Controlled Drugs - Summary PDF

Preview

Summary

Summary...

Description

Controlled Drugs - an Introduction

• • •

Medicines, Ethics and Practice: The professional guide for pharmacists Ed 39 British National Formulary (BNF) Legislative Framework

• Misuse of Drugs Act 1971 • Misuse of Drugs Regulations 2001 • Misuse of Drugs (Safe Custody) Regulations 1973 • Misuse of Drugs and Misuse of Drugs (Safe Custody) (amendment) Regulations 2007 • Misuse of Drugs (Supply to Addicts) Regulations 1997 • The Controlled Drugs (Supervision of Management and Use) Regulations 2006 also • Medicines Act 1968/Human Medicines Regulations 2012 • Health Act 2006 (introduced concept of ‘accountable officer’ & SOPs) •

Controlled Drugs and drug dependence

•

The Misuse of Drugs Act, 1971 prohibits certain activities in relation to ‘Controlled Drugs’, in particular their manufacture, supply, and possession. The penalties applicable to offences involving the different drugs are graded broadly according to the harmfulness attributable to a drug when it is misused and for this purpose the drugs are defined in the following three classes: Class A includes: alfentanil, cocaine, diamorphine (heroin), dipipanone, lysergide (LSD), methadone, methylenedioxymethamfetamine (MDMA, ‘ecstasy’), morphine, opium, pethidine, phencyclidine, remifentanil, and class B substances when prepared for injection Class B includes: oral amfetamines, barbiturates, cannabis, cannabis resin, codeine, ethylmorphine, glutethimide, ketamine, nabilone, pentazocine, phenmetrazine, and pholcodine Class C includes: certain drugs related to the amfetamines such as benzfetamine and chlorphentermine, buprenorphine, diethylpropion, mazindol, meprobamate, pemoline, pipradrol, most benzodiazepines, tramadol, zaleplon, zolpidem, zopiclone, androgenic and anabolic steroids, clenbuterol, chorionic gonadotrophin (HCG), non-human chorionic gonadotrophin, somatotropin, somatrem, and somatropin

• • •

•

Offences under the Misuse of Drugs Act 1971 Act include

Act prohibits certain activities in relation to Controlled Drugs, in particular their manufacture, possession and supply • possession of a Controlled Drug unlawfully • possession of a Controlled Drug with intent to supply it • supplying or offering to supply a controlled drug (even where no charge is made for the drug) • allowing premises you occupy or manage to be used for the purpose of drug taking • drug trafficking (supply) attracts serious punishment including life imprisonment To enforce this law the police have special powers to stop, detain and search people on ‘reasonable suspicion’ that they are in possession of a controlled drug • •

Who is this man? Dr Shipman

• • • • • • • • •

Harold Frederick Shipman (14 January 1946 – 13 January 2004) was a British doctor and one of the most prolific serial killers in recorded history It has been proved that he murdered up to 250 people (80% were women and his youngest victim was a 41 year old man) Shipman is the only British doctor who has been found guilty of murdering his patients. Much of Britain's legal structure concerning health care and medicine was reviewed and modified as a direct and indirect result of Shipman's crimes. http://www.theguardian.com/society/2005/aug/25/health.shipman Controlled Drugs recent changes Shipman Inquiry has led to the publication of 6 reports making wide ranging recommendations on the steps considered necessary to protect patients in the future (www.the-shipman-inquiry.org.uk) The fourth report, The Regulation of Controlled Drugs in the Community, made a series of recommendations around improving the systems in place to ensure the safe and appropriate use of CDs The Government response to this report, Safer management of controlled drugs: the Government’s response to the fourth report of the Shipman inquiry (www.dh.gov.uk), sets out a framework to modify the arrangements for the monitoring and inspection of CDs across all health and social care environments in the UK

•

Controlled Drugs Misuse of Drugs Regulations 2001 (as amended)

•

The Act imposes a total ban on possession, supply, etc of these drugs, except as allowed by the Regulations

•

The Regulations define classes of person who are authorised to possess and supply while acting in their professional capacity and sets out conditions under which these activities may be carried out

• •

Drugs are divided into 5 Schedules Controlled Drugs Misuse of Drugs Regulations 2001 (as amended)

Schedule 1 - drugs that are not used for medicinal purposes (e.g. cannabis, LSD etc) Schedule 2 – including opiates (morphine, diamorphine) and major stimulants such as amphetamines Schedule 3 – barbiturates (except secobarbital [quinalbarbitone]), buprenorphine, midazolam, temazepam, tramadol and minor stimulant drugs Schedule 4 – Part I: benzodiazepines; ketamine Part II: anabolic and androgenic steroids, and some other related hormones Schedule 5 – drugs where there is a lower risk of abuse than other schedules - it includes certain preparations containing Schedule 2 CDs such as codeine, dihydrocodeine, pholcodine, morphine, Common medicines in this schedule include: Oramorph solution 10mg/5ml; Kaolin and Morphine Mixture BP The classification may depend on the strength of the controlled substance in the preparation.

