Making Opioid Prescribing Safer: Time for a Checklist?

The safety of opioid analgesics is currently the subject of considerable medical, public and governmental scrutiny [101]. This attention to a class of medicines used for millennia, with well known beneficial and harmful effects, stems largely from a recent (relatively speaking) change in the therapeutic use of opioids. Efforts to promote improved pain control over the past decades resulted in greater acceptance and use of opioids with (hopefully) better pain management and less ‘fear‘ of these agents in both cancer and noncancer-related pain, producing a dramatic increase in the number of opioid prescriptions in the USA [1]. A consequence of this wider use has been a dramatic increase in patient encounters for opioid adverse patient events, diversion to non-medical uses, misuse and abuse [101]. The limitations and hazards of opioids in the treatment of chronic noncancer pain have been recognized and consensus guidelines for use have been developed [2]. In response to the public health problem of widespread misuse of opioids, the White House has developed a ‘Prescription Drug Abuse Prescription Plan‘ that includes a US FDA Risk Evaluation and Mitigation Strategy (REMS), and potentially, educational requirements for obtaining a Drug Enforcement Agency (DEA) license [101].

Despite the many problems with opioids, they remain key tools in the management of pain, and are unlikely to be replaced in the near future by safer, less abuse prone or more effective agents. Thus, most clinicians will continue to use opioids in their practices, and the only available approach to the ‘opioid problem‘ is to improve the way these drugs are used. Our experience [3], and others [4], suggest that the adverse outcomes observed with opioid use are the result of multiple factors, including suboptimal patient assessment, therapeutic planning, opioid choice and use, monitoring and patient education, and errors in executing a proper prescription. Prescribing errors and deficiencies are not unique to opioids, but as a ‘high-alert‘ drug class [5], opioids clearly present a more serious risk of harm than most other drug classes.

A primary focus of the White House plan is the education of care providers in the proper use of opioids and other abuse prone drugs [1]. The effectiveness of these efforts will likely be determined by their structure [6]. Numerous recommendations for teaching [7,8] and improving medication prescribing in general [5,6,9,10], and specifically opioid prescribing [1–4,11–13], are available. Addressing medication prescribing safety through passive education and training most likely has limited long-term benefits. Rather, changes in the systems of care are considered a more effective way to improve patient safety. Systematically standardizing practices and continuously supporting compliance are recommended as a more effective approach to improving patient outcomes [6]. Combining education, systems changes, cultural changes and ongoing ‘reminders‘ have long-lasting effects through continued consistent compliance with safety practices. Such an approach should also be taken with the prescribing of opioids.

The concept of ‘universal precautions‘ as suggested by Gourlay and Heit does provide the clinician with a helpful list of considerations when prescribing opioids [12]. In our experiences, the causes of adverse outcomes from opioids encompasses, and extends beyond, these ten universal precautions [3]. It is widely accepted that safe and effective prescribing of opioids involves a number of critical (and problem-prone) steps that involve:

• ▪ Patient assessment to determine if an opioid is an appropriate component of the pain management strategies to be used and to guide the therapeutic plan

• ▪ Abuse/misuse assessment

• ▪ Establish a comprehensive therapeutic plan based on the patient characteristics, candidate drug characteristics and risk for drug abuse/misuse

• ▪ Patient/family education

• ▪ Execution of the therapeutic plan including writing of the opioid prescription

• ▪ Documentation

• ▪ Monitoring and revision of the therapeutic plan

Each of the broadly defined steps of safe prescribing described above are critical whenever prescribing an opioid. However, the necessary specific components of these steps will vary depending on the patient and clinical scenario. On the other hand, the components of writing or ‘executing‘ a safe opioid prescription will generally be universal from one patient or setting to another.

