Drug Monitoring Guidelines DRUG MONITORING NOTES Gastrointestinal

					                                      Drug Monitoring Guidelines
This table is intended to provide guidance for drug monitoring. It is not an exhaustive list and it does
not replace or over-ride the information in the manufacturer’s Summary of Product Characteristics. The
information has been compiled from the references overleaf. You may also want to refer to individual
Shared Care Protocols for local recommendations.
Most labs will be reporting “eGFR” using the MDRD equation along with the creatinine result, as part of
the National Guidelines on Chronic Kidney Disease. The estimation of creatinine clearances is not
advocated.
Some labs report TDM’s in SI units, some a mixture of units please be aware of these differences.
⊕ Indicates shared care guideline available.
# NICE guidance for Epilepsy (Oct 04) does not recommend routine blood tests unless clinically
indicated. It states that monitoring should be carried out every 2-5 years in adults on enzyme-inducing
anti-epileptics.
    DRUG                                MONITORING                                             NOTES
 Gastrointestinal
                                             Maintenance
                                             Renal function should be
                      Baseline               assessed every 3 months for
 Mesalazine
                      U&E                    the first year, then 6 monthly
                                             for the next 4 years and yearly
                                             thereafter.
 CARDIOVASCULAR
 ACE inhibitors       Baseline:              Maintenance:                          Caution when prescribed with
 and Angiotensin II   BP, U&E’s (1)          BP, U&E’s 1 week after each ↑         potassium sparing diuretics or
                                                                   (1)
 antagonists                                 in dose then annually                 NSAIDs
                                                                                   Stop if >50%↑ in creatinine (2)
                                                                                   Stop or ↓ dosage if K > 5.5mmol/l
 Amiodarone           Baseline:              Maintenance:                          Abnormal TFT’s difficult to
                      ECG, serum             TFT’s + LFT’s 6 monthly               interpret, seek specialist advice
                      potassium, TFT’s +                                           (Contact local Endocrinologist or
                      LFT’s (3)              Ophthalmological examination          Biochemistry Lab).
                                                      (3)
                                             annually
                                                                                   If pulmonary toxicity is suspected
                                                                                   carry out chest x-ray and lung
                                                                                   function testing (3)
 Digoxin              Baseline:              Maintenance:                          Digoxin level only required if
                      U&E’s (2)              U&E’s annually                        toxicity is suspected or during dose
                                                                                   adjustment (4)
                                                                                   Potassium measurements must
                                                                                   always be made when checking for
                                                                                   digoxin toxicity, because of the
                                                                                   enhanced response to cardiac
                                                                                   glycosides in hypokalaemia.
                                                                                   Blood sample at least 6 hours post
                                                                                         (4)
                                                                                   dose
                                                                                   Derby report in nmol/L range 1.2-2.8
 Diuretics            Baseline:              Maintenance:                          Potassium sparing diuretics, e.g
                                                                             (2)
 (Loop, Thiazides     U&E’s and              U+E's 1 month after starting          amiloride, along with ACE inhibitors
 and Potassium        urinalysis (glucose)   and then annually.                    are the commonest cause for true
                      (2)
 sparing)                                    Urinalysis (glucose) annually         hyperkalaemia in GP patients.
                                                           (2)
                                             for thiazides
 Methyldopa           Baseline:              Maintenance:
                      LFT’s (5)              LFT’s at intervals during the
                                             first six weeks to twelve weeks
                                             of therapy, or whenever an
                                                                         (5)
                                             unexplained fever occurs
 Spironolactone       Baseline:              Maintenance:
                      U&E’s                  U&E’s at 5 days then weekly
                                             for 8 weeks after initiation,
                                             weekly for 5 weeks after dose
                                             change, then 3 monthly when
                                             stable.


Final Version                                   -1-                                     September 2006
 Statins           Baseline:              Maintenance:                      Stop if transaminases 3 x upper
                   Cholesterol (6)        Total (non-fasting) cholesterol   limit of normal
                                                                                            (8)

                                          at 3 months and then annually.    Review if CK raised, stop if CK
                   ALT (7)                                                                              (10)
                                                                            > 5 x upper limit of normal
                                          ALT at 3, 6 and 12 months         CK is dependent upon muscle
                                          only. No need for long term       mass, for example, an old lady with
                                          monitoring (7)                    a CK > 1000 would give cause for
                                                                            concern.
                                                                   (7)
                                          CK only if muscle pain
 ⊕ Warfarin        Baseline:              Maintenance:                      Check BNF for drug interactions
                   PT, APTT, LFT’s        INR weekly until stable then up
                   and platelet count     to every 12 weeks (9)
                   (9)


