Citation: Ministry of Health Consultation on Proposed Amendments to Regulations under the Medicines Act Wellington: Ministry of Health.

Transcription

1 Consultation on Proposed Amendments to Regulations under the Medicines Act 1981

2 Citation: Ministry of Health Consultation on Proposed Amendments to Regulations under the Medicines Act Wellington: Ministry of Health. Published in February 2010 by the Ministry of Health PO Box 5013, Wellington 6145, New Zealand ISBN (Online) HP 5058 This document is available on the Ministry of Health s website:

3 Foreword This discussion paper seeks your input on a set of proposals to amend regulations under the Medicines Act These proposals are part of a larger project to modernise the regulatory framework for therapeutic products to ensure there are adequate safeguards for consumers of therapeutic products while reducing barriers to innovation in the health sector. The proposals are also consistent with the Government s commitment to review existing regulations in order to identify and remove requirements that are unnecessary, ineffective or excessively costly. The proposed amendments address a number of long-standing and pressing issues. The Ministry and Minister of Health will carefully consider feedback from stakeholders, and final decisions on the proposals will be taken around the middle of the year. Any approved changes will come into effect in the second half of Please take the time to consider the proposed amendments and send in your feedback. Deborah Roche Deputy Director-General Health and Disability Systems Strategy Directorate Ministry of Health. Consultation on Proposed Amendments to Regulations under the Medicines Act 1981 iii

4 How to make a submission The Ministry of Health is seeking submissions on the proposals in this paper in order to update certain provisions in regulations under the Medicines Act Please send your submission to: Regulations under the Medicines Act 1981 Consultation Policy Unit Health and Disability Systems Strategy Directorate Ministry of Health PO Box 5013 Wellington 6145 or medregs@moh.govt.nz The closing date for submissions is 26 March A submission form and complete list of questions is provided as a separate document on the Ministry of Health website: A report on the analysis of submissions will be prepared and published on the Ministry website ( in due course. iv Consultation on Proposed Amendments to Regulations under the Medicines Act 1981

5 Contents Foreword How to make a submission iii iv Introduction 1 Background 1 What does this discussion paper cover? 1 THE PROPOSED AMENDMENTS 2 PART 1: Proposals to reduce unnecessary costs, remove barriers to innovation and improve access to medicines Exclude some fluoride dentifrices and some anti-dandruff products from regulation under the Medicines Act Amend the labelling requirements for medicines and related products Amend the advertising requirements Enable electronic transmission of prescriptions Align prescribing rights for medical practitioners, dentists and midwives Extend the period of supply of prescription medicines Restrict prescribing for patients who are not in New Zealand Allow pharmacists to substitute an alternative brand of a medicine in certain circumstances Amend the requirements for countersigning records of supply or administration of a medicine under a standing order Allow sale of general sale medicines by vending machine 15 PART 2: Updating technical requirements Amend requirements for data sheet content, format and publication Amend definitions relating to pharmacy qualifications Revoke the regulation on colouring substances permitted to be used in medicines Update requirements for prescriptions Update dispensing requirements 21 Consultation on Proposed Amendments to Regulations under the Medicines Act 1981 v

6 vi Consultation on Proposed Amendments to Regulations under the Medicines Act 1981

7 Introduction Background In New Zealand, medicines and medical devices are regulated by the Medicines Act 1981 and the regulations that sit under it, most notably the Medicines Regulations 1984 and the Medicines (Standing Order) Regulations This discussion paper seeks your input on a set of proposals to amend regulations under the Medicines Act These proposals are part of a larger project to modernise the regulatory framework for therapeutic products to ensure there are adequate safeguards for consumers of therapeutic products while reducing barriers to innovation in the health sector. They are also consistent with the Government s commitment to review existing regulation in order to identify and remove requirements that are unnecessary, ineffective or excessively costly. What does this discussion paper cover? This paper sets out proposals designed to address a number of issues that can be dealt with through amendments to the Medicines Regulations 1984 and the Medicines (Standing Order) Regulations Other changes to the regulatory framework that would require amendments to the Medicines Act 1981 (eg, changes to the prescribing framework to establish a new category of collaborative prescriber or amend the status of existing delegated prescribers) are not being progressed at this time and are not discussed in this paper. Changes that would require amendments to the Misuse of Drugs Act 1975 and Misuse of Drugs Regulations 1977 are also not included in this paper because the Misuse of Drugs Act 1975 is being reviewed separately by the Law Commission. The proposals in this paper fall into two groups. The first group (set out in Part 1) are changes aimed at reducing unnecessary costs, removing barriers to innovation and improving access to medicines. The second group (set out in Part 2) are changes of a more technical nature that are expected to have minimal regulatory impact. They are largely aimed at aligning regulatory requirements with what has become normal practice over the years since the regulations were developed. Throughout the paper, any reference to the Regulations refers to the Medicines Regulations 1984 and the Act to the Medicines Act 1981, unless otherwise specified. Consultation on Proposed Amendments to Regulations under the Medicines Act

