Technician Tutorial: Scheduled Drugs

Transcription

1 (Page 1 of 8) Technician Tutorial: Scheduled Drugs In the U.S., the federal Controlled Substances Act (CSA) regulates controlled substances. The U.S. Drug Enforcement Administration (DEA), which is a part of the U.S. Department of Justice, enforces the CSA. The CSA, in combination with individual state laws, dictates the specifics of the manufacturing, prescribing, and dispensing of controlled substances. In some cases, state laws are even more restrictive than federal laws. (The stricter laws always prevail.) The CSA designates five different schedules of controlled substances, Schedule I through Schedule V. Some drugs that are designated as controlled substances include opioids (e.g., codeine, morphine, oxycodone, etc), stimulants (e.g., amphetamine, methylphenidate, etc), and sedatives (e.g., barbiturates [phenobarbital, etc], benzodiazepines [alprazolam, diazepam, lorazepam, etc]). Factors that are considered when drugs are scheduled include abuse potential, history of abuse and current pattern of abuse, significance of abuse, and whether the substance is a precursor of another substance that is already scheduled. Schedule I controlled substances won t be seen in a pharmacy. These drugs have a high potential for abuse, lack data on safe use in humans, and have no currently accepted medical use. Heroin, for example, is a Schedule I controlled substance. This might seem odd, but it s important to remember that the CSA doesn t apply just to health care settings. The CSA was written for the purpose of general drug abuse prevention and control. Its application in health care is just one aspect. Drugs that are Schedule II through V are commonly prescribed and dispensed to patients. These drugs do have accepted medical uses. Schedule II drugs, often called C-IIs, have the highest potential for abuse and psychological dependence or addiction. Schedule V drugs have the lowest potential for abuse and addiction. Scheduled drugs will always have a large letter C on the label, with a Roman numeral designating the schedule. The schedule of a drug affects the way it can be prescribed, dispensed, stored in the pharmacy, and ordered from the wholesaler or manufacturer. In general, Schedule II drugs have the most stringent requirements. Here are some examples of scheduled drugs. A complete list can be found at Schedule II: cocaine codeine (single ingredient) fentanyl (Actiq, Duragesic, Fentora, etc) hydrocodone (Zohydro ER) hydrocodone combinations (Lortab, Vicodin, etc) hydromorphone (Dilaudid, etc) meperidine (Demerol) methadone (Dolophine, etc) methylphenidate (Concerta, Ritalin, etc) nabilone (Cesamet) opium tincture oxycodone products (OxyContin, Percocet, etc) Copyright 2013 by Therapeutic Research Center ~

2 (Page 2 of 8) Schedule III: acetaminophen/codeine (not more than 90 mg codeine per dosage unit) anabolic steroids buprenorphine (Buprenex, Butrans, etc) Schedule IV: alprazolam (Xanax) butorphanol (Stadol) carisoprodol (Soma) clonazepam (Klonopin) diazepam (Valium) eszopiclone (Lunesta) lorazepam (Ativan) modafinil (Provigil) tramadol (Ultram, etc) zaleplon (Sonata) zolpidem (Ambien) Schedule V: codeine combination products with no more than 200 mg of codeine per 100 ml (Robitussin AC) diphenoxylate combination products with no more than 2.5 mg of diphenoxylate and not less than 25 mcg of atropine sulfate per dosage unit (Lomotil) pregabalin (Lyrica) Note that some Schedule V drugs may not require a prescription in some states. However, they must be dispensed by a pharmacist because of DEA rules. Federal law restricts the sale of pseudoephedrine, since it s a precursor of methamphetamine. However, it s not scheduled in II-V according to federal law. In some states, pseudoephedrine is scheduled. Mr. Smith, a 65-year-old man who was diagnosed with bone cancer this year, brings in the following prescription: Copyright 2013 by Therapeutic Research Center ~

3 Copyright 2013 by Therapeutic Research Center ~ (Page 3 of 8) Mr. Smith has been getting oxycodone for a few months. This is the first time he s used Duragesic. This prescription is interpreted as Duragesic 25 mcg/h patch, apply one patch every three days. What are the requirements for prescriptions for Schedule II-V controlled substances? According to federal law, prescriptions for all controlled substances must include: Date of issue Patient s name and address Prescriber s name, address, and DEA registration number Drug name Drug strength Dosage form Quantity prescribed Directions for use Number of refills Schedule II prescriptions have the following additional restriction: No refills According to federal law, Schedule III through V prescriptions can be faxed, verbal, electronic, or written. This means, for example, a diazepam prescription can be faxed to the pharmacy by the prescriber. Or it can be called into the pharmacy or sent over electronically by the prescriber. But remember, state laws may have further restrictions for accepting and filling faxed, verbal, or electronic prescriptions for scheduled drugs. Schedule II prescriptions are different, and cannot be called in over the phone or faxed to the pharmacy in most cases. These prescriptions generally must be handwritten and signed by the prescriber, or electronically prescribed through a valid e-prescribing system. There are exceptions to this rule though. Federal law allows Schedule II prescriptions to be called into the pharmacy in an emergency situation. The prescription can only be for the amount of drug needed during the emergency period. The pharmacist must then obtain a written, signed prescription from the prescriber within seven days of their authorizing the emergency situation. Keep in mind this is another area where state laws may have further restrictions. In some cases, days supplies are limited or the original prescription must be received in three days instead of seven days. Federal law also allows Schedule II prescriptions to be faxed to the pharmacy by the prescriber s office under limited circumstances. For example, in order to expedite the filling of a prescription, a prescriber can fax a C-II prescription to the pharmacy. But before the pharmacist can dispense the med to the patient, the pharmacist must have the original, written Rx in hand. This way the pharmacist can verify the prescription first. Faxed C-II prescriptions are also allowed in long-term care facilities, and for certain hospice patients. In these cases, the faxed prescription is considered the original prescription. The pharmacy generally isn t required to obtain the original, written prescription. What is the significance of a prescriber s DEA number? How can pharmacists or technicians verify that a prescriber s DEA number is valid? A prescriber s Drug Enforcement Administration number, or DEA number, is assigned when the prescriber registers with the DEA. A DEA number is required to prescribe for controlled substances. The DEA number always has nine characters. The first two characters are letters, and the last seven are numbers. The first letter is always A, B, F, G, or M. (It might also be X if a prescriber is prescribing medications such as

