Forensic Summaries 2016

Transcription

1 Forensic Summaries 2016 This article summarises the legislation relating to Irish pharmacy and medicinal products which is of most relevance to community pharmacists. Consequently, not all legislation is covered. These summaries do not purport to be a definitive interpretation and no responsibility is accepted by the Irish Pharmacy Union (IPU) for any errors or omissions. If in doubt about any aspect of these summaries, reference should be made to the published Acts and Regulations on 1. Medicinal Products (Prescription and Control of Supply) Regulations 2003 to Schedules to the Regulations The Regulations contain seven schedules: The First Schedule lists all prescription controlled substances in column one. Column two indicates whether they are S1A, S1B or S1C. Columns three, four and five indicate the circumstances, if any, in which the substance is exempt from prescription control. The Second Schedule (Part 1) lists substances which, when contained in certain non-prescription medicinal products, may only be supplied in the manufacturer s original container showing the legal classification for supply. The Second Schedule (Part 2) lists substances which, when contained in certain non-prescription medicinal products, may be supplied in non-pharmacy outlets. (Deleted by 2008 amendments) The Second Schedule (Part 3) lists substances which, when contained in certain licensed homoeopathic medicinal products, may be supplied without a prescription and in non-pharmacy outlets. The Second Schedule (Part 4) lists herbal substances which, when contained in extemporaneously prepared medicinal products, may be supplied without a prescription in certain limited circumstances. The Third Schedule (Part 1) lists substances which, when contained in medicinal products for external use, may be dispensed in the manner prescribed for a product which is or which contains a substance which is S1B. The Third Schedule (Part 2) lists substances which, when contained in medicinal products that are intended for use as an oral contraceptive, may be dispensed in the manner prescribed for a product which is or contains a substance which is S1B. The Fourth Schedule lists substances which may not be contained in a preparation supplied in an emergency at the request of the patient. The Fifth Schedule contains a list of cautionary or warning notices which should appear on the labelling of dispensed medicines as appropriate. The Sixth Schedule shows the form of certificates of analyses. (Deleted by IMB Misc Prov Act 2006) The Seventh Schedule lists medicinal products that may be supplied by pre-hospital emergency care providers. 1.2 Exemptions from Prescription Control The following are exempt from prescription control: i) Medicinal products where there is an entry in one or more of columns 3, 4 and 5 of the First Schedule and (a) having a maximum period of treatment (MPT), maximum strength (MS) or maximum pack size (MPS) not exceeding that indicated in column 3; or (b) having a specified use only, a specified pharmaceutical form or a specified manner of administration only as indicated in column 4; or (c) whose maximum dose (MD) and maximum daily dose (MDD) does not exceed the limits specified in column 5. ii) Medicinal products which are not otherwise subject to prescription control by virtue of these Regulations.

2 1.2.1 Labelling of Non Prescription Medicines Where a medicine is exempt from prescription control for a particular use, e.g. Arret (loperamide) for the treatment of acute diarrhoea, the container must not detail any indication for use other than that for which the preparation has been exempted. In the case of a medicine for which a maximum period of treatment (MPT) has been specified for OTC sale, the product must be labelled with a warning not to exceed the said period of treatment. Where a maximum dose (MD) and/or maximum daily dose (MDD) have been specified for OTC sale, the container must be clearly labelled Warning: Do not exceed the stated dose Pharmacy-only Medicines (P) Medicinal preparations which are exempt from prescription control by virtue of these Regulations may only be supplied by or under the personal supervision of a pharmacist. Certain substances are specifically exempted from this pharmacist-supervised sale requirement, e.g. aspirin, nicotinic acid, some vitamins and toothpaste components. These substances may be supplied in non-pharmacy outlets when contained in OTC preparations. Paracetamol products may be supplied in non-pharmacy outlets subject to the provisions specified in Article 14 of the Regulations (see below). Any medicinal preparation which may only be supplied by or under the personal supervision of a pharmacist is given the designation (P) on the IPU Product File. Any substance which may be supplied in a non-pharmacy outlet is designated # on the IPU Product File Medicines to be Supplied in Original Pack The substances listed below, when sold over the counter, must be supplied in the manufacturer s original container and be labelled by the manufacturer to show that the medicine can be supplied without a prescription, i.e. a special OTC pack is required. Therefore, preparations containing these substances must not be repacked from the manufacturer s container for the purposes of OTC sale nor must a POM pack of such a medicine be over-labelled by the pharmacist and sold as an OTC medicine: Aciclovir, Diclofenac diethylammonium, Diclofenac sodium, Hydrocortisone/hydrocortisone acetate, Famotidine, Flurbiprofen, Ibuprofen, Ketoprofen, Minoxidil, Naproxen, Nicotine, Nicotine resinate, Oxetacaine, Piroxicam Homoeopathic Medicinal Products The Regulations provide for the exemption from prescription control of homoeopathic medicinal products containing a substance specified in Part 3 of the Second Schedule at a level not exceeding one part per million and which is subject to an authorisation or a certificate of registration. Such products are also exempted from the requirement to be supplied from a pharmacy or under the personal supervision of a pharmacist Herbal Substances The Regulations provide for the exemption of certain herbal substances from prescription control and from the requirement that they may only be supplied from a pharmacy by or under the direct supervision of a pharmacist provided all of the following conditions are adhered to: The person making the supply is the occupier of a premises not being a shop or other retail outlet; The medicinal product containing the herbal substance(s) is extemporaneously prepared on the premises; The premises is capable of being closed so as to exclude the public; The medicinal product, when extemporaneously prepared, is also administered on the premises to the person requesting it or on whose behalf it has been requested, in the presence of the occupier of the premises so that his/her professional judgement as to the treatment is available.

