Controlled Drugs 3.6 Flashcards
Background 3.6.1
1971 Act imposes prohibitions on the possession, supply, manufacture, import and export of CDs – except where permitted by the 2001 Regulations or under licence from the Secretary of State. The Safe Custody Regulations detail the storage and safe custody requirements for CDs.
enforcement body for CDs offences is the Home Office via police.
Pharmacists need to know SOPs for CDs management. take appropriate steps if issues occur,
RPS requires up to date ORGs policies and procedures for CD management some of them are:
* Security, including access to CDs
* Ordering and receipt
* Record-keeping, including audit requirements
* Prescribing and clinical monitoring
* Administration, including any witness requirements
* Supply, including prompt access to ensure care is not compromised
* Denaturing and disposal, including any witness requirements
* Use and storage of patients’ own CDs
* Transport (including transfer between care settings), including records
* Investigation and reporting of concerns
ACCOUNTABLE OFFICERS
Accountable officers are responsible for supervising and managing the use of CDs in their organisation or setting.
Roles and responsibilities:
* 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 at Local Intelligence Network meetings
* Submission of occurrence reports which describe the details of any concerns the organisation has had regarding the management of CDs in a required time frame
* The appointment of authorised witnesses for the destruction of CDs.
Places not needing CD accountable officer can have CD lead.
Classification 3.6.2
SCHEDULE 1 (CD LIC POM):
Most have NO therapeutic use license needed for their production, possession and supply. EG: LSD, ecstasy and raw opium
SCHEDULE 2 (CD POM):
Pharmacist have authority to prescribe, posses and supply in their capacity.
EG: opiates (e.g. diamorphine, morphine, methadone, oxycodone, pethidine), major stimulants (e.g. amfetamines), quinalbarbitone and ketamine.
SCHEDULE 3 (CD NO REGISTER POM)
Minor stimulants and others drugs (buprenorphine, temazepam, tramadol, midazolam, phenobarbital, gabapentin and pregabalin) that are less likely to be misused (and less harmful if misused)
SCHEDULE 4 (CD BENZ POM OR CD ANAB POM)
Part I (CD Benz POM) - Most benzodiazepines (diazepam etc), non benzo hypnotics (zopiclone), sativex (cannabinoid oromucosal mouth spray)
Part II (CD Anab POM) - most of the anabolic and androgenic steroids, together with clenbuterol (an adrenoceptor stimulant) and growth hormones.
SCHEDULE 5 (CD INV POM OR CD INV P)
contains preparations of certain CDs (such as codeine, pholcodine and morphine) that are exempt from full control when present in medicinal products of specifically low strengths.
CHECK TABLE 12 IN MEP!!!!!
Possession and supply 3.6.3
Pharmacists, DRs and dentists, acting in capacity are allowed to possess, supply and procure CD 2,3,4,5s.
Other mechanisms for the lawful possession of CDs include:
* Home Office licence - can posses and supply in line with licence,
* Home Office group authority - Group covered by home office licence.
* Legislation: class of person - specified in 2001 regulations. eg a postal operator or, for specified CDs, a registered practising midwife.
* Legislation: class of drug - 2001 regulation say possessing certain drugs is lawful. eg Schedule 4 Part II drugs when contained in medicinal products and Schedule 5 drugs
* Patients - ppl who have been prescribed a CD.
POSSESSION OF CD 1
Need home office licence.. Pharmacist can take CD1 for destruction or police handover.
B4 supply of CD 1 should take advice from accountable officer or org.
in hospital can deal with CD1 from patients. refer to policies. keep patient confidentiality and inform police if source cant be identified. BUT if quantity is too large that cant be just for personal use pharmacist may want to identify source. decide with other HCPs in patients case.
Patient need to give permission to remove the drug and destroy it. if patient refuses police can be informed. CANT HAND ILLEGAL DRUGS BACK TO PATIENT.
Administration of Controlled Drugs 3.6.4
CD 1s may only be administered, or prescribed under a Home Office licence.
Schedule 2, 3 or 4 CDs can be administered to a patient by:
* doctor, dentist, pharmacist IP or nurse IP acting in their own right
* A supplementary prescriber (including a pharmacist supplementary prescriber) acting in accordance with a clinical management plan
* person acting in accordance with the directions of a prescriber entitled to prescribe CDs (including pharmacist IPS).
