Regulatory, Pricing and Reimbursement Overview
An intro to the legal situation for regulatory, pricing and reimbursement in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for GBP 99.
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
The regulatory authority with responsibility for drugs, biologicals and medical devices in Ireland is the Health Products Regulatory Authority (HPRA). The HPRA is a state agency whose broad remit includes protecting and enhancing public and animal health by regulating medicines, medical devices and other health products, as well as cosmetics.
The National Standards Authority of Ireland (NSAI) is an Irish notified body designated by the HPRA to carry out conformity assessment procedures to ensure compliance with relevant legislation relating to medical devices. A notified body (NB) is an organisation designated by a European Union (EU) country to assess the conformity of certain products before being placed on the market. NBs carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. A list of NBs is published by the European Commission (EC).
The Health Services Executive (HSE) also plays a significant role in respect of drugs, biologicals and medical devices. It is charged with the provision of and running all the public health services in hospitals and communities in Ireland and is overseen by the Minister for Health. The HSE’s Corporate Pharmaceuticals Unit acts as the interface between the HSE and the pharmaceuticals industry with regards to medicinal pricing and reimbursement, and the operation of national pricing framework agreements.
2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
In the European Union (EU), all medicines must be authorised prior to their being marketed and being made available to patients. There are four different procedures that applicants can use in order to obtain a Marketing Authorisation (MA) depending on the type of medicine and the countries the product is going to be marketed in. The four procedures are:
- Centralised Application Process
- National Procedure
- Mutual Recognition Procedure
- Decentralised Procedure
Centralised Application Process:
Under the Centralised Procedure (CP) applicants can make a single MA application to the European Medicines Agency (EMA); this method ensures that once granted, the MA is valid in all EU Member States (MS). The legal framework governing the CP is contained in Regulation (EC) 726/2004. Medicinal products listed in the Annex to the Regulation (EC) 726/2004 must use this procedure for authorisation. The majority of new medicines in the EU obtain authorisation via the CP.
Conversely, the majority of medicines already available in the EU were authorised at national level via national competent authorities (i.e. the HPRA in Ireland) after a full assessment. This procedure is not permitted where applicants already hold an MA in another MS. The HPRA grants MAs under the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. 540/2007). The HPRA in Ireland issues a MA along with a Product Authorisation (PA) number which is to be included on the box or container of the product. Details regarding applications are contained in EU Directive 2003/63/EEC and full applications must be submitted in accordance with a Common Technical Document (CTD) format.
If a company wishes to request an MA in more than one EU Member State (MS) they can do so either using the Mutual Recognition Procedure (MRP) (i.e. an MA granted in one MS can be recognised in others) or via the Decentralised Procedure (DCP) where a medicine or biological not yet authorised in the EU can be authorised simultaneously in several MS.
Mutual Recognition Procedure:
Under the MRP, a product is assessed by one MS known as a Reference Member State (RMS), and further on in the process, MAs can be sought from other MS who are known as Concerned Member States (CMS). CMS recognise the decision of the RMS rather than undertaking their own assessment process. Therefore, an applicant can hold an MA in the RMS and various other CMS. If a medicinal product is required to be authorised under the CP then this authorisation procedure cannot be used.
The Decentralised Procedure (DCP) is used by applicants to apply for MAs in more than one MS where the product has not been authorised in any MS and where applicants do not want to use the CP or the product is not eligible for the CP.
The RMS does an initial evaluation of the product and issues a draft assessment report. The other CMS either agree with this initial evaluation or ask further questions or raise objections. If any potential issues are resolved, and each application is successful then each MS involved will issue an MA for that product in their country.
‘CE’ (Conformité Européene) markings appear on many products sold in the EU. CE marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation. Not all products sold in the EU require CE marking, however it is mandatory for medical devices and in-vitro diagnostic devices (IVDs). CE markings cannot be affixed to products until all necessary certifications have been obtained from a NB (or self-certification in some cases depending on the risk classification of the device). The HPRA has designated NSAI as a NB in Ireland to carry out conformity assessment procedures to ensure compliance with applicable medical devices legislation however manufacturers are free to choose any NB in the EU that has been legally designated to carry out the necessary conformity assessment procedure in respect of their device(s).
