Primary care review of Tramadol Prescribing Aim of the Audit To ensure the prescribing of tramadol is safe, appropriate and regularly reviewed, in line with local chronic pain guidelines 1 Background Tramadol is licensed for treatment of moderate to severe pain. However, it has not been shown to be either more effective or better tolerated than other weak opioid analgesics such as codeine. For severe pain, strong opioids are more effective. In 1996 the CMS stated that tramadol should only be used for moderate to severe pain. 2 In May 2012 Aneurin Bevan Health Board s Medical Director wrote to all practices highlighting his concerns with the high rate of Tramadol prescribing in Gwent. This was prompted by information from the Gwent Drug Related Deaths Review Panel who were concerned with the number of individuals dying from primarily illicit opiate overdoses who were also being prescribed or were acquiring Tramadol. In addition the Gwent Specialist Substance Misuse Service (GSSMS) reported increasing numbers of patients being referred for Tramadol addiction. GSSMS also had anecdotal reports of readily available supplies, primarily from people who continue to acquire repeat prescriptions but then stockpile the medication, treating it as a standard painkiller very much like paracetamol. They also reported anecdotal evidence of its use in gyms to allow people to exercise for longer. More recently, a report from the All Wales Therapeutics and Toxicology Centre 3 analysing data from 2012 shows that Tramadol items have increased by 21% between 2007 and 2012. with Tramadol now accounting for 43% of total opioids prescribed. The report also highlighted that Aneurin Bevan Health Board is the highest prescriber of Tramadol in Wales with three of the localities, Blaenau Gwent, Caerphilly and Torfaen in the top 5 highest prescribers. A recent article in the BMJ 4 noted that the Advisory Council on the Misuse of Drugs has recommended that UK government should make tramadol a controlled class C substance that carries a potential fine and prison sentence for anyone found using it without a prescription or dealing in the drug, after conducting a review in response to the rise in deaths from misuse of the drug. The council, which advises the government on issues related to drugs, reviewed the harms associated with the non-medical use of tramadol after NHS reports showed increasing misuse. Deaths in which tramadol was mentioned on death certificates rose from 83 in 2008 to 154 in 2011, most of these deaths were of people who had obtained tramadol without a prescription for it.
TOP 25 ABHB Practices - Tramadol DDDs Per 1000 PUs Mar Qtr 13 1,800.00 1,600.00 1,400.00 1,200.00 1,000.00 800.00 600.00 400.00 200.00 0.00 HOSSAIN SA FAKANDE OL JAMES LLAN N RUDLING J L GODWIN C EVANS AD BOSE MK EDWARDS DM THOMAS AJ SYAL KG STANIFORTH J PRIOR G JONES C JOHNSON DA LOHFINK A POTTS TM KUNJU MY JAMES N KAUSHAL SC PHILLIPS CW McGARRIGLE AP DAVIES K HENEGHAN SJ KHAN AU WAHEED A DDDs Per 1000 PUs Mar Qtr 13 KEY PRESCRIBING POINTS Tramadol should only be prescribed if side-effects with ABHB first-line weak opiates, codeine / co-codamol (Analgesic ladder Appendix 1) Tramadol (or any other weak opiate) should not be co-prescribed with strong opiates When using tramadol for persistent pain, tramadol MR at regular intervals should be prescribed as clinical experience suggests that immediate release preparations are more associated with tolerance and problem drug use 5. In order to minimise the risk of dependence it is important that 6 : Treatment with Tramadol is short and intermittent Tramadol should only be used for moderate and severe pain Tramadol should be used with great caution in patients with a history of addiction or dependence In order to minimise the risk of convulsions it is recommended that: Patients with a history of epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling reasons Tramadol should be used with caution in patients taking medication that can lower the seizure threshold, particularly SSRI s and tricyclic antidepressants A recent pilot of this audit in 114 patients from three practices highlighted that contrary to the recommendations above, - Tramadol is being prescribed long-term i.e. >5 years - Sub-optimal use of other non-opioid and other weak opioid analgesics prior to Tramadol being initiated - Tramadol is being co-prescribed with other weak and strong opiates - Lack of regular analgesic review - Tramadol use in patients with addiction and alcohol dependence
References 1. ABHB Pain Ladder, stepwise recommendadtions for primary and secondary care. http://www.wales.nhs.uk/sites3/documents/814/painladder-abhbnov2012.pdf 2. In focus: Tramadol (Zydol, Tramake and Zamadol). Curr Problems Pharmacovigilance 1996; 22:11. www.mhra.gov.uk/publications/safetyguidance/currentproblemsinpharmacovigilance/con007485. 3. Welsh Analytical Prescribing Support Unit, All Wales Therapeutics and Toxicology Centre. NHS Wales Primary Care Prescribing Analysis: Tramadol 2013 4. http://www.bmj.com/content/346/bmj.f1264 accessed 20/6/13 5. http://www.britishpainsociety.org/book_opioid_main.pdf accessed 24/6/13 6. CSM/MHRA. Current Problems in Pharmacovigilance. 1995; 21: 2