4 (Page 4 of 8) buprenorphine for opioid addiction.) The second letter of the DEA number is the first letter of the prescriber s last name, although it may be different if the prescriber s last name has changed, such as if he or she married. You can verify that a DEA number is authentic by looking at the numbers. Here s how: Add the first, third, and fifth digits together. Add the second, fourth, and sixth digits together. Multiply the sum by 2. Add these two results together. The last digit on the right must match the last digit of the DEA number. For example, Dr. Blue s DEA number is AB To check: Add the first, third, and fifth digits together. ( = 10) Add the second, fourth, and sixth digits together. Multiply the sum by 2. ([ ] * 2 = 24) Add these two results together. The last digit on the right must match the last digit of the DEA number. ( = 34. The last number of Dr. Blue s DEA number is, in fact, 4. This DEA number checks out.) Keep in mind that pharmacies are also required to have a DEA number to dispense prescriptions for controlled substances. Insurance companies may request the pharmacy s DEA number for questions regarding payment for controlled substance prescriptions. It may also be required when a pharmacy transfers a controlled substance prescription to or from another pharmacy. The pharmacy DEA number is often found in an easily accessible location in the pharmacy, such as on a piece of paper taped to the computer monitor. What is the maximum days supply of a Schedule II drug that can be authorized per prescription? Federal law doesn t dictate the maximum days supply of a Schedule II drug that can be authorized per prescription. Nor does federal law dictate that a C-II prescription be filled within a certain amount of time after it was issued. Instead, this is determined by state law. Check with your state board of pharmacy for specific laws in your state. Can a prescriber provide a patient with more than one prescription for a Schedule II drug on the same day? For example, would it be acceptable for Dr. Blue to give Mr. Smith extra prescriptions to put on hold to be filled in future months? Federal law does allow a prescriber to write multiple C-II prescriptions, for the same drug, for an individual patient, on the same day. These prescriptions can be written for a total of 90 days supply. This is beneficial for stable patients, when the prescriber judges that there is not a need to see the patient on a more frequent basis. Each prescription must include the actual date that it was written, and the earliest date that it can be filled. If a state has stricter rules that prohibit this practice, the state rules prevail. It is important to consult the pharmacist about the appropriateness of multiple C-II prescriptions. This practice is most often used for patients on a maintenance dose of a Schedule II drug, such as a child on longterm therapy with stimulant medication for the treatment of attention deficit hyperactivity disorder. In this case, it would not be appropriate for Dr. Blue to write multiple Duragesic prescriptions for Mr. Smith since it s a new medication for Mr. Smith and his dose may still need to be adjusted. Can prescriptions for controlled substances be refilled? Per federal law, prescriptions for Schedule II drugs cannot be refilled. Prescriptions for Schedule III and IV drugs can include up to five refills, and can be refilled for up to six months after the date of issue. This is in comparison to noncontrolled substances, which can be refilled for up to one year from the date when the Copyright 2013 by Therapeutic Research Center ~

5 (Page 5 of 8) prescription is issued, depending on the state. Schedule V substances can be refilled as authorized by the prescriber according to federal law. What should you think about when dispensing controlled drugs? Legal requirements. Especially for C-IIs, there are restrictions on dispensing. Remember that a written prescription is required for C-IIs, and that refills for C-IIs are not allowed. Partial fills are another issue for C-IIs. Partial fills are allowed, but the remainder of drug must be dispensed within 72 hours. After 72 hours, the prescription is void. This is discussed in more detail in one of the following sections. Amount dispensed. Always follow your pharmacy s procedures for counting and documenting the number of tablets, capsules, etc. dispensed in a controlled substance prescription. For example, many pharmacies require pharmacists or technicians to double-count and initial controlled prescriptions to support inventory control. Pharmacies may back-count the bottle, or count the number of pills remaining in the stock bottle to verify it against existing inventory levels. These procedures can also help verify the amount dispensed if a discrepancy is later identified by the patient. Keep in mind that the role of the technician in preparing controlled substance prescriptions may vary depending on the practice and the supervising pharmacist. Check with your pharmacist if you are unsure about your role in handling controlled substances. Auxiliary labels. The majority of controlled substances (e.g., barbiturates [phenobarbital, etc], benzodiazepines [alprazolam, diazepam, lorazepam, etc], opioids [codeine, hydrocodone, morphine, etc]) will require an auxiliary label warning about drowsiness or sedation. However, drugs like amphetamine, methylphenidate, and modafinil are stimulants. These have the opposite effect, and will not require a label warning about sedation. Check with your pharmacist if you are unsure about auxiliary labeling requirements for a controlled prescription. Safe use and disposal. Some controlled substances, such as opioids, are considered high-risk medications. These drugs aren t necessarily more likely to be misused or to be involved in medication errors. However, they do have a relatively heightened risk of causing significant patient harm when they are used in error. Fentanyl patches have made headlines in recent years for causing deaths when misused. Improper disposal of some controlled substances can be dangerous. This is especially true when there is still active drug available, as with unused drugs, or with some used transdermal patches, and with partially used lozenges, like Actiq. The CSA does not allow controlled substances to be returned to a pharmacy for disposal. Instead, most should be flushed down the toilet, not placed in the trash where they could be retrieved by kids or pets. Fentanyl patches should be folded, with the sticky side stuck together, and then flushed. Use our PL Patient Education Handout, Medication Disposal Guide, to help inform patients and caregivers of steps to dispose of unused or partially used drugs. This is very important to avoid potentially disastrous consequences. As you are filling the prescription, you realize that there are only eight Duragesic patches available in your inventory. What are the options for filling Mr. Smith s prescription? Mr. Smith s prescription will require a partial fill. If only eight patches are dispensed, the prescription will become void if the remainder of the prescription isn t filled within 72 hours. If your pharmacy can either order or borrow the remaining two patches and receive them within 72 hours, Mr. Smith could get his full ten patches from your pharmacy with no other action necessary. If the patches can t be obtained by your pharmacy within 72 hours, the pharmacist could call the prescriber, another prescription could be written for the remaining two patches, and Mr. Smith or his caregiver could pick them Copyright 2013 by Therapeutic Research Center ~

