, this is a very difficult time for everybody, and employers should try and take a sympathetic view to situations before coming to any final decisions regarding that employee’s status.

10. If a staff member is considered vulnerable to COVID-19 and does not wish to return to work, what obligations are there on the employer?

As outlined in the above answer, an employee is expected to return to work if their employer has put in place all the necessary steps to protect their employees from infection. However, if there are special medical reasons why a person may be concerned to return to work, they should be assessed, and appropriate steps put in place to try and accommodate the person. Again, there is an obligation under the Employment Equality Legislation to recognise a person with a disability or of a certain age and ensure they are not being treated unfairly as a consequence.

11. If a member of staff, who tested positive, cannot return to work due to long-term ill health after contracting the virus, what are the option regarding the replacement of that employee in the business?

An employee is contracted to attend work in accordance with the working hours as required by their terms and conditions. The fact that the person is suffering with a long-term illness which is associated with COVID-19 does not mean that illness should be treated any differently to an illness which is not related to COVID-19. Where an employee is absent due to ill-health, an employer would be expected to take reasonable steps in relation to deciding how they are going to fill that position. An employer should look at ascertaining the anticipated duration of that person being absent. If it appears to be uncertain or for a lengthy period, then the employer should examine whether they can be replaced on a temporary basis. Should it be the case that the absence is going to be for a significant period of time, then the employer should consider if they can continue to hold that position open, but no decision should be made until all the above matters have been considered, taking the appropriate medical advice from the employees’ doctor and, where possible, the company doctor, and having discussed with the employee concerned, what is being looked at. Where a person is essential to the business and their long-term absence would put an unreasonable strain on the business, the employer may choose to consider discussing whether or not they can continue to hold that position open, where it is not possible to come to any interim arrangement to cover that role while that person is unwell. In any of the circumstances relating to making such a decision for an employee, the employer should seek advice on what they are thinking of doing.

12. Is there a maximum number of statutory sick days in in one year and does looking after my children who are under strict movement count as sick leave?

There is no such thing as maximum statutory sick days. The only maximums relate to the length of sickness benefit. In relation to minding somebody else, it is not deemed to be sickness as a person is not suffering from any sickness themself but is carrying out another responsibility in relation to their children. In such circumstances any absence for the purpose of looking after children will not be deemed to be sick leave and even if a doctor submitted a medical certificate confirming that that person was looking after a sick child that would not qualify them to be regarded as being absent due to ill health.

13. How long should an employer hold a position open when an employee is fearful to attend work and deal with the public?

This situation has been covered already in relation to someone who is concerned about returning to work. However, in a case where the employer has agreed with a person, who is genuinely concerned about dealing with the public the employer should make it clear what duration of time they are willing to allow this to run for, or else put in a mechanism to review the situation on a regular basis. I would suggest monthly, so as to allow the employee to see how they are coping in the environment and secondly how the workplace is surviving in the same environment. In my opinion the longer the employer can show that the workplace is safe, the stronger the argument is that the employee has no reason not to return to the workplace.

14. What is the situation where a person receives a phone call from the school where the child is to go home?

Where a parent has been notified that their child is being sent home and it is essential the parent/guardian needs to collect the child as that child cannot be sent somewhere else to be looked after, then that employee will obviously need to look after the child and put in appropriate arrangements for the caring of that child until tested or has completed self-isolation. In such cases the day the employee is called away may be able to be treated as a day of Force Majeure, for which the employee would be paid. If the employee is not sick, they will not be entitled to sickness benefit. Once the child has been tested and if the test is positive, then the employee will become a close contact and will have to restrict their movements. Parents should ensure that the minding of a child is shared equally between couples where possible so that the responsibility is not placed completely on one individual employer.

15. What happens if a parent is unable to come to work because they need to look after their children?

When a parent is absent from work because they are looking after their child, they are not entitled to any payment from the employer and may not be entitled to any payment from the State either. As referred to above, employees are expected to attend work if they are asked to return to work. If they do not return to work because of their childcare arrangements, that is not the responsibility of the employer. Naturally, before any employer would consider terminating anybody’s employment the employer should go through a process of consultation with the employee concerned, review what steps can be taken to accommodate the employee if at all possible, and seek professional advice before any final decision is made.

