Workshop Adverse Drug Reactions acne

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					 Workshop 4.1: Adverse Drug Reactions
                                    Case Scenario 1
   Question        I have just been prescribed Roaccutane and have been told that I shouldn’t
                   wax my legs. Will this be forever or is it only for the duration of time that I
                   am on it?
  What further     PERSON                                  MEDICINES
 information do    Who is asking?                          Medicines (name,dose,freq)?
   you need to     19 year old female – about herself      Roaccutane 30mg once a day.
     clarify the                                           Microgynon 30 .
                   New or worsening symptoms?
  question and     No symptoms.                            Why asking about medicines?
  minimise the
                                                           Would like further explanation of
    risks when     Any allergies/medical conditions?       what the specialist said.
  advising the     No allergies. Acne since mid teens.

     Gather the further background information BEFORE searching for information.

What information   eBNF:
 sources would     Roaccutane contains isotretinoin.
   you use?        Counselling Warn patient to avoid wax epilation (risk of epidermal stripping),
                   dermabrasion, and laser skin treatments (risk of scarring) during treatment
                   and for at least 6 months after stopping; patient should avoid exposure to
                   UV light (including sunlight) and use sunscreen and emollient (including lip
                   balm) preparations from the start of treatment.
                   Side-effects dryness of skin (with dermatitis, scaling, thinning, erythema,
                   pruritus), epidermal fragility (trauma may cause blistering), dryness of lips
                   (sometimes cheilitis), dryness of eyes (with blepharitis and conjunctivitis),
                   dryness of pharyngeal mucosa (with hoarseness), dryness of nasal mucosa
                   (with epistaxis)
                   Cautions exclude pregnancy before starting (perform pregnancy test 2–3
                   days before expected menstruation, start treatment on day 2 or 3 of
                   menstrual cycle)—women must practice effective contraception at least 1
                   month before, during, and for at least 1 month after treatment

                   eMC – PIL/Roaccutane:
                   Possible side effects
                   Roaccutane can have side effects, though not everybody gets them. The
                   effects often wear off, or stop when treatment is stopped. Your doctor can
                   help you deal with them.
                   Skin and hair problems
                   Very common effects (may affect more than 1 in every 10 people)

                   Dryness of the skin, especially of the lips and face; inflamed skin, chapped
                   and inflamed lips, rash, mild itching and slight peeling. Use a moisturising
                   cream from the start of treatment.
                   Skin becomes more fragile and redder than usual, especially the face.

                   Women who could get pregnant are only prescribed Roaccutane under strict
                   rules, because of the risk of birth defects (damage to the unborn baby).

 Role Preparation for Nurse Advisors: Handling Medicines Calls         November 2007 v1.0
                  These are the rules:

                  You must only take Roaccutane if you have severe acne that has not got
                  better after any other anti-acne treatments, including antibiotics and skin

                  Your doctor must have explained the risk of birth defects: you understand
                  why you must not get pregnant and what you need to do to prevent it.

                  You must have discussed contraception (birth control) with your doctor.
                  They will give you information on preventing pregnancy. He or she may refer
                  you to a specialist for contraceptive advice.

                  You must agree to use one or preferably two effective methods of
                  contraception, including condoms or a cap plus spermicide, for a month
                  before taking Roaccutane, during treatment and for a month afterwards.
                  Before you start treatment your doctor will ask you to take a pregnancy test,
                  which must be negative.

                  You must use contraception even if you do not have periods or are not
                  currently sexually active (unless your doctor decides this is not necessary).

