Level 3 in Pharmaceutical Science

Level 3 in

Pharmaceutical Science

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MODULE 2 PART 3 CONTROLLED DRUGS

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Level 3 Pharmaceutical Science Module 2 Part 3 – Controlled Drugs

Copyright Buttercups Training Ltd – July 2019 1

Contents

Chapter 1 – Legislation of Controlled Drugs ....................................................................... 2

1.1 Misuse of Drugs Act and Misuse of Drugs Regulations ............................................... 2

1.2 Classes of Controlled Drugs ........................................................................................ 2

1.3 Possession and Supply of Controlled Drugs ................................................................ 6

1.4 PGDs for Controlled Drugs ......................................................................................... 6

1.5 Controlled Drugs and driving ...................................................................................... 7

Chapter 2 – Managing Controlled Drugs ............................................................................ 8

2.1 Prescriptions for Controlled Drugs ............................................................................. 8

2.2 Requisitions for CDs ................................................................................................. 11

2.3 Storage ..................................................................................................................... 13

2.4 Controlled Drug Registers (CDR) ............................................................................... 14

2.5 Collection ................................................................................................................. 16

2.6 Destruction of Controlled Drugs ............................................................................... 17

2.7 SOPs for Controlled Drugs ........................................................................................ 18

Chapter 3 – Controlled Drugs in Other Circumstances ...................................................... 22

3.1 Controlled Drugs in ward, theatres and departments .............................................. 22

3.2 Controlled Drugs and midwives ................................................................................ 24

3.3 Prescribing of Controlled Drugs by independent prescribers ................................... 24

3.4 Controlled Drugs as treatment for drug misusers .................................................... 25



Chapter 1 – Legislation of Controlled Drugs By the end of this chapter you will be able to:

• Outline the Misuse of Drugs Act

• List the schedules and 2 examples of drugs in each

• List persons permitted to possess, supply, administer, import and export these drugs by reference to the Medicines, Ethics and Practice Guide

1.1 Misuse of Drugs Act and Misuse of Drugs Regulations

The primary purpose of the Misuse of Drugs Act 1971 is to prevent the misuse of certain drugs,

defined under the Act as “Controlled Drugs”. It does that by prohibiting the possession, supply

and manufacture, import or export of Controlled Drugs except as allowed by regulations or

by licence from the Secretary of State.

Clearly some of the substances that have been classified as Controlled Drugs over the years

have important uses in medicine, and special arrangements are made to permit their supply.

The use of Controlled Drugs in medicine is permitted by the Misuse of Drug Regulations 2001.

The regulations categorise the Controlled Drugs that are used in medicines into different

schedules. They also cover the requirements for their supply on prescriptions and for record

keeping. Pharmacies are also required to have SOPs in place for managing CDs. This is a

requirement of the Controlled Drugs (Supervision of Management and Use) Regulations 2006.

Other regulations deal with the safe custody of Controlled Drugs (Misuse of Drugs Safe

Custody Regulations 1973) and with the supply of Controlled Drugs to addicts.

1.2 Classes of Controlled Drugs

Controlled Drugs are classified in five schedules according to different levels of control. The

classifications are as follows:

• Schedule 1 CD Lic

• Schedule 2 CD

• Schedule 3 CD No register

• Schedule 4 CD Benz/ CD Anab

• Schedule 5 CD Inv

To find out what schedule a controlled drug belongs to you can use the BNF, which now lists

them as part of the drug monograph.



Schedule 1 drugs (CD Lic)

Schedule 1 includes the hallucinogenic drugs (for example LSD) and cannabis, which have

limited medical use. Compounds with properties similar to ecstasy are included here making

their production, supply or possession unlawful without a Home Office licence.

Some pharmacists, particularly those working within hospital, may be asked to deal with

substances removed from patients on admission, which may be Schedule 1 products, for

example cannabis resin. There are only three circumstances where a pharmacist can take

possession of this class of drugs in the course of their work:

• The pharmacist can take possession of the drug in order to destroy it.

• The pharmacist can take possession of the drug in order to hand it to a police officer.

• The Medicines and Healthcare products Regulatory Agency (MHRA) has granted a

clinical trials certificate for the use of cannabis in medical research.

Schedule 2 drugs (CD)

This includes the opiates such as heroin, morphine and methadone, the major stimulants

(such as the amphetamines) and quinalbarbitone.

A pharmacist may supply them to a patient only on the authority of a prescription in the

required form issued by an appropriate practitioner. The drugs may be administered to a

patient by a doctor, dentist, nurse or pharmacist independent prescriber, acting in their own

right, or by a supplementary prescriber acting in accordance with a clinical management plan.

Nurse and pharmacist independent prescribers are not able to prescribe cocaine,

diamorphine (heroin) or dipipanone for the treatment of addiction, but can prescribe them

for the treatment of disease or injury suffered by addicts. Some requirements to be met by

Schedule 2 CDs are as follows:

• All Schedule 2 CDs except quinalbarbitone must be kept in a Controlled Drugs cabinet

• Controls over destruction and record keeping exist

• Prescription requirements apply

• The prescription may not be repeated and is only valid for 28 days

• Emergency supplies cannot be made

• Private prescriptions must be made on the appropriate prescription form and sent to

the appropriate monitoring bodies at the end of each month



Schedule 3 drugs (CD No register)

This schedule traditional included barbiturates such as phenobarbital and other drugs which

are less likely to be misused than those in Schedule 2. Temazepam, midazolam and tramadol

are more recent additions to this schedule, reclassified as a measure to help reduce their

misuse.

