Med Regs 5- CDs

Question 1

What are the aims of the Misuse of Drugs Act 1971

Answer 1

• Control of misuse
• Define and categorise controlled drugs
• Control of production and trading
• Control of possession and trafficking
• surveillance
• education, treatment and rehabilitation
• control of prescribing and supply

Question 2

What does the Misuse of drugs regulations 2001 do?

Answer 2

• Allows for the lawful possession and supply of controlled drugs
• details multiple classes of persons who can possess and supplu
• covers prescribing, administering, safe custody, dispensing, record keeping, destruction and disposal of Controlled Drugs

Question 3

What are the two methods of classification of Controlled Drugs

Answer 3

1. Misuse of Drugs Act 1971- classification relating to potential harm
2. Misuse of Drugs Regulations 2001- classification relating to their use in medicine and their potential for misuse

Question 4

What are the main offences under the misuse of drugs act 1971?

Answer 4

• possess a controlled substance unlawfully
• possess a controlled substance with intent to supply it (unlawfully)
- supplier carries ‘heavier penalties’
• trafficking- to unlawfully supply a controlled drug (even where no charge is made for the drug)
• to allow premises you occupy or manage to be used for preparing or smoking opium or cannabis

Question 5

What are schedule 1 controlled drugs?

Answer 5

• Includes hallucinogens such as LSD, ecstasy type drugs, cannabis (raw form)
• not used for medicinal purposes
• production, possession and supply are not allowed unless a Home Office licence is granted
• licence granted for research or other special purposes
• doctors and pharmacists do not routinely have this type of licence

Question 6

What are schedule 2 controlled drugs?

Answer 6

• includes diamorphine, morphine, fentanyl, pethidine, cocaine, amfetamine, quinalbarbitone and ketamine
• license required for import/export
• controls in place for:
- possession
- supply
- procurement
- prescription ‘writing requirements’
- administration
- storage
- record keeping
- destruction

Question 7

What are schedule 3 controlled drugs?

Answer 7

• includes buprenorphine, temazepam, midazolam, tramadol, barbiturates, gabapentin, pregabalin and minor stimulants
• less likely to be misused and less harmful if misused
• licence required for import/export
• controls in place for:
- possession
- supply
- prescription writing requirements
- administration
- storage
- record keeping
- destruction

Question 8

What are schedule 4 controlled drugs?

Answer 8

• Contains most of the benzodiazepines for example diazepam, hypnotics such as zolpidem, zopiclone and sativex (cannabis extract in oromucosal mouth spray)
• import/export license required
• controls in place for possession, supply, administration and destruction

Question 9

What are schedule 5 controlled drugs?

Answer 9

• included preparations of certain controlled drugs in medicinal products at very low strengths, such as codeine, pholcodine and morphine
• drugs with minimal potential for abuse
• may be POM or P

Question 10

What prescribers are authorised to prescribe CDs?

Answer 10

• Doctors
• Pharmacist and Nurse independent prescribers
- only prescribe within area of competency
- except cocaine, dipipanone, or diamorphine for treating addiction
• Vets- for animal treatment only
• Dentists- can only prescribe CDs included in dental prescribing formulary on an FP10D

Question 11

What are the prescription requirements for CD schedule 2 and 3

Answer 11

• applies to EPS prescriptions as well
• signature of prescriber
• prescribers address
• date- only valid for 28 days, including balances owed
• name and address of patient. if patient homeless may have NFA (no fixed abode) or PO box
• age if under 12 yrs
• dose- as directed or when required is not acceptable. must he more specific eg one as directed
• formulation eg capsules, tablets
• strength- only needs to be written if theres more than one strength
• quantity- must be specified in both words and figures
• good practice to prescribe no more than 30 days supply howver tis not legal requirement

• Dental prescriptions must have ‘for dental treatment only’
• veterinary prescribing must have name and address of person who will receive CD and needs declaration that its for animal/herd under care
• instalment prescriptions- require total amount and intervals to be supplied. first instalment must be within 28 days validity- others can run beyond
• may be computer generated apart from signature (unless EPS)

Question 12

What are instalment prescriptions

Answer 12

• FP10 MDA forms
• Maximum of 14 days supply in instalments
• The prescriber must specify the number of instalments to be dispensed and the interval between each instalment
• used for substance misuse patients

Question 13

What happens if the legal requirements for CD aren’t met by legal issues?

Answer 13

• contact prescriber
• explain to prescriber what is missing or needs amending
• return prescription to prescriber for amendment
• dispense once prescription is legally valid

Question 14

What happens if the legal requirements for CD aren’t met by typographical errors?

