Download standard operating procedure

NOTES AND GUIDANCE on supervision and instalment dispensing
New Patients
. As part of the assessment, the patient will be provided with information about which
pharmacies are part of the scheme (in some areas this may be all pharmacies). Either the
prescriber or key worker should contact the pharmacist to introduce the patient and may give
the patient a referral letter to give to the pharmacist on the first visit .At this stage key
worker/prescriber should tell the client they will need to take ID to the Pharmacy In the latter
case, the named pharmacy will be included on the formal shared care agreement. It is good
practice for the patient to bring a referral letter from the prescriber or key worker on the first
visit. Set a maximum number of patients your pharmacy can accept onto a supervised scheme
at any one time. This number should not be exceeded unless by agreement with the
pharmacist in charge.
In cases where the prescriber appears to be working in a different PCT/Health Board, you
will need to make a professional judgement as to the circumstances and, provided the
prescription is safe and legal, you can continue to dispense the prescription so as not to
inconvenience the patient.You will not be paid for supervising non w/ton prescriptions.
Tips – identifying patients
 Some pharmacies take pictures of the patients (with their consent) and file in the PMR This is so that
other staff, especially locum pharmacists, will subsequently be able to confirm the identity of the patient.
(NB. This photograph must not be made available to anyone else. Photographs can only be taken with the
consent of the patient.)
 Alternatively, the patient’s signature on the agreement can be checked with the signature on the back of
the prescription form, or You may want to agree a password with the patient to confirm their identity
when they come to collect a dose. If this is your normal practice, enter the password onto the patient’s
PMR.
Tips - Patient confidentiality
 Every effort must be made to ensure the supervised consumption, or collection of take home doses, is
done in as dignified and discreet a manner as possible.
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 The availability of a private area for supervised consumption matters most to patients, but don’t forget
that the attitude of the staff and pharmacist supervising the consumption is also important.
 If the process of supervision is handled smoothly and routinely, other customers are often not even
aware the process is happening.
 Remember the patient’s friends and family may not know the patient is on methadone or Subutex.
 Ensure all your staff are aware of the confidentiality issues surrounding this patient group and
do not inadvertently identify patients as drug misusers by making statements such as ‘patient
here for his methadone’.Best to say X is here for the medication or similar.
 Ensure all discussions about patients, for example when you are on the telephone or searching for a
prescription, cannot be overheard by other customers.
 You may have patients who are taking methadone or Subutex who ask to use the needle exchange
scheme to obtain clean needles. The two schemes are considered to be completely separate and you
should not share information about who used the needle exchange scheme. Informing a prescriber that
their patient had used the needle exchange scheme would be considered a breach of patient
confidentiality.
 You may have concerns about the patient that you want to discuss with the prescriber or key worker,
eg if the patient’s health is deteriorating, or if the patient has missed some doses. When you are
supplying methadone or Subutex as part of a shared care scheme there is usually a paragraph in the
patient-pharmacist agreement form giving the pharmacist ‘informed consent’ to disclose such
information to the prescriber or key worker, if it is considered to be in the best interests of the patient.
If you are dispensing methadone or Subutex to patients who are not part of a shared care agreement
you must be aware of patient confidentiality issues. The Code of Ethics states that one of the key
responsibilities of the pharmacist is to treat all those who seek professional service with courtesy,
respect and confidentiality. Disclosing information about a patient without their consent would be a
contravention of the pharmacist/patient
relationship. However, professional ethics dictate that we should attempt to provide the best level of
patient care that we can. You may feel justified in contacting the prescriber or key worker.
 Consider asking all patients to sign a patient-pharmacist agreement that includes an informed consent
paragraph.
 You may be asked by the police to disclose information about a patient. You should only disclose
information to the police if the police have no other source of information and can confirm in writing
that they are investigating a serious crime.
