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Choked while chewing product, chewed and swallowed the product like a breath mint, chewing and swallowing the product like a breath mint / eating the mints regularly, swallowing them like a breath mint / eating the mints regularly / erroneous administration of the product, worsening of breathing [dyspnea exacerbated], very confused, more memory loss / memory loss [amnesia aggravated], irritability, increased ph of urine, uti, recent increase in blood pressure, declining [general physical health deterioration], low blood pressure.Case description: this case was reported by a pharmacist via call center representative and described the occurrence of choke on medication in a (b)(6) female patient who received double salt denture cleanser (polident overnight denture cleanser tablets) unknown for drug use for unknown indication.Co-suspect products included double salt denture cleanser (polident daily care tablets) effervescent tablet for drug use for unknown indication and double salt dental adhesive cream (polident fresh mint) unknown for drug use for unknown indication.Concurrent medical conditions included mental confusion.On an unknown date, the patient started polident overnight denture cleanser tablets, polident daily care tablets and polident fresh mint.On an unknown date, an unknown time after starting polident overnight denture cleanser tablets, polident daily care tablets and polident fresh mint, the patient experienced choke on medication (serious criteria gsk medically significant), inappropriate chewing of medication and intentional device use issue.The action taken with polident overnight denture cleanser tablets was unknown.The action taken with polident daily care tablets was unknown.On an unknown date, the outcome of the choke on medication and inappropriate chewing of medication were not reported and the outcome of the intentional device use issue was unknown.The reporter considered the choke on medication to be related to polident overnight denture cleanser tablets and polident daily care tablets.It was unknown if the reporter considered the choke on medication, inappropriate chewing of medication and intentional device use issue to be related to polident fresh mint.A pharmacist reported that a patient had 3 boxes of polident (polident overnight, polident daily care, and polident fresh mint) and she was chewing and swallowing them like a breath mint.The patient choked on the product while chewing the product.The patient was treated in the er.The pharmacist stated that the consumer was elderly and mentally confused.The pharmacist stated that the consumer had been using the product for a while now.The pharmacist stated that it was unknown which polident product the consumer chewed and swallowed; therefore taking into consideration worst case scenario, all three products were listed as suspect.Follow up information received 06 january 2017: co-suspect products included polident (polident (unknown)) unknown for drug use for unknown indication.On an unknown date, the patient started polident (unknown).On an unknown date, an unknown time after starting polident (unknown), the patient experienced choke on medication (serious criteria gsk medically significant), inappropriate chewing of medication and intentional device use issue.The reporter considered the choke on medication to be related to polident (unknown).Please note that "polident fresh mint" is not a marketed product in canada.The loc believe the consumer did not provide the correct suspect product name (most polident products have "triple mint fresh" written on the box), therefore the suspect product 'polident fresh mint' has been changed to "polident unknown".For regulatory reporting purposes a qa investigation was conducted even though a product complaint event was not reported.Verbatim received from qa department: no lot number given so the batch file couldn't be reviewed.Package instructions state to not place in the mouth tablets or solution.It also states to not drink the solution or use it as a mouthwash.I am unable to explain why this consumer decided to place it in the mouth.The carton states to call the poison control center or doctor if swallowed.Follow-up information received on 10 february 2017: final qa results: no sample received and no lot number given.The carton directions state to not place the tablet in the mouth or use the solution as a mouthwash.I am unable to determine why the consumer placed the product in the mouth to become choked on them.No specific trends for this issue identified.Follow-up information received from pharmacist on 12 april 2017: the patient's past medical history included urinary tract infection.Concurrent medical conditions included mental confusion (has improved), dementia (moderate cognitive impairment), hypertension (controlled with prescription therapy), chronic obstructive pulmonary disease (controlled with prescription therapy), depression (controlled with prescription therapy), electrolyte imbalance, gastroesophageal reflux disease, osteoporosis, overactive