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                                                                                                                                                              Research Paper
                             IJPP 2009, 17: 269–274
                             2009TheAuthors                                   Development of protocols for the provision of headache
                             Received June 10, 2008                            and back-pain treatments in Maltese community pharmacies
                             Accepted February 03, 2009
                             DOI 10.1211/ijpp/17.05.0003
                             ISSN 0961-7671
                                                                               Elaine Vella, Lilian M. Azzopardi, Maurice Zarb-Adami
                                                                               and Anthony Serracino-Inglott
                                                                               Department of Pharmacy, University of Malta, Msida, Malta
                                                                               Abstract
                                                                               Objective ThepurposeofthisstudywastodrawuptwoprotocolsdesignedtohelpMaltese
                                                                               pharmacists care for consumers seeking treatment for headache and back pain and to
                                                                               subsequently use the protocols to assess pharmacists’ management of the named conditions.
                                                                               Method The setting was a sample of 10 of the 207 community pharmacies in Malta. Two
                                                                               flow-chart protocols for headache and back-pain management were developed from various
                                                                               reference sources. The protocols were first tested in a community pharmacy for practicality
                                                                               andapplicability in a pilot study. In nine other pharmacies chosen at random the pharmacists’
                                                                               manner of addressing 10 headache and 10 back-pain cases in each pharmacy was compared
                                                                               with that recommended in the protocols. Consumers who visited the pharmacy to fill a
                                                                               prescription, to purchase a named product or for advice on how to deal with symptoms were
                                                                               included in the study.
                                                                               Key findings Of the 212 pharmacist interventions assessed, cases where pharmacists
                                                                               responded to symptoms were managed with the highest average compliance (57%) whereas
                                                                               cases in which the consumer asked for a product by name were managed with an average
                                                                               compliance with the protocols of 46%. Cases in which consumers presented at the pharmacy
                                                                               with a prescription were managed with an average compliance of 55%.
                                                                               Conclusions Protocolsmaybeusedasameansofmeasuringtheimpactoftheintervention
                                                                               of community pharmacists in patient care. The findings suggest a lack of advice given to
                                                                               consumers presenting at the pharmacy to request a named product.
                                                                               Keywords back pain; community pharmacy; headache; protocols
                                                                               Introduction
                                                                               The intervention of community pharmacists in responding to consumers with minor
                                                                               ailments continues to be one of the major contributions by community pharmacists to the
                                                                               maintenance of the best health possible for their society.[1] The demand for primary care in
                                                                               a community pharmacy setting is on the increase[2–4] and is associated with a number of
                                                                               factors, including the need for medicines, patient perceptions of pharmacists’ healthcare
                                                                               role and the nature of the presenting condition; indeed, symptoms of minor self-limiting
                                                                                                                                                                                     [5]
                                                                               conditions are usually given as the main reason for using a pharmacy.
                                                                                   With more than 90% of the population experiencing one or more headaches in their
                                                                                         [6,7]
                                                                               lifetime         and approximately 80% of adults experiencing low back pain that will affect
                                                                                                                                                        [8]
                                                                               their daily activities at some point in their lives,                          the community pharmacist is often
                                                                                                                                                                                         [9]
                                                                               approached with regards to advice for and treatment of these conditions.                                       With 66% of
                                                                                                                                                                                                      [10]
                                                                               patients who take medications for headache actually buying these from a pharmacy                                             and
                                                                               back pain identified as one of the most common complaints pharmacists hear from patients
                                                                                                                                                   [11,12]
                                                                               seeking advice and over-the-counter pain relief,                            self-medication seems to be the main
                                                                               method of treatment. Headache and back pain were thus considered ideal topics for protocol
                                                                               developmentsincepharmacistsareinanidealplacetoprovideadvicefortheseconditionsand
                                                                               help improve patient care.
                                                                                   The identification and addressing of patients’ needs and concerns by community
                             Correspondence: Elaine Vella,                                                                                                 [13,14]
                                                                               pharmacists has, however, been shown to be variable.                                 With protocols, pharmacists are
                             Zammit Clapp Hospital,                            assisted in the decision-making process of responding to symptoms, recommended treatment
                             Pharmacy Department,                                                                                                                  [15,16]
                             St Julians, GZR 1540, Malta.                      choices are evidence-based and patient outcomes improved.                                    Aprotocol is defined as a
                             E-mail: elaine.vella@gov.mt                       disease-based therapeutic algorithm, which begins with a confirmed diagnosis of a particular
                             Author Copy: This article was published by the Pharmaceutical Press, which has granted the author permission                                                                  269
                             to distribute this material for personal or professional (non-commercial) use only, subject to the terms and conditions
                             of the Pharmaceutical Press Licence to Publish. Any substantial or systematic reproduction, re-distribution, re-selling,
                             sub-licensing or modification of the whole or part of the article in any form is expressly forbidden.
