1. FALSE

2. TRUE

3. TRUE

The Health Act 2006 Regulations brought into force:

• Periodic declaration on use and management of controlled drugs
• Requirement to have Standard Operating Procedures (SOPs) in place for management and use of controlled drugs

Every healthcare organisation (NHS Trust, NHS Foundation Trust, PCT and private hospital) to have an "accountable officer" accountable for use of CDs by organisation

Accountable Officers:

• Are formal appointments at Trust level
• Must notify the Healthcare Commission of their appointment
• Will need an understanding of the CD legal, governance and audit frameworks
• Will need ability to carry out all the responsibilities set in regulations, and develop own local framework - team approach
• Will provide local leadership

You can find details of your Accountable Officer on the Register listed on the Care Quality Commission website http://www.cqc.org.uk/_db/_documents/AOList2.pdf

Under The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 HSC organisations and Independent Hospitals must appoint their Chief Executive as Accountable Officer to be responsible for the management of controlled drugs and related governance issues in their organisation.

The day-to-day discharge of these responsibilities may be undertaken by Designated Officers, who will be responsible for providing appropriate assurances to the Accountable Officer.

SOPs are required to cover the following points:

• Ordering and receipt of CDs
• Assigning responsibilities
• Where the Controlled Drugs are stored
• Who has access to the CDs
• Who should be alerted if complications arise
• Security in relation to the storage and transportation of CDs as required by the Misuse of Drugs regulations
• Disposal and destruction of CDs
• Record keeping, including maintaining relevant CD Registers under the Misuse of Drugs legislation and maintaining a record of the CDs specified in Schedule 2 to the Misuse of Drugs Regulations 2001 that have been returned by patients

The National Pharmacy Association (NPA) has guidance on SOPs for CDs which can be downloaded by members from their website http://www.npa.co.uk

In Northern Ireland the following headings should either form the basis of, or inform additional points for licensee SOP documents. SOPs should take account of regulatory requirements and security practices.

• Check application of Regulations.
• Orders and arrangements for receipt of controlled drugs.
• Acceptance of deliveries & procedures upon receipt.
• QC/QA handling.
• Production and packing runs.
• Procedures for accepting orders and controlled drug dispatch.
• Record keeping and cross-checking processes.
• Controlled drug store access, operative and management responsibilities.
• Controlled drug destructions.
• Theft, loss or adverse incident reporting and handling.

http://www.dhsspsni.gov.uk/index/pas/pas-controlled-drug-licensing/pas-standard-operating-procedures/pas-2006-sop-guidelines.htm

Answer 2

1. TRUE

2. FALSE

3. FALSE

The Societies' Inspectors have included CD inspection of CDs in their routine inspection of community pharmacies. Police CD Inspectors no longer routinely visit community pharmacies

http://www.pjonline.com/libres/pdf/society/pj_20061209_inspectors.pdf

In Northern Ireland the Department of Health, Social Services and Public Safety has responsibility for inspection and enforcement under all medicines related legislation in Northern Ireland. This is assumed by the Medicines Inspection and Investigation Team within the Department.

http://www.dhsspsni.gov.uk/index/pas/pas-inspection-enforcement.htm

Answer 3

1. FALSE

2. FALSE

3. TRUE

4. TRUE

Although it is not a legal requirement to provide a requisition where one community pharmacy supplies another community pharmacy, both the Society and the Department of Health or the Scottish Executive or the DHSSW, advise that, as a matter of good practice, a written requisition should be obtained. This type of requisition should also be submitted to the relevant NHS agency for processing. A specific form for use by one community pharmacy to obtain stock from another community pharmacy has been developed in Scotland and should be used for this purpose.

A copy must be preserved and retained by the pharmacist for two years from the date of supply, with the original requisitions submitted along with the NHS prescriptions and private Controlled Drug prescriptions in the usual manner.

It is still lawful for a community pharmacist to supply against a requisition form written in a format other than on the newly introduced standardized forms, as long as all the legal requirements for a requisition are complied with.