16. I work in an office environment; I do not have to meet the public, can I work from home?

Employees are not entitled to work from home unless that is a specific condition of their employment. The employees’ normal place of work will be the workplace. Whilst Government guidelines do ask for people to work from home where at all possible, if the employer regards it as essential that a person work from the normal workplace, then the employer is entitled to request that employee attend work. Working from home is at the discretion of the employer. Where working from home on a temporary basis, the employee should be advised as to the steps that they should take to ensure it is done in the safest environment appropriate for doing such work. Where working from home on a long-term basis, in those circumstances the employer may have health and safety obligations as the home is becoming an area of work, thus ensuring that the proper equipment including seating and a desk is available to the employee to ensure their health and safety. Please note that at all times you should ensure you are complying with the requirements of the designated safe conduct level set for your area.

1. The prescription specifies an Exempt Medicinal Product (unlicensed medicine) which is on the HSE list – does the patient need to apply to the Local Health Office to have it covered under Hardship Arrangements?

If the Exempt Medicinal Product (ULM) (i) is consultant initiated, (ii) is on the HSE list and (iii) the cost claimed is not more than the maximum permitted, the patient does not have to apply for the product to be covered under the discretionary Hardship Arrangements.

2. Can I make an electronic claim for the Exempt Medicinal Product dispensed?

Providing the item (i) is consultant initiated, (ii) is on the HSE list and (iii) the cost claimed is not more than the maximum permitted, an electronic claim can be made by using the relevant codes from the HSE list. Those pharmacies who still code manually must also use these codes when submitting their claims to the PCRS.

3. What do I need to submit as supporting paperwork? I have been supplying the locally approved product on foot of a valid prescription, do I need to get a new prescription for each claim and submit it to PCRS?

In many cases, the prescription will already be written on the patients’ GMS prescription form. Where this is not the case, arrangements should be made to get it written on a GMS prescription form for submission in the usual way at the end of the month. You will also need to submit the invoice when providing the supporting paperwork to the PCRS.

4. Will the HSE reimburse me with the invoice price of the Exempt Medicinal Product?

The amount the HSE will reimburse is the reimbursement price specified on the HSE list.

5. My supplier has charged carriage – will the HSE reimburse me for this?

The maximum amount the HSE will reimburse is the reimbursement price specified on the HSE list. A supplier, Medisource, has confirmed to the HSE that carriage will not apply for any products on the list which are sourced from them.

6. Can I claim the balance of stock in hand in the same way as I can for GMS items?

No.

7. The patient has been getting the Exempt Medicinal Product under the discretionary Hardship Arrangements for some time, but the product is not on the HSE list, does the patient need to apply to the Local Health Office to have it covered under these arrangements?

If the patient has been previously approved for an Exempt Medicinal Product (ULM) at local level and the approval and prescription are still valid, the Pharmacist can continue to claim reimbursement from their Local Health Office until further notice.

8. The prescription specifies an Exempt Medicinal Product which is on the HSE list, but is written by a GP – does the patient need to apply to the Local Health Office to have it covered under these arrangements?

The HSE will accept a GP prescription where the Pharmacist is satisfied that the product has been consultant initiated. This is to ensure that existing patients do not experience any difficulties in the transition. For new patients, who have not previously received an Exempt Medicinal Product on the list, the Pharmacist should make a note on the pharmacy computer which Consultant at which hospital initiated the therapy.

9. The prescription specifies an Exempt Medicinal Product which is on the HSE list, but my supplier is charging me more than the list price – what do I do?

A supplier, Medisource, has committed to the HSE that it can supply Pharmacists with these products in a timely fashion at a price the HSE is prepared to pay. If you choose to use an alternative supplier and are charged a higher price, then you will only be reimbursed the HSE reimbursement price.

10. What other products will still require prior approval from the Local Health Office?

All products other than Exempt Medicinal Products outlined in the list attached will still continue to require approval from the Local Health Office

11. What do I do if I get a new prescription from a Consultant for an Exempt Medicinal Product for a GMS patient that is not on the attached document?