Appendix 1 ANALGESIC LADDER FOR PRIMARY CARE USE MILD intermittent prn PARACETAMOL 1g qds MILD constant Regular PARACETAMOL 1g qds + prn NSAID* (IBUPROFEN 400mg tds) MODERATE Regular PARACETAMOL 1g qds + Regular NSAID* (IBUPROFEN 400mg tds) consider co prescribing a ppi + PRN/regular CODEINE PHOSPHATE (varying preparations are available start with the lowest dose possible) SEVERE Regular PARACETAMOL 1g qds + Regular NSAID* (IBUPROFEN 400mg tds) + MORPHINE modified release (prescribe BY BRAND) twice daily Stop weak opioid and consider co prescribing an antiemetic and/or laxative(s) Strong opiates should only be used/considered in accordance with local guidance on the Use of Strong Opiates in Chronic Non malignant Pain 2010: http://www.wales.nhs.uk/sites3/documents/814/opioidinn onmalignantpain GwentGuidance%5BFinal%5DJan2010.pdf See also: Opioid medicines for persistent pain information for patients. British Pain Society January 2010 http://www.britishpainsociety.org/book_opioid_patient.pdf Additional Notes: Ensure that patients expectations are managed acute onset pain should only require a short period of analgesia/treatment. Chronic pain is not about CURE but MANAGEMENT. Total pain relief is not often achieved. Consider non pharmacological factors e.g., anxiety, lack of information, TENS, need for physiotherapy and role of alternative therapies. Useful tools are The Pain Toolkit http://www.paintoolkit.org The Back Book http://www2.nphs.wales.nhs.uk:8080/backbookrequests.nsf/mainform Expert Patient Programmes http://www.wales.nhs.uk/expertpatient *NSAID Stop if regular NSAIDs give no benefit Contra indications History of hypersensitivity to aspirin/nsaids Active GI ulceration or bleeding Severe heart failure, hepatic failure & renal failure Coagulopathy Anti coagulants Last trimester of pregnancy Caution in Asthma Elderly (reduce dose) Renal impairment CVD (and in those at risk of CVD) Codeine phosphate Avoid if severe constipation Tramadol 50 to 100mg qds is alternative Ensure that the need is reviewed regularly Ensure dose is titrated to maximum before switching to stronger opioid Ensure that the pain is nociceptive in nature; is the pain neuropathic? A neuropathic agent may then be more appropriate. See local guidance on Diagnosis and Management of Neuropathic Pain 2008: http://www.wales.nhs.uk/sites3/documents/814/neuropat hicpainguidance%2dgwentnov09.pdf
Data Collection Run search to identify patients currently prescribed Tramadol including brands and combination products (on acute within the last 4 weeks or current repeat); Exclude patients with terminal illness Collect data using form Appendix A (10 patients per 1000 practice list size, maximum 50 patients) Complete the the audit summary table (Appendix B) and return to locality pharmacy team by 31 st March 2014
Appendix A: Tramadol Data Collection Practice: Date: Patient ID / Age Drug / Dose Qty / month No. scripts in last 6m Acute or Repeat Initiated by; GP / Sec Care Indication Previous analgesia for same indication Other analgesia History of addiction or dependence Relevant comorbidities or medication i.e epilepsy, Tricyclics, SSRIs Comments
Appendix B: Audit Summary Sheet (Part 1) Review of Tramadol Practice name: Audit date: Practice list size: Number of patients on tramadol (acute + repeat): Number of patients on tramadol reviewed: Patient Age Age Under 40 40-49 50-59 60-69 70-79 Over 80 Number of patients Repeat / Acute Number of Repeat Rx: = Number of Acute Rx (regular acute) = Who initiated? Number initiated by GP: Number initiated by Secondary Care: Form and dose prescribed Form Dose Number 50mg Cap 1-2 MDU 1 BD 1 TDS 1-2 QDS 2 NOCTE 100mg MR BD 200mg MR BD Qty prescribed Qty < 30 30 31-59 60 200 Number
Average total daily dose (based on qty prescribed and number of scripts issued over 6 months) Av. Total Daily Dose < 50mg 50mg 100mg 100mg 200mg 300mg 400mg Number Indication (List all) Previous analgesia for same indication Drug Weak opioid (co-codamol, co-dydramol, coproxamol, dihydrocodeine, codeine) NSAID Paracetamol Strong Opioid (morphine, fentanyl) Patients who had not previously tried other analgesia Number Concomitant analgesia Drug None NSAID Paracetamol Weak opioid (co-codamol, codeine, DHC) Neuropathic agent DMARD Number Number of patients with History of addiction = Number of patients with epilepsy = Number of patients prescribed concomitant medication that could lower seizure threshold = Comments:
Appendix B: Audit Summary Sheet (Part 2) Review of Tramadol Identify 3 key actions for the practice following practice discussion of audit results: 1. 2. 3. Practice: Date: Signed: Designation: Submit a copy of audit summary sheet part 1 and 2 to the locality pharmacy team by 31 st March 2014