8 THE PROPOSED AMENDMENTS PART 1: Proposals to reduce unnecessary costs, remove barriers to innovation and improve access to medicines 1.1 Exclude some fluoride dentifrices and some anti-dandruff products from regulation under the Medicines Act 1981 Part 7 of the Act (sections 94 to 96) provides for cosmetics, dentifrices 1 or foods that have a therapeutic purpose to be regulated as related products (as defined in the Act) and specifies that certain provisions apply to related products as if they were medicines. Most fluoride toothpastes and mouthwashes and some anti-dandruff products fall within the definition of related product in section 94 of the Act because they are primarily cosmetics (eg, for cleaning teeth), do not contain any scheduled medicines 2 and have a therapeutic purpose (eg, preventing dental decay). Anti-dandruff shampoos and conditioners with only general claims about cleansing the hair, and fluoride toothpastes containing up to 0.15 percent fluoride with only general fluoride claims, are currently regulated as related products. Some dentifrices are considered to be medicines because they contain higher levels of fluoride (making them scheduled medicines) or derive their therapeutic effects from ingredients other than fluoride (eg, potassium nitrate for the treatment of tooth sensitivity). Similarly, some anti-dandruff products are considered medicines because they contain ingredients that are scheduled medicines. In some cases, such products are considered medicines because of the nature of the therapeutic claims made for the product. Pre-market approval of new products and notification of changes to existing products is required for related products. Manufacturers of fluoride toothpastes and mouthwashes and anti-dandruff products find these requirements onerous, particularly given the lowrisk nature of the products, the number of different variants marketed and the fact that regulation under therapeutic product legislation is not the norm in other jurisdictions. Cosmetics that contain a hazardous substance are covered by a Cosmetic Products Group Standard under the Hazardous Substances and New Organisms (HSNO) Act 1996, which was last updated in July Compliance with the Cosmetic Products Group Standard is considered to provide adequate assurance of the safety of those dentifrices and anti-dandruff products that are currently regulated as related products. The regulation-making powers in section 105(1)(i) of the Act enable the making of a regulation to declare that something is not a related product for the purposes of the Act. 1 Powders or pastes used for cleaning teeth. 2 Scheduled medicines are those that contain one or more ingredients listed in the First Schedule to the Medicines Regulations Consultation on Proposed Amendments to Regulations under the Medicines Act 1981

9 A declaration of this type means that such products would not be subject to any of the requirements of the Act or Regulations. It is proposed that a new regulation be made under section 105(1)(i) declaring that: dentifrices containing fluoride below the 0.15 percent level specified in Part 3 of the First Schedule to the Medicines Regulations 1984, and for which only general fluoride claims are made and anti-dandruff shampoos that do not contain a scheduled medicine and for which only dandruff treatment claims are made are not related products for the purposes of the Act. Dentifrices containing higher levels of fluoride or other active ingredients, or that make claims other than fluoride claims, would continue to be regulated as related products or medicines, as they are at present. Anti-dandruff products containing scheduled medicines or intended for the treatment of scalp conditions other than dandruff would continue to be regulated as medicines, as they are at present. Impacts of the proposal Removing the requirement for suppliers of certain fluoride dentifrices and certain antidandruff products to obtain consent to distribute their products under the Act will significantly reduce regulatory and compliance costs for suppliers. This may result in a wider range of products being marketed in New Zealand. Industry will also benefit through shorter lead times to enter the market because regulatory delays will no longer be a factor. Question 1 Do you agree that fluoride dentifrices and anti-dandruff preparations should no longer be regulated as related products under the Act? If not, why not? Question 2 Do you think compliance with the Cosmetic Products Group Standard provides adequate assurance about the safety of these products? If not, what alternative would you suggest? Please detail your alternative, give reasons for supporting that alternative and describe the impacts of the alternative you are suggesting. Question 3 Are there any other types of products you consider should be excluded from regulation under the Medicines Act? If so, why should they be excluded and how should they be regulated instead? What would be the impact of excluding these products? Consultation on Proposed Amendments to Regulations under the Medicines Act