3 In effect this exemption applies to the extemporaneous preparation of medicinal substances by herbal practitioners and does not apply to proprietary products. The herbal substances in question are listed in the Second Schedule, Part 4 and are Gingko biloba L and Hypericum perforatum L (also known as St John s Wort) Supply to Registered Optometrists A registered optometrist can be supplied by a pharmacist with the following medicinal products which are prescription only on supplying a signed order to the pharmacist: Cyclopentolate hydrochloride eye drops, Oxybuprocaine eye drops, Tropicamide eye drops, Fluorescein sodium, Lidocaine, Proxymetacaine hydrochloride, Tetracaine hydrochloride. The medicinal product is not intended for parenteral use and is supplied for administration by the optometrist to a patient in the course of his/her professional practice. This exemption does not entitle registered optometrists to write prescriptions for the products for patients in their professional care. The Pharmaceutical Society of Ireland (PSI) recommends that the signed order should fulfil the following conditions: it should have the name and address of the registered optometrist seeking supply; the date; details of the exempted product to be supplied including name, form, strength and quantity; a statement that the medicinal product is to be used in the course of the optometrist s professional practice; be signed by the optometrist. The pharmacist, at the time of supply, should endorse the signed order with: date of supply; details of supply (name and quantity of product supplied); name and address of supplying pharmacy. The signed order should be kept in the pharmacy for 2 years. 1.3 Prescriptions Prescriptions should: be in ink; be dated and signed by the prescriber with his usual signature; clearly indicate the prescriber s name and the prescriber s address (except for a GMS prescription); state whether the prescriber is a doctor, dentist or registered nurse prescriber; and state the patient s age if under 12 years Rules for Repeating Prescriptions S1A Rules A prescription for an S1A medicine may be dispensed on one occasion only, where neither the number of repeats nor the intervals between repeats is specified. Where the intervals are specified but the number of occasions is not, the prescription may be repeated twice. Where the number of repeats only is specified, the prescription may be repeated at such intervals as the pharmacist deems appropriate, having due regard to the prescribed dosage. As an S1A item cannot be repeated unless either the intervals of supply or the number of occasions of supply are specified in the prescriber s own hand-writing or own typed script, an S1A item on a three monthly GMS repeat form cannot be repeated unless specific directions for repeating it have been given by the prescriber on the form it is not sufficient to rely on the fact that the word repeat is printed on top of the form. Products containing steroidal substances are as a rule S1A; however, in certain circumstances they may be dispensed as repeatable S1B items, i.e.:

4 Any product intended for external use containing a substance listed in Part 1 of the Third Schedule; Any product intended for use as an oral contraceptive containing a substance listed in Part 2 of the Third Schedule; Any product containing hydrocortisone sodium succinate or triamcinolone acetonide specifically intended for the treatment of mouth ulcers; Any product intended for parenteral administration containing insulin S1B Rules A prescription for an S1B medicine may be repeated for six months at appropriate intervals, having due regard to the dose and quantity specified, unless the prescriber directs otherwise. Where the intervals only are specified, the prescription may be repeated for up to six months at the stated intervals. Where the number of repeats only is specified, the prescription may be repeated at such intervals as the pharmacist deems appropriate, having due regard to the prescribed dosage. A prescription issued by a dentist may not be repeated except in the case of a prescription for sodium fluoride tablets S1C Rules An S1C preparation may only be dispensed in a hospital. The HPRA no longer assigns this legal classification to medicinal products Prescription Validity Under no circumstances should a prescription for an S1A or S1B medicine be dispensed later than six months from the date of issue Nurse Prescribing The Regulations allow registered nurse prescribers to prescribe medicinal products which would normally be given in the usual course of the service provided in the health service setting in which the nurse prescriber is employed; an exception limits the prescribing of CD2 and CD3 medicines to those listed in a Schedule to the legislation. The Department of Health and the Nursing and Midwifery Board of Ireland have drawn up a document relating to nurse prescribing called the Collaborative Practice Agreement (CPA) which outlines the parameters of nurses prescriptive authority, i.e. their scope of practice. Details are available on the Nursing and Midwifery Board of Ireland website Nurse prescribers are not authorised to prescribe unlicensed medicines or to prescribe an emergency supply. Pharmacists can make the assumption that, if a nurse prescriber prescribes a medicinal product, then they are entitled to do so under their CPA EEA/EU Prescriptions Recent amendments to the Regulations facilitate the recognition of medical prescriptions issued in another EU/EEA Member State. The amendments arise from legislative change at a European level regarding patients rights in cross-border healthcare and the recognition of medical prescriptions issued in another EU/EEA Member State. The amending Regulations provide that prescriptions from the following practitioners practising in another EEA Member State may be dispensed in Ireland: a. a registered medical practitioner; b. a registered dentist; c. a registered nurse; or