Only medical prescribers who hold a special licence from the Home Secretary or Scottish Government’s Chief Medical Officer can prescribe cocaine, diamorphine or dipipanone for treating addiction. This licence is not needed if treating organic disease or injury.
Pharmacist IP, nurse IP and supplementary prescribers CANT prescribe cocaine, diamorphine or dipipanone for treating addiction, but can prescribe these medicines for treating organic disease or injury.
Import, export and travellers 3.6.5
A licence is needed for a pharmacy to import or export Schedule 1, 2, 3 and 4 (Part I) CDs. A licence is needed for Schedule 4 (Part II) CDs, UNLESS the substance is imported or exported by a person for self-administration.
No restriction on CD 5s import/export.
TRAVELLERS
Person licence not needed by home office if person is carrying less than 3 months supply of CDs.
Advised to have covering letter signed by prescriber that confirms patients name, travel plans, name of prescribed CD, total quantities and dose.
Patient should also check with the embassies or high commissions for the countries they will be travelling through to ensure that the import and export regulations in those countries are complied with.
Would be prudent for patients to check any additional requirements that their travel operator/ airline company may impose.
Obtaining Controlled Drugs – requisition requirements for CD 1,2,3. 3.6.6
2015 change to misuse of drugs regs - the use of an approved form for the requisitioning of Schedule 2 and 3 CDs in the community mandatory. This applies to both requisitions for human and for veterinary use. Hospices and prisons are EXEMPT from the requirement to use the approved form.
Aimed at ensuring the purchase of all stocks of CD 2,3 by HCPs within the community can be monitored. - due to SHIPMAN. (killer)
LEGAL REQUIREMENTS FOR A CD REQUISITION ARE:
1 Signature of the recipient
2 Name of the recipient
3 Address of the recipient
4 Profession or occupation
5 Total quantity of drug
6 Purpose of the requisition
Diagram 17:
Summary of when an approved mandatory requisition form must be used to request stock of CD 2,3:
(check MEP for better visual)
* Received by hospital pharmacy - is request on behalf of ward or department within same legal entity IF NO THEN =
APPROVED FORM NEEDED.
* Received by community pharmacy- Request from a hospital, community, health provider eg GP or Vet surgeon = APPROVED FORM NEEDED
Handling of CDs in prisons requires specific processes =
http://www.drugslibrary.wordpress.stir.ac.uk/files/2017/07/final_report_safe_management_and_use_of_controlled_drugs_in_prison_health_in_england_final.pdf
Approved mandatory requisition forms and where to obtain them
England = FP10CDF
Scotland = CDRF - PRIVATE
GP10A - NHS
Wales = WP10CDF
In prisons in England, hospital-style requisition forms (instead of a standardised form) are usually used and are printed in a bound, book format – sequentially numbered with a carbon copy of each requisition to provide a robust audit trail. In Scotland, an approved internal ordering form from the supplying pharmacy is used.
HOSPITAL REQUISITIONS:
Forms from ward/department given to pharmacy in separate legal entity must also meet these requirements including approved requisition form. Home Office has advised that the person in charge/acting in charge of a hospital can get a yearly ‘bulk’ or ‘global’ requisition on the approved mandatory form to the separate legal entity that supplies its wards or departments for the wards or departments to then draw on throughout the year using CDs requisition books with duplicate pages. Where the person in charge/acting in charge of a hospital issues and signs a requisition, this must also be signed by a doctor or dentist employed or engaged in that hospital.
Practise issues:
* Faxed/ photocopied unacceptable.
* Requisition in writing must be obtained by supplier b4 delivery of any CD 2,3 to following recipients:
- practitioners, hospitals, care homes, ship and offshore installation personnel, senior registered nurses in charge of wards, theatres and other hospital departments.
- home office advises requisition to 1 pharmacy to another should only be made after written requisition on a approved req form received.
* Emergency DR/dentist can be given CD2,3 if requisition is given within 24 hours. FAILURE= offence on DR/dentist.
* If stock is collected on behalf of someone else a written authorisation is needed to give supplying pharmacist.