10 1.2 Amend the labelling requirements for medicines and related products Part 4 of the Medicines Regulations 1984 (regulations 12 25) specifies the requirements for labelling medicines, related products and medical devices. These regulations cover matters such as the information that must be on a label and the position of certain information on a label. Problems arise where these requirements are not aligned with labelling requirements in other jurisdictions. Because the New Zealand market is small and most medicines are sourced from overseas, such labelling requirements can lead to additional costs (associated with having a product specifically labelled for the New Zealand market) or restrict the range of medicines able to be marketed in New Zealand (because it is not possible to get product labelled to meet our specific requirements). Where such situations arise, product suppliers may request an exemption from specific labelling requirements. These requests are considered by Medsafe on a case-by-case basis and an exemption is issued provided use of the non-compliant label is not considered to raise safety issues. Specific issues Requirement for a consumer information panel Regulation 20 requires that certain labelling statements be grouped on one portion of the label, known as the consumer information panel, which is clearly differentiated and conspicuously placed on the label. Although the same information is required to be on labels in other jurisdictions, it is not required to be grouped on a specific panel of the label. Consequently, labels on imported medicines may not comply with the detailed New Zealand requirements. Labelling of individually wrapped dose units such as transdermal patches Individually wrapped dosage units such as pessaries and transdermal patches are not small containers as described in the Regulations. Consequently, each wrapped dosage unit must be labelled with all of the information required on a medicine label. The individually wrapped units are then enclosed in a fully labelled box. The current labelling requirements are not aligned with other countries, such as Australia, which means labels on imported medicines might be non-compliant. Other countries permit a minimum information set on the pouch provided the remaining information is given on the label of the box and the individually wrapped dosage units are not taken out of the box for sale as individual items. The minimum information that, from a safety perspective, is needed on an individually wrapped dosage unit is the name of the medicine, the name and quantity of each active ingredient, the batch number and expiry date, so long as the remaining information is given on the label of the box. Warning statement on antihistamines Regulation 22 specifies that the label of any medicine containing an antihistamine must include a sedation warning. This requirement was set prior to the development of nonsedating antihistamines and is therefore outdated. To overcome this anomaly, 4 Consultation on Proposed Amendments to Regulations under the Medicines Act 1981

11 medicines containing non-sedating antihistamines have in practice been required, as part of the consent process for the medicine, to be labelled with the following warning (or words of similar meaning): Although this medicine is unlikely to affect your ability to drive or operate machinery, a few people may be impaired and care should be taken. The following amendments to the labelling provisions in the Regulations are proposed. Revoke regulation 20, thereby removing the requirement for certain information to be placed in a specific consumer information panel on the label of a medicine intended for retail sale without a prescription. The requirement for a label on an over-thecounter medicine to include a statement of the purpose for which the medicine is recommended would be retained. Insert a new regulation allowing medicines that are supplied as individually wrapped dosage units such as lozenges, pessaries, single doses of a powder or liquid, or a patch to be labelled with the name of the medicine, the name and quantity of each active ingredient, the batch number and expiry date, provided the box enclosing the individual dosage units is fully labelled in accordance with the Regulations. Amend regulation 22(1) so that it only applies to medicines containing a sedating antihistamine, and add a new subclause specifying an appropriate warning statement for medicines containing non-sedating antihistamines. Impacts of the proposal The proposed changes to labelling requirements are expected to benefit medicine suppliers through increased efficiency and reduced costs due to not having to prepare separate labels for New Zealand or make requests for labelling exemptions, and to benefit Medsafe through decreased time spent considering requests for labelling exemptions. Question 4 Do you support each of the proposed changes to the labelling requirements? If not, why not? What alternative changes would you prefer to see? Please detail your alternative, give reasons for supporting that alternative and describe the impacts of the alternative you are suggesting. Question 5 Are there other changes you consider should be made to labelling requirements for medicines and related products? Please detail the changes, your reasons for supporting those changes and the impacts of the changes you are suggesting. Consultation on Proposed Amendments to Regulations under the Medicines Act

12 1.3 Amend the advertising requirements Regulation 8 of the Regulations requires every advertisement for a medicine (other than a label or a price list) to include specified mandatory information about the active ingredients and uses of the medicine and its precautions, contra-indications and adverse reactions. The current requirements for advertisements for medicines that are directed at consumers are not harmonised with those applying to advertisements for nonprescription medicines in Australia. Consequently, separate copy must be developed for use in the two countries, resulting in higher costs for advertisers of non-prescription medicines. Because direct-to-consumer advertising of prescription medicines is not permitted in Australia, New Zealand advertisers need only comply with the New Zealand requirements. In addition, some of the information requirements in regulation 8 are difficult or costly to convey in some types of advertising (eg, television, radio or reminder advertisements) and are not necessarily appropriate for other types of advertising, such as point-of-sale advertising (shelf-talkers, etc) or on promotional items such as pens. Alternative approaches to conveying information and cautions about a medicine are being used in Australia and have been the subject of earlier consultations in New Zealand. They are based on the idea that consumers should be directed to read content and warning information on the label of the product before making a decision to buy the medicine. Because this approach is not available in the case of mail order or internet sales, such advertisements require additional information to enable the consumer to be adequately informed before making a purchasing decision. It is proposed that regulation 8 be amended in order to: expand the current set of types of advertisements that do not require mandatory information ( excluded advertisements ) by adding point-of-sale advertisements (such as shelf-talkers) and promotional items (such as pens), providing they do not include a therapeutic claim specify that the mandatory requirements for advertisements (other than excluded advertisements) are: the statement Always read the label or words of similar meaning the statement Use only as directed or words of similar meaning specify that advertisements (other than excluded advertisements) for pharmacist-only medicines include the statement Your pharmacist s advice is required or Available only from your pharmacist specify that advertisements (other than excluded advertisements) for nonprescription medicines must also include: the statement If symptoms persist see your doctor / health care professional or words of similar meaning a warning statement about any known serious adverse effects, or contraindications in a known group of people 6 Consultation on Proposed Amendments to Regulations under the Medicines Act 1981

