Course Content
Introduction
The American Society of Health-System Pharmacists (ASHP) believes that pharmacists have the unique knowledge, skills, and responsibilities for assuming an important role in substance abuse prevention, education, and assistance. Pharmacists, as healthcare providers, should be actively involved in reducing the negative effects that substance abuse has on society, health systems, and the pharmacy profession.
Pharmacists hold the key to the nation’s drug supply. One of the most important responsibilities of pharmacists is to assure that patients who need their medications receive them. At the same time pharmacy, in general, must be actively involved in assuring that persons who would divert and/or abuse medications are denied access to them. In recent years, the challenge of prescription drug abuse prevention has at times led to pharmacy practices that over-emphasize restrictions on access to medications, making it difficult for patients who truly need them to get them. Pharmacists can protect the public from harm due to prescription drug abuse, while at the same time providing necessary medications for patients whose medical conditions require their use.
Prescription Painkiller Overdoses in the U.S.
Overdose deaths from prescription painkillers have skyrocketed during the past decade. The number of overdose deaths is now greater than those of deaths from heroin and cocaine combined. A big part of the problem is nonmedical use of prescription painkillers using drugs without a prescription, or using drugs just for the “high” they cause. In 2010, about 12 million Americans (age 12 or older) reported nonmedical use of prescription painkillers in the past year.
Enough prescription painkillers were prescribed in 2010 to medicate every American adult around-the-clock for a month. Although most of these pills were prescribed for a medical purpose, many ended up in the hands of people who misused or abused them.
Improving the way prescription painkillers are prescribed can reduce the number of people who misuse, abuse or overdose from these powerful drugs, while making sure patients have access to safe, effective treatment.
Prescription painkiller overdoses are a public health epidemic.
Prescription painkiller overdoses killed nearly 15,000 people in the US in 2008. This is more than 3 times the 4,000 people killed by these drugs in 1999.
In 2010, about 12 million Americans (age 12 or older) reported nonmedical use of prescription painkillers in the past year.
Nearly half a million emergency department visits in 2009 were due to people misusing or abusing prescription painkillers.
Nonmedical use of prescription painkillers costs health insurers up to $72.5 billion annually in direct health care costs.
Certain groups are more likely to abuse or overdose on prescription painkillers.
Many more men than women die of overdoses from prescription painkillers.
Middle-aged adults have the highest prescription painkiller overdose rates.
People in rural counties are nearly twice as likely to overdose on prescription painkillers as people in big cities.
Whites and American Indian or Alaska Natives are more likely to overdose on prescription painkillers
About 1 in 10 American Indian or Alaska Natives aged 12 or older used prescription painkillers for nonmedical reasons in the past year, compared to 1 in 20 whites and 1 in 30 blacks.
The supply of prescription painkillers is larger than ever.
The quantity of prescription painkillers sold to pharmacies, hospitals, and doctors’ offices was 4 times larger in 2010 than in 1999.
Many states report problems with “pill mills” where doctors prescribe large quantities of painkillers to people who don’t need them medically. Some people also obtain prescriptions from multiple prescribers by “doctor shopping.“
Some states have a bigger problem with prescription painkillers than others.
Prescription painkiller sales per person were more than 3 times higher in Florida, which has the highest rate, than in Illinois, which has the lowest.
In 2008/2009, nonmedical use of painkillers in the past year ranged from 1 in 12 people (age 12 or older) in Oklahoma to 1 in 30 in Nebraska.
States with higher sales per person and more nonmedical use of prescription painkillers tend to have more deaths from drug overdoses.
In 2016, there were 2,798 opioid-related overdose deaths in Florida – a rate of 14.4 deaths per 100,000 persons – compared to the national rate of 13.3 deaths per 100,000 persons. In the past several years, Florida has seen a dramatic increase in the number of deaths, particularly among those related to synthetic opioids. In 2016, there were 1,566 synthetic opioid-related deaths compared to 200 in 2013.
Opioid Pain Reliever Prescriptions : In 2013, Florida providers wrote 69.6 opioid prescriptions for every 100 persons (approximately 13.6 million prescriptions), compared to the average U.S. rate of 79.3. Since then, opioid prescriptions in the United States have declined, with a nearly 7.3 percent decline in Florida from 2013 to 2015, resulting in an estimated 62.8 opioid prescriptions per 100 persons (12.7 million prescriptions) in 2015 (IMS Health, 2016).
Florida’s Efforts in Establishing Standards of Practice for Filling of Controlled Substance Prescriptions
Florida is “out front” in these areas. The Florida Board of Pharmacy has recently modified its regulation establishing standards of practice for the filling of controlled substance prescriptions (64B16-27.831).
The new language of that regulation includes recognition by the Board that it is important for patients in Florida to be able to fill valid prescriptions for controlled substances. The Board specifies that in screening controlled substance prescriptions, pharmacists are not expected to take any specific action beyond exercising sound professional judgment. Pharmacists should not fear disciplinary action from the Board, or any other regulatory or enforcement agency, for dispensing controlled substances that have been prescribed for a legitimate medical purpose and in the usual course of professional practice.
The Board recognizes that each patient’s situation is unique, and that prescriptions for controlled substances should be reviewed by a pharmacist based on that fact. Pharmacists are advised by the Board to work with both the patient and the prescriber to assist in determining the validity of each prescription.
The Board defines a “valid prescription” as one that is “based on a practitioner-patient relationship” and that has been “issued for a legitimate medical purpose.” By way of contrast, an “invalid prescription” is one that “the pharmacist knows or has reason to know. . .was not issued for a legitimate medical purpose.” There are circumstances that may cause a pharmacist to question the validity of a prescription for a controlled substance. However, a concern with validity does not necessarily mean a prescription should not be filled.
The Board instructs pharmacists to attempt to determine the validity of each controlled substance prescription, and to attempt to resolve any concerns about the validity of the prescription by exercising independent professional judgment.
The Board clarifies three important standards related to the validation of a controlled substance prescription by a pharmacist:
No person nor a licensee shall interfere with the exercise of a pharmacist’s independent professional judgment.
The pharmacist shall ensure that all communication with the patient is not overheard by others.
If, at any time, the pharmacist determines, based on professional judgment, that concerns with the validity of a prescription cannot be resolved, the pharmacist shall refuse to fill the prescription.
The Board has promulgated minimum standards for refusing to fill a prescription. Pursuant to these standards, a pharmacist is instructed by the Board to attempt validation of a prescription by initiating communication with the patient or with the patient’s representative to acquire information relevant to the pharmacist’s concern about the validity of a prescription. Pharmacists are also instructed to communicate with the prescriber or prescriber’s agent to acquire information relevant to a prescription’s validity.
As an alternative to either of these communication efforts, but not both, the pharmacist may access the state’s Prescription Drug Monitoring Program (E-FORCSE) to acquire information related to the pharmacist’s concern about the validity of a prescription. (E-FORCSE = Electronic Florida Online Controlled Substance Evaluation Program). Should a pharmacist’s efforts to communicate with a patient or prescriber be unsuccessful due to refusal by the patient or prescriber to cooperate with the pharmacist, the minimum standards for refusing to fill a prescription need not be met.