 You may have a situation where you feel you should contact the police, eg if you suspect the patient is
handing over their dose to a third party. Confidential information obtained during the course of the
pharmacist’s professional duties can be disclosed without the patient’s consent only in limited
circumstances. One such circumstance is where disclosure is necessary to prevent serious injury or
damage to the health of the patient or a third party, or serious risk to public health and also in the
detection of a crime. If it is apparent that diversion is taking place, the prescriber should be informed.
 Remember that your local police Chemist Inspection Officer may be a useful contact if you have
concerns about a doctor’s prescribing but do not want to approach him or her personally.
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 Pharmacies often become the focus for the local community wanting to disclose information about
drug dealing/illegal activity. In such cases you should provide the person with the Crimestoppers
number.
Tips
SUPERVISED CONSUMPTION
 Instructions concerning supervised consumption need not be written in the prescriber’s own
handwriting and may be stamped or typed. In some areas, it is acceptable for them to be added by the
pharmacist once it has been confirmed with the prescriber.
 Where more than one dose is to be supplied (eg Saturday and Sunday’s dose) and the prescription does
not request supervised consumption, you may supply the total amount in one container or you may
prefer to supply each day’s dose in individual containers. Whichever option you choose, you will be
paid only one dispensing fee. If you choose to supply the total amount in one container, ensure the
patient has the means to measure out each daily dose accurately.
 Remember if the prescription requests sugar free mixture, this is what must be dispensed. However,
some schemes recommend contacting the doctor as sugar free methadone is not recommended for
‘take home’ doses due to increased risk of misuse by injection.
 Conversely, if the prescription does not specify sugar free mixture then only the sugar based
formulation can be dispensed.
 Plastic bottles can be used for doses being supervised but patients may find it easier to drink from a
round, glass bottle. If plastic bottles are used, ensure they are stored upright in the CD cabinet as they
have a tendency to leak.
 Where it is practically possible, store prepared methadone and Subutex® in the CD cabinet until the
patient presents to collect their dose.
 Prescriptions for Subutex are likely to be written generically as buprenorphine. There are other
buprenorphine preparations available, eg Temgesic. Subutex is the only preparation of
buprenorphine licensed for use in the treatment of opiate dependence and is the only product that can
be dispensed against a prescription for buprenorphine on a FP10 MDA form.
 Subutex is available in 400 micrograms, 2mg and 8 mg tablets. The usual dose is 8 -12mg. Depending
on the dose there may be a mixture of strengths. These must be separately labelled in line with
standard ‘best practice’.
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 RPSGB and PPA advise that each individual dose must be dispensed and labelled for each instalment
dispensing. Each instalment must be entered on the PMR according to The Medicines, Ethics and
Practice guidelines
 Dispensing from bulk straight into cups and presenting this to the patient is contrary to the Medicines
Act, regarding labelling of dispensed medicines. It is important to distinguish between the two steps of
dispensing the methadone/Subutex® and supervising the patient’s consumption of the dose.
 It is important to maintain an accurate record of doses collected and not collected on the patient’s
PMR. If the dose was prepared but not collected, remember to delete the supply from the PMR.
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When should I not dispense?
These situations apply to take home doses and supervised consumption. This is for the patient’s
safety. The patient will have been told about these situations by the key worker, and you will
have discussed it with them when going through the patient – pharmacist agreement with them.
These situations are:
 If the patient is intoxicated with drugs or alcohol. Alcohol can increase the toxicity of
methadone and Subutex.
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 Missing a tritration dose
 If the patient has missed three or more consecutive doses. After missing three or more
consecutive doses of methadone the steady state plasma level will fall by as much as a
third and hence tolerance will fall. This may risk the patient overdosing if the patient
resumes the methadone at the same dose as before. The risk for Subutex is much less
but patients repeatedly missing doses should have their prescriptions reviewed.
In both situations you should refer the patient to the key worker or prescriber.
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Third party collection usually only in exceptional circumstances
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If the patient cannot collect a take home dose in person, they may arrange for a representative to
collect it on their behalf. We recommend that you obtain a letter from the patient stating that a named
person is authorised to collect the drug on their behalf. This is not a legal requirement but it may
prevent misunderstandings or theft. It is also a good idea to ask the person collecting the medicine to
sign some sort of record book although, again, this is not a legal requirement*.
