Access to controlled medication

[Guest guest]

Respected Gharpure madam and Dr Anupama madam,

There are legislative guidelines to strengthen the regulations for controlled drugs regarding the prescribing, record keeping destruction of controlled drugs under amendments to the Misuse of Drugs Regulations ;The Health Act. Under this scenario there are two important legislations play important role these are ;

1) Misuse of drug act 1971

The Misuse of Drugs Act 1971 and its Regulations control the availability of drugs that are considered sufficiently `dangerous or otherwise harmful', with the potential for diversion and misuse. The Act establishes a series of criminal offences for their unauthorised, and

therefore unlawful, possession, possession with intent to supply, supply, importation and unlawful

production.

2) Misuse of Drugs Regulations 2001 (2001 Regulations)

The current version of the Regulations made under the Misuse of Drugs Act 1971 are the Misuse of Drugs Regulations 2001

The 2001 Regulations divide controlled medication into five Schedules, which dictate the degree to which a controlled drugs use is regulated. The Schedule in which a controlled drug is placed depends upon its medicinal or therapeutic benefit balanced against its harm when misused. Schedule 1 controlled drugs are subject to the highest level of control, whereas Schedule 5 controlled drugs are subject to a much lower level of control.

(please read CD as Controlled drugs)

Schedule 1 drugs-

Production,possession and supply of drugs in this Schedule are limited to research or other special purposes that are considered to be in the public interest. Only certain persons can be licensed by the Home Office to possess them for these purposes. Practitioners (`practitioner' is defined in s.37 Misuse of Drugs Act 1971 as a doctor, dentist, veterinary practitioner or veterinary surgeon) and pharmacists may not lawfully possess Schedule 1 drugs except under licence from the Home Office.

Schedule 2 drugs-

Schedule 2 CDs (except quinalbarbitone) are subject to safe custody requirements (under the Misuse of Drugs Safe Custody Regulations 1973). They must be stored in a locked receptacle, such as an appropriate CD cabinet or approved safe, which can only be opened by the person in lawful possession of the CD or a person authorised by them.

A licence is required to import or export drugs in Schedule 2. They may be manufactured or

compounded by a licence holder, a practitioner, a pharmacist or a person lawfully conducting a retail pharmacy business acting in their capacity as such. A pharmacist may supply them to a patient only on the authority of a prescription in the required form (see page 27) issued by an appropriate prescriber. Schedule 2 CDs may be administered to a patient by a doctor or dentist, or by any person acting in accordance with the directions of an appropriately qualified prescriber. Nurse independent prescribers are permitted to prescribe, administer, or direct anyone to administer some CDs for specific conditions and routes of administration A register must be kept for Schedule 2 CDs and this register must comply with the requirements of the 2001 Regulations.

The destruction of Schedule 2 stock CDs must only take place in the presence of an ppropriately

authorised person. Patient returns do not currently have to be witnessed by an authorised person but good practice would deem that another person witnesses it.

Schedule 3 drugs-

The majority of Schedule 3 CDs are exempt from safe custody requirements and can be stored on the open dispensary shelf. Exceptions are flunitrazepam, temazepam, buprenorphine and diethylpropion, which must be stored in a locked receptacle, such as an appropriate CD cabinet or approved safe, which can only be opened by the person in lawful possession of the CD or a person authorised by them. There is no legal requirement to record transactions involving Schedule 3 CDs in a CD register. The requirements for destruction do not apply unless the CDs are manufactured by the individual. Schedule 3 CDs are subject to full import and export control.

Schedule 4 drugs-

There is no restriction on the possession of a Schedule 4 drug when it is in

the form of a medicinal product. Drugs like (Benzodiazepines) are subject to full import and export control. All substances in Schedule 4 are exempt from safe custody requirements, with destruction requirements only applying to importers, exporters and manufacturers.

Schedule 5 drugs-

There is no restriction on the import, export, possession, administration or destruction of these

preparations and safe custody Regulations do not apply. The Misuse of Drugs Regulations 2001 have been amended so that preparations containing not more than 0.1% cocaine are no longer exempt from prohibitions on import, export and possession. A practitioner or pharmacist acting in his capacity as such, or a person holding an appropriate licence, may manufacture or compound any CD in Schedule 5. Invoices must be retained for a minimum of two years.

Regards,

Dr Deepali