                  You must accept the need for monthly follow up visits and more pregnancy
                  tests as decided by your doctor. You may have a test 5 weeks after stopping
                  Roaccutane. You must not get pregnant during treatment and for a month

                  Your doctor may ask you (or a guardian) to sign a form that confirms that
                  you have been told about the risks, and that you accept the necessary
                  You should avoid exposing your skin to intense sunlight or UV light while
                  taking this medicine. You should use a sunscreen of at least SPF 15 when

                  Isotretinoin is likely to make your skin and lips very dry, so it is
                  recommended that you use a moisturiser and lip balm from the start of

                  You should avoid waxing any part of your body while taking isotretinoin, and
                  for at least six months after stopping treatment, as this could cause stripping
                  of the top layer of skin. Chemical dermabrasion and cutaneous laser
                  treatment should also be avoided during treatment with isotretinoin and for
                  five to six months after stopping treatment, as this could cause scarring.
                  Isotretinoin causes major birth defects (serious malformations of a
                  developing foetus) if taken during pregnancy. For this reason your doctor will
                  not prescribe the treatment to women who could get pregnant, unless the
                  following criteria are met: At least one, but preferably two (for example the
                  pill and condoms), effective methods of contraception must be used at all
                  times to prevent pregnancy. Contraception must start at least four weeks
                  before starting treatment, be used at all times during treatment and for at
                  least four weeks after stopping treatment, even if you don't have a period.
                  Your doctor cannot prescribe isotretinoin until you have been using effective
                  contraception for at least a month and have had a negative pregnancy test.

Role Preparation for Nurse Advisors: Handling Medicines Calls         November 2007 v1.0
                   Your doctor is only allowed to prescribe 30 days supply of isotretinoin at a
                   time. You will need to have a follow-up visit every month, at which you will
                   have to have a negative pregnancy test before a new prescription can be
                   issued. Five weeks after stopping treatment you should have a final
                   pregnancy test to make sure you have not fallen pregnant. If you think there
                   is a chance you could be pregnant, either during treatment, or in the first
                   month after stopping treatment, you must consult your doctor immediately.

 What advice       Well-known side effect of Roaccutane related to the high dose of vitamin A.
would you give?
 Or would you      Avoid waxing any part of the body during therapy with isotretinoin, and for up
    refer?         to six months after stopping therapy, due to risk of inflammation of the skin
                   (dermatitis) and scarring.

Further learning points
Isotretinoin, a Vitamin A analogue, is very toxic and may only be prescribed by / under
supervision of a consultant dermatologist. It is teratogenic. Women of childbearing age must be
fully informed and practice effective contraception.

 Role Preparation for Nurse Advisors: Handling Medicines Calls        November 2007 v1.0
 Workshop 4.1: Adverse Drug Reactions
                                    Case Scenario 2
   Question        My son has a rash all over his body and is feeling unwell. He has recently
                   started lamotrigine, could this be causing the rash?

  What further     PERSON                                  MEDICINES
 information do    Who is asking?                    Medicines (name,dose,freq)?
   you need to     Mother about 8 years old son.     Lamotrigine 5mg each day.
     clarify the                                     Sodium Valproate 200mg twice a
  question and     New or worsening symptoms?        day.
  minimise the     Rash – raised red bumps., not How long been on these, who
    risks when     bleeding, all over him. Started prescribed them?
  advising the     yesterday evening. He is hot and Lamotrigine started about 3 weeks
       caller?     feels unwell.                     ago by specialist as sodium valporate
                                                     not controlling the fits.
                   Any allergies/medical conditions?

     Gather the further background information BEFORE searching for information.

What information   eBNF:
 sources would     Skin reactions Serious skin reactions including Stevens-Johnson syndrome
   you use?        and toxic epidermal necrolysis (rarely with fatalities) have developed
                   especially in children; most rashes occur in the first 8 weeks. Rash is
                   sometimes associated with hypersensitivity syndrome (see Side-effects,
                   above) and is more common in patients with history of allergy or rash from
                   other antiepileptic drugs. Consider withdrawal if rash or signs of
                   hypersensitivity syndrome develop. The CSM has advised that factors
                   associated with increased risk of serious skin reactions include concomitant
                   use of valproate, initial lamotrigine dosing higher than recommended and
                   more rapid dose escalation than recommended.
                   Counselling Warn patients to see their doctor immediately if rash or signs or
                   symptoms of hypersensitivity syndrome develop

                   eMC SPC/ Lamictal:
                   Undesirable effects
                    In double-blind, add-on clinical trials, skin rashes occurred in up to 10% of
                   patients taking lamotrigine and in 5% of patients taking placebo. The skin
                   rashes led to the withdrawal of lamotrigine treatment in 2% of patients. The
                   rash, usually maculopapular in appearance, generally appears within eight
                   weeks of starting treatment and resolves on withdrawal of lamotrigine (see
                   Special Warnings and Special Precautions for Use).