5 d. a practitioner of status equivalent to a registered medical practitioner or a registered dentist, practising in an EEA state other than the State, or a member of a regulated health profession within the meaning of Article 3(1)(a) of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 who is legally entitled to issue a prescription for the medicinal product concerned in the EEA state in which the prescription is issued, if the prescription has not been issued with a view to enabling the supply of a medicinal product by mail order. The amending Regulations also provide that for such prescriptions to be legally valid in Ireland, they must: a. be in ink or other permanent and unalterable electronic form and be signed and dated by the person issuing the prescription with his or her usual signature, either in handwriting or by electronic signature; b. clearly indicate the full name, including the full first name, of the person issuing the prescription and specify his or her professional qualification; c. specify the work address, including the name of the relevant EEA state, of the person issuing the prescription; d. specify the address, and telephone or fax number (with the appropriate international prefix) of the person issuing the prescription; e. specify the full name, including the full first name, and date of birth of the person for whose treatment the prescription is issued; and f. specify the following details, where applicable, of the product to be supplied on foot of the prescription: the common name of the medicinal product; the brand name of the medicinal product if: a) the medicinal product prescribed is a biological medicinal product, or b) the person issuing the prescription has deemed it medically necessary to include the brand name on the prescription and has stated on the prescription the reasons justifying the use of the brand name; the pharmaceutical form; the quantity; the strength of the medicinal product; and the dosage regime. Practitioners are only entitled to prescribe medicinal products for which they are legally entitled to do in the EEA state in which the prescription is issued. Furthermore, it should be noted that products classified as schedule 2 or schedule 3 controlled drugs may not be prescribed by practitioners in another EEA state for dispensing in Ireland and that such prescriptions may not be used to authorise the supply of any such controlled drug. Corresponding arrangements and requirements are applicable to outgoing prescriptions. Prescriptions issued by a prescriber not registered in a Member State of the European Union have no validity and cannot be dispensed. 1.4 Labelling of Prescribed Medicines The container must be labelled with the following particulars: date of dispensing; the name of the patient; the name and address of the pharmacy; unless the prescriber directs otherwise, the proprietary name of the preparation or the generic name with the name of the manufacturer; the directions for use and any precautions specified on the prescription;

6 whichever of the cautionary or warning notices as specified in the Fifth Schedule as the pharmacist deems appropriate; the words Keep out of the reach of children, and; in the case of a preparation for external use, the words For external use only. If the pharmacist is of the opinion that any of the particulars given on the prescription are inappropriate and is unable to get in contact with the prescriber (despite having taken such steps as are reasonably practicable in the circumstances to make), he should label the preparation with particulars of the same kind as those requested by the prescriber, as appear to him to be appropriate. 1.5 Emergency Supply A pharmacist may sell or supply a scheduled medicine without prescription in the following circumstances: At the request of a prescriber The pharmacist is requested by a prescriber (i.e. a doctor or a dentist) to supply a prescription only medicine to a particular patient and the prescriber is unable to furnish a prescription immediately by reason of an emergency; The doctor or dentist concerned undertakes to furnish a prescription within 72 hours; The preparation is supplied in accordance with the directions of the prescriber; and The medicine is not listed in Schedule 1, 2, 3 or 4 of the Misuse of Drugs Regulations, except for methylphenobarbitone, phenobarbitone or phenobarbitone sodium for use in the treatment of epilepsy At the request of a patient The pharmacist having interviewed the person requesting the medicine is satisfied that there is an immediate need to supply it and that it is impracticable in the circumstances to obtain a prescription without undue delay; A doctor must have prescribed treatment for the patient with that medicine on a previous occasion (previously prescribed by a dentist is not sufficient); The pharmacist is satisfied that he can specify the appropriate dose for the patient; and o The quantity supplied is not greater than what is required for five days treatment, except in the case of: Aerosols for the relief of asthma and pre-packed ointments and creams the smallest size available may be supplied; Antibiotics in liquid form for oral use the smallest quantity that will provide a full course of treatment may be supplied; or Oral contraceptives: - a pack for a full cycle may be supplied. The medicine is not listed in Schedule 1, 2, 3 or 4 of the Misuse of Drugs Regulations, except for methylphenobarbitone, phenobarbitone or phenobarbitone sodium for use in the treatment of epilepsy. NB. CD4 includes most benzodiazepines Labelling of Medicines Dispensed in an Emergency The container or package must be labelled with the following: the date of supply; the proprietary name or the generic name with the name of the producer; the quantity, form and strength supplied; the name of the patient; the name and address of the pharmacy; and the words Emergency Supply.

