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What is the additional information following some of the Medication Guides? This is known as the "Instructions for Use" and is generally provided to you with the Medication Guide. Will this program affect my ability to get my opioid pain prescription? One of the goals of this program is to help you understand how to use, store, and dispose of your used or unused medicine safely.

Who should I contact if I develop a side effect from my opioid pain medicine? If you experience a side effect you should contact your healthcare provider for medical advice. You are strongly encouraged to report all side effects by contacting either of the following: Is this REMS program going to keep these pain medicines from getting into the wrong hands, like teenagers and children?

One of the goals of this program is to educate patients on the safe storage and disposal of their opioid pain medicine in order to avoid anyone else taking the medicine that your healthcare provider prescribed only for you. How is this REMS program going to stop that from happening? These medicines are strong prescription pain medicines that contain an opioid narcotic and have serious safety risks associated with them, especially if taken the wrong way or not as instructed by your healthcare provider.

One of the goals of this program is to help you understand how to use, store, and dispose of your used or unused medicine safely in order to avoid overdose. I have difficulty swallowing pills. Is it okay to crush my extended-release or long-acting opioid pain medicine? NO, do not break, chew, crush, dissolve, or inject your medicine. If you cannot swallow your medicine whole, talk to your healthcare provider. Is it really okay to flush my unused opioid pain medicine down the toilet?

According to FDA, flushing selected medicines down the sink or toilet is currently the safest way to immediately and permanently remove the risk of harm from the home. When a medicine take-back program isn't available, FDA believes that any potential risk to people and the environment from flushing ERLA opioid analgesics is outweighed by the real possibility of life-threatening risks from accidental ingestion of these medicines.

You should contact your city or county government's household trash and recycling services to see if there is a medicine take-back program in your community and learn about any special rules regarding which medicines can be taken back. The FDA posts the dates for national-take-back day at: For additional information on the safe disposal of specific medications please contact the FDA at and visit the FDA's website at: Does my doctor have to be certified to prescribe me an extended-release opioid?

No, at this time this REMS program does not require your doctor to complete any new certification to prescribe extended-release opioids. However, all healthcare providers that prescribe extended-release long-acting opioids must be licensed by the Drug Enforcement Agency DEA and may have to meet other license requirements in their State.

What is the difference between extended release and immediate release opioid analgesics and their involvement in this REMS? Extended-release ER opioid analgesics are designed to provide a longer period of drug release so that they can be taken less frequently. Long-acting LA opioid analgesics, such as methadone, have a longer period of action because of unique characteristics of the drug substance, which stays in the body for a longer time.

The amount of opioid analgesic contained in an ER tablet can be much more than the amount of opioid analgesic contained in an IR tablet because ER tablets are designed to release the opioid analgesic over a longer period of time. Please refer to the FDA website at http: How will this REMS affect my methadone or buprenorphine prescription? This REMS and associated materials e.

CE credits are available for these activities. This listing is updated regularly as Providers notify the RPC of new activities. Additionally, prescribers can learn how to recognize evidence of and potential for opioid misuse, abuse, addiction, and overdose.

Can you tell me more about the safety education available for patients? Click here for PCD. Opioid misuse and abuse, resulting in injury and death, has emerged as a major public health problem.

These outcomes are more likely to occur in patients at risk for abuse or misuse, as well as with accidental or intentional improper use. Doing so will help to ensure safe use of these drugs, play an important role in addressing the growing national problem of abuse and misuse of prescription drugs, and help to achieve the goals of this REMS program.

If this national problem is not addressed additional steps may need to be taken to restrict use of these drugs. Prescribers as referenced in this REMS program encompasses physicians, nurse practitioners, physician assistants, dentists, or any other health care professionals authorized by the Drug Enforcement Administration or their State to prescribe II or III drugs. HCPs are in a key position to balance the benefits of prescribing opioid analgesics against the risks of serious adverse outcomes.

The number of credits and the length of time to complete the activity depends on the scope of the educational activity. FDA's Blueprint contains core messages for the safe use of these medications. A link to the FDA Blueprint will be available at: According to the FDA description, immediate-release IR opioid analgesics work for shorter periods of time. Examples of opioid analgesics formulated as both IR and ER products include hydromorphone, morphine, oxycodone, oxymorphone, and tapentadol.

Long-acting LA opioid analgesics, such as methadone, have a longer period of action because of the inherent characteristics of the drug substance, which stays longer in the body, and not because of special design features of the finished product. Will this REMS affect the prescribing and dispensing of methadone or buprenorphine indicated for addiction therapy? There is no required change in the current prescribing or dispensing processes for methadone or buprenorphine for addiction-based therapies.

