PHARMACY HOUSE 124 DIXON STREET PO BOX 11 640 WELLINGTON NEW ZEALAND TELEPHONE 04 802 0030 FAX 04 382 9297 EMAIL p.society@psnz.org.nz WEBSITE www.psnz.org.nz 29 September 2010 Clerk of the Health Committee Select Committee Secretariat Parliament Buildings Wellington Submission to the Misuse of Drugs Amendment Bill 2010 from the Pharmaceutical Society of New Zealand September 2010 The Pharmaceutical Society and its Role and Functions The Pharmaceutical Society of New Zealand Inc is the professional association representing over 3,000 pharmacists, from all sectors of practice (community, hospital, academic, industry and PHOs). We provide to pharmacists professional support and representation, training for continuing professional development, and assistance to enable them to deliver to all New Zealanders the best pharmaceutical practice and professional services in relation to medicines. The Society focuses on the important role pharmacists have in medicines management and in the safe and quality use of medicines. The Society wishes to appear before the Select Committee and make oral submissions. Those who would like to appear are: Chief Executive Mr Richard Townley, and Chief Pharmacist Advisor Mr Euan Galloway. Contact details are; Mr Euan Galloway Pharmaceutical Society of New Zealand Inc 124 Dixon Street PO Box 11 640 Wellington Phone: 04 802 0032 Email: e.galloway@psnz.org.nz
Clause 6 To Reclassify Ephedrine and Pseudoephedrine Controlled Drugs as Class B2 The Pharmaceutical Society appreciates the reason why the government wishes to impose stricter controls on the supply of these medicines which are currently Class C controlled drugs. We acknowledge there is currently a major social problem with methamphetamine (P) misuse, but respectfully point out that it is methamphetamine that is the problem, not pseudoephedrine. The diversion of pseudoephedrine for illicit drug manufacture is of concern to pharmacists, as it is to the whole community. Ephedrine is currently a Class C5 controlled drug which requires the prescription of an authorised prescriber (such as a doctor) before it can be supplied or administered to any person. It currently has no therapeutic use, though in the past has been used to treat asthma and, inappropriately, by bodybuilders to burn off unwanted body fat. The Pharmaceutical Society has no interest in ephedrine and we will concentrate our submission on pseudoephedrine (PSE). Pseudoephedrine is currently a Class C3 controlled drug and sustained release forms are Class C5. Both ordinary and sustained release formulations have supply exemptions through the definition of a 'partially exempted drug' in regulation 2 of the Misuse of Drugs Regulations 1977. The Pharmaceutical Society queries the need for Parliament to use a Misuse of Drugs Amendment Bill to control the supply of pseudoephedrine. Most members speaking in the first reading of this Bill spoke of the reclassification having the effect of removing the over the counter (OTC) availability of preparations containing pseudoephedrine from pharmacies which will ensure that it is available only with a prescription from a medical practitioner. This was also stated in the recently published Report on Organised Crime in NZ 2010 "Forthcoming legislative changes that intend to make pseudoephedrine a prescription only medicine aim to significantly reduce domestic diversion." If that is the intent of the Bill a better method could be to, by Order in Council, revoke regulation 20(3) of the Misuse of Drugs Regulations 1977 and, consequently, amend regulation 20(2)(a) and subsection (b) of the 'partially exempted drug' interpretation in regulation 2. It is regulation 20(3) that permits pseudoephedrine in the current OTC cough and cold preparations to be sold in the circumstances set out in the definition of 'pharmacy only medicine' in section 3 of the Medicines Act 1981. Without regulation 20(3) and the extended definition of a partially exempted drug, pseudoephedrine has to be prescribed by an authorised prescriber. Shifting pseudoephedrine to Class B2 will bring it under the provisions of regulation 22 of the Misuse of Drugs Regulations which imposes extremely strict controls on who it may prescribed to. Regulation 22 prohibits the prescription, supply or administration of Class B2 controlled drugs (and Classes A, B1 and C1) except to the extent and in the circumstances approved by the Minister either generally or in relation to any particular case or class of cases. What exemptions will the Minister impose? This question needs serious consideration by the Health Committee and advice given to the Minister to permit its prescription by medical practitioners. Its supply will
be prohibited unless the Minister approves the circumstances generally or in relation to particular cases. for its use either We note in the 'Preferred Option' section of the Regulatory Impact Statement to this Bill that "As with other Class B2 controlled drugs, Ministerial approval (delegated to Medsafe) would be required before a medical practitioner could prescribe pseudoephedrine to an individual patient". Is this the intent of the Bill? If so, then it is inconsistent with the statements made by members in the first reading. Speakers to the first reading of the Bill spoke exclusively about the use of pseudoephedrine in treating the symptoms of colds and the flu. Pseudoephedrine has other important therapeutic uses to clear blocked eustachian tubes in the ears of air travellers and underwater divers, and in the treatment of priapism a side effect of treatment with prescribed erectile dysfunction and prostate enlargement (BPH) medicines. Priapism is the presence