Drug legislation and the ambulatory care setting
In the ambulatory care environment, medications can be prescribed, administered, and dispensed.
Federal and state legislation governs these three activities. The following sections will discuss these laws, the agencies responsible for overseeing the laws, and the laws’ effect on medical assistants.
Food, drug, and cosmetic act
The Food, Drug, and Cosmetic Act of 1938 is enforced by the Food and Drug Administration (FDA). The FDA is a federal agency in the Department of Health and Human Services (HHS). The FDA is responsible for the safety, effectiveness, security, and quality of drugs, cosmetics, and food. The FDA oversees a number of areas:
- Foods: Dietary supplements, bottled water, food additives, infant formula, and other food products
- Drugs: Prescription drugs (brand name and generic) and nonprescription (over-the-counter [OTC]) drugs
- Biologics: Vaccines, blood, and blood products
- Medical devices: Medical equipment (from simple [tongue depressor] to complex [heart pacemaker]), dental devices, and surgical implants
Manufacturers must submit applications for new products to the FDA. Manufacturers must provide adequate data to show the safety and effectiveness of the product. The FDA must determine if drugs, devices, and products are safe and effective. Once this is determined, then the product is released to the general public.
FDA adverse event reporting system
The FDA monitors the safety of products released to the market. The FDA Adverse Event Reporting System (FAERS) is a computerized database that helps the FDA monitor drugs. It contains reports of adverse events reported to the FDA. MedWatch is the FDA’s reporting program. It provides information on products overseen by the FDA. MedWatch is available to healthcare professionals (MedWatch reporting program).
If the FDA determines a medication is unsafe, it will recall the medication. The medical assistant should remove any recalled medications from the stock and sample cabinets. (Sample medications come from pharmaceutical companies and are used for patients.) Concerned patients may contact their providers. The provider will determine what action to take for each patient.
Controlled substances act
The Controlled Substances Act (CSA), Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, is a federal law. The Drug Enforcement Agency (DEA) is a federal law enforcement agency under the US Department of Justice. The DEA enforces the CSA. The DEA oversees the manufacturing, importation, possession, use, and distribution of legal (or prescription) controlled substances. The DEA also handles illegal controlled substances, which cannot legally be manufactured, purchased, or sold in the United States.
Under the CSA, controlled substances are divided into five schedules. These schedules are arranged from the greatest to the least abuse potential.
The five schedules, arranged from the greatest to the least potential for abuse, are as follows:
| Schedule | Abuse potential and medical use | Examples |
| Schedule I | High potential for abuse. No currently accepted medical use in the United States and no accepted safety for use under medical supervision. These drugs cannot be prescribed. | Heroin, lysergic acid diethylamide (LSD), marijuana (under federal law), ecstasy (MDMA), and peyote |
| Schedule II | High potential for abuse, which may lead to severe psychological or physical dependence. Accepted medical use, but the drugs are considered dangerous. | Hydrocodone combination products, oxycodone, morphine, fentanyl, methadone, methylphenidate (Ritalin), and amphetamine (Adderall) |
| Schedule III | Less potential for abuse than Schedule I or II. Abuse may lead to moderate or low physical dependence or high psychological dependence. | Products with no more than 90mg of codeine per dosage unit (e.g., Tylenol with Codeine), ketamine, buprenorphine, testosterone, and other anabolic steroids |
| Schedule IV | Low potential for abuse relative to Schedule III. Abuse may lead to limited physical or psychological dependence. | Alprazolam (Xanax), diazepam (Valium), lorazepam (Ativan), clonazepam (Klonopin), zolpidem (Ambien), and tramadol |
| Schedule V | Lowest potential for abuse. Consists mainly of preparations containing limited quantities of certain narcotics, used as antitussives, antidiarrheals, or analgesics. | Cough preparations with no more than 200mg of codeine per 100mL (e.g., Robitussin AC), diphenoxylate with atropine (Lomotil), and pregabalin (Lyrica) |
The schedule also governs how a prescription may be handled. A Schedule II prescription cannot be refilled at all; the patient needs a new prescription each time. Schedule III and IV prescriptions may be refilled up to five times within 6 months of the date the prescription was written. State law can be stricter than the federal rule, and where the two differ, the stricter one applies. State statutes also address procedures related to scheduled medications. It is important for the medical assistant to know the schedule of commonly ordered medications. Some controlled substance prescriptions are handled differently. This is discussed later in the chapter.