Directive 93/42/EEC contained the basic legal framework for the regulation of medical devices in the EU, however this has now been replaced by the Medical Devices Regulation 2017/745 (MDR). The MDR came into effect on 26 May 2021, having been postponed for a period of one year under Regulation 2020/561 due to the COVID-19 pandemic. In Ireland, the Medical Devices Regulations 2021 (S.I. 261/2021) (the 2021 Regulations) were enacted on 26 May 2021 to confer on the HPRA various regulatory functions provided for under the MDR such as classification, market surveillance, clinical investigations and enforcement. The European Union (National Research Ethics Committee for Clinical Investigations of Medical Devices) Regulations 2021 (S.I. 260/2021) have also been enacted to provide for the establishment of a National Research Ethics Committee for Medical Devices (NREC-MD), and the rules procedures applicable to its functions. An opinion from NREC-MD is required as part of the application process for clinical investigations on medical devices in Ireland.
In-Vitro Diagnostic Devices:
Directive 98/79/EC concerning In-Vitro Diagnostic Medical Devices (IVDD) provides for regulation of the safety and marketing of IVDs placed on the EU market and is transposed in Ireland using the European Communities (In-Vitro Diagnostic Medical Devices) Regulations 2001 (S.I. 304/2001). Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) entered into force on 25 May 2017 and will take full effect on 26 May 2022. This will bring about a number of significant changes such as new classes of IVDs, there will now be four categories ranging from Class A (lowest risk), to Class D (highest risk). Further, the IVDR also expanded the definition of an IVD to include software, introduced a unique device identifier (UDI) for each device to enhance traceability, as well as making it obligatory for IVDs and testing services offered online to comply with the IVDR the moment they are offered for use in the EU. Owing to concerns over market disruptions expected to be caused by a lack of appropriately designated notified bodies, the European Commission has recently proposed an extension of the 2-year transition phase currently provided for under the IVDR. Under this proposal, the highest risk devices (Class D) would have until May 2025 to undergo conformity assessment by a notified body. Moderate-risk devices (Class C) would have until May 2026 and lower risk Class B and Class A sterile devices would have until May 2027.
Pricing & Reimbursement:
In Ireland, the HSE has statutory responsibility for medicine and medical device pricing and reimbursement under the Health (Pricing and Supply of Medical Goods) Act 2013 (the 2013 Act). The 2013 Act requires the HSE to maintain a list of reimbursable items (the Reimbursement List) and there is a standardised application procedure that must be used by suppliers in order to have most products (other than those restricted to hospital or medical specialist use) included on the Reimbursement List. Ireland does not have a distinct approval procedure for reimbursements for rare disease medicines or hi – tech products, however applications in respect of cancer drugs involve specialist review by the National Cancer Control Programme Technology Review Committee (NCCP-TRC).
The 2013 Act outlines the criteria for decisions regarding the reimbursement of medicines and medical devices. The decisions made by the HSE are also informed by recommendations and analyses provided by the National Centre for Pharmacoeconomics (NCPE). An important metric used by the NCPE and the HSE to assess the cost effectiveness of a medicine is the Incremental Cost Effectiveness Ratio (ICER) of the medicine per Quality Adjusted Life Year (QALY). Where a medicine is considered by the NCPE to be cost-effective, the HSE may approve it for placement on the Reimbursement List. Alternatively, the HSE can request a further review of the application by the HSE Drugs Group, whose recommendation is then considered by HSE senior leadership in order to make a final decision on whether or not to place a medicine on the Reimbursement List.
In 2016 the Irish government also entered into a framework agreement with the Irish Pharmaceutical Healthcare Association (IPHA) for the supply and pricing of medicines (the Framework Agreement). Taken together, the 2013 Act and the Framework Agreement provides for a system for setting the reimbursement price for drugs. Although the Framework Agreement was scheduled to expire in 2020, an extension to the end of July 2021 was agreed owing to the need to prioritise responses to the Covid-19 pandemic. An updated agreement is currently being negotiated however at the time of writing the status of the Framework Agreement as remaining in force pending the outcome of those negotiations is uncertain and it is not clear if the Framework Agreement has now formally expired or when a new agreement will be announced.
The Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. 540/2007) outlines the requisite criteria for establishing the legal supply status of medicinal products. The two main categories of medicinal products are prescription – only and non – prescription products. New medicines generally may only be supplied on prescription; however when/if the medicine has a well-known, long established safety profile and there is evidence that the medicinal product may be safely used without supervision by a physician, an application can be made for reclassification from prescription-only medicine to pharmacy-only status.
Generally, the Irish State will only reimburse prescription – only products, however non – prescription items, such as generally available painkillers, can be reimbursable where prescribed by a doctor. The State operates the following four principal reimbursement schemes:
- General Medical Services Scheme: this is a means – tested scheme and patients pay €1.50 per item prescription and this goes up to a maximum of €15 per family per month. Pharmacists obtain dispensing fees but no mark – up fees.
- Long Term Illness Scheme: this applies to specific long-term conditions such as epilepsy and diabetes. Patients receive medicines free of charge and pharmacists receive a mark – up and dispensing fee.
- Hi – Tech Scheme: patients receive expensive medicines required for long – term care and, if they hold a medical card or the medicine is a specific condition under the Long-Term Illness Scheme they receive the medicine free of charge. Alternatively, they pay the first €114 a month as per the Drug Payment Scheme (see below).
- Drug Payment Scheme: patients pay a maximum of €114 per month and pharmacists receive a mark – up and dispensing fee.
3. What are the steps to obtaining authorization to develop, test, and market a product?
In Ireland, authorisations to market new medicinal products are granted by the HPRA under the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. 540/2007). An Irish authorisation for a human medicinal product is called a product authorisation (PA). Details on the content of an application are outlined in Directive 2003/63/EEC.
4. What are the approximate fees for each authorization?
The HPRA’s website provides a spread sheet listing numerous fees for varying applications and some of these are as follows:
- Authorisation of Medicines (new National Application) – €20,400
- Authorisation of Medicines (new Mutual Recognition Concerned Mem-ber State Application) – €14,280
- Authorisation of Medicines (new Mutual Recognition Reference Member State Application) – €15,300
- Authorisation of Medicines (new Decentralised Concerned Member State Application) – €20,400
- Authorisation of Medicines (new Decentralised Reference Member State Application) – €51,000
5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
Marketing authorisations are valid for a period of five years from the date of issue. In order for MAs to remain valid, renewal applications must be made to the HPRA at least nine months before expiry of the existing authorisation. Following renewal, the authorisation remains valid for an indefinite period unless further renewals are considered necessary on drug safety grounds.
For products authorised using the Centralised Procedure (see above) renewal applications must be submitted to the European Medicines Agency (EMA).
6. How does the authorization process differ between brand- name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
Brand-name & Generic Products:
Depending on the data submitted in an application for authorisation, medicines are classified into two main types, reference and generic (interchangeable) medicines. The data requirements for these are harmonised in law across the European Community and the definitions of these medicines are outlined in EU legislation (Directive 2001/83/EC).
A reference medicine is one that has been authorised following the submission of a dossier containing full pharmaceutical, pre-clinical and clinical trial data. These medicines are also called branded, originator or proprietary medicines. Following authorisation, they are entitled to a ten-year period of market protection prior to the introduction of a generic medicine.
A generic medicine contains the same quantity of active substance and is used in the same dose to treat the same condition as a reference medicine. It must meet the same standards of quality and safety and have the same effect as a reference medicine. However, the data submitted for authorisation of a generic medicine is reduced and there is scope for applicants to omit some or all of the preclinical and clinical data. The dossier for a generic application must contain full pharmaceutical data and the clinical data may include a study demonstrating bioequivalence with the reference product, however in certain circumstances a waiver of bioequivalence can be submitted.
The requirements for bioequivalence data are harmonised across the EU. A bioequivalence study is performed in healthy volunteers who receive single doses of the reference and generic medicine and blood samples are taken to determine the handling of the medicines by the body. The reference and generic medicines are considered “bioequivalent” when they produce the same plasma concentration of active substance in the body when tested. When a generic medicine is demonstrated to be bioequivalent to a reference medicine, the benefits and risks of both medicines are considered the same and the generic medicine can usually be substituted for the reference medicine. Where bioequivalence cannot be demonstrated, bridging data is required to demonstrate that the differences do not affect the product’s safety and effectiveness.
