controlled drug

Question 1

what is a controlled drug?

Answer 1

A drug that causes harm when misused
• Often have potential for abuse as a recreational drug
or for other purposes e.g. anabolic steroids in bodybuilding

Question 2

Legislations

Answer 2

Medicines Act 1968

Misuse of Drugs Act 1971

• controls and prohibit - possession, export, import, supply and manufacture
• the drugs which are part of the misuse drug act is ‘cd’ and they are classed a,b,c depending on how harmful they are

The Health Act 2006
-role is to have overarching responsibility for supervising and managing the use of CDs in their organisation

Misuse of Drugs (Safe Custody) Regulations 1973

• control of storage
• must be - lockable by key , made by metal, be fixed to the floor or wall, have a nominated key holder who is responsible

Question 3

schedule 1 CD

Answer 3

• E.g. LSD, ecstasy, mescaline, cannabis
• The majority of drugs in Schedule 1 have no recognised therapeutic use
• Generally limited to research – must hold a home office licence

• Practitioners may not lawfully possess these except under licence from
the Home Office

•Pharmacists cannot take possession of the material
except:
•For the purposes of destruction
•For the purpose of handing over to the police
•Under no circumstances return Schedule 1 drugs to a
patient at discharge

Question 4

example schedule 2 controlled drugs

Answer 4

Diamorphine
• Morphine
• Methadone
• Oxycodone
• Major stimulants (amfetamines)
• Quinalbarbitone
• Ketamine

Question 5

Schedule 2 and its standards

Answer 5

• Supply is restricted to licensed wholesalers, hospitals and pharmacies,
doctors and dentists acting in their professional capacity

• A licence is required to import or export

CD prescription requirements apply

• Safe custody (except quinalbarbitone) apply
• CD register for supplied (dispensing) and obtained (deliveries)
• Destruction – by appropriately authorised person with authorised witness and keep record
• Prescription valid for 28 days
• Emergency supplied NOT allowed
• Repeat prescribing NOT allowed

Question 6

what are example schedule 3 drugs

Answer 6

buprenorphine, midazolam, phenobarbitone, temazepam, tramadol

Question 7

standards for schedule 3 drugs - NO POM register

Answer 7

Subject to CD prescription writing requirements

• Most are exempt from safe custody requirements (except temazepam and
buprenorphine)

• No CD register record is needed
• Emergency supply is not allowed (except for phenobarbital for epilepsy)
• Repeat prescribing is not permitted
• Script is valid for 28 days
• Invoices must be retained for 2 years
• Subject to full import and export control
• The requirements relating to destruction do not apply
• New to this category (April 2019) is pregabalin and gabapentin

Question 8

schedule 4 standards

Answer 8

Prescription writing as per POM requirements

• Exempt from safe custody and CD entry recording
• Script is valid for 28 days
• Subjected to full import and export control
• EEA (European Economic Area) and Swiss prescribers can legally prescribe
• Repeat prescriptions are allowed
• Emergency supplies are allowed (max of 5 days should be given)

• This schedule is split into:
• Part I (CD Benz POM), which contains most of the benzodiazepines (e.g. diazepam),
non-benzodiazepines (e.g. zolpidem, zopiclone) and Sativex® (a cannabinoid oral spray)
• Part II (CD Anab POM), which contains anabolic and androgenic steroids (e.g.
testosterone), clenbuterol and growth hormone

Question 9

standards for schedule 5 drugs

Answer 9

Contains certain Schedule 2 CDs in low strengths (e.g. codeine, pholcodine
and morphine) which are exempt from full control

• Invoices must be kept for two years

• A practitioner, pharmacist or a person holding an appropriate licence may
manufacture or compound any schedule 5 substances

• Some are available OTC!

Question 10

how much quantity should be supplied for controlled drugs

Answer 10

• The quantity prescribed should be appropriate for the
clinical need of the patient

• Schedule 2, 3 and 4 should be limited to 30 days supply

• This is good practice and not a legal requirement
– use your professional judgement, but prescribers should
justify why more than 30 days is needed in all cases

Question 11

what are the CD prescription requirements?