The Board recognizes that pharmacists may become aware of a prescriber’s involvement with the diversion of controlled substances. When a pharmacist has reason to believe that prescriber involvement with controlled substance diversion is occurring, the pharmacist must report the prescriber to the Florida Department of Health.
Controlled Substance Schedules
All controlled substances are classified according to the schedule system that was enacted nationwide in 1970 with the passage of the Controlled Substances Act. Under Florida law, they are codified in Florida Statute 893.03.
Schedule I:
A substance in Schedule I has a high potential for abuse and has no currently accepted medical use in treatment in the United States and in its use under medical supervision does not meet accepted safety standards. The following substances are controlled in Schedule I:
Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following hallucinogenic substances or that contains any of their salts, isomers, including optical, positional, or geometric isomers, homologues, nitrogen-heterocyclic analogs, esters, ethers, and salts of isomers, homologues, nitrogen-heterocyclic analogs, esters, or ethers, if the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation or class description:
There are several hundred controlled substances classified as Schedule I, but some common examples include Marijuana, Heroin, LSD, and GHB (common date rape drug).
Schedule II:
A substance in Schedule II has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States, and abuse of the substance may lead to Unless specifically excepted or unless listed in another schedule, any of the following substances, whether produced directly or indirectly by extraction from substances of vegetable origin or independently by means of chemical synthesis:
Opium and any salt, compound, derivative, or preparation of opium, except nalmefene or isoquinoline alkaloids of opium, including, but not limited to the following: Raw opium, Opium extracts, Opium fluid extracts, Powdered opium, Granulated opium, Tincture of opium, Codeine, Dihydroetorphine, Ethylmorphine, Etorphine hydrochloride, Hydrocodone and hydrocodone combination products, Hydromorphone, Levo-alphacetylmethadol (also known as levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM), Metopon (methyldihydromorphinone), Morphine, Oripavine, Oxycodone, Oxymorphone, and Thebaine.
Any salt, compound, derivative, or preparation of a substance which is chemically equivalent to or identical with any of the substances referred to in subparagraph 1., except that these substances shall not include the isoquinoline alkaloids of opium.
Any part of the plant of the species Papaver somniferum, L.
Cocaine or ecgonine, including any of their stereoisomers, and any salt, compound, derivative, or preparation of cocaine or ecgonine, except that these substances shall not include ioflupane I 123.
Unless specifically excepted or unless listed in another schedule, any of the following substances, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation:
Alfentanil.
Alphaprodine.
Anileridine.
Bezitramide.
Bulk propoxyphene (nondosage forms).
Carfentanil.
Dihydrocodeine.
Diphenoxylate.
Fentanyl.
Isomethadone.
Levomethorphan.
Levorphanol.
Metazocine.
Methadone.
Methadone-Intermediate,4-cyano-2-dimethylamino-4,4-diphenylbutane.
Moramide-Intermediate,2-methyl-3-morpholoino-1,1-diphenylpropane-carboxylic acid.
Nabilone.
Pethidine (meperidine).
Pethidine-Intermediate-A,4-cyano-1-methyl-4-phenylpiperidine.
Pethidine-Intermediate-B,ethyl-4-phenylpiperidine-4-carboxylate.
Pethidine-Intermediate-C,1-methyl-4- phenylpiperidine-4-carboxylic acid.
Phenazocine.
Phencyclidine.
1-Phenylcyclohexylamine.
Piminodine.
1-Piperidinocyclohexanecarbonitrile.
Racemethorphan.
Racemorphan.
Remifentanil.
Sufentanil.
Tapentadol.
Thiafentanil.
Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including their salts, isomers, optical isomers, salts of their isomers, and salts of their optical isomers: Amobarbital, Amphetamine, Glutethimide, Lisdexamfetamine, Methamphetamine, Methylphenidate, Pentobarbital, Phenmetrazine, Phenylacetone, and Secobarbital.
Dronabinol (synthetic THC) in oral solution in a drug product approved by the United States Food and Drug Administration.
A prescription for a controlled substance listed in Schedule II may be dispensed only upon a written or electronic prescription of a practitioner, except that in an emergency situation, as defined by regulation of the Department of Health, such controlled substance may be dispensed upon oral prescription but is limited to a 72-hour supply. A prescription for a controlled substance listed in Schedule II may not be refilled.
Schedule III :
A substance in Schedule III has a potential for abuse less than the substances contained in Schedules I and II and has a currently accepted medical use in treatment in the United States, and abuse of the substance may lead to moderate or low physical dependence or high psychological dependence or, in the case of anabolic steroids, may lead to physical damage.
Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant or stimulant effect on the nervous system:
Any substance which contains any quantity of a derivative of barbituric acid, including thiobarbituric acid, or any salt of a derivative of barbituric acid or thiobarbituric acid, including, but not limited to, butabarbital and butalbital.
Benzphetamine.
Buprenorphine.
Chlorhexadol.
Chlorphentermine.
Clortermine.
Embutramide.
Lysergic acid.
Lysergic acid amide.
Methyprylon.
Perampanel.
Phendimetrazine.
Sulfondiethylmethane.
Sulfonethylmethane.
Sulfonmethane.
Tiletamine and zolazepam or any salt thereof.
(b) Nalorphine.
(c) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing limited quantities of any of the following controlled substances or any salts thereof:
Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium.
Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with recognized therapeutic amounts of one or more active ingredients which are not controlled substances.
Not more than 300 milligrams of hydrocodone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium.
Not more than 300 milligrams of hydrocodone per 100 milliliters or not more than 15 milligrams per dosage unit, with recognized therapeutic amounts of one or more active ingredients that are not controlled substances.
Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with recognized therapeutic amounts of one or more active ingredients which are not controlled substances.
Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams, with recognized therapeutic amounts of one or more active ingredients which are not controlled substances.
For purposes of charging a person with a violation of s. 893.135 involving any controlled substance described in subparagraph 3. or subparagraph 4., the controlled substance is a Schedule III controlled substance pursuant to this paragraph but the weight of the controlled substance per milliliters or per dosage unit is not relevant to the charging of a violation of s. 893.135. The weight of the controlled substance shall be determined pursuant to s.893.135(6).
(d) Anabolic steroids.
The term “anabolic steroid” means any drug or hormonal substance, chemically and pharmacologically related to testosterone, other than estrogens, progestins, and corticosteroids, that promotes muscle growth and includes:
Androsterone.
Androsterone acetate.
Boldenone.
Boldenone acetate.
Boldenone benzoate.
Boldenone undecylenate.
Chlorotestosterone (Clostebol).
Dehydrochlormethyltestosterone.
Dihydrotestosterone (Stanolone).
Drostanolone.
Ethylestrenol.