13 specify that advertisements for prescription medicines (other than excluded advertisements) must also include: the words Prescription Medicine or words of similar meaning advice that this medicine has risks and benefits appropriate and prominent warning statements about the contra-indications and major risks associated with use of the medicine these should be stated in a manner that is relevant to, and easily understood by, the consumer advice on how consumers can access more detailed information about the risks and benefits of the medicine retain the requirement that advertisements for the supply of medicines by mail order, direct mail or the internet include the name and quantity of each active ingredient. Impacts of the proposal The proposal is expected to make it easier for companies to use the same advertising copy in New Zealand and Australia. This would have the positive impact of reducing the direct costs of advertising as well as reducing compliance costs associated with amending advertising copy to meet New Zealand requirements. The proposal does not, however, address barriers to harmonisation that arise from detailed requirements in the Medicines Act. The proposal is not expected to have any impact on patient safety. Question 6 Do you support the proposed changes to the advertising requirements? If not, why not? Question 7 Are there other changes you consider should be made to the advertising requirements? Please detail the changes, give reasons for supporting those changes and describe the impacts of the changes you are suggesting. 1.4 Enable electronic transmission of prescriptions Electronic transmission of prescriptions between prescribers and pharmacists is an important element of the Health Information Strategy s epharmacy component and considerable progress has been made on the development of standards for the electronic exchange of information in the health sector. Existing requirements for prescriptions set out in regulation 41 of the Regulations are based on the use of paper prescriptions that must be indelibly printed and signed by the prescriber. The Regulations do not envisage prescriptions being electronically transmitted, and there is no provision for standards to be set for electronic transmission. While it would be possible to amend regulation 41 to remove references to printed prescriptions and handwritten signatures, it would not be possible to mandate any Consultation on Proposed Amendments to Regulations under the Medicines Act

14 standards for electronic transmission of prescriptions without changes to primary legislation. It is not, therefore, considered appropriate to make such amendments at this time. Regulation 43(a) enables the Director-General to issue a waiver in respect of compliance with the requirements of regulation 41 in special circumstances, subject to any requirements the Director-General thinks fit. Applications for the granting of a waiver under regulation 43(a) need to be considered on a case-by-case basis to assess the nature of the special circumstances and determine any other requirements that should apply. This can be a complex and lengthy process. It is proposed that, in order to facilitate implementation of electronic transmission of prescriptions, regulation 43 should be amended to remove the term in special circumstances. Regulation 43(a) would then be amended to state that the form of prescription authorised under the waiver could include (but would not be limited to) an electronic form. This would enable a set of criteria for applicants and a standard set of requirements to be established, and waivers to be granted to applicants who met those criteria and could demonstrate an ability to fulfil the specified requirements. The requirements could include, for example, compliance with a specified standard. This would provide transparency for applicants and reduce the complexity of the task of considering waiver applications on a case-by-case basis. The criteria and requirements could be published (and therefore be readily accessible to prospective applicants) and could be updated as necessary (eg, as new standards are developed or new systems implemented). Impacts of the proposal The proposal is expected to enable a mechanism to be developed that will reduce the amount of time applicants need to spend preparing an application for a waiver that will allow them to progress initiatives that involve electronic transmission of prescriptions between prescribers and pharmacists. There would be some costs associated with becoming familiar with the application process and requirements and with preparing applications. However, these costs should be more than offset by the time saved in preparing applications and the reduced waiting time for a decision to be made on a waiver application compared with the time currently taken for case-by-case consideration. This may lead to earlier implementation of electronic prescribing initiatives that can improve efficiency for prescribers and pharmacists. 8 Consultation on Proposed Amendments to Regulations under the Medicines Act 1981