• •

Identification of Controlled Drugs in the BNF Exercise: BNF 68 page 8 look at the symbols that identify the different schedules of controlled drugs in the BNF Note: no symbol for schedule 5 What is the legal classification of the following?

    

Actiq® Lozenges – CD2 Transtec® Patches- CD3 Oramorph® Oral Solution 10mg/5ml- POM Oramorph® Concentrated Oral Solution 100mg/5ml- CD2 Tramadol 50mg Capsules- CD3

•

Controlled Drugs Misuse of Drugs Regulations 2001 (as amended)

•

Schedule 1 (CD licence): • have no recognised medicinal use* and include hallucinogenic drugs • examples include coca leaf, LSD and mescaline • production, possession and supply of these drugs are limited to research or other special purposes. • practitioners and pharmacists may not lawfully possess Schedule 1 drugs except under licence

• •

* Note: Sativex – now Schedule 4 Part 1 having previously been Schedule 1; required to keep records for a minimum of 2 years •

Controlled Drugs Misuse of Drugs Regulations 2001 (as amended)

•

Schedule 2 (POMs) • Controlled Drug prescription requirements • NO repeats allowed on prescription • NO emergency supplies • safe custody requirements (except quinalbarbitone • (secobarbital)). • record keeping (CD Register) requirements Schedule 3 (POMs) • Controlled Drug prescription requirements • NO repeats allowed on prescription • NO emergency supplies (except phenobarbitone for epilepsy) • Most exempted from safe custody requirements (except temazepam, buprenorphine, diethylpropion,flunitrazepam) • NO record keeping (CD Register) requirements • retention of invoices for 2 years

•

•

Controlled Drugs Misuse of Drugs Regulations 2001 (as amended)

•

•

•

• • •

Schedule 4 (POMs) • NO Controlled Drug prescription requirements • validity 28 days • repeats allowed on prescription • emergency supplies allowed • NO safe custody requirements • NO record keeping (CD Register) requirements Schedule 5 (some preparations are POM and some P medicines) • NO Controlled Drug prescription requirements • repeats allowed on prescription • emergency supplies allowed • retention of invoices for 2 years MEP guide • Schedule 2 – CD POM • Schedule 3 – CD No Reg POM • Schedule 4 – CD Benz POM or CD Anab POM • Schedule 5 – CD Inv (CD Inv POM or CD Inv P)

MEP Table 10: Summary of Various Characteristics of Controlled Drugs Prescription Requirements for Schedule 2 and 3 Controlled Drugs Controlled Drugs Misuse of Drugs Regulations 2001 (as amended)

Current prescription requirements • the legal requirements for prescriptions for Schedule 2 and 3 CDs are summarised in the British National Formulary (BNF) and Medicines, Ethics and Practice: The professional guide for pharmacists • prescriptions are currently valid for 28 days from the date of issue • prescriptions must be indelible • prescriptions must always state: • the prescriber’s address • the name and address of the patient • In the case of a preparation, the form and where appropriate the strength of the preparation • the total quantity of the preparation, or the number of dose units, in both words and figures • the dose • the words 'for dental treatment only' if issued by a dentist • the signature of the prescriber • the date issued • Contents of the Prescription • Date • Date the prescription is issued or written • Allows the determination of the life of the prescription • POMs – expire 6 months from date issued • Controlled Drugs • Schedule 5 – expire 6 months from date issued (if POMs) • Schedule 4 – expire 28 days from date issued • Schedule 2 & 3 – expire 28 days from date issued

