Fall Risk Awareness and Experiences Among Adult Users of Opioids in Denmark: A Community Pharmacy‐Based Questionnaire Pilot Study

In 2024, 365 000 Danes redeemed at least one opioid prescription, with more than half being aged 65 years or older [1, 2]. Use of opioids is associated with increased fall risk, fall-related injuries and fractures [3], particularly among older adults [4]. Falls affect about one-third of people aged ≥ 65 annually [5] and can have serious consequences, including a decrease in functionality, problems with self-care [6] and mortality [7]. A recent systematic review found a prevalence for use of any fall-risk increasing drug at the time of fall-related injury among older adults between 65% and 93%, with a prevalence for opioids between 4.4% and 21% [8]. In Denmark, falls requiring hospital admission occur at rates of 74.6 and 38.4 per 1000 person-years among women and men aged 65 and older, respectively [9]. It is thus essential to increase falls awareness among users of opioids. Studies have shown that users of opioids have concerns about opioids' side effects, including addiction, but varied or no awareness of opioids' fall risk [10, 11]. To our knowledge, no previous studies have investigated fall experience and knowledge regarding opioids' fall risk among users of opioids in a Danish setting. Such information is crucial to improve and secure fall prevention. With this pilot study, we aimed to explore characteristics, opioid use and experienced falls among Danish adult users of opioids. We further explored their knowledge about the association between opioid use and fall risk. This was a questionnaire-based pilot study exploring the fall risk awareness and experiences among adults redeeming prescriptions on opioids at nine community pharmacies across Denmark. An invitation was sent to all members of the Danish Network for Research and Development in Pharmacy Practice through e-mail and posted on the network's Facebook page [12]. Pharmacies interested in study participation received additional information regarding the project and data collection process. A contact person from each participating pharmacy had an online video meeting with one author (J.M.R.) before data collection initiation, receiving detailed information about the project. The questionnaire was based on literature on opioids' fall risk [4] and the project group's expertise and experience within opioid use, falls and previous community pharmacy-based questionnaires [13-15]. The first draft of the questionnaire was piloted by J.M.R. at one community pharmacy. Individuals aged ≥ 65 years redeeming an opioid prescription were interviewed about question clarity and relevance and whether they felt uncomfortable about the questions. Based on their feedback, the questionnaire was adjusted and underwent a second pilot test at two community pharmacies. During the first pilot test, we encountered that it was difficult to recruit individuals aged ≥ 65 years, mainly due to relatives redeeming their opioid prescriptions. For the second pilot test and onwards, we therefore decided that individuals aged ≥ 18 years redeeming an opioid prescription for themselves were eligible for study participation. Based on the feedback from the second pilot test, the questionnaire was adjusted into a final version. An English version of the questionnaire is available in Appendix A. Data were collected from September to November 2024. All pharmacies collected data over a period of 10 working days (excluding weekends). Community pharmacy staff, including pharmacists, pharmaconomists and students, invited eligible individuals to participate in the study, read the questions out loud and entered participant responses directly into the online data collection tool REDCap [16]. By the end of the data collection, the pharmacies provided sales statistics. Data were analysed using descriptive statistics. The pilot study was registered in the repository of Region of Southern Denmark (24/32296). The Regional Committees on Health Research Ethics for Southern Denmark waived registration (S-20242000-128). All participants gave verbal consent and received a written document containing details about the project and their rights as participants. The study was conducted in accordance with the Basic & Clinical Pharmacology & Toxicology policy for experimental and clinical studies [17]. Nine community pharmacies across Denmark invited 204 individuals to participate in the pilot study, of which 78 (38%) accepted. Of those, 21 were excluded as they redeemed the prescription on behalf of a relative, meaning that 57 adult users of opioids were included. The participating community pharmacies represented three out of five regions in Denmark. More than half of users were women (63%; n = 36), three in four were aged 50–79 years (72%; n = 41), the majority were prior opioid users (81%; n = 46), half had been taking their current opioid treatment for > 12 months (47%; n = 27), and the majority used opioids for chronic pain (65%; n = 37) (Table 1). Users most often redeemed prescriptions on tramadol (35%; n = 20), followed by morphine (25%; n = 14) and oxycodone (19%; n = 11). The majority of prescriptions included conventional tablets (54%; n = 31) and extended-release tablets (49%; n = 28), whereas few included patches and oral drops (n < 5) (data not shown). Half of users reported consistent daily use of opioids (47%; n = 27), followed by as needed use for breakthrough pain (28%; n = 16), and a combination of consistent daily use and as needed use (14%; n = 8). Half of opioid users reported awareness of potential side effects (49%, n = 28), most often constipation (25%; n = 14), nausea (16%; n = 9), and drowsiness (14%; n = 8), whereas only a few (n < 5) spontaneously reported awareness of falls (Table 2). When asked directly about falls as a potential side effect, one-third of users reported awareness of this (32%; n = 18). Among those