A. Where the product had been previously approved for this patient, but local authorisation has expired, application should be made by the patient / pharmacy to the Local Health Office for approval for a further period. B. Where the product has not been previously approved for this patient, the patient / pharmacy should make application to the Local Health Office for approval. C. Where the product has been previously approved by the Local Health Office for other patients, the patient / pharmacy will be informed that the product is approved. D. Where the product has never been previously approved by the particular Local Health Office, the Local Health Office has been instructed to seek clarification whether the product conforms with the Department of Health & Children protocol for the supply of Exempt Medicinal products in the community. You cannot assume that approval from the Local Health Office will be forthcoming.

12. Summary:

This initiative will provide greater equity for patients and clarity for Pharmacists. If a Medical Card Patient is prescribed a product on the list, Pharmacists will be able to submit claims for the Exempt Medicinal Product written on a properly completed GMS Prescription Form at the end of the month in the usual manner. The list of products with their claiming codes should also be used for claims under the DPS and where relevant for LTI and HAA.

GENERIC SUBSTITUTION:

1. What is generic substitution?

Generic substitution, under this legislation, permits pharmacists to substitute a brand medicine for a generic version which has been designated as interchangeable by the HPRA.

2. Will the HPRA be providing a standard name for each list of interchangeable medicines?

Yes – an interchangeable code (IC Code) will link all of the products in a list.

3. What types of medicines will be in a particular list?

A list will be linked to an INN (International Non-proprietary Name), e.g. atorvastatin tablets. A medicine can only appear in one list.

4. What happens if all of the medicines within a list do not have the same licensed indications?

If the HPRA puts such medicines into a list then they are to be considered interchangeable and no liability will fall on the pharmacist.

5. Will salts, esters, ethers, isomers, etc. be considered interchangeable?

Yes, unless equivalence is not demonstrated or if a dose change is required.

6. Will excipients be considered as interchangeable, e.g. sugar free versus sugar-containing?

This will be decided on a case-by-case basis when the HPRA reviews that list.

7. Will dose forms be considered interchangeable?

It is likely that, in general, non-coated/film-coated tablets would be considered interchangeable, as would effervescent/soluble/dispersible tablets. It is not likely that modified release and slow release, etc. would be considered interchangeable. Depending on the active substance in question and the approved generic medicines, immediate release capsules and tablets may be considered interchangeable; this will be decided on a case-by-case basis.

8. Will biologicals be considered interchangeable with biosimilars?

No, biologicals are excluded from this legislation.

9. Will every medicine be considered interchangeable?

No, a medicine will not be considered interchangeable if it cannot be safely substituted, e.g. narrow therapeutic index. For a small number of medicines, it is not advisable for patients to switch between different brands, e.g. considerable variance in bioavailability between brands.

10. When will the HPRA publish the lists?

The HPRA has to date published 31 lists. They will continue to publish the generic substitution lists for individual groups of medicines on an ongoing basis. The plan is to publish one list at a time, subject to successful completion of the consultation phase, with the aim of publishing 2-3 lists per month. Each list will take 42 days to formally publish post initial publication (28 days consultation and 14 days review).

11. How has the HPRA determined which lists to publish first?

The HPRA has been asked by DoH to prioritise the classes of medicines that currently result in the greatest costs. The initial twenty medicines identified included statins, proton pump inhibitors, ACE inhibitors and angiotensin II receptor blockers (ARBs): atorvastatin, simvastatin, pravastatin, rosuvastatin, omeprazole, lansoprazole, pantoprazole, esomeprazole, rabeprazole, perindopril, ramipril, candesartan, losartan, valsartan, clopidogrel, lercanidipine, olanzapine, quetiapine, risperidone, anastrozole.

