CD MEP

Question 1

what is an accountable officier

Answer 1

Accountable officers are responsible for supervising and managing the use of CDs in their organisation or setting. Their roles and responsibilities include:

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

For those organisations not required to appoint a CDAO (e.g. general practice, dental clinic, community pharmacy) then an appointed ‘Controlled Drugs lead’ performs the same role.

Question 2

examples of schedule 1 drugs

Answer 2

Most Schedule 1 drugs have no therapeutic use and a licence is generally required for their production, possession or supply.

Examples include hallucinogenic drugs (e.g. ‘LSD’), ecstasy-type substances and raw opium.

Question 3

what are sch 2 drugs

Answer 3

Pharmacists and other classes of person named in the 2001 Regulations have a general authority to prescribe, possess, supply and procure Schedule 2 CDs when acting in that capacity.

Schedule 2 includes opiates (e.g. diamorphine, morphine, methadone, oxycodone, pethidine), major stimulants (e.g. amfetamines), quinalbarbitone and ketamine.

Question 4

what are schedule 3 drugs

Answer 4

Schedule 3 CDs include minor stimulants and other drugs (such as buprenorphine, temazepam, tramadol, midazolam, phenobarbital, gabapentin and pregabalin) that are less likely to be misused (and less harmful if misused) than those in Schedule 2.

Question 5

what are schedule 4 drugs

Answer 5

Part I (CD Benz POM) Contains most of the benzodiazepines (such as diazepam), non-benzodiazepine hypnotics (such as zopiclone), and Sativex (a cannabinoid oromucosal mouth spray)

Part II (CD Anab POM) Contains most of the anabolic and androgenic steroids, together with clenbuterol (an adrenoceptor stimulant) and growth hormones.

Question 6

what are schedule 5 drugs

Answer 6

Schedule 5 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

Question 7

how and who can possess control drug

Answer 7

Pharmacists, doctors and dentists - sch 2,3,4,5

Other mechanisms for the lawful possession of CDs include:

Home Office licence Persons who have an applicable Home Office licence can possess and supply CDs in accordance with the terms of the licence (e.g. the RPS museum holds a Home Office licence to possess CDs for the purposes of the museum)

Home Office group authority Persons who are covered by an applicable Home Office licence group authority can possess and supply CDs in accordance with the terms of the group authority (e.g. there is currently a group authority covering paramedics that allows them to possess and supply certain CDs)

Legislation: class of person Other classes of person specified in the 2001 Regulations, provided they are acting in the capacity of the specified class (e.g. a postal operator or, for specified CDs, a registered practising midwife)

Legislation: class of drug The 2001 Regulations indicate that possessing certain classes of CDs is lawful (e.g. Schedule 4 Part II drugs when contained in medicinal products and Schedule 5 drugs)

Patients Persons who have been prescribed a CD by a doctor, supplementary prescriber, nurse independent prescriber, pharmacist independent prescriber, dentist or veterinary surgeon (for an animal).

Question 8

what to do in posession with sch 1

Answer 8

A Home Office licence is required to possess Schedule 1 CDs; however, a pharmacist can take possession of such CDs for the purpose of destruction or to handover to a police officer.

at hospital
-remove potential cd 1 from patients
-refer to organisation policy
-The patient’s confidentiality should normally be maintained and the police should be informed on the understanding that the source will not be identified. If, however, the quantity is so large that the drug could not be purely for personal use the pharmacist may decide that the greater interests of the public require identification of the source.
-The patient should give authority for the drug to be removed and destroyed. If the patient refuses, the pharmacist may feel that he or she has no alternative other than to call in the police.
-dont give back to patient

Question 9

who can prescribe sch 1, 2,3,4,5

Answer 9

Schedule 1 CDs may only be administered, or prescribed under a Home Office licence.

Schedule 2, 3 or 4 CDs can be administered to a patient by:

A doctor, dentist, pharmacist independent prescriber or nurse independent prescriber acting in their own right

A supplementary prescriber (including a pharmacist supplementary prescriber) acting in accordance with a clinical management plan

A person acting in accordance with the directions of a prescriber entitled to prescribe CDs (including pharmacist independent prescribers).

• Pharmacist independent prescribers, nurse independent prescribers and supplementary prescribers may not prescribe cocaine, diamorphine or dipipanone for treating addiction, but may prescribe these medicines for treating organic disease or injury.

