Controlled Drugs PDF

Preview

Summary

Lecture notes on the supply of controlled drugs...

Description

CONTROLLED DRUGS P1 (The law and CDs) LEGISLATION- involving CDs 1) Misuse of Drugs Act 1971 (MDA) - This states the drugs that are illegal (Intended to prevent non-medical use of certain drugs) Came into operation 1st July 1973 – in response to increasing levels of drug misuse (no legislation prior to this)

= possession, supply, manufacture, import and export of CDs is illegal (exceptions under the terms of the MDR 2001 ie when supplied as a med on a legally written prescription or imported on a license) sets out offences. This includes: - Unlawful possession - Possession w/ intent to supply (It is an offence to supply or offer for supply even if no charge is made)

And it is an offence to allow your premises to be used (unlawfully)for producing or supplying CDs MDA categorizes CDs into 3 distinct classes: A, B, C - Solely for the purpose of determining penalties based on harmfulness of the drug

MAXIMUM PENALTIES UNDER MDA

2) Misuse of Drugs regulations 2001 (MDR) -

This governs how they can be used as medicines (i.e as schedule 5 CDs) CLASSIFIES CDs INTO 5 SCHEDULES States how CDs may be prescribed, handled, stored and supplied

3) Misuse of drugs (safe custody) regulations 4) The Health Act 2006 - made some administrative changes with/ the NHS and introduced Accountable Officers and the need for SOPs

5) The CD regulations 2013 aim to strengthen governance arrangements for the use and management of CDs (in response to the Shipman enquiry) • Overview of government response Led to amendments in legislation: • Script validity (CD form) (prior valid for 13 weeks but now 28 days) • Record keeping (Running total) in CD register • Record of collector of script • Central records of supply (eg private Rxs, CD requisition forms) • Introduction of Accountable officers

TO PREVENT ANOTHER DR SHIPMANTO PROTECT PATIENTS

6) The RP Regulations 2008 a) b) c) d) e) f) g)

- say that we must have SOPS in place for CDs: For ordering and receiving Assigning responsibilities Security with Storage and transportation Access to CDs (restricting access to CD cupboard and keys) Who to alert if complications arise Disposal and destruction Record keeping

Enforcement body for CD offences is the Home Office via the Police

The Gosport Report In response to another doctor serial killer Inappropriately administering high doses of opioids GPhC introduced number 8 on the 9 standards ‘speak up when they have concerns or when things go wrong’

This means Pharmacists should challenge prescribing practices if you believe it to be unsafe for pt As a result of this, it was deemed necessary: - Increases used of IT and databases to monitor CD usage patterns - To appoint CD accountable officer (CDAOs)

-

Role of CDAOs: - Oversight of the monitoring and auditing of the management, prescribing and use of CDs

- Ensuring that systems are in place for recording concerns and incidents involving CDs and the operation of these systems

- Attendance of Local Intelligence Network meetings - Submission of occurrence reports which describe the details of any -

concerns the organisation has had regarding the management of CDs within a certain time frame Appointing authorised witnesses for the destruction of CDs

ALL AREAS THAT MUST APPOINT CDAOs- who must be registered with CQC • Oversight of the monitoring and auditing of the management, prescribing and use of CDs • Ensuring that systems are in place for recording concerns and incidents involving CDs and the operation of these systems • Attendance of Local Intelligence Network meetings • Submission of occurrence reports which describe the details of any concerns the organisation has had regarding the management of CDs within a certain time frame • Appointing authorised witnesses for the destruction of CDs

CLASSIFICATION (of CDs for use as med) Q) HOW CAN THESE DRUGS BE USED AS MEDICINES IF MDA 1971 INCITES THAT THEY ARE ILLEGAL??? A) MDR 2001- stipulates how CDs may be prescribed handled stored and supplied by pharmacist And classifies CDs into 5 schedules - Possession, supply and procurement is authorised for pharmacists and other classes of persons named in the 2001 Regulations.