6 Copyright 2013 by Therapeutic Research Center ~ (Page 6 of 8) up before he needs them. Alternately, the pharmacist might refer Mr. Smith to another pharmacy that has the full ten patches in stock. Keep in mind that there is an exception to the rule for partially filling a C-II. This applies to patients who are in a long-term care facility or who are terminally ill. Terminally ill or LTCF must be noted on face of the prescription. The date of the partial fill, the quantity dispensed, the remaining quantity to be dispensed, and the pharmacist s initials must be noted on the back of the prescription. Are there special procedures for ordering and storing controlled drugs? The CSA requires that Schedule II controlled substances are ordered using a special form called the DEA Form 222. It s available either as a paper form or electronically. The paper form is supplied in triplicate. The first and second copies are sent to the supplier, and the third copy is kept for pharmacy records. The second copy gets sent on to the DEA by the supplier. As each order arrives in the pharmacy, the pharmacy s copy of Form 222 should be pulled and the date and amount of drug received must be documented on that form. The form should be re-filed and saved for two years. Other scheduled drugs can be ordered through a supplier or wholesaler without a special form. Since prevention of drug abuse and diversion is the main reason for scheduling controlled substances, inventory control is extremely important. The idea behind storage requirements for controlled substances is to prevent theft and diversion. All controlled substances must be stored in a securely locked cabinet or dispersed throughout the pharmacy shelves with noncontrolled medications. Many pharmacies keep their C-IIs in a safe, a cabinet, or locked drawers. But don t be surprised if your pharmacy stores C-IIs on the pharmacy shelves with other meds. This is okay as long as your state law doesn t restrict this practice. The meds just shouldn t be in a section by themselves designated controlled meds or C-IIs without being locked up. The idea is to make it harder for a person trying to steal to find them. Many pharmacies store their Schedule III, IV, and V medications on pharmacy shelves with other noncontrolled meds. They don t have to be locked up. They can be stored alphabetically with other meds. The only requirement is that the area be secure. So it is important to keep the pharmacy doors locked and only allow pharmacy personnel in the pharmacy. All prescription and inventory records for C-II medications must be kept separately from all other pharmacy records. This means written prescriptions must be stored separately from other controlled substance and noncontrolled substance prescriptions. The same goes for electronic prescriptions, DEA 222 forms, and biennial inventory reports for C-II medications. Prescription records for Schedule III, IV, and V drugs must be kept either separately from C-II and noncontrolled substance records, or together with noncontrolled substance records. But the catch is that these records must be readily retrievable if the pharmacy is audited by DEA. These rules apply to electronic prescriptions, as well as inventory and order records. Some pharmacies will have three separate files for prescription records: one for C-II prescriptions; one for Schedule III, IV, and V prescriptions; and one for noncontrolled prescriptions. They ll also do this for their orders and inventories. It helps keep everything separate and easily retrievable if audited by the DEA. The DEA requires that pharmacies hold onto prescription and order records for at least two years. This is the same amount of time that is required for controlled substance inventory records. Many states or employers require you to hold on to them for longer.

7 (Page 7 of 8) What should I do if there is a discrepancy in the count of a controlled substance? If there s a discrepancy between the amount of drug you should have and the amount of drug you actually have, steps must be taken to resolve the discrepancy. Double-checking arithmetic and comparing dispensing records and orders received to check for omissions or duplications in the inventory record are steps that can be taken to resolve discrepancies. How should controlled substances be disposed of in the pharmacy? There may be circumstances when a controlled substance needs to be destroyed and disposed of at the pharmacy level. You ll see this frequently if you work in a hospital. Many times the full dose of a controlled substance is not given to a patient. In these cases, technicians may be asked to witness the disposal of the remainder of the dose. This process is called wasting and typically requires two signatures, the one destroying the medication and the witness. Many hospitals are given a blanket approval from the DEA for regular, periodic destruction. Community pharmacies are also allowed to destroy controlled substances at the pharmacy level. However, they must request permission from DEA before destroying controlled substances. The pharmacy is required to submit a DEA Form 41 to document the destruction. How can I identify a forged prescription? Most forged prescriptions are for C-IIs, although patients may forge prescriptions for other controlled or noncontrolled substances. If you notice something fishy about a prescription, alert the pharmacist discreetly and immediately. Here are some things to watch out for: Altered quantity to dispense Prescriptions that are written on stolen or photocopied prescription forms, or on prescription forms from hospitals that don t have a physician s name on them Prescriptions that are from other cities or other states Altered DEA number, or a DEA number that is not authentic Prescriptions with a textbook appearance Prescriptions that are out of the ordinary, such as those with no abbreviations, different inks or writing, odd days supply, etc. Prescriptions with excessive quantities, doses, or directions Depending on the situation and on pharmacy policy, the pharmacist might take a number of actions, such as contacting the prescriber to verify the prescription or returning the prescription to the patient. Keep in mind that this can be a very serious situation, and that the patient might become angry and volatile. Talk to your pharmacist if you are unsure about how to handle this type of situation in your pharmacy. Also, find out if you are able to access your state s prescription drug monitoring program, and when this would be appropriate. What are some considerations about controlled drugs in the hospital setting? Some of the concerns in the community setting, like appropriate number of refills, getting a written prescription for all C-IIs, etc. aren t issues for hospital inpatients. Here are some things for technicians to consider that are specific to hospital practice: When controlled drugs are kept on a patient care unit, they must be stored in a secure, locked place. Often, an automated dispensing machine, like Pyxis, is used for this purpose. When you re delivering controlled drugs to a patient care unit, be sure to never leave them unattended on a cart in an elevator or hallway. Copyright 2013 by Therapeutic Research Center ~

