Transcript Controlled Drug Regulations 2001

Controlled Drugs
The Legal Issues
Matthew Thomas
Accountable Officer, Hampshire PCT
[email protected]
07515 190584
• The Accountable Officer has responsibility for
establishing and operating appropriate
arrangements for securing the safe
management and use of controlled drugs (CDs)
and ensuring that bodies and persons acting on
behalf of, or providing services to or for, the
PCTs establish and operate appropriate
arrangements for securing the safe
management and use of CDs.
• The first point of contact for all controlled drug
issues.
• PCTs are responsible for establishing and
leading the local intelligence network (LIN)
on behalf of the PCTs, outside agencies,
hospitals and social services.
• Hampshire PCT Accountable Officer is the
lead manager of the SHIP LIN, covering,
Southampton City, Hampshire, the Isle of
Wight and Portsmouth City.
Harold Shipman
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Born in 1946
1970: House Officer, Pontefract General
1971: Fully registered with GMC
1971-4: 3 suspicious and 8 natural deaths
plus one patient attacked at home
• 1975: 1 unlawful, 6 suspicious and 10
natural deaths
• 1975: Pethidine addiction discovered
1977: joins Donneybrook practice, Hyde
• 1978-91: 63 unlawful, 29 suspicious and
119 natural deaths
• 1991: Moves to Market Street surgery
• 1992-98: 127 unlawful, 8 suspicious and
49 natural deaths plus 15 murders
• 1993: collected 14 single 30mg amps on
14 visits; 4 days where he collected twice!
• 1998: Forged a will, which led to his
discovery, trial and conviction (in 2000)
• 2004: Shipman commits suicide
Other Incidents
• Nurse Colin Norris – Leeds Teaching Hospitals
NHS Trust (2002) – convicted of 4 murders and
one attempted murder (Insulin overdoses) and
jailed.
• Sister Anne Grigg-Booth – Airedale NHS Trust
(2000-2002) -Charged with 3 offences of murder,
one attempted murder and 13 offences of
administering noxious substances with intent to
cause grievous bodily harm or harm. Died prior to
trial. 3 other Night Nurse Practitioners and 2
Senior Managers were also involved but none
were charged with any offences.
• Dr Jane Barton – Gosport War Memorial
Hospital (1996-1999)– GMC hearing found her
guilty of multiple instances of Serious
Professional Misconduct but no criminal charges
will be brought. 12 patients involved.
• Mid Staffordshire NHS Foundation Trust –
Stafford Hospital – Hundreds of deaths! Public
Inquiry commenced November 2010.
Overarching law
• Controlled drugs are defined in The Misuse
of Drugs Act 1971 and The Misuse of Drugs
Regulations 2001.
Controlled Drug Regulations 2001
Schedule 1 - Controlled drugs which may not be used for medicinal
purposes (e.g. cannabis, LSD, mephedrone etc)
Schedule 2 – Controlled drugs including opiates (morphine, diamorphine)
and major stimulants such as amphetamines
Schedule 3 – Barbiturates (except quinalbarbitone), midazolam and
minor stimulant drugs
Schedule 4 – Benzodiazepines, anabolic and androgenic steroids, and
some other related hormones.
Schedule 5 – Controlled drugs where there is a lower risk of abuse than
other schedules. It includes certain preparations containing codeine,
dihydrocodeine, pholcodeine, cocaine, morphine,
dextropropoxyphene, and diphenoxylate. Common medicines in this
schedule include co-proxamol, co-codaprin, co-codamol, co-dydramol,
and Oramorph solution 10mg/5ml. The classification may depend on
the strength of the controlled substance in the preparation.
Ordering, Receiving and Storing
• Ordering is restricted to specified groups
• Receipt should be undertaken by two
people
• All details should be recorded immediately
• Schedule 2 drugs must be kept in a locked
cupboard within a locked cupboard or
locked room.
• Where a hospital has a pharmacy, the
senior nurse on a ward or an ODP can
order CDs from that pharmacy. Otherwise,
a doctor must countersign a requisition.
• A certified copy of the order / requisition
must be retained to verify the drugs
supplied.
• At all times, only the minimum amount of CDs
necessary to meet expected needs should be
held.
