Access to controlled medicines

[Guest guest]

Hi,

Bountiful nature, cultivation of poppy in plenty, production of

morphine in abundance, export in quantum, plethora of existing laws,

strict checks and balances in place, yet restricted access to the

product by the practitioners and limited availability to the

deserving patients in dire need!

Dard uthta hai to baith jata hoon.

Baith jata hoon to dard uthta hai.

I translate in English. When it starts paining I sit down. When I

sit down, it starts paining.

When will this pain be managed?

Vijay

>

>

> HELLO TO AII,

>

> Regulations made under the Health Act 2006 require each healthcare

> organisation to appoint an Accountable Officer, responsible for

the safe

> and effective use of controlled drugs in their organization. The

> Regulations also introduce standard operating procedures (SOPs)

for the

> use and management of controlled drugs. (Please read CD as

controlled

> drugs).

>

> · A SOP is a document that describes the responsibilities and the

> procedures, including audit, necessary to safely and accountably

manage

> controlled drugs. The standard operating procedures must include:

>

> o Ordering and receipt of CDs

>

> o Assigning responsibilities

>

> o Where the controlled drugs are stored

>

> o Who has access to the controlled drugs

>

> o Security in the storage and transportation of controlled

drugs

> as required by misuse of drugs legislation

>

> o Disposal and destruction of controlled drugs

>

> o Who is to be alerted if complications arise

>

> o Record keeping, including:

>

> § Maintaining relevant controlled drugs registers under

> misuse of drugs legislation

>

> § Maintaining a record of the controlled drugs specified in

> Schedule 2 to the Misuse of Drugs Regulations 2001 that have been

> returned by patients

>

> · The practice SOP should also include:

>

> o Responsibilities within the practice team

>

> o Review period, e.g. one, two or three years

>

> o Lead author and named people contributing to the SOP

>

> Prescriptions for Controlled Drugs

>

> · The amendments to the Misuse of Drugs Regulations 2001 that came

> into force in November 2005 removed the requirement that

controlled drug

> prescriptions should be written in the prescriber's own

handwriting was

> removed. This means that CD prescriptions can be type-written,

> handwritten or computer printed. Only the signature of the

prescriber

> has to be handwritten.

>

> · Further changes following amendments to the Misuse of Drugs

> Regulations came into force in July 2006. These include:

>

> o A new requirement that patients or other people collecting

> medicines on their behalf must sign for them.

>

> o Validity of any prescription for schedule 2, 3 & 4

controlled

> drugs to be restricted to 28 days.

>

> o Strong recommendation that the maximum quantity is

limited to

> 30 days for prescriptions of schedule 2, 3 and 4 controlled drugs.

>

> o Re-emphasis of professional guidance that doctors should

> prescribe controlled drugs for themselves or family members only in

> exceptional circumstances.

>

> · Doctors are only able to prescribe diamorphine, dipipanone and

> cocaine to substance misusers for the treatment of addiction if

they

> hold a licence issued by the Home Office. All doctors may

prescribe such

> drugs for patients, including substance misusers, for the relief

of pain

> due to organic disease or injury without a specific licence.

>

> · Prescriptions for temazepam and for Schedule 4 and 5 controlled

> drugs are exempt from the specific prescription requirements of the

> Misuse of Drugs Regulations 2001. However, they must still comply

with

> the general prescription requirements as specified under the

Medicines

> Act.

>

> · Emergency supplies of Schedule 2 and 3 controlled drugs, for a

> specific patient, are not permitted either at the request of the

patient

> or a practitioner. The only exception to this rule is

Phenobarbital for

> the treatment of epilepsy.

>

> Prescription Form

>

> · Prescription forms now include a box on the back of the

> prescription where the signature of the patient or other person

> collecting a Schedule 2 or 3 CD must be recorded.

>

> · The prescriber should include the patient's number on the

> prescription form.

>

> · The prescriber should sign any script changes. The prescription

> must contain the following details:

>

> o The patient's full name, address and, where appropriate,

age.

>

> o The name and form of the drug, even if only one form

exists.

>

> o The strength of the preparation, where appropriate.

>

> o The dose to be taken.

>

> o The total quantity of the preparation, or the number of

dose

> units, to be supplied in both words and figure.

>

> Prescribing in Installments

>

> · The prescription must be dispensed on the date on which it is

due.

> If the client does not collect an installment when it is due that

supply

> is no longer valid. The client cannot collect that supply the

following

> day.

>

> · If a controlled drug prescription is to be dispensed in

> installments, e.g. daily, then the must specify:

>

> o The number of installments

>

> o The intervals to be observed between installments (if

> necessary, instructions for supplies at weekends or bank holidays

should

> be included)

>

> o The total quantity of controlled drug that will provide

> treatment for a period not exceeding 14 days

>

> o The quantity to be supplied in each installment

>

> · Current legislation does not allow Schedule 2 and 3 controlled

> drugs to be prescribed as repeat prescriptions (i.e. to be part of

the

> repeat prescribing or dispensing system)

>

> Ordering, Possessing and Supplying Controlled Drugs

>

> · Doctors, dentists and pharmacists are authorized under the Misuse

> of Drugs Regulations 2001 to possess, supply and compound

controlled

> drugs in Schedules 2, 3, 4 and 5. They may only supply controlled

drugs

> to those who may lawfully possess them, including patients for

whom a

> drug is prescribed.

>

> · Practitioners must not use patient-specific controlled drug

> prescriptions to replace or top-up their bags or practice stock,

even if

> the stock was used for that patient initially.