15 Question 8 Do you support the proposed amendments to regulation 43, coupled with the development of clear criteria and standard requirements for the issue of waivers, as a way to enable electronic transmission of prescriptions to proceed in the short term, until more extensive provisions can be included in primary legislation? If not, why not? What alternative mechanism would you suggest? Please detail your alternative, give reasons for supporting that alternative and describe the impacts of the alternative you are suggesting. 1.5 Align prescribing rights for medical practitioners, dentists and midwives Regulation 39 of the Regulations specifies the conditions under which prescription medicines may be prescribed. They specify that: medical practitioners may prescribe only for the treatment of patients under their care dentists may prescribe only for the dental treatment of patients under their care midwives may prescribe only for antenatal, intrapartum and postnatal care those authorised to prescribe prescription medicines by regulations under the Act (currently nurse practitioners and optometrists, who are designated prescribers) must prescribe within their scope of practice. A practitioner s scope of practice refers to the range of services the practitioner is competent to provide and the parameters within which such services can be offered. Under the Health Practitioners Competence Assurance Act 2003 (HPCAA), health professionals are required to operate within their particular scope of practice. This includes prescribing where they are permitted by law to prescribe prescription medicines. The conditions under which the different groups of prescribers may prescribe prescription medicines are framed differently in the Regulations because some pre-date the scope of practice concept and have not been updated since the Regulations came into force in For medical practitioners there is no reference to a scope of practice in the Regulations. For dentists the restriction is to prescribing for dental treatment only, and for midwives the reference is to antenatal, intrapartum and postnatal care. Given that scopes of practice for these three groups are defined by the Medical Council, Dental Council and Midwifery Council, respectively, each of which is established under the HPCAA, it would be sensible for the Regulations to also require each group to prescribe within their scope of practice. This would align the way in which prescribing conditions for medical practitioners, dentists and midwives are expressed in the Regulations, as well as aligning the Regulations with the HPCAA. Whether or not it would permit dentists or midwives to prescribe medicines they would not currently be permitted to prescribe would depend on Consultation on Proposed Amendments to Regulations under the Medicines Act

16 the way in which the scope of practice was defined. For example, the Regulations would no longer prohibit a dentist from prescribing, for example, a gastro-protective medicine when this was indicated for a patient requiring a non-steroidal anti-inflammatory. However, such prescribing would still only be permitted if it fell within the dentist s scope of practice. It is proposed that the requirements for dentists to prescribe prescription medicines for dental treatment only and for midwives to prescribe prescription medicines for antenatal, intra-partum or postnatal care only be removed, and that medical practitioners, dentists and midwives be required to prescribe within their scope of practice as defined by their councils established under the HPCAA. Impacts of the proposal Patients may benefit from this proposal if using the scope of practice to define prescribing rights results in dentists or midwives being able to prescribe medicines that would currently have to be prescribed by a medical practitioner. If this were to be the case, patients would benefit by having to pay only one consultation fee and having their overall treatment managed by a single health practitioner. This could result in an increase in the number of items prescribed by dentists and/or midwives. However, this should be offset by a corresponding decrease in items prescribed by medical practitioners. Question 9 Do you agree that the Regulations should be amended so that prescribing rights for medical practitioners, dentists and midwives are aligned and are governed by the practitioner s scope of practice? If not, why not? What alternative changes (if any) would you suggest? Please detail the changes, give reasons for supporting those changes and describe the impacts of the changes you are suggesting. 1.6 Extend the period of supply of prescription medicines Regulation 39 of the Regulations permits medical practitioners, midwives, nurse practitioners and optometrists to prescribe up to three months supply of a prescription medicine at a time (or up to six months supply in the case of an oral contraceptive). A dentist may prescribe for a total period of 10 days (five days, with a repeat of five days). There are two issues relating to the limitations on period of supply in regulation 39. Firstly, given that the HPCAA requires that dentists prescribe within their scope of practice, as must other health practitioners, there appears to be no justification for maintaining this difference in the Regulations. Secondly, there are some circumstances in which the three-month supply limit is problematic for prescribers and patients. For example, when missionaries or armed 10 Consultation on Proposed Amendments to Regulations under the Medicines Act 1981

17 forces personnel are travelling to remote areas for extended periods there is currently no provision for the three-month limit to be waived so that patients can lawfully obtain the prescription medicines they require during their period of absence from New Zealand. It is proposed that regulation 39(4) be amended to allow dentists to prescribe treatment for a period of three months, as for all other authorised prescribers. It is also proposed that provision be made for the Director-General to waive the threemonth limit in special circumstances. Impacts of the change The proposal to align the period of supply under a dentist s prescription with that for other health practitioners may have a positive impact for the small number of people who require an extended period of treatment for a dental condition. In such a case, there would be fewer prescriptions to be issued, dispensed and collected, without any increase in the total amount of medicine used. The proposal to allow the three-month supply limit to be waived in special circumstances is expected to benefit people travelling to remote areas and those prescribing for them, as it will provide a proper mechanism for obtaining adequate quantities of the medicines they require for ongoing conditions. Question 10 Do you agree that dentists prescribing timeframes should be extended and brought into line with other prescribers? If not, why not? Question 11 Do you agree that it would be appropriate to extend the limits on supply of prescription medicines in the proposed circumstances? If not, why not? Question 12 Are there other circumstances in which you think the period of supply should be extended beyond three months (or six months for an oral contraceptive)? Please specify the circumstances and the impact of the changes you are suggesting. 1.7 Restrict prescribing for patients who are not in New Zealand Regulation 39(1) of the Regulations permits medical practitioners to prescribe prescription medicines for the treatment of patients under their care. The Regulations do not define what under the care of the medical practitioner means in this context. Some New Zealand doctors have become involved in issuing prescriptions for people in other countries who have submitted treatment requests via the internet. The medicine is Consultation on Proposed Amendments to Regulations under the Medicines Act