Ensures continual patient supervision Promotes patient follow–up Minimises quantity of medication available Note: ‘owings’ from Sch 2, 3 & 4 cannot be supplied more than 28 days after the appropriate date Contents of the Prescription Indelible • handwritten in indelible ink • computer-generated • typewritten • rubber stamped N.B. NOT a facsimile or photocopy or Carbon Paper or similar N.B. changes will be confirmed in the near future with regards to electronic signatures Signed • signed in ink with prescriber’s usual signature Address of the prescriber • must be within the UK for Schedule 2 and 3 • • • •

• •

• • • •

• • • • •

• •

•

• • • • • •

•

Contents of the Prescription Patient’s full name and address Patient’s age (where appropriate) Name of the preparation Strength of the preparation if more than one strength is available • a prescription ordering a strength which does not exist, or which can only be obtained by combining several different strengths (e.g. Tablets MST Continus 40mg) is NOT valid – should be prescribed separately Contents of the Prescription Form (i.e. pharmaceutical formulation) - even if only one form exists • “Pamergan P100®” is NOT acceptable • “Pamergan P100® Injection” is acceptable • “I. Pamergan P100®” is NOT acceptable The dose to be taken • “as directed” or “when required” NOT acceptable • “ONE as directed” and “One as required” are acceptable • Refer to MEP 39 Table 12 page 101 for doses that are , and are not legally acceptable Contents of the Prescription Total quantity to be supplied in BOTH words and figures • total amount of Controlled Drug in a preparation, e.g. “Pethidine Tablets 50 mg x 10 (Five hundred milligrams)” is NOT acceptable – must be written as “10 (Ten)” the words 'for dental treatment only' if issued by a dentist Liquids should be expressed as millilitres

Good Practice guidelines Length of treatment • DoH recommendation • quantity of Schedule 2 or 3 (and 4) Controlled Drug prescribed at any one time should not exceed 30 days treatment Evidence of identity legally

required to establish whether the person collecting a Schedule 2 CD is the patient, the patient’s representative or a healthcare professional on behalf of the patient professionally • patients or their representative need to sign the back of the prescription on collection •

• •

•

Good Practice and future guidelines Evidence of identity (continued) • where the person collecting the Schedule 2 prescription is a healthcare professional it is a legal requirement to: • obtain the person’s name and address • unless acquainted with that person, request evidence of that person’s identity • also a legal requirement to: • required to record in the CD Register whether the person collecting a Schedule 2 CD is the patient, the patient’s representative or a healthcare professional on behalf of the patient • whether the patient or the patient’s representative collecting the Schedule 2 CD was asked for, and whether s/he provided evidence of identity • the name and address of the healthcare professional who collects the Schedule 2 CD on behalf of a patient Proposed in the future • patient identifiers on prescriptions • patient NHS number included on Schedule 2 and 3 CDs

• •

Amending minor ‘technical’ errors Pharmacist able to amend minor technical errors on Schedule 2 and 3 CD prescriptions (except temazepam) • relates to minor typographical errors, spelling mistakes and where the total quantity of the CD or total number of dosage units is specified in either words or figure – NB NOT BOTH –i.e. can add the words OR the figures if omitted • before making the amendment, the pharmacist must exercise due diligence and be satisfied on reasonable grounds that the prescription is genuine and that they are supplying in accordance with the instructions of the prescriber • amend prescription in ink (indelibly) and mark in a way so as to indicate that the amendment can be attributed to them self (e.g name, date, signature and GPhC registration number)

• •

Phenobarbital/Phenobarbital sodium Phenobarbital CD No Reg (Schedule 3)POM • CD prescription requirements • validity 28 days • private prescriptions must be on special (standardised) form & private prescriber’s identification number • emergency supply ONLY for epilepsy • NO repeats • NO safe custody requirement • NO CD records

•

Additional CD requirements - cocaine, diamorphine and dipipanone

• • •

cocaine, diamorphine and dipipanone - only specially authorised doctors can prescribe for treatment of addiction special Home Office licence required N.B. all doctors can prescribe these drugs for patients (including drug addicts) for the relief of pain due to organic disease (e.g. cancer) or injury without a specific licence

• •

Dispensing/supply of Controlled Drug prescriptions prescribed Schedule 2 and 3 Controlled Drugs MUST NOT BE SUPPLIED unless • prescription complies with requirements (N.B. offence on behalf of prescriber to issue an unlawful prescription) • prescriber’s address is in the UK • supplier (i.e.pharmacist) is acquainted with the prescriber’s signature and has no reason to suppose that it is not genuine OR has taken reasonable steps to satisfy himself that it is genuine • before the date on the prescription • later than 28 days after the prescription start date* (N.B. with instalment prescriptions, first instalment must be dispensed within 28 days) • prescription must be marked with DATE OF SUPPLY - typically endorse prescription with letters CD and date of supply