12. Does this mean I have to wait for the HPRA to publish a list before I can substitute?

Yes. For example, you may get a prescription for Lipitor and Amoxil and the HPRA has only produced the list for “atorvastatin” but not for “amoxicillin”. In this case, you can only substitute the Lipitor but not the Amoxil, under this legislation. However, you may wish to discuss such scenarios with your local GP and agree that it is ok for you to substitute other medicines, where appropriate, in such cases. You would also need to inform the patient of this substitution and make sure that you claim for exactly what you supplied. You must make sure that, in such cases, you do not substitute medicines which are unsuitable for substitution. For example, Epilepsy Ireland recommends that patients on established anti-epilepsy drugs (AEDs) should not have their medicines substituted for a different brand. Epilepsy Ireland is not against the use of generic AEDs when prescribed for new patients, on the condition that there will be an adequate supply of that generic available in the longer term. However, they are opposed to any switching of AEDs, both from brand-to-generic and from generic-to-generic. Pharmacists should record the relevant brand or generic AED on the patient’s medication record (PMR) to ensure that no substitution takes place.

13. Will there be pricing information on the HPRA lists?

No, this is outside the remit of the HPRA. The HPRA will forward their lists to the HSE who will add in the prices. Please note that reference pricing does not commence until at least 8 weeks after the publication of an HPRA interchangeable list.

14. Will there be any change to the reimbursement price of generic medicines once included on an interchangeable list?

This will depend on whether the medicines had previously been reduced to or below 40% of the pre-patent expiry price agreed under the APMI Agreement 2012. In the case of atorvastatin, all generic atorvastatin products on the HPRA list of interchangeable medicines had their prices reduced to not more than 40% of the pre-patent expiry price of the branded product, Lipitor, on 1 September 2013. Likewise, all generic esomeprazole 40mg products on the HPRA list of interchangeable medicines had their prices reduced to not more than 40% of the pre-patent expiry prices of the respective branded products on 1 December 2013. However, in the case of rosuvastatin, omeprazole, pravastatin, lansoprazole, quetiapine and ramipril products, these medicines did not experience a price reduction as they were already slightly below the 40% pre-patent expiry price agreed under the APMI Agreement. For subsequent lists, where considered applicable, those medicines will likely be reduced in price on the first day of the month following publication of the interchangeable list.

15. In general, what are the criteria for inclusion in a list of interchangeable medicines?

Medicines will be included in the list if they have the same qualitative and quantitative composition, same pharmaceutical form (in most cases) and the same route of administration.

16. In general, what are the criteria for exclusion from interchangeability?

Medicines will be excluded from being interchangeable: if differences in bioavailability lead to clinically significant differences in efficacy; if the medicine contains more than two active ingredients; if the medicine is contained in a device with significantly different instructions for use, e.g. inhalers (although some simple inhalers may be considered for substitution); if the medicine is a biological/biosimilar; if the medicine cannot be safely substituted, e.g. narrow therapeutic index, modified release; if the medicine is unlicensed; and if the medicine is patented.

17. How will the HPRA notify prescribers and pharmacists of the lists?

The HPRA will establish and publish the lists on its website. A new version of the list will be created each time an addition or deletion is made. The HPRA would like pharmacists to register with the HPRA for notification by text or email regarding changes/updates to the lists.

18. Since most EU Member States have some form of generic substitution/reference pricing in place, why doesn’t the HPRA use those lists instead of creating their own?

The HPRA is using lists from other Member States as a starting point, especially those from Denmark, Sweden and the Netherlands.

19. How will the HPRA address food stuffs and medical devices?

The focus will just be on medicines for now. The HPRA will only review products that have a Product Authorisation (PA) Number; many food stuffs do not.

REFERENCE PRICING

20. What is reference pricing?

Reference pricing involves the setting of a common reimbursement price, or reference price, for a group of interchangeable medicines. It means that one reference price is set for each group or list of interchangeable medicines, and this is the price that the HSE will reimburse to pharmacies for all medicines in the group, regardless of the individual medicine’s price.

21. When will the first reference price be published?

The consultation and notification periods provided for in the legislation mean that the first reference price can be implemented no earlier than 8 weeks after the publication of the interchangeable list and the HSE must give 28 days’ notice to pharmacists. The reference price for atorvastatin was introduced on 1 November 2013. The reference prices for esomeprazole and rosuvastatin were expected to be introduced on 1 December 2013. However, the HSE only gave notice of the reference price of esomeprazole 20mg on 28 November; consequently this was implemented on 1 January 2014.