Answer 11

• patients full name
• patients address
• drug name
• drug strength
• drug form
• drug dose
• total quantity words, as well as figures (twenty, 20 tablets)
• date - Valid for 28 days (6 months if Sch 5)
• prescribers name and address
• prescribers Signature

Prescriber identification number must be included

Good practice to keep a copy of the FP10PCD
• Good practice to keep a copy in POM register as well as in the CD register (CD reg is legal requirement)

Question 12

what is the prescription for controlled drugs called

Answer 12

England – FP10PCD
•Wales – WP10PCD
•Scotland – PPCD (I)

• Private human Rx for Schedule 2 and 3 CDs must be written on the designated prescription form
• But not when CDs are issued and dispensed in private hospital
• Or issued by a vet (= private Rx)

Question 13

what is the prescription for controlled drugs called

Answer 13

England – FP10PCD
•Wales – WP10PCD
•Scotland – PPCD (I)

• Private human Rx for Schedule 2 and 3 CDs must be written on the designated prescription form
• But not when CDs are issued and dispensed in private hospital
• Or issued by a vet (= private Rx)

Question 14

where should the original Rx for sch 2 and 3 be submitted

Answer 14

relevant NHS agency along with a CD submission form

Question 15

what are technical errors which can be amended by the pharmacist?

Answer 15

• Minor typographical errors or spelling mistakes
• The total quantity specified in either words or figures but not both
• contact prescriber to confirm the prescription verbally e.g. confirm
  quantity

• After confirmation, pharmacist can amend the Rx. Must use indelible ink (pen, NOT pencil) on main body of script, and clearly show the amendments are made by them (name, sign, date and GPhC reg. no.)

Add pc (prescriber contacted) in the endorsement column on left hand side of prescription form

• All other amendments or omissions must be corrected by the original prescriber

Question 16

Controlled drug register requirements

Answer 16

For all Schedule 2 CDs and Sativex (Schedule 4 Part I CD Benz POM) received
or supplied by a pharmacy

• No fixed format of CD registers but certain headings and information must be
recorded

• A separate page must be used for each strength and form of that drug
• Must be kept at the premises to which it relates and be available for inspection at any time
• Not to be used for any other purpose

When CDs are obtained (e.g. from a supplier), you must
record:
•Date the CD supply was obtained
•Name and address from whom it was obtained
(e.g. wholesaler)
•Quantity

BALANCE is checked aswell

Question 17

what is the CD register entry requirement?

Answer 17

• When supplying CDs (e.g. to patients), must record:
• Date supplied
• Name and address of patient
• Details of authority to possess- prescriber or licence holder’s details
• Quantity and form supplied
• Details of person collecting (Schedule 2 CDs)
• Whether proof of identity was requested
• Whether proof of identity was provided
• Entries must be made on the day of the transaction or on the next following day
• Be kept for 2 years from the date of last entry
• Entries and corrections must be indelible
• Entries must not be cancelled, obliterated (crossed out) or altered. Corrections must be made by dated marginal notes or footnotes (bracket or * the error)
• As good practice, pharmacists should maintain a running balance of stock in the CD register and enter prescriber identification number and name and registration number of the pharmacist supplying

Question 18

electronic CD registers

Answer 18

• The regulations require that every computerised entry must be attributable
to the person making it and capable of being audited

• It must be accessible from the premises and capable of being printed

• Must ensure safeguards are incorporated into the software to ensure author
of each entry is identifiable; entries cannot be altered at a later date.

Question 18

electronic CD registers

Answer 18

• The regulations require that every computerised entry must be attributable
to the person making it and capable of being audited

• It must be accessible from the premises and capable of being printed

• Must ensure safeguards are incorporated into the software to ensure author
of each entry is identifiable; entries cannot be altered at a later date.

Question 19

what is owing?