Where a third party is collecting the take home dose, ask him or her to verify and sign for the quantity
dispensed to avoid later allegations of dispensing short measure.
A separate letter is required for each dosage pick up
What’s your policy on…..?
The majority of the patients you provide this service for will be perfectly well behaved. However, from
time to time you may have problems with a patient. This could be any patient, not just those on substitute
prescribing. You will need to deal with such problems in a consistent way. You will need to decide your
procedure for dealing with unacceptable behaviour from the patient and include this in your SOP. The
main aim is to avoid inflaming situations and to protect staff. Many pharmacies use a warning system –
one warning and then out, or you could make use of the football referee’s yellow card (warning)/red card
(banning) system. You may want to produce a ‘yellow card’ letter to give to the patient, and a monitoring
form to record yellow cards given. Include these in your SOP. Some of the situations you may need to
consider, and some possible actions are listed below (if you have an agreement to share information you
might consider informing the prescriber of any incident and warnings given):
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1. Stealing from the pharmacy (patients or their associates)
Yellow card – increase to a red card if goods not paid for. Consider informing the police.
2. Verbal abuse
Yellow card – increase to a red card if repeated and serious
3. Physical abuse
Immediate red card and police
4. Noisy, disruptive behaviour
Yellow card – increase to a red card if repeated and serious
5. Jumping the queue
Verbal warning
6. Dealing near the pharmacy
Yellow card – increase to a red card if repeated and involve police
7. Begging near the pharmacy
Verbal warning
8. Attempting to alter prescription or presenting a forged prescription
Yellow/red card depending on seriousness. Alert prescriber, police, PCT and NHS counter fraud team
9. Discarding used needles and syringes unsafely
Refer to the nearest needle exchange outlet and/or warning and/or inform key-worker
10. Non compliance with the rules of the scheme
Yellow card – increase to a red card if repeated and serious
11. Presenting under the influence of any other substance
Do not dispense if possible, inform key worker immediately
Reducing leakage or spillage of drugs liable to misuse into the community
 Make sure that the patient is taken to the private area for consumption of the dose. Use of the dispensary for this
purpose is not acceptable. We advise that your private area is laid out in such a way as to prevent the public
accessing the dispensary.
 Be alert to duplicate and forged prescriptions. Query anything you are not sure about with the prescriber.
Obtain the prescriber’s telephone number by independent means such as directory enquiries or via the PCT.
 It is a professional requirement and legal imperative not to dispense a forged or stolen prescription. You must
have checking procedures in place to reduce the risk of a forgery to a minimum.
 If you suspect the prescription is a forgery, or has been altered in any way, contact the police. Do not alert the
patient to your suspicions. Try to retain the prescription. Stamp the prescription with the shop stamp to prevent
prescription being dispensed elsewhere. Take a description of the patient.
 If a patient presents with a prescription without introduction, contact the prescriber. They may have obtained a
duplicate prescription and are also collected from their usual pharmacy.
 Do not give the dose to a third party unless previously arranged with the prescriber and the patient (see below).
 A written note from the patient authorising the representative to collect the dose and then asking the
representative to sign that s/he has collected the dose will help avoid misunderstandings which may occur at a
later time if the patient subsequently appears asking for that day’s dose.
 You will need to decide on your procedures for third party collection, include it in your SOP, and ensure that all
patients and prescribers know the procedure.
 Be aware of swapping bottles – always make sure you take the top off the methadone bottle when giving to the
patient so that this can’t be swapped with an empty one.
 Some patients might say that they prefer to wash down their methadone with a can of soft drink. However, they
may discharge (spit) the methadone into the can instead for later sale. This is known as ‘spit-methadone.’
 Offer a beaker of water for patient to wash down the dose of methadone. This ensures the dose has been
swallowed and allows the patient to rinse excess methadone from the oral cavity.
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 Be suspicious of requests for extra tablet or medicine bottles. The patient may be storing the methadone
mixture in their cheek to spit out as soon as they leave the pharmacy.
 Remember, some patients may be under considerable pressure to ‘hand over’ their dose. If supervised
consumption procedures are thorough, then this can help patients keep their dose for themselves.
 It is recommended that measurements of methadone are always double checked, preferably by a second person.
Any allegations of short measure can be refuted with confidence.
 If a patient does insist they were given a short measure, do not give them any more. Contact the prescriber or
key worker.
 There have been reports of drug users attempting to inject partially dissolved Subutex tablets. However, due
to its partial agonist/antagonist effects, it appears to have less street value. Asking the patient to wait in the
pharmacy while the dose is finished seems to be, on the whole, a satisfactory resolution in the majority of cases.
 The manufacturers say that the buprenorphine is absorbed within the first three minutes after which time the
inert carriage remains.
 A drink of water before taking the tablet will speed up absorption. Do not allow sips while tasking the subutex
is dissolving they will not get a full dose or benefit
 The pharmacist’s responsibility is to ensure the tablet goes under the tongue and to confirm the dose has been
absorbed.
What should I report to the prescriber or key-worker?
 You are the only healthcare professional that has daily contact with the patient.
 You can build a valuable and supportive relationship with the patient.
 Daily contact allows you to monitor the patient compliance, suspected drug/alcohol intake, physical
appearance, and family support.
 You have an important role to play in monitoring treatment and may contribute to the patient’s review
by the healthcare team.
 Consider reporting back to the prescriber or key worker:
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Regularly missed doses or if whole dose are not consumed under supervision
If the patient is attempting to avoid supervised consumption
If three or more consecutive doses are missed
A dose missed during titration of increasing doses.
Unacceptable behaviour
Intoxication
Deterioration in health and other health concerns
Problems concerning the prescription (eg legal issues)
If the patient requests supervision
Any health related advice given, or referrals to other drug agencies made
Any positive feedback on the patients progress
Any suspected child care issues
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Referral to other services
As part of your health promotion role, you may need to refer patients to other drug treatment services within
the locality. You will need to find out what local services are available and what their remit is. Keep
information about the other drug treatment services in your SOP. You may want to attach leaflets from the
services to your SOP and include details of where new leaflets can be ordered from. Examples of some drug
services include:
 Drug Dependency Units – a statutory NHS service. The range of service provision usually includes
prescribing, information and advice, counselling, home visits, after care, condom provision,
psychiatric and psychological provision.
 Community Drugs Teams – a statutory NHS service. Most teams offer drop-in services for advice and
counselling and usually provide a prescribing service.
 Street agencies. These are based in the community and are non statutory. Street agencies can provide
a range of services including information, advice, counselling, home visits, outreach work,
needle/syringe provision, condoms, drop in service, structured day care and return to work
programmes.
 Self-help groups such as Narcotics Anonymous and Families Anonymous.
 Needle/syringe exchange – most agency services and many pharmacies provide needles, syringes and
condoms.
 Inpatient units – these are restricted and usually reserved for assessment of a severe drug problem, or
for detoxification.
 Drug Action Team (DAT), or in some areas Drug and Alcohol Action Teams (DAAT). These are
multi-agency teams which bring together all the local agencies involved with drug-related issues
including health and social care, local authorities dealing with housing and education, police and
probation, and the non-statutory sector. DATs co -ordinate service planning and delivery according to
local action plans.
 National Treatment Agency (NTA). This is a special health authority that plays a leading role in
setting and monitoring drug treatment standards and oversees a pooled national treatment budget.
Driving under the influence of drugs
You may have patients who you know are driving whilst taking a medication that may impair their reflexes or
judgment. Their ability to drive may cause you concern. You need to be clear on the regulations surrounding
driving whilst under the influence of drugs, and have a clear procedure covering what action to take if you
have concerns about a patient.
The Road Traffic Act requires licence holders or applicants to tell the DVLA of ‘any disability likely to
affect safe driving’. They consider drug use to be a disability in this context.
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It is illegal to drive a motor vehicle while taking any medication which may impair your reflexes and
judgment. Patients fall into this category when initially entering a methadone (or buprenorphine) programme.
However, once the patient is stabilized they can apply to the DVLA to be granted a licence.
The patient will be required to have a short medical examination including a urine screen for illicit drugs. If
there is only prescribed methadone or buprenorphine in the urine they will normally issue a licence for one
year at a time, until three years have elapsed since the cessation of treatment. The patient will be called back
each year for a medical until the end of the three years. The issue of a licence is subject to a favourable
consultant report.
If any illicit drugs are found in the urine the licence will be removed for one year. There is another medical
on reapplication for the licence.
It is the patient’s responsibility to inform the DVLA, not the prescribing doctor’s, the drug service or
the pharmacist.
Advice for patients prescribed methadone is included in ‘The Methadone Handbook’.
If you are concerned about a patient driving, possible action you could take:
 Remind them it is an offence to be in charge of a vehicle when unfit to drive through drink and drugs –
this includes prescribed ones.
 Advise them to take care and not to drive if they feel sedated or if they have had any alcohol.
 Suggest they contact the DVLA
 Remind them that if they are involved in an accident and their insurance company finds out they are on
a medication that may affect their ability to drive, they might be able to claim that it invalidates their
insurance.
 Talk to the patient’s prescriber or key worker.
 Make a note on the patient’s PMR that you have given advice on this issue.
Over the Counter Advice
Many patients receiving methadone will initially present with poor health due to years of neglect and abuse.
Most will have avoided any regular contact with members of the primary healthcare team. You have an ideal
opportunity to help the patient improve their health and well being. Advice about diet, exercise and oral
hygiene can be of particular value. The treatment of the majority of minor ailments is no different than for any
other patient in the pharmacy. However there are a certain requests which may be common in drug misuse
treatment patients and certain OTC medicines which may cause problems or be ineffective:
 Analgesia. Methadone offers little analgesic effect on chronic dosing. Simple analgesics should
be recommended, eg paracetamol or ibuprofen.
 Constipation. Constipation can be a common problem due to side-effects of opiates, poor diet,
dehydration and lack of exercise. Short term use of a stimulant laxative, eg senna or bisacodyl,
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may be useful together with advice on diet, exercise and fluid intake. More severe constipation
should be referred to the GP.
 Diarrhoea. Diarrhoea and distension (wind) can be side effects of high doses of some sugar free
formulations
 Insomnia. OTC preparations should not be recommended. However, you have an important role
to play in counselling the patient. The ‘Good Sleep Guide’ may be useful. The insomnia should
improve as the patient becomes stabilized
 Dyspepsia. This should be treated as for any other patient. The interaction between cimetidine and
methadone due to enzyme inhibition is unlikely to occur at OTC doses of cimetidine.
 Cystitis. Drugs which make the urine more alkaline, eg potassium citrate mixture, will potentially
reduce the renal excretion of methadone and therefore raise plasma levels; however this is unlikely
to be clinically significant.
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The Misuse of Over the Counter Medicines
In recent years there has been an increasing trend in self-medication by the general public and an increasing
number of products have been made available without a prescription. These products may have the potential
to be misused. Patients who purposefully misuse OTC medicines may do so for either their psycho stimulant
effects or to counter the effects of withdrawal from illicit drugs. Others may have become dependent through
over-use of a particular product after an initial genuine need for symptomatic relief. The spectrum of misuse
ranges from the over-consumption of codeine to produce a relaxation effect, to the excessive use of laxatives
to lose weight. The patient may not be aware that they are considered to be misusing their medicines.
You need to be aware of those medicines with the potential for misuse (by all patients, not just those being
prescribed substitute therapy). You need to have a procedure to prevent the misuse of OTC medicines. This
should include a protocol to ensure that all sales of OTC medicines are combined with advice on how to take
the medicine appropriately and safely. You need to have a procedure to deal with suspected OTC medicine
misuse. This might include refusing the sale questioning the customer, keeping the product out of sight,
limiting stock, offering alternatives, keeping records of sales, alerting staff to any potential abusers and
alerting other pharmacists in the area.
Some OTC medicines that have the potential to be misused include:
 Opioids, eg Gee’s Linctus, Codeine Linctus, Codis, J Collis Browne’s mixture and tablets,
Kaolin and Morphine mixture, Panadol Ultra, Paracodol, Pulmo Bailly, Solpadeine, Veganin,
Nurofen Plus.
Drug users will take these weaker opioids when more potent opioids are not available, despite the risk
of overdose of paracetamol, aspirin or ibuprofen. Misuse of OTC opioids may occur in patients with
chronic pain. These patients may not be receiving adequate pain relief and should be referred to their
GP.
 Sympathomimetics, eg Mu-Cron, Sinutab, Sudafed, Day-Nurse, Do-Do, some cough mixtures.
Use of oral pseudoephedrine in high doses can produce symptoms of hyper alertness and euphoria, but
chronic use may cause paranoia, hostility and aggression. Drug misuse substitution patients may use
stimulants to overcome lethargy so may attempt to purchase more than is necessary.
 Anticholinergics, eg Hyoscine contained in Kwells, Joy rides, Feminax.
Effects range from mild euphoria and increased sociability to hallucinations and toxic psychosis.
 Antihistamines, eg Brompheniramine (Dimotane), Cyclizine (Valoid), Diphenhydramine (some
Benylin, Nytol), Chlorpheniramine, Promethazine (Avomine, Phenergan), Triprolidine (Actifed).
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The first generation antihistamines produce a feeling of euphoria and wakefulness with the patient
experiencing a ‘buzz’, but at the same time have a short term sedative effect in those with chronic
sleep disturbance. This sedative effect is usually short lived and the patient takes escalating doses with
resultant adverse effects. Cyclizine has been misused for its psychomotor effects for many years and
is sometimes combined with methadone to produce ‘buzz’ effects similar to the effects of heroin. It is
available as Valoid tablets and RPSGB advises pharmacists to sell it personally.
 Caffeine, eg Panadol Extra, Pro-Plus, some Anadin products.
It is a central nervous stimulant. It is frequently used by patients with severe and chronic mental
illness and can exacerbate psychotic symptoms and make them more difficult to treat.
 Laxatives, eg Dulcolax, Castor Oil, Lactulose, Senokot, Ex-lax, Nylax, Micralax enemas, Syrup of
Figs.
Laxative abuse is found in approximately 4% of new patients evaluated for chronic diarrhoea1.
The majority of laxative abusers are female. Such patients are either attempting to control their
weight or have an obsessional need to defecate regularly. The majority of people who purchase
laxative do so because they have constipation due to lack of sufficient fibre and fluid in their diet
and lack of exercise, which could be addressed by non-pharmacological methods.
 Inhalants, eg Camphor, Menthol, Moth Balls, PR Spray, Ralgex Freeze Spray, Surgical and
Methylated spirit, Vicks Vaporub.
Inhalant abuse is predominantly seen in adolescents and young adults because inhalants are readily
available and inexpensive. Significant social, economic and medical consequences are associated
with their use. Inhalants commonly cause euphoria, hallucinations, and perceptual disturbances,
and can heighten emotions prevalent at the times. Tolerance may develop over time.
OTC medicines can be misused by a wide range of people. The pharmacist must be aware of the abuse
potential of the medicines and the warning signs and symptoms.
1. The abuse and misuse of prescribed and over the counter medicines. Hospital Pharmacist Vol 7 No 9
p242-250
RESPONSIBILITY OF STAFF
Your SOP needs to specify who is responsible for carrying out the dispensing and supervision of
consumption, both under normal circumstances and during holiday, sickness absence etc. This will vary
widely between (and even within) pharmacies depending on local circumstances. This is as per SLA ie
Pharmacist and qualified dispensers(see SLA for details)
Since all measurements of methadone should be double checked, you may decide that it is part of your
competent and fully trained dispenser’s responsibilities to measure and label the methadone. The pharmacist
would double check each measurement.