Records do not need to be made in the CD register and the controls relating to classes of

people who may possess and supply are different. Some requirements to be met by Schedule

3 CDs are as follows:

• Some, but not all, schedule 3 drugs need to be kept in the CD cupboard including

temazepam preparations, diethylpropion, and buprenorphine. (Any drugs added to

Schedule 3 require safe custody unless specifically exempted)

• Emergency supplies cannot be made except for phenobarbital and then only for

epilepsy (a maximum of 5 days’ supply is permitted)

• Prescriptions are valid for 28 days and invoices must be kept for 2 years from date of

supply.

• Private prescriptions must be written on the appropriate prescription form and sent

to the appropriate monitoring bodies at the end of each month; repeat prescriptions

are not allowed.

• Additional prescription requirements apply. Note that temazepam is no longer exempt

from these requirements from June 2015.

• Some controls exist over destruction of stock and patient returned medicines

From 1 April 2019, gabapentin and pregabalin are reclassified from POM to Schedule 3 CDs.

This means that prescription requirements for Schedule 3 CDs must be met for gabapentin

and pregabalin. They are exempt from safe custody requirements. They can no longer be

supplied on the Repeat Dispensing service as Schedule 3 CD prescriptions cannot be repeated.

Emergency supply for these drugs are no longer permitted.

Schedule 4 drugs

Part I (CD Benz): This contains most of the benzodiazepines plus zopiclone and zaleplon

Part II (CD Anab): This contains most of the anabolic and androgenic steroids along with

growth hormones

The restrictions are pretty similar to Schedule 3 with a number of differences; those most

applicable to you include:

• no need for record in CD register



• no requirement for storage in CD cupboard

• emergency supplies at the request of a patient are permitted up to a maximum of 5

days’ treatment

• no special prescription and labelling requirements except the 28-day validity of the

prescription

• There are fewer controls over their disposal.

Sativex: Schedule 4, Part I - a special case Sativex is an oromucosal spray that contains cannabinoids derived from Cannabis sativa. It is

used for patients with multiple sclerosis with moderate to severe spasticity. When it was

licensed in 2010 it was classed as a Schedule 1 Controlled Drug available under a special

general open licence from the Home Office.

In April 2013 Sativex became a Schedule 4 Part 1 Controlled Drug. This meant that the Home

Office general licence was no longer required so was revoked. Records of the receipt and

destruction of Sativex have to be made and kept for two years; this does not have to be in a

Controlled Drugs register (although the Home Office strongly recommends that the CD

register is used).

Prescriptions for Sativex need only meet the usual legal prescription requirements for this

Schedule and private prescriptions for Sativex do not need to be on the standardised

Controlled Drug Private Prescription form (FP10PCD)

Sativex does not need to be kept in safe custody but does require refrigeration. The

destruction of expired stock and patient returns do not need to be witnessed by an authorised

witness.

Schedule 5 drugs (CD Inv.)

In certain circumstances community pharmacists are able to sell Schedule 5 Controlled Drugs

from a pharmacy. Earlier in this module we mentioned the fact that certain drugs are P when

in low strength and POM at a higher strength. Certain drugs are CD at high strength but when

present in sufficiently low strength are termed CD Inv. According to their strength they are

classified as either CDInvPOM or CDInvP.

Examples of drugs to which this applies are pholcodine, codeine, morphine and medicinal

opium:

• CDInvPOM - dihydrocodeine 30mg tablets, codeine 15mg tablets

• CDInvP - codeine linctus, kaolin and morphine mixture, pholcodine linctus

Note that a medicine containing a mixture of 2 or more CDs will automatically be POM.



No special restrictions apply except that where an emergency supply is made at the request

of a patient the maximum period of treatment permitted is five days. Sales invoices must be

kept for 2 years.

1.3 Possession and Supply of Controlled Drugs

Other than drugs listed in schedule 5 you cannot be legally in possession of a Controlled Drug

unless:

• An appropriate licence is held from the Home Office

• The regulations specify that you can

• The regulations say possession of the drug is not unlawful

Practitioners and pharmacists are amongst those who have a general authority to possess,

supply and obtain all Controlled Drugs in the course of their work, except for those in Schedule

1.

1.4 PGDs for Controlled Drugs

There are only three occasions when a CD can be supplied via a PGD:

• If it is for the supply or administration of a Schedule 5 CDs

• If it is for the supply or administration of a Schedule 4 Part 1 CD or midazolam,

providing it is not in a parenteral (injection) form or for the treatment of addiction

• Pharmacists or nurses working under PGDs are able to supply diamorphine or

morphine where it is needed for the immediate and necessary treatment of the sick

or injured.



1.5 Controlled Drugs and Driving

From 2 March 2015 it will become illegal to drive with certain CDs in the blood above specified

limits. The list of drugs includes some licensed medicines including morphine, diamorphine,

methadone, amfetamine, diazepam, oxazepam and temazepam. After this date anyone

found to have any of these drugs in their blood above the specified limits will be guilty of an

offence. However there will be a medical defence for people who are taking drugs on the list

for medical reasons if their driving ability was not affected. Affected patients should be

advised:

• To continue to take their medicine

• To check the patient information leaflet that comes with it to find out whether and

how their driving ability might be affected

• Not to drive until they know how the medicine affects them

• Not to drive if they feel sleepy, dizzy or unable to concentrate



Chapter 2 – Managing Controlled Drugs

By the end of this chapter you will be able to:

• Understand the additional prescriptions requirements for CDs

• State the requirements for a CD requisition

• Explain the storage and register requirements for CDs

• List the SOPs required for the management of CDs

• Understand the correct destruction procedures for destroying CD stocks and patient

returns

2.1 Prescriptions for Controlled Drugs

A prescription for a Schedule 2 or 3 Controlled Drug must comply with the following

requirements. It is actually an offence for the practitioner to issue a prescription for a CD

which does not comply with the regulations and it is an offence to dispense an incorrectly

written prescription.

A prescription for a controlled drug must be validated before it is dispensed.