Although prescription writing is the most common patient intervention made by caregivers, errors in writing prescriptions occur all too commonly. Writing a prescription should be viewed more broadly than simply as an order to supply medications to the patient. Rather, a prescription is a critical component encompassing and supporting all aspects of the overall therapeutic plan and is a ‘sharp point‘ of the medication use system. In our experience, many prescribing errors result from simple failure to follow and execute widely accepted prescribing practices and execute a correct prescription.

Checklists as a method of improving consistent compliance with important steps during critical tasks have been widely used outside medicine, and have more recently been shown to be effective in improving performance in medical care. Checklists can define and promote compliance to required tasks, safety procedures and desired behaviors [14].

Could checklists be useful to guide safer prescribing? We created two opioid prescribing checklists that incorporate critical considerations when prescribing in general, and when specifically prescribing opioids (Tables 1 & 2). The checklist components were gathered from a number of references and experiences of the authors, and organized for ease of use. The longer, more comprehensive ‘SCRIPT-SAFE‘ checklist includes both items that can be ‘checked‘ when actually executing a prescription as well as ‘reminders‘ of critical behaviors and actions of prescribers, but do not ‘appear‘ on a prescription. The much shorter ‘PAINED_x4-R‘ checklist is designed to be used whenever writing prescriptions for opioids, and incorporates specific problem-prone prescription-writing components. The difficulties of constructing a short checklist confirms the complexity of prescribing, and demonstrated to us how such complexity contributes to errors.

By their nature, checklists need to be simple and easy to use ‘reminders‘ to perform both simple and complex tasks. However, like a preflight checklist is not meant to allow just anyone to fly an aircraft, a prescribing checklist does not substitute for a sound knowledge of pain therapy, but rather as a method to prompt use of such knowledge by the clinician [14]. Because many prescribers may be unfamiliar with the rationale and specifics related to medication safety, extensive footnotes are provided.

Checklists might also be considered as educational tools, as performance assessment tools, or as a template for decision support in computerized prescribing systems. We have not validated the effectiveness of these checklists, and present them as concepts only to prompt thinking about potential solutions to ‘America‘s prescription drug abuse epidemic‘. Even though many prescribers might be highly averse to such an approach to safety, given the current state of opioid prescribing and prescribing in general [15], we wonder; could such a checklist prove helpful in reducing error, improving therapeutic outcomes and limiting the risk of abuse and diversion of opioids?

Table 1. Example of a possible comprehensive checklist for prescribing opioids (‘SCRIPT – SAFE‘ checklist for safe opioid prescribing).