 RESPIRATORY
 Theophylline                             Maintenance:                      Blood sample immediately prior to
                                          Theophylline level                next dose. Note interactions e.g.
                                          6 – 12 monthly (10) if toxicity   erythromycin and ciprofloxacin.
                                          suspected or taking interacting   Therapeutic range 10 – 20mg/L OR
                                          drugs                             55-110µmol/L
 CENTRAL NERVOUS SYSTEM – Antidepressants
 ⊕ Venlafaxine     Baseline:              Maintenance:                      Dosage reduction or
                   BP                     BP at 4 weeks, 8 weeks, then      discontinuation should be
                                          6 monthly (3 monthly for doses    considered if there is a sustained
                                          > 200mg/day) or following any     increase in BP.
                                          subsequent dose increase.
 CENTRAL NERVOUS SYSTEM – Anti-epileptics
 # Carbamazepine   Baseline:              Maintenance:                      Note elevated gamma GT
                                                                            anticipated because of enzyme
                                                          (12)
                   LFT's, U&E + FBC       FBC 6 monthly                     induction.
                   including platelets
                   (11)
                                                                            Drug level only if interactions or
                                                                            toxicity suspected (blood sample
                                                                            immediately prior to next dose).

                                                                            Warn patients to look out for
                                                                            symptoms of neutropenia.
 #Phenytoin        Baseline:              Maintenance:                      Phenytoin levels only needed with
                                                                            dose changes, seizures, side
                   LFT’s + FBC (13)       LFT’s + FBC 12 monthly            effects or to check compliance.
                                                                   (14)
                                          Folate level 6 monthly            Blood sample any time at steady
                                                                            state i.e. after 14 days.
                                                                            Clinically effective level is usually
                                                                                          (14)
                                                                            10-20mg/L

                                                                            Check for drug interactions -
                                                                            induces p450 enzymes.
 #Sodium           Baseline:              Maintenance:                      If spontaneous bruising or bleeding
 Valproate         LFT's (15) FBC         LFT’s monthly for 3 months        withdraw drug pending
                   Weight                 and then annually (10)            investigations (FBC) (15)
 ⊕ #Vigabatrin     Baseline:              Maintenance:                      Visual field defects have been
                   Visual field testing   Visual field testing by           reported in approximately one third
                   by perimetry (16)      perimetry every 6 months (16)     of patients receiving vigabatrin (16)

                                                                            Monitoring of serum concentrations
                                                                            is not indicated (23)
 CENTRAL NERVOUS SYSTEM – antipsychotic and antimanic drugs
 Amisulpride       Baseline:              Maintenance:
                   CK, Serum              FBC + U&E’s 6 monthly (10)
                   prolactin, FBC,
                   U&E’s, LFT’s,
                   TFT’s, BP and
                   weight




Final Version                                -2-                                 September 2006
 ⊕ Aripiprazole      Baseline:                Maintenance:                       Olanzapine & Quetiapine ↑
                     Serum prolactin,         U&E, LFT’s, FBC, FBG, BMI,         triglycerides
 ⊕ Olanzapine        FBC, FBG, U&E’s,         waist circumference at 3 + 6
                     LFT’s, TFTs, BP,         months.                            Quetiapine ↑ cholesterol
 ⊕ Quetiapine        Pulse, BMI. In high      BP, Pulse – 3 + 6 months and
                     risk patients also       annually thereafter
                     ECG, waist               ECG – repeat at maintenance
                     circumference, full      dose
                     fasting lipid profile    Fasting lipid profile – 3 months
                     (21), (24)
                                              and annually
                                              TFTs – annually (21), (24),(39)
 Risperidone         Baseline:                Maintenance:
                     CK, serum                FBC, LFT’s, U&E’s 6 monthly
                                              (10)
                     prolactin, FBC,
                     U&E’s, LFT’s,
                     TFTs, BP and
                     weight (10)
 ⊕ Lithium           Baseline:                Maintenance:                       Avoid Thiazides and NSAID's
                                    17)
                     U&E’s, TFT’s (           Lithium level 3 monthly when
                                       (40)
 (Should only be     Cardiac function         stable (40)                        Monitor lithium concentration if
 prescribed by                                TFTs and Calcium levels            patient becomes dehydrated or
 brand)                                       annually if agreed with            nausea and vomiting
                                              psychiatrist (40)
                                              Serum creatinine 6 monthly (3      Take blood levels 12-16 hours after
                                              monthly for older patients or      last lithium dose.
                                              those with special precautions
                                              or interacting drugs).
 CENTRAL NERVOUS SYSTEM – Dopaminergic drugs
 Levodopa            Baseline:                Maintenance:                       SPC advises blood sugar tests in
                     FBC, U&E’s, LFT’s,       FBC, U&E’s, LFT’s, BP              diabetics (36)
                     BP (36)                  annually
 ENDOCRINE
 Alendronic acid     Baseline:
                     U&E, corrected
                     calcium
 Antidiabetic        Baseline:                Maintenance:                       Avoid metformin in patients with
                                                    (15)
 agents              Metformin – U&E’s        HbA1c      3-6 monthly             renal failure.
                     (20)
                                                                                 Avoid long acting sulphonylureas in
                                              Metformin – U&E annually (20)      elderly patients.
 Carbimazole         Baseline:                Maintenance:                       Warn patients to look out for
                     TFTs                     FBC+ TFTs annually (18)            symptoms of neutropenia.
 Glitazones          Baseline:                Maintenance:                       Do not initiate if ALT 2.5x upper
                                                             st
                     ALT                      ALT 2 monthly 1 year then          limit of normal. During treatment if
                                                      (10)
                                              annually .                         ALT 3x upper limit of normal
                                                                                 reassess and discontinue if ALT
                                                                                 remain raised at this level
 Levothyroxine       Baseline:                Maintenance:                       Titrate dose slowly in patients with
 some patients are   TSH + T4 (10)            TSH 3 monthly following a          cardiac problems.
 being put on T3                              dose change then annually
                                              when stable (18)
 Propylthiouracil    Baseline:                Maintenance:
                     TFTs                     FBC+ TFTs annually (18)
 Risedronate         Baseline:
                     U&E’s, corrected
                     calcium
 NUTRITION AND BLOOD
 Ferrous sulphate/   Baseline:                Maintenance:
 Hydroxo-            FBC                      FBC annually
 cobalamin
 ANTI-RHEUMATIC DRUGS AND NSAIDS.
 NSAIDs (including                            Maintenance:                       Except low dose Aspirin
 COX-2 Inhibitors)                            U&E’s in patients >65 (25)         Avoid the use of long term NSAIDs
                                              annually                           in patients over 65