Compliance with the controlled substance act
Providers prescribing controlled substances need a DEA registration number, and each provider is issued a unique number that must be renewed every 3 years. The medical assistant may need to assist the provider in renewing or obtaining a DEA number, which can be done at the DEA website at DEA diversion control division. Additional state requirements may need to be met before a provider can prescribe controlled substances.
Controlled substances have a paper trail that starts with the manufacturer and ends when the medication is dispensed or administered. In a facility with an in-house pharmacy, the provider gives the medical assistant a prescription, the medical assistant exchanges it with the pharmacist for the medication, and the pharmacist manages the related controlled-substance paperwork.
In a facility without a pharmacy, the provider takes on the responsibility of ordering controlled substances directly from the manufacturer, and the medical assistant helps the provider comply with the Controlled Substances Act. The following sections cover common compliance activities.
Storage
All controlled substances must be adequately safeguarded - kept in a locked cabinet or safe of substantial construction, with keys stored in a locked area accessible only to authorized persons. Store controlled substances in a location separate from non-narcotic medications. Additional storage guidelines apply to all medications:
- Make sure all medications are kept in their original containers.
- Store medications in a cool, dry location. Keep medications away from light, heat, or moisture. Refer to package inserts for specific storage information.
- Do not combine or repackage medications with different lot numbers or expiration dates.
- Keep stock medications (purchased by department) separated from sample medications (given by pharmaceutical manufacturers for patients).
- Keep medications out of exam rooms. Lock medication cabinets at the end of the day.
Inventory records
It is important to keep an ongoing log of controlled substances received from manufacturers and administered to patients. Medications are tracked by the manufacturer, lot number, and expiration date. This information is found on the package. When a patient needs a controlled substance, the medical assistant must complete the log. The log typically requires the following data:
- The medication information (name, dose, lot number, and expiration date)
- The ordering provider’s name
- Information on the patient receiving the medication (name, date of birth, address, health record number, and so on)
- The name or initials of the healthcare professional administering the medication
The log must be kept separate from the patient’s health record. The medication must also be documented in the patient’s health record after it is administered.
Periodic reconciling of the log with the actual inventory count is important to identify missing medications. An inventory of all controlled substances must be done at least annually unless required more often by law. Some states have special requirements for the inventory. It is important for the medical assistant to be knowledgeable about the special state requirements. The controlled substance inventory and log records need to be kept for 2 years. The records may be inspected by individuals authorized by the state attorney general.
Drug destruction
Expired controlled substances are returned to the place they were received from - for example, controlled substances sent by the manufacturer must be returned to the manufacturer, along with the required paperwork.
A controlled substance must sometimes be destroyed on-site instead, such as when only part of a dose is used and the remainder must be discarded, when a patient refuses a medication after it’s been opened and prepared, or when a medication is accidentally contaminated before it can be administered. In these situations, the controlled substance must be destroyed in the presence of two authorized persons (e.g., medical assistants, nurses), and an entry must be made on the waste log recording the date; the drug’s name, strength, and quantity; the reason for destruction; and both persons’ signatures. This same two-witness, waste-log rule applies whenever the medication being discarded - expired, contaminated, unlabeled, or opened and unused - happens to be a controlled substance.
For non-controlled medications, many facilities use a medication take-back or disposal program to keep drugs out of the water supply. Current FDA guidance favors take-back options first: flushing is reserved for medicines on the FDA’s flush list, and other unused medications should generally go out with household trash, following label instructions, rather than being flushed by default.
Theft and diversion reporting
If a medical assistant identifies that controlled substances are missing, it’s important to notify the provider and supervisor right away. Many states and the DEA require any theft or loss to be reported to them within a given period, and a report must be completed and filed by that deadline.
Medical assistant’s role in preventing drug abuse
By following these guidelines, the medical assistant can help prevent drug abuse:
- Carefully monitor patients who repeatedly call for prescription refills of controlled substances. Be aware that some patients will give aliases (false names).
- Request health records from other facilities for patients who report previous prescriptions for scheduled drugs.
- If the facility uses paper prescription pads, keep blank pads in a locked cabinet. They should be stored away from patient treatment areas.
- Never use prescription pads for notepads. Never use preprinted or presigned forms.
- Secure computers used for electronic health record (EHR) documentation to prevent patient access to prescription generation.
- Keep only a limited supply of controlled substances on hand.
- Keep accurate, complete records of controlled substances administered. Patients’ records should contain information on prescribed and administered controlled substances.