Development of a community pharmacy-based model to identify and treat OTC drug abuse/misuse: a pilot study

G l e n d a F. F l e m i n g , J a m e s C . M c E l n a y a n d C a r m e l M . H u g h e s

Research article
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Pharm World Sci 2004; 26: 282288. 2004 Kluwer Academic Publishers. Printed in the Netherlands. G.F. Fleming: Research and Development Office, 1222 Linenhall Street, Belfast BT2 8BS, Northern Ireland J.C. McElnay (correspondence, e-mail: j.mcelnay@qub.ac.uk), C.M. Hughes: School of Pharmacy, The Queens University of Belfast, 97 Lisburn Road, Belfast BT9 7BL, Northern Ireland Key words Abuse Community pharmacy Harm minimisation Medicine misuse Non-prescription products Northern Ireland Over-the-counter products Abstract Objective: The aim of this study was to develop and pilot a harm-minimisation model for the identification and treatment of over-the-counter (OTC) drug abuse/misuse by community pharmacists. Method: Extensive consultation was conducted during the development of the model. This included an exploratory conference involving an interdisciplinary group of delegates and detailed individual consultation with a range of healthcare practitioners. Consultation with a psychologist specialising in communication skills allowed development of the communication aspects of the model. A comprehensive manual detailing the model was prepared. Results: The model is designed to be used by community pharmacists in conjunction with other healthcare professionals. It focuses on the abuse/misuse of opioids, laxatives and antihistamines and can be broadly divided into three phases, namely: patient identification and recruitment, treatment/referrals and data collection/outcome measurement. Client identification is via record-keeping which is implemented alongside an information campaign promoting safe use of OTC medicines. Once identified, the pharmacist aims to recruit clients using the developed communication strategies. Treatment depends on whether the problem is misuse or abuse and on the product. Several treatment paths are available including treatment according to an agreed protocol and referring to the GP or community addiction team (CAT). Two pharmacists were recruited and trained to pilot the model. Of the clients, 18 were identified as abusing/misusing OTC products over a one-month period. The subject of inappropriate OTC use was raised with 14 of these clients. Some success was noted in that clients agreed to stop using the product and/or to try safer alternatives. As expected, some sales had to be refused, as the client was unwilling to accept the pharmacists intervention. Conclusion: This study represents the first reported structured attempt by community pharmacists in the UK to address the abuse/misuse of OTC medication. Work is now ongoing to modify this model in light of the pilot study findings. Accepted January 2004

Introduction
A large number of medications are available in the United Kingdom (UK) for purchase without a doctors prescription. These may be referred to as non-prescription or over-the-counter (OTC) products. Although the majority are used safely, there are a number of circumstances in which they may be used inappropriately. For example, an individual suffering from a genuine medical condition may ignore the advice on the product packaging to seek medical advice if symptoms persist, and as a result, may continue to use the OTC product for a prolonged period. In other cases, indi-