Answer 14

• Pharmacists are able to amend typographical errors as long as they are satisfied that the prescription is genuine and the CD is being supplied in accordance with the intention of the prescriber
• this includes:
- minor spelling errors
- minor typographical errors
- where total quantity of CD is specified in words but not figures or vice versa. At least one must be specified by prescriber
- amendments must be indelible and should be signed by the pharmacist amending

Question 15

What are private prescription requirements for sched 2 and 3 CDs

Answer 15

• standardised form must be used (FP10CD) apart from vets and in hospital prescriptions
• for CDs ONLY
• prescription identification number
• submission (original prescription must be sent to appropriate NHS agency at end of every month after dispensing using FP34PCD form)

Question 16

What are the requisitions for CDs sched 2 and 3

Answer 16

Approved form FP10CDF is mandatory as it ensured purchases of all stocks of sched 2 and 3 CDs by healthcare professionals can be monitored

Question 17

What are the requisitions requirements?

Answer 17

• can be handwritten or computer generated
• signature of recipient must be hand written
• name, address and profession/occupation of recipient
• purpose for which drug is supplied
• name, form and strength of drug and total quantity required
• requires an identifying code for the prescriber or account code of pharmacy raising requisition

Question 18

What do you do in receipt of a requisition?

Answer 18

• check it is on correct form
• supply only on receipt of original form. Faxed or photocopy NOT acceptable
• doctor or dentist may be supplied in emergency, when this happens requisition MUST be supplied within 24 hrs
• on supply mark the requisition indelibly with suppliers name and address (can be pharmacy branch)
• record supply in CD register
• submit original requisition to relevant NHS agency unless veterinary
• supplier should retain a copy of requisitions sched 2 and 3 CD for min 2 yrs

Question 19

How should you fill out CD registers?

Answer 19

• Use a pen- cannot be erased
• all entries should be in date order, and entered on day of supply/receipt. Very latest next day
• check section is correct for that drug, form and strength
• count stock and confirm correct- means physical stock and register balance matches
• DO NOT CROSS ANYTHING OUT OR WRITE OVER IT, annotate errors with asterisk, and add footnote with correct info, initials, date and GPhC no.

Question 20

How are CDs kept in safe custody?

Answer 20

• kept in locked safe/cabinet/room unless when under pharmacist supervision eg being dispensed
• identify who has access to CDs from electronic logs or key holder audit trails- includes overnight storage of keys and swapping shifts
• all sched 1 and 2 here except some liquid preparations and sched 3 unless exempted under misuse of drugs regulations 1973

Question 21

What are the roles of accountable officers?

Answer 21

• appointment of authorised witnesses for destruction of CDs
• monitoring and auditing management
• prescribing and use of CDs
• making sure systems in place for concern reports regarding management of CDs

Question 22

How are patient returns CDs destroyed?

Answer 22

• ALL unused returned to pharmacy for destruction
• only from patients or residential home- not nursing
• CDs need to be marker as patient returns and stored in CD cupboard until destroyed- should be segregated from other CDs
• record date of return of CD to be destroyed, the destruction date and good practice to be witnessed by another person (not in CD reg). doesnt need to be an authorised person to witness

Question 23

How are CD stock destroyed?

Answer 23

• must be segregated from other CDs to prevent inappropriate use
• sched 2 stock drug must be destroyed in presence of an authorised person
• sched 2,3 and 4 (pt1) must be denatured before being deposited into waste container
• record destruction in CD register for sched 2
• drug name, form, strength, date of destruction, quantity destroyed, authorised person must sign the entry in the CD register and their authority

Question 24

How are schedule 2 and 3 CDs collected

Answer 24

• must be dispensed and collected within 28 days of date on Rx unless sch 5, which are valid for 6 months
• box on back of form to be signed for collection
- good practice not legal requirement yet
- instalment Rx needs only signing ONCE

Question 25

How do you do owings of CDs?

Answer 25

• if unable to provide full quantity required, possible to supply quantity in stock and owe remainder
• this quantity must be entered into CD register for sch2. record as ‘part supply’
• further entry made when balance is collected- ‘completed supply’
• owings must be dispensed within 28 days
• if owing is no longer required, endorse quantity dispensed and good practice to provide reason why owing not dispensed

Question 26

What are running balances and stock checks for?

Answer 26

• important to ensure an audit trail
• ensure irregularities or discrepancies are identified as soon as possible
• running balances are completed at each entry
• stock checks are mostly done once a week
• they are not yet a legal requirement, however once electronic registers become common use it will

Question 27

How should you counsel patients on CDs?

Answer 27

• Giving appropriate and relevant information when supplying CDs is important for patient safety
• when giving ANY meds always get patient/carer to confirm ID
• advise on dosage and formulation
• advise on safe keeping in household
• advise to return any unwanted meds to the pharmacy for safe destruction