8 (Page 8 of 8) Since each patient care unit is likely to have its own inventory of controlled substances, discrepancies in the counts can occur from time to time. It is important to resolve these discrepancies as soon as they are discovered. Know your pharmacy s procedure for resolving and reporting discrepancies. If you are delivering a controlled drug directly to a nurse, it s likely that he or she will need to sign for it. Know your pharmacy s procedure for this. In general, controlled substances should not be sent to patient care units via pneumatic tube system. Since the full dose of a controlled substance might not always be given to a patient, you may be asked to witness the disposal of the remainder of the dose. This is called wasting and typically requires a double signature. If an automated dispensing system is used, you will have to enter your username and password instead. Injectable opioids are considered high-risk drugs, so they may require special auxiliary labels. Know your pharmacy s policy for this. Cite this document as follows: PL Technician Tutorial, Scheduled Drugs. Pharmacist s Letter/Pharmacy Technician s Letter. December Copyright 2013 by Therapeutic Research Center ~

9 (Page 1 of 7) Technician Tutorial: Safety Considerations With Opioids Deaths from opioid overdoses were five times higher in 2016 compared to The opioid epidemic has been declared a public health emergency in the U.S and is considered a national public health crisis in Canada. Opioid prescription meds include codeine, hydrocodone, morphine, fentanyl, oxycodone, etc. As a class, they re considered to be high-alert. The reason certain medications are designated as high-alert is because patients are more likely to experience serious harm if there s an error. There is also a risk of serious harm when patients misuse opioids. Misuse refers to using a medication in a way that s different from what was prescribed. Examples of misuse include using a prescription medication without having a prescription for it, using a higher dose of a medication than prescribed, etc. Patients who take doses of opioids that are too high may experience a reduced level of alertness, increased sedation, and respiratory depression (i.e., dangerously slowed breathing which can result in death). These side effects are also possible in patients with certain conditions (e.g., asthma or kidney disease) who take normal doses of opioids. In many cases, deaths caused by opioids are accidental. It s important that patients understand how to safely use their opioids to prevent accidental injury or death from occurring. This technician tutorial provides important information to help you improve patient safety with opioids. Mary Jones is a 55-year-old female patient. She was discharged from the hospital yesterday after having surgery the day before. Her husband Ed comes in with her new prescription for fentanyl 25 mcg/hr patch. You tell him the wait will be about 30 minutes, and he says, No problem. He needed to grab a few items from the pharmacy anyway. What types of safety issues can occur with opioid prescriptions? Drug allergies. It s not uncommon to hear patients report allergies to opioids, but less than 2% of opioid reactions are true allergies. For example, opioids can cause upset stomach, nausea, vomiting, etc, which a patient might report as an allergy. But these are really side effects or intolerances. Be aware that some opioids, such as codeine and morphine, cause reactions that mimic allergies, referred to as a pseudoallergy (i.e., they cause the release of a substance in the body called histamine, which can lead to skin reactions such as flushing, itching, and hives). Use our chart, Opioid Allergy, for more examples of the different symptoms patients may report as allergies. If a patient reports an allergy to codeine, morphine, oxycodone, etc, ask about the specific reaction, including when it happened. Double check with the pharmacist to find out if the reaction should be entered into the computer system as an allergy, or noted as an intolerance. You don t want a patient to get a drug that he or she is allergic to, but you also don t want a drug to be unnecessarily avoided if it would truly help the patient. Drug interactions. There are a number of important drug interactions with opioids. If a patient takes other meds that cause sedation such as a benzodiazepine (alprazolam [Xanax], diazepam [Valium], etc), sleep aid (zolpidem [Ambien (U.S.), Sublinox (Canada), etc], eszopiclone [Lunesta (U.S.)], diphenhydramine, etc), or even alcohol, this can increase the risk for respiratory depression with opioids. Always get the pharmacist involved if you notice that a patient is taking both an opioid and a benzodiazepine. In the U.S., opioids have Copyright 2018 by Therapeutic Research Center PharmacistsLetter.com ~ PharmacyTechniciansLetter.com