• Storage regulations apply to all schedule 2
drugs (except Secobarbital) plus Buprenorphine
(Subutex), Diethylpropion, Flunitrazepam
(Rohypnol) and Temazepam from schedule 3.
• CDs should be stored in original packaging, by
type, dose and form.
• CDs should be stored separately to other
items.
• One person should be wholly responsible
for the CDs.
• CD keys should be held separately to
other keys.
• The CD Register should be stored near,
but not in, the CD container.
• Receipt of Controlled Drugs within a
Patient’s home should be documented
within the patient notes.
Transfer and Transport
• Designated healthcare professionals
can transport CDs to a named patient
for whom the CDs have been
prescribed and dispensed but this is
not recommended by the GMC or
NMC.
• All healthcare professionals have a duty of
care to maintain the security of drugs in
transit.
• CDs must be kept out of sight in transit.
• CDs should not be left in unattended
vehicles.
• CDs must be in a locked container if
conveyed by a healthcare professional.
• A signature must be obtained for the
package at every stage of the delivery i.e.
from the driver and then from the patient /
member of staff, and this must be returned
back to the sender as proof of delivery.
• CDs must be in a secure package, if
conveyed by messenger, courier or
service driver. The package should be
prepared and sealed in front of a witness.
• In the instance of the community nurse
delivering drugs to the patients house, the
community nurse should where possible
obtain a signature within the community
notes to assign responsibility of the drugs
to the patient / patient’s Next of Kin.
• Controlled drugs cannot be transferred from one
ward to another, except for patient’s own drugs
when the patient transfers.
• If a ward (A) does not hold a required CD, the
senior nurse in charge of another ward (B) may
use CDs from that ward (B) to administer to the
patient. The process must be witnessed by a
member of staff from the patient’s ward (A) and
the administration must be recorded in the
patient’s notes and in the other ward’s (B) CD
records with signatures from both wards.
• Verbal prescriptions are not permitted for
CDs.
• Repeat prescriptions are not permitted for
schedule 2 and 3 drugs.
• The same rules apply to private
prescribing, although different forms are
used with different prescriber identifier
numbers.
• Dose (“as directed” or “when
required” is not acceptable but “one
to be taken as directed/when
required” is acceptable)
• Total quantity in words and figures
OR the number (in words and
figures) of dosage units (But not for
temazepam or Schedule 4 CDs)
Prescription forms
• Supplementary prescribing under clinical
management plans
– Drug misuse treatment FP10MDA-SS or
FP10MDA-SP
– Other FP10P or FP10SS
• Independent Nurse Prescribers
– FP10P for general practice patients
– FP10SS for hospital outpatients
Nurse Independent Prescribers may prescribe any licensed medicine,
including some CDs, for any medical condition within their clinical
competence
Buprenorphine
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• Chlordiazepoxide
hydrochloride
• Codeine phosphate
• Co-phenotrope
• Diamorphine
hydrochloride
• Diazepam
• Dihydrocodeine
tartrate
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Fentanyl
Lorazepam
Midazolam
Morphine
hydrochloride
• Morphine sulphate
• Oxycodone
hydrochloride
• Nurse Supplementary Prescribers can
prescribe ALL CDs providing they are part
of the Clinical Management Plan
• Midwives have specific exemptions to
supply or administer medicines, without
requiring a PGD
– (Sch 5 Part III 1997 POM Order)
CDs and PGDs
• Diamorphine for cardiac pain in coronary
care unit or A&E
• Schedule 5 CD iaw valid PGD
• Part 1 Schedule 4 CD or Midazolam iaw
valid PGD but not for treatment of
addiction
Administration
• In law, anyone can administer controlled drugs
that have been supplied legally for a legal
purpose, as directed by an appropriate
practitioner. In practice, the NHS limits
administration to trained staff!
• The prescriber should not normally administer.
• Administration should be recorded in patient
notes and the CD Register / Book ASAP. In the
community setting, the CDR is the patient’s
medical record.
• 2 people should perform the procedure,
where possible; one acting as witness /
checker.
• Both should be registered healthcare
professionals, if possible.
• It is recognised that this may not be
possible in the community due to the
circumstances that are generally
present.
• Nurses are now legally permitted to mix
medicines under the direction of a
prescriber but this relaxation does not
apply to controlled drugs!
• Naloxone should be available if morphine
or diamorphine is being administered.
Controlled Drug Registers and Records
• Each class of drug in a separate part,
each strength / formulation on a separate
page.
• Patient own drugs recorded in a separate
book.
• Retained for at least 2 years but
recommended period is 11 years.
• Schedule 3, 4 and 5 CDs do not require a
bound register but transactions must be
recorded somewhere.
• Registers must be uniquely numbered.
• Sample signatures are recommended.
• Entries must be legible and permanent.
• Entries must be made at the time of the
transaction (or within 24 hours)
• Errors must be corrected by reference and writing in the
margin. No deletions, lining through or snopake!
• Errors / Broken Vials – or incorrect drawing up of
medication - should be reported on Datix information
sheet, ticking the CD box or directly reported to Matthew
Thomas.
• Use of running balance, calculated by adding new
deliveries or deducting amounts used / destroyed,
simplifies stock checks.
• A separate register is required for each location and for
each emergency bag. Registers are not mandatory for
hospital wards but are recommended.
Patient Own CDs
• Dispensing - ID of collector to be verified
and recorded. Letter of authority required
– If patient / relative; dispenser may refuse to
supply if identity is in doubt.
– If a healthcare professional, acting in a
professional capacity; name, address and
registration details to be recorded. The
dispenser may dispense the drug, even if
identity remains in doubt!
• POD CDs transfer with the patient. Register
entries must be made and double signed on
arrival and departure, as appropriate. POD CDs
are the patient’s property.
• On discharge, the POD CDs may be returned to
the patient. Staff should verify that the drug is
still appropriate, following the treatment received
in hospital. Register entries must be made and
double signed
Destruction – Stock
• The Environment Agency is in the process
of clarifying requirements for disposal.
• Schedule 2, 3 and 4 Part I Controlled
Drugs must be denatured prior to disposal.
• Schedule 4 Part II and Schedule 5 do not
need to be denatured.
Destruction – Patients’ Own
• Patient property therefore, legally, no
records required.
• For staff safety and protection, witness
should be used and everything should be
recorded and double signed – may be
internal staff.
• Best practice – use an authorised person
from the PCT!
• As for stock, denature.
Disposal Of Patients’ CDs
• The family of the patient is responsible for
the disposal of CDs.
• If there is no family available, it is
permissible for CDs to be returned to the
pharmacy for disposal but a signature
should be obtained (in the patient notes, if
possible) to demonstrate return.
RIP
• Remove battery from Syringe driver
• Remove syringe driver and butterfly from
patient.
• Use denaturing kit for disposal of syringe
driver medications.
Disposal Of Residual Medication
• Any volume over 3mls; discharge into a
denaturing kit
• Seal denaturing kit
• Place in yellow bag for incineration.
• Volume less than 3mls; place syringe in
yellow lidded sharps box and seal sharps
box.
Disposal Of Patches
• Fold patch over on itself
• Place discarded patch in denaturing kit• Once denaturing kit ½ full; add water and
replace lid.
• Place denaturing kit in yellow bag for
incineration
Incident Reporting
• All incidents and near misses to be reported. All
such events concerning controlled drugs are to
be reported to the accountable officer [Datix will
do this if the CD box is ticked].
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Incorrect contents in a sealed carton
Running balance discrepancies
Broken bottles /ampoules (if frequent or regular)
Defective medicine
• Register to be updated to show type of incident
and balance to be corrected once reconciled.
A guide to good practice
in the management of
controlled drugs in
primary care (England)
• http://www.npci.org.uk/cd/public/
docs/controlleddrugsthirdedition.
pdf
• 3rd Edition December 2009
Safer Management of Controlled
Drugs: A guide to good practice in
secondary care (England)
•
http://www.dh.gov.uk/en/Publicationsandstatistics
/Publications/PublicationsPolicyAndGuidance/DH
_079618
• First edition May 2007
• Amendments October 2007
NMC ‘Standards for medicines management’
• This document replaces ‘Guidelines for the
administration of medicines’ to reflect
contemporary nursing and midwifery practice.
The NMC will continually review these
standards and notify registrants of all further
amendments.
• Section 10 devoted to Controlled Drugs
• http://www.nmc-uk.org/Publications/Standards/
Matthew Thomas
Accountable Officer
NHS Hampshire
And
Hampshire Community Health Care
[email protected]
07515 190584
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Administration
Prescription with drug chart
Identify page in Notes
Identify page for drug / form / strength
Select correct drug
Verify against prescription and Drug Page
Remove amount required, return balance
Update CDR balance.
• Prepare dose, checking all details against
the prescription / chart.
• CDs should not form part of the normal
drugs round.
• Naloxone should be available if morphine
or diamorphine is being administered.
• Check the patient’s identity.
• Inform the patient to gain consent.
• One person administers the CD while the
second person observes, where possible.
• Destroy any residue locally **
• Both staff complete and sign the CDR (to show
amount administered and amount destroyed)
and the patient record.
• POD CDs administered by staff must be stored
in the CD cupboard clearly labelled with the
patient’s details. However, ward stock should
normally be used [This may change].
• POD CDs which are self-administered may be
stored in the locked bedside cabinet.
• POD CDs must never be used for another
patient.
Prescribing
• Prescriptions may be computer-generated,
typed or hand-written. The signature has
to be hand-written.
• The professional registration number and
the profession of the prescriber must be
shown.
• Sample signatures should be provided to
dispensers.
• Unique prescriber, dispenser and
patient identifiers on CD prescriptions
• Private prescribers to use
standardised CD prescription forms
(FP10PCD) for Schedules 2 and 3
• http://www.dh.gov.uk/PolicyAndGuidance/Medici
nesPharmacyAndIndustry/Prescriptions/Controll
edDrugs/fs/en
• For Schedule 2 and 3 CDs:
– Patient full name, address and , where appropriate,
age. NHS Number!
– Name and form of drug
– Strength of the preparation, where appropriate
– The dose to be taken (plus Frequency, as good
practice)
– Total quantity or number of dose units, in words and
figures (Good practice – no more than 30 days)
– Date or start date (Prescription expires 28 days after
this date)
• The CD prescription must be signed by the
prescriber.
• The address of the prescriber must be
stated on the prescription.
• The prescription must be written in the UK.
• Prescriptions issued by a dentist must
contain the words ‘for dental treatment
only’.
• The validity of a Schedule 2,3 or 4
prescription is restricted to 28 days
• The prescription must be dispensed within 28
days
• For instalment prescriptions, the 1st
instalment must be dispensed within 28 days
of date of signing / start date
• Bed cards may be used for prescribing in
hospital
Instalment Prescribing
• The amount of the instalment,
including a dose and an instalment
amount, and the intervals
• Repeat prescriptions are NOT
permitted for Schedule 2 or 3 CDs
• There is no approved wording for ‘missed’
instalments in the regulations, however the
Home Office has provided approved wording
which would “protect” the pharmacist.
• Talk to me afterwards if you think you may need
to have this wording; for missed instalments or
for providing instalments in advance for days
when the pharmacy would be closed.
CD prescribing – good practice
• Maximum quantity of 30 days supply for schedule 2,3
and 4
• Professional guidance on self prescribing of CDs /
prescribing of CDs for family or friends - Professional
bodies all have clear statements about being ONLY
acceptable for purposes of
– Saving a life
– Avoiding significant deterioration in health
– Alleviating otherwise uncontrollable pain
Schedule 2 Stock (and other CDs that must be recorded)
• Authorised person required as a witness – contact
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07881 824029 or [email protected]
Everything is recorded under double signature.
Denaturing kit to be supplied by staff at location.
** Sharps containing small amounts of residue should
be placed into a yellow-lidded sharps bin. This should
then be stored securely until collected for incineration.
CD syringes should not be deliberately “discharged” prior
to disposal, unless this is into a denaturing kit.
Further information is available at:
http://nww.hampshire.nhs.uk/index.php?o
ption=com_teams&view=alldocs&teams
_id=98&Itemid=577
OR
https://nww.hchc.nhs.uk/index.php?option
=com_teams&view=alldocs&teams_id=
176&Itemid=577