                   Rarely, serious potentially life threatening skin rashes, including Stevens
                   Johnson syndrome and toxic epidermal necrolysis (Lyell Syndrome) have
                   been reported. Although the majority recover on drug withdrawal, some
                   patients experience irreversible scarring and there have been rare cases of
                   associated death. (See Special Warnings and Special Precautions for Use)

 Role Preparation for Nurse Advisors: Handling Medicines Calls         November 2007 v1.0
                  The approximate incidence of serious skin rashes reported as SJS in adults
                  and children over the age of 12 is 1 in 1000. The risk in children under the
                  age of 12 is higher than in adults. Available data from a number of studies
                  suggest that the incidence in children under the age of 12 requiring
                  hospitalisation due to rash ranges from 1 in 300 to 1 in 100 (see Special
                  Warnings and Special Precautions for Use).

                  In children, the initial presentation of a rash can be mistaken for an infection;
                  physicians should consider the possibility of a drug reaction in children that
                  develop symptoms of rash and fever during the first eight weeks of therapy.

                  Additionally the overall risk of rash appears to be strongly associated with:-

                        High initial doses of lamotrigine and exceeding the recommended
                         dose escalation of lamotrigine therapy (see Posology and Method of

                        Concomitant use of valproate

                  Adverse skin reactions have been reported with lamotrigine. These reactions
                  are usually mild and get better on their own, but can on rare occasions be
                  more serious and potentially life-threatening. The risk is higher in children
                  under 12 years of age and in people who are also taking the medicine
                  valproate. When starting treatment with lamotrigine the dose is increased
                  gradually to minimise the risk of developing a skin rash. For this reason it is
                  very important to follow the instructions you are given with this medicine,
                  and not to exceed the prescribed dose. If you or your child develop a rash,
                  fever, facial swelling or swollen glands while taking this medicine you should
                  consult your doctor immediately. If the doctor decides the reaction is related
                  to this medicine you will need to stop taking it.

 What advice      Rash is a common side effect of lamotrigine. It is usually red and raised and
would you give?   often begins within the first 8 weeks of treatment. However, it can be a more
 Or would you     serious side effect especially if there is also fever.
                  Advise that the son sees the GP immediately or is taken to A&E. Please
                  explain that you have phoned NHS Direct and this is what was advised. It is
                  important that the rash be seen by a doctor and if due to lamotrigine then
                  treated quickly.

Role Preparation for Nurse Advisors: Handling Medicines Calls          November 2007 v1.0
 Workshop 4.1: Adverse Drug Reactions
                                    Case Scenario 3
   Question        My husband has recently started simvastatin and has developed muscle
                   pain in his leg. Could it be due to this new drug?

  What further     PERSON                                  MEDICINES
 information do    Who is asking?                          Medicines (name, dose, freq)?
   you need to     Wife about 62yr old husband.            Simvastatin 10mg once daily
     clarify the                                           Aspirin 75mg once daily
  question and     New or worsening symptoms?
  minimise the     Muscle pain developed over last 24 How long has the patient been on
    risks when     hours in lower legs and generally these prescribed medications?
  advising the     feels unwell.                      GP started simvastatin last week
       caller?                                        because cholesterol level 5.7
                   Any allergies/medical conditions? Aspirin taken for several years.
                   High cholesterol

     Gather the further background information BEFORE searching for information.