Fluoxymesterone.
Formebulone (Formebolone).
Mesterolone.
Methandrostenolone (Methandienone).
Methandranone.
Methandriol.
Methenolone.
Methyltestosterone.
Mibolerone.
Nortestosterone (Nandrolone).
Norethandrolone.
Nortestosterone decanoate.
Nortestosterone phenylpropionate.
Nortestosterone propionate.
Oxandrolone.
Oxymesterone.
Oxymetholone.
Stanozolol.
Testolactone.
Testosterone.
Testosterone acetate.
Testosterone benzoate.
Testosterone cypionate.
Testosterone decanoate.
Testosterone enanthate.
Testosterone isocaproate.
Testosterone oleate.
Testosterone phenylpropionate.
Testosterone propionate.
Testosterone undecanoate.
Trenbolone.
Trenbolone acetate.
Any salt, ester, or isomer of a drug or substance described or listed in this subparagraph if that salt, ester, or isomer promotes muscle growth.
The term does not include an anabolic steroid that is expressly intended for administration through implants to cattle or other nonhuman species and that has been approved by the United States Secretary of Health and Human Services for such administration. However, any person who prescribes, dispenses, or distributes such a steroid for human use is considered to have prescribed, dispensed, or distributed an anabolic steroid within the meaning of this paragraph.
(e) Ketamine, including any isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation.
(f) Dronabinol (synthetic THC) in sesame oil and encapsulated in a soft gelatin capsule in a drug product approved by the United States Food and Drug Administration.
(g) Any drug product containing gamma-hydroxybutyric acid, including its salts, isomers, and salts of isomers, for which an application is approved under s. 505 of the Federal Food, Drug, and Cosmetic Act.
Schedule IV :
(a) A substance in Schedule IV has a low potential for abuse relative to the substances in Schedule III and has a currently accepted medical use in treatment in the United States, and abuse of the substance may lead to limited physical or psychological dependence relative to the substances in Schedule III.
(b) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, are controlled in Schedule IV:
Alfaxalone.
Alprazolam.
Barbital.
Bromazepam.
Butorphanol tartrate.
Camazepam.
Carisoprodol.
Cathine.
Chloral betaine.
Chloral hydrate.
Chlordiazepoxide.
Clobazam.
Clonazepam.
Clorazepate.
Clotiazepam.
Cloxazolam.
Dexfenfluramine.
Delorazepam.
Dichloralphenazone.
Diazepam.
Diethylpropion.
Eluxadoline.
Estazolam.
Eszopiclone.
Ethchlorvynol.
Ethinamate.
Ethyl loflazepate.
Fencamfamin.
Fenfluramine.
Fenproporex.
Fludiazepam.
Flurazepam.
Fospropofol.
Halazepam.
Haloxazolam.
Ketazolam.
Loprazolam.
Lorazepam.
Lorcaserin.
Lormetazepam.
Mazindol.
Mebutamate.
Medazepam.
Mefenorex.
Meprobamate.
Methohexital.
Methylphenobarbital.
Midazolam.
Modafinil.
Nimetazepam.
Nitrazepam.
Nordiazepam.
Oxazepam.
Oxazolam.
Paraldehyde.
Pemoline.
Pentazocine.
Petrichloral.
Phenobarbital.
Phentermine.
Pinazepam.
Pipradrol.
Prazepam.
Propoxyphene (dosage forms).
Propylhexedrine, excluding any patent or proprietary preparation containing propylhexedrine, unless otherwise provided by federal law.
Quazepam.
Sibutramine.
SPA[(-)-1 dimethylamino-1, 2 diphenylethane].
Suvorexant.
Temazepam.
Tetrazepam.
Tramadol.
Triazolam.
Zaleplon.
Zolpidem.
Zopiclone.
Not more than 1 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
Schedule V:
A substance, compound, mixture, or preparation of a substance in Schedule V has a low potential for abuse relative to the substances in Schedule IV and has a currently accepted medical use in treatment in the United States, and abuse of such compound, mixture, or preparation may lead to limited physical or psychological dependence relative to the substances in Schedule IV.
Substances controlled in Schedule V include any compound, mixture, or preparation containing any of the following limited quantities of controlled substances, which must include one or more active medicinal ingredients that are not controlled substances in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by the controlled substance alone:
Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams.
Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams.
Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams.
Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.
Not more than 100 milligrams of opium per 100 milliliters or per 100 grams.
Not more than 0.5 milligrams of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
(b) Unless a specific exception exists or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following substances is controlled in Schedule V:
Brivaracetam.
Ezogabine.
Lacosamide.
Pregabalin
(c) Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers: Pyrovalerone.
Federal Laws on Prescribing Controlled Substances
Federal law prohibits prescribers from pre-signing prescriptions. Here is the legal language: “Manner of issuance of prescriptions. (a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address, and registration number of the practitioner” (21 CFR, Section 1306.05).
According to federal law, a prescription for a controlled substance must include the following information (21 CFR 1306.05[a]):
Prescription Face Validity
Date of issue
Patient’s name and address
Practitioner’s name, address, and DEA registration number
Drug name
Drug strength
Dosage form
Quantity prescribed
Directions for use
Number of refills (if any) authorized
Manual signature of prescriber
A prescription must be written in ink or indelible pencil or typewritten and must be signed manually by the practitioner. Signature stamps are not legal. An individual may be designated by the practitioner to prepare the prescriptions for his/her signature, except that prescriptions for Schedule II controlled substances must be written and signed by the practitioner. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulation.
Here is the federal regulation on how to write a prescription: “Manner of issuance of prescriptions: (a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address, and registration number of the practitioner. Where a prescription is for gamma-hydroxybutyric acid, the practitioner shall note on the face of the prescription the medical need of the patient for the prescription. A practitioner may sign a prescription in the same manner as he would sign a check or legal document (e.g., J. H. Smith or John H. Smith).“
“Where an oral order is not permitted, prescriptions shall be written with ink or indelible pencil or typewriter and shall be manually signed by the practitioner. The prescriptions may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations” (21 CFR 1306.05).
Concepts Basic to Pain Management Guidelines
Structured approach to patient evaluation: determine correct diagnosis, type of pain, previous treatment, co-morbid conditions and risk of abuse or addiction
Psychological assessment for co-morbid mood disorders
Establish treatment goals (increase function should be primary goal)
Non-pharmacologic and/or non-narcotic treatment modalities first
Weight loss
Physical therapy
Cognitive Behavioral Therapy and Biofeedback techniques
Non-narcotic modalities
If narcotics are started, lowest dose on a trial basis should be used
Frequent reassessment for effect, complications (hyperanalgesia) or abuse
STOP NARCOTICS IF NO IMPROVEMENT
Morphine Equivalent Dosing
Converts all opioids to their approximate equivalent in morphine,
helps standardize opioid dosing or “Equianalgesic” dose
Generally expressed as Morphine Equivalent Daily Dose (MEDD)
Helps when converting one opioid for another
Dose calculators are widely available
Example: Oxymorphone 10mg = 30mg morphine
CDC Guidelines for Prescribing Opioids for Chronic Pain
First federal prescribing guidelines
Targeted to primary care prescribers (who prescribe half of all narcotics)
Three key principles and twelve recommendations
Designed to “support clinicians caring for patients with chronic pain that is outside the context of active cancer treatment, palliative care or end-of-life care”.