RPSGB Law and Ethics Bulletin Changes to the arrangements for dealing with Controlled Drug requisitions - Part I December 2007

http://www.rpsgb.org/pdfs/LEBcdreqschanges.pdf

RPSGB Law and Ethics Bulletin Changes to the arrangements for dealing with Controlled Drug requisitions - Part II January 2008

http://www.rpsgb.org/pdfs/LEBcdreqschangespart2.pdf

Answer 4

1. TRUE

2. FALSE

3. TRUE

4. FALSE

Examples of some of the Schedules:

Schedule 1 - cannabis and LSD

Schedule 2 - diamorphine, morphine, pethidine, secobarbital, amfetamine

Schedule 3 - barbiturates, buprenorphine, midazolam, temazepam

Schedule 4 - benzodiazepines (except temazepam and midazolam), zolpidem

Schedule 5 - other preps, which because of strength are exempt

Answer 5

Methadone bottles often contain more than the stated volume, do you:

1. Dispose of the excess to keep your running balances correct FALSE

2. Make an entry in the register to account for the overage TRUE

3. Store up the excess for eventual disposal by an approved official FALSE

It is recognised that discrepancies are most likely to arise with liquid preparations. The majority of original packs of liquid preparations have some degree of overage. This can vary from manufacturer to manufacturer and between different batches from the same manufacturer. The Home Office has confirmed that manufacturers' overage can become part of pharmacy stock; provided appropriate records are made to account for this i.e. the overage should be entered in the obtained section of the register.

RPSGB Maintaining Running Balances of Controlled Drug Stock

http://www.rpsgb.org.uk/pdfs/cdrunningbalanceguid.pdf

Answer 6

If people are travelling abroad with CDs which are the following are true:

1. They should contact the Embassy/Consulate/High Commission of the country they are travelling to find out the local policy on importation TRUE

2. They will require a personal export licence if they are travelling in excess of three weeks FALSE

3. The drugs should be stored in the hold luggage FALSE

Travellers are advised to contact the Embassy/Consulate/High Commission of the country of destination (or any country through which they may be travelling) regarding the local policy on the importation of controlled drugs.

With effect from the 1st January 2008 persons travelling abroad (or visitors travelling to the UK) for longer than three months, or travellers carrying more than three months' supply of medication will require a personal export or import licence, as appropriate.

Controlled drugs should be:

* carried in original packaging

* carried in hand luggage (Airline regulations permitting)

* carried with a valid personal import/export licence if necessary

* carried with a letter from the prescribing doctor confirming the carriers name, destination, drug details/amounts, unless a personal licence is held.

Home Office Important information for travellers carrying prescribed controlled drugs http://drugs.homeoffice.gov.uk/publication-search/drug-licences/Personal_licences_Guidance.pdf?view=Binary

Answer 7

With regard to the validity of CD prescriptions for Schedule 2, 3, and 4 CDs which of the following are true:

1. Generally they are only valid for 28 days from the date of signing TRUE

2. The prescriber can indicate a different start date after the date of signing TRUE

3. Owings for a Schedule 2, 3 or 4 CDs can be collected more than 28 days after the appropriate date on the prescription FALSE

4. For instalment dispensing of CDs all the instalments must be dispensed within 28 days of the appropriate date FALSE

Schedule 2, 3 and 4 CD prescriptions are only valid for 28 days. The 28 days will either start from the date the prescription was signed by the prescriber issuing it or the date indicated by him / her as being the start date.

Schedule 2, 3 and 4 CDs cannot be supplied more than 28 days after the appropriate date. If owings are not collected, you need to endorse the prescription with the amount of CD that you have supplied and submit it in the normal way.

The first instalment must be dispensed within 28 days of the appropriate date, after which the prescription can run until all the instalments are filled

Answer 8

1. FALSE

2. FALSE

3. TRUE

4. FALSE

Prescribing in excess of 30 days is allowed in exceptional circumstances where there is a clinical need.

You do not need to contact the prescriber each time they request a supply of a Schedule 2-4 CD over 30 days. There may be circumstances where there is a genuine need to prescribe more than 30 days supply and pharmacists should exercise their professional judgement and assess both the prescription and the situation to check the suitability for the patient. As with all prescriptions, if you are concerned that the prescription may not be appropriate then you should contact the prescriber.

RPSGB Queries on 30 days supply http://www.rpsgb.org/pdfs/cdfaq30day.pdf

Answer 9

1. TRUE

2. FALSE

3. FALSE

4. FALSE

If you are satisfied you know what the prescriber intended you can:

* amend minor typographical errors

* amend spelling mistakes

* add in either the words or the figures to the total quantity if the prescriber has missed one or the other off

* the amendment must be in ink and attributable. It is good practice to add both your registration number and signature.

* if another pharmacist hands out, s/he must also indicate they are in agreement with the amendment

RPSGB Top tips NHS prescriptions for Schedule 2 and 3 Controlled Drugs http://www.rpsgb.org/pdfs/toptips2.pdf

RPSGB Queries on technical errors http://www.rpsgb.org.uk/pdfs/cdfaqtecherrors.pdf

Answer 10

1. TRUE

2. FALSE

3. TRUE

It is a legal requirement to ascertain if patient, rep, or HCP, but identity proof is discretionary.