Question 10

import and export

Answer 10

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. There are no restrictions on the import or export of Schedule 5 CDs

Question 11

travellers licence - when is it required?

Answer 11

A personal licence is not required by the Home Office if a person travelling is carrying less than three months’ supply of CDs.

However, it is advised that a covering letter signed by the prescriber is obtained that confirms the name of the patient, travel plans, name of the prescribed CDs, total quantities and dose.

-check with airline and high commissions for the countty

Question 12

check requisition in signed order for controlled drugs

Question 13

what are the prescription requirements for sch 2, 3

Answer 13

Patients name
patients address
name of cd
form
strength
dose
total quantity - both words and figures
quantity prescribed
dental wording where appropriate
instalment wording where appropriate
signature
date - valid for 28 days (1,2,3,4)
address of prescriber

*noqualificatuion needed

Question 14

examples of doses which are not legally acceptable

Answer 14

As directed
When required
PRN
As per chart
Titration dose
Weekly (this is just a frequency and not a dose)
Decrease dose by 3.5ml every four days
Twice a day.

Question 15

examples of doses which are legally acceptable

Answer 15

One as directed
Two when required
One PRN
Three ampoules to be given as directed (better still – three ampoules to be given over 24 hours as directed)
One to two when required.

Question 16

Instalement for sch 2 and 3

Answer 16

An instalment direction combines two pieces of information:

1) Amount of medicine to be supplied per instalment (this is in addition to the dose – see below)

2) Interval between each time the medicine can be supplied

The first instalment must be dispensed no later than 28 days after the appropriate date. The remainder of the instalments should be dispensed in accordance with the instructions (even if this runs beyond 28 days after the appropriate date).

-MUST be signed
-must be marked with the date of each supply

Home Office approved wordings
Please dispense instalments due on pharmacy closed days on a prior suitable day.

If an instalment’s collection day has been missed, please still dispense the amount due for any remaining day(s) of that instalment.

Consult the prescriber if three or more consecutive days of a prescription have been missed.

Supervise consumption on collection days.

Dispense daily doses in separate containers.

Question 17

why refer to doctor after 3 days for instalment?

Answer 17

there is a risk that they will have lost tolerance to the drug and the usual dose may cause overdose. In the best interests of the patient, consider contacting the prescriber to discuss appropriate next steps.

Question 18

what amendments needs to be made when making technical corrections

Answer 18

The prescription must also be marked to show that the amendments are attributable to the pharmacist (e.g. name, date, signature and GPhC registration number, etc.).

Question 19

sch 2 and 3 private controlled drugs

Answer 19

prescribers identification number must be included

Question 20

submission

Answer 20

(NHS Business Services Authority or equivalent) for private and normal

vet- ONLY need to retain for 5 years

Question 21

collection of dispensed controlled drug

Answer 21

When a Schedule 2 CD is collected from a pharmacy, the pharmacist is legally required to determine whether the person collecting is a patient (Identity), patient’s representative or healthcare professional (name and address and identity).

COLLECTION BY A REPRESENTATIVE OF A DRUG MISUSE PATIENT

If a drug misuser wants a representative to collect a dispensed CD on his or her behalf, pharmacists are advised to first obtain a letter from the drug misuser that authorises and names the representative
-separate letter is needed each time and Identification is required
-insist on seeing the patient in person at least once a week unless known not possible

IF YOU NEED SUPERVISED
- If the directions on the prescription state that the dose must be supervised, the pharmacist should contact the prescriber before the medicine is supplied to the representative – since supervision will not be possible

. It is legally acceptable to confirm verbally with the prescriber that they are happy with this arrangement since supervision, while important,

make record of conversation with prescriber

• It would NOT be necessary to contact the prescriber if the person has been detained in POLICE custody and the representative collecting the dose is a police custody officer or a custody healthcare professional. This is because the administration of any Schedule 2 or 3 CD in custody will be supervised by a healthcare professional. If the dose is usually supervised, but has been supplied, the pharmacist should consider annotating the prescription and patient medication records to advise others that the dose has not been supervised in the pharmacy.

Question 22

good practice when collecting CD

Answer 22

It is good practice for the person collecting a Schedule 2 or 3 CD to sign the space on the reverse 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.

Question 23

what is safe cutody

The Controlled Drugs that must be kept under safe custody are:

Answer 23

The Safe Custody Regulations refer to the physical security of certain Schedule 2 or 3 CDs.