Evidence Reviewed to Answer Five Key Clinical Questions:
Effectiveness after > 1 year therapy related to pain, function and quality of live
Risk of addiction, overdose and other harms and how they vary according to type of pain and dose
Comparative effectiveness of opioid dosing strategies
Accuracy of instruments for predicting risk for addiction, abuse or overdose
Effects of prescribing opioids vs not prescribing for acute pain on long term use
First Key Principle: Determining When to Initiate or Continue Opioids for Pain
Nonopioid and Nonpharmacologic therapy is preferred
Evaluate patient and establish or confirm the diagnosis
Nonpharmacologic therapy: Physical therapy, weight loss, cognitive behavioral therapy (CBT), interventions (joint injections)
Nonopioid Rx: NSAIDS, selected antidepressants, anticonvulsants
Develop patient specific therapy where benefit > risk
Before starting opioid therapy, establish realistic treatment goals
Pain control and improvement in function
Risk assessment instruments (addiction, co-morbid depression)
How to discontinue therapy if no meaningful improvement
Before starting and periodically during opioid therapy, discuss risks, benefits and responsibilities for managing therapy
Involve patients in decisions whether to start or continue opioids
Realistic explanation about long term use and complete relief of pain unlikely
Emphasize improved function is primary goal
Advise patient about common (constipation, sedation) and severe side effects (respiratory depression, overdose and addiction)
Before starting and periodically during opioid therapy, discuss risks, benefits and responsibilities for managing therapy (cont.)
Importance of periodic reassessment
Advise use of precautions to reduce risk (automated prescription drug monitoring systems, random urine drug screens)
Second Key Principle : Opioid selection, Dosage, Duration, Follow-up and Discontinuation
Immediate release opioids should be used when starting therapy
Extended Release (ER) or Long Acting (LA) narcotics (methadone, transdermal fentanyl, ER/LA versions of oxycodone, hydrocodone, morphine) have a higher risk of overdose when initiating treatment
Abuse-deterrent technologies
When opioids are started, lowest effective dose should be used
Titrate doses to morphine milligram equivalents (MME), calculators available
Should be < 50 MME/day, Avoid doses > 90 MME/day
Example: 100mg Oxymorphone/day = 300mg Morphine/day
Quantity prescribed: acute pain < 3 days supply, rarely >7 days
Acute pain severe enough to require opioids
Long term opioid use can begin with treatment of acute pain
Evaluate benefit vs harm in patient within 1-4 weeks of starting opioid therapy
Evaluate benefits vs harm every 3 months or more frequently for chronic pain or dose escalation
If benefits < harms, work with patient to optimize other therapies and taper/discontinue opioids
Third Key Principle : Exercise caution when prescribing opioids and monitor all patients closely
Before starting and during therapy, evaluate risk factors
Increased risk: history of overdose, substance use disorder, high opioid dose (> 50 MME/day), concurrent medications (benzodiazepines)
Incorporate risk mitigation strategies into management plan
Consider offering naloxone
Review patient’s history of controlled substance use by using the state’s automated prescription drug monitoring system (PDMP)
Review when starting therapy and during therapy, either every prescription or every 3 months
When prescribing opioids for chronic pain, clinicians should use urine drug screens (UDS)
Ovoid prescribing opioid medications with benzodiazepines
Offer substance use disorder treatment for patients when needed
Take Control of Controlled Substances (Chapter 2018-13, Laws of Florida)
In 2018, Florida passed the Controlled Substances Bill that establishes prescribing limits, requires continuing education on controlled substance prescribing, expands required use of Florida’s Prescription Drug Monitoring Program, EFORCSE, and more.
Required Continuing Education
Each prescribing practitioner who is registered with the United States Drug Enforcement Agency, is required to take a Board-approved continuing education course, unless the practitioner is already required to complete such a course under his or her practice act.
The course must be completed by January 31, 2019, and at each subsequent licensure renewal.
Prescription limits for Acute Pain: A prescribing practitioner may prescribe or dispense up to a 3-day supply of a Schedule II opioid to alleviate acute pain. However, a prescribing practitioner may prescribe or dispense up to a 7-day supply for acute pain if the physician determines:
more than a three-day supply is needed based on the professional judgement of the prescriber; indicates “acute pain exception” on the prescription, AND
documents the justification for deviating from the 3-day supply limit in the patient’s medical record.
Prescriptions for Nonacute Pain:
If the prescriber writes a prescription for a Schedule II opioid for the treatment of pain other than acute pain, the prescriber must indicate “Nonacute Pain” on the prescription.
Pain Management Clinics:
All pain management clinics must be registered with the Department of Health as a pain management clinic or hold a certificate of exemption by January 1, 2019.
An applicant for a certificate of exemption must provide:
The name or names under which the applicant does business;
The address at which the pain management clinic is located;
The specific exemption that the applicant is claiming, along with supporting documentation; AND
Any other information DOH deems necessary.
Each certificate must be renewed biennially, be prominently displayed, and made available to the DOH or applicable board upon request.
Prescription Drug Monitoring Program:
Each prescriber and dispenser or his/her designee has a duty to consult the PDMP system to a patient’s controlled substance dispensing history each time a controlled substance is prescribed or dispensed to a patient age 16 or older unless a statutory exemption applies.
There is required consultation of the PDMP except:
Patient is less than 16 years of age
Drug being prescribed is a nonopioid Schedule V
System is not operational
Requestor has technological or electrical failure
Failure to consult the PDMP may result in a non-disciplinary citation by the regulatory board or further discipline.
You may register for the PDMP at: https://?orida.pmpaware.net
Prescription Drug Monitoring Program (PDMP)
Pursuant to Florida Statutes (893.055), a Prescription Drug Monitoring Program (PDMP) has been established. Through the PDMP, a pharmacist may request a patient advisory report. All advisory reports are for informational purposes only and impose no obligations of any nature or any legal duty on a prescriber, dispenser, pharmacy, or patient.
The PDMP is designed to provide information regarding dispensed prescriptions of controlled substances. It is not intended to infringe on the legitimate prescribing of controlled substances by a prescriber or dispenser acting in good faith or in the course of professional practice.
The patient advisory reports provided by the PDMP to pharmacists are created from a database of information accumulated through the aggregation of prescription data provided to the program by dispensing pharmacies.
These data include:
The name of the prescribing practitioner, the practitioner’s Drug Enforcement Administration registration number, the practitioner’s National Provider Identification or other appropriate identifier, and the issuance date of each prescription.