bladder, osteoarthritis, hypomagnesemia, anxiety (controlled with prescription therapy) and cognitive impairment (moderate).On (b)(6) 2016, an unknown time after starting polident overnight denture cleanser tablets, polident daily care tablets and polident (unknown), the patient experienced choke on medication (serious criteria gsk medically significant).On an unknown date, the patient experienced inappropriate chewing of medication (serious criteria clinically significant/intervention required), accidental device ingestion (serious criteria gsk medically significant), device use error, dyspnea exacerbated, confusion, amnesia aggravated, irritability, ph urine increased, urinary tract infection, increased blood pressure, general physical health deterioration, low blood pressure and product complaint.The patient was treated with antibiotics nos.Polident overnight denture cleanser tablets was discontinued (dechallenge was unknown).Polident daily care tablets was discontinued (dechallenge was unknown).On an unknown date, the outcome of the choke on medication, inappropriate chewing of medication, accidental device ingestion, device use error, dyspnea exacerbated, confusion, amnesia aggravated, irritability, ph urine increased, urinary tract infection, increased blood pressure, general physical health deterioration, low blood pressure and product complaint were unknown.The reporter considered the choke on medication to be related to polident overnight denture cleanser tablets, polident daily care tablets and polident (unknown).The reporter considered the inappropriate chewing of medication, accidental device ingestion, device use error, dyspnea exacerbated, confusion, amnesia aggravated, irritability, ph urine increased, urinary tract infection, increased blood pressure, general physical health deterioration and low blood pressure to be possibly related to polident overnight denture cleanser tablets, polident daily care tablets and polident (unknown).The pharmacist performed a med review with the patient, her daughter, and an rn.The pharmacist indicated that the polident was removed from the patient's room.The pharmacist indicated that chewing and swallowing the product like a breath mint jeopardized the patient or required significant intervention to prevent one of the following criteria: death, life threatening, overnight or prolonged hospitalisation, congenital anomaly, severely or permanently disabling.The pharmacist provided a medical history / concurrent illness for the patient including dementia (moderate cognitive impairment).The reporter indicated that the events may have been associated with the dementia as well as erroneous administration of the product.The pharmacist also indicated that the patient was mentally confused, but this had improved.The patient also had hypertension, copd and depression/anxiety, which were controlled with prescription therapy.The patient had an ongoing electrolyte imbalance.The patient also had gerd, osteoporosis, oab and osteoarthritis.The patient had experienced a recent increase in blood pressure, which had previously been low in (b)(6) 2016.The patient also had ongoing hypomagnesemia.The pharmacist noted that the patient had a history of utis and had experienced worsening of breathing.The pharmacist stated that the patient had choked on a polident tablet on (b)(6) 2016 as she thought it was a mint.Ems was called, the polident tablet was dislodged, and the patient was advised to go to the er for throat assessment.The patient refused and was doing okay.When questioned, the patient stated that she had been eating the mints regularly.The pharmacist stated that she was not sure if this was true or if it was an isolated incident over the last few weeks.The patient's daughter stated that her mother had been declining, very confused, and had more memory loss.The pharmacist stated that after review, she checked the ingredients in polident and noted that sodium bicarbonate is one of the main ones.The pharmacist did her own research and stated that sodium bicarbonate could cause: impaired breathing (patient breathing had worsened), increased blood pressure (patient had been having low blood pressure in (b)(6) 2016 resulting in discontinuation of one of her blood pressure prescriptions.Her blood pressure had been stable but had recently increased), confusion, irritability and memory loss (this had happened), increase ph of urine causing utis (antibiotic was prescribed (b)(6) 2017 for uti).The pharmacist indicated the causality was yes for choking, and was possible for the other events.The pharmacist also stated that all of this could be coincidental and merely a result of age and cognitive impairment.The pharmacist stated that over the next 1-2 weeks, the patient improved but also stated that this could simply be the patient responded to the antibiotic.No further information was provided.The reporter selected both recovering/resolving and unknown for the outcome of "chewed and swallowed the product like a breath mint.".
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