7 1.6 Pharmacy Records Each pharmacy must record all transactions involving the supply of scheduled medicines. Such transactions include prescriptions, emergency supplies, and wholesale-type transactions Prescription Records The following details must be recorded on the dispensary system: the date of supply; the name, quantity, form and strength of the product supplied; name of the prescriber, and where the prescriber is not known to the pharmacist, his address; the name and address of the patient; the date of prescription Repeat Prescription Records In addition to above, the following details must be recorded on the dispensary system: Reference number of the original entry in the register or all the particulars required for the original prescription; Where the prescription was dispensed at another pharmacy: The name and address of that pharmacy; and The reference number used by that pharmacy Endorsing of Prescriptions Where a prescription is dispensed in part, the pharmacist must record on it the quantity of each preparation supplied, the date of supply, and the name and address of the pharmacy. Where the dispensing of a prescription has been completed, namely, when no further repeats are permitted or the prescription is out-ofdate, the pharmacist must write or print on the prescription, the word dispensed and the date of dispensing and retain it for two years Emergency Supply Records In the case of medicines supplied in an emergency, the following information must also be recorded on the dispensary system in addition to that specified above: In the case of an emergency supply at the request of a prescriber, the date on which the prescription is subsequently received; In the case of an emergency supply at the request of a patient: the nature of emergency; and where the supply on the previous occasion was at another pharmacy, the name and address of that pharmacy and the prescription reference number from that pharmacy Wholesale Transaction Records Wholesale transactions include supply to another pharmacy; supply to a medical practitioner, dentist, optician, optometrist, vet; supply to a hospital, nursing home, clinic or similar institution; supply to a person who is acting as a pre-hospital emergency care provider; the return of a medicine to a wholesaler. Where written orders or invoices are not retained, the pharmacist should record: the date of supply; the name, quantity, form and strength of the medicine; the name, address, trade, business or profession of the recipient, and the purpose for which the medicine was supplied. NB. A pharmacy can only transfer medicines to another pharmacy with a view to meeting the immediate prescription needs of an individual patient unless the sending pharmacy has a wholesaler s licence.

8 1.6.6 Exemptions to Records Recording in a prescription register or the production of a daily printout (see below) is not required for the following: GMS prescriptions; the sale or supply of controlled drugs where a separate record is kept in the Controlled Drugs Register; wholesale-type transactions where a copy order form or invoice is retained at the pharmacy; supply to a sampling officer Computerised Records The Regulation of Retail Pharmacy Businesses Regulations require that patient records be kept in electronic form, i.e. on the dispensary system. The daily printout must be dated and certified by the authorised person on the day to which it relates or within 24 hours of that date Retention of Records All registers and prescriptions, GMS prescription copies, orders and invoices in respect of human medicines must be retained at the pharmacy for two years from the date of the last entry, the date of sale or supply, or the date of the last dispensing, as appropriate (NB 5 years for veterinary medicines). However, for the purposes of the Revenue, copies of all financial records, including all PCRS Summary of Claims, should be kept for a period of six years. 1.7 Expiry Dates It is an offence to sell, supply or keep for sale or supply, a preparation which has passed the manufacturer s expiry date shown on the package. An exemption may be made in exceptional circumstances where the body which has authorised the placing of the product on the market has determined that the expiry date may be extended. 1.8 Mail Order/Internet Pharmacy The Regulations prohibit the supply of all prescription only medicines by mail order and consequently by internet. Mail order or internet supply of non-prescription medicines is permitted. Supply by mail order is defined in the Regulations as meaning any supply made, after solicitation of custom by the supplier, without the supplier and customer being simultaneously present and using a means of communication at a distance, whether written or electronic, to convey the custom solicitation and the order for supply. It is also an offence for the owner or occupier of a premises to allow the premises to be used for the receipt, collection or transmission of orders or correspondence relating to the mail order supply of medicines. If it is not clear what the address of the premises is because of the use of a post office box, phone number or address, the subscriber to the server providing the post office box, telecommunication or facilities will be deemed to be the occupier of the premises. The regulations also provide that anyone who supplies a post office box, telecommunication or facilities to persons who may be illegally supplying medicines by mail order must give such information requested by Officers of the Minister for Health, the PSI, the Health Service Executive or the HPRA as is necessary to identify the subscriber concerned PSI List/Common Logo for Internet Pharmacies The Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2015 require all pharmacies and other entities engaged in internet supply of non-prescription medicines to notify the PSI of

