14.7 Safety and Controlled Substances

Not all safety issues are about personal injuries. Many safety issues affect families and communities, such as prescription drug abuse. Prescription and illegal drug abuse are growing national problems that need to be addressed by the pharmacy field. The abuse of prescription pain medication is the fastest-growing drug problem in the United States.

The statistics speak for themselves. According to the Drug Enforcement Administration (DEA), more than seven million Americans abuse pain and anxiety medications every year, and the numbers are increasing at a fast rate. More than 130 people die every day from opioid overdose. The NIH has declared the opioid abuse problem a crisis.

President Kennedy hands a pen to Dr. Frances O. Kelsey after passing the Kefauver-Harris Amendments, establishing safeguards now used by the FDA.

Physical and Psychological Dangers of Dependence

Understanding drug dependence can give pharmacy personnel a healthy caution in dispensing drugs. It is a complex and difficult mental health and biological problem that drastically affects individuals, families, and communities, contributing to crime and violence. As with alcohol, prescription drug and controlled substance dependence often begin with drug tolerance and progressively escalate to dependence, both psychological and physical, and then to completely controlling addiction:

• Drug tolerance is when the body adapts to a drug so that higher doses are needed to produce the same pharmacological effect. For example, a patient who is taking a Schedule II narcotic for pain relief may build up a drug tolerance, resulting in less pain relief. Consequently, that patient must take higher doses or more frequent doses to achieve the same degree of pain relief they once had at a lower dose. Long-term drug tolerance can lead to psychological and physical dependence, and addiction.

• Psychological dependence is when the patient takes a drug on a regular basis because it produces a sense of well-being that the patient does not want to consider being without. If the patient stops taking the drug, they experience anxiety or withdrawal symptoms due to the psychological security that the drug offered. For example, a patient who takes sleeping medication every night may experience fear of going off the drug because it may mean no sleep or a disruptive sleep pattern. The patient has associated getting a good night’s sleep with taking the medication and has a hard time imagining doing without it.

• Physical dependence is defined as taking a drug continuously so that when the medication is stopped, physical withdrawal symptoms occur, such as restlessness, anxiety, insomnia, diarrhea, vomiting, and goosebumps. Withdrawal symptoms commonly occur with high doses of Schedule II drugs, and, for some patients, may occur after four weeks of many high doses. In some cases, the physical dependence on one drug such as Suboxone can substitute for the physical dependence on another drug, such as narcotic pain relievers.

• Addiction is defined as a chronic disease marked by compulsive and uncontrollable use of a drug substance. Addiction is characterized by a powerful, compulsive urge to use a drug or substance when it is not required medically. Those with addiction may prioritize getting and using drugs over other activities in their lives. Addiction builds on a spectrum of increasing severity the longer it goes unchecked. Addiction can be harmful to the patient and the public at large. That is why the DEA controls substances that are highly addictive like the Schedule II drugs.

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Prescription Strategies to Fight Abuse

Hydrocodone (Vicodin), oxycodone (OxyContin), and oxymorphone (Opana) are prescription opioids that are popularly misused recreationally. Because of the high rates of abuse and death from prescription opioids, pain clinics at the Mayo Clinic and other major health facilities aim to get chronic pain sufferers (especially older patients) to avoid or get off of opioid medications. The pain counselors recommend the following:

• Start at a low dose, perhaps half the usual, and go slowly with dosage increases.

• Avoid mixing with alcohol or any other medications.

• Monitor medications and follow up with the doctor often.

• Be realistic and don’t expect a medication to take away all aches and pains.

• Try to find nonpharmaceutical ways to reduce pain, such as yoga, rehabilitation therapies, meditation, and others.

• Keep prescriptions in a locked drawer or cabinet.

Pharmacy Techniques for Abuse Prevention

Dispensing controlled substances requires a great deal more documentation and checking throughout the filling, dispensing, delivery, purchasing, and inventory processes, as has been explained throughout other chapters. Stay alert for forged prescriptions and drug-seeking behaviors of patients and also coworkers. This can be difficult, especially during a busy pharmacy workday. However, there are some telltale signs and trends to watch for (see Table 14.15).

Be on the Lookout for Drug Seekers

As a technician, you need to be on the lookout for the behavioral red flags of drug seekers, those patients who constantly request “early refills” or receive prescriptions for the same or similar controlled drugs from several physicians. They are also known as “doctor shoppers.” Drug seekers often use more than one physician, dentist, and pharmacy and pay with cash to minimize insurance tracking. Pay close attention to prescription dates. The original prescription date for all controlled drugs must be entered into the profile rather than the prescription filling date so that customer trends can be seen by checking the medication history. If you see any of these signs or have a gut feeling, consult the pharmacist.