It is not a criminal offence to supply a Schedule 2 CD without proof of identity, even when the pharmacist does not know the person collecting the CD. If the pharmacist asks for ID but the person collecting the Schedule 2 CD does not show ID for whatever reason, it is up to the pharmacist's professional judgement whether or not they supply the CD, taking into account the patient's clinical need.

If the person is a healthcare professional the pharmacist must obtain the person's name and address and must ask for proof of identity unless the health professional is known to them.

RPSGB Queries on asking for ID http://www.rpsgb.org/pdfs/cdfaqaskID.pdf

RPSGB Queries on signing on collection http://www.rpsgb.org.uk/pdfs/cdfaqsigncollect.pdf

Answer 11

1. FALSE

2. YES possibly

3. YES possibly

Private prescriptions for CDs to be dispensed in the community should be written on the appropriate standardised form i.e. FP10PCD (England), PPCD1 (Scotland) WP10PCD (Wales) PCD1 (NI)

Remember in order to dispense private prescriptions for CDs a Private CD account number is needed by pharmacies for submitting the standard form to the appropriate agency. It can be obtained from the Primary Care Organisation. [At present pharmacies in Northern Ireland are not required to submit forms to the Central Agency]

Also remember you cannot issue a CD as an Emergency Supply, except for phenobarbital for epilepsy

Some hospitals use sticky labels for the patients name and address. These are acceptable for CD but they should not be peelable labels and the prescriber should sign across the label.

However with the electronic scanning of prescriptions they may not be acceptable by the NHS Agency e.g. NHSBSA or NHSNSS

RPSGB Queries on private prescription forms http://www.rpsgb.org.uk/pdfs/cdfaqprivprescforms.pdf

Answer 12

With regard to CD registers, which of the following are true?

1. CD Registers can be kept electronically TRUE

2. Out-of-date stock must be included as this is still CD stock until it is destroyed - TRUE

3. It is a legal requirement to record running balances FALSE

4. When a Schedule 2 CD is being delivered to a patient it should be signed out of the register when the delivery driver employed by the pharmacy is supplied with the CD TRUE

As an alternative to a bound book, pharmacists may elect to keep their CDR electronically. Electronic CD registers must be capable of printing or displaying the name, form and strength of the drug in such a way that the details appear at the top of each display or printout to comply with the new requirements.

Controlled Drug stock which is out of date and awaiting destruction is still classed as part of the pharmacy's stock and therefore must be included in the running balance. Once the stock has been destroyed in the presence of an authorised witness it can be excluded from the running balance. An entry would have to be included to account for this in the CD register.

RPSGB Queries on running balances http://www.rpsgb.org.uk/pdfs/cdfaqrunbal.pdf

At present it is good practice to keep running balances, but this is likely to be a legal requirement for electronic registers. Running balances are an example of additional information that will help guarantee the integrity and accuracy of the audit trail that may be recorded in the CD register.

RPSGB Queries on running balances http://www.rpsgb.org.uk/pdfs/cdfaqrunbal.pdf

It is advised that an entry is made in the CD register when the delivery driver employed by the pharmacy is supplied with the CD. Before leaving to make the delivery it should be ensured that the patient or patient's representative is at home to receive it. However, if subsequently the delivery of the medicine was unsuccessful, on returning with the item to the pharmacy the original CD register entry should be annotated by marginal note or footnote to correct the fact that this supply was not in fact made (and the entry is not accurate). The entry should be annotated to state that the patient was not in etc. If the pharmacist remains satisfied as to the storage requirements that the item has been subjected to whilst under the pharmacy delivery driver's control and that the item is suitable to be given to the patient on another occasion the item should then be re-entered in the supplied section of the CD register when the supply is made again. This method would provide a robust audit trail.

RPSGB Law and Ethics Bulletin Changes to the Controlled Drug Register January 2008

http://www.rpsgb.org/pdfs/LEBchgcdreg.pdf

RPSGB Queries on CD registers

http://www.rpsgb.org/pdfs/cdfaqcdreg.pdf

Answer 13

1. TRUE

2. FALSE

3. FALSE

The RPSGB advise that the running balance should normally be checked with the physical amount of drug each week. However, depending on the volume of Controlled Drugs you dispense, you might decide to reconcile the stock more often.

The reconciliation may be carried out by any person who the pharmacist considers to be competent. Ultimate responsibility for maintaining the running balance, ensuring the accuracy of it and dealing with any discrepancies will remain with the pharmacist. However, this does not mean that only the pharmacist can check the running balance against the CD stock.