Answer 19

Owings = when you can’t supply full amount at once, the remaining amount
is called an ‘owing’
e.g. prescription for 56 tablets, only 28 in stock. Dispense 28 and
you owe the patient 28. Supply the ‘owing’ 28 when order is received. Patient comes back another time to collect them.

Owings- CD register must only record what is actually supplied. A further
entry must be made when the remaining balance is supplied

• The owing balance for schedule 2, 3 or 4 CDs cannot be dispensed later
than 28 days after the date of the prescription

• For Schedule 5 CDs, the balance of an owing cannot be collected more than
6 months after the date of the prescription

Question 20

collection of dispensed CD

Answer 20

Pharmacist is legally required to determine who is collecting
Schedule 2 CD

•Ask for proof of identity (unless already known to the pharmacist)

•Pharmacist has the discretion to decide to supply even if ID is not
provided

• Patient- Request ID
• Patient’s representative - Request ID
• Healthcare professional - request ID and obtain name and address

Question 21

FP10SS for a POM medicine

2. FP10D for a POM drug -
3. A private prescription -
4. A prescription for a cat -
5. A private prescription for a schedule 2 CD -
6. A private prescription for a schedule 3 CD
7. A schedule 2 CD for a horse

Answer 21

FP10SS for a POM medicine – No Reg
2. FP10D for a POM drug - No Reg
3. A private prescription - POM Reg
4. A prescription for a cat - POM Reg
5. A private prescription for a schedule 2 CD - CD Reg (Good practice to put in POM
Reg as well)
6. A private prescription for a schedule 3 CD – POM Reg
7. A schedule 2 CD for a horse – CD Register ( good practice POM)

Question 22

CD destruction

Answer 22

• Pharmacy contractors must have appropriate arrangements in place for the safe disposal of CDs

• The home office advises that all schedule 2, 3 and 4 (part 1) CDs should be
DENATURED (irretrievable) BEFORE being placed into waste containers

• Pharmacists should use CD denaturing kits to denature CDs wherever possible, or another suitable product e.g. cat litter!

Question 23

Patient CD returns

Answer 23

• Community pharmacies can accept CDs returned by patients from their own
home or care homes

• In England and Wales, cannot accept waste medicine from care homes which
provide nursing care (nursing homes)

• A record should be made (but not in the CD register) for patient returned Schedule 2 CDs
• No legal requirement to destroy them in the presence of an authorised witness, but is good practice to do so.

Question 24

Unknown substances in possession of patient

Answer 24

• in hospital (and other similar settings) occasionally a patient might have a suspected controlled substance in their possession. • patient should be asked to surrender the substance, place it in sealed envelope (or similar) labelled ‘suspected illegal drug surrendered’, patient’s hospital number, signed and dated by the Nurse In Charge and a witness. • Store in CD cupboard and entered in ‘Patient’s Own Drug’ section of the CD register, with a description of the substance * Removed by a pharmacist for destruction (or police if they are involved) * If patient refuses to surrender the substance, the police should be informed.

Question 25

date expired stock

Answer 25

For expired/unwanted Schedule 2 stock, the destruction must be witnessed by an authorised person * For Schedule 3, it would be good practice to have staff witness the denaturing * Accountable officers can authorise people or groups of people to witness the destruction * E.g. in hospitals, pharmacists and technicians are authorised by the AO. * A record must be made in the CD register and include: * Drug name * Form * Strength and quantity * Destroyed date * Signature of the authorised witness * Signature of the professional destroying it

Question 26

destruction method - solid dosage form | + if there is no denaturing kit available

Answer 26

1) grind or crush the solid dosage form 2) use small amount of water whilst grinding (minimise dust going into air) 3) add to denaturing kit when denaturing kit is not available then 1) crush/grind 2) place into a warm soapy water 3) stir until dissolved/dispersed 4) disposed in appropriate waste disposal

Question 27

destruction method liquid

Answer 27

-pour into denaturing kit when no denaturing kit -pour into suitable product and then disposal waste