The prescription must be:

• Signed and dated (the date can be computer generated)

• Written in indelible ink

• Written on a standardised form if it is a private prescription for human use (except for

any dispensed within the hospital they are written)

o England FP10PCD

o Scotland PPCD(1)

o Wales WP10PCD

• It also needs to include the prescriber’s identification number for private CD

prescriptions. This is different to the GMC number and can be issued to the prescriber

by the local primary care organisation

• Veterinary prescriptions for Schedules 2 and 3 CDs need to include the prescriber’s

RCVS (Royal College of Veterinary Surgeon) number

The prescription must state:

• The name and address of the patient

• The address of the prescriber

• The dose to be taken - note that ‘when required’ is not acceptable but ‘one to be taken

as directed’ or ‘one when required’ is acceptable



• The appropriate form and strength of the preparation (note that the form must be

included even if only one form is available, e.g. tablets - the abbreviation T is not

acceptable; tab is minimum

• The total quantity in both words and figures of dosage units to be supplied - in any

other case the total quantity in words and figures

• If the prescription is to be dispensed in instalments, it must state the number of

instalments required and the intervals between their dispensing

• If issued by a dentist the words "for dental treatment only"

The prescription must not be dispensed unless:

• The prescription meets all the criteria already listed

• The prescriber’s address is within the UK and they are on the appropriate register in

the United Kingdom (does not include the Channel Islands or the Isle of Man). Whilst

it is legally acceptable for the prescription to be stamped or pre-printed with the

details of one doctor and signed by a different prescribing doctor, their addresses must

be the same. However, the Department of Health does not consider this to be best

practice

• The pharmacist / dispenser knows the prescriber’s signature or has taken steps to

prove that it is genuine

and must not be dispensed:

• Before the date

• More than 28 days after the appropriate date on the prescription (this could be the

date of signing or another date indicated by the prescriber as being the start date)

unless for a Schedule 5 CD which would be valid for 6 months

The date must be marked on the prescription at the time of supply.

The General Medical Council guidance states that doctors will be expected to make their

registered names and unique GMC reference numbers available to patients. The GMC can be

contacted on 0845 357 3456 to check that the number given corresponds to the name and

also details are available on http://www.gmc-uk.org

http://www.gmc-uk.org/



30-day supplies of CD prescriptions

Although not a legal requirement, the Department of Health has issued a strong

recommendation that as good practice the quantity of Schedule 2, 3 and 4 controlled drugs

prescribed should not exceed 30 days’ supply. Prescribers will need to be able to justify on

the basis of clinical need and believe that it would not pose an unacceptable risk to patient

safety to request a supply of more than 30 days. Prescribers have been advised that the

reason for prescribing in excess of 30 days’ supply should be noted in the patient’s notes and

should be ready to justify their reason for prescribing in this way.

Minor errors on CD prescriptions

Pharmacists can amend minor errors such as typographical/spelling mistakes or where the

total quantity of the preparation of the CD or the number of dosage units as the case may be

is specified in either words or figures but not both (i.e. they can add the words or the figures

to the CD prescription if they have been omitted).

Owings

The restriction in legislation, as described above, preventing a pharmacist supplying a

Schedule 2, 3 or 4 controlled drug later than 28 days after the appropriate date on the

prescription, also applies to owing balances on prescriptions. It has been confirmed by the

Home Office that the remainder of a Schedule 2, 3 or 4 controlled drug prescription cannot

be supplied after this time period.

Private Prescriptions for Schedules 2 & 3

In the community any private prescription for a CD schedule 2 or 3 (for human use) must be

written on a standardised private CD prescription form and state the unique 6-digit private

prescriber’s identification number. Normal CD prescription requirements also apply.

These private prescription forms must be sent to the appropriate pricing agency with the NHS

prescriptions at the end of each month. It is advisable that the Practice or Pharmacy retains a

copy. Don’t send the prescription until all the potential supplies have been made as you are

required to mark the date at the time of supply.

Private prescribers in hospital do not have to use the standardised form or have an

identification number on the private prescription, however, patients will only be able to have

these prescriptions dispensed in a hospital pharmacy.



Electronic prescriptions (EPS) for Schedules 2 & 3

From July 2015, Schedules 2 and 3 controlled drugs can be prescribed and dispensed via EPS,

(except oral liquid methadone). However, this is not yet mandatory. All of the current

prescription requirements apply, including writing the total quantity in both words and

figures.

It will probably take some time before this is used because all pharmacies and dispensing

systems need to be updated to support this first. Otherwise the electronic prescription may

arrive in a pharmacy with a system that cannot dispense it! Look out for further updates.

2.2 Requisitions for CDs

A request in writing known as a signed order or requisition, must be

obtained by a pharmacist before any Controlled Drug in Schedules 1, 2

or 3 is supplied other than against a prescription. The following people

may make requisitions:

• A doctor or dentist

• Nurse and pharmacist independent prescribers

• A sister in charge (matron) of a hospital or care home may make a requisition but it

must be signed by a doctor or dentist employed there

• A nurse in charge of any ward, who obtains a CD from the pharmacy must provide a

written requisition stating the total quantity of the drug required

• An operating department practitioner, who can obtain it from the pharmacy

department in his/her hospital

• A person in charge of a laboratory involved in scientific education

• The owner of a ship or the master of a ship which does not carry a doctor as part of

the staff

• The installation manager of an offshore installation

• The master of a foreign ship in a port in Great Britain

• Supplementary prescribers

From November 2015, it is mandatory for all CD requisitions for all Schedule 2 and 3 drugs in

the community to be made on the mandatory standardised CD Requisition form. Requisitions

not made on this form cannot be accepted. This applies to both human and veterinary care in

the community. *(FP10CDF in England, WP10CDF in Wales and CDRF (for private supplies) or GP10A (for NHS supplies) in Scotland)

The FP10CDF CD Requisition Form contains:

• name, address and occupation of recipient, and their signature



• purpose for which the drug is supplied such as “for practice use”

• name, form and strength of drug

• total quantity of the drug (it doesn’t have to be in words and figures)

You can find a copy of the FP10CDF form and relevant guidance here:

http://bit.ly/CDrequisitionform

A supplier supplying controlled drugs against a requisition must be reasonably satisfied that

the signed requisition is genuine and the person signing the requisition is engaged in the

occupation stated.