Local Manufacturers versus Foreign–owned Manufacturers:
As discussed in Question 2, there are four methods of obtaining an MA and these are as follows:
- Centralised Procedure
- National Procedure
- Mutual Recognition Procedure
- Decentralised Procedure
If local manufacturers only wish to put their products on the Irish market, they can use the National Procedure. The other three methods can be used by both local manufacturers and foreign–owned manufacturers in order that their products can be offered throughout the EU.
7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?
As per the EMA’s guidelines, medicines can be marketed for use in combination with a medical device, usually to enable the delivery of the medicine. However, the specific manner in which any given drug-device combination will be regulated depends on the nature of the combination and the respective roles of the drug and device elements. If the principal intended action of the combination product is achieved by the medicine component, the entire product will ordinarily be regulated as a medicinal product under Directive 2001/83/EC or Regulation (EC) 726/2004. The two types of combination product are as follows:
- Integral – medicinal product and the device form a single integrated product for example single dose pre-filled syringes, pens and injectors and;
- Co- packaged – the medicinal product and the device are separate items contained in the same pack. For example, an injection pack which has separate needles and filter needles.
Article 117 of the MDR has also introduced new rules for drug-device combinations which are applicable in Ireland. Article 117 amends Directive 2001/83/EC and provides that authorisation applications for integral drug-device combinations shall be subject to the MDR and should include evidence of the conformity of the device element of the combination with the relevant requirements (General Safety and Performance Requirements) contained in Annex I of the MDR. This can take the form of a certificate of conformity issued by a notified body or a Notified Body Opinion (NBOp) as necessary. The EMA has published guidance such as a Q&A on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) (Rev. 2) and a Guideline on quality documentation for medicinal products when used with a medical device to assist stakeholders in ensuring compliance with these requirements.
8. How is compliance with regulations monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?
In Ireland, compliance with regulatory requirements is monitored and evaluated by the HPRA in accordance with EU legislation and regulations which include EMA expectations and requirements. The HPRA as the national competent authority has the requisite statutory authority for oversight of the regulation of the pharmaceutical, medical device and IVD industries and is active in its role of ensuring regulatory compliance by stakeholders.
9. What is the potential range of penalties for noncompliance?
The Irish Medicines Board Act 1995 (as amended by the Irish Medicines Board (Miscellaneous Provisions) Act 2006)(the 1995 Act), provides for the HPRA (formally known as the Irish Medicines Board) to appoint authorised officers who have a wide range of investigatory powers that may be exercised in the course of an investigation, inspection or any other function undertaken under the 1995 Act or the various regulations made under the 1995 Act.
Section 32 of the 1995 Act also confers extensive powers on the Minister for Health to make regulations for the purposes of the Act. Section 32(4) of the Act makes it an offence to contravene any regulation made under Section 32. The HPRA can bring summary proceedings for an offence under the 1995 Act; the time limit for prosecution is two years from the date of the offence. In cases of more serious offences where summary proceedings are not appropriate, trial will be on indictment by direction of the Director of Public Prosecutions and the penalties for conviction are:
- First offence: a fine not exceeding €120,000 or imprisonment for a term not exceeding ten years or both.
- Subsequent offence(s): a fine not exceeding €300,000 or imprisonment for a term not exceeding ten years or both.
If an offence is committed by a body corporate with the consent, connivance or by the negligence of a director, manager or other officer of the body corporate, that person may also be found to be personally liable in respect of that offence. The HPRA carry out investigations relating to illegal supply, manufacture or advertising of health products and they prosecute where they have detected a significant risk to public health or where compliance cannot be achieved or if there are other aggravating factors. They also liaise with other national agencies including the police and Customs as well as with their international counterparts where necessary.