The date the prescription was filled and the method of payment, such as cash by an individual, insurance coverage through a third party, or Medicaid payment.
The full name, address, and date of birth of the patient for whom the prescription was issued.
The name, national drug code, quantity, and strength of the controlled substance dispensed.
The full name, federal Drug Enforcement Registration number, and address of the pharmacy or other location where the controlled substance was dispensed.
Each time a controlled substance is dispensed to an individual, the controlled substance must be reported to the PDMP through the system as soon thereafter as is possible, but not more than seven (7) days after the date the controlled substance was dispensed.
Through the Florida PDMP, (E-FORCSE), pharmacists who request patient advisory reports can equip themselves with a useful tool to support their validation of the controlled substance prescriptions for which concerns of validity exist. An E-FORCSE patient advisory report cannot, by itself, validate or invalidate a prescription. However, the patient’s history of controlled substance acquisition can inform the decision a pharmacist independently makes about a prescription’s validity, based on the exercise of the pharmacist’s professional judgment.
Therapeutic Appropriateness
There are always risks in the use of controlled substances in the treatment of pain. These risks must be considered when evaluating prescriptions for validity. Pharmacists have a responsibility to evaluate each patient’s drug therapy and to resolve questions that may arise regarding he appropriateness of the patient’s therapy and whether the patient will derive therapeutic value from the drug therapy. In doing this, pharmacists may want to develop and apply specific criteria that can be objectively measured. The use of specific and objective criteria can support concerns that a pharmacist may wish to raise with a prescriber during consultation regarding the therapeutic value of a prescription.
These same criteria may, on the other hand, support an explanation by a pharmacist of why initial concerns about a prescription have been resolved without the necessity of consultation with the prescriber.
The following are examples of factors that a pharmacist may recognize as raising questions about the therapeutic value of a prescription:
The patient is using three or more different opioids at the same time.
The patient is using an opioid, a benzodiazepine, and a skeletal muscle relaxant such as carisoprodol at the same time.
The instruction “PRN” has been used in the directions for an extended release/long acting (ER/LA) opioid.
The prescription is for an ER/LA opioid that is intended to be used every 12 hours, yet the instructions on the prescription are to use more often.
The prescription is for an ER/LA opioid to be used to treat post-operative pain.
The prescription is for a q12 ER/LA opioid, and the quantity prescribed is 14 dosage units or less.
The prescription is for a q12 ER/LA opioid, and the quantity prescribed is 65 dosage units or more.
The following are examples of additional factors that a pharmacist may recognize as relieving concerns about the therapeutic value of a prescription:
The patient regularly receives prescriptions from a mental health professional who is caring for the patient.
The patient has not requested an additional supply of opioids more than 20% “too early” within the previous 6 months.
There is documentation of the patient using over 60 mg of oral morphine equivalent daily for 7 previous days.
The patient’s total opioid dosage is less than 200 mg of oral morphine equivalent daily.
The patient uses fewer than 20 total dosage units of controlled substances daily.
The directions for use of the prescribed medication are consistent with the dosing frequency in the product labeling (i.e., q12h, q24h).
Prescriptions Not for a Legitimate Medical Purpose
For a legitimate medical purpose, by an individual practitioner acting in the usual course of his professional practice
Legitimate Medical Purpose or Not?:
Dentist prescribing alprazolam for anxiety?
Podiatrist prescribing latanoprost for glaucoma?
Physician prescribing methadone for the maintenance or detoxification of individuals addicted to opioids?
The following are examples of specific and objective factors that a pharmacist may recognize as raising concerns about the legitimate medical purpose of a prescription:
Another person at the same address is also using opioids dispensed by the pharmacy.
The patient has reported lost or stolen medications more than once in the past 6 months.
The patient resides in a group setting (i.e., college dorm, halfway house) with 3 or more other persons.
The patient has been “inherited” from another pharmacy from which the patient was dismissed.
Five or more of the exact same prescriptions (same drug, strength, quantity, directions, prescriber) were filled for others on the previous day.
The medication is being picked up on a Saturday or Sunday when the prescriber is difficult to locate for verification.
The medication is being picked up between 6pm and 9am when the prescriber is difficult to locate for verification.
The following are examples of factors that a pharmacist may recognize as alleviating concerns about the legitimate medical purpose of a prescription:
Patient’s address is same 3-digit zip code as pharmacy’s address.
Pharmacy’s address is same 3-digit zip code as prescriber’s address.
Patient’s address is same 3-digit zip code as prescriber’s address.
The patient is willing to accept generic products.
The patient’s controlled substances are paid for by a third-party payer.
The pharmacist has determined that the patient’s PDMP report is non-problematic.
The prescribed drug is an abuse-deterrent formulation.
The pharmacy has dispensed non-controlled substance medications to the patient each month for the past 6 months.
The prescriber is a pain specialist known to the pharmacy.
The patient has signed a medication use agreement that has been shared with the pharmacy.
The patient is a “regular customer” at the pharmacy.
Drug Enforcement Administration Criteria
The federal Drug Enforcement Administration has for many years published criteria that may indicate a prescription was not issued for a legitimate medical purpose. The traditional DEA criteria, quoted verbatim from the DEA’s “Pharmacist’s Manual” are as follows:
The prescriber writes significantly more prescriptions (or in larger quantities) compared to other practitioners in the area.
The patient appears to be returning too frequently. A prescription that should last for a month in legitimate use is being refilled on a biweekly, weekly, or even daily basis.
The prescriber writes prescriptions for antagonistic drugs, such as depressants and stimulants, at the same time. (Drug abusers often request prescriptions for “uppers and downers” at the same time).
The patient presents prescriptions written in the names of other people.
A number of people appear simultaneously, or within a short time, all bearing similar prescriptions from the same physician.
People who are not regular patrons or residents of the community show up with prescriptions from the same physician.
The DEA also publishes criteria that may indicate a forged prescription. These are also from the DEA’s “Pharmacist’s Manual,” and are as follows:
Prescription looks “too good.” The prescriber’s handwriting is too legible.
Quantities, directions, or dosages differ from usual medical usage.
Prescription does not comply with the acceptable standard abbreviations or appears to be textbook presentation.
Prescription appears to be photocopied.
Directions are written in full with no abbreviations.
Prescription is written in different color inks or written in different handwriting.
Florida’s Laws and Rules Regarding Prescribing & Dispensing of Controlled Substances
According to Florida Statutes (456.42) the following requirements must be met for a prescription:
Legibly printed or typed so as to be capable of being understood by the pharmacist.
Must contain the name of the prescriber, the name and strength of the drug prescribed, the quantity prescribed, and the directions for use.
Must be dated and signed by the prescriber on the date of issuance.
In addition, for controlled substance prescriptions, Florida Statutes require the following:
The quantity of the drug must be specified in both textual and numerical formats.
The date of the prescription must be stated in numerical month/day/year format, or with the abbreviated month written out, or the month written out in whole.