9 their internet activities. All websites in the European Union which supply medicines online have to display a common logo. The common logo, which is recognisable throughout the EU, will provide a link to the approved supplier list for the country where the website is established; in Ireland this list is maintained by the PSI. 1.9 Supply of Medicinal Products from Vending Machines It is prohibited to supply a medicinal product from a vending machine or by means of any other mechanically or electronically controlled device of a self-service nature Supply of Medicines in Hospitals Public Hospitals The exemptions for the supply of medicines in hospitals provide that: where medicines are supplied in the course of a service provided by a hospital, a valid prescription is not required provided the supply is made in accordance with the written directions of a doctor or dentist. In the case of a hospital which is not one providing community mental health services, such medicines may be supplied by either a pharmacist or by a registered nurse; in the case of a hospital providing community mental health services to patients, registered nurses may in the course of a service provided by such a hospital, supply up to three days supply of a medicinal product in accordance with the written directions of a doctor involved in that service Private Hospitals The above exemptions do not apply to private hospitals; therefore, private hospitals must comply with the provisions of the Regulations with respect to prescriptions and control of supply Supply of Paracetamol The Regulations govern the sale and supply of medicinal products containing paracetamol Supply of Paracetamol from Pharmacies Products containing paracetamol can only be supplied on foot of a prescription except in the following circumstances, whereby supply is exempted from prescription control: For products where each single dosage unit contains more than 120mg of paracetamol but not more than 500mg, the maximum pack size that can be supplied is 24 dosage units; For products where each single dosage unit contains more than 500mg of paracetamol but not more than 600mg, the maximum pack size that can be supplied is 20 dosage units; For products where each single dosage unit contains more than 600mg of paracetamol but not more than 1000mg, the maximum pack size that can be supplied is 12 dosage units; For products intended for use in children under six years of age and which contain not more than 120mg of paracetamol per single dosage unit, the maximum pack size that can be supplied is 24 dosage units. Where such products are in liquid form and contain not more than 120mg of paracetamol per 5ml, the maximum pack size that can be supplied is 140ml; For liquid products intended for use in children over six years of age and under twelve years of age and which contain not more than 250mg of paracetamol per 5ml (other than a product to which the above applies), the maximum pack size that can be supplied is 140 ml; For liquid products that contain not more than 250mg of paracetamol per 5ml (other than those paediatric preparations referred to above), the maximum pack size that can be supplied is 240ml; Supply of any product containing paracetamol must only be conducted by a pharmacist or under his/her personal supervision.

10 There is one exception to the limits on the quantity that can be supplied detailed above. Where a pharmacist personally interviews a person requesting a product containing paracetamol and is satisfied that it is safe to do so, he/she may supply that person with up to a maximum of 50 dosage units of that product, i.e. tablets or capsules. Where the dosage unit is not a tablet, capsule or other such similar pharmaceutical form, the person can be supplied with two packs Packaging of Paracetamol Products containing paracetamol in tablet, capsule or other solid unit dosage form can only be supplied if they are blister packed or in other equivalent form of packaging as may be specified in the product authorisation. This requirement does not apply to products containing paracetamol supplied on foot of a prescription. The PSI has recommended that when a pharmacist is dispensing paracetamol and the dosage units are not blister packed, he/she should dispense the tablets/capsules in child resistant containers except where, in his/her professional judgment, this might pose excessive difficulty for the patient concerned Labelling of Paracetamol The outer packaging of paracetamol-containing products, or the immediate packaging if there is no outer packaging, must be labelled with the following unless otherwise approved by the HPRA: 1) Contains paracetamol 2) Do not take any other paracetamol containing products 3) Do not exceed the stated dose 4) Immediate medical advice should be sought in the event of overdosage, even if you feel well. Please read the enclosed leaflet carefully in cases where a package leaflet is supplied with the product and the product is intended for use mainly in adults or Immediate medical advice should be sought in the event of overdosage even if the child seems well. Please read the enclosed leaflet carefully in cases where a package leaflet is supplied with the product and the product is intended mainly for use in children not over 12 years of age. 5) Immediate medical advice should be sought in the event of overdosage because of the risk of irreversible liver damage in cases where no package leaflet is supplied with the product. The package leaflet of a medicinal product containing paracetamol must contain the following statements, unless otherwise approved by the HPRA: 1) Contains paracetamol 2) Do not take any other paracetamol containing products 3) Do not exceed the stated dose 4) Immediate medical advice should be sought in the event of overdosage because of the risk of irreversible liver damage Supply of Paracetamol from Non-pharmacies Products containing paracetamol can be supplied from outlets other than pharmacies. Such supply is restricted to products intended for oral use, containing paracetamol as the only active analgesic ingredient and in the following quantities: For products where each single dosage unit contains more than 120mg of paracetamol but not more than 500mg, the maximum pack size that can be supplied is 12 dosage units; For products where each single dosage unit contains more than 500mg of paracetamol but not more than 600mg, the maximum pack size that can be supplied is 10 dosage units; For products where each single dosage unit contains more than 600mg of paracetamol but not more than 1000mg the maximum pack size that can be supplied is 6 dosage units;