The IPHA also operates a self-regulatory code, the Code of Practice for the Pharmaceutical Industry (the IPHA Code), which IPHA members undertake to adhere to. In cases of proven breaches of the IPHA Code by members, the IPHA Council can opt for a range of penalties including (but not limited to), reprimanding the member company for breach of the IPHA Code; asking the member company to cease the practice which brought them into breach; and/or recommending to the IPHA Board of Directors that the member company be suspended or expelled from the IPHA. They may also opt to charge administrative fees, and their findings are published annually and made available to IPHA members as well as the HPRA and the Minister for Health.
The HPRA also has responsibility for ensuring that medical devices legislation is complied with. The 2021 Regulations set out a range of general offences related to the oversight of medical devices in Ireland, as well as lists of offences that are specific to manufacturers, importers, distributors, authorised representatives, notified bodies and the sponsors of clinical investigations.
Proceedings in relation to a summary offence under the 2021 Regulations may be brought and prosecuted by the HPRA. As the 2021 Regulations were made under section 32 of the 1995 Act, the same penalty range will apply for medical device offences as for those relating to medicines. If an offence is committed by a body corporate with the consent, connivance or by the negligence of a director, manager or other officer of the body corporate, that person may be held to be personally liable in respect of that offence. Any person or body corporate found guilty of an offence will be liable on summary conviction and can be subject to six months imprisonment, a fine, or both.
There are also potential penalties under the Irish Medtech Code of Ethical Business Practice, which, similar to the IPHA Code, is a self-regulatory code operated by the Irish MedTech Association. In cases of proven breaches by its members, the Irish Medtech Association can decide to issue a formal letter of reprimand, issue a letter of reprimand and recommend suspension of the member company from the Irish Medtech Association (with various conditions) or recommend expulsion from the Irish Medtech Association.
10. Is there a national healthcare system? If so, how is it administered and funded?
In Ireland, national healthcare policy and expenditure is determined by the Department of Health under the guidance of the Minister for Health and is funded by an annual government budget. Public healthcare services are provided by the HSE which owns and runs public hospitals. The HSE was established under the Health Act 2004 as the single body with statutory responsibility for management and delivery of health and personal social services in Ireland. Every resident in Ireland is entitled to subsidised or free approved prescribed medicines as well as certain medical aids and appliances.
11. How does the government (or public) healthcare system function with private sector healthcare?
The Irish healthcare system is two tiered, comprising of the public healthcare service which is administered by the HSE, and the private healthcare system which is funded by private funds and private insurance. There are also voluntary public hospitals and the majority of their income comes from State funds. They are sometimes owned by private bodies such as religious orders. In practice, public hospitals and public voluntary hospitals are not different and most of them offer private healthcare, but there is a clear distinction between public and private beds. There is a set daily charge for private patients in public hospitals.
Private hospitals operate purely independently of state health service, and patients who opt to go private must pay (or their insurance company must pay) for the full cost of their treatment. Private hospitals are free to set their charges to their patients at rates of their own choice. As of the end of 2020, almost half of the Irish population held private health insurance and can avoid the potential for lengthy waiting lists associated with public health services
12. Are prices of drugs and devices regulated and, if so, how?
Where reimbursement is not being sought, a price does not need to be agreed by the HSE for a medicine or medical device prior to it being placed on the Irish market. Generally speaking, and as outlined in Question 2 under ‘Pricing and Reimbursement’, the reimbursement prices of drugs and medical devices are considered by the HSE in line with Health (Supply and Pricing of Medical Goods) Act 2013 and the associated IPHA Framework Agreement where manufacturers (or others in the supply chain) are seeking reimbursement.
13. How are the drugs and devices used by patients paid for? What roles do public and private payers play?
If you are ordinarily resident in Ireland, then you may be eligible for free or subsidised prescribed drugs and medicines as well as certain medical and surgical aids and appliances. As outlined in Question 2, there are four principal means-tested reimbursement schemes run by the State under which patients can receive free or subsidised drugs, medicines and aids and appliances. The HSE Primary Care Reimbursement Scheme provides for a Reimbursement List of medicines or aids, which will be free or subsidised for holders of a HSE Medical Card or if provided under a HSE scheme.