10 (Page 2 of 7) a black box warning about the risk of respiratory depression, coma, and death when they are taken with benzodiazepines. Methadone (Dolophine [U.S.], Methadose, Metadol [Canada]) is a good example to watch out for because it interacts with a lot of medications. Drugs such as amiodarone (Cordarone [U.S.]) and erythromycin, when taken with methadone, can increase the risk for dangerous irregular heartbeats. Certain drugs, such as fluoxetine (Prozac), fluvoxamine (Luvox), and fluconazole (Diflucan) can slow the elimination of methadone from the body. This can cause a buildup of methadone, which could lead to oversedation, slow breathing, etc. The black box warning in the U.S. labeling for extended-release oxycodone (OxyContin) points out similar types of drug interactions for oxycodone. When a drug such as clarithromycin (Biaxin), ketoconazole, or ritonavir (Norvir) is used by a patient who is also taking oxycodone, blood levels of oxycodone can increase and cause severe adverse effects. Other opioids that might be affected by these types of drug interactions include fentanyl (Duragesic), hydrocodone (e.g., Zohydro ER [U.S.]), and tramadol (Ultram). If you get a drug interaction alert with an opioid, don t bypass it. Make sure to let the pharmacist know because these interactions can lead to very serious problems. Doses that are too high. Since opioids can cause serious side effects, like sedation and slow breathing, it s important that patients who have not taken an opioid recently are started out on the lowest dose possible. This way they can build up tolerance to the side effects as the dose is increased to better control their pain. When patients are started on doses that are too high, there s a chance that they will become too sedated and their breathing can be affected. Get the pharmacist involved anytime your dispensing system flags dose too high with opioid prescriptions. Improper dosing intervals. Many opioids come in an extended-release (long-acting) form. Some examples include the morphine formulation Kadian, and the oxycodone formulation OxyContin in the U.S. or OxyNEO in Canada. Extended-release opioids are usually given either once or twice daily. Fentanyl patches are a long-acting transdermal formulation that should be used once every 72 hours in most patients. If you see one of these formulations dosed more frequently (e.g., Q8H, Q6H, Q4H, or PRN) or in the case of fentanyl patches more frequently than every 72 hours, alert the pharmacist. This could be an error and could put the patient at risk for an overdose. Inappropriate use of certain drugs and/or dosage forms. Some opioids are very potent, meaning that a small dose can have very strong effects. Potent opioids should only be used in patients who have already been taking opioids. These opioid-experienced patients have built a tolerance to the opioid side effects. Examples of opioids that should only be used in patients who have been taking opioids are long-acting opioids, including formulations such as extended-release or controlled-release, and all dosage forms of fentanyl or methadone. A patient who has not been on an opioid (also called opioid-naive) and who is then given a potent opioid is at high risk of becoming oversedated and having breathing problems. This is very dangerous for outpatients who may not have someone around to check on them. Starting a patient with an immediate-release (short-acting) opioid instead of a long-acting form is best. Starting with a short-acting opioid makes it easier and safer to find the appropriate dose that will control the patient s pain. In fact, the U.S. Food and Drug Administration (FDA) has mandated that labeling for long-acting opioids include a warning saying that these products should only be used when other options, such as non-opioids or short-acting opioids, don t provide adequate pain relief. Copyright 2018 by Therapeutic Research Center PharmacistsLetter.com ~ PharmacyTechniciansLetter.com

11 (Page 3 of 7) Multiple prescriptions with the same or similar ingredient. Patients will sometimes be prescribed more than one opioid formulation. When this is the case, there will usually be a prescription for a maintenance dose that is given around-the-clock, such as OxyContin 40 mg Q12H. There might also be a prescription for PRN use, for when the patient has breakthrough pain (i.e., pain that occurs before the next scheduled maintenance dose is due). An example of this would be oxycodone immediate-release 10 mg Q4H PRN. However, it is important to watch for inappropriate duplications from multiple products with the same or similar ingredients. If you get a refill too soon or therapeutic duplication flag with an opioid, let the pharmacist know. He or she may need to put in an override for patients who are appropriately getting more than one dosage form. Or the pharmacist may need to address an actual duplication that is inappropriate. In the hospital, it s also important to keep an eye out for opioids being given by different routes. For example, a patient getting an epidural infusion that contains an opioid such as fentanyl or an intravenous infusion of an opioid such as morphine or hydromorphone. Alert the pharmacist if you see additional orders for intravenous or oral opioids so that the appropriateness of the orders can be double checked. A lot of opioids come in combinations with acetaminophen such as hydrocodone/acetaminophen (e.g., Norco [U.S.]), oxycodone/acetaminophen (Percocet), or codeine/acetaminophen (Tylenol #3). It s a good idea to make sure patients aren t getting too much acetaminophen from these products, or from multiple sources of acetaminophen. In the U.S., the amount of acetaminophen per dosage unit (e.g., capsule, tablet, oral liquid) in prescription combo products is now capped at 325 mg. Most adult patients shouldn t get more than 4,000 mg of acetaminophen per day. Alert the pharmacist if you notice a situation where a patient could potentially get more than 4,000 mg of acetaminophen per day. Questionable prescriptions. As mentioned, deaths from opioid overdoses have increased substantially over the past two decades. This is in part due to misuse of opioids, such as diversion. It s important to watch for red flags that might indicate a prescription is inappropriate. However, it s also important to keep in mind that many patients do use opioids appropriately to control pain, and that red flags aren t absolute indicators of inappropriate prescriptions. Let the pharmacist know if you see any of the following red flags, so he or she can investigate further: Patients who ask to pay cash for controlled substances Patients who demand certain brands Patients with frequent prescriptions or prescriptions for large quantities Patients who aren t local, or bring in prescriptions from prescribers who aren t local Patients who are prescriber or pharmacy shoppers Prescriptions that are incomplete Prescriptions that could potentially be altered or forged (e.g., different inks or handwriting used, a too perfect appearance, etc) Additional examples of potential red flags can be found in our clinical resource, Red Flags : Tips for Appropriate Dispensing of Controlled Substances, and our continuing education course, The Technician s Role in Opioid Management in the Community Pharmacy Setting. The pharmacist will likely take steps such as contacting the prescriber, checking your state s prescription drug monitoring program (or provincial prescription or narcotic monitoring system in Canada), asking for the patient s identification, validating the prescriber s DEA number (or license number in Canada), etc. Remember to be discreet when these situations occur. You don t want to make a patient who has a legitimate prescription for a legitimate reason feel embarrassed or self-conscious. You notice Mrs. Jones has never had a prescription for an opioid filled at your pharmacy. You are not sure if or for how long she received an opioid during her hospital stay. You know that fentanyl is a potent, longacting opioid that is dangerous to use in patients who haven t been taking opioids already. You bring this to Copyright 2018 by Therapeutic Research Center PharmacistsLetter.com ~ PharmacyTechniciansLetter.com