Requisitions cannot be placed electronically or by fax so the supplier should be in possession

of a signed requisition before supplying the Controlled Drug. In an emergency the supply

could be made as long as the requisition is in the suppliers’ hands within 24 hours of receipt.

The practitioner commits an offence if this is not forthcoming.

The supplier must then record their name and address on the requisition and the forms must

be submitted to the PPD monthly (along with their private CD prescriptions). A copy of the

requisition must be kept for two years from the date of supply. Veterinary CD prescriptions

and requisitions do not need to be submitted and should be kept for five years.

http://bit.ly/CDrequisitionform



2.3 Storage

Under the Misuse of Drugs (Safe Custody) Regulations 1971 (as amended), schedule 1 CDs,

schedule 2 CDs except quinalbarbitone and some schedule 3 CDs must be stored in a locked

cupboard, safe or room that meets stated technical specifications. The CD cupboard must be

locked at all times and only be opened by those authorised to possess keys. The number of

keys must be controlled and the number of people allowed to have them must be limited.

Normally the pharmacist on duty will keep the keys on them when on duty, but may delegate

responsibility for key handling to a pharmacy technician or dispenser if they are dispensing a

CD or carrying out a stock balance. A doctor’s locked bag also falls under these regulations,

but a locked car is not acceptable.

Dispensed items awaiting collection must always be kept in this locked receptacle. This can

be very inconvenient if the items are bulky e.g., if they have been dispensed into Monitored

Dosage Systems, or if there are large numbers of methadone doses awaiting collection by drug

misusers. No matter the inconvenience, they must be locked away and arrangements made

for additional safe storage as necessary.

A CD cupboard must be securely fixed to the wall or floor. No money or documents should

be kept in the cupboard and it goes without saying (I hope) that it should be in an alarmed

room with nothing indicating that it holds CDs. Other drugs that may be open to misuse can

be kept in the cupboard. You should make arrangements to be able to keep a record of stock

level of Controlled drugs to ensure that an audit trail is available. This means that you can

complete a reconciliation of stock.



2.4 Controlled Drug registers (CDR)

Records must be made of all movements of Schedule 1 and 2 controlled drugs; their receipt

as well as supply. Traditionally this was always in a bound register but it can now be kept

electronically. A separate part of the register must be used for each strength and form of each

drug. Entries made in respect of drugs obtained and supplied may be made on the same page

or on separate pages.

The following must be specified in the CDR at the head of each page:

• The class of the drug

• The strength of the drug

• The form of the drug

• The name of the drug

The following table specifies the information which must be recorded in the controlled drugs

register when obtaining or supplying stocks of CDs

CDs Obtained CDs Supplied

• Date received

• Name and address

from authorised

person from whom

received

• Amount received

• Date on which supply was made

• Name and address of person to whom supplied

• Details of authority to possess – prescriber or licence

holder’s details

• Quantity supplied

• Details of the person collecting Schedule 2 CD

(patient/patient’s representative/healthcare

professional) and if a healthcare professional, name and

address

• Was proof of identity requested of

patient/representative? Yes/No

• Was proof of identity of person collecting provided?

Yes/No

It is a requirement to record in the CDR whether the person collecting a Schedule 2 CD is the

patient, the patient’s representative or a health care professional. It is also compulsory to

record whether evidence of the patient or their representative’s identity was provided or to

record the name and address of the health care professional collecting the Schedule 2

controlled drug.

Additional information can be recorded (although not a legal requirement) such as:



• Running balances

• Private prescriber ID number or NHS prescriber code

• Professional registration number of the prescriber

• The name and registration number of the healthcare professional supervising the

supply of drug to the patient

Once electronic CDRs are in common usage these additional points will become mandatory.

For private CD prescriptions it is also good practice to record the entry in the private

prescription book, although not a legal requirement.

Find out whether you are required to keep a running balance.

Compliance with the following is required when filling out the CDR:

• Entries must be in date order (chronologically)

• A separate section is required for each class of drugs

• Class of drugs must be specified at the head of each page

• Entries must be made on the day of supply or on the next day. If there is a balance owing

the record is completed for the amount that has been dispensed. A second entry is made

when the balance is supplied

• No cancellation or alteration of any type may be made - you must asterisk (*) the error

and make a note of the correction at the end of the page. This must be dated and marked

to show who the amendment is attributable to

• Entries must be made in ink or otherwise indelible

• The register must not be used for anything else

• The register must be kept on the premises at all times - although preferably not in the

Controlled Drug cupboard

• The register must be made available to authorised persons e.g. General Pharmaceutical

Council inspectors, Controlled Drug Liaison Officers or Accountable Officers. Documents

relating to stock, receipt and supply of drugs must also be produced

• Registers must be kept for 2 years from the date of the last entry

• Records can be kept in their original form or copied and kept in an approved computerised

form.



2.5 Collection

You must ascertain the identity of the person (i.e. patient, representative or healthcare

professional) collecting Schedule 2 CDs by asking for proof of identity. If the person collecting

is a healthcare professional acting in their capacity as such, you must obtain their name and

address.

Types of ID that may be considered suitable include:

✓ Professional registration number for a healthcare

professional

✓ Driving licence (including photo card section)

✓ Any official photo ID

✓ Passport

✓ Cheque guarantee, debit or credit card

✓ Birth/marriage certificate

✓ Pension or benefit book

✓ Council tax payment book

✓ Recent bank or building society statement (within last 6 months)

✓ Council rent book

…...this list is not exhaustive!