Schedule 1 drugs

Schedule 2 drugs except some liquid preparations and quinalbarbitone (secobarbital) Details of exempted Schedule 2 CDs are available from the Misuse of Drugs (Safe Custody) Regulations 1973 as amended

Schedule 3 drugs unless exempted under the Misuse of Drugs (Safe Custody) Regulations 1973 as amended, where the full lists are available.
Common exemptions include:
gabapentin
mazindol
meprobamate
midazolam
pentazocine
phentermine
phenobarbital
pregabalin
tramadol

Common Schedule 3 CDs which require safe custody include temazepam and buprenorphine

Question 24

acessing CD and cabinet

Answer 24

When CDs requiring safe custody are not kept in the CD cabinet, safe or room (e.g. during the dispensing process), they must be under the ‘direct personal supervision’ of a pharmacist.

A key log could be used to keep an audit trail of who has had access to the keys, including overnight storage in the pharmacy, the transfer of the keys from one pharmacist at the end of a shift to another pharmacist.

access to CD and kets should be documented within the policy to avoid unauthorised access

Question 25

PATIENT-RETURNED AND OUT-OF-DATE OR OBSOLETE CONTROLLED DRUGS

Answer 25

Safe custody applies to patient-returned, out-of-date and obsolete CDs until they can be destroyed (see section 3.6.10). To minimise the risk of supplying these to patients, this stock should be segregated from other pharmacy stock and be clearly marked (e.g. mark the stock as ‘patient returns waiting to be destroyed’ or ‘out of date, waiting authorised witness to destroy’, etc).

Question 26

which controlled drugs needs to be denatured

Answer 26

The Home Office has advised that all CDs in Schedules 2, 3 and 4 (Part 1) should be denatured and, therefore, rendered irretrievable before disposal.

Question 27

witnessing destruction

Answer 27

Typically, the destruction of pharmacy stock of Schedule 2 CDs needs to be witnessed. The destruction of patient-returned CDs, whether they require denaturing or not, does not require witnessing by an authorised person.

Question 28

Denaturing and witness requirements for patient-returned and expired controlled drugs

Answer 28

Patient returned controlled drug
Is denaturing required?

Yes, if Schedule 2, 3 or 4 (Part 1).

Is an authorised witness required?

No. However it is preferable for denaturing to be witnessed by another member of staff familiar with CDs (preferably a registered health professional).

Record keeping

A record should not be made in the CD register but records of patient-returned Schedule 2 CDs and their subsequent destruction should be recorded in a separate record for this purpose.

Question 29

denaturation of Expired/obsolete/unwanted stock

Answer 29

Expired/obsolete/unwanted stock
Is denaturing required?

Yes, if Schedule 2, 3 or 4 (Part 1).

Is an authorised witness required?

Yes, if Schedule 2. For Schedule 3 medicines it would be good practice to have another member of staff witness the denaturing.

Record keeping

An entry should be made in the CD register for Schedule 2 CDs.

Question 30

destruction methods of controlled drugs

Answer 30

**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.

Where a CD denaturing kit is not available, an alternative method of denaturing is to 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.

Where a CD denaturing kit is not available, an alternative method is to pour the liquid onto an appropriate amount of suitable product* and add this to an appropriate waste disposal bin.

When a 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. You may only dispose of rinsings 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 (remember to remove or obliterate any labels). Disposal of irretrievable amounts of CD does not need to be recorded.

*****Ampoules and vials

For 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.

For 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.

An alternative but less preferable, disposal method is where the 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.

Alternatively 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.

*A risk assessment should be carried out to determine whether a product is suitable. A suitable product should render the CD irretrievable without compromising patient safety, the safety of the person carrying out the destruction, or the environment.

Question 31

Record keeping for controlled drugs

Answer 31

For Controlled Drugs supplied, the following must be recorded:

Date supplied

Name and address of recipient

Details of authority to possess – prescriber or licence holder’s details

Quantity supplied

Details of person collecting Schedule 2 CD – patient, patient’s representative or healthcare representative (if the latter, also record their name and address)

Whether proof of identity was requested of the person collecting

Whether proof of identity was provided.

• running balance

These are the minimum fields of information that must be recorded; additional relevant information can be added.

Question 32

controlled drug recieved - records

Answer 32

Date supply received
Name and address from whom received
Quantity received.