12 (Page 4 of 7) the attention to the pharmacist who calls Mr. Jones back to the pharmacy to ask some questions. Mr. Jones is able to tell the pharmacist that he thinks his wife received one or two doses of morphine after her surgery. The pharmacist tells Mr. Jones that she needs to call the prescriber to discuss the prescription. She explains that she s concerned this medication may be too strong for Mrs. Jones. What should I do to prevent errors and ensure patient safety when dispensing opioids? Choose the right drug and dosage form. Be very careful when you select a drug on the computer screen. There is a number of look-alike/sound-alikes, such as oxymorphone (U.S.) and oxycodone, hydromorphone and hydrocodone, etc. Plus, as mentioned before, many opioids come in both an immediate-release and a controlled-release form, such as hydromorphone immediate-release and the extended-release version, Exalgo [U.S.] or Jurnista [Canada]. It s easy for mix-ups to happen. Pay special attention to prevent them. Choose the right dose. This is especially applicable for liquid dosage forms. Some opioids, such as morphine oral liquid, come in different concentrations. In the U.S., morphine oral liquid is available in concentrations of 20 mg/5 ml, 10 mg/5 ml, and 20 mg/ml. In Canada, it comes in even more strengths, and as high as 50 mg/ml. Methadone oral liquid comes as 1 mg/ml, 2 mg/ml (U.S. only), and 10 mg/ml. Mix-ups with these could lead to serious patient harm. Watch for confusion between mg and ml. If the dose is given in ml on a prescription, make sure the prescription also notes the concentration that you need to dispense. If not, ask the pharmacist to get clarification. If the handwriting on a prescription makes it hard to tell if the dose is given in mg or in ml, also have the pharmacist clarify. Ensure prescriptions have clear directions for use. Make sure the directions for use are very clear on the prescription label, so the patient doesn t get confused and take too much or too little of the drug. Talk with your pharmacist about including metric units on prescription labels. For example, saying Take 5 ml or Take 1 teaspoonful (5 ml), so the patient knows exactly how much to measure. If the product doesn t already come with a measuring device, provide a dosing cup or oral syringe with liquids to help patients measure an accurate dose. When dispensing measuring devices, ensure the dosing units on the prescription label match the dosing units on the device. Watch for payer or pharmacy system messaging. Some U.S. payers and state laws may restrict first-time opioids, such as limiting to a three- to ten-day supply or capping doses. Follow your state laws and pharmacy policies when filling opioid prescriptions. For example, if an opioid is written for a 30 days supply but you can only fill a seven days supply, don t adjust the quantity without talking to the pharmacist. The prescriber and the patient may need to be notified of the change, and the dispensed quantity documented. Don t automatically switch an opioid prescription to cash if it exceeds payer limits. Instead get the pharmacist involved to help explain the reasons for the restrictions. The pharmacist may also suggest a different pain med, such as an NSAID (ibuprofen, etc), acetaminophen, or both. Prior authorizations may be required by some payers for longer durations or higher doses of opioids that certain patients may legitimately need. U.S. subscribers can use our prescriber fax letter the help expedite the process. Apply appropriate auxiliary labels. Always include a label to let the patient know that his or her opioid prescription can cause drowsiness. If possible, a warning to avoid drinking alcohol should also be included. Alcohol can increase the risk for sedation with opioids, but it can also cause dangerously high blood levels of some controlled-release opioids. Include a label reminding the patient not to crush or chew an extended-release opioid, and a label to avoid grapefruit with methadone. Also, be sure to include a label warning that an opioid must be kept out of reach of children. In the hospital, you ll want to make sure that opioids have labels showing that they are high-alert drugs. Do this according to your pharmacy s policy. Copyright 2018 by Therapeutic Research Center PharmacistsLetter.com ~ PharmacyTechniciansLetter.com