22. Will pack sizes be considered interchangeable for reference pricing purposes, e.g. 2 x 28 = 1 x 56?

The HPRA will include all pack sizes in a list of interchangeable medicines. When it comes to reference pricing, HSE will apply a reference price on a per-unit basis, i.e. per tablet or per capsule.

23. How will pharmacists know what the reference and reimbursement prices are?

HSE will produce a list for both prescribers and pharmacists, indicating the reference price (where applicable) and the reimbursement price. This information will be carried on the IPU Product File. HSE shall give 28 days’ notice to community pharmacy contractors prior to implementing the reference price.

24. How often will the reference price be changed?

HSE has said that they do not intend to change reference prices frequently. The Act says that the reference price should be reviewed at least once a year but not more than once every 3 months. HSE has said that they would give a minimum of 4 weeks’ notice before changing a reference price, as per the legislation. HSE confirmed that it was their intention to implement any price changes on the 1st of the month (unless DoH says otherwise). Reference prices will be determined by reviewing prices in all other EU Member States, taking into account any previous agreements in place, e.g. IPHA Agreement, and also considering security of supply concerns.

PHARMACISTS AND PRESCRIBERS:

25. What must the pharmacist do to implement this legislation?

If no clinical exemption is indicated, the pharmacist must offer the patient the least expensive medicine that they have in stock within a list of interchangeable medicines as determined by the HPRA (in some cases, this may indeed be the branded product). If a clinical exemption is indicated, the pharmacist must dispense that brand. The pharmacist should also explain about generic substitution to the patient, highlighting that generics have the same active ingredients, same effects and same safety profile as previously supplied medicines but may not look the same. When reference pricing is introduced for a specific group, the pharmacist should provide information to patients regarding the price of: the prescribed product; the product offered for substitution; and the group reference price. Once reference pricing is introduced, in addition to recording exactly what was dispensed, the pharmacist must also record and transmit data on the product prescribed, i.e. whether the medicine was prescribed as proprietary, branded generic or INN. If a clinical exemption was indicated, the pharmacist must indicate the clinical exemption on the dispensary system. The following specific scenarios are outlined in the Act (with reference to the relevant section of the Act in brackets): The pharmacy has the branded medicinal product and one generic substitute of lower cost (S7) On receipt of a prescription for a branded interchangeable medicinal product, the pharmacist offers the patient the generic substitute. If the patient agrees, dispense. The pharmacy has the branded medicinal product and two or more generic substitutes of lower cost (S8) On receipt of a prescription for a branded interchangeable medicinal product, the pharmacist offers the patient the generic substitute with the lowest cost. If the patient agrees, dispense. If substitution is not agreed, proceed to offer the substitute at the next lowest cost and so on until substitution has been agreed, then dispense. The pharmacy does not have the branded medicinal product in stock but does have one substitute medicinal product which the pharmacist reasonably believes is of equal or lower cost than the branded product (S9) On receipt of a prescription for a branded interchangeable medicinal product, the pharmacist, after informing the patient that they do not have stock of the branded product, offers the patient the substitute. If the patient agrees, dispense. The pharmacy does not have the branded medicinal product in stock but does have two or more substitute medicinal products which the pharmacist reasonably believes are of equal or lower cost than the branded product (S10) On receipt of a prescription for a branded interchangeable medicinal product, the pharmacist, after informing the patient that they do not have stock of the branded product, offers the patient the generic substitute with the lowest cost. If the patient agrees, dispense. If substitution is not agreed, proceed to offer the substitute at the next lowest cost and so on until substitution has been agreed, then dispense. Patients who decline substitution (S26) If the patient does not agree to the substitution and the product has a reference price, the patient is liable to pay the difference between the reference price and the medicine dispensed and any other related cost arising under the relevant scheme (GMS levy/DPS co-payment). This also applies even if the pharmacy did not have stock of the cheaper medicines. Payment of the supplement is mandatory, not discretionary. The prescription for an interchangeable medicinal product is written using a common name e.g. generic, INN (S11) If the prescription is issued using the common/generic/INN name, the pharmacist must dispense the cheapest medicinal product which is in stock at that time. The prescription is for a medicinal product which is not listed as interchangeable but is prescribed generically (S16) If the prescription is issued using the common/generic/INN name, the pharmacist must dispense the cheapest medicinal product which is in stock at that time. However, if the patient requests a different generic/brand than the cheapest, that can be dispensed at no extra cost to the patient.