Prescriptions must be issued either on a standardized counterfeit-proof prescription pad produced by a vendor approved by the Florida Department of Health, or issued through electronic means that satisfy legal requirements.
In addition to these state requirements, the federal DEA requires these pieces of information on a controlled substance prescription (21 CFT 1306.05):
Full name and address of the patient.
Dosage form of the drug.
Address and DEA registration number of the prescriber.
Federal & Florida’s Laws and Rules Regarding Prescribing & Dispensing of Controlled Substances
Federal and state laws impose additional requirements related to controlled substance prescribing and dispensing. Several of these requirements are particularly relevant to the reduction of prescription drug abuse, due to the possibility of misunderstandings created by well intentioned parties. For example, some prescribers have recently suggested that they would prefer to allow their patients to acquire controlled substance medications at periodic intervals over a month’s time. The purpose of this approach is to prevent intentional or inadvertent overuse of a large amount of medication by dispensing only small amounts of medication at one time. While this is an approach that has traditionally not been allowed under many insurance plans, recently there have been discussions of the value of controlling access to an entire month supply, and some insurance companies have indicated a willingness to allow periodic acquisition of a 5-day or 10-day supply over the course of a month. This approach, while it is perhaps a useful technique to prevent uncontrolled access to large quantities of medication at one time, nevertheless is subject to DEA rules for prescribing and dispensing.
The challenge presented by any plan to allow periodic acquisition of Schedule II medications over a period of time is that the DEA restricts partial filling (21 CFR 1306.13). Schedule II prescriptions cannot be refilled, so providing periodic refills of an amount prescribed through a single prescription will not work for Schedule II medications as could be done for controlled substances in Schedules III, IV and V. A one-time partial supply of Schedule II medications can be provided when a pharmacist is “unable to supply” the full quantity prescribed, but the balance must be dispensed within a 72-hour period. For patients who are either “terminally ill” or an “LTCF patient,” partial filling may be conducted of a single prescription for up to a 60- day period. Thus, the partial filling approach to the provision of periodic supplies of Schedule II medication over a period of time pursuant to a single prescription is not allowed under federal law for most patients.
Fortunately, DEA regulations provide an approach that can be used to provide periodic supplies of Schedule II medications over time. This approach requires the issuance of multiple prescriptions on the same day (21 CFR 1306.12). All prescriptions must be dated as of the date of issuance. On the first prescription, no additional information need be provided. But on each of the additional prescriptions, the prescriber must indicate the earliest date on which they may subsequently be filled. Pursuant to this multiple prescriptions process, patients may be authorized to receive up to a 90-day supply, dispensed periodically over a specified time.
Schedule II prescriptions have additional requirements under DEA regulations. They must be in writing or be issued through a compliant electronic prescribing program. Emergency authorization of C-II dispensing is permitted through verbal order in the case of a true emergency. In such circumstances, the quantity authorized must be limited to that necessary to treat the patient during the emergency. The order must be immediately reduced to writing by the pharmacist, with all necessary information for a C-II prescription, other than the prescriber’s signature. If the prescriber is unknown to the pharmacist, then the pharmacist must make a reasonable effort to identify the prescriber and assure that the prescriber is authorized to prescribe the ordered drug. Within seven days after the verbal emergency prescription, the prescriber must deliver to the pharmacist a written prescription that states “authorization for emergency dispensing” on it.
Facsimile transmission of C-II prescriptions from prescriber to pharmacist is always allowed as an accommodation to permit the pharmacist to prepare the medication while the patient travels to the pharmacy to obtain it. But the patient must present the original hard copy of the faxed prescription to the pharmacist prior to receiving the medication.
There are three circumstances in which a facsimile of a C-II prescription can serve as the original:
A patient who resides in a long-term care facility.
A patient who is enrolled in a state or federally recognized hospice program, or
A drug that is to be delivered to the patient through parenteral administration.
The rules for C-III, C-IV and C-V controlled substances are significantly less stringent. Prescriptions for drugs in these schedules can be transmitted verbally, in addition to being written or issued through a compliant electronic prescribing program. Refills of prescriptions for drugs in these schedules are permitted up to five times within six months of the date of issuance, as long as the refilling is authorized by the prescriber. Partial filling with a quantity less than the face amount of the prescription is permitted, as long as the partial filling is documented and the total quantity dispensed pursuant to the prescription does not exceed the total quantity authorized by the prescription.
Prescription Monitoring Program Benefits & Problems
Benefits:
If used properly, could be the single most effective tool to prevent diversion and grant access to patients in need
Every player must be committed to its use
Problems:
Time consuming
Accessing the software
Outdated hardware
Store metrics affected
Unreliable
Multiple patient names (Maiden, married, hyphenated, and misspelled names)
It is not a national database
Red Flags for Pharmacists
The National Association Boards of Pharmacy stakeholders coalition has identified several RED FLAGS pharmacists and physicians can look for to help them responsibly prescribe, dispense, and report controlled substances.
Repeatedly dispensing “cocktailed” prescriptions
No individualization of dosing by the prescriber
Filling multiple prescriptions for the strongest formulations
Requests for early refills
Doctors located 100 miles away from pharmacy
A large portion (75%) of prescriptions filled by the pharmacy were controlled substances written by one particular physician
Pharmacist doesn’t reach out to other pharmacists to see why they aren’t filling the particular doctor’s prescription
Patients travel in groups to the pharmacy
Filling a large percentage of cash prescriptions
“Verification” of a prescription as “legitimate” was not satisfied simply because the practitioner said so
Red Flags for Prescribers
Patient appears sedated, confused, intoxicated, or exhibits withdrawal symptoms
Patients travel in groups and/or have unusual common factors in their relationships with each other when requesting controlled substance prescriptions on the same day
Patient repeatedly resists changes in therapy despite clear evidence of adverse effects
PMP (Prescription Monitoring Program) suggests evidence of “doctor shopping“
Patient pressures physician to prescribe by implying or making direct threats to prescriber or staff
Patient refuses to sign an opioid pain care agreement
Patient fails urine toxicology screen
Prescriber is aware that patient alters, forges or rewrites prescription
Patient requests specific drug combinations
Patient repeatedly seeks medications from ED
Patient suffers unintentional or intentional overdose
Corresponding Responsibility
Every prescription involves at least two responsible health care professionals – the prescriber and the pharmacist. Each has a responsibility to ensure that the prescription is issued
for a legitimate medical purpose and
by an individual practitioner acting in the usual course of professional practice.
Pharmacist also needs to know there is a corresponding responsibility for the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is an invalid prescription within the meaning and intent of the Controlled Substances Act. The person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. A pharmacist is required to exercise sound professional judgment when making a determination about the legitimacy of a controlled substance prescription. Such a determination is made before the prescription is dispensed. The law does not require a pharmacist to dispense a prescription of doubtful, questionable, or suspicious origin.
A prescription for a controlled substance may be prepared by an agent of the practitioner for their signature, but the prescribing practitioner is responsible in case it does not conform in all essential aspects to the law and regulations.