                            270      International Journal of Pharmacy Practice           2009; 17: 269–274
                            disease and directs the healthcare provider through a series        background information and references to support information
                            of decisions that differentiate patients into alternative           in the flow charts.
                                      [17]
                            pathways.
                               Notwithstanding the advantages of protocols, little work on      Evaluation of the protocols
                            their development and use has been carried out in Malta. In         Qualitative validity, applicability and practicality testing were
                            Malta, the availability of over-the-counter medicines is limited    employed. To assess validity of the protocols, two general
                            to pharmacies and no other retail outlet. There is on average       practitioners and two pharmacists were approached. The aims
                            one community pharmacy for every 2000 persons. Pharmacies           of the study were outlined. Meetings were held with each to
                            have only one pharmacist on duty at a particular time. Other        review content validity of the protocols. The length of the
                            pharmacists replace the managing pharmacist on a part-time          protocol was questioned; however, it was agreed to retain all
                            basis. This results in 44% of Maltese pharmacists contributing      areas so as to present a comprehensive overview of both
                                                                          [18] Seventy seven
                            to the profession through pharmacy practice.                        conditions. Applicability and practicality of the protocols were
                            per cent of pharmacies employ one or more pharmacy                  assessed through a pilot test. The researcher visited one
                                                                 [1]
                            technicians or salespersons or both.    There is no requirement     community pharmacy, chosen for convenience, to ascertain
                            for salespersons to hold a minimum qualification to work in         that the protocols were acceptable for use in the practical
                            pharmacies. Pharmacy technicians may dispense medicinal             setting and that it was feasible to use the protocols to assess
                            products only under the supervision of a pharmacist.                pharmacists’ interventions through observation. The pilot
                               The purpose of this study was thus to develop flow-chart         study also helped determine whether 10 cases were likely to
                            headacheandback-painprotocolstobeusedinthecommunity                 be collected within the set time frame and how long data
                            pharmacy setting. The protocols were intended to act as a           collection was likely to take. The documentation form was
                            guideline by highlighting a specific plan according to which        also reviewed to check its adequacy for recording the
                            the condition of the patient was best managed. The protocols        necessary information. Results from this pharmacy were
                            weresubsequentlyusedinapilotstudytotest their practicality          included in the final analysis since the minor changes made to
                            and applicability in the community pharmacy setting. A final        the protocols still permitted the grouping of data.
                            goal was to use the protocols as a means of evaluating
                            pharmacists’ interventions according to the manner in which         Assessing pharmacists’ interventions
                            patients were questioned, advice given and treatment                For the assessment of pharmacists’ interventions using the
                            recommended.                                                        protocols, the non-participant observation technique was
                                                                                                adopted since it is simple and feasible to perform within the
                                                                                                environment of a community pharmacy when compared to
                            Method                                                              other documentation techniques.[1] It does not rely on a
                                                                                                consumer’s disposition to respond to questions or ability to
                            Protocol design                                                     recall events (as opposed to self-completed questionnaires),
                            Twoflow-chartprotocols,forheadacheandback-painmanage-               and avoids eligible consumers not participating during times
                            ment, were developed using key pharmacy journals, standard          when the pharmacy is particularly busy or short of staff
                            textbooks and other references. The format selected for the         (reasons for non-recruitment by pharmacists).[21]
                            presentation of the protocols was that used by the American            Nine pharmacies were chosen at random (from a list of all
                                                                   [17]
                            Pharmaceutical Association (APhA),         which translates the     pharmacies in Malta), in which to perform the research. This
                            information into a flow chart, deemed ideal for succinctly          brought the total number of pharmacies to 10 since pilot data
                            conveying the relationship and sequential direction of steps.       collected from the first pharmacy were also included in the
                            Each protocol included the following. (1) Questions about           final analysis. The managing pharmacists were contacted and
                            patient identity as well as the duration, location, intensity and   informed of the aims of the study. The dates and times of
                            type of pain: this type of specific information about the person    each observation session were agreed.
