Controlled drugs

Destruction of controlled drugs

Any person required by the Regulations to keep records of Controlled Drugs, (i.e. schedule 1 or schedule 2 drugs) may only destroy them in the presence of a person authorised by the Secretary of State:

Royal Pharmaceutical Society
Police chemist liaison officers
Home Office inspectors.

Particulars of the date of destruction and the quantity destroyed must be entered in the register and signed by the authorised person, in whose presence the drug is destroyed. The authorised person may take a sample of the drug that is to be destroyed.

A pharmacist or practitioner may destroy Controlled Drugs returned to him by a patient or a patient's representative without the presence of an authorised person. Such controlled drugs should not be returned to stock. As a quantity of Controlled Drugs being returned can often cause a storage problem, as well as an increased security risk, pharmacists are encouraged to destroy patient returned Controlled Drugs as soon as possible, and not wait for the authorised person to visit.

Although not a legal requirement, in view of the Shipman case, the Health Authority advises that the destruction of controlled drugs (including patients own) should be witnessed. Further advice will be issued after discussion with police chemist inspectors. The record of destruction should be made somewhere other than the CD register.

The following procedure should be adopted so that the CD is rendered irretrievable before disposal.

Liquid dose formulations: should be added to, and absorbed by, an appropriate amount of cat litter, or similar product.
Solid dose formulations: should be crushed and placed into a small amount of hot soapy water. The resultant mixture should be stirred to ensure that the drug has been dissolved or dispersed.
Parenteral formulations: ampoules should be crushed with a pestle inside an empty plastic container. After ensuring that all ampoules are broken, a small quantity of hot soapy water or cat lifter should be added.
Fentanyl patches: the active ingredient in the patches can be rendered irretrievable by removing the backing and folding the patch upon itself.

Once the above procedure has been carried out, the resultant mixture should be added to the general pharmaceutical waste. It is advisable to keep the liquid content to a minimum.

Alternatively, use a specialist CD destruction kit available from DOOP. This is more suitable if you have many controlled drugs for disposal.

Advisory notes

Controlled drug stocks should be kept to a minimum
Within the surgery these drugs should be kept in a locked, fixed cabinet sited away from the public
The number of keys to the cabinet, and the keyholders, should be known
Controlled drugs should be requisitioned, and paid for, by the partnership
All outgoing transactions of controlled drugs from the partn ership must be recorded in a bound register
A separate page must be used for each drug, each strength and each preparation (e.g. tablet or ampoule)
Entries must be indelible and cannot be altered Each partner is held responsible for maintaining the controlled drug register It is suggested that only a doctor should sign the register
The register must be kept for two years after the date of the last transaction
The drug stock should be available for inspection by authorised personnel
Outside the surgery controlled drugs must be kept in a locked container out of sight in a locked car
The controlled drugs carried by the individual should be the minimum consistent with what their responsibilities require and that stock should be known and constant A separate informal record should be kept for controlled drugs carried by the individual doctor detailing to who that stock has been administered and when it has been replenished.

There are two distinct purposes for which a drug register may be required in general practice.

Each doctor requires to keep a separate personal register of controlled drugs entering therein all quantities of drugs received by him/her, and those administered to patients or supplied to any other authorised person.
When doctors in partnership or a group practice keep a common stock of controlled drugs at a surgery or other premises, a separate register must be maintained at each of the premises where such drugs are kept.

Instructions for use of registers

Use a separate page for each form of each drug. Enter the name and form of the drug at the top of the page.
Note in index which page is being used for each form of each drug.
Make entries in chronological order. Lines are numbered to facilitate this.
Enter one transaction only on each line under the appropriate section (obtained or administered)
Cancel that part of the line not used, by drawing a horizontal line through the space.
Check the stock held at the end of the transaction, and enter under the appropriate heading.
Append signature in the appropriate space.
Do not cancel, obliterate or erase any entry. Correction of alteration shall be made only be way of marginal note or footnote which shall specify the date on which the correction is made.

Controlled drugs - schedules and additional notes

Under the Misuse of Drugs Regulations 1985, drugs were defined within 5 schedules.

On the 1 St February 2002, this was amended to the Misuse of Drugs Regulations 2001; -

Schedule one

The Drugs listed in Schedule One have no recognised medicinal uses. These include Cannabis, Coca Leaf, LSD, and Mescaline. Only persons with a Home Office licence may possess Schedule One Drugs. This is order that they can legally be held for use in medical research. From the 1St February 2002 Schedule One will include 35 of the 36 Ecstasy-Type substances. The one remaining Ecstasy-Type substance: -(N-Hydroxyamphetamine), will be in Schedule Two, because this substance is currently being used in eye therapy at a London Hospital and may become a recognised medicinal product.

Schedule two

Schedule Two contains more than 100 substances, mainly opiates. This includes drugs such as Diamorphine, Dipipanone, Fentanyl, Methadone, Pethidine etc.

All in Schedule Two are to be kept in Safe Custody and recorded in Drugs Registers.

Schedule three

Schedule Three includes most of the Barbiturates e.g. Phenobarbitone, but also *Temazepam *Buprenorphine *Flunitrazepam

(* These require Safe Custody as with Schedule Two Drugs).

Schedule four

From 1St February 2002, Schedule Four is divided into two parts: -

Part 1 — consists of 33 Benzodiazepines: -

Diazepam, Lorazepam and Nitrazepam etc and 8 other substances.

