Access to controlled medication

[Guest guest]

hello Deepali,

All the medicines in the 5 schedules you mentioned have more or less dependence liability. Do all these need a special licence to sell, stock, display?

kunda

From: Deepali <deepali_tehre@...>Subject: Access to controlled medicationnetrum Date: Monday, 10 March, 2008, 1:08 AM

Hello Netrumians,

I thank Dr Bashaar sir for providing a useful informative link on access to controlled medication programme, it certainly made my job easier to clarify discussion topic.

Let us start topic with definition of controlled medication or controlled substances, it refers to a drug or chemical substance whose possession and use are controlled by the law. This may include illegal drugs and prescription medications. They are also known as "scheduled drugs" or "controlled medications" because of their potential for abuse, dependence and diversion and subjected to special provisional laws because of the same. They are grouped into five "schedules" based on their abuse potential.

Schedule I

are substances that have a high abuse potential and no accepted medical use. They include heroin, (LSD ) lysergic acid diethylamide, and ecstasy (MDMA) 3,4 methylenedioxymetha mphetamine

Schedule II

Substances in this schedule have a high potential for abuse with severe psychological or physical dependence. Examples of single entity Sched­ule II narcotics include morphine, codeine, and opium. Other Sched­ule II narcotic substances and their common name brand products include: hydromorphone (Dilaudid), methadone (Dolophine), me­peridine (Demerol), oxycodone (OxyContin), and fentanyl (Sub­limaze or Duragesic). Examples of Schedule II stimulants include amphetamine (Dexedrine or Adderall), methamphetamine (Des­oxyn), and methylphenidate (Ritalin). Other Schedule II substances include cocaine, amobarbital,

glutethimide, and pentobarbital.

Schedule III

Substances in this schedule have a potential for abuse less than substances in Schedules I or II. Examples of Schedule III narcotics include combination products containing less than 15 milligrams of hydrocodone per dosage unit (i.e., Vicodin) and products containing not more than 90 milligrams of codeine per dosage unit (i.e., Tylenol with codeine). Examples of Schedule III non-narcotics include benzphetamine (Didrex), phendimetrazine, dronabinol (Marinol), ketamine, and anabolic steroids such as oxandrolone (Oxandrin).

Schedule IV

Substances in this schedule have a lower potential for abuse relative to substances in Schedule III. Examples of Schedule IV narcotics include propoxyphene (Darvon and Darvocet-N 100). Other Schedule IV substances include alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), and triazolam (Halcion).

Schedule V Substances

Substances in this schedule have a lower potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotic and stimulant drugs. These are generally used for antitussive, obstetrics, antidiarrheal, and analgesic purposes. Examples include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC and Phenergan with codeine), ephedrine, and ergometrine.

Controlled Medications in Medical Practice

Controlled medications are integral to the provision of medical care. Their uses are wide and varied. In primary care, controlled medications are used for treating coughs, anxiety, and pain associated with minor trauma such as sports injuries. They are commonly used by surgical practices in the treatment of surgical pain , for treatment of trauma patients whose injuries require transport for stabilization, in emergency departments, and by health care teams who care for patients with terminal illnesses. cancer pain, chronic pain, diabetic neuropathy, HIV neuropathy, sickle-cell disease,

According to the federal Drug Enforcement Administration (DEA), "controlled substances have legitimate clinical usefulness and the prescriber should not hesitate to consider prescribing them when they are indicated for the comfort and well being of patients."

WHO states that The right to health (i.e. "the right to the enjoyment of the highest attainable standard of health") includes access to necessary treatment and care and to all essential medicines including controlled medication.

Comments and views are awaited from netrum members.

Regards,

Dr Deepali

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[Guest guest]

Dear Dr Smita,

Yours is a nice contribution, regarding storage, recording destruction of controlled drugs.

Here are some of the key principles that must be addressed, when considering the provision and use of any controlled drugs in an out-of-hours situation,

(Out of hour situation defined as,¡¦ Other than in exceptional circumstances, where patients should be able to receive the medication they need at the sametime and in the same place as the out-of-hours consultation.¡¦)

These include:

1)doctors and pharmacists are legally permitted to possess and supply controlled drugs when acting in their capacity as such. As long as the ordering and handling of such drugs in an organization is undertaken by a doctor or a pharmacist, no licence is necessary. However, if these duties are to be undertaken by anyone else (e.g. an office manager), an organization requires a Home Office license.

2)ƒneach provider should keep a ¡¥central¡¦ register for all controlled drugs;

a complete documented and coherent audit trail should also exist ¡V from requisition to stock room, prescription to patient location, administration and/or destruction, where relevant;

3)ƒnfull and robust clinical records should be kept. They should make clear the date, time of administration, strength, presentation, form, batch number and expiry date of any drugs involved;

4)ƒncontrolled drugs should be stored within a locked cabinet, complying with the relevant legislation, in the out-of-hours primary care centre. Procedures allowing access to the controlled drugs stock should always ensure it is carried out

in the presence of two of the following types of individual: a doctor or pharmacist and a designated out-of-hours supervisor, each with appropriate identification;

5)a lead clinician, ideally a pharmacist, should be nominated to monitor, audit and reconcile the use of any controlled drugs and the relevant register;

6)all clinical practitioners involved in local schemes should have access to national/local guidance, plus local training on statutory requirements and good practice in the use of controlled drugs, particularly in primary care.

7)For controlled drugs, a complete, documented and coherent audit trail should exist from stock room to patient. This should include drugs administered in the patients¡¦ home and drugs returned for destruction.

Regards,

Dr Deepali