aware of increased fall risk, the most frequent source of information was their physician (14%; n = 8) (data not shown). One in four users reported that they felt they lacked information about potential side effects of opioids, including falls (26%; n = 15). Among those, the most wanted sources of information were physician/nurse (21%; n = 12) and community pharmacy staff (14%; n = 8) (data not shown). One tenth of users reported having experienced a fall during their opioid treatment (11%; n = 6) (Table 2), with < 5 having experienced this more than three times within the last year (data not shown). Few reported having taken any precautions at the initiation of opioid treatment to avoid falls (12%; n = 7). In this pilot study of Danish adult users of opioids, we found that the majority were prior users, who most often used tramadol with predominantly consistent daily use. Half of users were long-term users. One-third of users reported being aware of opioids' fall risk when asked directly; however, only few reported awareness of fall as a potential side effect to opioids by themselves. One-tenth of users reported having experienced a fall while using opioids. The strengths of this pilot study are the inclusion of community pharmacies from both rural and urban areas, use of participants' feedback during questionnaire development and multiple pilot tests. The study also has several limitations. We had a small sample size affecting the generalizability of the pilot study. Further, our study might be subject to selection bias due to a low response rate (28%). The validity of our findings would likely have been improved with a larger sample size. Multiple factors might explain the low response rate. First, users might not redeem their own prescription of opioids due to pain, and only those redeeming a prescription for themselves could complete the questionnaire, which could lead to exclusion of the most vulnerable users. Second, not all users were invited to participate in the questionnaire. Derived from the sale statistics provided by the participating community pharmacies, 27% of individuals redeeming a prescription on opioids were invited to participate (range 13%–42%), the main reason possibly being the pharmacies' delivery of opioids to the user's home. Use of opioids, fall-risk knowledge and fall experience reported in the study are self-reported by users; hence, the results might not reflect the actual tendencies among the entire population. In addition, the reported falls could be due to other factors than opioid use, such as use of other medication, alcohol consumption, decreased mobility or cognition. Self-reported fall experience among users provides a risk of recall bias. Our questionnaire-based study might be subject to the risk of social desirability bias, that is, users responding to what is considered socially acceptable. Both new and long-term opioid users were included to capture complementary perspectives. Long-term users provide insights into prior falls while using opioids, whereas new users provide a perspective on initial exposure to opioids. Both groups yield information on whether they received guidance regarding opioid's fall risk and, if so, from which resources. We found that only a few users reported to know fall as a side effect to opioids by themselves and one-third of users reported to know opioids' fall risk when asked directly. This aligns with the findings from recent studies investigating opioid users' perspective on opioids [10, 11]. The differences in the number of users who mention fall by themselves or when asked directly might reflect that users might not perceive fall as a traditional side effect of opioids; however, they are aware that using opioids could result in a fall. One-tenth of users reported having experienced a fall while using opioids, which aligns with findings in a cohort study investigating the age-related risk of serious fall events among opioid users [4]. However, outcomes in the cohort study were identified using International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes. Thus, falls not resulting in contact with healthcare professionals would not be identified. Medication review is important in older adults but at the same time complex due to the need to weigh the potential benefits against possible side effects such as falls. Since opioids are among the recognized fall-risk increasing drugs [18], these are important to include in a medication review. However, in a recent systematic review and meta-analysis on fall outcomes and medication review, it is emphasized that medication review should not stand alone in fall prevention [19]. Furthermore, the recent World Falls Guideline recommends that a medication review and appropriate deprescribing of fall-risk increasing drugs should be part of multidomain falls prevention interventions with Grade 1B evidence [20]. Considering this is a pilot study, our findings should be investigated on a larger scale to confirm the results, which include a longer data collection period, data on educational level, co-medication use and alcohol consumption. Despite this, our findings suggest that Danish users of opioids have limited knowledge regarding opioids' fall risk, whereas the majority of users do not perceive that they lack knowledge regarding potential side effects of opioids, including falls. Despite this, it is important that healthcare professionals, especially those treating older adults, inform users about the associated fall risk due to the serious consequences of a fall [7]. Our study emphasizes the need to raise awareness of fall risks associated with opioid use, for instance, through national campaigns and initiatives. Previous focus on the rational use of opioids from Danish health authorities has resulted in decreased consumption of opioids [21], which could indicate that a national campaign about opioids' fall risk might be effective in preventing falls among