If ID is not seen, the pharmacist may still supply the CD in order not to deny the patient access

to the drugs that they require. It is not a criminal offence to supply a Schedule 2 CD without

proof of identity, even when the pharmacist does not know that person.

Circumstances where ID may not be required includes when the person collecting the CD is

known to the pharmacist (the patient, close relative or friend) or when the pharmacist feels

that asking for ID may compromise patient confidentiality.

Prescription forms contain a space on the back of the prescription for the person collecting

the prescription to sign and for the pharmacy to confirm whether or not the identity of those

collecting Schedule 2 or 3 CDs has been checked. This declaration appears on both NHS and

private forms.



2.6 Destruction of Controlled Drugs

Stock which is out of date

Any person required by the Regulations to keep records of controlled drugs (i.e. schedule 2

CDs), may only destroy them in the presence of a person authorised by the Secretary of State

either personally or as a member of a specific group/class of individuals. The latter includes

inspectors of the General Pharmaceutical Council, Accountable Officers and Controlled Drugs

Liaison Officers (certain police officers).

Particulars of the date of destruction and the quantity destroyed must be entered in the CD

register and signed by the authorised person in whose presence the drug is destroyed. The

authorised person may take a sample of the drug which is to be destroyed.

Patient returns

Patient returned CD schedule 2 and 3 drugs do not need to be destroyed by an authorised

witness but should be destroyed by a registered healthcare practitioner and ideally witnessed

by a second person who is familiar with CD requirements.

Details of drugs returned by patients should not be entered into the CD register, however a

record of the returned CDs and details of their destruction must be made in a separate book

kept for this purpose.

It is good practice to destroy returned CDs as soon as possible after receipt. However, until

such time that patient returned controlled drugs can be destroyed, they must be stored in the

CD cabinet if they would normally require safe custody. Any patient returned controlled drugs

must be kept segregated from stock controlled drugs, and clearly marked as such, to minimise

the risk of errors and inadvertent supply.



Destruction Methods

Have a look back at module 1 for guidance on destruction of medicines

The Home Office has advised that Schedule 2, 3 and 4 Part I controlled drugs should be

denatured (i.e. made unusable) before being placed into waste containers. If possible, CD

denaturing kits should be used.

Remember de-blistering is only permitted for controlled drugs in order to denature the drug

and render it irretrievable. De-blistering involves removal of the solid dosage form from its

blister strip or bottle.

2.7 SOPs for Controlled Drugs

Standard Operating Procedures are required by all healthcare providers under the Controlled

Drugs (Supervision of Management and Use) Regulations 2013 covering certain aspects of

controlled drugs handling. This is to ensure that there is safer management of CDs in practice

by providing more auditable procedures and therefore any misuse should be easier to spot.

Your SOPs in the pharmacy should cover:

1. Who has access to CDs

2. Where the CDs are stored and security when they are

transported

3. Disposal and destruction of CDs

4. Who to alert if problems arise with the management of

CDs

5. Record keeping of stock and patient returns

Under point 4 above, this will often refer to your Accountable Officer. An Accountable Officer

is an experienced person appointed by NHS England, an NHS Trust or board, or a private

hospital to ensure safe, appropriate and effective management of controlled drugs within the

organisation they work for. The Accountable Officer should not deal with CDs on a day to day

basis but should be a suitably senior person within the organisation that can deal with any

issues appropriately. Their responsibilities include:

• Establishing and ensuring appropriate arrangements to comply with Misuse of Drugs

legislation



• Ensuring adequate and up-to-date SOPs are in place in relation to the management

and use of CDs

• Ensuring adequate destruction and disposal arrangements for CDs

• Ensuring monitoring and auditing of the management and use of CDs

• Assessing and investigating concerns

For more detailed information on the regulations that cover the safe management and use of

CDs across England and Scotland consult the Department of Health Guidance:

http://bit.ly/CDmanagement

Chapter 1 & 2 Summary

• The Misuse of Drugs Act and Misuse of Drugs Regulations list additional requirements and

restrictions for the supply of controlled drugs • There are 5 schedules of controlled drugs; schedule 1 having the most restrictions and

schedule 5 having the least restrictions

• Schedule 2 drugs require secure storage

• Pharmacists have a general authority to possess and supply controlled drugs

• Prescriptions for schedule 2 & 3 CDs have additional requirements

• Prescriptions for schedule 2, 3 & 4 CDs should be dispensed within 28 days of the

prescription date and any owing must be collected within that 28-day period

• CD prescriptions for schedule 2, 3 & 4 should normally only be supplied for up to 30 days’

supply

• Records of receipts and supplies schedule 2 CDs must be recorded in a CD register

• Records must also be kept of schedule 2 & 3 CDs returned from patients and the

destruction of these (although this must be separate to the CD register)

http://bit.ly/CDmanagement



Chapter 1 & 2 Quiz - Test Yourself

1. What information is required on a CD schedule 2 requisition?

2. Under which one of the following circumstances can CDs be destroyed in the absence of an

authorised witness?