Final Version                                        -3-                              September 2006
 ⊕ Sodium          Baseline:              Maintenance:                        Lots of actions see table in BSR
                                                                                         (42)
 Aurothiomalate    Chest x-ray FBC, ,     FBC initially at the time of each   Guidance
                   Serum creatinine,      injection(41) After 6 months of
                   LFT’s and              uncomplicated treatment              (The Patient should be asked
                   urinalysis for blood   reduce FBC to monthly and           about presence of rash or mouth
                   and protein (27, 41)   urinalysis for blood and protein    ulcers before each injection.)
                                          before each injection
 ⊕ Auranofin       Baseline:              Maintenance:                        Contact rheumatology dept. if there
                   FBC, U&E, LFT &        FBC & Urinalysis every month        is a progressive fall in white cell
                   urinalysis for         CXR annually SPC but not in         count or platelet levels even within
                   proteinuria            BSR                                 the normal range or an absolute
                                                                              white cell count below 3.5 x 109/L
                                                                              and a neutrophil count below 2 x
                                                                              109/L or a platelet count drops
                                                                                              9   (26)
                                                                              below 120 x 10 /L
                                                                              Lots of actions see table in BSR
                                                                                         (42)
                                                                              Guidance
 ⊕ Azathioprine    Baseline:              Maintenance:                        Contact rheumatology dept. if there
                   FBC U&E                FBC weekly for first 6 weeks        is a progressive fall in white cell
                   Creatinine & LFT       and 2 weekly after each dose        count or platelet levels even within
                   TPMT assay             increase and, if stable             the normal range or an absolute
                                                                                                               9
                                          MONTHLY thereafter. LFT             white cell count below 3.5 x 10 /L
                                          MONTHLY until the dose is           and a neutrophil count below 2 x
                                          stable. Once the disease, dose      109/L or a platelet count drops
                                          and blood monitoring is stable      below 120 x 109/L (28) Lots of
                                          reduce the FBC&LFT to 3             actions see table in BSR guidance
                                                                              (42)
                                          monthly. U&E and Creatinine
                                          should be repeated 6 monthly.
                                          CRP/ESR may be done every
                                          3 months.
 Chloroquine/      Baseline:              Maintenance:                        Warn patient to check for signs of
 hydroxychloro -   FBC U&E LFT            Eye check annually (29)             neutropenia and report any visual
 quine             Eye check (29)                                             disturbances