MDR implements extra controls in the handling of CDs THIS MEANS: \

Prescription requirements - 28 day validity as opposed to 6 months in POM prescription - No repeats- not on RA/RD repeat dispensing scheme - Quantity in Words and figures (BOTH!!!) - No ‘as directed’ doses

- No emergency supplies for schedule 1, 2, 3 except phenobarbital for epilepsy - 30 days max supply recommended

Storage requirements - CD cupboard (safe storage regulations 1983 cover handling of CD storage)

Handling Returned CDs Out of date CDs

Supply- extra controls (not with other POMs) ID of person collecting Signature of person collecting

Record keeping CD register Register for returns

Schedule 1 (CD lic POM) -

Virtually no therapeutic use Limited to use for research purposes Never recommended due to high abuse potential A License is required from Home Secretary to produce, possess or supply. - Examples include: LSD, ecstasy, raw opium and cannabis. (Sativex is an exception to the rules and does not require a licence- Sched 4, also “Cannabis-based products for medicinal use in humans” are now Sched 2)

Schedule 2 (CD POM) - Subject to the tightest control measures + full CD drug requirements • full Rx req (quantity in words & figures, dose, 28-day validity) – clinical and legal req in order to dispense Rx • safe custody requirements ie. CD cupboard • witnessed destruction • record keeping (CD register) • No emergency supplies are allowed • Recommended 30 days max supply - Licenced needed to import and export - Examples include: Opiates: Fentanyl, oxycodone, morphine, methylphenidate, diamorphine, heroin Major stimulants: amphetamines, quinalbarbitone (secobarbital), cocaine, ketamine, and cannabis-based products for medicinal use in humans



Possession, supply and procurement is authorised for pharmacists and other classes of persons named in the 2001 Regulations.

Schedule 3 (CD no register POM) § § § §

Reduced control (e.g. no record keeping in CD register) Invoices, however, must be retained for 2 years Witnessed destruction not legal req but good practice Schedule 3 CDs require: § Full CD Rx req § safe custody- kept in cupboard (except midazolam, phenobarbital, tramadol, pentazocine, pregabalin and gabapentin)

§ Recommended 30 days max supply § No emergency supplies except phenobarbital for epilepsy (5 days max) Examples: temazepam, buprenorphine, midazolam, phenobarbital, tramadol, gabapentin and pregabalin

Schedule 4 CDs • • • • • • • • • •

Fewer restrictions Not subject to CD Rx req – only POM Rx req (quantity in words and figures not req) No safe custody, witnessed destruction or prescription requirements but validity of prescription is 28 days (true for schedules 2,3 & 4 Good practice – 30 days clinical need (true for schedules 2,3 & 4) Emergency supplies are allowed ( 5 days) - But use professional judgement to determine if this is appropriate Licence to import req except w/ (cd 4 part 2) anab POM for selfmedication Examples: CD part 1: Benz- benzodiazepines and ketamine CD part 2: Anab – anabolic and androgenic steroids plus growth hormones

Schedule 5 CDs

IMPORT, EXPORT AND TRAVELERS - Licensing req for import and export of all CD drugs except schedule 5 - Home office may req pt travelling to have a personal license in certain circumstances – not usually req if carrying less than 3 months supply - Advised to take covering letter signed by prescriber, confirming patient name, travel plans, name, quantity and dose of CD

- Also check with embassy or high commission of the country(ies) and with travel operator/airline

CD REQUISITION (schedule 2 and 3) A requisition refers to the process of formally requesting a service or item The requisition process is a standardized way of keeping track Healthcare professionals may need to requisition CDs from other HCPs. (e. g surgery may ask for a supply of CDs for ‘doctors bag’) Prior to shipman enquiry- prescription could be written on any piece of paper But now it has to be on a standardized form and fulfil these req: Legal requirements of CD requisition: Name, Address Of recipient profession/occupation signature total drug quantity purpose of requisition

mark requisition indelibly w/ supplier name and address (i.e w/ pharmacy stamp) send original to relevant NHS agency Good practice to keep a copy for 2 years from supply for vet requisition- keep original for 5 years

- Hospices and prisons are exempt from requiring these requisition forms

- Hospitals have their own mandatory forms - These requisition forms only apply to human and veterinary medicines in community pharmacy

CD requisitions; midwife supply orders - Used to obtain diamorphine, morphine and pethidine

Must contain:

PRESCRIPTION REQUIREMNTS (for schedule 2 and 3 CDs)

Full requirements of CD prescriptions apply to both NHS and private CD prescriptions- only exemption is if either words/figures of quantity is missing - Max 30 days’ supply recommended (good clinical justification req for longer supply) - Also, can only be prescribed by UK registered doctor, PIP, NIP, dentists (in this case must include ‘for dental treatment only’)

- No repeats allowed - Must always be recorded in CD register - Can accept no fixed abode (NFA)- if homeless or under witness protection scheme (PO BOX- not acceptable)

NHS Usual forms are FP10- but now also allowed on electronic prescription FP10MDA for instalment dispensing in treatment of addiction- Looks like any NHS Rx- but full req needed for dispensing So, must be vigilant as can be mistaken for POM