a) A community pharmacist who no longer requires stocks of TUINAL which he kept

for one particular patient who has now moved out of the area

b) A Master of a ship who finds out of date ampoules of Cyclimorph® injection

c) A community pharmacist who has a quantity of MST 100mg tablets returned to

her/him by a relative of a patient who has recently died

d) A community midwife who has some expired ampoules of pethidine injection in

her bag

3. What is the correct procedure if you make an error when completing the CD register?

4. True or False: Your pharmacy must have SOPs outlining who to alert if there is a problem

with the management of CDs

5. True or False: Running Balances in CDRs are a legal requirement

6. True or False: Prescriptions for controlled drugs schedule 2, 3 and 4 are valid for 13 weeks

7. Complete the table below from the information you have studied

Schedule 2 Schedule 3 Schedule 4

Part I

Schedule 4

Part II

Schedule 5

Category CD No Reg

Safe Custody No

Additional CD Prescription

requirements

No

Records to be kept in CD

register

No

Emergency supplies allowed Yes

Repeats allowed Yes

Invoices to be retained for 2

years



Schedule 2 Schedule 3 Schedule 4

Part I Schedule 4

Part II Schedule 5

Address of prescriber must

be in the UK

Yes No

Validity of prescription 28 days

Private prescriptions to be

written on standardised

forms

Chapter 1 & 2 Quiz answers1. Name, address and occupation; purpose for which the drug is supplied such as “for practice use”; name, form and strength of drug; total quantity of the drug; date on which it was supplied

2. c

3. Asterisk it with detials of the amendment as a footnote. This should dated and marked to show who the amendment is attributed to. (Do not enter again as another line)

4. True

5. False -They are good practice but not mandatory

6. They are only valid for 28 days from the appropriate date

7. Check your answers in the Medicines Ethics and Practice Guide by looking at the table 9 in the CD section.



Chapter 3 – Controlled Drugs in Other Circumstances

By the end of this chapter you will be able to:

• Understand the use of controlled drugs in hospital wards, theatres and departments

• Explain how community midwives obtain supplies of CDs

• Identify which CDs nurses and pharmacist are able to prescribe

• Explain the supply of CDs to drug misusers and how to deal with problems that may

arise

3.1 Controlled drugs in ward, theatres and departments

In hospitals there are additional requirements for

the administration, supply, requisitions and

record keeping of CDs.

A registered nurse, midwife or operating

department practitioner (ODP) in charge of a ward

theatre or department (WTD) has overall

responsibility for the management of CDs in their

area. Whilst they may sometimes delegate the

access to CDs to other members of staff, they are still legally responsible for overall

management.

There should be SOPs covering each of the activities that are undertaken such as

requisitioning, receipt and administration. These should reflect current legal and good

practice requirements and must be kept up to date. There should be a list of CDs held in each

WTD as stock items. These should reflect patterns of usage and the speciality of the area and

be agreed between the registered nurse, midwife or ODP in charge and the pharmacist or

pharmacy technician responsible for stock control of medicines in that area.

Registered nurses, midwives or ODP in charge are allowed to requisition CDs from within the

hospital for use within their area. They can delegate the task of preparing requisitions but

remain legally responsible. Requisitions should be written on suitable stationery such as a CD

requisition book and must be signed by an authorised person. A copy of all authorised

signatures should be available in the pharmacy so that requisitions can be validated.

Electronic requisitions are permitted but there must be a reliable way of validating the identity

of the individuals making the requisition.



Requisitions must contain the following:

• Name of hospital

• Ward/Department

• Drug name, form, strength, ampoule size if more than one available

• Total quantity

• Signature and printed name of registered nurse, midwife or ODP

• Date

• Signature of person issuing the item from the pharmacy

A person who delivers CDs to the WTD must sign either the requisition or a separate book

kept for that purpose to show that he/she has received or collected them. At the WTD, the

CDs must be handed to an appropriate individual who should sign a duplicate copy of the

requisition as evidence of their receipt. The CDs must be checked against the requisition

including the number ordered and received.

Each ward, theatre or department must have its own CD cupboard with a lock that is not the

same as any other lock in the hospital. Only authorised staff should have access to keys and

arrangements must be in place for keeping the keys secure. If CD keys cannot be found,

urgent efforts must be made to retrieve them as soon as possible, for example by contacting

staff who have gone off duty. Procedures should allow for a spare key to be issued where

appropriate to ensure that patient care is not compromised.

Each WTD must also keep its own CD register in which records of CDs received or administered

in that area must be made. These should include running balances for each item stocked. The

registered nurse, midwife or ODP responsible for the WTD should ensure that the register is

checked on a regular basis to identify any discrepancies in a timely manner. Entries in the CD

register should ideally be witnessed by a second nurse, midwife or ODP. Where these are not

available entries can be witnessed by a second competent professional.

In certain circumstances, for example when CD discharge medicines are sent to a ward several

hours before the patient is due to leave it is good practice to store the medicines in the CD

cupboard, but to segregate them from the ward stock.

Ideally, destruction of CD stock should not take place on a ward, theatre or department and

unwanted stock of CDs should be returned to the pharmacy where it can be denatured as

described earlier. However if small amounts are destroyed on the ward, for example if an

amount of liquid drawn up into a syringe is less than the total amount in an ampoule, then a

second competent person such as a nurse, midwife or ODP must witness their destruction. All

destruction must be documented in the appropriate section of the CD register.



New guidance on the safe management and use of CDs is being developed by the National

Institute of Health and Care Excellence and this is expected to be completed by March 2016.

In the meantime, for more information about the management of CDs management in

hospitals, view the following guidance:

http://bit.ly/CDsinhosptial

3.2 Controlled drugs and midwives

Midwives are allowed to possess diamorphine, morphine and pethidine for use in their

practice. However they can only be supplied to a midwife on the production of a midwife

supply order (MSO) signed by an “appropriate medical officer”, this is normally the doctor

authorised by the local supervising authority.

From July 2015, all MSOs must be specific to a patient. Because of this change, midwives can

now supply or administer controlled drugs to the specific patients.

The supply order must state:

• the name and occupation of the midwife

• the purpose for which the CD is required

• the total quantity to be obtained

• the name of the patient or expecting mother

The midwife must maintain a register of CDs received and administered. Any out of date or

surplus stock must be returned back to the “appropriate medical officer” and cannot be

destroyed by the midwife.