* Authorisation must be retained by supplying pharmacist for 2 years.
* Licence needed for any HCPs to posses CD1 Pharmacist not able to requisition CD 1.
PROCESSING REQUISITION FORMS (MARKING AND SENDING)
When a requisition for a CD 1, 2, 3 is received, it is a legal requirement to:
* Mark the requisition indelibly with the supplier’s name and address. If stamp is used needs to be clear and legible.
* Send the original requisition to the relevant NHS agency
Pharmacist should retain copy of requisition 2 years from date of supply.
Processing requirements do not apply when the supply is made:
* By a person responsible for the dispensing and supply of medicines at a hospital, care home, hospice, prison or organisation providing ambulance services who must mark and retain the original requisition for two years
* By pharmaceutical manufacturers or wholesalers
* Against veterinary requisitions (the original requisition should be retained for five years).
MIDWIFE SUPPLY ORDERS:
A registered midwife may use a midwife supply order to obtain the following CDs:
Diamorphine, morphine, pethidine.
Order must contain: (6)
* Name of the midwife
* Occupation of the midwife
* Name of the patient/ person supplied
* Purpose for which the CD is required
* Total quantity of the drug to be obtained
* Signature of an appropriate medical officer – a doctor authorised (in writing) by the local supervising authority or the person appointed by the supervising authority to exercise supervision over midwives within the area
Prescription requirements for CD 2,3. 3.6.7
**CD 2,3 prescription requirements: **
1. Signature - can be signed by prescriber other than named 1 and be valid But address needs to be same. CD register should record details of actual prescriber (signature). Advanced electronic signatures can be accepted where EPS is used.
2. Date - Valid 28 days. either signature date or other appropriate date.
3. Prescriber address - Must be UK. PO box acceptable - home office said.
4. Name of CD
5. Form - abbreviation accepted
6. Strength - only if more than 1 strength is available.
7. Dose
8. Total quantity - Written on words and figures. for volume liquid amount should be said.
9. Quantity prescribed - if more than 30 days supply needs to be justified.
10. name of patient
11. Address of patient
12. dental prescriptions - ‘for dental treatment only’ must be present.
13. Instalment direction -
Additional requirements- when supply is made should mark prescription with date and time of supply. Indelible ink and can be computer made.
Sugar free products - more risk of abuse - only supplied specifically
Examples of allowed vs not allowed in MEP
Instalment direction for CD 2,3:
1. amount of meds to be supplied per instalment
2. time between each supply.
Home Office has confirmed that an instalment prescription must have both a dose and an instalment amount specified separately.
first instalment has to be within 28 days. Each date of supply prescription must be marked.
HOME OFFICE APPROVED WORDING FOR INSTALMENT PRESCRIBING
Instalment direction is a legal requirement.
HOME OFFICE APPROVED WORDING:
1. Please dispense instalments due on pharmacy closed days on a prior suitable day.
2. If an instalment’s collection day has been missed, please still dispense the amount due for any remaining day(s) of that instalment.
3. Consult the prescriber if three or more consecutive days of a prescription have been missed.
4. Supervise consumption on collection days.
5. Dispense daily doses in separate containers.
IF wording is used without new prescription pharmacist can:
* Supply an appropriate balance of an instalment if the interval date is missed
* Supply treatment prior to the start date on a prescription, if this is on a day the pharmacy is closed/
Missed doses
If patient missed 3 days prescribed treatment contact prescriber, they may have lost tolerance to drug.
Technical errors
Pharmacist can amend minor typos or if words or Figueres is missing of total quantity,
amendments need to be marked name, date, signature and GPhC number.
PRIVATE PRESCRIPTION REQUIREMENTS FORCD2,3 :
1. Standardised form - (FP10 PCD etc)
Private prescription for CD 2,3 HAVE TO BE ON standardised form.
Private prescriptions that are not on the designated standardised form must NOT be accepted unless they are vet prescriptions. For a hospital pharmacy to lawfully supply a CD 2,3 against a private prescription issued outside that hospital (i.e. outside its legal entity), a standardised form must be used. Where the private prescription is issued and dispensed within the same legal entity, a standardised form is NOT required.