WILL COVER THIS LATER - READUP

PRIVATE Private Rx can be written on any paper – except for schedule 2 and 3 CDs. Schedule 4 and 5 CDs are allowed on regular private Rx forms Private CD Rx must be written on standardized form- pink prescription FP10CDNC - (CD, non-computerised)

if the printed name of prescriber and signature is different - this is allowed if this is legitimate and they are both registered at the same practice/surgery address who do we include in the cd register in this scenario? A) write the name of prescriber who signed the prescription as they authorised this prescription how long is prescription valid for if prescriber signs prescription on particular date (25/10/20) but indicates date that prescription can be dispensed to pt (1/11/20)? A) prescription is valid for 28 DAYS from appropiate date that pt can pick up prescription (1/11/20)

-

-

1) Take as directed – is not acceptable as dose As directed When required PRN As per chart NOT ACCEPTABLE Titration dose Weekly Decrease dose by 3.5mls every four days Twice a day

3) Although the handwriting is bad –this is the only legal prescription as different strengths for different days are written in a stepwise manner rather than list of strengths. TECHNICAL ERRORS OF SHCEDULE 2 AND 3 CDs Pharmacists can amend Rx to make it compliant if; - In this situation you are satisfied that Rx is not forged and that you’re supplying in line with prescriber intentions - Rx contains minor typographical error or spelling mistake - Where quantity in words or figures is missing (but not both) - No other amendment can be corrected by a pharmacist e.g missing date, incorrect dose form or strength - Must sign, date, state name and registration no. to make clear amendments are attributable to yourself

EXAMPLE I.Makewell M.B. Ch. B. MRCGP The Surgery Acacia Place Mediton Rx Diazepam 5mg Tablets

1. SCHEDULE 4 DRUG (DIAZEPAM) ON PRIVATE Rx 2. NOT SUBJECT TO FULL CD Rx REQ 3. = DOES NOT REQ QUANTITY IN FIGURES AND WORDS

1. NO TOWN INCLUDED FOR PT ADDRESS (LEGAL REQ) = CANNOT DISPENSE 2. Rx IS FOR 40 DAYS SUPPLE One to be taken three times a day = NOT ILLEGAL BUT 30 DAYS MAX IS 120 RECOMMENDED = GOOD PRACTICE WOULD BE TO CALL SURGERY ENQUIRE ABOUT THIS CLINICAL I. Makewell DECISION (ASK FRO RATIONALE) SUGGEST THAT THIS IS AMENDED TO 30 DAYS SUPPLY 3. SIG AND NAME OF PRESCRIBER IS 2/11/2020 DIFFERENT Mr Wilber Force - NOT ILLEGAL BUT MAY BE CAUSE FOR 15 West Street CONCERN

https://www.thepsi.ie/Libraries/Practice_Guidance/PSI_and_Medical_Council_J oint_guidance.sflb.ashx read up for understanding on cd 2 3 prescription installment prescitipn s examples etc..

CD PART 2 Collection of dispensed CDs

REQ FOR CD COLLECTION 1) Not req- but GOOD PRACTICE to ask for signature of person collecting sched 2 and 3 CDs 2) Instalment Rx (to treat drug abuse) – only needs to be signed once 3) If being signed by a delivery driver, keep a good audit trail to confirm successful delivery. What are the options? - Not always a good idea to order CDs at the end of day - Driver may not always be able to deliver in time before pharmacy closes – not good practice for CDs to be left with non-trained staff 4) Rx should be endorsed with date of item collection (endorsement margin on the left)

This is at the back of the FP10 prescription Good practice for person collecting Sched 2 + 3 CD to sign. NOT LEGAL REQ - Can still supply this without signature

SAFE CUSTODY OF CDs  Governed by Safe Custody regulations 1973 (SCR) - was amended in 2007 

This states the controls on the storage of CDs

Must be kept in a ‘locked safe, cabinet or room’ to prevent access to the CDs

 Construction of the safe, cabinet or room must comply with the SCR, check with the manufacturer. -

•

safe or cabinet should be made of metal and securely fixed to a wall or floor

if storage does not comply with manufacturers must be deemed secure by police

DRUGS THAT ARE SUBJECT TO SAFE CUSTODY REQ: - All Sched 1 CDs - Sched 2 CDs (except some liq preparations and quinalbarbitone) - Sched 3 CDs (except midazolam, tramadol, gabapentin, pregabalin, phenobarbital, meprobrobamate, pentazocine, phentermine, mazindol)