26. Does the patient have to pay the supplement?

Members are reminded that the requirement for the patient to pay the difference between the reference price and the medicine dispensed is enshrined in Section 26 of the Health (Pricing and Supply of Medical Goods) Act 2013 and is therefore mandatory and not discretionary. The payment of this supplement is in addition to the prescription levy for GMS patients (which is also mandatory) and the DPS co-payment for DPS patients.

27. Can the pharmacist be held liable for substitution?

If a pharmacist substitutes a branded interchangeable medicinal product for another in the group listed by the HPRA, no action or other proceedings can be taken against the pharmacist or the prescriber on the grounds of substitution (S12).

28. What are the criteria for clinical exemption?

If the prescriber feels that, for clinical reasons, the medicinal product should not be substituted, they must write, by hand, “Do not substitute” on the prescription (S13). The pharmacist must dispense that brand and complete the clinical exemption field on the dispensary system.

29. Who in the pharmacy is responsible for ensuring this legislation is implemented?

This Act prescribes that the pharmacy contractor must ensure that all employee pharmacists comply with this legislation; failure to do so shall be deemed failure to comply with the conditions of the Community Drugs Schemes (S14).

30. Can a pharmacist still exercise their professional judgment?

Nothing in this legislation affects a pharmacist’s discretion not to dispense a medicinal product if, in his or her professional opinion, it is prejudicial to the health of the patient or the health and safety of members of the public (S15).

31. Who supervises compliance of pharmacists with this Act?

Amendments have been made to the Pharmacy Act (S32) to facilitate the PSI in imposing duties on pharmacy owners, superintendent pharmacists and supervising pharmacists to supervise compliance with this legislation by their pharmacists. Failure to comply is dealt with under Part 6 (Fitness to Practise) of the Pharmacy Act. Similar provisions have been made for doctors, dentists and nurses and their respective regulators.

32. What must prescribers do to implement this legislation?

Prescribers have been asked to write all prescriptions using the INN where appropriate and also to explain to patients about generic substitution. Where a prescriber wishes, for clinical reasons, to be exempt from substitution, they must write “Do Not Substitute” in their own handwriting on the prescription. The prescriber must keep a record of his/her reason for this clinical exemption. It is not the intention of DoH to make generic prescribing mandatory but it can be made so if considered necessary. The Troika recommended in their last review of the programme that doctors should be required to write prescriptions using the active ingredient.

33. What happens if the prescriber does not indicate “Do Not Substitute” in his/her own handwriting?

DoH said that they have informed prescribers that this is a requirement of the legislation. If prescribers do not do this, then the Minister can make further regulations.

34. What happens if a doctor requisitions a branded product in a stock order?

Only interchangeable products that are at the reference price can be supplied on stock orders. Where the doctor does not wish the patient to use a generic and the proprietary cannot be procured at the reference price, a prescription should be written, indicating the clinical exemption, and provided to the patient to present in a pharmacy.

DISPENSARY SYSTEMS:

35. What prices need to be included on the dispensary system?

The reference price (where there is one), the reimbursement price (for use when there is no reference price or for when there is a reference price but the prescriber indicates a clinical exemption) and the trade price (for pharmacy use). The IPU liaised with system vendors to ensure that the necessary IT changes were made prior to the introduction of the first reference price (for atorvastatin) on 1st November 2013.