Controlled Drugs awaiting collection should only be signed out of the running balance in the CD register when they have actually been supplied to the patient, patient's representative or healthcare professional acting in their capacity as such.

RPSGB Queries on running balances http://www.rpsgb.org.uk/pdfs/cdfaqrunbal.pdf

Answer 14

1. TRUE

2. FALSE

3. FALSE

4. FALSE

Once electronic registers are in place this is likely to be 11 years http://www.pharmj.com/pdf/society/pj_20050611_shipmaninquiry.pdf

Answer 15

What should you do with empty stock bottles of Methadone?

1. Rinse in the sink and put in the bin FALSE

2. Rinse, put the rinsings in the CD denaturing kit and put bottle in bin FALSE

3. Rinse, put the rinsings in the CD denaturing kit and put bottle in the waste medicines bin TRUE

4. Save for safe disposal by the accountable officer FALSE

RPSGB advice is that:

• Rinsings should be denatured
• Since they are theoretically stock their disposal should be witnessed
• Bottles should be put disposed of as for waste medicines

This last point is based on DH waste guidance [http://www.nelm.nhs.uk/en/Download/?file=MDs0OTI5ODQ7TmV3cy8yMDA3IC0gRGVjZW1iZXIvMTAvSFRNIDA3LTA2LnBkZg.pdf

Empty medicine containers that have held liquids must be disposed of as waste medicines for incineration, as it is not possible to ensure that the contents have been completely removed (containers cannot be rinsed into the sewerage system). If residues of liquid controlled drugs are present, these should be emptied, so far as possible, and denatured before the container is placed in the waste container.

Answer 16

1. TRUE

2. TRUE

3. FALSE

The record of destruction should currently be made somewhere other than the CD register - for example at the back of the private prescription register or in a separate book designated for that purpose. It is recommended that the following details are recorded:

* the date of return of the CDs

* the name, quantity, strength and form of the CDs

* the role of the person who returned the CDs (if known)

* the name and signature of the person who received the CDs

* the patient's name and address (if known)

* the name, position and signature of the person destroying the CDs and the witness

* the date of destruction

The Society recommends that these records be retained for a period of at least 7 years. Forms to record these details are available from the Society's website at

http://www.rpsgb.org.uk/pdfs/restooldestrcd.pdf  and other organisations/bodies/suppliers, such as the NPA, can supply a record book for this purpose.

Answer 17

1. TRUE (SCOTLAND)

2. FALSE (ENGLAND, WALES AND SCOTLAND)

3. TRUE (ENGLAND AND WALES)

Pharmacies in England and Wales are not able to accept waste medicines, including CDs, from care homes that provide nursing care.

In Scotland, the Scottish Parliament has approved legislation which allows pharmacies to accept a range of waste, including CDs, from individuals, households and "Care Services" as defined by section 2 of the Regulation of Care (Scotland) Act

2001. It should be noted that the definition of "care services" may exclude certain NHS premises.

Guidance for Pharmacists on the safe destruction of Controlled Drugs

England, Scotland and Wales

September 2007

http://www.rpsgb.org/pdfs/cdsafedestructionguid.pdf

Answer 18

1. TRUE

2. FALSE

3. FALSE

4. TRUE

Ampoules containing the CD in a powder form can be opened, water added to dissolve the powder and the resultant mixture poured into the CD denaturing kit or the bin that is used for disposal of liquid medicines. The ampoule can then be disposed of in the sharps bin. The sharps bin should be labelled "contains mixed pharmaceutical waste and sharps - for incineration". These are the ideal methods of denaturing ampoules. Suitable gloves should be worn by the person breaking open glass ampoules as a safety measure and to minimise the risk of injury from sharps.

An alternative but less preferable, disposal method is where the ampoules are crushed with a pestle inside an empty plastic container. Once broken, a small quantity of hot soapy water (for powder ampoules) or cat litter (for liquid ampoules) is added. If these methods are used, care should be taken to ensure that the glass does not harm the person destroying the CD. The resulting liquid mixture should then be disposed of in a CD denaturing kit or in the bin that is used for disposal of liquid medicines.

The active ingredient in the patches can be rendered irretrievable by removing the backing and folding the patch over on itself and then placing it in a waste disposal bin, or preferably a CD denaturing kit. Gloves must be worn by the person destroying the CD.

Guidance for Pharmacists on the safe destruction of Controlled Drugs

England, Scotland and Wales

http://www.rpsgb.org/pdfs/cdsafedestructionguid.pdf

In Northern Ireland Improving Patient Safety - Building Public Confidence contained an Action Plan designed to take forward a number of proposals to improve quality of care and patient safety.