The change in status for these Drugs, created by the Misuse of Drugs Regulations 2001, makes it a Criminal Offence for a person to possess Schedule Four Part 1 drugs without a prescription or other lawful authority.

This being an acknowledgement that these substances are becoming the subject of widespread abuse, and a way of trying to inhibit this abuse without placing restrictions on prescribers. Restrictions would be incumbent upon them if these drugs were rescheduled into schedule 3.

Part 2- made up mainly of 54 Anabolic Steroids, such as Nandrolone, Stanozolone, Testosterone etc.

When contained within a medicinal product possession alone of a Schedule 4 part 2 substance will not be unlawful.

Schedule 5

Schedule 5 contains Drugs where the risk of abuse is considered to be negligible. Many of the Drugs listed in schedule 5 are also listed in schedule 2, but because of their form or reduced strength they become schedule 5.

For example Dihydrocodeine injections are in schedule 2, tablets below 100mg are in schedule 5,

As with schedule 4, schedule 5 substances, when contained in a medicinal product, possession alone is not unlawful.

Safe custody

All drugs: included in schedule 2 and some of the schedule 3 Controlled drugs must be kept in safe custody. This means they are to be kept in a locked receptacle. This must remain locked at all times. Except when the person authorised to possess these Drugs is accessing this receptacle.

Locked receptacle

Has to be located within the surgery.

Must be of robust construction, made of steel and secured by rag bolts to a solid wall or floor. The cabinet should be locked by key, a key / combination lock configuration can be used. However a combination lock only will not be approved for such use as the integrity of the lock security could not be ensured.

Keys should be kept to a minimum and held by individuals within the practice for whom it is necessary to have access to the cabinet. If a key for the cabinet is kept in a 'SAFE PLACE' e.g. on a hook, in a drawer, or in a safe which is used to store other items essential to the practice, then the door to the cabinet may as well be left unlocked, as access is then available to anyone who knows the location of the key.

The cabinet should be alarm protected; usually this means either the room or the building in which it is housed.

The locked receptacle must meet with the requirements of the Misuse of Drugs Regulations. If a practice wished to use a cabinet / safe not specifically manufactured for that purpose the approval for such use can be obtained from the Police through the office of The Chemical Liaison or Chemist Inspection Officer.

Doctor bags

'Locked receptacle' includes Doctors bags. This must be a lockable bag, box or case. They should always be kept locked when not in use. Keys are to be kept separate. It is intended that these bags be in the doctors possession at all times.

Doctors bags- best practice

Leaving a Doctors Bag in a Motor Vehicle overnight or when a vehicle is left unattended for long periods of time is not recommended, and may be considered a breach of the Safe Custody Regulations resulting in a Police prosecution.

Doctors, who use estate cars, people carriers, 4 x 4 type vehicles should be extra careful as the opportunity for security and concealment of their bags is poor in comparison to that of a traditional saloon type car.

An endorsement of this concept as long ago as 1949 was the case RAG v WYLES. The Judge ruled that a locked car was not held to be safe custody for a Doctors Bag.

Record keeping

Doctors in General Practice can opt for two modes of Record Keeping: -

as a Practice
as individual Doctors within the Practice

As a practice

A central drugs register has to be kept for all schedule 2 Drugs purchased by the practice, these Drugs will be stored in a suitable C D cabinet. If the practice has more than one site where Drugs are stored then there must be a Drugs register for each site.

All Doctors in the practice must keep a personal Drugs register recording their use of schedule 2 Drugs from their bags.

As individual doctors

Where a practice has no central register and store, Doctors in that practice may purchase by signed order their own stock of schedule 2 Drugs. They must keep their own personal Drugs register.

Registers

Registers have to be bound books (no loose leaves permitted), they are divided into two parts: -

Drugs Obtained.
Drugs Supplied.

Each part is also sub-divided for each class of drug.

Register entries

Must be made in ink or be indelible, and hand written.
In chronological order, made on the same day or within 24 hours and shall include: -
- The date the drug was obtained or supplied.
- The name and address from whom the supply is obtained or made.
- The prescriber.
- The amount obtained or supplied.
- The form obtained or supplied.
All registers have to be kept for 2 years from the date of the last entry made.

Recycling

It is illegal to recycle any drugs, once a Pharmacist or a Doctor has dispensed a drug to a patient, if it is subsequently returned to either a Pharmacy or Doctors Practice it must be destroyed.

Patient returns if accepted by the practice can be destroyed without the need for an approved witnessed destruction. However it is good practice to detail this in the back of the register, information about the returns e.g. name of patient, quantity and form of CD returned, and who witnessed the destruction.

Following recent high profile court cases, it is recommended that patients are told to take All unwanted medicines to their local pharmacy.

Destruction- out of date drugs

Destruction of out of date schedule 2 drugs held by a practice cannot be destroyed unless an approved witness is present.

An approved witness can be a Police Officer, a Home Office Drugs Branch Inspector, or other person authorised by the secretary of state. This may be the Health Authority Pharmaceutical Advisor for your area.

The protocol in respect of Police Officers: -

Whilst any can be an approved witness this role is delegated by the Chief Constable to the office of Chemical Liaison or Chemist Inspection officer who are trained to carry out this task.

When out of date schedule 2 drugs are destroyed a full register entry must be made. This entry should contain, the date, the drug its form and amount and the signature of the approved witness.