11 For products intended for use in children under six years of age and which contain not more than 120mg of paracetamol per single dosage unit, the maximum pack size that can be supplied is 12 dosage units. Where such products are in liquid form, and contain not more than 120mg of paracetamol per 5ml, the maximum pack size that can be supplied is 60ml. Not more than one pack of a paracetamol-containing product can be supplied in the course of any one retail transaction from a non-pharmacy. The supply of paracetamol-containing products from an automatic vending machine or by means of any other mechanically or electronically controlled device of a self-service nature is prohibited Black Triangle Medicines Under EU pharmacovigilance legislation, any new medicine authorised after 1 September 2013, which is subject to additional monitoring, will include an inverted black triangle accompanied by text in the package leaflet and SmPC, encouraging the reporting of adverse drug reactions (ADRs). The symbol will be used to identify the following pharmaceutical products that are subject to additional monitoring: All medicinal products authorised after 1 January 2011 that contain a new active substance; Biological medicinal products, such as vaccines or plasma derived products, authorised after 1 January 2011; and Products for which certain additional information is required post-authorisation, or for which authorisation is subject to conditions or restrictions on their safe and effective use. This monitoring list is a dynamic list and is reviewed on a monthly basis by the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC). These products are flagged on the IPU Product File and additional products from the EMA list are updated monthly. System vendors display these flagged products on screen and on pharmacy labels. 2. Misuse of Drugs Regulations 1988 to 2014 These Regulations set out the conditions under which controlled drugs may be produced, possessed, supplied, imported or exported. A consolidated version of these Regulations is available on Schedules to the Regulations Controlled drugs (CDs) are classified into five schedules with different controls applying to each. Schedule 1 (CD1) includes raw opium, coca leaf, cannabis (except Sativex) and the major hallucinogenic drugs (L.S.D. mescaline, psilocin, etc.), khat, 4-methyl aminorex and 4-hydroxytenamfetamine. CD1 substances have little, if any, therapeutic value but have a strong potential for abuse. A special licence is required for any activity in respect of these drugs. In practice, such activities are strictly limited to scientific research or forensic analysis. They are therefore of little interest to pharmacists. Schedule 2 (CD2) includes opiates such as morphine, major stimulants like the amfetamines and synthetic narcotics such as pethidine, dextromoramide, methadone, hydrocodone, dihydrocodeine tartrate, buprenorphine and dipipanone. New Regulations allow the inclusion of the following in Schedule 2: extract of cannabis which (a) is a medicinal product for human use which has been granted a marketing authorisation and which is presented as a liquid formulation for administration to a person through a meter dose pump as a mucosal mouth spray and (b), has a concentration of not more than 30 milligrams of cannabidiol per millilitre, and not more than 30 milligrams of delta-9- tetrahydrocannabinol per millilitre, where the ratio of cannabidiol to delta-9-tetrahydrocannabinol is between 0.7 to 1.3 (i.e. Sativex).

12 A licence is required for importing and exporting CD2 drugs. Those entitled to produce, supply or possess are listed. A pharmacist may supply to a patient only on receipt of a valid prescription in the requisite controlled drugs format. Record-keeping requirements (including CD register) apply in full. Safe custody provisions (see below) apply to the storage of CD2 drugs in a community pharmacy. Schedule 3 (CD3) includes most barbiturates, some potent analgesics and minor stimulants, flunitrazepam and temazepam. Whilst record-keeping requirements in a CD Register do not apply and destruction need not be witnessed, safe custody provisions do apply to these drugs, as do the controlled drug prescription requirements. Schedule 4 (CD4) includes most benzodiazepines, selegiline, phenobarbitone and methylphenobarbitone preparations containing less than 100 mg or 0.5% calculated as base. Control of these preparations is minimal and in practice they should be supplied in accordance with the Medicinal Products (Prescription and Control of Supply) Regulations, where they are classified as S1A (with the exception of selegiline (Eldepryl) which is S1B). Record-keeping in a CD register and safe custody requirements do not apply to CD4 preparations. However, it should be noted that emergency supply of CD4 substances cannot be made with the exception of phenobarbitone, methylphenobarbitone sodium for the treatment of epilepsy. Schedule 5 (CD5) includes preparations exempt from most restrictions under the Regulations. It includes inter alia: (a) preparations (but not injections) containing codeine, nicodine, nicodicodine, norcodeine, acetyldihydrocodeine, ethylmorphine and pholcodine when compounded with other ingredients and containing less than 100mg per dosage unit or not more than 2.5% in undivided preparations; (b) preparations of dihydrocodeine (not being injections) containing not more than 10mg per dosage unit or 1.5% calculated as dihydrocodeine base; (c) preparations of cocaine containing not more than 0.1% calculated as cocaine base; (d) preparations of medicinal opium or morphine, containing not more than 0.2% calculated as anhydrous morphine base; (e) preparations of diphenoxylate containing not more than 2.5mg of diphenoxylate calculated as base and a quantity of atropine sulphate equivalent to at least 1% of the dose of diphenoxylate; (f) preparations of dextropropoxyphene for oral administration containing not more than 135mg of dextropropoxyphene. 2.2 General Prohibitions for CDs A person shall not produce, supply, offer to supply, import, export or possess a controlled drug unless he is authorised to do so. A person may be authorised by virtue of: a general authority, e.g. practitioners, pharmacists; a licence; or registration. 2.3 Importing/Exporting CDs Practitioners or pharmacists require a licence to import or export CD2 and CD3 drugs. Exports of controlled drugs must be properly documented and related shipping documentation must properly identify the drug.

