Counselling and advice on medicines and appliances in community pharmacy practice

Section 2: Guidelines On The Counselling Process

Section 2.1

Steps And Objectives

The process of counselling and providing advice can be broken down into a series of steps, each of which has a particular objective. The purpose of this section is to distinguish between the different steps in the process and to give guidance on the achievement of the objective for each step. The steps and objectives are as follows:

STEP 1 : RECOGNISING THE NEED ( Section 2.1.1)
Objective 1:		To recognise the need for counselling and advice.
STEP 2 : ASSESSING AND PRIORITISING NEEDS ( Section 2.1.2)
Objective 2:		To assess and prioritise the counselling and advice needs of the patient.
STEP 3 : SPECIFYING ASSESSMENT METHODS ( Section 2.1.3)
Objective 3:		To specify for each identified need how the result of the counselling and advice will be determined.
STEP 4 : IMPLEMENTATION ( Section 2.1.4)
Objective 4:		To implement the counselling and advice process.
STEP 5 : ASSESSMENT ( Section 2.1.5)
Objective 5:		To assess the effectiveness of the counselling and advice process.

These steps are not necessarily intended as a chronologically ordered sequence of events. On the one hand the real counselling and advice needs of a patient may only become apparent well into a counselling session and on the other, the process of assessment may be continuous, e.g. as a series of stepwise checks one or more counselling sessions for a particular patient. In practice a number of these steps may be achieved almost simultaneously and, for patients who are well known to the pharmacist, some of the steps may not prove to be necessary.

Step 1 : Recognising The Need

Objective 1: To recognise the need for counselling and advice.

Guidance Notes

When a patient presents a prescription for dispensing the desired outcome is that the medicine or the appliance is used safely and effectively, in order to alleviate symptoms or effect a cure (see Case Example 1). There could be a need for counselling and advice in every such situation. The same need may also exist when a patient purchases an over-the-counter medicine or appliance.

In recognising and assessing needs, an essential first step is to establish what the patient already knows about a particular medicine or appliance,
and what counselling and advice they have received at their GP surgery.

Particular factors related to the medicine or the patient, and commonly a combination of these factors, make counselling imperative (see Case Examples 2 and 3). Recognition of these various situations, where advice must be offered will facilitate the realisation of the potential benefit to the patient and minimisation of risk in vulnerable groups.

The responsibility for the provision of counselling and advice is that of the pharmacist who should normally be personally involved (see Case Example 4). Appropriately trained pharmacy staff may be involved in assisting both with the recognition of need for counselling and advice and in the actual provision of certain aspects of counselling and advice (see Case Example 5).

Some examples of situations in community pharmacy practice where counselling and advice may be offered are:

1. General Examples

1.1	Prescription - is for a medicine new to the patient - is for several items - has ambiguous instructions or involves a complex regimen
1.2	Prescribed medicines - have low safety margin - require several additional labels
1.3	Patient - has compliance problems, previously identified - has physical disabilities, dexterity problems, dysphagia - has problems with memory or is confused or anxious - taking oral contraceptives or asks for contraceptive advice - requires to be measured for an appliance

When patients are confined to the house, exceptionally, needs may be ascertained through a domiciliary visit. However in many circumstances there may be no direct patient contact and the pharmacist would have to assess the need for counselling indirectly by discussion with a carer, relative or representative of the patient. If advice is being given to the carer to relay to the patient, some form of written information may ensure that the patient receives full and accurate information.

2. Illustrated Examples

Prescription has special drug delivery system	- e.g. a transdermal patch
Prescribed medicines have potential for interactions	- e.g. warfarin
Prescribed medicines have well recognised side effects	- e.g. NSAID producing gastro-intestinal upset
Prescribed medicines could be indicated for treatment of side effects of previously prescribed medicines	- e.g. an anticholinergic being given to treat the side effects of metoclopramide
Patient asks for an item not to be dispensed	- e.g. patient asks for the bronchodilator inhaler to be dispensed but not the steroid inhaler
Medicine to be given by non-oral route of administration	- e.g. suppositories, pessaries
Patient asks for over-the-counter product incompatible with prescribed medicines	- e.g. pseudoephedrine with an MAOI
Patient asks for medicines which could potentially be used to treat side effects of previously prescribed therapy	- e.g. patient taking compound analgesic requests laxative