- PRESCRIBER IDENTIFICATION NUMBER - Must be on standardised form. not the prescriber’s professional registration number. a number issued by the relevant NHS agency and the prescriber can obtain it from their local primary care organisation.
CDs private prescription forms and where to obtain them:
England
FP10 PCD, Local NHS England area team.
Scotland
PPCD(1), local NHS health board.
Wales
WP10 PCD, Local NHS health board.
- Submission:
Pharmacies must submit the original private prescription to the relevant NHS agency, requires an identifying code assigned to the pharmacy for this purpose by the local primary care organisation.
VETERINARY PRESCRIPTIONS
Veterinary prescriptions for CDs do NOT need to be written on standardised forms and do NOT need to be submitted to the relevant NHS agency. Forms must be retained for 5 years.
Practise issue:
Medicines that are not CDs should NOT be prescribed on the same form as a Schedule 2 or 3 CD. This is because the form needs to be sent to the relevant NHS agency so the pharmacist would be unable to comply with the requirement to keep private prescriptions for a POM for two years.
Collection of dispensed CDs 3.6.8
When CD 2 is collected pharmacist needs to find out if patient is collecting or patient representative or HCP. Depending on collector different actions are taken.
COLLECTION BY A REPRESENTATIVE OF A DRUG MISUSE PATIENT
* need letter from drug misuser giving permission. (includes ppl in police custody).
* Separate letter for each time some1 else collects
* Collector needs ID.
*CD record of supply needs to include representative details.
* If doses need to be supervised contact prescriber. Don’t need to contact prescriber if person is in police custody. BC CD2,3 in police custody is supervised by HCP.
*If dose is given unsupervised pharmacist should make note of this.
Practise issue:
*Good practice for the person collecting a CD2,3 to sign the space on back of the prescription form that is specifically for this purpose. A supply can be made if this is not signed, subject to the professional judgement of the pharmacist
*Instalment prescriptions only need to be signed once
*A representative, including a delivery driver, can sign on behalf of a patient. However, a robust audit trail should be available to confirm successful delivery of the medicine to the patient.
Actions required when a dispensed CD2 is collected by
Patient or patient’s representative:
- Pharmacist may request evidence of that person’s identity, unless already known to the pharmacist.
HCP* acting in their professional capacity on behalf of the patient:
- Unless already known to the pharmacist, obtain:
1. Name of HCP
2. Address of HCP
Also request evidence of identity.
*HCP here can be any1 authorised to collect CD 2 for patient who is acting under contract of employment in a health or social care workplace.
Safe custody 3.6.9
Relevant CDs need to be in a locked case, cabinet or room. applies to certain CD2,3
STRUCTURAL REQUIREMENTS OF SAFES, CABINETS AND ROOMS USED FOR STORING CDs
Individual brands of cabinets not approved for CD cabinets. When buying safe/cabinet need to ensure that they comply with requirements in safe custody regulations.
ALT - apply for an exemption certificate from the police, which certifies that the safe, cabinet or room provides an adequate degree of security for holding CDs
CDs THAT MUST BE KEPT UNDER SAFET CUSTODY ARE:
* CD1
* CD2 except some liquid preparations and quinalbarbitone (secobarbital) Details of exempted Schedule 2 CDs in the Misuse of Drugs (Safe Custody) Regulations 1973 as amended
* CD3 unless exempted under the Regulations 1973 = full lists.
Common exemptions include:
gabapentin
mazindol
meprobamate
midazolam
pentazocine
phentermine
phenobarbital
pregabalin
tramadol
* Common CD3 include temazepam and buprenorphine.
SAFE CUSTODY REQUIREMENTS FOR SECURE ENVIRONMENTS AND SECONDARY CARE:
Details in prison building regulations. Prison and hospital cabinet should meet sold secure silver standard.
Some orgs may do risk assesment and decide some CD3,4,5 need to be in safe custody - these drugs are not their by law. Should be stated which drugs in policies and SOPs. Need regular monitoring and auditing.
If CD that needs safe custody isnt kept there they need to be under direct personal supervision of pharmacist.
Access tp CD inlcuding keys needs to be doccumented. Prevents unathourised usage and idnetify who has used it.