The supervision of consumption is a professional service. It is not just the consumption that is being
supervised. In addition the following checks are being carried out:
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Checking the patient is taking the medicine correctly.
Checking compliance – is the patient coming in every day?
Carrying out a basic health check.
Checking if there is anything that should be reported to the prescriber. Is the patient intoxicated? Are
there any other health problems the patient has raised that should be reported back to the prescriber?
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Any staff involved in providing a service for drug users, even if their responsibility lies solely in identifying
the patient and referring them onto the pharmacist, should be fully trained. Ask your local shared care coordinator for information about the training they offer.
In addition all staff providing services to drug misusers should be offered Hepatitis B vaccinations.
You will need to think about what happens during holidays or sickness, or when you have to get locum cover.
Do you have a regular locum? Will they be prepared to participate in the service? If you are part of a
supervised consumption scheme, you must ensure that any locum pharmacist is familiar with the scheme and
your standard operating procedures.
Remember, this section will be particularly useful for locum pharmacist, relief managers, and new members
of staff to refer to. You may specify either named individuals or individual job titles in the SOP. Remember
that if you specify members of staff by name, you may need to revise your SOP frequently to take account of
staff turnover, increased competence and so on. We suggest you specify job titles and then use the Staff
Responsibility Sheet to detail which members of staff hold which posts.
CHECK THE FINISHED PROCEDURE
Once you have finished drafting your SOP, you need to find out whether it works!
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Check that your draft SOP meets the objectives you set at the beginning
Check that it works in practice and that it is feasible
Check that the order of events is correct
Check that all staff understand what is expected of them
When you are satisfied with your answers to the above, we recommend that you operate it for a few weeks
and then meet with staff to review whether it is working or whether there are any areas which could be
improved.
When the SOP has been completed, it is a good idea to ask all staff to read it and sign to say they have
understood what it means, even if they are not involved in the carrying out the scheme. There is a section on
the blank SOP at the back of this booklet for this purpose. As well as clarifying who does what, this can be a
good opportunity for training and developing your staff.
REVIEW
As well as carrying out initial checks to ensure your SOP actually works, you need to specify how you will
ensure that it remains valid and up-to-date. For example, there may be changes in the law, changes of staff or
changes to the local protocol for supervised consumption. The NPA will keep you informed of changes in the
law through the Supplement and NPAnet and where possible will try to relate these to SOPs. It is particularly
important to review your SOP in the event of errors. On investigation, these usually reveal holes in the system
and you may want to think about how the error can be prevented from reoccurring.
However, even where there have been no major changes, you should define a minimum review period and we
suggest this should be an annual process.
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 It is often useful to review your SOP after three months initial use – you may find that
parts need tweaking or that there are areas of non-conformance which need addressing.
 Use the Review and Incident Log to note feedback or comments from locums and other
members of staff on your SOPs
 It is useful to review your SOP after errors or critical incidents to try to find out why they
occurred and to prevent recurrence.
 Keep an eye on the Supplement for notification of changes that might affect SOPs.
 In the absence of any obvious changes, we suggest you review your SOP annually. You
should appoint someone to be responsible for ensuring this occurs.
KNOWN RISKS
This section should contain a description of anything you are aware of that can make the procedure more risky
than usual. These are circumstances that you know can increase the likelihood of things going wrong and
where you believe extra care and attention should be paid. For example, when dispensing in instalments for
substance misusers, known risks might include:
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New staff, locums etc
New patients, unfamiliar with the service
Patients attending with their friends
Patients who present with a prescription who have not been introduced to you
Untrained staff
Patient behaving in an unacceptable manner.
Intoxicated patients
These could be based on areas where you have had concerns about the risk in the past, or those you have read
about in other pharmacies.
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