36. What information is the pharmacy expected to transmit to HSE?

The IPU and HSE have agreed that, in addition to recording exactly what has been dispensed, pharmacies will record the medicines prescribed by the GP which have been designated interchangeable and for which a reference price has been allocated. The Pharmacy Contractors’ Committee (PCC) has liaised with the HSE to reduce the burden of additional administration being placed on pharmacists. While there is still work to be done by pharmacists in counselling patients on the new legislation, there is significantly less administration than was originally proposed by the HSE. The following will take place for reference priced products only:

• Record how the medicine was prescribed by the prescriber Once you have dispensed a prescription for a reference-priced product, you will be asked by your IT system to tick one of four boxes set out below. This will show the HSE how the medicine was prescribed. The four options, from which you will tick one, are: -INN (International Non-proprietary Name) Prescribed; -Proprietary Prescribed; -Branded Generic Prescribed; or -‘Do not Substitute’ written by the prescriber

• Transmit the name of prescriber to the HSE The HSE had originally requested that pharmacists collect and transmit the Medical Council number. However, it has now been agreed that for reimbursable claims where the prescriber does not hold a GMS Contract, the prescriber name on the prescription record will be transmitted to the HSE. This is an IT solution which will not require extra administrative work for pharmacists.

• DPS prescriptions with ‘Do Not Substitute’ (Clinical Exemption) The HSE originally wanted pharmacists to send the HSE copies of all prescriptions which state ‘Do Not Substitute’. However, they have now agreed that, for the small number of prescriptions which will fall into this category, you should keep a copy in your pharmacy, rather than sending them in.

37. What fields will be required on the dispensary system?

The changes listed above have been made to dispensary systems to facilitate this legislation.

38. How often will I get an update to my IPU Product File?

The IPU will facilitate a live download of the IPU Interchangeable File every time the HPRA produces a new interchangeable list, even if this occurs several times a month. Your IT vendor should be able to facilitate such multiple downloads. Pharmacies that update using CDs will only receive an update once a month.

PATIENTS:

39. How will this legislation affect patients?

Once reference pricing is introduced, eligible patients using State drug schemes like the Medical Card or Drugs Payment Scheme will not face any additional costs for products priced at or below the reference price. If a patient would like to receive a 29 July 2014 particular brand that costs more than the reference price then the patient will have to pay the additional cost of that product. In cases where substitution is prohibited for clinical reasons, patients will not face any additional costs if the prescribed product costs more than the reference price.

• If there is no clinical exemption and the patient accepts the cheapest interchangeable medicine offered, that medicine is dispensed.
• If there is no clinical exemption and the patient is not happy to accept the cheapest interchangeable medicine offered and a reference price is in place, where the patient is a GMS patient, they pay the difference between the cost of the brand and the reference price, in addition to the prescription levy. Where the patient is a DPS patient, they pay the difference between the cost of the brand and the reference price, in addition to the €144 monthly co-payment (or part thereof).
• If the patient is a private patient, they should be offered the cheapest generic in stock but they will pay in full for whatever they wish to have.
• If the prescriber has indicated a clinical exemption, the patient does not have to pay the difference between the brand and the reference price if GMS or DPS.
• The patient can claim the tax back for any supplements paid on their MED 1 form.

COMMUNICATIONS:

40. What has the IPU done to assist members with the implementation of the legislation?

We did everything within our remit to ensure that you were as adequately prepared as possible to deal with the proposed changes. The following were among the issues we addressed:

• We held regional roadshows in September 2013 to brief members on the legislation and its implementation;
• We produced this IPU Pharmacist’s Guide to Reference Pricing and Generic Substitution, which includes everything you need to know about how the legislation will be implemented. The online guide is updated regularly. This guide will assist in staff training;
•  A comprehensive communications programme, including a radio campaign, was rolled-out in association with the IPU, HSE, DoH, HPRA, IMO, ICGP, PSI and patient groups. Leaflets and posters were posted to all pharmacies;
• The HPRA and DoH websites both contain detailed information for healthcare professionals and for patients. The HSE has developed a website www.hse.ie/generics with general information on generic medicines, substitution, and an introduction to reference pricing. The HSE website also has two information videos, featuring a GP and a Pharmacist, to introduce the new legislation to patients and explain how they will be affected and how to get more information if they need it. These are available on the website, but also can be circulated to surgeries and pharmacies for use on patient display screens, where they exist.