3.3 Prescribing of controlled drugs by independent prescribers

Independent nurse and pharmacist prescribers are able to prescribe, administer and give

direction for the administration of schedule 2, 3, 4 and 5 controlled drugs. This extends to

diamorphine, dipipanone or cocaine for treating a disease or injury, but not for treating

addiction. Like other medicines they should only be prescribing CDs for areas of practice in

which they are clinically competent.

On the other hand, nurse and pharmacist supplementary prescribers can prescribe any

controlled drug under a clinical management plan for a patient in partnership with an

independent prescriber who is entitled to prescribe that CD.

Physiotherapist and Chiropodist/Podiatrist Independent Prescribers can only prescribe the following Controlled Drugs: temazepam, lorazepam, diazepam and dihydrocodeine.

http://bit.ly/CDsinhosptial



Physiotherapist Independent Prescribers can also prescribe morphine, fentanyl and oxycodone.

3.4 Controlled drugs as treatment for drug misusers

A person is regarded as being addicted if they have an overpowering desire for a drug brought

about by repeatedly using it. A person addicted to a drug will often have a high degree of

tolerance for that drug. By this we mean that they can withstand much higher doses of a drug

than those who have never taken it. (This is because the body has got used to the effects of

the drug and over a period of time reduces its response to it.) Drug misuse is one area of our

work which may cause some ethical problems. We aim to treat all our patients with respect

and to be tolerant and not make judgements about their lifestyles or the reasons why they

need our care. This is a basic principle of healthcare ethics.

Unfortunately, because drug misusers have an overwhelming desire and need for the drugs

to which they are addicted, their behaviour can often be challenging. Many behave well but

some may be abusive, aggressive, offensive, threaten violence, engage in shop lifting or

otherwise upset your staff and the business of your pharmacy. Nevertheless, they are still

patients and they must be treated with respect. Sometimes it helps to set some “ground rules”

for conduct before accepting the dispensing of prescription or other services for drug

misusers. If your pharmacy offers these services, discuss these matters with your pharmacist

to identify how problems can be managed professionally and ethically. At the end of this

section, we describe some case studies for you to discuss with your pharmacist.

Prescription forms

Drug misusers in the UK can be prescribed certain controlled drugs to help treat their

addiction to illegal drugs. The most common of these is methadone. Usually the medication

is given to the misuser in instalments, often supervised on a daily basis. This is to prevent them

selling, sharing or overdosing on their medication.

The types of prescriptions used for the treatment of drug misusers by instalments depend on

the part of the country you are in.

England

Currently the types of prescription forms in use in England to prescribe any Schedule 2

controlled drug, buprenorphine and diazepam by instalment on the NHS are:

• FP10(MDA)-S are issued by General Practitioners.

No other items can be prescribed on this form, other than water for injection supplied

with dry powder injections which should be supplied in a single instalment.



• FP10(MDA)-SS are issued by supplementary prescribers, hospital prescribers and GPs.

They are intended for use as computer generated prescriptions, although they can still be

handwritten. Other drugs and allowed drug tariff items can be ordered on this form but

not in instalments. Only one dispensing fee will be paid for supplying any other item.

• FP10(MDA)-SP are issued by supplementary prescribers.

They are intended for use as handwritten controlled drug instalment prescriptions.

• FP10H(MDA)-S are issued by hospital prescribers.

A maximum of 14 consecutive days’ treatment may be ordered. If more than 14 days’ supply

is prescribed it is understood that the pharmacist will be reimbursed for the quantity of

controlled drug supplied but that the Prescription Pricing Division of the NHS Business Services

Agency (PPD-NHSBSA) will refer the prescriber to the NHS England. It is therefore advisable

that the prescription is amended by the prescriber.

Scotland

Currently the types of prescription forms in use in Scotland to prescribe by instalment on the

NHS are:

• GP10 and GP10-SS (computer generated) are issued by General Practitioners, (GPs).

Any medicine normally prescribable on a GP10 can be prescribed by instalment on a GP10,

including Schedule 2, 3, 4 and 5 controlled drugs.

• GP10(N) and GP10(N)-SS (computer generated) are issued by Nurse Independent and

Supplementary Prescribers.

• GP10(P) are issued by Pharmacist Supplementary Prescribers.

• HBP(A) and HBP(A)-SS (computer generated) are issued from drug addiction clinics.

They can be used to prescribe, in instalments, any drug used in the treatment of addiction.

• HBP and HBP-SS (computer generated) are issued from hospitals by hospital-based

prescribers

• HBP(N) and HBP(N)-SS (computer generated) are issued by hospital-based Nurse

Independent Prescribers and Nurse Supplementary Prescribers.

• HBP(P) are issued by hospital-based Pharmacist Supplementary Prescribers.

There are no limits to the number of days’ treatment that can be supplied against these



prescriptions. However, the Scottish Executive has stated that as a matter of good practice

the amount of controlled drug prescribed on a prescription should not exceed 30 days’ supply.

(This limit can be exceeded if the prescriber believes that such a supply is clinically indicated

and would not pose an unacceptable risk to patient safety).

Wales

In Wales the WP10(MDA) is issued by GPs and the WP10(HP)Ad is used by the drug treatment

centres. Again reimbursement from the NHS will only allow 14 days treatment to be given but

any Controlled Drug listed in Schedules 2-5 can be prescribed on these forms.

Northern Ireland

In Northern Ireland the forms HS21 and SP1 can be used by GPs and hospital consultants

respectively for methadone and buprenorphine.

Instalment dispensing

All the prescription requirements previously discussed must be complied with. The controlled

drug is often ordered to be dispensed in daily instalments and the prescription must contain

a direction specifying the amount of the instalment which may be supplied and the intervals

to be observed when supplying. (It is not a legal requirement for the number of instalments

to be specified.)

For instalment prescriptions the first dispensing must be within 28 days of the appropriate

date (this could be the date of signing or a start date written on the prescription).