                            requiring treatment is essential for the pharmacist. (2) A one-        During the first observation session in each pharmacy,
                            page diagram, termed the prescription sheet, which contained        pharmacists went through the protocols and gave their
                            the series of steps to be followed when the pharmacist was          feedback. Each pharmacy was then attended for the length
                            presentedwithaprescription.(3)Statementsdetailing the most          of time required to document pharmacists’ interventions in
                            encountered headache or back-pain conditions. These state-          10 headache and 10 back-pain cases. A record was also kept
                            ments were designed to distinguish between the different            of the total number of consumers walking into the pharmacy
                            conditions on the basis of the different accompanying               during the observation sessions.
                            symptoms and trigger factors. For example, the constricting            Consumers visiting a pharmacy have a number of options
                                                                                                                                           [22] For the purposes
                            bandofpainfeltaroundtheheadwhenapatientisunderstress,               when presenting with a minor condition.
                            typical of a tension headache, helps to differentiate it from the   of this study, all pharmacist interventions were placed in
                            dull pain and tenderness around the eyes and cheekbones             three categories. Cases where consumers presented at the
                                                                                  [19,20] The   pharmacy to fill a prescription were termed Prescription
                            accompanied by a blocked nose, typical of sinusitis.
                            diagnosis ends with a decision of whether to treat or refer the     cases. Those cases where consumers requested a product by
                            patient. (4) A treatment sheet which outlined the management        name were classified as Specific product cases and those
                            of the condition, including non-pharmacological measures and        cases where consumers frequented the pharmacy for advice
                            over-the-counter pharmacological treatment. (5) An explana-         onhowtodealwithsymptomsweredesignatedasDescribing
                            tory text, the main purpose of which was to present the             symptoms cases. The inclusion criterion for these three
                            Author Copy: This article was published by the Pharmaceutical Press, which has granted the author permission
                            to distribute this material for personal or professional (non-commercial) use only, subject to the terms and conditions
                            of the Pharmaceutical Press Licence to Publish. Any substantial or systematic reproduction, re-distribution, re-selling,
                            sub-licensing or modification of the whole or part of the article in any form is expressly forbidden.
                     Headache and back-pain treatments                                                                    Elaine Vella et al.      271
                     categories was that there had to be some exchange of                          Patient presents
                     information between consumer and pharmacist, allowing the                  1   with complaint
                     observer to identify the case as being pertinent to the study.                 of headache.
                        Data for each case were recorded on a documentation
                     form. In the first column, the observer ticked the steps from                       Yes                                         3
                     the protocol which were followed by the pharmacist during                     Pharmacist                     Pharmacist asks
                                                                                              2   familiar with      No          questions to know
                     the management of a particular case. In a second column,                                                   identity of patient.
                     the observer ticked all the steps which should have been                       patient?                       Go to Box 4 
                     followed according to the protocol. By comparing the                                Yes
                     divergence between the two sets of data the pharmacist’s
                     compliance with the protocol for each case was calculated.               4 Pharmacist asks
                     For the purpose of the study compliance was defined as ‘a                 about duration of                 See text.
                                                                                                   headache.                    Go to Box 5
                     measure of the extent to which the pharmacist’s behaviour
                     matched the recommendations in the protocols’.[23]
                        Ethical approval was not required for the purposes of this                       Yes
                     study, since no patient data were recorded. Only pharmacists
                     who consented to participate in the study and their manage-             5  Pharmacist asks
                     ment of headache and back-pain cases were observed.                        about location of                See text.
                                                                                                     pain.                     Go to Box 6
                     Results
                     Response rate and demographics                                     Figure 1  Excerpt from the headache protocol
                     Ninepharmacists out of the 10 contacted agreed to take part in     and comprehensive to diagnose and manage the different
                     the study. One pharmacist refused to participate, claiming         headache and back-pain conditions encountered in the
                     restrained space in the pharmacy. Another pharmacy was             community pharmacy setting; uncomplicated to follow with
                     chosen at random instead. Of the pharmacies recruited to take      an evident layout of information flow; and able to be used as
                     part in the study, three were in the Southern Harbour district,    a means of assessing pharmacists’ interventions in the
                     two in the Northern Harbour district, one in the Western           management of headache and back-pain disorders.