opioid users. In conclusion, in this pilot study, we found that a minority of users of opioids reported being aware of the associated fall risk while using opioids. National campaigns are a powerful tool for raising awareness of drug risks and can be used in this context to help prevent falls, particularly among older adults. We would like to express our sincere appreciation to all users of opioids who participated in this pilot study. In addition, we would like to thank the participating community pharmacies regarding their devotion to data collection. We would like to thank the Danish Network for Research and Development in Pharmacy Practice for consultation and recruitment of community pharmacies. Finally, we would like to thank Open Patient data Explorative Network. The authors have nothing to report. J.M.R. was employed at Kerteminde Apotek, unrelated to the work reported in this article. The other authors declare no conflicts of interest. How many packages of opioids were dispensed? 1 2 3 4 5 More than 5, how many? (free text field) Is the customer interested in participating in the project? Yes No (questionnaire ends) Has the information been read out loud, and the customer accepted to participate? Yes No (questionnaire ends) Does the customer redeem the prescription for opioids for themselves? Yes No (questionnaire ends) Sex (filled out by the pharmacy staff, based on prescription) Man Woman Birth year (filled out by the pharmacy staff, based on prescription) 1995-2006 1985-1994 1975-1984 1965-1974 1955-1964 1945-1954 1935-1944 1934 or earlier Which active pharmaceutical ingredient(s) was dispensed to the customer? (filled out by the pharmacy staff, multiple answers allowed) Morphine Tramadol Codeine Oxycodone Buprenorphine Fentanyl Hydromorphone Ketobemidone Methadone Alfentanil Remifentanil Sufentanil Tapentadol Other, describe (free text field) Which pharmaceutical form(s) was dispensed to the customer? (filled out by the pharmacy staff, multiple answers allowed) Extended-release tablets Conventional tablets (non-extended-release tablets) Patch Oral drops 0 1 2 3 4 5 More than 5, how many (free text field) 0 1 2 3 4 5 More than 5, how many (free text field) If ‘patch’ was selected, how many packages of opioids as patches were dispensed to the customer? (filled out by the pharmacy staff) 0 1 2 3 4 5 More than 5, how many (free text field) If ‘oral drops’ was selected, how many packages of opioids as oral drops were dispensed to the customer? (filled out by the pharmacy staff) 0 1 2 3 4 5 More than 5, how many (free text field) Is it the first time you redeem a prescription on an opioid? Yes No Do not wish to disclose Do not know If yes, how has the physician told you to take the opioids? Consistent every day Consistent every day + breakthrough pain treated as necessary Breakthrough pain treated as necessary Do not wish to disclose Other, please describe (free text field) If no, how do you take the opioids? Consistent every day Consistent every day + breakthrough pain treated as necessary Breakthrough pain treated as necessary Do not wish to disclose Other, please describe (free text field) For how long have you been in your current treatment with opioids? 0–7 days 8–13 days 2–4 weeks 5–8 weeks 9–12 weeks 4–5 months 6–7 months 8–12 months More than 12 months Do not wish to disclose Do not know Which type of pain do you have? (multiple answers allowed) Acute pain, e.g., back pain (duration less than 3 months) Chronical pain (duration above 3 months) Pain related to operation Pain related to cancer Do not know Do not wish to disclose Other, please describe (free text field) Do you know any side effects of opioids? Yes No If yes, which side effects of opioids do you know? (Note: The customer must mention which side effects they know on their own, meaning the response options must not be mentioned to the customer, but can be used to tick off which side effects the customer mentions themself) Constipation Nausea Vomiting Drop in blood pressure when standing up Mood swings Fall Small pupils Dry mouth Dizziness Confusion Drowsiness Fatigue Other, please describe (free text field) Did you know that opioids are related to the risk of falls? (Customer was asked if reported not to know any side effects or did not mention fall as a side effect of opioids on their own) Yes No If yes, from where do you have the information regarding fall as a side effect of opioids? My physician Family/friends Campaigns from health authorities/package leaflets Information found on the internet, e.g., Min.medicin or Patienthåndbogen Own education/profession Do not know Other, please describe (free text field) Have you ever fallen while using opioids? We define a fall as one accidentally ends up lying on the ground/floor. Yes No Do not wish to disclose Do not know If yes, how many times did you fall within the past year while using opioids? 0 1 2 3 or more Do not know If yes, were you injured when falling in such a way that you required help from a nurse, general practitioner or at the hospital? Yes No Do not wish to disclose Do not know Did you take any precautions to avoid falling in connection with initiation of treatment with opioids, e.g., slip-proof loose rugs or remove loose wires? Yes No If yes, which one(s)? (multiple answers allowed) Slip-proof loose rugs Remove loose wires Slip-prof rug in the bathroom Ensure better lighting Remove loose items that one could trip Start using a cane/rollator Get up slowly from the chair/bed Moving less Start using shoes with more support Other, please describe (free text field) Do you think that you lack information about possible side effects of opioids, such as falls? Yes No Do not know If yes, how would you like to receive information about possible side effects of opioids, such as falls? Through physician/nurse Community pharmacy staff Campaigns from health authorities Do not know Other, please describe (free text field) Research data are not shared.