Prescription component	Individual checklist or reminder items
Safe Checklist	Legible handwriting or printer-generated^† Reviewed for clarity and any possible ambiguity^† No abbreviations used for drug names Limit other abbreviations, and do not use any error-prone abbreviations^‡ All decimal points clearly visible^§ No zero used following a decimal point^§ Use zero before decimal points for doses less than one (e.g., 0.5 mg)^¶ Possible sound- and look-alike drug names rechecked^#	Calculations include dose equation and final calculated dose^†† Calculations independently double checked by second individual whenever possible^†† Telephone/verbal order for opioids should be avoided. When use is essential, have the listener transcribe the order and read back what was transcribed (not repeat back)^‡‡ If used, telephone/verbal orders for opioids must be given by clinician (e.g., MD, RN, PA)^§§ Use e-prescribing if available
C omplete Checklist	Patient full name and second unique identifier such as date of birth^¶¶ Patient address for outpatients Printed prescriber name, address and phone/contact number	Date of prescription (and time for inpatient) All other legal requirements DEA number and appropriate provider number(s) Prescriber signature
R eference review (reminder)	Check prescription dose regimen and therapeutic plan in a medical/drug therapy reference^##
I nformation sharing with other providers (reminder)^†††	Indication for use of opioid and therapy goals Allergies, sensitivities and reactions Weight when less than 50 kg or above 100 kg Significant risk of abuse	Coexisting disease/physiologic states Concurrent drug therapy Special patient considerations Special warnings/concerns
P rescription Checklist	Full drug name in machine-printed type or hand-printed in block letters with both generic and brand names. Include suffix, if any, with brand name Generic name dosage form spelled out^‡‡‡ Dose in “mg” units, not package unit or volume only^§§§ Route of administration spelled out (not abbreviated) Dose frequency spelled out (not only “as directed”) Specific indication for administration (always include when prescribed “as needed”)	Allergies and sensitivities listed Abuse ‘resistant‘ dosage form specified if needed? Concentration of liquid medication to dispense? Complete and specific instructions for use in terms the patient understands
T reatment plan (reminder)	Based on thorough patient assessment Considers coexisting disease states/physiologic states Considers current and past medication history Includes appropriate nonpharmacologic therapy	Includes nonopioid analgesics when appropriate Document patient assessment Document plan and rationale for unique modification
S upply Checklist	Prescribe the minimum amount of doses appropriate^¶¶¶ Specify amount to dispense per prescription in both Arabic numerals and spelled out (e.g., 30 [thirty])^### Specify maximum daily dose allowed	Specify number of refills to be provided in both Arabic numerals and spelled out (e.g., 2 [two]) If no refills, write “no refills”
A buse/misuse and diversion (reminder)	Universal precautions for opioids applied^†††† Assess risk for abuse/misuse^†††† Assess risk of diversion/home environment^†††† Assess risk for self-harm Assess home environment^††††	Plan what to do if patient loses medication Plan for handling requests for early refills Plan for patient to discard unused doses^‡‡‡‡ Is the patient‘s pharmacy known to you?
F ollow-up plan (reminder)	Includes date set for follow-up visit Includes appropriate components of follow-up Includes measure of treatment success	Includes plan for treatment failure Includes plan for managing adverse events Includes plan for discontinuation
E ducation and patient understanding (reminder)	Provide as written document at proper reading level Patient and/or their care providers understand therapeutic plan and goals Patient/care provider knows what to expect from medications Patient/care provider understands potential adverse effects and actions to take to avoid/manage them Patient/care provider understands risk of misuse/abuse	Patient/care provider understands actions to take if adverse event occurs Patient/care provider understands safe handling of dosage form (e.g., measuring liquids, placing patches, disrupting controlled-release oral dosage forms) Patient/care provider understands need for security/safe storage and disposal of medication^§§§§

† Legibility, clarity and ambiguity are subjective – review your prescription and ask yourself if it could be misread or misinterpreted. Re-evaluate your practice when your prescriptions are misread or misinterpreted.

^‡For list of error-prone abbreviations see Institute for Safe Medication Practices (ISMP) [102] – especially ‘APAP‘ for acetaminophen, which most patients will not recognize if pharmacy places on Rx label. This could lead to dangerous duplicate acetaminophen dosing if simultaneous over-the-counter therapy.

^§Trailing zero example “5.0” – decimal might not be seen resulting in interpretation as “50” resulting in tenfold overdose.

^¶Always use leading zero before decimal point example: “.5” since decimal might be missed and read as “5” resulting in tenfold overdose.

^#For list of confusing and sound-alike/look-alike drug names see [103].

^††Calculation errors are one of the most common types of prescribing errors. Errors occur with both the equation used and in the calculation of a dose. Providing both allows others to check appropriateness of both.

^‡‡The purpose of ‘read back‘ is to confirm accurate transcription of the prescription. Repeat back is not acceptable since your prescription may be heard correctly but transcribed incorrectly.

^§§Do not allow nonprofessionals to transmit your verbal/telephone opioid orders or prescriptions.

^¶¶Always provide at least two identifiers (e.g., name and date of birth, address and phone number).

^##Use medical reference to specifically check problem-prone prescription components: starting doses in opioid-naive patients; doses in pediatric patients; doses requiring calculation of a dose; doses in patients with altered renal or hepatic function; doses in elderly; potential drug–drug interactions; equi-analgesic dosing for patients moving from one opioid to another; equi-analgesic dosing for patients moving from one route of administration to another; dosing in patients moving from one dosage form of the same drug to another; opioids with multiple dosage forms and routes of administration; simultaneous use of long-acting and short-acting drugs for breakthrough pain or ‘rescue‘; prescribing methadone or transdermal products; infrequently used and complicated treatments.