Distributor Initiative
Educate and inform distributors/manufacturers of their due diligence responsibilities under the CSA by discussing their Suspicious Order Monitoring System, reviewing their ARCOS data for sales and purchases of Schedule I and III controlled substance, and discussing national trends involving the abuse of prescription controlled substances.
Distributors must detect and report to DEA suspicious orders for controlled substance in accordance with 21 CFR 13014.70 (b)
Suspicious orders are “orders of unusual sizes, orders deviating substantially from a normal pattern, and orders of unusual frequency”
Metrics used to detect suspicious activity vary considerably among distributors. Some factors used include:
Size if the pharmacy, prescriptions filled, both non-controlled and controlled substances in relation to controlled substances purchased
Any specialty practice within pharmacy
Affiliation(s) with healthcare institutions, such as hospitals or clinics
The type(s) of patient population a pharmacy serves
Variations in geographical or regional prescribing patterns that may affect which products are dispensed and purchased
There is lack of clear guidance
Every distributor uses different internal criteria and different weights to each criteria
The variables created have caused pharmacies to challenge distributors in legal proceedings regarding lack of access to these products
Closed System:
The comprehensive Drug Abuse Prevention and Control Act of 1970, as amended in 1990 and 1994 created a system for the legitimate manufacturing, distribution, and prescribing/dispensing of controlled substance.
Each registrant within this “closed system of distribution” has defined privileges and responsibilities in which they must operate.
Validation Minimum Standards
Some states have instituted new rules to guarantee patients access to controlled substance prescriptions. Florida requires 2 credits on validation of controlled substance prescription every biennium.
There is a specific guideline on how to access the validity of a prescription
A concern with the validity of a prescription does not mean the prescription shall not be filled, rather, when a pharmacist is presented with a prescription for a controlled substance, the pharmacist shall attempt to determine the validity of the prescription and shall attempt to resolve any concerns about the validity of the prescription by exercising his/her independent professional judgement
If the pharmacist determines that, in his/her professional judgment concerns with the validity of the prescription can not be resolved, the pharmacist shall refuse to fill or dispense the prescription
Before refusing to fill a prescription, the pharmacist shall attempt to validate the prescription by performing the following.
Initiate communication with the patient or the patient’s representative to acquire information relevant to the concern with the validity of the prescription.
Initiate communication with the prescriber or the prescriber’s agent to acquire information relevant to the pharmacist’s concern with the validity of the prescription.
In lieu of either 1 or 2, but not both, the pharmacist may elect to access the Prescription Drug Monitoring Database to acquire information relevant to the pharmacist’s concern with validity of the prescription.
Emergency Treatment for Suspected Opioid Overdose
Section 381.887, F.S. : The purpose of this section is to provide for the prescription of an emergency opioid antagonist to patients and caregivers and to encourage the prescription of emergency opioid antagonists by authorized health care practitioners.
An authorized health care practitioner may prescribe and dispense an emergency opioid antagonist to a patient or caregiver for use in accordance with this section, and pharmacists may dispense an emergency opioid antagonist pursuant to such a prescription or pursuant to a non-patient-specific standing order for an auto injection delivery system or intranasal application delivery system, which must be appropriately labeled with instructions for use. Such patient or caregiver is authorized to store and possess approved emergency opioid antagonists and, in an emergency situation when a physician is not immediately available, administer the emergency opioid antagonist to a person believed in good faith to be experiencing an opioid overdose, regardless of whether that person has a prescription for an emergency opioid antagonist (“Emergency opioid antagonist” means naloxone hydrochloride or any similarly acting drug that blocks the effects of opioids administered from outside the body and that is approved by the United States Food and Drug Administration for the treatment of an opioid overdose.)
The following persons are authorized to possess, store, and administer emergency opioid antagonists as clinically indicated:
Emergency responders, including, but not limited to, law enforcement officers, paramedics, and emergency medical technicians.
Crime laboratory personnel for the statewide criminal analysis laboratory system as described in s. 943.32, including, but not limited to, analysts, evidence intake personnel, and their supervisors.
A person, including, but not limited to, an authorized health care practitioner, a dispensing health care practitioner, or a pharmacist, who possesses, administers, prescribes, dispenses, or stores an approved emergency opioid antagonist in compliance with this section and s. 768.13 is afforded the civil liability immunity protections provided under s. 768.13.
An authorized health care practitioner, acting in good faith and exercising reasonable care, is not subject to discipline or other adverse action under any professional licensure statute or rule and is immune from any civil or criminal liability as a result of prescribing an emergency opioid antagonist in accordance with this section.
A dispensing health care practitioner or pharmacist, acting in good faith and exercising reasonable care, is not subject to discipline or other adverse action under any professional licensure statute or rule and is immune from any civil or criminal liability as a result of dispensing an emergency opioid antagonist in accordance with this section.
This section does not limit any existing immunities for emergency responders or other persons which are provided under this chapter or any other applicable provision of law. This section does not create a duty or standard of care for a person to prescribe or administer an emergency opioid antagonist.
Counseling of Patients with Opioid Prescriptions
When patients present with a prescription for an opioid, counseling must be a top priority for pharmacists. Since many patients may not know which questions to ask, or may be reluctant to ask questions, where is a good place to start? FDA’s guide on what consumers should ask about new opioid prescriptions offers sample questions and ways to get the conversation started.
Each of these questions opens an opportunity for discussion on the safe use, storage, and disposal of opioids. The questions include:
Why do I need this medication – is it right for me?
According to FDA, the conversation could begin: “What medication are you giving me? If it’s an opioid, are there non-opioid options that could help with pain relief while I recover?” If pain is best managed with a prescription opioid, then:
How long should I take this medication?
FDA said patients should find out when and how to stop using, or taper off, opioids. Follow-up questions can include:
Is this the lowest dose and the smallest quantity I may need?
How can I reduce the risk of potential side effects from this medication?
What if I have a history of addiction?
What about the other medications I’m taking?
How should I store my opioid medicine?
What should I do with unused opioid medicine?
Can I share this medication with someone else?
A recent Washington Post/Kaiser Family Foundation survey, which found that one-third of long-term users said they’re hooked on prescription opioids, offers additional counseling pointers: keep medications in a safe place so they are not misused by others, and avoid alcohol or certain medications while taking opioids.
Can I have a prescription for naloxone?
Patients receiving a new prescription for an opioid medicine should discuss whether they should receive a prescription for naloxone, an antidote for opioid overdose. Patients should be aware of naloxone and how it can be obtained, said FDA.
Initiating the conversation
Pharmacists are taking an increasingly important role in the education and safe use of opioid prescriptions. They have the expertise to speak candidly with patients about the benefits and harms of these agents, as well as the long-term effects these medications may have on their pain.
In all cases where any opioid prescription is being presented to a pharmacist, the situation needs to be handled with more care. Pharmacists need to be prepared to know what to say if the patient doesn’t know what questions to ask.