viduals may increase the dosage in order to obtain improved symptom relief. Another possible scenario is that of an individual intentionally consuming high doses of an OTC product in order to experience its psychoactive effects. It is clear that the two situations are different, hence, the following definitions have been employed: OTC drug misuse: the use of an OTC product for a medical purpose but it is used incorrectly, usually in terms of dosage or duration of use; OTC drug abuse: the use of an OTC product for a nonmedical purpose. OTC products are usually abused to achieve mind-altering effects or in some cases to achieve weight loss (e.g., laxative abuse). From these definitions, it is evident that any product can be misused and as such give rise to adverse effects. A limited number of product groups, however, have been identified by pharmacists in the UK as having abuse potential, for example, opioid-containing products, laxatives and antihistamines 13. Abuse or indeed misuse of these latter product groups can have adverse effects on health resulting from the drugs themselves or from other ingredients in formulated products. There have been reports, for example, of cardiac glycoside toxicity with abuse of opioid-containing cough mixtures 47. In these cases, toxicity resulted from the consumption of the cardiac glycosides scillarin A and B, found in squill oxymel contained in the formulations as an expectorant. In another case, an individual died after prolonged ingestion of high doses of kaolin and morphine mixture 8. Many non-prescription analgesic products available in the UK contain codeine in combination with aspirin or paracetamol. Abuse/misuse of such products can result in non-opioid toxicity. It is also suggested that prolonged use of combination analgesic products, even for genuine complaints, may contribute to analgesic nephropathy 912. With regard to antihistamines, reports of abuse have centred around older, sedating products such as dimenhydrinate, diphenhydramine and cyclizine. Ingestion of high doses of these agents can cause euphoria, hallucinations, disorientation and ataxia 1315 and reported abuse cases often involve use by teenagers wishing to experience euphoric effects. Adverse effects from ingestion of high doses of antihistamines include cardiac dysrhythmias, seizures 13,1618 and psychiatric symptoms, for example, depression 19 and in some cases, psychosis 20,21. The long-term use of stimulant laxatives can have serious negative health consequences as highlighted by several authors 2227. Complications include diarrhoea, which leads to sodium and water loss. In addition, hypokalaemia, dehydration, hypotension, muscle weakness and rhabdomyolisis can occur. Hypocalcaemia and hypomagnesaemia may be precipitated, resulting in tetany. Blood may be lost in the stool and if this is sustained, anaemia can result. Renal failure as a result of hypokalaemia and volume depletion has also been reported 2830.

In order to avoid such complications, pharmacists in the UK are directed by their Code of Ethics to prevent the supply of unnecessary and excessive quantities of OTC products and where necessary, to refuse the sale 31. Research in Northern Ireland 3 found that pharmacists employ a number of strategies to limit the supply of products liable to abuse, for example, refusing the sale or keeping the product out of sight. However, these methods are of limited value and do not offer a solution in the longer term as patients may seek a supply from another pharmacy. An alternative strategy involving a harm-reduction approach has been suggested by Temple 32. In his proposal, he suggested that those individuals abusing OTC products would form a contract with an individual pharmacy. The pharmacist would supply agreed amounts of specified products, preferably on a reducing-dose basis, with full records being kept for each transaction; he suggested that the scheme would be co-ordinated by a member of the local community drug team. This harm-reduction model only considered those who were abusing OTC products and did not address OTC misuse. In Australia, a group of researchers 33 have proposed a range of communication interventions which could be used in OTC abuse cases. These are based on brief motivational interviewing techniques 34, taking account of the transtheoretical model of change 35 and are currently being tested. In view of the limited amount of research in this area, the aim of the present pilot study was to develop a harm-minimisation model for the identification and treatment of OTC drug abuse and misuse (by community pharmacists), in conjunction with other health care professionals, in two community pharmacies.

techniques prepared the chapter for the manual which focuses on the key communication issues relating to OTC drug abuse and misuse. This introduces a number of key psychological aspects and communication techniques, including the transtheoretical model of change 35 and brief motivational interviewing 34, both of which have been extensively used in lifestyle changes, e.g., smoking cessation. We considered that this would be a logical approach to changing behaviour in OTC misuse and abuse. Concepts such as the boomerang effect (whereby poorly timed interventions lead to an individual developing an increased resistance to change) and the sleeper effect (whereby a person may initially reject a persuasion attempt, but after a period of time sleeping on it, may eventually accept the message) were also introduced. This chapter in the manual stressed the importance of non-verbal communication and explored the use of non-verbal communication when detecting deception. The various strategies which can be used in persuasion were also outlined. Piloting of the model Ethical approval for piloting of the developed model was obtained from the Research Ethics Committee, Queens University, Belfast. Support for the project was also obtained from the Council of the Pharmaceutical Society of Northern Ireland and the Proprietary Association of Great Britain (PAGB). Two pharmacists were recruited to take part in the pilot study through personal contact and because of their interest in drug misuse/abuse. One pharmacy was based in a residential area within a city (pharmacy A). The other was based in the high street of a busy provincial town (pharmacy B). Training on the model and pilot project was provided for the participating pharmacists. This incorporated training in communication techniques and included the use of role-play. These were recorded and video play-back was used in order that the participants could assess their performance and obtain feedback GPs from surgeries in the locality of the pharmacies were invited to the launch of the project which incorporated a training session. This event was cancelled due to poor response from the GPs. After discussion, the project team agreed that the pilot could proceed, however, should a pharmacist need to refer a client to the GP, a member of the team would contact the GP personally in advance of the referral. The CAT based in Belfast agreed to provide specialist treatment in cases of abuse if required. The two pharmacists were asked to implement the model and to collect details on patients recruited and the outcome of their interventions. In addition they were asked to assess the health-related quality of life (SF36 36) of clients, at initiation of the treatment and at the end of treatment (or at six months in the case of prolonged treatment) and their satisfaction with the programme (custom designed questionnaire).

