Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

[Giuseppe]

Hong Kong: Drug used by patients in cases of mucormycosis found contaminated (3/6/2009) [DH]

The Department of Health (DH) today (March 6) announced that follow-up investigations into patient cases of invasive gastrointestinal mucormycosis in public hospitals last month had revealed that one of the pharmaceutical products prescribed to the patients concerned was found to be contaminated.


A DH spokesman said laboratory tests by the University of Hong Kong (HKU) on four batches of allopurinol (brand name: Purinol, registration no: HK??30662) taken from Queen Mary Hospital were found to be contaminated by a fungus called Rhizopus microsporus.

The batch numbers are 804159, 807199, 808179 and 811015.

The spokesman said Rhizopus microsporus could be found in soil and decaying matter.

''Such kind of fungal infection is not common. Only immunocompromised patients will be infected and suffer from severe infection with high fatality,'' he said.

The drug concerned was manufactured by a local pharmaceutical company called Europharm.

Allopurinol is commonly used to treat hyperuricemia and chronic gout.

It is also commonly used as a prophylactic treatment for patients on chemotherapeutic treatments.

DH inspected the company this afternoon and instructed the operator to immediately withhold all manufacturing operations.

Pharmaceutical and environmental samples from the company have been taken for investigation, including laboratory tests to ascertain HKU's findings.

The company has also been ordered to stop the distribution of all the affected products.

It was reported that some two million tablets of four batches had been delivered to the Hospital Authority, DH,institutions of Correctional Services Department, pharmacies and private medical practitioners.

DH has sent letters to all doctors, hospitals and pharmacists to alert them about the findings.

The spokesman called on members of the public to stop using Purinol, the affected pharmaceutical products produced by the company for the time being.

Pharmacies and drug stores should also stop selling Purinol.

''They have been advised not to use Purinol and should dispense allopurinol manufactured by other manufacturers for the time being. DH has set up a hotline 2125 1122 for public enquiries. The hotline will operate to midnight (March 6)and from 9 am to 5 pm starting tomorrow. Europharm also set up a hotline 2665 3788 for public enquiries.
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[Giuseppe]

Re: Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

Hong Kong: Hospital Authority follow-up action for drug suspension (3/6/2009) [HA]

The following is issued on behalf of the Hospital Authority: In response to the announcement by the Department of Health tonight (March 6) on the immediate suspension of Allopurinol 100mg manufactured by EuroPharm due to contamination, the spokesman for the Hospital Authority (HA) issued the following statement:


The HA has already informed all public hospitals and out-patient clinics to suspend the dispensing of the concerned drug Allopurinol 100mg with immediate effect.

At the same time, alternative source of supplies of 1,450,000 tablets have already been secured which will be delivered in batches starting from tonight. According to the patient records of HA, there are currently 230 high risk patients who are immuno-compromised leukaemia and lymphoma patients, will be contacted by the respective hospitals tomorrow (March 7) for the arrangement of replacing the concerned drug.

The patients' clinical condition will be closely monitored.

Furthermore, there are some other 40,000 general patients with gout or hyperuricemia who are also currently taking the medication.

The HA will arrange for replacement of the concerned drug for the patients from this Sunday (March 8) at the pharmacy of the following 15 public hospitals:
- Alice Ho Miu Ling Nethersole Hospital
- Caritas Medical Centre
- Kwong Wah Hospital
- North District Hospital
- Our Lady of Maryknoll Hospital
- Princess Margaret Hospital
- Pamela Youde Nethersole Eastern Hospital
- Prince of Wales Hospital
- Pok Oi Hospital
- Queen Elizabeth Hospital
- Queen Mary Hospital
- Tseung Kwan O Hospital
- Tuen Mun Hospital
- United Christian Hospital
- Yan Chai Hospital

The drug replacement service will be available since this Sunday and will last for two weeks.

The operating hours is from 9:00am to 7:00pm on weekdays in the subsequent two weeks.