What information   eBNF:
 sources would     Side-effects
   you use?        Reversible myositis is a rare but significant side-effect of the statins (see
                   also CSM advice (Muscle Effects), section 2.12 and below). The statins also
                   cause headache, altered liver-function tests (rarely, hepatitis), paraesthesia,
                   and gastro-intestinal effects including abdominal pain, flatulence,
                   constipation, diarrhoea, nausea and vomiting. Rash and hypersensitivity
                   reactions (including angioedema and anaphylaxis) have been reported
                   Muscle effects Myalgia, myositis, and myopathy have been reported with
                   the statins; if myopathy is suspected and creatine kinase is markedly
                   elevated (more than 5 times upper limit of normal), or muscular symptoms
                   are severe, treatment should be discontinued; in patients at high risk of
                   muscle effects, a statin should not be started if creatine kinase is elevated.
                   There is an increased incidence of myopathy if the statins are given at high
                   doses or given with a fibrate (see also CSM advice), with lipid-lowering
                   doses of nicotinic acid, or with immunosuppressants such as ciclosporin;
                   close monitoring of liver function and, if symptomatic, of creatine kinase is
                   required in patients receiving these drugs. Rhabdomyolysis with acute renal
                   impairment secondary to myoglobinuria has also been reported.
                   Advise patient to report promptly unexplained muscle pain, tenderness, or
                   CSM advice (muscle effects)
                   The CSM has advised that rhabdomyolysis associated with lipid-regulating
                   drugs such as the fibrates and statins appears to be rare (approx. 1 case in
                   every 100 000 treatment years) but may be increased in those with renal
                   impairment and possibly in those with hypothyroidism (see also notes
                   above). Concomitant treatment with drugs that increase plasma-statin
                   concentration increase the risk of muscle toxicity; concomitant treatment with
                   a fibrate and a statin may also be associated with an increased risk of
                   serious muscle toxicity.

 Role Preparation for Nurse Advisors: Handling Medicines Calls         November 2007 v1.0
                  eMC SPC- Zocor:
                  Before the treatment All patients starting therapy with simvastatin, or whose
                  dose of simvastatin is being increased, should be advised of the risk of
                  myopathy and told to report promptly any unexplained muscle pain,
                  tenderness or weakness.
                  Whilst on treatment If muscle pain, weakness or cramps occur whilst a
                  patient is receiving treatment with a statin, their CK levels should be
                  measured. If these levels are found, in the absence of strenuous exercise, to
                  be significantly elevated (> 5 x ULN), treatment should be stopped. If
                  muscular symptoms are severe and cause daily discomfort, even if CK
                  levels are < 5 x ULN, treatment discontinuation may be considered. If
                  myopathy is suspected for any other reason, treatment should be
                  eMC PIL - Zocor
                  Tell your doctor quickly if you experience unexplained muscle pain,
                  tenderness or weakness. This is because on rare occasions, there is a risk
                  of muscle problems which may be serious, including muscle breakdown
                  which can result in kidney damage. The doctor may perform a blood test to
                  check the condition of your muscles before and after starting treatment.
                  Things to note regarding muscle effects
                  The risk of muscle breakdown is greater at higher doses of ‘Zocor’.
                  The risk of muscle breakdown is greater in certain patients. Tell your doctor
                  if any of the following applies to you:
                  kidney problems
                  thyroid problems
                  you are more than 70 years old
                  you have ever had muscle problems during treatment with cholesterol
                  lowering medicines called "statins" (such as simvastatin, atorvastatin,
                  pravastatin) or fibrates (such as gemfibrozil, bezafibrate).
                  you or close family members have a hereditary muscle disorder.
                  The risk of muscle problems can be greater if ‘Zocor’ is taken with certain
                  This medicine may occasionally have side effects on the muscles. For this
                  reason you should inform your doctor immediately if you experience any
                  unexplained muscular symptoms such as pain, tenderness, cramps or
                  weakness while taking this medicine. Your doctor may need to check for
                  side effects on the muscles by taking a blood test to measure the level of a
                  compound called creatine kinase (CK) in your blood. If this is the case, the
                  test should not be done following strenuous exercise.

 What advice      Statins may have very rare side effects on muscles.
would you give?
 Or would you     Advise that the husband see the GP immediately. The GP may advise that
    refer?        you stop this medication and may wish to do some blood test.

Role Preparation for Nurse Advisors: Handling Medicines Calls       November 2007 v1.0

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