PATIENT-RETURNED AND OUT-OF-DATE OR OBSOLETE CDs:
To minimise the risk of supplying these to patients, this stock should be segregated from other pharmacy stock and be clearly marked.
Destruction of CDs 3.6.10
Need to denature CD before disposal. Requires appropriate licence but pharmacies can register an exemption without licence.
England & wales exemption is issues by environment agency - T28 exemption. Allows pharmacies to sort and dispose CDs and comply with 2001 regs by denaturing b4 disposal.
Scotland exemption issues by environment protection agency - accepts denaturing of CDs forms part of the exempt activity to secure storage.
CDs THAT NEED TO BE DENATURED BEFORE DISPOSAL:
ALL CDs 2.3.4(part1) should be denatures and made irretrievable b4 disposal.
PERSONS AUTHORISED TO WITNESS THE DENATURING OF CDs:
Some cases denaturing needs to be witnessed by a authorised person. Where CD register is needed witnessed is needed for destruction. Patient returned CD dont require witness but stock of CD2 does.
In prison for audit CD3 and CD 4 like diazepam and chlordiazepoxide should be recorded in CD register and destruction should be recorded.
Home secretary, secretary of state and accountable officer can authorise who is allowed to witness. accountable officer CANT be witness themselves. Persons authorised by the accountable officer are usually senior members of staff who are not involved in the day-to-day management or use of CDs.
Denaturing and witness requirements for patient-returned and expired CDs
Patient returned controlled drug:
* Is denaturing required?
Yes, if CD 2, 3 or 4 (Part 1).
- Authorised witness required?
No. However it is preferable for denaturing to be witnessed by another member of staff familiar with CDs (preferably a registered HCP). - Record keeping
A record should NOT be made in the CD register but records of patient-returned CD 2s and their subsequent destruction should be recorded in a separate record for this purpose.
Expired/obsolete/unwanted stock:
* Is denaturing required?
Yes, if CD 2, 3, 4 (part 1)
- Authorised witness required?
Yes, if CD2. For CD3 medicines good practice to have another member of staff witness the denaturing. - Record keeping
An entry should be made in the CD register for CD 2.
METHODS OF DENATURING CDs
Disposed in waste containers - sent for incineration.
All CDs in CD 2, 3 and 4 (Part 1) should be destroyed by being denatured and rendered irretrievable before being placed into pharmaceutical waste containers and sent for incineration.
When denaturing work in a well-ventilated area and wear suitable protective gloves, a face mask and goggles as appropriate.
Pharmacists are responsible for using a kit that has been obtained from a reputable source and to use those kits in accordance with the manufacturers’ instructions.
Destruction methods of controlled drugs:
1. Solid dosage forms, e.g., capsules and tablets:
Grind or crush the solid dose formulation before adding to the CD denaturing kit to ensure that whole tablets or capsules are not retrievable. The use of a small amount of water whilst grinding or crushing may assist in minimising particles of dust being released into the air.
NO KIT ALT - crush or grind the solid dose formulation and place it into a small amount of warm, soapy water stirring sufficiently to ensure the drug has been dissolved or dispersed. The resulting mixture is poured onto an appropriate amount of suitable product$ and added to an appropriate waste disposal bin supplied by the waste contractor.
- Liquid dosage forms
Pour into an appropriately-sized CD denaturing kit.
NO KIT ALT - pour the liquid onto an appropriate amount of suitable product$ and add this to an appropriate waste disposal bin.
Bottle containing a liquid CD has been emptied, small amounts of the pharmaceutical can remain.
Bottles can be rinsed and the liquid disposed using the denaturing kit and then as the correct category of pharmaceutical waste only dispose of rinsing’s contaminated with pharmaceuticals via the sewerage system IF you have a relevant Trade Effluent Consent from the relevant sewerage undertaker. Clean empty bottles are disposed of into the recycling or general waste . Disposal of irretrievable amounts of CD does not need to be recorded.
- Ampoules and vials
Liquid containing ampoules, open the ampoule and empty the contents into a CD denaturing kit, or dispose of in the same manner as liquid dose formulations above. Dispose of the ampoule as sharps pharmaceutical waste.