Methods
Development of the model The following stages were undertaken during the development of the model: An outline model was drawn up by the authors. The outline model was discussed in detail at an exploratory conference involving an interdisciplinary group of delegates (n 24) with wide-ranging expertise in community pharmacy practice and on drug misuse and abuse. Delegates included academic pharmacists, sociologists, general practitioners (GPs), health promotion practitioners, psychiatrist specialising in addiction, voluntary drug agency representatives and a former abuser. Based on the discussions at this conference, three researchers drew up a draft model. Further detailed consultation regarding the draft model was held with a local GP, community pharmacist, community addiction nurse, a consultant psychiatrist in charge of the local community addiction team (CAT) and the pharmacy inspector for Northern Ireland. A comprehensive study manual detailing the model was prepared. This included background information, information on communication techniques, treatment pathways and details relating to the pilot methodology. Due to the sensitive and difficult nature of the subject matter, the need for good communication skills is essential. A psychologist specialising in communication

Results
Harm-minimisation model The main outcome from the present research project was the harm-minimisation model. The model is designed to be used by community pharmacists in conjunction with other healthcare professionals. It consid-

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ers the abuse and misuse of opioid, antihistamine and laxative-containing product groups as these were highlighted as being problematic by pharmacists in Northern Ireland and elsewhere 13. The model is divided into three elements, namely: (i) client identification and recruitment; (ii) treatment and referrals; (iii) data collection and outcome measurement. i) Client identification and recruitment Client identification is via an information campaign and by keeping records of sales. The information campaign consists of posters and leaflets displayed in the participating pharmacies. These aim to raise awareness of the safe use of OTC medicines, to encourage customers to seek advice from the pharmacist on the safe use of OTC medicines, to highlight problems of abuse and misuse and to prompt individuals who are abusing or misusing OTC products into seeking advice. Parallel with the information campaign, pharmacists and their staff record details of requests for sales of products in the opioid, antihistamine and laxative groups. The details recorded include the clients name or description, information relating to the product, if misuse or abuse is suspected and if a sale is made. These records are carefully examined (after a maximum of one month) to assist in the identification of clients who appear to be purchasing excessive quantities of these OTC products. Once the pharmacist has identified a client suspected of abusing or misusing OTC medicines, he/she is approached. This approach utilises the communication techniques described in the manual (including motivational interviewing) and details of all approaches are recorded on a specific record sheet designed for the purpose. Individuals who do not wish to accept the pharmacists advice after a number of approaches (the number left to the professional discretion of the pharmacist / based on patient position on the cycle of change) are refused further sales of the product and other pharmacists in the area are informed of such refusals by telephone. If a client agrees to participate in the programme, demographic information and details relating to the pattern of product use are used by the pharmacist in the development of their overall treatment path. ii) Treatment and referrals The model contains two treatment algorithms showing possible treatment paths (Figures 1 and 2). The treatment path chosen depends on the product involved and if the product is being abused or misused. If a patient is identified as misusing an OTC product, the algorithm in Figure 1 is applied. This indicates when treatment by the pharmacist alone is appropriate and when referral to a GP is required. To promote local ownership, referral criteria and patient management plans are agreed between pharmacists and GPs in a particular locality, based on guidelines contained in the manual. These latter guidelines include approaches to the treatment of chronic conditions which may lead to misuse of OTC products (e.g., pain, cough), when treatment involving the pharmacist alone is appropriate and when referral to the GP is required. 284