18 then prescribed by the doctor in New Zealand (on the basis of information provided over the internet), dispensed and sent to the patient. This may be putting the health of the overseas patient at risk, but it is the role of regulatory authorities in their own country to control access to medicines, including those coming into the country by post. Sourcing medicines through New Zealand is an attractive proposition for patients in other countries because in many cases prices are lower in New Zealand. This activity also poses a risk to New Zealand patients through the potential loss of supply of certain medicines. If large volumes of a particular product are used to fill prescriptions for patients in other countries, there may be insufficient stock available to treat New Zealanders. Alternatively, pharmaceutical companies may withdraw products from the New Zealand market to avoid a situation where they are supplying into the New Zealand market at a lower price (because of the funding arrangements in place here), then seeing those products re-sold at a higher price to patients in other countries where the products are already available (albeit at a higher price). Medical practitioners must be able to prescribe for people who are in New Zealand, even temporarily. There are also limited circumstances in which it may be necessary for a medical practitioner to issue a prescription for a patient who is normally resident in New Zealand and under their care, but is temporarily overseas. Whether prescriptions written in such circumstances are covered under the Pharmaceutical Schedule is a separate issue. However, prescribing for a patient who has never lived in New Zealand is not considered appropriate. It is proposed that, in addition to the requirement for a patient to be under the care of the prescriber, there is a requirement for the patient to be in New Zealand at the time the prescribing occurs, or normally resident in New Zealand but temporarily overseas at the time the prescribing occurs. Impacts of the proposal It is expected that prescribers and consumers will benefit from a reduction in the risk of products being lost from the New Zealand market. Doctors and pharmacists currently exploiting this loophole in the legislation will no longer be able to do so lawfully. Question 13 Do you support the requirement for the patient to be in New Zealand when prescription medicines are prescribed for them (or normally resident in New Zealand but temporarily overseas)? If not, what alternative measures (if any) do you suggest? Please detail your alternative, give reasons for supporting that alternative and describe the impacts of the alternative you are suggesting. 12 Consultation on Proposed Amendments to Regulations under the Medicines Act 1981

19 1.8 Allow pharmacists to substitute an alternative brand of a medicine in certain circumstances Regulation 42(4) of the Regulations requires a pharmacist to dispense the brand of medicine specified by the prescriber, unless the prescriber sanctions substitution of another brand. Prescribers are permitted to issue substitution authorities to allow pharmacists to substitute in specified circumstances. While some prescribers choose to do this, many don t, with the consequence that the pharmacists must seek their authority to substitute a different brand whenever a substitution is required. There are a number of circumstances in which substitution may be required, such as where a discontinued or temporarily unavailable brand of medicine has been prescribed, or where changes to subsidy rules mean that a patient would otherwise have to pay the full cost of the prescribed brand. Prescribing of non-subsidised brands is common (because computer systems have not been updated to show changes in subsidy rules) but is usually not intentional. Seeking authority to substitute on a case-by-case basis is inefficient for both the pharmacist and the prescriber, and not substituting can be costly for the patient. Consultation on the issue in 2002 indicated that many supported substitution by pharmacists, along with suggestions that it should be subject to certain conditions (such as the two brands being interchangeable) or only permitted in certain situations (such as the prescribed medicine being unavailable). Since 2002 the prescribing landscape has changed and PHARMAC has instituted sole supply arrangements for a number of medicines. This has tended to increase the number of instances where the pharmacist is required to contact the prescriber to seek authority to substitute in order to supply a subsidised brand to the patient. Consideration of the efficacy of generic medicines is part of the pre-market approval process for manufactured medicines and is generally established by reference to the innovator product or market leader. If a new generic medicine is not considered to be interchangeable with another brand, this must be stated on the medicine s data sheet, providing pharmacists with the information they need to determine whether it would be safe to make a substitution without seeking authorisation from the prescriber. In certain circumstances a prescriber (or patient) may wish a particular brand to be supplied. This could be catered for by allowing a prescriber to mark the prescription to indicate that substitution is not authorised. It is proposed that regulation 42(4) be amended to allow a pharmacist to substitute an alternative brand of a prescribed medicine (but not a different medicine) provided: there are no clinical reasons why substitution should not occur the prescriber has not marked the prescription with a statement such as no brand substitution permitted and Consultation on Proposed Amendments to Regulations under the Medicines Act