Powder containing ampoules, open the ampoule and add water to dissolve the powder inside. The resulting mixture can be poured into the CD denaturing kit and the ampoule disposed of as sharps pharmaceutical waste.
ALT
Ampoules are crushed with a pestle inside an empty plastic container. Once broken, a small quantity of warm soapy water (for powder ampoules) or suitable product$ (for liquid ampoules) is added. If these methods are used, care should be taken to ensure that the glass does not harm the person destroying the CD. The resulting liquid mixture should then be disposed of in a CD denaturing kit or in the bin that is used for disposal of liquid medicines.
- Patches
Remove the backing and fold the patch over on itself. Place into a pharmaceutical waste disposal bin or a CD denaturing kit. - Aerosol formulations
Expel into water and dispose of the resulting liquid in accordance with the guidance above on destroying liquid formulations.
If this is not possible because of the nature of the formulation, expel into an absorbent material and dispose of this as pharmaceutical waste.
ALT
consider if it would be safe to open or to otherwise compromise the container to release the CD safely. The resulting liquid mixture should then be disposed of in a CD denaturing kit and disposed of as pharmaceutical waste.
$ risk assessment should be carried out to determine whether a product is suitable. Suitable product makes the CD irretrievable without compromising patient safety, the safety of the person carrying out the destruction, or the environment.
Record keeping and CDs registers 3.6.11
CDs register must be used to record details of any CD 1, 2 received/supplied by a pharmacy.
ALSO need to keep records of SATIVEX CD4.1. Use CD register.
CDs received, the following must be recorded: (3)
* Date supply received
* Name and address from whom received
* Quantity received
CDs supplied, the following must be recorded: (7)
- Date supplied
- Name and address of recipient
- Details of authority to possess – prescriber or licence holder’s details
- Quantity supplied
- Details of person collecting CD2 – patient, patient’s representative or healthcare representative (if the latter, also record their name and address)
- Whether proof of id was requested of the person collecting
- Whether proof of id was provided.
Minimum that needs to be recorded can have more.
Nature of register
Class, strength, form needed at top of each page. Book bound. Requirement - different classes are kept in a separate part of the register and within each class, a separate page is used for different strengths and formulations of each drug. Multiple registers for the same class of CD are allowable if approved by the Home Office.
Prisons have one legally compliant register that records all the details. However, several areas in each prison where CDs are stored, administered or issued, each of these areas should maintain a CD record book. Movement of CD between areas are recorded internal requisition - keep audit trial.
NATURE OF THE ENTRIES
All entries made in CD registers should be:
- Entered chronologically
- Entered promptly – be made on the/following day of the transaction.
- In ink or indelible – entries and corrections must be in ink or indelible (or computerised - see below)
- Unaltered – entries must not be cancelled, obliterated or altered. Corrections must be made by dated marginal notes or footnotes. The register should be marked to show who the amendments made are attributable to (e.g. name, initials/signature, GPhC number if applicable).
RECORD KEEPING
Must do:
* Location – each register should be kept at the premises to which it applies
* Duration – registers should be kept for two years from the date of the last entry
* Form – records can be kept in their original form or copied and kept in an approved computerised form
* Inspection – a copy of the register, and other details of stock, receipts and supplies, must be made available to authorised persons (e.g. a GPhC inspector or CD liaison officer) upon request.
ELECTRONIC CONTROLLED DRUGS REGISTERS
Allowed as ALT. computerised entries must have:
* Attributable
* Capable of being audited
* Compliant with best practice.
Electronic CD register must be accessible from premises and able to print. must ensure:
* The author of each entry is identifiable
* Entries cannot be altered at a later date
* A log of all data entered is kept and can be recalled for audit purposes.
Need control system to minimise risk of unauthorised access. Need sufficient back ups. Examiner should be able to examine registers with minimum disruption.
RUNNING BALANCES AND STOCK CHECKS
running balance aim - find errors or odd stuff easier. Stock checks should be once a week can be less depending on risk assessment, volume of CDs, freq of error, or loads of pharmacists in charge at once. Liquid checks to be done visibly. stock checks to be recorded and dated. 2 ppl should do stock check.
reasons stock can be zero - destruction, no recording, stop of the drug.