In abuse cases, pharmacist-only treatment is deemed not to be appropriate and referral to either the GP or CAT is always required (Figure 2). An exception is where occasional or recreational use is identified in such cases the sale is refused. Where referral to the GP or CAT is required, the pharmacist arranges the appointment by telephone, while the client is present in the pharmacy and then provides the client with a written referral form. iii) Data collection and outcome measurement Once a patient has been identified and approached and has agreed to participate in the programme, individualised confidential records are initiated. These include details of the clients demographics, history of product use and treatment interventions (including details of medications dispensed). These records are updated each time the client attends the pharmacy and as such allows the pharmacist to monitor client progress and outcomes. Results of pilot study Both pharmacists ran the information campaign in their pharmacies and kept records of sales for a period of one month. They reported that the record-keeping was manageable, although, during particularly busy times, some sales may have gone unrecorded. A total of 18 clients suspected of abusing/misusing products were identified during the pilot. The pharmacists raised the subject of inappropriate OTC use with 14 of these clients. Both reported that it was easier to approach clients whom they suspected were misusing products, rather than those they suspected were abusing products. Details relating to the clients identified and approached in each pharmacy are provided below. Pharmacist A identified 10 clients she suspected were abusing/misusing OTC products. Six of those identified were females and four were males. All were regular customers and all were suspected of misusing (rather than abusing) OTC products. Of the 10, 3 were already known to the pharmacist and record-keeping served only to confirm her suspicions of inappropriate use. The remaining seven had not been suspected of inappropriate use in the past. Pharmacist A approached six of the identified clients. Of the four she did not approach, two were using co-codamol effervescent, one was using an antihistamine-containing sleep aid and the fourth was using a stimulant laxative. Table 1 provides an example of one misuse case encountered by Pharmacist A. Pharmacist B identified a total of eight clients (four males and four females; four suspected misuse and four suspected abuse cases). Six of these clients were identified from the records of sales. The remaining two clients were identified shortly after the formal keeping of records of sales had ceased due to the increased awareness among the staff of inappropriate OTC drug use. Of the clients identified by record-keeping (n 6), all were regular customers and three were already suspected of purchasing inappropriate quantities of products. The pharmacist also had unconfirmed suspicions regarding several other clients as a result of record-keeping. However, a number of factors made it difficult for her to confirm that these clients were buying OTC products in inappropriate quantities, for ex-

ample, doubt as to the identity of some of the clients due to the descriptions recorded by staff. Pharmacist B approached all eight identified clients. She experienced some negative reactions towards her advice, for example, one male client became quite angry and left the pharmacy. On another occasion a female client tried to run behind the counter and grab a bottle of kaolin and morphine mixture when the pharmacist refused the sale. Examples of misuse and abuse cases are given in Table 1. Neither pharmacist reached the stage of formally enrolling clients into the pilot project. Both pharmacists reported that they believed the clients they approached would be unwilling to provide the necessary details or to complete questionnaires. They agreed that the training in communication skills had been helpful, however, they felt a more intensive training programme on this aspect of the model was required.