Unlike other programs, this REMS is a Federal program, and at this time there is no certification requirement or connection to any state certification programs or requirements. However, there are several organizations that have templates available for your review to determine what is appropriate for your practice. Please refer to the websites for these organizations to obtain a sample PPA. The CE provider determines the target audience based on needs assessment they conduct. If you have any concerns regarding a Prescriber, please contact your state's medical board or other local professional governing body e.

Are there components of this REMS program that impact outpatient or mail-order pharmacy practice? Medication Guides provide information in patient friendly language about the drug's risks and how to use the drug safely. Are there components of this REMS program that impact inpatient or long-term care pharmacy practice? There is no component of this REMS program that specifically applies to inpatient or long-term care pharmacies.

However, product-specific Medication Guides should be available and provided to inpatients, upon request. The IFU should also be available in the product-specific packaging. Pharmacists should continue to counsel patients in the same manner and follow existing state-specific regulations regarding patient counseling.

Each company is responsible for providing Medication Guides in sufficient numbers to pharmacies in order to provide a Medication Guide to each patient receiving a prescription for the dispensed drug product. If additional Medication Guides are needed they can be accessed via:. Please check regularly as frequent updates will be made.

How can I determine which product-specific Medication Guide is the correct one to dispense? The existing process for identifying the appropriate Medication Guide to dispense to a patient receiving any medication that has a Medication Guide has not changed. This is important because information may have changed since their last prescription.

Pharmacists will have product-specific Medication Guides to provide safe use information to patients. If patients are seeking additional information, they should be referred back to their healthcare provider who prescribed the medication. Medication Guides are product-specific and include both common language regarding opioid risks and risks specific to the product.

Patients should be referred back to the healthcare provider who prescribed the medication. What will prescribers and patients need to know about this REMS program?

Prescribers should also review and provide patients with the Patient Counseling Document. Patients - The REMS will also include a Patient Counseling Document that prescribers can review and provide to patients to help them understand safe use and their responsibilities associated with using these products.

Can we also receive CE credit? The RPC recognizes that pharmacists are an important member of the patient care team, and as such, has supported a broadly-accessible online REMS-compliant educational activity that will be available by September All information related to the grant application process can be accessed at www. If I am a CE Provider, what is the process for applying for grant monies?

There will be a finite pool of resources available each year. Information will shortly be available at www. Go to the specific Accreditor's website for detailed information on the accreditation process.

The husband presents requesting repeat pain killers for his wife who is 52 years of age. Unfortunately, your colleague has not completed the sections in the medical record on past history, medications or allergies. Since moving here and unpacking the furniture she has had severe pain and has had no sleep at all. She had a breast lumpectomy and radiotherapy 6 months ago. Her neck is rigid with marked muscle spasm. You prescribe oral morphine and order a bone scan.

On review, they are delighted that she has finally been able to get some sleep, but unfortunately the scan shows bony metastases. A psychiatric history should consider diagnoses including depression and somatisation, as well as a history of trauma, and physical, emotional and sexual abuse in either childhood or adulthood.

A suicide assessment should be performed. It is important to remember that depression and pain can trigger and perpetuate each other. This is not simply to allocate diagnoses such as abuse, addiction or dependency — which all may well change with the fifth version of the Diagnostic and Statistical Manual of Mental Disorders DSM-V. Ask specifically about pharmaceuticals including opioids or benzodiazepines. Has there ever been hoarding or diversion, eg. Has there been use other than prescribed, eg.

This may include over- or under-consumption, topping up with other drugs or pills, or tampering with tablets or patches. Tampering turns slow release formulations into immediate acting ones for smoking, swallowing or intranasal or intravenous consumption. The physical examination should aim to clarify the pain diagnosis, monitor therapy effects and side effects, assess any opioid misuse risk and observe the behavioural responses to physical examination.

Beware the tendency to over-rely on non-verbal indicators of pain eg. Look for signs of intoxication or substance withdrawal.

Respectfully but firmly explain you must inspect areas of potential intravenous access, including the upper limb, the femoral vein area, the feet and ankles and the neck Figure 1. Initial and regular assessments should employ measures such as the Brief Pain Inventory, which is freely available online see Resources.

Better documentation than that shown in Case study 2 assists longitudinal diagnosis and continuity of care, and may minimise potential regulatory or medicolegal risks.

A full initial assessment and planning for holistic care for a patient with chronic pain as described can be time consuming.

These could include a time-based item for each prescription, and where appropriate, accessing care plans, team care arrangements, mental health plans, medication reviews, health assessments and multidisciplinary case conferences. The neck of a patient who has been injecting the oxycodone her GP had been rescribing to her mother for cancer pain. However, the inherent limitations of such approaches need to be clearly discussed with the patient. Some non-pharmacological therapies are listed in Table 1 and many should be possible to implement in most general practice locations.