13 2.4 Production and Supply of CDs The following, when acting in his capacity as such for the purpose of his profession or business, may manufacture or compound, and supply or offer to supply a CD2, CD3, CD4 or CD5 drug to any person who may lawfully have that drug in his possession: a practitioner; or a pharmacist; or a person lawfully keeping open shop under the Pharmacy Acts for the dispensing or compounding of medical preparations and for the sale of poisons at the premises at which he keeps open shop. 2.5 Supply of CDs The following when acting in their capacity as members of their class may supply any CD2, CD3, CD4 or CD5 drug to any person who may lawfully have that drug in his possession: a) the matron (or acting matron) of a hospital or nursing home which is maintained by public funding or voluntary subscriptions, where the drug is in the form of a medical preparation (and only in the case of an institution where a pharmacist is not employed); b) the ward sister (or acting sister) of such a hospital or nursing home, where the drug is in the form of a medical preparation and supplied to her in accordance with the Regulations; c) a person in charge of laboratory, engaged in scientific education or research; d) the State Chemist; e) the Director of the Forensic Science Laboratory; f) a public analyst duly appointed; g) the Medical Director of the HPRA; h) an inspector of the HPRA; i) a person engaged in an official drug testing scheme; j) an inspector under Section 65 of the Health Acts; k) an inspector of the PSI. 2.6 Wholesalers and Suppliers of CDs A person who supplies a CD2 or CD3 drug to a community pharmacy or a hospital must furnish a receipt with each consignment of such drug. This must be checked by the recipient, any deviations noted, dated and signed by him and returned to the supplier within three working days. 2.7 Possession of CDs It is unlawful for a person to have a CD2 or CD3 drug in his possession unless: a. he possesses a general authority (for example, he is a practitioner or a pharmacist); or b. he holds an appropriate licence from the Minister; or c. he is a member of an authorised class and such possession conforms with the terms of his authority; or d. in the case of CD3 or CD4 drugs, his name appears on a Register kept for the purpose by the Minister. Persons in category (c) include the following: a patient to whom the drug has been lawfully supplied on foot of a valid prescription; the matron or acting matron of a hospital or nursing home (see special conditions above); a ward sister or acting ward sister in a hospital or nursing home (see special conditions above); a person in charge of a laboratory, the recognised activities of which consist of, or include, the conduct of scientific education or research, and which is attached to a hospital or a university; the State chemist; a public analyst; the Medical Director of the HPRA;

14 a person engaged in an official drug testing scheme; a sampling inspector under the GMS scheme; an inspector of the PSI; inspectors under section 65 of the Health Acts; the owner or master of a ship (see special conditions below); the manager of an off-shore installation (see conditions below); the Director of the Forensic Science Laboratory of the Department of Justice; persons authorised as members of a group. The following are entitled to have controlled drugs in their possession only when acting in their capacity as members of their class. They are not entitled, however, to be supplied, as an individual, except otherwise as provided for in the Regulations: a. a member of the Garda Síochána acting in the course of his duty; b. an officer of Customs and Excise acting in the course of his duty; c. a person engaged in the work of any laboratory to which the drug has been sent for forensic examination; d. a person authorised in writing by the Minister under Section 14 of the Act; e. a person engaged in conveying the drug to a person authorised to have it in his possession; f. a postman or bona fide carrier. NB: A person who is lawfully in possession of a controlled drug may supply that drug to a person for whom he obtained it. A person is not in lawful possession of a controlled drug if he obtained it on a prescription which he obtained: by a false statement or declaration; or by not disclosing to a practitioner that he was being supplied by, or on the prescription of, another practitioner. NB: A special licence is required by anyone to possess a CD1 drug. 2.8 Licence for CDs The Minister for Health may grant a licence to a person not covered by a general authorisation to produce, supply or offer to supply, import or export, or have in his possession any controlled drug to which the licence refers. 2.9 Administration of CDs Any CD2, CD3 or CD4 drug or preparation may be administered to a patient only by, or under the direction of, a registered medical practitioner, a registered nurse or a registered dentist CD Safe Regulation 4(4) of the Retail Pharmacy Businesses Regulations 2008 states that the pharmacy owner shall provide and maintain a safe or cabinet that meets the requirements of Regulation 5 of the Misuse of Drugs (Safe Custody) Regulations 1982, as amended. The regulation also states that the pharmacy owner shall ensure that the safe has a sufficient capacity to permit the orderly storage and safe keeping of all relevant controlled drugs Option A Regulation 5 of the Misuse of Drugs (Safe Custody) Regulations 1982, as amended, indicates that a person shall not install a safe or cabinet for the custody of controlled drugs unless such safe or cabinet complies with the specifications set out in the standard specification for Burglar-Resistant Cabinets for the Storage of