The replacement is only required for those patients who have been dispensed with the concerned drug as clearly labeled with ''ALLOPURINOL 100MG''.

A hotline 2125 1122 has been jointly set up and operated by the Department of Health and HA to take enquiries from the public and the patients concerned.
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[Giuseppe]

Re: Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

Hong Kong: DH patients get substitutes for suspended Purinol (3/7/2009) [DH]

Following the suspension of Purinol (a kind of drug commonly used to treat hyperuricemia and chronic gout with common name allopurinol) due to contamination, a spokesman for the Department of Health (DH) today (March 7) announced that DH would dispense allopurinol made by other manufacturers to patients who had been prescribed with the drugs in question at DH out-patient services.

The spokesman said the patients concerned should approach the respective clinics where the drug was dispensed for replacement during clinical hours starting Monday (March 9).

The services involved are chest clinics, Kowloon Bay Integrated Treatment Centre, elderly health centres, families clinics and Ngau Tau Kok Education and Training Centre in Family Medicine.

A hotline 2125 1122 has been jointly set up by DH and the Hospital Authority for public enquiries.
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[Giuseppe]

Re: Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

MUCORMYCOSIS, NOSOCOMIAL - CHINA (HONG KONG): (02) CONTAMINATED DRUG ALERT
**************************************************************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>

Date: Fri 6 Mar 2009
Source: The Standard [edited]
<http://www.thestandard.com.hk/breaking_news_detail.asp?id=13061>


A popular gout medicine has been found to have been contaminated with
a rare fungus that was linked to the deaths of 3 Queen Mary Hospital
[Hong Kong] patients over the past year. In an unscheduled and urgent
press conference, the [Hong Kong] Department of Health warned the
public against using the allopurinol product made by a local
pharmaceutical company after the level of _Mucorales_ fungi found in
samples exceeded the safety limit by 100 times.

Director of Health Lam Ping-yan said his officers are at the
company's production line trying to trace the source of the
contamination. The Hospital Authority is trying to trace all patients
who have been given prescriptions to get them to come in for medicine
exchanges. The department has also notified the medical and
pharmaceutical sectors.

Microbiologist Yuen Kwok-yung of University of Hong Kong said wooden
chopsticks were initially believed to be the source of infection but
further investigation shown none of those who died had used the
chopsticks. Yuen said those who have taken the tainted medical product
are unlikely to be at risk if they are healthy. He voiced concern for
those with poor immune systems, especially people who have received
bone marrow transplants, as well as leukemia and lymphoma patients.

_Mucorales_, fungi that are ubiquitously found in the environment,
food and wooden material, can cause mucormycosis in people with
weakened immune systems.

--
Communicated by:
ProMED Rapporteur Dan Silver
<promed@promedmail.org>

[This posting seems to strongly suggest that contaminated allopurinol,
used to prevent uric acid production in patients with gout and in some
undergoing chemotherapy, was the source of the fungus causing
gastrointestinal mucormycosis. - Mod.LL]

[see also:
Mucormycosis, nosocomial - China (Hong Kong) 20090216.0652
2005
----
Mucormycosis - Australia ex tsunami areas (02): corr. 20050202.0362
Mucormycosis - Australia ex tsunami areas 20050131.0338]
-

....................ll/ejp/jw
-
http://apex.oracle.com/pls/otn/f?p=..._BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,76470
------
</pre>

 

[Giuseppe]

Re: Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

Hong Kong: Hospital Authority starts drug replacement today (3/8/2009) [HA]

The following is issued on behalf of Hospital Authority:

The Hospital Authority (HA) today (March 8) starts to arrange drug replacement for patients under medication treatment of Allopurinol 100mg.

The spokesman for HA announced the following arrangement:

The drug replacement service started this morning and will last for two weeks. The operating hours is from 9am to 7pm on weekdays in the subsequent two weeks.

Patients concerned are required to bring along their Identity Card or a copy of the ID card and the drug bag labeling "ALLOPURINOL TABLET 100MG" to the pharmacy of 15 designated public hospitals for replacement.

