Non-prescription supply of combination analgesics containing codeine in community pharmacy: A simulated patient study.

BACKGROUND: The inappropriate use of non-prescription combination analgesics containing codeine (NP-CACC) has become a significant health issue in Australia. OBJECTIVE: To investigate the current management of NP-CACC direct product requests in community pharmacies located in Victoria, Australia. METHODS: A covert simulated patient (SP) method was used to observe the responses of pharmacy staff during an NP-CACC request. Four SPs were trained to complete 1 of 2 scenarios. Each scenario involved a direct product request for Nurofen Plus (200 mg ibuprofen, 12.8 mg codeine) with identical reason for use, symptoms, and medical history but varied previous product use. Scenario One (Sc1) involved a first time NP-CACC user and in Scenario Two (Sc2) the SP had used NP-CACC regularly for the past month. Each visit was documented by the SP immediately after they left the pharmacy. A NP-CACC supply score, created from 4 outcomes (pharmacist involvement, establishment of therapeutic need, establishment of safety and provision of counselling), was given to each pharmacy visit (maximum of 8) during data analysis. RESULTS: 145 pharmacy visits were completed. Both scenarios were performed in most of the 75 pharmacies visited (73 Sc1 and 72 Sc2). Treatment was provided in the majority of visits but refused in 37(24%) because the SP was unable to provide photo identification. A pharmacist was involved (directly or indirectly) in 77% of visits. Adequate questioning to establish therapeutic need occurred in 50% of pharmacy visits, safety was established in 17% of visits, and adequate counselling provided in 17% of visits. The SP scenario did not significantly affect the NP-CACC supply outcomes. NP-CACC supply scores ranged from 1 to 8, (Md = 5) with only 1 pharmacy visit achieving the maximum score of 8. CONCLUSIONS: The majority of pharmacy visits did not achieve a full score relating to NP-CACC supply, illustrating the need for improved awareness of how to assess and manage patients requesting NP-CACC.

Managing inappropriate use of non-prescription combination analgesics containing codeine: A modified Delphi study.

BACKGROUND: Misuse and/or dependence upon non-prescription combination analgesics containing codeine (NP-CACC) can result in serious physiological and psychological harms. OBJECTIVE: To explore pharmacists' and other health care professionals' ideas and views on strategies for managing NP-CACC misuse and/or dependence in a community pharmacy setting. METHODS: A 3-iteration modified Delphi study was conducted to gain the consensus view of panelists. Forty experts within the fields of pharmacy and drug misuse and/or dependence agreed to be on the panel. Questionnaires explored opinions on issues and possible strategies that could be used to manage NP-CACC misuse and/or dependence. Responses from the first-round questionnaire were summarized and reported back to panelists through the second-round questionnaire for further reflection and evaluation using a 6-point, Likert-type scale. Strategies included in the third-round questionnaire had agreement by more than 80% of panelists. Panelists provided feedback on effectiveness using a 6-point, Likert-type scale for impact. RESULTS: The response rates for the 3 rounds were 65%, 67.5% and 55%, respectively. Panelists provided 54 strategies in round 1. In round 2 there was consensus agreement with 31 of these strategies. In round 3 there was consensus that 21 strategies were expected to be effective (>80% of panelists expected the strategy to be effective, median above Somewhat Effective (4), IQD ≤1). Of these, 8 were expected to have the most impact if implemented into clinical practice (chosen by 5 or more panelists in their Top 5 for impact). The strategies identified as effective and likely to have the most impact on NP-CACC misuse/dependence in a community pharmacy setting were: utilization of a national real-time database to monitor product sales to aid identification of at-risk people (100% effectiveness, rank 1 for impact); development of a referral pathway for management of people whom pharmacists have identified as at-risk (95.2% effectiveness, rank 2 for impact), and training to improve pharmacist communication with people (95% effectiveness, rank 2 for impact). CONCLUSIONS: The high level of consensus achieved indicates that the strategies generated represent useful approaches which could be utilized to manage NP-CACC misuse and/or dependence within community pharmacy in the future.

The upscheduling of combination analgesics containing codeine: the impact on the practice of pharmacists.

BACKGROUND: Prior to the 1st May 2010 some combination analgesics containing codeine (CACC) were available for sale over the counter (OTC) in Australia with no requirement for input from a pharmacist. Since then the upscheduling of these medications requires the involvement of a pharmacist in all OTC CACC sales. OBJECTIVE: To explore how the upscheduling of OTC CACC has impacted the practice of community pharmacists. METHODS: A descriptive qualitative design was used, with data collected via face-to-face semi-structured interviews that were recorded and transcribed verbatim. The data were analyzed thematically via open, axial and selective coding. RESULTS: Pharmacists were found to monitor the supply of OTC CACC by recording sales and to intervene when they felt that the medication was being used too frequently. They perceived a number of challenges surrounding the provision of OTC CACC including; supply from other pharmacies, establishing therapeutic need, managing codeine dependent people, lacking confidence in discussing misuse with people, being unsure where to refer dependent people for help and purchaser resentment towards pharmacist involvement in all sales. People who request OTC CACC tended to be stereotyped by participants as either 'genuine' or 'misusers.' CONCLUSION: A number of challenges faced by community pharmacists to ensure the safe provision of OTC CACC and to assist codeine dependent people were identified, highlighting the need for more effective ways of monitoring the use of OTC CACC and intervening in OTC codeine dependence.

Impact of a genomic classifier of metastatic risk on postoperative treatment recommendations for prostate cancer patients: a report from the DECIDE study group.

BACKGROUND: Only a minority of prostate cancer patients with adverse pathology and biochemical recurrence (BCR) post radical prostatectomy (RP) experience metastasis and die from prostate cancer. Improved risk prediction models using genomic information may enable clinicians to better weigh the risk of metastasis and the morbidity and costs of treatment in a clinically heterogeneous population. PURPOSE: We present a clinical utility study that evaluates the influence on urologist treatment recommendations for patients at risk of metastasis using a genomic-based prediction model (DecipherTM). METHODS: A prospective, pre-post design was used to assess urologist treatment recommendations following RP in both the adjuvant (without any evidence of PSA rise) and salvage (BCR) settings. Urologists were presented de-identified pathology reports and genomic classifier (GC) test results for 24 patients from a previously conducted GC validation study in high-risk post-RP men. Participants were fellowship trained, high-volume urologic oncologists (n=21) from 18 US institutions. Treatment recommendations for secondary therapy were made based solely on clinical information (pre-GC) and then with genomic biomarker information (post-GC). This study was approved by an independent IRB. RESULTS: Treatment recommendations changed from pre-GC to post-GC in 43% of adjuvant, and in 53% of salvage setting case evaluations. In the adjuvant setting, urologists changed their treatment recommendations from treatment (i.e. radiation and/or hormones) to close observation post-GC in 27% of cases. For cases with low GC risk (more than 3% risk of metastasis), observation was recommended for 79% of the case evaluations post-GC. Consistent trends were observed in the salvage setting. CONCLUSION: These results indicate that urologists across a range of practice settings are likely to change treatment decisions when presented with genomic biomarker information following RP. Implementation of genomic risk stratification into routine clinical practice may better direct treatment decision-making post-RP.