13 Copyright 2018 by Therapeutic Research Center PharmacistsLetter.com ~ PharmacyTechniciansLetter.com (Page 5 of 7) Provide safety, disposal, and storage information. In the U.S., to ensure you are following Risk Evaluation Mitigation Strategy (REMS) program requirements for opioids, provide a Medication Guide (MedGuide) when dispensing them. A MedGuide helps educate patients on the risks associated with opioids. Remember that for outpatients, these MedGuides must be dispensed the first time you fill a prescription for an opioid and with every refill as well. MedGuides are currently only required for longacting opioids, but it s expected that FDA will begin requiring these for immediate-release opioids in the near future. In Canada, starting in October 2018, a warning sticker and patient handout will be required for all prescription opioids. The warning sticker will state that opioids can cause dependence, addiction, and overdose. The patient handout contains broader information about warnings, possible side effects, signs of overdose, etc. Proper disposal of opioids is very important for keeping them away from others, especially children and pets. The best option is for the patient to bring these to a take-back program. Otherwise, it s generally best not to put these types of meds in household trash and to follow the FDA s recommendation of flushing them down the toilet instead. (Note that flushing of meds is not recommended by Health Canada. In Canada, take-back programs are more readily available.) A discarded fentanyl patch, for example, might still contain enough drug to seriously harm or even cause the death of a child or small animal. When fentanyl patches are discarded, they should be folded in half, so the sticky side sticks together, and then flushed down the toilet. A partially used dose of Actiq (oral transmucosal fentanyl citrate [U.S.]) might look like a lollipop, which could be tempting for children. These should be run under hot water until the drug is completely dissolved, and then the empty plastic stick should be thrown in the garbage, out of reach of children and pets. We have a handout for U.S. patients with more information on disposing medications, Medication Disposal Guide. Patients who take opioids are at high risk of having them stolen, even by family members or friends. It s a good idea for patients to keep these prescriptions out of view and reach of others, and not to advertise to anyone that they are taking these meds. It is unfortunate, but opioids are worth a lot of money on the street, which might make them a tempting item for an individual with less than honorable intentions. The prescriber is able to send over an e-prescription for immediate-release morphine oral liquid. The prescription comes over as morphine oral soln 10 mg/5 ml, 1 tsp po Q6H x 10 days. As you are entering Mrs. Jones new prescription, you look for the morphine liquid in the computer system. You notice there are 10 mg/5 ml, 20 mg/ml, and 20 mg/5 ml concentrations. You make sure to select the correct concentration of 10 mg/5 ml. Your pharmacist prefers that you include metric units when entering instructions for oral liquid prescriptions, so the directions you input say, Take 1 teaspoonful (5 ml) by mouth every six hours for ten days. You also prepare to provide the patient with an oral syringe that holds up to 5 ml. How else can I get involved to promote opioid safety? Streamline the process for dispensing naloxone (Narcan, Evzio [U.S.], S.O.S [Canada], etc). Opioid overdose can happen to anyone. Even the most careful patient can forget if a dose was taken and accidentally take more. Help patients think of naloxone like a seat belt. Most people won t need it, but it s there if they ever do and can save lives. All states and provinces/territories have a way for pharmacists to provide naloxone directly to patients, so don t be surprised to hear patients asking for OTC naloxone. Work with your pharmacist to identify patients who need naloxone. For example, look for patients taking high opioid doses, such as 50 mg/day or more of oral morphine or a fentanyl 25 mcg/hr patch. Also watch for opioid patients who have COPD or asthma or who also use benzodiazepines (lorazepam, etc) or sleep meds (zolpidem, etc). These factors may increase the risk of dangerously slow breathing. Send patients and caregivers getting naloxone to the pharmacist for counseling on proper administration and for an overdose action plan. And point out expiration dates on naloxone products. Suggest patients check

14 (Page 6 of 7) these regularly since products may expire before they re needed. Be sure to stay on top of naloxone inventory as well. Naloxone can t be helpful for patients if your pharmacy doesn t keep it in stock. To learn more about naloxone, check out our chart, Naloxone for Opioid Overdose (FAQs). Dispense medications used to treat opioid use disorder correctly. Patients who develop opioid use disorder, defined as a problematic pattern of opioid use leading to impairment or distress, often require treatment with prescription medications. Medications typically used to treat opioid use disorder include buprenorphine/naloxone (Bunavail [U.S.], Suboxone, Zubsolv [U.S.], etc) or naltrexone (ReVia, Vivitrol [U.S.], etc). These drugs also bind to opioid receptors in the body. However, they compete with opioids and displace them from binding to receptors, blocking their effects. This can lead to withdrawal symptoms such as agitation, anxiety, chills, diarrhea, difficulty sleeping, increased heart rate, nausea, or sweating. You may see medications, such as clonidine or lofexidine (Lucemyra [U.S.]), prescribed for short-term use (less than ten to 14 days) along with meds for opioid use disorder to help manage these symptoms. Keep in mind that buprenorphine/naloxone products are considered controlled substances in both the U.S. (Schedule III) and Canada (Schedule I), so dispensing restrictions will apply. In the U.S., make sure buprenorphine/naloxone prescriptions for opioid dependence have the special X DEA number. It s required by U.S. federal law when used to treat opioid use disorder. In Canada, check with your provincial licensing body for buprenorphine/naloxone prescribing requirements. Double check dosage forms and strengths. Zubsolv comes in 0.7 mg, 1.4 mg, 2.9 mg, 5.7 mg, 8.6 mg, and 11.4 mg sublingual tabs; generic buprenorphine/naloxone sublingual tabs come in 2 mg and 8 mg tabs; Suboxone sublingual films come in 2 mg, 4 mg, 8 mg, and 12 mg; and Bunavail buccal films are available as 2.1 mg, 4.2 mg, and 6.3 mg. In addition, naltrexone is available as both a monthly IM injection (Vivitrol) and a daily oral tablet (ReVia), so be sure to select the right product. Ensure the administration instructions match the dosage form. For example, enter Place one tablet under the tongue once daily instead of Take one tablet by mouth once daily on prescriptions for sublingual tabs. Swallowing them may reduce or delay drug effects. Anticipate dosage changes, especially when patients are starting on buprenorphine-containing products. Many will start on 4 mg of buprenorphine, increasing by 4 mg as needed to avoid withdrawal symptoms. Expect most patients to get around 16 mg of buprenorphine a day. Taking doses higher than 24 mg increases the chance of developing serious breathing problems and other side effects without much added benefit. Watch for patients getting buprenorphine/naloxone or naltrexone who are also using opioids and get the pharmacist involved. For example, patients must be opioid-free for seven to ten days before starting naltrexone since it can cause withdrawal if the patient is still opioid-dependent. Keep in mind that methadone can also be used to treat opioid use disorder. However, in the U.S. it can only be dispensed for this purpose in specially licensed facilities. When methadone is used for pain, it can be dispensed in retail pharmacies. Confirm with your pharmacist if you ever have a question about the intended use of a methadone prescription. Project Leader in preparation of this technician tutorial (340980): Flora Harp, PharmD/Assistant Editor Cite this document as follows: Technician Tutorial, Safety Considerations With Opioids. Pharmacist s Letter/Pharmacy Technician s Letter. September Please continue to the next page for a Cheat Sheet on opioid safety Copyright 2018 by Therapeutic Research Center PharmacistsLetter.com ~ PharmacyTechniciansLetter.com