The replacement does not require any prior booking or medical consultation.

Depending on clinical needs, concerned patients will be dispensed with the replaced dosage of at least 10 days to three weeks (ranging from 21 to 30 tablets).

As at 7pm today, HA arranged to replace the drug for a total of 4,399 patients.

The arrangement was smooth and orderly.

The 15 designated public hospitals for drug replacement are as below:

Alice Ho Miu Ling Nethersole Hospital
Caritas Medical Centre
Kwong Wah Hospital
North District Hospital
Our Lady of Maryknoll Hospital
Princess Margaret Hospital
Pamela Youde Nethersole Eastern Hospital
Prince of Wales Hospital
Pok Oi Hospital
Queen Elizabeth Hospital
Queen Mary Hospital
Tseung Kwan O Hospital
Tuen Mun Hospital
United Christian Hospital
Yan Chai Hospital

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[Giuseppe]

Re: Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

Hong Kong: SFH on contaminated drug (3/8/2009) [SFH]

Following is the transcript of remarks made by the Secretary for Food and Health, Dr York Chow, at a stand-up media session after officiating at the kick-off ceremony cum Carnival of Southern District Healthy and Safety City today (March 8):


Reporter:
Is the well-being of patients in public hospitals being neglected given that private hospitals have already suspended the use of other drugs produced by the Europharm but the Hospital Authority is still using......

Secretary for Food and Health:
As far as the drugs are concerned, the Hospital Authority has found a number of drugs also produced by this drug company. It is important to know that the manufacturing process and the ingredients in different drugs, whether they have any shared cause with this particular Allopurinol. The Hospital Authority and the Department of Health will be investigating this continuously. As soon as they have results, of course, they will take appropriate actions.

Reporter:
Why don't you suspend every single drug produced by the Europharm?

Secretary for Food and Health:
Because at the moment, there is no evidence that the other drugs are affected. Unless we find any common cause or common ingredients of the other drugs, otherwise, it would be inappropriate for us to stop using these drugs at the moment. As you know, the effect of this drug only affects those patients who are immuno-compromised. This type of fungus actually occurs in natural environment. So, it would not affect the normal people but only affect those immuno-compromised such as patients undergoing marrow transplant.

Reporter:
Are you suggesting that it is inappropriate just for the private hospitals to suspend the use of other drugs?

Secretary for Food and Health:
The private hospitals have their own policy of deciding what to do with their own drugs. It is important that we focus on those groups of patients. At the moment, we have checked all the other drugs that are used by the leukaemia and marrow transplant patients and we have not discovered any other drugs that have been contaminated with any bacteria or fungus.

Reporter:
Is this the issue with money that the HA did not suspend all the drugs manufactured by Europharm?

Secretary for Food and Health:
No, I don't think that is a matter of money. If we found that the drugs are contaminated, of course, we will suspend it and try to find the contamination sources. But in this case, we have not found any evidence of any other drugs being contaminated. The Department of Health is investigating whether those drugs are manufacturing with a different process or whether they have any shared components. Until we find any evidence that they have contaminated other drugs, we will take appropriate actions.

Reporter:
Is it actually too slow?

Secretary for Food and Health:
I think those patients at risk are those immuno-compromised and we have already handled these cases with extra precautions. So, they are not receiving any of those drugs.

(Please also refer to the Chinese portion of the transcript.)
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[Giuseppe]

Re: Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

Hong Kong: HA press release on drug supply by EuroPharm (3/9/2009) [HA]

The following is issued on behalf of the Hospital Authority: Regarding the drug supply to public hospitals by EuroPharm, the Hospital Authority spokesman announced the following arrangement today (March 9):


In line with the initial findings of the Department of Health, HA will implement the following measures with immediate effect:

1. Stop prescription of the drugs supplied by EuroPharm if there are alternative supplies.
2. Hospitals will contact the high risk patients again, who are immuno-compromised leukaemia and lymphoma patients, to explain the situation and reassure that all drugs supplied by EuroPharm will not be used on them. The drug replacement service for patients under medication treatment of Allopurinol 100mg started yesterday (March 8) will last for two weeks.