3. Case Examples

EXAMPLE 1

A 5-year old girl with tonislitis is prescribed a 5 day cource of Penicilin V Paediatric Syrup. Her mother presents the prescription at the pharmacy. The pharmacist checks with the mother whether the child has any history of allergy to penicillins and counsels her on the following points:

- The need to shake the bottle

- The medicine regimen in relation to food and times of the day

- The importance of completing the 5 day course

- The storage of the medicine

A patient presents a prescription of aspirin 150mg in the morning. The pharmacist counsels the patient on the benefits of low dose aspirin and advises against the use of additional aspirin or aspirin containing preparations whilst he is on this medication. (Reference to his patient medication record indicates that he occasionally purchases Askit powders for headaches.) Paracetamol is recommended as a suitable alternative for the treatment of the patient's headaches.

A patient asks for Pepcid AC which she has seen advertised on television. During the counselling and advice which followed, the pharmacist establishes that the patient is in the early stages of pregnancy. He sells her a small supply of Gaviscon and recommends that she consults her GP.

A patient requests a cough mixture for a persistent dry cough. The pharmacist establishes that he has no other related symptoms and that captopril has recently been added to his medication regimen. The pharmacist recognizes that this may be an adverse effect of captopril and, with the patient's agreement, contacts his general practitioner who suggests that the patient makes an appointment to see him again within the next few days.

An elderly patient well known to the pharmacy staff hands over a prescription for Trasicor which she has had previously. The counter assistant is concerned that this patient who is normally alert and sprightly, seems confused, aggressive, and a little unsteady. She reports this concern to the pharmacist who agrees and establishes that the patient, who has just returned from holiday, had received a supply of tablets whilst on holiday to see her daughter. It transpires that she received a supply of generic oxprenolol whilst on holiday which she continued to take on return in addition to her Trasicor which she had left at home. The pharmacist explains to the patient that the two medicines are the same and, with the patient's agreement, contacts her general practitioner to inform him of the situation and agree on a suitable course of action.

Step 2 : Assessing And Prioritising Needs

Objective 2: To assess and prioritise the counselling and advice needs of the patient.

Guidance Notes

Once the indication for counselling and advice has been recognised, an individual patient's needs should be assessed by reference to accurate and appropriate patient and medicine information. Such information may be obtained from a number of sources including the patient or carer, hospital or community-based health care professionals, and clinical records, where available. As stated in the previous section, establishing what the patient already knows about the medicine is essential. Patient medication records ( PMRs) held by community pharmacists may offer additional data on compliance and medication history, including problems with previous medication and use of over-the-counter ( OTC) medicines.

In assessing needs for counselling and advice, various patient and medication/appliance factors should be considered. For individual patients, the pharmacist should obtain and assess only that data which is relevant to the patient's particular counselling and advice needs; thus not all of the factors listed below would be considered for each patient.

1. Patient Factors
	- Patient Characteristics e.g. age, height and weight, pregnancy or breast feeding, past medical history. - Disease Characteristics e.g. presenting complaint and diagnosis. - Functional and Cognitive Characteristics e.g. sight, hearing, dexterity, ability to swallow, comprehension. - Social and Environmental Characteristics e.g. occupational or domestic activities, home environment, support services.
2. Medication / Appliance Factors
	- Current and Previous Drug Treatment Response Any known response to current and previous treatment with prescription medicines, OTC medicines or complementary medicines may be relevant. - Indication for Present Therapy Consideration of the patient's knowledge of the indication for therapy should be considered in the light of the prescriber's intentions. - Administration Factors e.g. complexity of regimen, delivery devices, route of administration, duration of therapy. - Expected Response e.g. onset, duration of response, expected effect. - Adverse Effects Consideration of the patient's knowledge of potential adverse effects and how to deal with them should be considered (if possible, with a knowledge of the likely patient response and the prescriber's intentions). - Precautions e.g. contra-indications, interactions, special precautions in use, allergies/hypersensitivities. - Availability e.g. legal status, source of supply, delivery time. The patient's needs should be prioritised in order of potential risk to the patient and this should determine the timing of the counselling and advice given by the pharmacist. For example, if a patient has a number of needs for counselling and advice identified and prioritised and, in the pharmacist's opinion, there are too many to deal with on one occasion, the pharmacist may ask the patient to return for further counselling and advice, arrange to visit the patient at home, or arrange to provide further counselling through visiting community based health care professionals. It is the pharmacist's professional responsibility to ensure that the counselling and advice undertaken will allow the patient to use their medication or appliance in a safe and effective manner. Consideration should be given to any needs not yet addressed when re-evaluating priorities at a later stage.

EXAMPLE 6 A patient presents a new prescription for:
Salbutamol MDI	2 puffs when required
Beclomethasone 100mcg MDI	2 puffs twice daily
Desired outputs		Priority
1. Patient understands asthma therapy
- proper use		high
- technique required to use an MDI		high
- expected outcomes of therapy		medium
2. Patient has correct inhaler technique and is able to comply with the instructions		high
In the above scenario (a 30-year old male with asthma), there are a number of counselling and advice needs which may be prioritised. The pharmacist decides to deal with high priority issues only on the patient's first visit to the pharmacy and he is asked to return for further counselling and advice. However, patient information leaflets are supplied in case the patient does not return.

Step 3 : Specifying Assessment Methods

Objective 3: To specify for each identified need how the result of the counselling and advice will be determined.

Guidance Notes

It is all too easy to cover the standard points of advice required for a particular prescription without checking the patient's knowledge, understanding or ability to use the medicine(s) and/or appliance(s) prescribed. Thus, before starting on any counselling and advice-giving process, the pharmacist should have a mental plan of how the success of the process can be determined.

Patient counselling and advice may improve therapeutic outcomes by helping the patient (or carer) to understand and use the medicine or appliance appropriately. It is important therefore, that for each identified need for counselling and advice, the pharmacist makes a mental note of a desired output, ie what wish the patient to know, understand or be able to do as a result of the counselling and advice. Achievement of the desired output should not be assumed and, where possible, it should be measured or verified objectively.

The methods of checking the success of any counselling and advice will vary widely depending on the type and complexity of advice being given and many of the patient/medication/appliance factors listed under the Guidance Notes for Objective 2. Other factors influencing the means by which Objective 3 is achieved include whether the pharmacist is dealing with the patient directly or indirectly and the pharmacist's knowledge of the patient.

EXAMPLE 7

A carer presents a prescription for erythromycin 500mg EC, one to be taken four times daily, for a housebound patient.

The patient is a regular customer of the pharmacy and reference to her patient medication record indicates that:

- she has poor eyesight and requires large print labels

- she is not currently on any prescribed medicines which would interact with erythromycin

The carer is counselled to advise the patient on the following points:

- swallow tablets whole (do not chew or crush)

- take with a large quantity of water with or after food

- avoid use of antacids within 2 hours of dosing

- take the medicine at regular intervals and complete the course

The counselling given to the carer is reinforced with written instructions and the latter, together with the label, is produced in large print. The carer is asked to return to confirm that the patient understood and can comply with the instructions.

EXAMPLE 8 A patient presents a new prescription for:
	Sulphasalazine EC 500 mg T	1 to be taken four times daily
	Hypromellose eye drops	1 drop to be used when required
From patient medication records current drug therapy is as follows:
	Diclofenac Retard 100 mg T	1 to be taken in the morning
	Ranitidine 150 mg T	1 to be taken twice daily
	Maalox Suspension	10 ml to be taken when required
Desired Outputs		Method of Assessment
1.	Patient understands new therapy for rheumatoid arthritis	Pharmacist asks patient about: - proper use - expected outcomes of therapy/time for onset of action - potential adverse drug reactions
2.	Patient is able to use eye drops as instructed	Pharmacist is asked to demonstrate instillation of eye drops. Patient is questioned on: - use/frequency - purpose - expiry/storage
3.	Patient understands the need to continue with existing drug therapy	Patient is questioned on: - need to continue Diclofenac - need to continue Ranitidine - need to continue Maalox but space dosing with Sulphasalazine
4.	Patient is able to self-medicate	In addition to 1, 2 and 3 above: - patient is able to open containers - patient is able to read labeling instruction

Step 4 : Implementation

Objective 4: To implement the counselling and advice process

Guidance Notes

As stated in the Introduction ( Section 1.7), these Guidelines make no attempt to provide the technical or scientific knowledge or to teach the communication skills which underpin the counselling process. However, pharmacists should ensure that they have the knowledge and skills required to provide counselling and advice to patients effectively and efficiently (see Annex A5).

It should be apparent that counselling and advice is offered as a professional service by the pharmacy. This may be achieved through appropriate publicity in the window of the pharmacy and should be evident to customers/patients within the pharmacy premises. Practice leaflets are a useful means of advertising the professional services offered by a community pharmacy.

The Royal Pharmaceutical Society of Great Britain ( RPSGB) directs that the pharmacist should ensure that the patient or his agent understands sufficient information and advice to enable safe and effective use of the medicine. Information and advice should normally be given personally by a pharmacist and when this is not practicable, it should be made clear that the advice of the pharmacist is available if required ( RPSGB Code of Ethics Appendix). Effective preparation for this important function should include a consideration of patients' expectations, the counselling environment and the time available for counselling.

Counselling should be carried out in an environment which is non-threatening and conducive to forming good relationships between the pharmacist and patients or carers. There is a need to establish a rapport with the patient/carer. It is important to tell them what the counselling and advice process involves, how long it is going to take and where the counselling will be carried out. In designing or selecting an appropriate area for counselling, due attention should be paid to Principle 4 of the RPSGB Code of Ethics concerning the confidentiality of information relating to a patient and their family. All of this helps to ensure that the patient is receptive to the proposed counselling and advice.

Time is probably the most important factor which governs the extent to which counselling takes place in the community. The pharmacist should allow enough time to complete the counselling and advice process. If time is limited, the pharmacist may agree with the patient to spread the counselling over a number of occasions.

Implementing the counselling and advice process

1. Giving the patient the appropriate advice on specified details previously identified.

2. Introducing, when necessary, aids to comprehension and/or compliance at this stage and explaining their use throughout the process. Aids to comprehension in the counselling and advice process may include general information leaflets, patient information leaflets (Plls) on
specific products, placebo inhalers and audio-visual aids.

Aids to compliance may range from simple ( e.g. large print labels, plain caps), to more complex measures ( e.g. individual patient charts and diaries).

3. Determining (as far as possible) that the patient is able to comply with the instructions for use of the appliance(s) and/or medicine(s) and determining the level of understanding of the patient. If the patient appears unable to understand or to implement the advice given then referral back to the general practitioner may need to be considered.

4. Inviting the patient to pose further questions and report any problems, giving a time scale which would be appropriate for the patient to return or to seek further help.

5. Discussing with the patient the time scale and methods of review.

6. Reinforcing the important points at the end of the counselling and
advice process.

7. Where the patient is unable to attend the pharmacy, inviting the carer to provide feedback that the patient is able/unable to comply with the instructions for the use of the appliance and/or the medicine regimen.

EXAMPLE 9 A patient presents a prescription for: Triple Therapy
Omeprazole Amoxycillin Metronidazole	20 mg twice daily 500 mg three times daily 400 mg three times daily	all for 7 days
Implementation steps: - The patient is given an estimation of the time that the counselling advice will take. - Patient is given information regarding the association of peptic ulcers with particular bacteria in the stomach (Helicobacter pylori), and of the need to eradicate the bacteria. - Patient is given advice on triple therapy and this is reinforced with a Patient Information Leaflet detailing the drug regimens, adverse effects and expected response. - The importance of compliance with the regimen for the whole 7 days is stressed to ensure successful treatment. - If there are any questions or problems at any time during treatment, the patient is advised to contact the pharmacist or the GP. - The importance of compliance with the regimen is again reinforced at the end of the counselling and advice process.

EXAMPLE 10

A request is made at the counter for a tube of Zovirax Cold Sore Cream. The counter assistant refers the request to the pharmacist.

Implementation steps:

- The pharmacist explains to the customer that it is important to ensure firstly that the treatment is indicated and secondly that the customer knows how to use it.

- The patient's self diagnosis is confirmed.

- The stage of development of the lesion is assessed to be within 72 hours.

- The pharmacist confirms that there are no contra-indications or special precautions applying to this patient.

- The pharmacist gives the patient the instructions for use of the product with reference to the patient information leaflet.

- The patient's understanding of these instructions is confirmed.

- The patient is invited to ask any further questions and to report back on any problems.

- Important points are reinforced at end of the process.

Step 5 : Assessment

Objective 5: To assess the effectiveness of the counselling and advice process

Guidance Notes

Assessment involves the comparison of the actual outputs with the desired outputs identified under Objective 3 ( Section 2.1.3, page 11).

The patient's need for counselling and advice should be continuously reviewed. This review process can be used both to reinforce previous counselling, if necessary, and/or identify new needs.

1. Assessing knowledge and understanding

The importance of communication during the counselling process cannot be over-emphasized. For a variety of reasons a patient may not understand all of the information, instructions or advice which they receive during a counselling session. Thus it is important to check the patient's knowledge and understanding by direct questioning. The patient should again be given the opportunity at this stage to ask any further questions which they may have.

EXAMPLE 11

A patient presents with a prescription for hydrocortisone 1% cream (to be applied to the face) and Stiedex Oily Cream (to be applied to the upper trunk). The counselling process involves an explanation of the difference in potency between the creams. Instructions are given on the application of the creams to the face and upper trunk, respectively.

Following the counselling the pharmacist assesses the patient's knowledge and understanding by questioning the patient on the appropriate use of both creams.

2. Assessing ability to use the medication/appliance

For the same reasons as stated above under 1, there are occasions when it is important to give the patient the opportunity to demonstrate that they can use the medication/appliance appropriately.

EXAMPLE 12

An asthmatic patient with rheumatoid arthritis presents a prescription for metered dose inhalers. Despite introducing a Haleraid, it becomes apparent during counselling that he is unable to use these devices. With the pateint's agreement, the pharmacist contacts the GP and recommends an alternative device.

3. Assessing compliance

The pharmacist may have a record of a particular patient's history of non-compliance, may deduce it from the time between repeat prescriptions, or from discussions with the patient or other health care professionals.

EXAMPLE 13

An elderly patient presents a prescription for Timoptol eye drops. Reference to his patient medication record indicates that his previous prescription for this was dispensed seven weeks ago. On discussion with the patient it was confirmed that he had been using the same bottle of eye drops for the last seven weeks.

4. Evaluating the achievement of the counselling and advice process

It should be recognised that routine documentation of the counselling and advice process for all patients would not be feasible currently in most busy community pharmacies. However, pharacists may opt to document this activity for selected patients. For such patients a record of counselling and advice given would assist in providing a more comprehensive patient medication record which would aid future consultations. These may be with the patient through the same community pharmacy or with, for example, a hospital pharmacist, another community pharmacist or a physician requesting information when subsequently reviewing the patient.

Pharmacists may also wish to document their counselling and advisory activities for the purposes of self-audit, clinical audit (see Annex A4, page 26) or research (see Annex A5, page 30).

Assessing the level of compliance and follow-up of patients is difficult and the pharmacist may have no opportunity to do so, for example, if the patient does not return to the pharmacy. In certain cases pharmacists may learn of a patient's progress through other community based health care professionals who maintain contact with the patient. In this respect community nurses, practice nurses, midwives and health visitors may be well placed to refer suspected medicine related problems to pharmacists and/or GPs.

Methods of assessing patient compliance require to be investigated and validated as many existing methods have their limitations. In addition, since many factors other than the quality of counselling and advice can affect compliance with the prescribed regimen, well designed prospective research studies are required to investigate any relationship between the quality of counselling and advice given by the pharmacist and patient compliance with the prescribed regimen (see Annex A5, page 30).

A Checklist For Counselling

PREPARATION	Be familiar with the recommended counselling points for the most commonly prescribed medicines and appliances Consider patients' expectations, the counselling environment and the time available
RECOGNISE THE NEED	Establish what the patient already knows about the medicine/appliance Recognise characteristics of the medicine, appliance or patient which indicate particular needs
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ASSESS AND PRIORITISE NEEDS	Use all available sources of information, including as necessary, the patient, carers, relatives or health care professionals and patient medication records to assess relevant patient and medication/appliance factors and prioritise needs
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SPECIFY ASSESSMENT METHODS	Decide for each identified need what it is you wish to achieve and how you will determine the output from the counselling process
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IMPLEMENT	Counsel, introducing as necessary aids to comprehension and/or compliance and explain their use Reinforce important points and invite patient to ask further questions
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ASSESS	Check knowledge and understanding by direct questioning Where possible, assess actual compliance through follow-up
EVALUATION AND REVIEW	The counselling and advisory service which you offer may be evaluated, reviewed and developed through audit and/or practice research.