15 (Page 7 of 7) Cheat Sheet for Safety Considerations With Opioids Why is it so important to focus on safety with opioids? Deaths due to opioid overdoses have increased five-fold between 1999 and The opioid epidemic has been declared a public health emergency in the U.S. and is a national public health crisis in Canada. In addition, prescription opioids (codeine, hydrocodone, fentanyl, morphine, oxycodone, etc) are considered high-alert drugs. This means that the chance a patient will be seriously harmed if there s an error is higher than with other meds that aren t considered high-alert. What should I watch for when filling prescriptions for opioids? Dosage forms be sure to select the correct form; alert the pharmacist if an opioid-naïve patient is prescribed a long-acting opioid Doses watch for high doses and keep in mind patients should start at low doses and gradually increase as needed; pay close attention and choose the correct dose with oral liquid dosage forms Dosing intervals question long-acting opioids dosed more frequently than once or twice daily Drug allergies ask about reactions to differentiate true allergy from pseudoallergy or side effects Drug interactions don t bypass drug interaction alerts, get the pharmacist involved Multiple Rxs with same ingredient watch for refill too soon or therapeutic duplication flags; watch for duplication of acetaminophen in opioid combination products Questionable Rxs get the pharmacist involved if you identify any red flags Unclear directions for use make sure directions for use are very clear on the Rx label How can I ensure patients have important safety information when dispensing opioids? Provide required safety information to educate patients on opioid risks Give information on medication disposal Remind patients to store their Rxs out of view and reach of others What is naloxone and how can I help streamline the process for dispensing it? Naloxone (Narcan, Evzio, etc) helps save lives by reversing the dangerous side effects experienced during an opioid overdose. All states and provinces/territories have a way for pharmacists to provide naloxone directly to patients. Pharmacy technicians can help pharmacists identify patients who need naloxone, maintain naloxone inventory, and remind patients to check expiration dates on naloxone products. How can I help prevent errors in patients being treated for opioid use disorder? Opioid use disorder (problematic pattern of opioid use leading to impairment or distress) can be treated with buprenorphine/naloxone (Bunavail [U.S.], Suboxone, Zubsolv [U.S.], etc) or naltrexone (ReVia, Vivitrol [U.S.], etc). Pharmacy technicians can help prevent errors with these meds by: Anticipating dose changes for buprenorphine/naloxone products especially when patients are starting therapy Double checking strengths buprenorphine/naloxone products come in multiple strengths Ensuring administration instructions match the dosage form Following applicable controlled substances laws for buprenorphine/naloxone Schedule III in the U.S.; Schedule 1 in Canada Looking for X DEA number for buprenorphine/naloxone Rxs filled in the U.S. Selecting the right dosage form buprenorphine/naloxone comes in sublingual tablets, sublingual films (U.S.), and buccal films (U.S.); naltrexone comes as an injection and an oral tablet Watching for patients still using opioids patients should ideally be opioid-free [September 2018; ] Copyright 2018 by Therapeutic Research Center PharmacistsLetter.com ~ PharmacyTechniciansLetter.com

16 (PL Detail-Document #300842) Red Flags : Tips for Appropriate Dispensing of Controlled Substances As the last line of defense in preventing drug abuse and diversion, pharmacists have a corresponding responsibility when dispensing controlled substances. Pharmacists, along with prescribers, have a responsibility to ensure that controlled substances and other potentially abused medications are prescribed and dispensed for a legitimate medical purpose in the usual course of the practitioner s professional practice. Follow your pharmacy s policies and continue to watch for red flags when filling controlled substance prescriptions. Red flags aren t stop signs, but they raise questions about the validity of a prescription that require investigation and resolution. Here are some examples of red flags to consider: Prescriber writes significantly more controlled substance Rxs, or in larger quantities, than others in the area Multiple patients appear within a short time, with similar Rxs from the same prescriber People who aren t regular patients show up with Rxs from the same prescriber Prescriber writes Rxs for conditions not consistent with their specialty (e.g., dentist writing ADHD Rxs) Prescriber writes for antagonistic combinations of drugs, such as depressants and stimulants Drug cocktails that might indicate abuse, such as the combo of an opioid, benzodiazepine, and muscle relaxant Non-local prescribers or patients Doctor or pharmacy shoppers Patient presents Rxs written for other people Patient pays cash only for controlled substances Patient requests Rxs early Patient has unusual behavior or an assertive personality Patient has unusual knowledge of controlled substances or uses street slang Patient demands certain brands or generics of controlled substances Patient has unusual appearance (either unkempt or over-dressed) Patient has signs of drug abuse such as skin tracks or scars on neck, arms, and feet or ankles Altered or forged prescriptions, such as: o Rx looks too good or textbook o Quantities, directions, or doses that differ from usual medical use o Directions are written in full with no abbreviations, or not using standard abbreviations o Rx appears photocopied, or is written in different color inks or different handwriting Knowingly filling an illegitimate prescription is in violation of federal and state controlled substance laws. Use your professional judgment when determining the legitimacy of a controlled substance Rx. For more tips on identifying and addressing potential red flags in your pharmacy, here are just a few resources available from Pharmacist s Letter and Pharmacy Technician s Letter: PL CEs, o Controlled Substances: Keeping Patients Safe and Preventing Diversion (pharmacists only) o o Stemming the Tide: Stopping Prescription Opioid Diversion (pharmacists only) Managing Opioids in the Community Pharmacy Setting: Balancing Risks and Benefits (Pharmacists)(Technicians) Technician Tutorials, o Scheduled Drugs o Safety Considerations with Opioids Additional resources used for the preparation of this document include: 1. U.S. Department of Justice Drug Enforcement Administration. Pharmacist s guide to prescription fraud. Pharmacist s Manual. Appendix D. appdx_d.htm. (Accessed July 25, 2014). 2. U.S. Department of Justice Drug Enforcement Administration. Don t be scammed by a drug abuser. December (Accessed July 25, 2014). Copyright 2014 by Therapeutic Research Center ~