The operating hours is from 9 am to 7 pm on weekdays in the subsequent two weeks.

Patients concerned are required to bring along their Identity Card or a copy of the ID card and the drug bag labeling "ALLOPURINOL TABLET 100MG" to the pharmacies of 15 designated public hospitals for replacement.

The replacement does not require any prior booking or medical consultation.

Depending on clinical needs, concerned patients will be dispensed with the replaced dosage of at least 10 days to three weeks (ranging from 21 to 30 tablets).

Up to 7:00 pm today (March 9), HA has already replaced the drug for a total of 10,363 patients.

The arrangement was smooth and orderly.

The 15 designated public hospitals for drug replacement are as below:

Alice Ho Miu Ling Nethersole Hospital
Caritas Medical Centre
Kwong Wah Hospital
North District Hospital
Our Lady of Maryknoll Hospital
Princess Margaret Hospital
Pamela Youde Nethersole Eastern Hospital
Prince of Wales Hospital
Pok Oi Hospital
Queen Elizabeth Hospital
Queen Mary Hospital
Tseung Kwan O Hospital
Tuen Mun Hospital
United Christian Hospital Yan Chai Hospital

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[Giuseppe]

Re: Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

Hong Kong: Contaminated drug case investigation continues (3/9/2009) [SFH]

The Secretary for Food and Health, Dr York Chow, said today (March 9) that he had asked the Department of Health to find out whether other drugs produced by Europharm were contaminated by fungus and announce the results and follow-up measures as early as possible.


"The results can serve as references to private doctors and hospitals for taking appropriate measures correspondingly," he said.

"The Department of Health has initially identified the cause leading to fungal contamination of allopurinol manufactured by Europharm and taken a series of measures, including recalling all Purinol tablets produced by the company and requesting the company to fully assist in investigations.

"The Hospital Authority has stopped the use of drugs produced by the company on high-risk patients. The authority is also formulating contingency measures to prepare for possible need to replace drugs for patients depending on the department's impending drug test results.

"I have also instructed the Department of Health to comprehensively review and improve the monitoring mechanism of drug manufacturing and take reference of overseas experience to prevent recurrence of similar incidents," Dr Chow said.
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[Giuseppe]

Re: Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

Hong Kong: Hospital Authority updates on drug replacement arrangement (3/10/2009) [HA]

The following is issued on behalf of the Hospital Authority:

The Hospital Authority (HA) started to arrange drug replacement for patients under medication treatment of Allopurinol 100mg since March 8 (Sunday).

The spokesman for HA announced the following arrangement:

The drug replacement service started on March 8 will last for two weeks. The operating hours is from 9am to 7pm on weekdays in the subsequent two weeks. Patients concerned are required to bring along their Identity Card or a copy of the ID card and the drug bag labeling "ALLOPURINOL TABLET 100MG" to the pharmacy of 15 designated public hospitals for replacement.

The replacement does not require any prior booking or medical consultation.

Depending on clinical needs, concerned patients will be dispensed with the replaced dosage of at least 10 days to three weeks (ranging from 21 to 30 tablets).

As at 7pm today (March 10), HA arranged to replace the drug for a total of 13,913 patients.

The arrangement was smooth and orderly.

The 15 designated public hospitals for drug replacement are as below:

- Alice Ho Miu Ling Nethersole Hospital
- Caritas Medical Centre
- Kwong Wah Hospital
- North District Hospital
- Our Lady of Maryknoll Hospital
- Princess Margaret Hospital
- Pamela Youde Nethersole Eastern Hospital
- Prince of Wales Hospital
- Pok Oi Hospital
- Queen Elizabeth Hospital
- Queen Mary Hospital
- Tseung Kwan O Hospital
- Tuen Mun Hospital
- United Christian Hospital
- Yan Chai Hospital

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[Giuseppe]

Re: Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

Hong Kong: No growth of rhizopus found in Europharm drugs to HA (3/10/2009) [DH]

A spokesman for the Department of Health (DH) said today (March 10) that initial laboratory analysis of samples of all 41 pharmaceutical products (not including the recalled allopurinol) which were supplied to the Hospital Authority (see annex) by Europharm had indicated no growth of rhizpous so far in the products.