1. Is my pharmacy registered on IPUnet?

Type in www.ipunet.ie in your browser.
If your pharmacy is registered, the pharmacy name should appear in top right hand side of
screen. If it doesn’t appear try logging in by using the pharmacy GMS Number and password used
at time of registration. If you are unable to log in, please register.

2. Am I (as a pharmacist) registered on IPUnet?

Only pharmacies are registered on the new IPUnet platform. Additional
IPUnet users are created in the Users area of the Admin section. Create additional users by
entering the following three pieces of information:

• User Name
• User ID – we suggest the Users initials
• User Description (from dropdown menu)

Click on Save button to store this users’ details.

3. What is my pharmacy password?

You set the pharmacy password when registering on IPUnet. We don’t know
your password. Please see question 5 on how to reset your pharmacy password.

4. What is my pharmacist password?

There is no pharmacist password, access to modules is via User ID – we
suggest the Users initials. User ID can be amended/deleted in the Users Area of the Admin
section.

5. Can I reset my pharmacy password?

Click on Forgot your password? on login page. Enter the
pharmacy GMS number and answer one security question, recorded at registration;
mother’s maiden name. An email will be sent to you, containing a link which
allows you to reset your pharmacy password. A pop up message appears when the password has been
successfully updated and an email is sent to you confirming the IPUnet password update.

6. I don’t know the answer to the security question to reset the pharmacy
password?

If you are unable to answer the security question, please contact us at ipunet@ipu.ie or telephone 01 406 1559 and we will
assist you to reset your pharmacy password.

7. I didn’t receive a pharmacy registration verification email?

On registration of your pharmacy, an email verification to verify your
identity is automatically sent. If you did not receive this email and it is not in spam/junk,
please contact us at ipunet@ipu.ie or telephone 01 406
1559 and we will assist you as otherwise, you will be unable to log in to IPUnet.

8. Can I change my • Shop/pharmacy GMS Number • Shop/pharmacy email address

These details can be changed in the Reports and Admin Section. This is a
restricted area and if you wish you can create an additional password for this area.

In the Pharmacy Profile Section, the following details can be amended:

• Pharmacy Name
• Pharmacy GMS Number
• Pharmacy Registration Number (PSI)
• Primary Contact Name
• Email address
• Mother’s Maiden Name
• Pharmacy address
• Pharmacy telephone number

Once you change the pharmacy GMS number, the pharmacy will now log in using the new GMS number.

What is a preferred drug?

A preferred drug is a drug that the Medicines Management Programme has identified as the drug that should be prescribed to patients. In the first instance there are two drug areas considered, PPI’s and Statin. The preferred drug for PPI’s is Lansoprazole (Zoton Fastab). The preferred drug for statins is Sim vastatin (Zorcor).

What is the role of consumers?

In relation to PPI’s and Statins consumers or patients who pay for their medications, who are prescribed these medicines, should be encouraged to have a conversation with their prescribers/GP to see if the preferred PPI or Statin could be prescribed for them. This could save the consumer in the region of €200 – €300 per year as a private customer paying for their medications.

What is the role of healthcare professionals?

Healthcare professionals, in particular prescribers, have a key role in following the advise of the MMP by prescribing the preferred medicines and also to help consumers understand any real or perceived differences (or lack thereof) between different brands of medicines.

How easy is it for my doctor change my prescription to the preferred drug?

In the case of PPI’s there is little difference in efficacy (how the drug works) but significant difference in prices. Therefore patients are encouraged to discuss with their doctors the possibility of switching to the preferred drug. In relation to Statins there are some differences in the medicine and patients should discuss with their doctor to see if they are suitable/eligible patients for the preferred drug initiative. There are guidelines set out for switching patients from one statin to another. These guidelines aid the prescriber when making the decision to switching medicines prescribed to a patient.

What is a PPI?

PPI’s are medicines that are prescribed to patients for the treatment of conditions such as peptic ulcer disease and gastroesophageal reflux disease. There are 5 PPI’s on the market at present. They include the following products: