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PHARMACY: Pre registration > MEP: Controlled Drugs > Flashcards

MEP: Controlled Drugs Flashcards

1
Q

Legislation applicable to CDs and

pharmacy include:

A
  • The Misuse of Drugs Act 1971 as amended
    • The Misuse of Drugs Regulations 2001
    • The Misuse of Drugs (Safe Custody) Regulations 1973 as amended (herein referred to as ‘Safe Custody Regulations’)
    • The Health Act 2006
    • Controlled Drugs (Supervision of Management and Use) Regulations 2013 which affect England and Scotland.
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2
Q

What is the 1971 act?

A

The 1971 Act imposes prohibitions on the possession, supply, manufacture, import and export of CDs – except where permitted by the 2001 Regulations or
under licence from the Secretary of State. The Safe Custody Regulations detail the storage and safe custody requirements for CDs.

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3
Q

What act introduced the concept of an accountable officer?

A

The Health Act 2006 –> requires healthcare organisations, and those providing services to healthcare organisations, to have standard
operating procedures in place for using and managing CDs.

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4
Q

What is the Gosport report?

A

At least 450 patients are thought to have died after the administration of inappropriately high doses of opioids between 1988 and 2000 at Gosport
War Memorial Hospital. In June 2018, the report of the Gosport Independent Panel into failures of care was published.

The report found no evidence that the
pharmacists providing services to the hospital, or the Portsmouth Hospitals NHS trust drug and therapeutics committee which covered the Gosport War Memorial Hospital had challenged prescribing practices.

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5
Q

What are accountable officers?

A

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

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6
Q

Is an accountable officer required everywhere?

A

No, 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.

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7
Q

Describe CD Schedule 1:

A

• Schedule 1 (CD Lic POM)
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.

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8
Q

Describe SCHEDULE 2 (CD POM):

A

Pharmacists and other classes of person named in the 2001 Regulations have a general authority to 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.

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9
Q

Describe SCHEDULE 3 (CD NO REGISTER POM):

A

Schedule 3 CDs include minor stimulants and other drugs (such as buprenorphine, temazepam, tramadol, midazolam and phenobarbital) that are less likely to be misused (and less harmful if misused) than those in Schedule 2.
From 1st April 2019, gabapentin and pregabalin were rescheduled as Schedule 3 CDs.

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10
Q

Describe SCHEDULE 4 (CD BENZ POM OR CD ANAB POM):

A

Schedule 4 is split into two parts:
• 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

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11
Q

Describe SCHEDULE 5

CD INV POM OR CD INV P

A

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.

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12
Q

How long is a CD schedule 5 valid for?

A

6 months

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13
Q

How long is a CD schedule 4 valid for?

A

28 days

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14
Q

Are the CD form requirements required for all CD schedules?

A

Just sch 2 + 3

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15
Q

Are CD sch2 prescriptions repeatable?

A

All are repeatable for 2 + 3

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16
Q

Can you give an emergency supply of sch2 and 3 CD’s?

A

No (expect phenobarbital which is a CD3 for epilepsy by a uk registered prescriber)

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17
Q

Can EEA and swiss HCP’s legally prescribe all cd’s?

A

All apart from cd sch 2+3

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18
Q

Do invoices need to be retained for 2 years?

A

Sch 2 = no
Sch 3 = yes
Sch 4 = no
Sch 5 = Yes

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19
Q

Other mechanisms for the lawful possession

of CDs include:

A

• 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).
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20
Q

What is required for possession of Schedule 1 CD’s?

A

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.

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21
Q

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

A

True

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22
Q

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

A

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).

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23
Q

Do you need a licence to import or export Schedule 1,2,3 and 4 (Part 1) CDs?

A

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

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24
Q

What advice would you give to a patient travelling abroad with CD’s?

A

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

25
Q

What are the requisition requirements for Schedule 1, 2 and 3 CD’S:

A

The introduction of an approved mandatory requisition form is a remaining Shipman Inquiry recommendation aimed at ensuring the purchase of all stocks of Schedule 2 and 3 CDs by healthcare professionals within the community
can be monitored.

The legal requirements of a 
CONTROLLED DRUG REQUISITION ARE:
-  Signature of the recipient
-  Name of the recipient
-  Address of the recipient
-  Profession or occupation
-  Total quantity of drug
-  Purpose of the requisition
26
Q

When a requisition for a Schedule 1, 2 or 3 CD is received, it is a legal requirement to:

A

• Mark the requisition indelibly with the supplier’s name and address (i.e. the name of the pharmacy); where a pharmacy stamp is used this must be clear and legible
• Send the original requisition to the relevant NHS agency.
As a matter of good practice, pharmacies should retain a copy of the requisition for two years from the date of supply.

27
Q

A registered midwife may use a midwife supply order to obtain the following CDs:

A
  • Diamorphine
  • Morphine
  • Pethidine.
28
Q

The midwife supply order must contain the following:

A
  • Name of the midwife
  • Occupation of the midwife
  • Name of the person to whom the CD is to be administered or supplied
  • Purpose for which the CD is required
  • Total quantity of the drug to be obtained
  • Signature of an appropriate medical officer – a doctor authorised (in writing) by the local supervising authority or the person appointed by the supervising authority to exercise supervision over midwives within the area
29
Q

Schedule 2 and 3 rx requirements:

A

1) Signature
2) Date - 28 days (Sch 4 also = 28 days)
3) Prescribers address
4) Name of CD- write name in full
5) Form - formulation must be stated: the abbreviation caps and caps are acceptable
6) Strength - The strength only needs to be written on the prescription if the medicine is available in more than one strength
7) Dose - the does doesn’t need to be in both words and figures
8) Total quantity: The total quantity must be written in both words and figures
9) Quantity prescribed - he Department of Health and the Scottish Government have issued strong recommendations that the maximum quantity of Schedule 2, 3 or 4 CDs prescribed should not exceed 30 days. This is not a legal restriction
10) Name of patient
11) Address of patient
12) Dental prescriptions–>
Where the CD prescription is written by a dentist, the words ‘for dental treatment only’ must be present.
13) Instalment direction - where the prescription is intended to be supplied in instalments a valid instalment direction is required.

30
Q

An instalment direction combines two pieces of information:

A

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

31
Q

How soon must an instalment prescription be dispensed?

A

The first instalment must be dispensed within 28 days of 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).

32
Q

How many days can be missed on an instalment prescription?

A

If you know a patient has missed three days’ prescribed treatment (or the number of days defined by any local agreement with the prescriber), 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.

33
Q

Can pharmacists amend CD scripts?

A

Where a prescription for a Schedule 2 or 3 CD contains a minor typographical error or spelling mistake, or where either the words or figures (but not both) of the total quantity has been omitted,
a pharmacist can amend the prescription indelibly so that it becomes compliant with legislation.

Pharmacists cannot correct other amendments
or omissions (e.g. missing date, incorrect dose, form or strength). These should be corrected by
the original prescriber or, in an emergency, another prescriber authorised to prescribe CDs.

34
Q

PRIVATE PRESCRIPTION

REQUIREMENTS FOR SCHEDULE 2 AND 3 CONTROLLED DRUGS:

A

1) STANDARDISED FORM
2) Prescriber identifications number–> This number is not the prescriber’s professional registration number (i.e. the GMC number). It is a number issued by the relevant NHS agency
3) SUBMISSION –>
Pharmacies must submit the original private prescription to the relevant NHS agency

35
Q

Do veterinary CD’s need to be written on standardised forms:

A

Veterinary prescriptions for CDs do not need to be written on standardised forms and do not need to be submitted to the relevant NHS agency. Forms must be retained for five years.

36
Q

Do you prescribe normal drugs on a CD script?

A

Medicines that are not CDs should not be prescribed on the same form as a Schedule 2 or 3 CD. This is because the form needs to be sent to the relevant NHS agency so the pharmacist would be unable to comply with the requirement to keep private prescriptions for a POM for two years.

37
Q

Can a relative/friend collect a prescription for a drug misuse patient?

A

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

A separate letter should be obtained each time the drug misuser sends a representative to collect and the representative should bring identification. The pharmacist must be satisfied that the letter is genuine. It is also good practice to insist on seeing the patient in person at least once a week unless this is known not to be possible.

The record of supply in the CD register should include details of the representative.

38
Q

Can a HCP collect a CD script?

A

Unless already known to the pharmacist, obtain:

1) Name of healthcare professional
2) Address of healthcare professional

Also request evidence of identity

39
Q

If a CD script is a supervised medicine and the patient is in police custody, is it okay for the police to pick the script up?

A

Yes as it will be supervised in police custody - however, in other circumstances, prescriber must be contacted before to make sure it is okay

40
Q

What are The Safe Custody Regulations?

A

The Safe Custody Regulations refer to the physical security of certain Schedule 2 or 3 CDs. It requires that pharmacies, private hospitals and care homes keep relevant CDs in a ‘locked safe, cabinet or room which is constructed as to prevent unauthorised access to the drugs’.

41
Q

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

A 
• 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
42
Q

What to do with PATIENT-RETURNED AND OUT-OF-DATE OR OBSOLETE CONTROLLED DRUGS?

A

Safe custody applies to patient-returned, out-of- date and obsolete CDs until they can be destroyed

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).

43
Q

What I the process for disposing of CD’s?

A

Pharmacies are required to denature CDs prior
to disposal. Usually, this process requires an appropriate licence but pharmacies can register an exemption without needing to obtain a licence.

44
Q

What CD’s need to be denatured before disposal?

A

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.

45
Q

What CD’s require a witness for destruction?

A

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

46
Q

Is it a legal requirement for a sativex register?

A 
Pharmacists are also required to keep records
of Sativex (which is a Schedule 4 Part 1 CD). The Home Office strongly recommends the use of a CD register for making records relating to Sativex.
47
Q

Does a record of Schedule 1 and Schedule 2 CDs received or supplied by a pharmacy need to be kept?

A

Yes

48
Q

For Controlled Drugs received, the following must be recorded:

A
  • Date supply received
  • Name and address from whom received
  • Quantity received.
49
Q

For Controlled Drugs supplied, the following must be recorded:

A
  • 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.
50
Q

All entries made in CD registers should be:

A

• Entered chronologically
• Entered promptly – entries must be made on the day of the transaction or on the following day
• In ink or indelible – entries and corrections
must be in ink or indelible (or computerised - see below)
• Unaltered – entries must not be cancelled, obliterated or altered. Corrections must be made by dated marginal notes or footnotes. The register should be marked to show who the amendments made are attributable to (e.g. name, initials/signature, GPhC number if applicable).

51
Q

Electronic CD registers are permitted as an
alternative to having a bound-book CD register.
Legislation requires that computerised entries
must be:

A
  • Attributable
  • Capable of being audited
  • Compliant with best practice
52
Q

Every patient has
every right to expect that when an unlicensed
medicine is prepared, it is of equivalent quality to
a licensed medicine. True or false?

A

True

53
Q

There are a wide range of cannabis-based
products used for medicinal purposes, with varying
constituents and covered by different aspects of
legislation. These can be broadly categorised as:

A

Licensed products
• THC combined with CBD (Sativex)
• Nabilone
• CBD (Epidyolex)

Synthetic compounds
• Dronabinol

Cannabis-based products for medicinal
use (CBPMS)
• As set out in the 2018 Regulations

54
Q

What is sativex’s legal category and use?

A

Schedule 4 CD

Moderate to severe spasticity in multiple sclerosis

55
Q

What is Nabilone’s legal category and use?

A

POM -Nausea and vomiting caused by cytotoxic
chemotherapy, unresponsive to conventional
antiemetic treatments

56
Q

What is epidyolex legal category and use?

A

Cannabidiol - schedule 5 CD

Seizures associated with Lennox-Gastaut Syndrome
or Dravets Syndrome (adjunctive treatment with
clobazam)

57
Q

Dronabinol - legal category and use:

A

Synthetic compound –> CD sch 2

Available as a special (approved by the US Food
and Drug Administration): to treat loss of appetite
in people with AIDS, and to treat severe nausea and
vomiting caused by cancer chemotherapy in
patients with inadequate response to conventional
antiemetic treatments

58
Q

CBMP definition
There are three broad requirements that a product
should satisfy:

A

• The product is or contains cannabis, cannabis
resin, cannabinol or a cannabinol derivative

• It is produced for medicinal use in humans; and

• It is a product that is regulated as a medicinal
product, or an ingredient of a medicinal product.

59
Q

What type of cannabis products fall into the CBMP category:

A

Currently the only CBPMs are unlicensed med
CBPMs are Schedule 2 CDs and staff must follow
all the legal and CD requirements for Schedule
2 CDs, including any Trust CD requirements (see
section 3.6.7).
• Prescribing is currently restricted to clinicians
listed on the Specialist Register of the GMCicines

PHARMACY: Pre registration (18 decks)

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