The spokesman said laboratory tests were on going and the results were expected to be available later this week.

Meanwhile, DH hotline 2125 1122, which operates from 9am to 10pm, has so far received more than 4,400 public enquiries.
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[Giuseppe]

Re: Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

Hong Kong: No growth of rhizopus found in Europharm drugs (3/11/2009) [DH]

A spokesman for the Department of Health (DH) said today (March 11) that laboratory analysis of samples of pharmaceutical products manufactured by Europharm had indicated no growth of rhizpous so far in the products.


The spokesman said laboratory tests were on going and the results were expected to be available later this week.

Meanwhile, DH hotline 2125 1122, which operates from 9am to 10pm, has so far received more than 4,600 public enquiries.
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[Giuseppe]

Re: Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

Hong Kong: Hospital Authority Updates on Drug Replacement Arrangement (3/11/2009)

The following is issued on behalf of the Hospital Authority:

The Hospital Authority (HA) started to arrange drug replacement for patients under medication treatment of Allopurinol 100mg since 8 March 2009 (Sunday).


The spokesman for HA announced the following arrangement:

The drug replacement service started on 8 March will last for two weeks.

The operating hours is from 9:00 am to 7:00 pm on weekdays in the subsequent two weeks.

Patients concerned are required to bring along their Identity Card or a copy of the ID card and the drug bag labeling "ALLOPURINOL TABLET 100MG" to the pharmacy of 15 designated public hospitals for replacement.

The replacement does not require any prior booking or medical consultation.

Depending on clinical needs, concerned patients will be dispensed with the replaced dosage of at least 10 days to three weeks (ranging from 21 to 30 tablets).

As at 7:00 pm today (11 March), HA arranged to replace the drug for a total of 15,114 patients.

The arrangement was smooth and orderly.

The 15 designated public hospitals for drug replacement are as below:

- Alice Ho Miu Ling Nethersole Hospital
- Caritas Medical Centre
- Kwong Wah Hospital
- North District Hospital
- Our Lady of Maryknoll Hospital
- Princess Margaret Hospital
- Pamela Youde Nethersole Eastern Hospital
- Prince of Wales Hospital
- Pok Oi Hospital
- Queen Elizabeth Hospital
- Queen Mary Hospital
- Tseung Kwan O Hospital
- Tuen Mun Hospital
- United Christian Hospital Yan Chai Hospital

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[Giuseppe]

Re: Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

Tuen Mun Hospital (3/11/2009) [TMH]

The following is issued on behalf of the Hospital Authority:

The spokesperson of Tuen Mun Hospital (TMH) today (11 March) announced a suspected patient case of rhizopus infection:


A 50-year-old female patient who has been suffering from leukaemia was admitted to the surgical of TMH for abdominal pain.

She was transferred to haematology ward on the following day.

Surgical operations and chemotherapy was arranged according to her clinical condition.

Patient's condition deteriorated and was transferred to the Intensive Care Unit for further treatment.

Patient passed away on 7 March 2009.

Patient started medication treatment included allopurinol on 15 February 2009.

The report available today (11 March) on surgical specimen taken earlier showed rhizopus infection.

TMH expressed condolence to the family of the deceased.

The case has been reported to the Centre of Health Protection and Hospital Authority Head Office.

The case has been referred to coroner for follow up.
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[Giuseppe]

Re: Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

Hong Kong: No growth of fungus in Europharm drugs (3/14/2009) [DH]

A spokesman for the Department of Health (DH) said today (March 14) that laboratory analysis of samples of a total of 359 pharmaceutical products (including Gluformin for diabetics) manufactured by Europharm had indicated no growth of fungus in the products.


The products which were tested include tablets, capsules, powder, syrup, eye drops, cream and ointment.

They were supplied to the Hospital Authority (HA), Department of Health and other users.

The spokesman said tests on 39 raw material samples taken from Europharm also yielded negative results for fungus.

"Laboratory test results for the last batch of samples will be available early next week," the spokesman said.

The spokesman said investigation was on going with focus on the results of microbiological tests which could provide a clear picture to facilitate an overall review of the incident.

The spokesman said, based on the findings thus far of the investigation, Europharm would be instructed to conduct a thorough disinfection in its production lines.

The management will also been required to review and streamline its production procedures and enhance quality control measures.

Europharm could resume manufacturing operations only after the improvements made by the company on all its production lines were implemented and tested to the satisfaction of DH, the spokesman said.
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[Giuseppe]

Re: Drug recall: ''ALLOPURINOL'', Hong Kong PRC SAR, March 6, 2009.

Hong Kong: SFH on drug incidents (3/18/2009) [SFH]

Following is the transcript of remarks (English portion) made by the Secretary for Food and Health, Dr York Chow, at a stand-up media session at the Legislative Council Building today (March 18):


Reporter:
(about the recent drug incidents)

Secretary for Food and Health:
I had a meeting with the Department of Health and the Hospital Authority yesterday.
We have instructed the two organisations to address certain issues.
For the Department of Health, I would like them to review the GMP criteria and conditions, including the governance and internal audit system of individual production and factories.
Secondly is to update the requirement for our inspection and the checklist while our inspectors are actually at the factories.
Thirdly, we would also like them to have a look at the penalty system of the GMP, whether there is a need to review it.
For the Hospital Authority, we feel that they need to strengthen the pre-procurement procedure regarding sourcing of drugs and ensure that the drug that is being delivered is safe and of good quality.
This includes a small trial of usage by some designated units and clinicians to make sure we do not actually buy the drugs and that we are quite sure about the quality.

Reporter:
(about the review)

Secretary for Food and Health:
At the moment, the Department of Health will review the GMP requirements and the additional work they need to do.I think by the end of this month, they will have a more systematic proposal for us and for the public.
Regarding the resources required, it depends on what they are recommending.I think we can certainly do some internal deployment for the moment, but eventually we have to plan perhaps some additional staffing as well.
But that depends on what they are going to recommend.

Reporter:
(about regulation)

Secretary for Food and Health:
I think the current Pharmacy and Poisons Ordinance should be able to cover most of the requirements internationally.
But whether Hong Kong would require certain adjustment or review of certain areas of the regulation, it depends on the recommendation of the Director of Health.

Reporter:
How can people feel safe about this?

Secretary for Food and Health:
I think people have to understand that GMP itself is a standard imposed by the World Health Organisation for most of the developed countries. And we are one of them. The flaw lies in some of the lapse of the governance of certain factories. Perhaps we also have to strengthen our inspection and some of our testing of samples and drugs as well. And certainly we need to strengthen the governance and internal audit of those factories and drug firms so that they can detect any abnormality or irregularity early and correct them internally. I think the Department of Health will also strengthen some of the inspections, particularly in risk assessment areas on certain factories or types of drugs, they have to be more stringent in terms of regulation and approval.

Reporter:
(about drug safety)?}

Secretary for Food and Health:
I think the existing system still has its merit. I can assure the public that most of the drugs in Hong Kong, particularly those that the Hospital Authority is providing to the public patients, are safe. Of course with what happened in the last few weeks, I think we have to be more cautious about getting new drugs and looking after patients who have high risk of immunity and perhaps high risk of other complications. This is also a lesson learned by all sectors including the health regulators, the health carers as well as the people in the frontline. Because this incident shows that if we are more sensitive about side effects and also complications, we can actually detect any irregularity early and be able to stop it.

(Please also refer to the Chinese portion of the transcript.)
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