One US study of primary care patients with both pain and depression, found psychotherapies compared to usual care increased the likelihood of significant pain improvement by 2. There is an increasing interest in the practice of yoga for chronic pain management. Yoga assists with flexibility, core stability, psychological training and spiritual development: Non-opioid pharmaceutical strategies may include omega-3 fish oil, paracetamol, non-steroidal anti-inflammatory drugs NSAIDs , anticonvulsants, topical therapies and disease specific therapy such as sumatriptan for the treatment of migraines.

Doses tend to be lower than those used for depression eg. The use of evidence based consensus guidelines can help GPs to manage patients according to current best practice.

The Australian non-industry sponsored guideline Opioid use in persistent pain: Information for health professionals 8 is available free online see Resources. In analgesia, relying on ad hoc judgements reflects cultural stereotyping and is frequently inaccurate. For this reason, if analgesia is to include opioids, it cannot be just a simple matter of a prescription.

The ORT is available online see Resources. However, you still have to deal with misuse among genuine pain patients and pain among genuine drug addicts. If analgesia is to include opioids, this requires negotiation, constant monitoring and dealing with the psycho-emotional effects of both the pain and the analgesics. Intermittent prescribing for acute pain creates a subtle inertia to simply continue prescribing as the pain becomes chronic, despite a lack of scientific evidence for such ongoing use.

The current trend is to recommend time-limited rather than lifelong opioid use unless the opioid is used in terminal care. The aim of time-limited opioid use is to create breathing space in which the patient can develop active management approaches. A urinary drug screen is a good tool to use initially and regularly.

While some misusers may purchase a urine sample or even deliver it through a penile prosthesis, it may pick up a few surprises or reveal the absence of the drug that was prescribed. Be aware that oxycodone, fentanyl and buprenorphine are often omitted from routine immunoassay screens and analysis for these drugs with gas chromatography-mass spectrometry may need to be specifically requested, involving additional time and cost. It is important to find out what is required to meet individual state regulations, such as obtaining a prescribing permit.

A real-time online prescription surveillance system has been successfully piloted in Tasmania, and in the future should be rolled out across Bass Strait. Until this is available, for doctors on the mainland the PSIS remains a vital resource and GPs should register and routinely check it. Unfortunately, this limited and delayed service overlooks private prescriptions, prescriptions from specialists or dentists and identity fraud.

You can also access a complete list of PBS prescriptions for an individual patient, albeit retrospectively, from Medicare see Resources. A patient centred care plan or contract, either written or verbal, educates about entry and exit strategies, informs consent and may cover boundaries and goals, benefits and harms Table 2 and Resources. Two-way communiation takes time and should improve pain assessment and decrease overprescribing: You decline as last week she injected three of her pain tablets and required admission for 4 days for assessment and management of abdominal pain, hallucinations, agitation, aggression, incoherence and dyspnoea.

Necessary sedation included midazolam, diazepam, morphine, clonazepam and haloperidol. She required airway management as her Glasgow Coma Score was 8. Her child has since been removed by the Department of Community Services. However, I am committed to give you the best care I can. This does not involve continuing chaotic use of pain killers.

However, I can help you find stability and control with regular opioid doses like in a methadone program. Then together we can work on the broader issues of the pain and getting your life and family back together again.

Will you come back in tomorrow so we can meet to discuss it? Opioid rotation has been used to deal with tolerance and escalating doses. However, the evidence is poor unless one is rotating to an opioid substitution program. As such, they should be used cautiously, as indiscriminate use in patients with chronic non-cancer pain may risk an overdose. A panel beater, 42 years of age, fractured his pelvis and femur in a motorbike accident 3 months ago. He was discharged from hospital on 40 mg slow release oxycodone twice daily, 28 tablets of which have been prescribed regularly seven times.

Today he presents requesting his next prescription. You can see that he is neither getting on with his life, nor getting any relief from his pain. What could you say? My fractures are real, Doc, and my pain is real and they said they may need to replace the hip. I just need to increase the dose until then.

It would be magic if one medication could cure it. But you are already on a dose of opiates that would flatten most people and they clearly are not working. We need to look at some longer term options to manage your pain that are much safer than narcotics. He has lost some weight and reports more energy and a clearer head without the sweats or constipation. He has returned to selected work duties and is swimming more and walking.

Abrupt termination of long-term prescribing may be regarded as an abuse of power and should be avoided unless in response to violence or criminal activity. Prescribers need to become as comfortable weaning patients off an opioid trial as they are at initiating one. There is no evidence-based recommended rate.