Medical card holders who are prescribed items that are not on the Reimbursement List can apply for a discretionary hardship scheme. Furthermore, under the reference pricing system established by the 2013 Act, where a medicine is interchangeable, the HSE will pay the reference price if you have a Medical Card. That is to say, where generic medicines have been deemed interchangeable with brand name medicines, the HSE will establish a reimbursement price for these grouped medicines, and this will be the group reference price. If you are a holder of a Medical Card and seek a medicine deemed interchangeable, the HSE will reimburse this reference price. However, if you wish to choose a more expensive medicine, you must pay the difference between the reference price and the retail price. Medical aids and appliances are usually free to medical card holders and those who do not have a medical card often get their aids for free if the aids are required as part of hospital treatment. If someone does not hold a Medical Card, they can apply to their local health office for a contribution towards the price. Furthermore, health insurers will also often refund part of the cost of surgical or medical aids.
14. Who dispenses drugs and devices to patients and how are those dispensers compensated?
Drugs dispensed in the community are funded by the State through reimbursements of pharmacists where patients are covered by a reimbursement scheme and where the product being dispensed is on the Reimbursement List. Payments are regulated by the Public Service Pay and Pensions Act 2017 (Payments to Community Pharmacy Contractors) Regulations 2019 (S.I. 639/2019) and HSE Community Pharmacy Contractor Agreements. In general, all pharmacies have agreements with the HSE under the Primary Care Reimbursement Services Scheme to dispense approved drugs and medicines. General Practitioners (GPs) can also provide drugs and medicines directly to patients in circumstances where there is only one practice centre which is three or more miles from a retail pharmacy.
The HSE reimburses medical devices (that are on the Reimbursement List) via their Aids and Appliances Schemes. Hospitals and other specialist institutions provide the aids and appliances (as well as drugs and medicines) directly to patients.
15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
Medical practitioners and pharmacists commit themselves to abiding by and adhering to the ethical guidelines and professional standards set by their statutory regulators. Medical practitioners in Ireland must adhere to the provisions of the Medical Practitioners Act 2007 (as amended) as well as the Medical Council’s Guide to Professional Conduct and Ethics for Registered Medical Practitioners (the Ethical Guide). Pharmacists are obliged to adhere to the provisions of the Pharmacy Act 2007 (as amended) as well as the Pharmaceutical Society of Ireland’s Code of Conduct (the Code of Conduct).
Both the Ethical Guide and Code of Conduct require compliance by medical practitioners and pharmacists with medicines legislation. Regulation of the sale and supply of medicinal products is provided for under the Medicinal Products (Control of Advertising) Regulations 2007 (S.I. 541/2007) and the Medicinal Products (Prescription & Control of Supply) Regulations 2003 (S.I. 540/2003). Regulation of the supply of controlled drugs is also legislated for under the Misuse of Drugs Acts and more specifically, the Misuse of Drugs Regulations 2017 (S.I. 173/2017).
The Pharmaceutical Society of Ireland (PSI) and the Medical Council have also issued joint guidance regarding the safe prescribing and dispensing of medicines. The joint guidance lists the following respective obligations:
- Provide a valid prescription which meets the requirements of the legislation.
- Be satisfied as to the identity of the person for whose treatment the prescription is to be issued.
- Follow relevant national and international prescribing guidelines.
- Within reason, be available to confirm or discuss any matters related to the prescription and the patient.
- Ensure the safe keeping of prescription pads to reduce the risk of theft and forgery.
- Facilitate appropriate withdrawal of controlled drugs and follow-up and refer as necessary.
- Only dispense on the basis of a legally valid prescription.
- Be satisfied that the signature of the prescriber is genuine.
- Prior to supply, be satisfied as to the identity of the person or bona fide representative presenting the prescription or collecting controlled drugs.
- Be vigilant for forgeries or unusual prescribing patterns.
- Store controlled drugs in a safe manner, in accordance with the relevant legislation.
- Record all supplies of schedule 2 controlled drugs (Misuse of Drugs Regulations 2017) in the pharmacy’s controlled drugs register.
- Communicate with the medical practitioner if there is any query about the prescription or care of the patient.
- Adhere to national guidelines and facilitate appropriate withdrawal of controlled drugs and follow-up and refer as necessary.