PTCB Study Guide: Controlled Substances

Guidelines for Filling Prescription Orders

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<b>Prescription Order Expiration Dates:</b> A prescription order must be dated, and have an appropriate expiration date based on the type of drug ordered. If it's not filled in time, the script expires.<br />
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<b>Refills:</b> If refills are allowed by the prescriber, it will be noted on the prescription. However, there are boundaries and limitations.<br />
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<b>Generic Substitutions:</b> Generic drug substitutions may not be used unless the prescriber has authorized it. Generic substitutions may only be used if the prescriber has requested or authorized them.<br />
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<b>DEA Controlled Drug Prescriptions Must contain: </b><br />
<ul>
<li>Date of prescription issue </li>
<li>Patient's name and address</li>
<li>Practitioner's name, address, and phone number</li>
<li>Drug name </li>
<li>Drug strength</li>
<li>Exact quantity prescribed</li>
<li>Have a valid DEA Number</li>
<li>Complete directions for use</li>
<li>Number of refills authorized</li>
<li>Dosage form and instructions</li>
</ul>
<b>In addition Schedule II drug prescriptions:</b><br />
<ul>
<li>Must be manually signed by the practitioner. No exceptions.</li>
<li>May not be Faxed or Called in, except for a valid emergency.</li>
<li>May not have any refills.</li>
</ul>
New York State <a href="http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_content.htm" target="_blank">VALID PRESCRIPTION REQUIREMENTS</a><br />
<ul></ul>
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<table style="width: 100%;"><tbody>
<tr>     <th></th>     <th colspan="2">Prescription order expiration dates</th>     <th colspan="2">Refills</th>   </tr>
<tr>     <td></td>     <td>Federal</td>     <td>State Ex. NY</td>     <td>Federal</td>     <td>State Ex. NY</td>   </tr>
<tr>     <td>DEA Sch II </td>     <td>No Expiration</td>     <td>30 days</td>     <td>NO REFILLS ALLOWED</td>     <td>NO REFILLS ALLOWED</td>   </tr>
<tr>     <td>DEA Sch III thru V</td>     <td>6 Months</td>     <td>6 Months</td>     <td>up to 5 times, but only 5 times</td>     <td>up to 5 times within 6 months</td>   </tr>
<tr>     <td>Legend Drugs</td>     <td>12 Months</td>     <td>No Expiration</td>     <td>up to 12 Months worth</td>     <td>up to 3 Months worth</td>   </tr>
</tbody></table>

Guidelines for Filling Prescription Orders

Prescription Order Expiration Dates: A prescription order must be dated, and have an appropriate expiration date based on the type of dru...

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Controlled Substances

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Controlled substances are subject to stricter controls through Federal and State laws and regulations due to their potential for misuse, abuse, diversion, and addiction.<br />
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The Federal law regulating controlled substances is the Controlled Substance Act.<br />
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The Law and its regulations controls over the manufacture, import, export, distribution, ordering, dispensing and prescribing of controlled substances.<br />
Pharmacies must comply with both State and Federal controlled substance laws.<br />
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<b>Schedules of Controlled Substances</b><br />
The Federal Controlled Substance Law created five classifications for controlled substances numbering I, II, III, IV, and V.<br />
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A drug is placed into a controlled Schedule based on certain criteria, such as it’s potential for abuse or addiction and its medical use.<br />
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Schedule I is the most restrictive and Schedule V is the least restrictive of the controlled substances.<br />
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<b>Labeling Controlled Substances</b><br />
The symbol that indicates a controlled substance is the capital letter “C” with the appropriate roman numeral placed inside the “C” symbol.<br />
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<b>Dispensing Controlled Substances</b><br />
For a controlled substance prescription to be valid, it must be prescribed by a licensed prescriber for a legitimate medical purpose in the normal course of the prescriber’s professional practice. <br />
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The prescribing practice must be registered with the DEA and be licensed to prescribe controlled substances by the state. Controlled substances prescription must contain:<br />
<ol>
<li>The date issued</li>
<li>The patients full name & address</li>
<li>The practitioners name, address & DEA registration number</li>
<li>The drug name</li>
<li>Strength</li>
<li>Dosage form </li>
<li>Quantity prescribed</li>
<li>Direction of use</li>
<li>Number of authorized refills</li>
<li>Signature of prescriber</li>
</ol>
Federal law allows Schedule III and IV prescriptions to be refilled up to five times within six months after the issuing date.<br />
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Schedule V prescriptions may be refilled more than five times, but have a six-month the limit on refills.<br />
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Schedule II prescriptions may not be refilled and are not transferable between pharmacies.<br />
Federal law allows schedule III, IV, and V prescriptions to be transferred from one pharmacy to another for refill (if the state permits).<br />
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Pharmacies are required to maintain complete and accurate records for all controlled substances that they purchase , receive, distribute or dispense.<br />
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Federal law requires that pharmacy to keep controlled substance records for two years and have them readily available for DEA inspection if requested. Examples of records include: <br />
<ol>
<li>Invoices</li>
<li>Receipts of purchases</li>
<li>Inventory of records</li>
<li>Records of transfer</li>
</ol>
State Prescription Monitoring Programs, require pharmacies to report information on controlled substance prescriptions dispensed for drugs in Schedules II, III, IV and V. (varies from state to state.) The programs help states identify potential diversion and abuse. Required information includes:<br />
<ol>
<li>Patient info</li>
<li>Prescriber info</li>
<li>Pharmacy ID</li>
<li>Prescription info</li>
</ol>

Controlled Substances

Controlled substances are subject to stricter controls through Federal and State laws and regulations due to their potential for misuse, a...

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Key Terms: Pharmacy Law

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<b>Controlled Substances - </b>Drugs are chemicals whose possession and use are regulated under the Federal Controlled Substances Act and by state controlled substance laws and regulations. Controlled substances are subject to stricter regulations than other prescription and non-prescription drugs.</div>
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<b>Drug Enforcement Administration (DEA)</b>: The federal agency that administers and enforces federal laws for controlled substances such as narcotics and other dangerous drugs and illegal substances. The DEA is part of the U.S. Department of Justice.</div>
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<b>Legend Drug</b> - A drug that is required by federal law to be dispensed by prescription only. It is the old term for drugs that are now identified as “Rx Only”. </div>
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<b>Prescription Monitoring Programs (PMPs)</b>: or prescription drug monitoring programs (PDMPs) are state-run programs that store and distribute prescriptions for federally controlled substances. These serve physicians, physician assistants, nurse practitioners, dentists and other prescribers, as well as law-enforcement agencies, and support legitimate medical use of controlled substances while limiting drug abuse and diversion. </div>

Key Terms: Pharmacy Law

Controlled Substances - Drugs are chemicals whose possession and use are regulated under the Federal Controlled Substances Act and by s...

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