The remainder of the instalments must be dispensed on the due date specified on the

prescription. If the patient fails to turn up then the supply for that day is forfeited and the

prescription must be marked ‘not dispensed’. Clients who wish another person to collect their

methadone supply on their behalf should provide proof that it is their intention. Late arrivals

or early requests for methadone should always be referred to the pharmacist.

Where a number of days’ supply are due on a specific day and the person fails to show, it is

now possible to dispense the remainder of the instalment on a different day. This can only

happen if the prescriber has indicated that this would be his/her intention. There is specific

approved wording in the MEP guide that should be used for this purpose.

From November 2015, the Home Office has issued guidance on the new approved wording of

instalment prescriptions. Prescribers can carry on using the old wording or use the new

wording, but they cannot mix the new and the old. More details can be found here:

http://bit.ly/CDinstalmentwording

http://bit.ly/CDinstalmentwording



Doctors need a special Home Office licence to prescribe the drugs cocaine, diamorphine, and

dipipanone, to addicts except for the purpose of treating organic disease or injury.

Some pharmacies that handle large numbers of prescriptions for drug misusing clients now

use computerised methadone dispensing systems. As well as automated dispensing these

systems can offer electronic patient profiles, patient verification using a camera or fingerprint

recognition and can generate electronic CD registers with running balances. For more

information about these systems have a look at the following websites:

http://www.methameasure.co.uk/

http://www.medilogicuk.com/products/methasoft-systems/

Other services to drug misusers

1. Supervised consumption

It is increasingly common for community pharmacists to be asked to supervise the

consumption of methadone and buprenorphine. This is normally under an agreement as a

service provider with a local commissioning body. Clear procedures for this must be in place

to ensure safe delivery of the service. If you are to assist in the provision of this service you

will usually be given additional training.

2. Needle and syringe exchange

This is another service provided by community

pharmacies under local agreement. To participate in

the scheme there must be a protocol and training must

be provided, particularly to ensure safety of the staff.

The needle and syringe packs are usually provided by

the local commissioning body and the pharmacy is paid

a fee for each client transaction.

The idea is to encourage the return of used needles in exchange for new, clean ones. This

helps to reduce the spread of blood born disease amongst the drug injecting population, and

provides a safer environment for the public at large as used needles are returned for disposal

and not discarded in public places or in the vicinity of children.

Usually the pharmacy will display this logo on the front window of the shop to

indicate that they offer the service.

http://www.methameasure.co.uk/

http://www.medilogicuk.com/products/methasoft-systems/



3. Drug paraphernalia

When providing drug treatment services, pharmacists are allowed to supply the following

drug paraphernalia to drug misusers:

- Swabs

- Citric acid

- Ascorbic acid

- Filters

- Aluminum foil

- Ampoules of sterile water for injection (max 2ml)

Ethical issues and drug misuse

The law only lays down a framework for managing the controlled supply of medicines which

are liable to abuse. There are many situations that may arise where the law does not cover

the problem that is in front of you or where the law actually hinders your ability to follow

ethical principle number 1 of always making the patient your first concern and principle 2

which requires you to act in the best interests of your patients and members of the public

who use your services. These situations throw up “ethical problems”.

In a later part of this module we will look at situations where ethical principles may conflict

with each other creating “ethical dilemmas”.

Read this case study, think about how you might deal with it and then discuss with your

pharmacist. Ask your pharmacist to agree with you how much they might want you to find

out or do on their behalf and at what point they would like to be asked to deal with any

problems themselves.

What is the legal position?

How should you go about making the care of Gavin your first concern?

What facts should you gather before discussing this situation with your pharmacist?

Case Study

The drug misuser who has broken his bottle of methadone

While you are training, you are involved with the regular supply of instalment prescriptions for drug

misusers and you are learning about supervised consumption and the supply of clean needles and

syringes for those of your clients who inject their drugs. One of your “regulars”, Gavin, arrives in an

agitated state one morning and he tells you that he had a bit of a fight last night and the methadone

bottle you gave him yesterday was knocked out of his pocket and broke. He shows you bits of broken

glass and liquid to support his request for a replacement.

…What should you do?



Do you think you and your pharmacist might respond differently if the “regular” was a

daughter looking after her elderly mother with terminal cancer, and the medicine bottle that

had broken had contained diamorphine solution? Why?

Again, discuss with your pharmacist what options you might have in responding to this case

study.

Chapter 3 Summary

• Controlled drugs in hospital wards, theatres and departments are the responsibility of the

nurse, midwife or operating department practitioner • Each hospital area will have an agreed list of CDs they require and will have a CD register

to record the stock levels • Community midwives are allowed to possess 3 CDs for use in their practice. They must

have an authorised doctor sign the supply order • The prescribing for the treatment of drug addiction varies in different parts of the UK.

There are designated forms to be used. • Dispensing for drug misusers is usually by instalments and may sometimes be supervised.

Chapter 3 Quiz - Test Yourself

Indicate if each of the following statements are true or false:



1. Excess stock of CDs on a ward must be destroyed with the accountable officer as witness.

2. A midwife in charge of a maternity ward can allow another nurse to have the access key to

the CD cabinet on the ward.

3. Stocks of CDs on a ward should be recorded in the pharmacy CD register.

4. A community midwife can destroy any excess stock when supervised by another midwife.

5. Pharmacist independent prescribers are not allowed to prescribe any CDs.

6. In Scotland prescriptions to treat drug addiction via installments can be for up to 30 days’

supply.

7. You are allowed to sell citric acid to a drug misuser registered on a needle exchange scheme

Chapter 3 Quiz answers

1. False -Ideally it is returned to the pharmacy for destruction but small amount can be witnessed by another competent practitioner

2. True

3. False -The ward should have a CD register

4. False -It must be surrendered to the authorised doctor

5. False

6. True

7. False -No it can only be supplied to those on a drug treatment programme