Saturday, February 9, 2013

Scheduling of Controlled Drug Substances

Scheduling of controlled drug substances is based on the Controlled Substances Act of 1970 which was enacted to improve the administration and regulation of all parties involved with the manufacturing, distribution, and dispensing of controlled substances. The schedule is classified (in descending order) based on their potential for abuse, psychological or physiological dependence, and medical use.

Schedule I
Drugs with no importance in medical used, or other substances, with high potential of abuse. Any substances that being abused can be categorized in this schedule. Prescription has no significance to be written for this drug class.

Schedule II
Drugs with acceptable therapeutic uses and have high potential for drug abuse that if abused, the person may be led to serious psychological or physical dependence.
Pharmacists should knowledgeable about the following: 
  • Prescriptions are not refillable and required a new prescription order. Pharmacist requires to record the written amount requires the number of units dispensed and to fill the remaining within 72 hours. If the remaining units cannot be filled with the said time frame, the remainder cannot be dispensed already and should inform the physician.
  • For long-term care facility (LTCF) partial dispensing of prescriptions in Schedule II for patient or who are medically diagnosed at terminally ill has the validity of 60 days from the time of issuance. The pharmacist must record that the patient is terminally ill or LTCF. He must to indicate the date, quantity dispensed, and quantity remaining. He must also put his initials or signature on the back of the prescription.
  • In an inadvertently situation, prescriptions involving Schedule II drugs may be called into a pharmacy through telephone provided that certain criteria are met such as, immediate administration is necessary for proper treatment and no appropriate alternative is available. 
Schedule III
Drugs with therapeutic medical significance. The potential for abuse is low compare to those in listed in Schedule I and II which, if abused, may lead to moderate psychological or physical dependence. The prescription may be refilled up to five time within 6 months of the date that the prescription was first used. The pharmacist must record the quantity dispensed and indicating his initials either on the front or the original prescription or on the back of a refill. Within 6 months of the issuance of the original order, all partial dispensing must be fully served.

Schedule IV
Drugs with therapeutic medical significance with low potential of relative abuse to those in Schedule III which, if abused, may lead to marginalized psychological or physical dependence relative to drugs in Schedule III. Dispensing rules are comparable as for Schedule III drugs.

Schedule V
Drugs with therapeutic significance and have low potential for abuse relevant to those in Schedule IV. If abused, may lead to limited physical dependence or psychological dependence relatively to drugs in Schedule IV. These drugs are mainly used for treatment of coughs and diarrhea. No limitations of refill except that all refills must be dispensed in good faith based on the professional judgment of the pharmacist and the physician.
The following are criteria for dispensing Schedule V:
  1. Drug substance must be sold by a pharmacist.
  2. Should have limit up to 240ml ( or 48 solid dosage units) of opium-containing substances or 120ml (24 solid dosage units) of non-opium-containing controlled substances may be dispensed within a 48 hour period.
  3. At least 18 years old or at legal age presenting a valid identification card to the pharmacist.
  4. The pharmacist must have a record book to be maintained for Schedule V substances within 2 years. Information such as name, address, name and quantity of controlled substances, date of sale and initials of pharmacist.