^†††Make important information to other care providers – pharmacists, nurses, physicians. Information and complete directions will help other providers (e.g., nurses, pharmacists, physicians, psychologists, physical therapists). Complete directions can also help the pharmacist confirm the drug regimen prescribed.

^‡‡‡Avoid using abbreviations for dosage forms with generic names such as “IR”, “ER”, “SR”, “TD”. These abbreviations are not standardized and have different meanings with different drugs. With generic name use “standard release”, “delayed”, “extended release”, “sustained release”, “tablet/capsule”, “transdermal system/patch”, “oral liquid”, “buccal tablet” etc. When using the brand name of a drug always assure that appropriate brand name suffix, if any, is included, so that appropriate dosage form may be discerned by the nurse or pharmacist.

^§§§Use of volume only to prescribe a drug is error prone. For example, never use “take 5 ml” or “one teaspoonful” – rather specify the “mg” dose such as “Take 5 mg”, or if concentration of drug is known, provide both as confirmation, such as “Take 5 mg (5 ml)”. Avoid using teaspoonfuls, tablespoonful, drops, etc.

^¶¶¶The number of doses allowed per prescription should be based on the usual expected doses used per day and minimum duration pain, or time to follow-up encounter.

^###Arabic numerals are easily manipulated – a prescription for “20 tablets” can easily be changed to “120 tablets” by simply adding a “1” in front of the 20.

^††††See [2] available at [104].

^‡‡‡‡National Council of Patient Information and Education. Tips on safe storage and disposal of your prescription medications. Available at [105].

^§§§§US FDA. Disposal of unused medications: what you should know. Available at [106].

DEA: Drug Enforcement Agency; ER: Extended-release dosage form; IR: Immediate-release dosage form; MD: Medical doctor; PA: Physician‘s assistant; RN: Registered nurse; SR: Sustained-release dosage form; TD: Transdermal.

Table 2. Example of a possible short checklist for use when executing opioid prescriptions (‘PAINEDx4 –R‘ checklist for safe opioid precribing).

P	P atient full name and second unique identifier such as date of birth. Include patient address for outpatients
A	A mount of dose units prescribed to be dispensed is minimum necessary
I	I nstructions are complete and specific for use in terms the patient understands including dose to be taken, frequency of dosing and reason for use (never only “as directed”)
N	N o abbreviations used for drug names and No missing zero before a decimal point and No zero used following a decimal point
E	E quations for doses and final calculated dose included
Dx4	D rug, Dose unit, Dose to be taken and Dosage form clearly specified Drug name: provide both the full generic and brand names and include name suffix, if any, with brand name Dose unit in “mg” units (e.g., 5 mg tablets) – not package unit or volume only^† in machine-printed type or hand-printed in block letters for clarity Dose to be taken in total “mg” amounts, and if more than one dose units, also include the number of dose units to be taken per dose (e.g., “10 mg [two] tablets”) Dosage form: tablet/capsule, oral liquid, patch or sustained release
-R	Refills prescribed only when clearly needed – then specify number of refills to be provided in both Arabic numeral and spelled out (e.g., 2 [two]), if no refills, write “no refills”, not “0”

† Use of volume only to prescribe a drug is error prone. For example, never use “Take 5 ml” or “One teaspoonful” – rather specify the “mg” dose such as “Take 5 mg”, or if concentration of drug is known, provide both as confirmation, such as “Take 5 mg (5 ml)”. Avoid using teaspoonfuls, tablespoonfuls, drops, etc.

Acknowledgements

The authors would like to thank MR Cohen and S Paparella for their insightful and invaluable suggestions on this article.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.