of a persistent, usually very painful, erection of the penis unrelated to sexual stimulation or desire. It is a medical emergency and pseudoephedrine is the antidote. Before treatment of this adverse event can begin will the Minister or Medsafe have to be contacted to approve its use in the patient? The Expert Advisory Committee on Drugs and Sir Peter Gluckman, the Prime Minister's Science Advisor, have stated that effective alternative remedies to pseudoephedrine are available. The experience of many consumers is that this is not so. We would support greater restrictions if an equally effective oral decongestant with less abuse potential was available to replace it. There is more to P than over the counter pseudoephedrine. The Pharmaceutical Society does wish to point out to the Health Committee that the OTC sale of pseudoephedrine is not the only source of precursor materials for the manufacture of methamphetamine. There is the extensive illegal importation of pseudoephedrine (such as ContacNT) that bypass our border controls, and the supply of the various chemicals and chemical equipment required to convert pseudoephedrine into P. Nor will additional controls on pseudoephedrine affect the illicit manufacture of methamphetamine by other means, such as the reductive amination of P2P (phenyl 2 propanone) through catalytic hydrogenation using Adams Catalyst as described at the Australian National Chemical Diversion Congress November 2008 and at www.erowid.org/archive/rhodium/chemistry/meth.louisfreeh.html which do not require pseudoephedrine as an ingredient. We note that both pseudoephedrine and ephedrine are already listed as precursor substances in Schedule 4 of the Misuse of Drugs Act 1975. Therefore it is currently an offence to knowingly supply them for use in the commission of an offence under the dealing with controlled drugs provisions of the Act. The Pharmaceutical Society believes that implementation in New Zealand of a real time decision support tool such as Project STOP to monitor pharmacy based requests for and sales of pseudoephedrine containing products, would have been the most effective instrument to reduce the illicit diversion of pseudoephedrine for manufacture of methamphetamine, whilst maintaining its availability for those with a legitimate
therapeutic need for the medicine. We are disappointed the Government did not accept the very generous offer of the Pharmacy Guild of Australia to provide free of charge for a period of one year access to their Project STOP programme. Project STOP addresses many of the issues and concerns that plague current activities pharmacists undertake to ensure purchases for illegitimate purposes are minimal, while enabling access for genuine therapeutic purposes. By allowing real time evaluation of the identification presented by purchasers, it can provide pharmacists with a level of comfort when deciding whether or not to allow pseudoephedrine sales, and can avoid them making more subjective value judgements based on things such as appearance of the purchaser. The fact that Project STOP enables data immediately to be viewed by all those participating makes the scheme very responsive a most important benefit, both to the next pharmacy down the road and to the Police. The Pharmaceutical Society of New Zealand: 1. Recommends that clauses 6, 7(1), 7(2), 8 and 9 of the Bill be removed. 2. Recommends as an alternative that the exemption requirements for non prescription sale or supply be strengthened by amending in regulation 20 (3)(a) of the Misuse of Drugs Regulations 1977 the reference to 'pharmacy only medicine' to 'restricted medicine' in section 3 of the Medicines Act. This will have the effect of making low dose small packs of pseudoephedrine a 'pharmacist only medicine' with the special legislative responsibilities that controls the sale, record keeping and storage of those medicines. 3. Recommends as a further alternative if the recommendation above is not acceptable, to revoke regulation 20(3) of the Misuse of Drugs Regulations 1977 and, consequently, amend regulation 20(2)(a) and subsection (b) of the partially exempted drug interpretation in regulation 2. This will have the effect of requiring the prescription of an authorised prescriber (such as a medical practitioner, dentist, veterinarian, or designated prescriber authorised to prescribe it) before pseudoephedrine can be supplied or administered to any person. Clause 5 and Clause 10 Removal of Thalidomide as a Class A Controlled Drug The Pharmaceutical Society supports the removal of thalidomide from the Schedules of the Misuse of Drugs Act 1975 and instead schedule it as a prescription medicine under the Medicines Act 1981. While it is important there are controls in place for its safe use regarding pregnancy, scheduling it as a Class A controlled drug is not necessary as it has no potential to be misused for a psychoactive effect. The Minister has given consent to its use in New Zealand only with an approved risk management programme in place, which is currently operated by the distributor/sponsor. Whereas previously thalidomide was exempt from the provisions of the drug driving provisions of the Land Transport Act 1998, this amendment and subsequent proposed reclassification by Gazette notice will now capture it under the "any prescription medicine' section (b)(ii) of the definition of a qualifying drug in section 2(1). Is this intended? 4
Conclusion Thank you for the opportunity to make a submission. wish to discuss technical aspects of it. I am available should any official Euan Galloway B Pharm, FPS, FHPA, MNZCP, ED Chief Pharmacist Advisor Pharmaceutical Society of New Zealand Inc