Discussion
The development of the model and subsequent pilot represents the first reported use of a structured programme for community pharmacists in the UK to address the abuse and misuse of OTC medication. The project was ambitious and although several difficulties have been encountered, valuable experience has been gained. It is clear that the record of sales as an identification process was a useful tool. It enabled the participating pharmacists to identify clients who were purchasing inappropriate quantities of OTC products. It is believed that this is the first attempt in the UK to document prospectively the level of inappropriate use of OTC products, with previous methods depending on retrospective surveys of pharmacists in which they were asked to estimate the numbers of clients they suspected of abuse/misuse. Although the pharmacists did not perceive an increased number of requests about OTC use over the pilot period, it is difficult to assess if leaflets taken by customers, or indeed the posters

Figure 1 Treatment algorithm for misuse cases where misuse is defined as use of a product for a correct medical purpose, but in an incorrect manner, usually in terms of dosage or duration of use.

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prompted individuals to further consider their OTC use. Although no client was formally enrolled in the pilot project, the issue of inappropriate OTC use was raised with a total of 14 clients over the one-month client-identification period. As expected, the pharmacists advice was not always accepted and in several cases, sales of products eventually had to be refused; nevertheless, the intervention gave the pharmacist the opportunity for patient education. Indeed, if one considers the concept of the sleeper effect (i.e., the target person initially rejects a persuasion attempt, but after a period of time spent sleeping on it eventually begins to accept the message), the results of such interventions may have been more positive than recorded during the pilot study. It is possible that although the client initially rejected the advice of the pharmacist, they may indeed accept the advice at a later date. Several barriers to programme implementation have been identified during the course of the pilot. Both pharmacists reported that the model was man-

ageable, however, they reported that on occasion they missed the opportunity to record sales of certain products or to approach clients when they were busy with other customers or preparing prescriptions. Both pharmacists indicated that they lacked confidence in their approach to clients and they suggested an extension of the communication training with the inclusion of more role play situations. The lack of response from GPs to participate in the launch of the project was disappointing, however, during the present pilot, GP referral was not required and hence, this did not hinder progress. Nevertheless, with regards to further research, greater GP involvement would be preferable.

Conclusion
The harm-minimisation model developed during the present research, represents the first reported, structured attempt by community pharmacists in the UK to address the abuse/misuse of OTC medication. Although successful in a number of areas, the completion of the pilot has identified opportunities for further

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Figure 2 Treatment algorithm for abuse cases where abuse is defined as the use of a medication for an incorrect purpose, usually in order to experience its mind-altering effect or to achieve weight-loss.

Table 1 Examples of misuse and abuse case

Product Co-codamol effervescent (Pharmacist A) Misuse case Comments

Male client had been using co-codamol for a prolonged period to treat headaches Pharmacist suspected these were caused by use of nicotine gum Pharmacist advised that paracetamol was a safer alternative Client accepted the pharmacists advice and commenced use of soluble paracetamol Stimulant laxative (Phar Female client had been using the product for a prolonged period as she felt macist B) Misuse case she was always constipated She was willing to accept the pharmacists advice and happy to try a bulkforming product and dietary measures; leaflets on dietary measures were provided Client accepted the advice; commenced treatment with the new product Kaolin and morphine mix- Well known regular purchaser no reason for use given ture (Pharmacist B) Abuse Female client was well known in the area as an abuser of this product. The pharmacist raised the issue of dependence with her; she denied the problem case Pharmacists advice was not accepted and therefore further sales were refused Other pharmacies in the area were also refusing sales The client continued to use pharmacy for other pharmaceutical services

refinement of the model. Future work will focus on improving pharmacist communication skills, particularly in the area of motivational interviewing. An improved awareness campaign for both the general public and health care professionals may heighten the issue of appropriate OTC drug use. Finally, we plan to refine the model further and test it in a greater number of pharmacies, with the focus remaining on the same drug categories.

Acknowledgements
The authors would like to acknowledge the contribution of the community pharmacists and of all those who took part in the consultations for this project.

Funding
Financial support for this study was gained from the Proprietary Association of Great Britain (PAGB)

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