Patients need to be counseled every single time.
Pharmacists also have the right to refuse a prescription if there are any red flags.
Pharmacists are part of the team and for the most part physicians are cooperative if the pharmacist calls them up with concerns about an opioid prescription. Although laws vary by state, most pharmacists have some way to initiate prescriptions for naloxone. Organizations including the American Medical Association, among others, recommend dual prescribing for naloxone in patients who are at risk for an overdose.
Available Treatment Resources for Opioid Physical Dependence, Addiction, Misuse, or Abuse
As the Florida works to develop more effective opioid addiction prevention, treatment, and recovery programs that will mitigate the effects of the epidemic, other organizations in the state are working to provide resources to the families and communities directly and indirectly affected by opioid abuse. These organizations include the National Institutes of Health, the National Institute on Drug Abuse, and the Narcotics Overdose Prevention & Education (NOPE) Task Force. Although the opioid epidemic is still strong in Florida and throughout the country, the awareness of the effects and signs of opioid dependency, including the extremely addictive nature of the drug, the rates in which families are being divided, and the rates in which people are dying, is contributing to a louder discussion across the country. As more information comes to light and local and state governments continue to be vigilant in developing programs to assist those dealing with opioid addictions, states are better able to formulate strategies to effectively combat the crisis of the opioid epidemic.
Narcotics Overdose Prevention & Education (NOPE) Task Force: http://www.nopetaskforce.org/
In Florida, the Substance Abuse and Mental Health (SAMH) Program, within the Florida Department of Children and Families (DCF), is the single state authority on substance abuse and mental health as designated by the federal Substance Abuse and Mental Health Services Administration.
The Florida Department of Health partners with DCF in seeking to prevent and reduce substance abuse and its negative effects on health. Providing this website is one of many ways we hope to educate the public and health care providers.
Treatment and Referral Services
The U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration’s (SAMHSA) National Drug and Alcohol Treatment Referral Service provides free and confidential information in English and Spanish for individuals and family members facing substance abuse and mental health issues. 24 hours a day, 7 days a week.
SAMHSA’s Toll-Free Treatment Referral Helpline:
1-800-662-HELP (4357)
Online Treatment Facility Locator (http://findtreatment.samhsa.gov/)
Department of Health Resources:
Effects of drug use during pregnancy (http://www.floridahealth.gov/programs-and-services/prevention/substance-abuse/substance-abuse-during-pregnancy/index.html ) —When you are pregnant, the drugs you take also go to your fetus. If you or someone in your home is using any illegal drug while you are pregnant, get help immediately.
Preconception health (http://www.floridahealth.gov/programs-and-services/prevention/substance-abuse/preconception-health/index.html) refers to the health of women and men during their reproductive years, which are the years they can have a child. It focuses on taking steps now to protect the health of a baby they might have sometime in the future.
Conclusion
Those of us working in healthcare are required by ethics and by law to help fight the epidemic of prescription drug abuse. But that’s easier said than done. We need to strike a delicate balance between helping patients who legitimately need assistance safely managing pain and deterring those who may be seeking controlled substances for illegitimate reasons, all while staying complaint with state and federal regulations and requirements for reporting on controlled substances.
Pharmacists are faced with significant challenges in determining the validity of prescriptions for pain medications. The law requires that pharmacists use their professional judgment in determining whether a prescription is valid. This use of professional judgment requires the application of therapeutic expertise and the assessment of circumstances that may suggest a prescription has not been issued for a legitimate medical purpose. In fulfilling this responsibility, pharmacists are required to refuse prescriptions that they know, or have reason to know, are invalid. Pharmacists are also required to attempt to determine the validity of prescriptions, and attempt to resolve any concerns about prescription validity by exercising their professional judgment.
References
SOURCES: National Vital Statistics System, 1999-2008; Automation of Reports and Consolidated Orders System (ARCOS) of the Drug Enforcement Administration (DEA), 1999-2010; Treatment Episode Data Set, 1999-2009
National Association of Boards of Pharmacy. Stakeholders’ challenges and red flag warning signs related to prescribing and dispensing controlled substances. www.nabp.net/system/rich/rich_files/rich_files/000/000/870/original/consensusdocumentmarch2015.pdf. Accessed March 13, 2015.
US Department of Justice Drug Enforcement Administration. 1306.04 Purpose of issue of prescription. www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm. Accessed March 13, 2015.
DEA. http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm.
NABP. http://www.nabp.net/system/rich/rich_files/rich_files/000/001/321/original/redflagsstakeholders.pdf.
U.S. Department of Justice. Drug Enforcement Administration. (2015, February). 2015 National Drug Threat Assessment Summary. Retrieved January 7, 2016, from http://www.dea.gov/docs/2015%20NDTA%20Report.pdf
Centers for Disease Control. (2011, November). Prescription Painkiller Overdoses in the US. Vital Signs. Retrieved January 7, 2016, from http://www.cdc.gov/VitalSigns/pdf/2011-11-vitalsigns.pdf
The National Alliance of Advocates for Buprenorphine Treatment. (n.d.). Education. Opiates/Opioids. Retrieved January 7, 2016, from http://www.naabt.org/education/opiates_opioids.cfm
U.S. Department of Justice. Drug Enforcement Administration. (n.d.). Controlled Substance Schedules. Retrieved January 8, 2016, from http://www.deadiversion.usdoj.gov/schedules/index.html
U.S. Department of Justice. Drug Enforcement Administration. (n.d.). Pharmacist’s Manual. Retrieved January 8, 2016, from http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_content.htm
U.S. Department of Justice. Drug Enforcement Administration. (2013, May 28). Controlled Substances. Retrieved January 8, 2016, from http://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf
U.S. DEPARTMENT OF JUSTICE – DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division https://www.deadiversion.usdoj.gov/pubs/manuals/pract/section1.htmState of Florida. Florida Health. (2015, December 1). E-FORCSE: Electronic-Florida Online Reporting of Controlled Substances Evaluation: 2014–2015 Prescription Drug Monitoring Program Annual Report (pp. 5–6). Retrieved January 8, 2016, from http://www.floridahealth.gov/statistics-and-data/e-forcse/newsreports/_documents/2015-pdmp-annual-report.pdf
§ 456.42, Florida Statutes – Written prescriptions for medicinal drugs (commonly referred to as the legible prescription law)
Rule 64B-3.005, Florida Administrative Code – Counterfeit-resistant Prescription Blanks for Controlled Substance Prescribing
§ 456.43, Florida Statutes – Electronic prescribing for medicinal drugs
§ 668, Florida Statutes – Electronic signatures
Florida Statutes: http://www.leg.state.fl.us/statutes/index.cfin
Florida Administrative Code: https://www.flrules.org/Default.asp
Drug Enforcement Agency Web Site: http://www.usdoj.gov/dea/index.htm
Narcotics Overdose Prevention & Education (NOPE) Task Force: http://www.nopetaskforce.org/