15 Controlled Drugs 1985 (I.S. 267:1985). Cabinets purporting to comply with the requirements of the specification I.S 267:1985 are permanently and legibly marked with the following information: a. The manufacturer s name and address b. The capacity of the cabinet in cubic metres c. The type approval test reference number d. The inscription I.S. 267: 1985 Enquiries have indicated that safes are not currently being manufactured with the above inscription. Therefore Option B is the only valid option available at present Option B Regulation 6(2)(b) of the Misuse of Drugs (Safe Custody) Regulations 1982, as amended, provides that a member of an Garda Síochána (not below the rank of Superintendent) may, on receipt of an application in writing, inspect or cause to be inspected, any safe or cabinet in which controlled drugs are kept. The member of an Garda Síochána (not below the rank of Superintendent) should certify that the safe or cabinet provides a degree of security which, in his opinion, in all the circumstances of the case is at least equivalent to the relevant requirements. A certificate is then issued which will remain in force for a period of two years. A template certificate can be downloaded from The following is a summary of the requirements in relation for a CD safe: The safe must be constructed of pressed and welded sheet steel metal or pressed and welded steel mesh, welded upon an angle iron frame of at least 25mm by 25mm and of at least 5mm thickness. The safe shall be rigidly and securely fixed to a wall or floor by two rag-bolts passing through an anchor plate of mild steel 3mm in thickness with a surface area of at least 19,335mm 2. The wall or floor to which it is attached must be constructed of solid brick, concrete block or mass concrete or sufficient thickness, depth and strength to provide a secure anchor. The door must have an effective lock of at least 5 different levers or at least 6 pins in a pin and tumbler mechanism, be designed to permit at least 1000 effective key differs independent of wards or any other fixed obstruction to the movement of the keys, be provided with a dead-bolt which is either of mild steel of at least 19mm by 8mm section or incorporates a suitable anti-cutting device and which has a total throw of a least 12mm Labelling of CDs Except when supplied on a prescription, the bottle or package containing a CD2 or CD3 drug must be clearly marked with: the amount of drug therein in the case of raw drugs; or either the number of dosage units and the amount of controlled drug in each, or the total amount of controlled drug in each, or the total amount and the percentage of each controlled drug present in the case of preparations Prescriptions for CDs It is unlawful for a practitioner to issue, or for a pharmacist to dispense a prescription for a CD2 or CD3 drug unless it complies with the following requirements. The prescriber must be also satisfied as to the identity of the patient. The prescription must: a. be in ink or otherwise so as to be indelible and signed by the practitioner with his usual signature and dated by him; b. except in the case of a GMS prescription, specify the address of the person issuing it;

16 c. specify (in the prescriber s own handwriting) the name and address of the person for whose treatment it is issued or, if issued by a registered veterinary surgeon, the name and address of the person to whom the prescribed drug is to be delivered. (In the case of a patient in a hospital or nursing home, the address of the patient need not be specified provided the prescription is written on the patient s bed card or case sheet); d. clearly indicate the name of the person issuing it and state whether that person is a registered medical practitioner, registered dentist, registered veterinary surgeon or registered nurse prescriber; e. specify a telephone number at which the prescriber may be contacted; f. specify (in the prescriber s own handwriting) (i) the dose to be taken, (ii) the form in the case of preparations, (iii) the strength (when appropriate) and (iv) in both words and figures, either the total quantity of the drug or preparation or the number of dosage units to be supplied; g. in the case of a prescription for a total quantity intended to be dispensed by instalments, specify the quantity, the number of instalments and the intervals to be observed when dispensing. NB. In the case of methadone for opiate-dependent patients, (c) and (f) are not required to be in the prescriber s own handwriting Dispensing of CDs A pharmacist dispensing a prescription for a CD2 or CD3 drug must ensure that it conforms to the requirements listed above and that: a. the address of the prescriber as written on the prescription is one within the State; b. he is acquainted with the signature of the prescriber and has no reason to believe it is not genuine, or else takes reasonable steps to ensure that is genuine; c. the prescription is not dispensed before the date specified on it or later than 14 days afterwards; d. in the case of a prescription to be dispensed by instalments, the first instalment is not dispensed later than 14 days from the date on the prescription and no instalment is dispensed later than two months after that date; e. he is satisfied of the identity of the patient or patient s representative as appropriate; f. the date of supply is marked on the prescription and on each occasion an instalment is supplied; g. the prescription or duplicate copy of a GMS prescription is retained on the premises for two years Forged or Altered CD Prescriptions The Act prohibits the possession of either a forged prescription or an altered prescription. The Regulations permit such possession where a person in doing so prevents another from committing or continuing to commit an offence and intends to deliver it into the custody of the Garda Síochána or to an Inspector of the PSI Requisitions for CDs A pharmacist who supplies a controlled drug other than on a prescription to any of the following must obtain a requisition, in writing, before the drug is delivered: a. a practitioner; b. the matron of a hospital or nursing home (see under hospitals); c. a person who is in charge of a laboratory; d. the owner or master of a ship (see under ships); e. the installation manager of an off-shore installation (see off-shore installations). The requisition must in all cases be in writing and: a. be signed by recipient; b. state his name, address and occupation;