A drug seeker is most likely psychologically or physically dependent or addicted to the medication—or may be illegally selling the drugs. Many are very skilled and may try to flatter you and the pharmacists to gain trust and allay any concerns about drug abuse or diversion. If these individuals have been dispensed a narcotic and an antibiotic from an ER, they may request that only the pain medication be filled. The policy for most emergency rooms is “all or nothing” on the prescriptions written. Again, if you suspect that a patient may have illegal intentions, seek the professional judgment of the pharmacist.

Pharmacists and technicians have to be on the lookout for drug seekers and forged prescriptions without jumping to conclusions and offending customers. Look patients in the eyes and at the trends in their profile to get to know them as much as possible and watch for warning signs of abuse.

Also exercise caution when another person (other than the patient or a family member) attempts to call in a refill or pick up a prescription for a controlled substance. When in doubt, call the patient to relay the situation and verify approval for medication pickup, documenting everything. Pharmacies generally request a photo ID (such as a driver’s license) to confirm the identity of the person picking up a controlled substance prescription. Federal law requires a name, signature, and physical address (not a post office box) for patients with all controlled substance prescriptions and for those picking them up. If another individual picks up the prescription, ask for the patient’s address and/or date of birth.

Watch for Prescription Forgeries

A key way to catch illegal drug activity is to detect a falsified prescription. E-prescriptions for controlled substances have double authentication protocols, so they are considered more difficult to forge, but it is not impossible. Paper prescriptions are easier to forge but also easier to detect. Problematic DEA numbers are a first sign.

DEA Number Check Most pharmacies have a computerized physician database containing DEA, NPI, state license numbers, and contact information. Pharmacy technicians should learn to recognize the names and legal signatures of the local prescribers who send prescriptions to the pharmacy, especially for controlled substances. Insurance plans require a pharmacy to have a physician’s DEA number on file to be reimbursed for prescriptions for all controlled medications. The validity of the prescriber can be checked by adding the numerals of the DEA number combined with the first letter of the physician’s last name (see Table 14.16).

Other Signs of Forgeries Wrong DEA numbers are not the only signs. Caution must be used when accepting prescriptions from out-of-state patients, especially at night or on weekends when the prescription authenticity cannot be proven by calling the prescribing office or prescriber. Some pharmacies fill controlled substances only for patients residing in their immediate geographical area and for prescribers who practice in their community and write their prescriptions with tamper-proof paper.

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Response to Potential Forgery If a forgery or drug-seeking behavior is suspected, retain the prescription (in case of forgery), try to detain the individual, and notify the police. To allow time to consult the pharmacist without offending the patient (who may not be guilty), simply say, “This prescription may take some time to fill. Can you come back in one hour?” Always keep the name and phone number of the local DEA agent handy. A new DEA-sponsored anonymous texting tip line may be also available in your area as it is being gradually implemented across the nation.

In addition, most pharmacists will usually make some sort of notation on the prescription to alert other pharmacists to a potential problem in filling the prescription. Many local pharmacies activate a “calling tree list” or email to alert other pharmacies of a potential problem prescription circulating in the community. If there is concern that the patient is abusing a legal prescription or receiving controlled substances from more than one prescriber or more than one pharmacy, the pharmacist has the professional responsibility to contact the prescriber.

The Right of Refusal

A pharmacist always has the right of refusal, declining with cause to fill any prescription, especially those for controlled substances. For example, it does not make sense to fill a narcotic prescription for severe pain three months after the date it was written; or a patient may request a three-month supply of a narcotic medication when only one month is covered by insurance and the patient is willing to pay with cash. The patient’s medication profile may also show numerous pain medications from different prescribers. The pharmacist often directs the technician to express concern for the patient but also state that the pharmacy does not have the prescribed drug or prescribed quantity in stock.

What if a prescriber orders an excessive amount of a narcotic that could do harm to a patient, and the prescriber verifies it? The pharmacist can still elect not to fill it and most likely should do so unless there are extenuating medical reasons that make sense. Perhaps the provider is not qualified in pain management but is writing prescriptions outside the scope of their practice. If that is the case, the prescription also should not be filled. However, if the diagnosis is cancer or the patient is under care of a hospice team or oncologist (cancer physician), the use of high-dose narcotics for comfort and pain relief is generally considered medically necessary.

Prescribers are becoming more aware of and proactive about preventing prescription drug abuse by discussing the drugs and their effects, checking the patient’s prescription data with other healthcare providers, and being more cautious about their prescribing.

State and Federal Efforts for Prevention

Most states have authorized their state drugs and narcotic agencies to establish a Prescription Drug Monitoring Program (PDMP) or a similar program to gather data for monitoring, tracking, and analyzing trends and sharing information on drug dispensing. As of 2019, 49 states had operational PDMPs. These data networking programs have been designed to offer healthcare professionals access to a regional multi-state database of prescription data. This access helps professionals:

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• share information and work together to make informed decisions about dispensing controlled substances and reducing abuse,

• improve the quality of health care by limiting the use of medications to proper treatment of pain and terminal illness, and

• reduce overprescribing and duplication in controlled substance prescriptions.