>

> · Practitioners may obtain Schedule 2 and 3 controlled drugs from

> pharmacies or wholesalers for practice use or stock upon the

production

> of a written requisition. The requisitions must be:

>

> o Signed by the prescriber.

>

> o State the transcriber's name and address, and their

> profession or occupation.

>

> o Specify the total quantity of the drug

>

> o Specify the purpose for which it is required, e.g. for

practice

> use.

>

> · Suppliers must keep all requisitions for a minimum of two years.

A

> requisition is not required before supplying or obtaining Schedule

4 or

> 5 controlled drugs.

>

> · A practitioner who requires a Schedule 2 or 3 controlled drug

> urgently and who is unable to supply a signed order can request the

> drugs to be supplied in an emergency. The practitioner may be

supplied

> with the controlled drug provided he or she gives an undertaking to

> supply a written, signed requisition within 24 hours. Failure to

do this

> is a criminal offence on the part of the practitioner.

>

> · It is the responsibility of the pharmacist or doctor, when

> receiving a supply of controlled drugs from the wholesaler, to

ensure

> that the correct item is delivered and that all appropriate

entries are

> made in the CD register on the day of supply, or the day following

the

> day of supply.

>

> · There is now a requirement for persons asked to supply Schedule 2

> CDs on prescription to seek to establish whether the person

collecting

> the drug is the patient, the patient's representative or a health

care

> professional acting in his professional capacity on behalf of the

> patient.

>

> · Where the person is the patient or the patient's representative,

> e.g. a friend, neighbour, the dispenser:

>

> o May request evidence of that person's identity, and

>

> o May refuse to supply the drug if he is not satisfied as

to the

> identity of that person.

>

> · Where the person collecting the prescription is a health care

> professional acting in his professional capacity on behalf of the

> patient, the dispenser:

>

> o Must obtain that person's name and address.

>

> o Must, unless he is acquainted with that person, request

> evidence of that person's identity; but

>

> o May supply the drug even if he is not satisfied as to the

> identity of that person.

>

> · The new regulations do allow discretion not to ask patients or

> patient representatives for proof of identity if for example they

have

> concerns that to do so may compromise patient confidentiality or

deter

> patients from having their medicine dispensed.

>

> Requirements for records

>

> · Records for Schedule 2 CDs must be kept in a CD register. This is

> not a legal requirement for Schedule 3, 4 or 5 CDs.

>

> · All health care professionals who hold personal CD stock must

keep

> their own CD register, and they are personally responsible for

keeping

> this accurate and up-to-date.

>

> · The register must:

>

> o Be bound (not loose-leaved) or a computerized system

which is

> in accordance with best practice guidance.

>

> o Contain class sections for each individual drug.

>

> o Have the name of the drug specified at the top of each

page.

>

> o Have the entries in chronological order and made on the

day of

> the transaction or the next day.

>

> o Have the entries made in ink or otherwise so as to be

indelible

> or in a computerized form in which every such entry is

attributable and

> capable of being audited.

>

> o Not have cancellations, obliterations or alterations;

> corrections must be made by a signed and dated entry in the margin

or at

> the bottom of the page.

>

> o Be kept at the premises to which it relates and be

available

> for inspection at any time. A separate register must be kept for

each

> set of premises (e.g. at each branch surgery).

>

> o Be kept for a minimum of two years after the date of the

last

> entry, once completed.

>

> o Not be used for any other purpose.

>

> · For CDs received into stock the following details must be

recorded

> in the CD register:

>

> o The date on which the CD was received

>

> o The name and address of the supplier, e.g. wholesaler,

pharmacy

>

> o The quantity received

>

> o The name, form and strength of the CD

>

> · For CDs supplied to patients (via prescriptions), or to

> practitioners (via requisitions), the following details must be

recorded

> in the CD register:

>

> o The date on which the supply was made

>

> o The name and address of the patient or practitioner

receiving

> the CD

>

> o Particulars of the authority of person who prescribed or

> ordered the CD

>

> o The quantity supplied

>

> o The name, form and strength in which the CD was supplied

>

> · The Secretary of State for Health can authorise the medical

adviser

> of the Primary Care Trust or other appointed doctor to ask general

> practitioners(GPs) to produce records and to view stocks. Failure

to

> comply is an offence.

>

> Destroying Controlled Drugs

>

> · Professional guidance strongly recommends that any medication

> returned from patient stocks should not be re-issued or used to

treat

> other patients.

>

> · There is no current legal requirement that 'patient-returned'

> Schedule 2 and 3 controlled drugs should be destroyed in the

presence of

> an authorised witness, but it is strongly recommended that doctors

and

> pharmacists have the destruction of these returns witnessed by

another

> member of staff (preferably by a registered health care

professional)

> and to make a record of the destruction in a separate book set

aside for

> this purpose.

>

> · Those health care professionals and service providers required by

> law to maintain a CD register are not allowed to destroy expired

> Schedule 2 (or 1) controlled drugs from their stock without

destruction

> being witnessed by an authorised person.

>

> · When a controlled drug is destroyed, details of the drug must be

> entered into the CD register. This should include: the name of the

drug;

> form; strength and quantity; the date it was destroyed; and the

> signature of the authorised person who witnessed the destruction

and the

> professional destroying it (i.e. two signatures).

>

> · The list of those authorised to witness the destruction of

> controlled drugs includes:

>

> o A chief pharmacist or pharmaceutical prescribing adviser

who

> reports directly to the chief executive or to a director of the

PCT.

>

> o A registered medical practitioner who has been appointed

to the

> PCT Professional Executive Committee or equivalent.

>

> o The board executive member with responsibility for

clinical

> governance or risk management.

>

> Regards,

>

> Dr Deepali

>