• • •

Controlled Drug Registers Controlled Drug Record Keeping Schedule 2 CDs • Records of all controlled drugs received and supplied must be kept for ALL schedule 2 CDs • bound book or electronic • bound book – could be • one for both receipts and supplies • two books – one for receipts and one for supplies • stapled register for each drug that is put together in one binder (as NPA CD register) • Specified headings required • Drug Class/Name/Brand/Strength/Form Controlled Drug Record Keeping Schedule 2 CDs • Receipts: • Date on which received • Name and address of person or firm from whom received • Amount received Controlled Drug Record Keeping Schedule 2 CDs • Supplies • Date on which supply was made (i.e. date on which drug was handed to patient or representative) • Name and address of person to whom supplied • Particulars of authority of the person supplied to be in possession (e.g. prescriber details – ‘a NHS prescription from Doctor Xxx’) • Amount supplied • Person collecting • Name/Address of health professional collecting • Whether proof of identity requested • Whether proof of identity provided

• •

• •

A running balance should be maintained as a matter of good practice and is a recommendation from the Shipman Inquiry Controlled Drug Record Keeping Schedule 2 CDs • entries must be in date (chronological) order – do not leave any lines between entries • entries must be in ink or otherwise indelible • a separate part of the register (or a separate register) for each class of drug, e.g. morphine sulphate - a separate page of the register may be kept for each product form and strength, e.g. morphine sulphate S/R tablets 5mg, as a drug within a class • i.e. a separate page must be kept for each strength and form of the drug; and the class, strength and form must be specified at the head of each page • entries in respect of drugs obtained and drugs supplied may be made on the same page or on separate pages in the register Controlled Drug Record Keeping Schedule 2 CDs • Entries must be made on the day of supply or receipt or on the next day following – N.B GOOD PRACTICE TO MAKE THE ENTRIES IMMEDIATELY • No cancellation, obliteration or alteration may be made to an entry – any correction must be made by reference to a marginal note or footnote which must be dated and signed clearly – N.B do not attempt to alter words or figures, do not put a line through and do not use an eraser or use correction fluid! • The register must be kept on the premises to which it is related – one per premises • The register must not be used for any other purposes •

• •

• •

• •

Controlled Drug Record Keeping Schedule 2 CDs • Computerised register • permissible providing certain requirements are met • every entry must be attributable and capable of being audited • capable of printing or displaying the name, form and strength of the drug at the top of display/printout – i.e. comply with regulations • must be accessible from the premises to which it relates • must comply with best practice guidance

• Controlled Drug Record Keeping Schedule 2 CDs • Computerised register • best practice guidance • safeguards incorporated into the software to ensure • the author of each entry is identifiable • entries cannot be altered at a later date • a log of all entries is kept and can be recalled for audit purposes • access control systems should be in place to minimise the risk of unauthorised or unnecessary access to the data • adequate backups must be made • arrangements must be made so that inspectors can examine computerised registers during a visit with minimum disruption to the dispensing process

•

Controlled Drug Record Keeping

•

Preservation of records • Registers must be kept for 2 years from the date of the last entry • Regulations have been amended to allow the information contained in these records to be kept in the original paper form, or all a copy on a computer

The Controlled Drugs Register • Checklist – CD Prescription • prescriber’s address (within UK) • date • prescriber’s signature • patient’s name and address • dose • form of preparation • strength (if more than one available) • total quantity in words and figures • declaration if relevant • dentist – ‘for dental treatment only’ • vet –’ for an animal or herd under my care’ * • Private prescribers/ ℞s – standardised form with prescriber’s identification number (not vet) • • • • • • • • •

• • • • •

Prescriptions and dispensing it is an offence for a prescriber to issue an incomplete prescription and a pharmacist is not allowed to dispense a Controlled Drug prescription unless all the information required by law is given on the prescription pharmacy should have a Standard Operating Procedures (SOPs) for all aspects of Controlled Drugs Prescriptions and dispensing the pharmacist should not supply a CD unless he/she is acquainted with the signature of the prescriber and have no reason to suppose that it is not genuine or has taken sufficient steps to ensure that the prescription is genuine if the presc...