If you are presented with a suspicious prescription, you can ask the pharmacist to access the database to see if the patient is receiving controlled drugs from other pharmacies.

Pharmacy personnel should also be aware that each state has its own requirements and definitions for a “tamper-resistant” prescription (TRP). Consequently, a prescription for a Schedule II drug that was written out of state will probably not meet in-state requirements and thus can only be filled in the state in which it was written.

Prescribers and Pharmacists Work to Prevent Opioid Abuse

A 2015 Boston Medical Center study showed that over 90% of patients who nearly died of opioid overdose received a refill or new opioid prescription immediately afterwards. Part of the problem is that there has been no system to alert the physicians of the overdose.

In light of the public health epidemic of overprescribing opioid medications, the CDC published guidelines in 2016 for healthcare prescribers of these drugs for pain. The guidelines encourage prescribers to favor nondrug and non-opioid therapy, using opioid therapy as a last resort. There are 12 recommendations that focus on criteria for when and why to begin opioid therapy for chronic pain; guidelines on opioid selection, dosages, duration, follow-up, and situations for discontinuation; and methods to assess the risk and harm of opioid use for each patient. The guidelines include recommendations for how to ease patients off opioid therapies too. For the complete guidelines and background, visit: https://PharmPractice7e.ParadigmEducation.com/CDCGuidelines2019.

Prescribers are encouraged to use e-prescriptions for controlled substances instead of written ones. If using paper, they should carry their tamper-proof and other prescription pads with them or lock them in the drawers of the examination rooms. These measures prevent patients and other healthcare personnel from accessing blank prescriptions for illegal use. Prescribers are also encouraged to write out the numeral names of quantities so that 12 tablets of a narcotic cannot be altered by adding a zero, thus creating 120.

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It is illegal for a physician to write a prescription for a Schedule II drug for a family member, and it is considered unethical for a prescriber to write a Schedule III or IV prescription for themselves or a family member. Circumstances vary, and it will be up to the professional judgment of the pharmacist to fill or refuse to fill such a prescription. If a pharmacist or a technician has a prescription for a controlled substance, it should be filled by another pharmacist or technician. Professional drug abuse signs and responses are handled in the next chapter, Chapter 15.

The Complex Case of Medical Marijuana

As some states are legalizing marijuana, or cannabis, pharmacies are left in a strange zone. They cannot legally sell the drug (which is an illegal Schedule I controlled substance, according to the DEA), but in some states where it has been legalized for some or all uses, other vendors can sell within restrictions. Many state-legalized dispensaries are becoming marijuana medication therapy clinical offices, with patient education and high security. Yet the drug can interact with other medications, so ideally it should be overseen by a pharmacist and have a DUR to check interactions with other drugs.

The legalization of marijuana in some states has led to questions about how to address the need to check interactions with other medications, as federal law prohibits pharmacists from dispensing the drug.

How are states with legalized medical marijuana addressing this problem? Through its 2012 law legalizing medical cannabis, Connecticut requires that the medical marijuana dispensaries have a board-certified pharmacist on-site. As with other prescription drugs, the pharmacists (and technicians) must check the patient medication profiles before dispensing the marijuana medication. Patients and the physicians licensed to prescribe the drug count on the pharmacists for counsel on type, dosages, and drug interactions. Minnesota has followed Connecticut’s lead of involving pharmacists in its medical marijuana law. Pennsylvania requires either a pharmacist or a physician be on-site at a dispensary.

Connecticut’s pharmacy law that requires one pharmacist for every three technicians is the same for marijuana dispensaries. The medications come in prepackaged dosages from licensed state growers, and four of the first six state dispensaries have been owned by pharmacists. Medical marijuana was at first restricted to treat only eleven conditions: cancer, Parkinson’s disease, multiple sclerosis, spinal cord nerve damage, glaucoma, Crohn’s disease, epilepsy, post-traumatic stress disorder, wasting disease, HIV/AIDS, and cachexia. More conditions have been added. Each state has its own list of covered medical conditions.

Patients in Connecticut must have a physician’s diagnosis of a qualifying condition, and be registered with a medical marijuana card. No more than 2.5 ounces can be dispensed within 30 days. The medication comes in tablets, capsules, oils for vaporization and vape pens (personal oil vaporizing devices), topical creams and oils, strips that melt in the mouth, dried leaves and flowers for cooking or smoking (heat releases the active ingredients), and some consumable food products such as pastries with the medical dosage incorporated.

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