Controlled Drugs Lecture 3 PDF

Controlled Drugs Medicines Act 1981 Medicines Regulations 1984 Misuse of Drugs Act 1975 and associated Regulations Misuse of Drugs Regulations 1977 Controlled Drugs Controlled Drugs (CDs) include medicines available on prescription from a health professional. Prescribing of controlled drugs is more...

Controlled Drugs Medicines Act 1981 Medicines Regulations 1984 Misuse of Drugs Act 1975 and associated Regulations Misuse of Drugs Regulations 1977 Controlled Drugs Controlled Drugs (CDs) include medicines available on prescription from a health professional. Prescribing of controlled drugs is more tightly controlled than prescribing of other medicines, reflecting the need to restrict access to, and minimise the misuse of, controlled drugs. Misuse of Drugs Act 1975 The classification of a drug under the Act is determined by broad criteria concerning the risk of harm the drug poses to individuals or to society by its misuse. Drugs posing a very high risk of harm are classified as Class A, Those posing a high risk of harm are classified Class B, and Those posing a moderate risk of harm are classified as Class C. Misuse of Drugs Act 1975 More detailed criteria that must be considered in assessing the risk of harm are listed in section 4B(2) of the Act: 1) The likelihood or evidence of drug abuse, including such matters as the prevalence of the drug, levels of consumption, drug seizure trends, and the potential appeal to vulnerable populations. 2) The specific effects of the drug, including pharmacological, psychoactive, and toxicological effects. Misuse of Drugs Act 1975 (cont.) More detailed criteria that must be considered in assessing the risk of harm are listed in section 4B(2) of the Act: 3) The risks, if any, to public health. 4) The therapeutic value of the drug, if any. 5) The potential for use of the drug to cause death. 6) The ability of the drug to create physical or psychological dependence. 7) The international classification and experience of the drug in other jurisdictions. 8) Any other matters that the Minister of Health considers relevant. Misuse of Drugs Act 1975 (cont.) – Class A Class A classification is limited to the most serious drugs requiring severe restrictions. The category has been described by Dr Bob Boyd, Ministry of Health Chief Advisor, as “reserved for substances that one doesn’t want to see in the country at all, and to presume that somebody in possession is either going to harm themselves or somebody else quite severely.” Misuse of Drugs Act 1975 (cont.) – Class A Currently, thirty-seven substances are listed as Class A in the First Schedule to the Act; these include cocaine, heroin, LSD, phencyclidine (‘angel dust’ or ‘PCP’), thalidomide, amphetamine substances (MDA, MMDA) and most recently methamphetamine. The penalties for offences involving Class A drugs extend to a maximum term of life imprisonment for manufacture, importation and supply offences. Misuse of Drugs Act 1975 (cont.) Drug offences and penalties The Act provides a statement of liability for offending in relation to controlled substances and imposes different maximum penalties depending on the classification of the substance in question. Misuse of Drugs Act 1975 (cont.) Drug offences and penalties The Act’s main focus is to restrict the illicit use of controlled drugs; however, it does allow exemptions for the appropriate use of drugs for mostly therapeutic and medical purposes. Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 & Misuse of Drugs Regulations 1977 Medical Practitioner Nurse Practitioner A Midwife A Dentist Designated Prescriber Nurse Designated prescriber Pharmacist Veterinarian ALL must be NZ registered. Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 & Misuse of Drugs Regulations 1977 Medical Practitioner Nurse Practitioner Not more than 7 days after the date of prescription for all Class B. First Dispensed within 6 months of prescribing, but within 3 months for subsidy for all Class C. Class B: maximum period of supply is 1 month (30 days) – Triplicate Prescription Form (H572) - handwritten. However, all class B CD (i.e., oxycodone & morphine) can be prescribed for a supply for up to 3 months (90 days) if the prescription is issued and transmitted using NZePS. Class C: maximum period of supply is 3 months (90 days). No special prescription form is required. Misuse of Drugs Amendment Regulations (No 2) 2023 Medical Practitioner Nurse Practitioner From 5 October 2023 all opioids classified under the Misuse of Drugs Act 1975 can be prescribed for a maximum amount that is required for one month of treatment (regulation 21(5D)(a)). This limit of one month will apply to Class A, B, and C opioids. This limit will apply to all controlled drug prescribers (medical practitioners, nurse practitioners, designated prescriber nurse, designated prescriber pharmacists, midwives, and dentists). However, this does not impact the specific controlled drugs that some groups of prescribers are authorised to prescribe. Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 & Misuse of Drugs Regulations 1977 Dentists For Class B and C: for a maximum period of 7 days (1 week) Only subsidised for 5 days treatment. Every controlled drug Prescription Form must state ‘for dental treatment only’. May NOT authorise any repeats. They don’t use NZePS system. Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 & Misuse of Drugs Regulations 1977 Midwives (an Authorised Prescriber) For the treatment of a patient under their care. Midwives may only prescribe pethidine, morphine, tramadol or fentanyl. Maximum period of supply is 1 month (30 days). They don’t use NZePS system. Every controlled drug Prescription Form must state ‘for midwifery use only’. First Dispensed no more than 4 days after the date of the prescription. May only authorise 1 repeat at a specified interval. Note: They may not prescribe any other controlled drugs, such as codeine and benzodiazepines. Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 & Misuse of Drugs Regulations 1977 Pharmacist Prescribers (a Designated Prescriber) Designated Nurse Prescribers (a Designated Prescriber) For the treatment of a patient under their care. Class B and C: maximum period of supply is 3 days. First Dispensed not more than 7 days after the date of prescription. Misuse of Drugs Amendment Regulations (No 2) 2023 From 5 October 2023 all opioids classified under the Misuse of Drugs Act 1975 can be prescribed for a maximum amount that is required for one month of treatment (regulation 21(5D)(a)). This limit of one month will apply to Class A, B and C opioids. This limit will apply to all controlled drug prescribers (medical practitioners, nurse practitioners, designated prescriber nurse, designated prescriber pharmacists, midwives, and dentists). However, this does not impact the specific controlled drugs that some groups of prescribers are authorised to prescribe. Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 & Misuse of Drugs Regulations 1977 Veterinarians For the treatment of an animal under their care (NOT ALLOWED TO TREAT HUMANS) First Dispensed not more than 7 days after the date of prescription for Class B. Prescriptions for Class C Controlled Drugs are valid for 180 days (6 months). Class B: maximum period of supply is 1 month (30 days). Class C: maximum period of supply is 90 days (3 months). Every Prescription Form must state “for animal treatment only” Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 & Misuse of Drugs Regulations 1977 Veterinarians Veterinarians are not required to prescribe controlled drugs on a Triplicate Prescription Form. No veterinary prescriptions are funded (not subsidised by the Ministry of Health). The owner must pay the full price. Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 & Misuse of Drugs Regulations 1977 Veterinarians A prescription relating to the treatment of an animal (written by a veterinarian) must contain (in addition to all other legal requirements of the prescription) the following information: 1) The surname, each given name of the animal owner 2) The address of the animal owner Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 & Misuse of Drugs Regulations 1977 Optometrists and Dietitians have NO prescribing rights for Controlled Drugs (Class C & Class B). Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 & Misuse of Drugs Regulations 1977 Notes specific to NZePS A NZePS controlled drug Prescription Form is not a legal controlled drug Prescription Form until the barcoded Prescription Form has been downloaded from the electronic Prescription Form repository (the NZePS broker). The controlled drug may not be Dispensed if the Prescription Form is unable to be downloaded. Any Provider can Dispense a barcoded controlled drug Prescription Form as long as the above criteria are met. It is not the responsibility of the Provider to have to check if the Prescriber is from a practice with MoH approval to issue controlled drug barcode Prescription Forms. Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 & Misuse of Drugs Regulations 1977 Pseudoephedrine and Ephedrine Pseudoephedrine, ephedrine, methylphenidate and dexamfetamine are scheduled as Class B2 controlled drugs, and Ministerial Approval is required before these Pharmaceuticals can be prescribed or supplied. Listed below are the circumstances under which approval are considered met. Further information can be found on the Medsafe website: Medicines with Restrictions (medsafe.govt.nz) Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 & Misuse of Drugs Regulations 1977 Pseudoephedrine and Ephedrine Prescriptions must only be written by medical practitioners registered with the Medical Council of New Zealand under the Health Practitioners Competence Assurance (HPCA) Act 2003. No other Prescriber including veterinarians may write a Prescription Form for ephedrine or pseudoephedrine, unless they have a specific written authority from the Director General of Health. Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 & Misuse of Drugs Regulations 1977 Prescribing Dexamfetamine Prescriptions of dexamfetamine may only be written by: Medical practitioners with a vocational scope of practice of Paediatrics or Psychiatry, registered with the Medical Council of New Zealand under the Health Practitioners Competence Assurance (HPCA) Act 2003, for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD); or Medical practitioners with a vocational scope of practice of Internal Medicine, registered with the Medical Council of New Zealand under the HPCA Act 2003, for the treatment of narcolepsy; or Any other medical practitioner registered with the Medical Council of New Zealand (“registered Medical Practitioner”), or nurse practitioner practising within their area of practice, when acting on the written recommendation of one of the vocationally registered medical practitioners described above, for the conditions specified. Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 & Misuse of Drugs Regulations 1977 Prescribing Methylphenidate Prescriptions of methylphenidate may only be written by: Medical practitioners with a vocational scope of practice of Paediatrics or Psychiatry, registered with the Medical Council of New Zealand under the Health Practitioners Competence Assurance (HPCA) Act 2003, for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD); or Medical practitioners with a vocational scope of practice of Internal Medicine, registered with the Medical Council of New Zealand under the HPCA Act 2003, for the treatment of narcolepsy; or Any other medical practitioner registered with the Medical Council of New Zealand (“registered Medical Practitioner”), or nurse practitioner practising within their area of practice, when acting on the written recommendation of one of the vocationally registered medical practitioners described above, for the conditions specified. Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 Class B & Class C Controlled Drugs have different prescribing & dispensing requirements. Class B: Oxycodone, Fentanyl, Morphine, Methadone, Methylphenidate and Dexamfetamine. Class C: All Benzodiazepines (Benzos) such as Diazepam, Clonazepam, Lorazepam and Oxazepam. Codeine is also Class C Controlled Drug. General requirements in relation to prescriptions - Misuse of Drugs Regulations 1977 Part 5 - Misuse of Drugs Regulations 1977 (SR 1977/37) (as at 22 December 2022) – New Zealand Legislation Controlled Drugs – dispensing. How long must controlled drug information be held after dispensing? Pharmacies are required to retain on the licensed premises the pharmacy copy of dispensed controlled drug prescriptions for 4 years, and Controlled Drugs Registers for 4 years after the date of last entry, as required by Regulation 42 of the Misuse of Drugs Regulations 1977. Every pharmacy must have controlled drug register. Controlled Drugs – dispensing. Controlled Drugs - NZePS Let’s have a look at Pharmacy Procedure Manual & Controlled Drugs ePrescriptions Important Legislation Changes from 22nd December 2022 Controlled-Drug-LegislationUpdate-Dec-2022.pdf (pegasus.health.nz) Where would store all Controlled Drugs belonging to Class B and Class C2? Answer: Drugs Safe or Locked Safe Any Questions?