                     District, and four in the Northern District. Two districts – the
                     South-Eastern District and Gozo (geographically isolated) –
                     were not represented. The mean population per pharmacy was         Interventions
                     1912. In these pharmacies only one pharmacist was in               A total of 212 pharmacist interventions were assessed in
                     attendance at any one time. Salespersons were absent in three      the 182 observation hours spent at the 10 participating
                     pharmacies, all three owned by a pharmacist. Five pharmacies       pharmacies. All cases were managed with an average
                     had one salesperson and two pharmacies had two and three           compliance of 52% (range 6–100%). Figure 2 graphically
                     salespersons respectively. An estimated 21 consumers per hour      portrays the percentage compliance of all the recorded cases
                     visited the pharmacies.                                            with the respective protocols.
                                                                                           Describing symptoms cases accounted for almost half of
                     The protocols                                                      thetotalcases(42%,n = 90cases).Theyweremanagedwithan
                     This study set out to draw up two protocols based on two           averagecomplianceof57%(range6–100%).Prescriptioncases
                     conditions commonly present in primary care: headache and          (n = 63 cases) made up a further 30% of the total. They were
                     back pain. One hundred and fourteen steps were set up to           managedwithanaveragecomplianceof55%(range29–94%).
                     diagnose and manage the different headache conditions while        Specific product cases (n = 59 cases) were the least encoun-
                     89 steps made up the back-pain protocol. Figure 1 shows an         tered, with 28% of the total cases. They were managed with an
                     excerpt from the headache protocol. In Box 1, a consumer           average compliance of 41% (range 10–90%).
                     presents at the pharmacy with a complaint of headache. Box 2
                     establishes whether the pharmacist is familiar with the            Headache protocol
                     consumer, in which case the pharmacist is directed to Box 4.       Theaveragecomplianceforthe109headachecaseswas52%
                     If the person presenting at the pharmacy is a new consumer,        (range 6–100%).
                     the pharmacist is directed to Box 3 where questions are asked         Describing symptoms cases (n = 57 cases) accounted for
                     about the patient’s identity. In Boxes 4 and 5 the pharmacist      morethanhalfofthetotalheadachecases.Theyweremanaged
                     asks about the duration and location of pain. These boxes refer    withanaveragecomplianceof56%(range6–100%).Onlyone
                     the pharmacist to the explanatory text where more detail can       case was managed with 100% compliance to the headache
                     be found.                                                          protocol. There were 18 cases managed with a compliance
                                                                                        higher than 70%.
                     Validity, applicability and practicality                              Headache Prescription cases were the least encountered,
                     Content validity of the two protocols was found to be strong.      making up 20% (n = 22 cases) of all headache cases. The
                     Statements in the protocol were clear and comprehensive.           average compliance was 53% (range 29–75%). Only five
                     During the pilot test, the protocols were found to be: detailed    cases were managed with a compliance higher that 70%.
                     Author Copy: This article was published by the Pharmaceutical Press, which has granted the author permission
                     to distribute this material for personal or professional (non-commercial) use only, subject to the terms and conditions
                     of the Pharmaceutical Press Licence to Publish. Any substantial or systematic reproduction, re-distribution, re-selling,
                     sub-licensing or modification of the whole or part of the article in any form is expressly forbidden.
                           272       International Journal of Pharmacy Practice         2009; 17: 269–274
                                            30      Headache cases
                                                    Back-pain cases                         26
                                            25
                                            20                                           19           18
                                                                                                   15        16       15
                                            15                                                                 13
                                                                               1211
                                            10                                                                           10      9
                                          Number of cases   8         8 8                                                           7
                                             5     4           5
                                                     2                                                                                     3 3
                                             0
                                                  0–10     11–20     21–30     31–40     41–50     51–60    61–70     71–80     81–90    91–100
                                                                                     Percentage compliance
                           Figure 2   Graph showing the percentage compliance of headache and back-pain cases with the respective protocols. Numbers above each bar
                           indicate the number of cases.
                               The 28% (n = 30 cases) of headache cases classified as          cases (n = 30), the pharmacist did not establish the type of
                           Specific product cases had the lowest average compliance of         back pain or the circumstances that caused it, mostly cases in
                           46%(range 14–90%). Only four cases were managed with a              which the consumer presented with a prescription.
                           compliance higher than 70%.                                            Atopicalanalgesicwasthemostcommonlydispensedfirst-
                               The most commonly presented headaches were those as             linetreatment,bothonitsownortogetherwithanoralanalgesic,
                           part of cold symptoms, which added up to 19% of all cases           usually a combination product. Topical non-steroidal anti-
                           (n = 21 cases). These were followed by tension headaches            inflammatory drugs classified as non-prescription items were
                           (n = 18 cases), sinus headaches (n = 16 cases) and migraine         the most frequently dispensed agents of all.
                           headaches (n = 15 cases). There were four cases in which the
                           headache was thought to be drug-induced. In 11% of cases            Compliance to individual steps in the headache
                           (n = 12 cases) the pharmacist did not establish the type of         and back-pain protocol
                           headache or the circumstances that caused it. These were            Average compliance to the steps in the first part of each
                           mostly cases where the consumer requested a named product.          protocol – establishing patient identity and nature of symp-
                               The most commonly dispensed medications were para-              toms–was43%fortheheadacheprotocol(range7–100%)and
                           cetamol, ibuprofen and combination products, which con-             42% for the back-pain protocol (range 4–100%). Average
                           tained paracetamol, ibuprofen, aspirin, caffeine, codeine (up to    compliancetotheprescriptionsheetwas48%fortheheadache
                           12.5 mg per tablet), antihistamines and nasal decongestants.        protocol (range 0–100%) and 63% for the back-pain protocol
                                                                                               (range 0–100%).Astepwith100%complianceinthissection
                           Back-pain protocol                                                  was one in which the pharmacist was required to explain the
                           The average compliance for the 103 back-pain cases                  doseanddosageregimenofaprescribedmedication.Average
                           collected was 52% (range 10–94%).                                   compliance to the steps containing the statements detailing
                               The 32% (n = 33 cases) of back-pain cases placed in the         particular headache or back-pain conditions was 25% for the
                           Describing symptoms category had an average compliance of           headache protocol (range 0–92%) and 23% for the back-pain
                           59% (range 10–93%). There were 13 cases managed with a              protocol (range 0–76%). A step with 0% compliance in
                           compliance higher than 70%.                                         this section was one which requested referral when migraine
                               Back-pain Prescription cases were the most encountered,         symptoms occurred for the first time. Average compliance
                           making up 40% (n = 41 cases) of all back-pain cases. The            to the treatment sheet was 42% for the headache protocol
                           average compliance was 57% (range 33–94%). Only six                 (range 0–98%) and 33% for the back-pain protocol
                           cases were managed with a compliance higher that 70%.               (range 0–100%).
                               The 28% (n = 29 cases) of back-pain cases placed in the
                           Specific product category had the lowest average compliance         Discussion
                           of 37% (range 10–81%). Only one case was managed with a
                           compliance higher than 70%.                                         All outcomes devised for this study were achieved. The main
                               The most commonly presented type of back pain was that          objective was the development of two protocols which were
                           associated with acute muscle strain (n = 39 cases). Patients        well received and generated positive comments from the
                           complained of lifting too heavy objects, lifting objects            participating pharmacists. The assessment of pharmacist
                           improperly and imprudent exercising. The second most                interventions was then carried out through their compliance
                           common type of back pain was non-specific back pain                 with the protocols, rather than through evaluation of patient
                           (n = 10 cases). In most of these cases the consumer would           outcomes.
                           have had the pain before, it reoccurred, but the consumer              The average compliance with which all cases were
                           could not pinpoint the cause of the back pain. In 29% of            managed was 52%. This indicated that there was not an
                           Author Copy: This article was published by the Pharmaceutical Press, which has granted the author permission
                           to distribute this material for personal or professional (non-commercial) use only, subject to the terms and conditions
                           of the Pharmaceutical Press Licence to Publish. Any substantial or systematic reproduction, re-distribution, re-selling,
                           sub-licensing or modification of the whole or part of the article in any form is expressly forbidden.
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...View metadata citation and similar papers at core ac uk brought to you by provided oar um research paper ijpp theauthors development of protocols for the provision headache received june back pain treatments in maltese community pharmacies accepted february doi issn elaine vella lilian m azzopardi maurice zarb adami anthony serracino inglott department pharmacy university malta msida abstract objective thepurposeofthisstudywastodrawuptwoprotocolsdesignedtohelpmaltese pharmacists care consumers seeking treatment subsequently use assess management named conditions method setting was a sample two flow chart were developed from various reference sources first tested practicality andapplicability pilot study nine other chosen random manner addressing cases each compared with that recommended who visited fill prescription purchase product or advice on how deal symptoms included key findings pharmacist interventions assessed where responded managed highest average compliance whereas which con...

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