- Maintaining running balances and dealing with discrepancies = pharmacist job but can be delegated.
- Discrepancy can be resolved following checks, a marginal note or footnote should be made in the register and the discrepancy corrected.
- Running balances for liquid CDs can be affected by overage, residue and spillage.
- CD register entry has been made for a CD 2, the usual requirement to make a record in the POM register does not apply.
Extemporaneous methadone 3.6.12
Every patient has every right to expect that when an unlicensed medicine is prepared, it is of equivalent quality to a licensed medicine.
Applies to methadone made like this too.
GPhc made guidance.
guidance explains that pharmacies preparing unlicensed medicines must mitigate risks to patients and meet the GPhC’s standards for registered pharmacies.
Cannabis and cannabis-based products 3.6.13
wide range of cannabis-based products used for medicinal purposes, with varying constituents and covered by different aspects of legislation. These can be broadly categorised as:
Licensed products:
Sativex
*Cannabis extracts containing CBD and THC
*CD 4
*moderate to severe spasticity in multiple sclerosis.
Nabilone
*Synthetic, non-natural cannabinoid
* CD 2
* N+V caused by cytotoxic chemotherapy, unresponsive to conventional antiemetic treatments.
CBD (Epidyolex)
*Cannabidiol
* CD 5
* Seizures associated with Lennox-Gastaut Syndrome or Dravets Syndrome (adjunctive treatment with clobazam).
Synthetic compounds:
Dronabinol
*Synthetic, nature-identical, version of THC
*CD 2
*Available as a special (approved by the US FDA): to treat loss of appetite in people with AIDS, and to treat severe N+V caused by cancer chemotherapy in patients with inadequate response to conventional antiemetic treatments.
CANNABIS-BASED PRODUCTS FOR MEDICINAL USE (CBPM):
Regulations in 2018 moved CBPM CD 1 to CD 2.
This allows defined cannabis-based products for medicinal use, restricts routes of access, and limits the prescribing of these products to specialist doctors on the GMC’s Specialist Register.
CBPM definitions:
3 broad requirements that a product should satisfy:
1. product is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative
2. is produced for medicinal use in humans
3. is a product that is regulated as a medicinal product, or an ingredient of a medicinal product.
Definition is broad to include all range of preparations that are used for therapeutic purpose.
Prescribing CBPM:
CBPM - unlicensed use only rn. Clinician decides most appropriate use/ course of treatment taking in account patient, condition, evidence of safety and efficacy.
to start treatment decision should be joint between prescriber and patient/ carer.
* CBPMs are CD2s and staff must follow all the legal and CD requirements for CD2s, including any Trust CD requirements
* Prescribing is currently restricted to clinicians listed on the Specialist Register of the GMC
* decision to prescribe must be in line with guidance from NHS England or other country specific guidance and consideration given to guidance issued by Royal Colleges, and the Trust’s unlicensed medicines and CD policies. Patients and/carers must be involved in the treatment decision.
* Patient should know med is unlicensed and note should be made in medical notes.
Supplying CBPMs against prescription:
Private prescriptions must meet legal requirements of CD2, and be on the right forms. (FP10PCD (England), PPCD(1) (Scotland), WP10PCD (Wales)) and specify the private prescriber’s six digit identification number.
* limited domestic availability of these products. However, several specialist importers have imported a range of products on a named patient basis. Products currently available via import come in a variety of forms (flos, oils, granules) and variety of CBD/THC ratios. The pharmacy should be able to advise on available products and routes of supply.
* Patients needs to be told there can be delay in getting product, as there are limited THC products available in England. So may need import.
CANNABIDIOL (CBD) OIL
CBD extracted from strains ;like industrial hemp - contains high conc CBD and low conc THC.
CBD oils marketed as food supplements are classed as novel foods. Novel foods regulated by FDA - needs to be evaluated, authorised and approved b4 they can be placed on the market.
CBD sale enforced by local trading authorities. IF they make medicinal claim then its medicines legislation.
These products cant have THC BC its a CD.
PURE CBD is very difficult to isolate and products with THC highly likely to be a CD.
Highly purified liquid containing cannabidiol = Epidyolex
for seizures (more info above)