Safe custody in practice: -

However, if there is space – it’s good practice to maintain storage of CDs that are exempt from safe custody requirements (i.e., quinalbarbitone). (As these drugs may also have CD Rx req)

-

If CDs not in cabinet or safe or room (i.e., dispensing or delivery) ---- must always be under direct supervision of pharmacist Pharmacy should have SOPs in place covering safe storage of CDs --- handling of CD keys (by pharmacist) may include a key log for this Direct audit trail of anyone that has had access to the cd cabinet keys --- access to CD cupboard by pharmacist and possibly dispensing assistant

RECORD KEEPING – (CD register) -

Must record all Sched 1 and 2 CDs received or supplied Register for Sativex – used for MS (cannabis) (Sched 4 part 1) – recommended Register must always be kept at premises Available for inspection (By GPhC inspector and CD liaison officer) Kept for 2 years from date of last entry (can be kept longer if electronic)

This is possible if: • • • •

Attributable Capable of being audited Compliant with best practice Adequate backups

Author of each entry is identifiable Entries cannot be altered at a later date Capable of being printed Access control in place

Record keeping req if CDs: RECEIVED: • • •

Date received Name and address from whom received Quantity received

SUPPLIED • • • • • • •

Date supplied Name and address of recipient Details prescriber or license holder – W/ authority to possess and supply Quantity supplied Details of person collecting- patient/representative/HCP Name and address is also required if HCP is collecting ( ref Dr Shipman!) Was proof of identity requested/seen?

EXAMPLE:

Running balances and regular stock checks - must have SOPs in place for this

A Shipman recommendation, not a legal requirement

Aim; to detect discrepancies ASAP

Usually done once a week. Good practice to check a balance each time you dispense freq of stock checks depending on number of CDs dispensed, number of different pharmacists, frequency of past discrepancies

Should have a SOP for checking and dealing with discrepancies

Liquid balances should be checked visually with periodic volume checks

Sign & date the stock check, ideally 2 people (good practice) to confirm the running balance in CD cupboard

STEPS TO FOLLOW IF THERE IS A DISCRPEANCY:

1. -

Attempt to resolve this

Run a stock usage report – to check details of each time this CD was dispensed Check invoices – missing stock entered in register? Check for math errors Check for errors in register i.e., entered into wrong book

2. 3.

If unresolved, report it to your superintendent’s department If still unresolved they must report it to the Accountable Officer

How are CD entries recorded? - CD register bound to a book register - Separate sections in the CD register for each drug and w/in that a separate booklet for different brand, strengths and formulation - Entries must be in chronological order of date - Must be made on the day of receipt/supply or the following day - Ink or computerized - If a mistake is made - make footnote, sign, initial or write your name and registration number --- DO NOT CROSS OUT MISTAKES Section separation

Footnote amendment after mistakes

DESTRUCTION OF CDs Rules -

Pt returned CD should be destroyed by pharmacist – immediately!!

-

However, destruction of out-of-date sched 2 CD stock must be witnessed by authorised person. Carrying this out with sched 3 CDs is not req but good practice

-

Pt returned and out-of-date CD stock (that req safe custody) – must be stored safely and segregated from other pharmacy stock in the CD safe and must be clearly marked – so to prevent accidental dispensing

-

i.e. can be placed in a bag that is marked as “waiting to be destroyed patient returns” or “out of date, waiting authorised witness to destroy”

-

record in CD register should be made upon destruction of expired sched 2 CDs ----- separate register for pt returned sched 2 CDs in pt returned CD register also until destroyed, expired schedule 2 CD should be included in running balance

-

How are they destroyed? -

Schedule 2,3, and 4 part 1 CDs must be denatured (rendered irretrievable) prior to disposal using denaturing kits depending on formulation

-

INSTALMENT Rx- FP10MDA Why is substitute treatment given -

Reduce drug associated crimes Harm minimisation (of the actual drug and from route of administration -inj)

Purpose of instalment Rx -

Allow daily supply of substitute Avoid temptation to overdose Protects them from other misusers or misplacing if given a months’ supply

Supervised consumption -

Initially administration supervised by community pharmacist Once pt is stabilised or working they can assume some responsibility in overcoming drug addiction

Contract between pharmacy and patient Example:

• If your prescriber requests supervised consumption, then this must be done within the pharmacy, and each dose will be taken in this manner unless specified on the prescription, or unless the pharmacy is closed (Sundays and bank or public holidays, depending o...