20 the pharmacist records details of the brand substitution on the prescription and informs the patient of the change of brand. Impacts of the proposal This proposed change would improve efficiency for prescribers and pharmacists by enabling pharmacists to make a substitution without seeking authorisation from the prescriber in circumstances where the prescribing of an unsubsidised or discontinued brand was unintentional. Consumers could also be expected to benefit from this increased efficiency. Prescribers and their patients would benefit from being able to specify a particular brand and prevent substitution where this was considered important. Question 14 Do you agree that substitution should be allowed under the proposed conditions? If not, why not and what alternative provision for substitution would you suggest? Please detail your alternative, give reasons for supporting that alternative and describe the impacts of the alternative you are suggesting. 1.9 Amend the requirements for countersigning records of supply or administration of a medicine under a standing order Under regulation 8 of the Medicines (Standing Order) Regulations 2002, the issuer of a standing order is required to countersign the record of every supply or administration of a medicine occurring under that order. This requirement for countersigning is seen as problematic in areas such as the ambulance service, where paramedics administer medicines under a standing order given by the medical director, and countersigning every record of administration or supply imposes a significant administrative burden. Consultation undertaken in 2006 indicated that there was strong support for introducing more flexibility around this requirement. At that time stakeholders considered that the need for countersigning should be at the discretion of the person issuing the standing order and should be specified in the order, provided there was regular monitoring of the practices of all persons working under the order. No changes were made to the Medicines (Standing Order) Regulations 2002 as an outcome of the 2006 review. It is proposed that the Medicines (Standing Order) Regulations 2002 be amended to require an authorised prescriber issuing a standing order to specify the arrangements for countersigning, including specifying: when countersigning is and is not required who may supply and/or administer treatments under the order without countersigning being required on each occasion; and 14 Consultation on Proposed Amendments to Regulations under the Medicines Act 1981

21 the interval at which the issuer of the order will review the practices of those working under the order. Impacts of the proposal This change is expected to significantly reduce the time taken by the issuer of a standing order to countersign a potentially large number of records of administration or supply under the order. Question 15 Do you agree with the proposal to allow the issuer of a standing order to determine the circumstances in which countersigning of administration records is required? If not, why not? What alternative (if any) would you suggest? Please detail your alternative, give reasons for supporting that alternative and describe the impacts of the alternative you are suggesting Allow sale of general sale medicines by vending machine Section 18(4) of the Act prohibits the sale of medicines by means of an automatic vending machine except as permitted by regulations made under the Act. Regulation 59 of the Regulations allows chemical contraceptives, which are general sale medicines, to be sold via vending machines when they are supplied with condoms. There have been no regulations made to permit vending machine sales of other general sales medicines. However, such medicines are commonly sold from outlets such as supermarkets, dairies, petrol stations and other mixed-merchandise stores where there is no special supervision of the storage or sale of the medicines. Vending machines can provide storage that is out of reach of young children and make it more difficult for a consumer to buy multiple packs of a medicine. They can also be placed in locations such as lobbies or waiting areas where there is no retailer operating, thus improving consumer access to general sale medicines. The risk arising from the supply of medicines from vending machines, which are securely sealed units dispensing one pack of medicine at a time, is likely to be less than the risk arising in retail outlets where storage and sale are unsupervised. It is proposed that regulation 59 be revoked and a new regulation made to permit the sale of unscheduled (general sale) medicines by vending machine. This would continue the permission for the sale of chemical contraceptives by vending machine (because they are general sale medicines), but they would no longer need to be supplied with condoms. Consultation on Proposed Amendments to Regulations under the Medicines Act

22 Impacts of the proposal This proposal is expected to benefit consumers by providing access to commonly used general sale medicines at a wider range of locations. It would also benefit vending machine operators, who have for some time sought to extend the range of products they can offer to include a small range of medicines. Sales from retail outlets such as supermarkets may reduce slightly, although this is likely to remain a convenient way for consumers to purchase medicines. If vending machines are placed in public areas of hospitals and medical centres, this may reduce the sales of general sale medicines through pharmacies. The extent to which vending machine sales replace sales from other retailers is likely to depend to a large extent on product price. Question 16 Do you agree that unscheduled medicines should be able to be sold by vending machine? If not, why not? Question 17 What do you consider would be the impact on businesses of allowing unscheduled medicines to be sold by vending machine? Question 18 Are there any particular limitations you consider should be placed on vending machine operators? Please specify. 16 Consultation on Proposed Amendments to Regulations under the Medicines Act 1981