 ⊕ Ciclosporin     Baseline:              Maintenance:                        Lots of actions see table in BSR
                   FBC, LFT, U&E,         FBC & LFT – ONCE a month            guidance (42), refer to shared care
                   BP, fasting lipid      until the dose & trend stable       or specialist as appropriate
                   profile,               for 3 months & then every 3
                   Creatinine (TWICE      months. Serum creatinine,
                   to obtain a mean       electrolytes and potassium
                   value) creatinine      two weekly until dose & trend
                   clearance.             stable and then, monthly.
                    Blood Pressure:       Watch when given with
                   to be within the       NSAID, particularly with
                   normal range on        Diclofenac.
                   two measurements;      Check fasting lipids
                   or treat               periodically (6 monthly review
                   Hypertension.          is probably o k. - not based on
                                          evidence)
                                          Blood Pressure: Check B.P.
                                          each time patient attends
                                          monitoring clinic.
 Dantrolene        Baseline:              Maintenance:
                   LFT’s (35)             LFT’s annually
 ⊕ Leflunomide     Baseline:              Maintenance:                        Contact rheumatology dept. if there
                   FBC, body weight,      FBC, LFT’s and BP monthly           is a progressive fall in white cell
                              (31)
                   LFT’s, BP              for 6 months then 8 weekly if       count or platelet levels even within
                                          disease, drug dose &                the normal range or an absolute
                                          monitoring stable(31)or long        white cell count below 3.5 x 109/L
                                          term once a month if co-            and a neutrophil count below 2 x
                                                                                 9
                                          prescribed another                  10 /L or a platelet count drops
                                                                                              9   (31)
                                          immunosuppressant or                below 120 x 10 /L        Lots of
                                          heaptotoxic drug                    actions see table in BSR guidance
                                                                              (42)

 ⊕ Methotrexate    Baseline:              Maintenance:                        Contact rheumatology dept. if there
                   FBC, U&E’s, LFT’s,     FBC, U&E and LFT’s                  is a progressive fall in white cell
                   (32)
                                          (requested as MP on                 count or platelet levels even within
                   Chest x-ray before     biochemistry form) every 2          the normal range or an absolute



Final Version                                -4-                                     September 2006
                        initiation (33)         weeks for 6 weeks after the          white cell count below 3.5 x 109/L
                        Pulmonary function      last dose change, then               and a neutrophil count below 2 x
                                                                                       9
                        tests may be            monthly until patient is             10 /L or a platelet count drops
                                                                                                     9   (32)
                        undertaken in some      stabilised. If patient, dose &       below 120 x 10 /L        Lots of
                        patients.               trend is stable then frequency       actions see table in BSR guidance
                                                                                     (42)
                                                of monitoring can be reduced
                                                to 3 monthly.

 ⊕Mycophenolate         Baseline                Maintenance                          Lots of actions see table in BSR
 mofetil                FBC U&E LFT and         FBC once a week for 4 weeks,         guidance (42)
                        CXR                     every 2 weeks for 2 months
                                                and monthly thereafter
 ⊕ Penicillamine        Baseline:               Maintenance:                         Contact rheumatology dept. if there
                        FBC, U&E’s Serum        FBC, urinalysis for blood and        is a progressive fall in white cell
                        creatinine,             protein every 2 weeks until          count or platelet levels even within
                        urinalysis for blood    dose stable, then monthly (34)       the normal range or an absolute
                        and protein (34)        Patients should be asked             white cell count below 3.5 x 109/L
                                                about presence of rash or oral       and a neutrophil count below 2 x
                                                ulceration at each visit             109/L or a platelet count drops
                                                                                                     9   (34)
                                                                                     below 120 x 10 /L        Lots of
                                                                                     actions see table in BSR guidance
                                                                                     (42)

 ⊕ Sulphasalazine       Baseline:               Maintenance:                         Lots of actions see table in BSR
                                                                                               (42)
                        FBC, LFT’s, U&E’s,      FBC, LFT’s, monthly for 3            guidance
                        creatinine              months then 3 monthly
                                                (requested as MP on
                                                biochemistry form)
                                                If during the first year dose
                                                and blood results have been
                                                stable, 6 monthly tests will
                                                suffice for the second year
                                                and thereafter, monitoring of
                                                toxicity could be discarded.
                                                Patient should be asked about
                                                the presence of rash or oral
                                                ulceration at each visit
                                                Following dose changes:
                                                Repeat FBC, LFT one month
                                                after dose increases, if stable
                                                revert to usual monitoring
                                                regime.
                                                Reviews: U&E,
                                                creatinine,CRP/ESRorPV 6
                                                monthly may be helpful to
                                                monitor disease activity
 Mesalazine             Baseline:               Maintenance:                         FBC only in patients who develop
                        U&E’s (37)              U&E’s 3 monthly for first year,      unexplained bleeding, bruising,
                                                then 6 monthly for the next 4        fever or sore throat (37)
                                                years and annually thereafter
                                                (37)



Abbreviations
ALT    Alanine aminotransferase                                  FBG       Fasting blood glucose
BMI    Body mass index                                           LFT’s     Liver function tests
BP     Blood pressure                                            SPC       Summary of product characteristics
CK     Creatinine kinase                                         TFT’s     Thyroid function tests
ECG Ecocardiogram                                                T4        Thyroxine
FBC    Full blood count                                          U&E’s     Urea and electrolytes


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Final Version                                          -6-                                     September 2006

				
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