23 PART 2: Updating technical requirements 2.1 Amend requirements for data sheet content, format and publication Regulations 51, 53 and 54 and Schedule 3 of the Regulations specify the physical format and content for a data sheet. Regulation 52 requires that data sheets be approved by the Director-General and that copies of the approved data sheet be sent to the Director-General for distribution to interested persons. The requirements for data sheets are based on the concept of paper documents that may be distributed to users for storage in ring binders or published in a compendium. However, for some time it has been accepted practice for data sheets to be submitted electronically and published on the Medsafe website. New Zealand suppliers would need to reformat prescribing information used internationally in order to comply with the prescriptive requirements for the headings, layout and content specified in the Regulations. The use of alternative formats is not seen as a safety issue, and for some time data sheets using the Australian or other formats have been accepted. Regulation 52 requires that data sheets be forwarded to the Director-General for approval after consent for distribution of the medicine has been granted. In practice, a draft data sheet is submitted as part of a new medicine application and is considered and approved as part of the new medicine approval process. This means that the data sheet can be published by the time the medicine is placed on the market. It is proposed that: regulation 51 be amended to define data sheet as the prescribing information relating to a particular medicine and to remove reference to a data sheet compendium regulation 52 be replaced with a regulation that requires the approved data sheet for a medicine to be submitted to Medsafe, in the format required for publication on the Medsafe website, not less than 10 working days before the medicine (whether a new or changed product) is placed on the market regulations 53 and 54 and Schedule 3 be revoked, and guidance on the content and layout of data sheets be provided in guidelines published by Medsafe. Impacts of the proposal The impact of this proposal is likely to be minimal because the changes would align the Regulations with current practice. Consultation on Proposed Amendments to Regulations under the Medicines Act

24 Question 19 Do you support the proposed changes to the Regulations in relation to data sheets to bring them into line with current practice? If not, why not? What alternative would you suggest? Please detail your alternative, give reasons for supporting that alternative and describe the impacts of the alternative you are suggesting. Question 20 Do you agree that the content and format of data sheets should be specified in guidelines rather than in the Regulations? 2.2 Amend definitions relating to pharmacy qualifications A number of the definitions in regulation 2 (Interpretation) of the Regulations that refer to qualifications held by people in pharmacy-related practice areas are outdated. They refer to old legislation (such as the Pharmacy Regulations 1975) or to qualifications that are no longer awarded or relevant. It is proposed that definitions in regulation 2 be amended as follows: dispensary technician a person who holds a certificate issued by the Pharmaceutical Society of New Zealand before 18 September 2004 that classifies the holder as a dispensary assistant, or records that the person has completed the requirements of the Pharmacy Technician s Certificate pharmacy graduate a person who is not a pharmacist, but who has a qualification prescribed by the Pharmacy Council under section 12(1) of the Health Practitioners Competence Assurance Act 2003 as a qualification necessary to practise in the profession of pharmacy and who is actively taking steps towards registration with the Pharmacy Council as a pharmacist under the Health Practitioners Competence Assurance Act pharmacy student a person who is undertaking, but has not yet completed the course or examinations leading to, a qualification of a kind stated by the Pharmacy Council, for the purposes of section 12(2)(a) or (b) of the Health Practitioners Competence Assurance Act It is proposed that the definition of approved school be removed from regulation 2 as this term will no longer be used in other definitions and will therefore be redundant. It is also proposed that the definition of Dispensary Assistant s Certificate be removed as this certificate is no longer issued or relevant, making the definition redundant. 18 Consultation on Proposed Amendments to Regulations under the Medicines Act 1981

25 Impact of the proposal The proposed changes would remove some redundant definitions and align other definitions with current terminology for pharmacy-related qualifications. This will provide clarity and align the Regulations with current practice, but is not expected to have any impact in practical terms. Question 21 Do you support the above changes to definitions relating to pharmacy qualifications? If not, why not? Question 22 Are there any other definitions in regulation 2 that you think should be updated? Please provide details, give reasons why you think the changes are necessary and describe the impact of those changes. 2.3 Revoke the regulation on colouring substances permitted to be used in medicines Regulation 6 of the Regulations lists the colouring substances that are permitted in medicines and related products. It also allows other colours to be used if the colour has been considered as part of the pre-market approval process for the product. This list is outdated and does not reflect current international practice regarding the use of colouring substances. Consideration of the safety of a colouring substance is part of the pre-market approval process for manufactured medicines. For products extemporaneously compounded, the chance of a pharmacist using an inappropriate colouring substance is considered to be minimal (given the difficulty in obtaining colouring substances other than those in common use) and the risk low (given the small number of patients treated with extemporaneously compounded medicines and the ethical obligation on pharmacists to supply medicines that are safe and fit for purpose). It is proposed that regulation 6 be revoked. Medsafe would instead maintain an up-todate list of acceptable colouring substances in regulatory guidelines published on the Medsafe website. Impact of the proposal This change is likely to provide some benefit to those manufacturing or compounding medicines because they will have ready access to a current list of colouring substances considered suitable for use in medicines. Consultation on Proposed Amendments to Regulations under the Medicines Act